Objectives To assess long-term coronary arterial response to biodegradable polymer-coated sirolimus-eluting stent(BSES) in vivo by using virtual histology intravascular ultrasound(VH-IVUS).Methods 41 patients were enr...Objectives To assess long-term coronary arterial response to biodegradable polymer-coated sirolimus-eluting stent(BSES) in vivo by using virtual histology intravascular ultrasound(VH-IVUS).Methods 41 patients were enrolled in this study and VH-IVUS was performed to assess the native artery vascular responses to BSES compared with durable polymer-coated SES(DSES) during long-term follow-up(median =8 months).The presence of necrotic core abutting to the lumen was evaluated at follow-up.Results With similar in-stent late luminal loss(0.15[0.06,0.30]vs 0.19[0.03, 0.30]mm,P=0.772),the overall incidence of necrotic core abutting to the lumen was significantly less in BSES than DSES group(44%vs.63%,P=0.019)(proximal 18%,stented site 14%and distal 12%in BSES group,proximal 19%, stented site 28%and distal 16%in DSES group).Compared with stented segments each other,the DSES -treated segments had a significant higher incidence of necrotic core abutting to the lumen through the stent struts(73%vs.36%, P=0.005).In addition,more multiple necrotic core abutting to the lumen was observed in DSES group(overall:63%vs. 36%,P=0.015).Furthermore,among the total number of stented segments with necrotic core abutting to the lumen, DSES -treated lesions had more multiple necrotic core abutting to the lumen through the stent struts than BSES -treated lesions in evidence(74%vs.33%,P=0.027).Conclusions By VH-IVUS analysis at follow-up,a greater frequency of stable lesion morphometry was shown in lesions treated with BSESs compared with lesions treated with DSESs.The major reason was BSES produced less toxicity to the arterial wall and facilitated neointimal healing as a result of polymer coating on drug-eluting stent(DES) surface biodegraded as time went by.展开更多
Current new generation stent technology has made remarkable progress in stent design, structure, and component material to improve its performance in reducing stent thrombosis, and restenosis compared to earlier DES a...Current new generation stent technology has made remarkable progress in stent design, structure, and component material to improve its performance in reducing stent thrombosis, and restenosis compared to earlier DES and BMS. Orsiro-Sirolimus eluting stent is new generation ultra-thin strut stent with biodegradable abluminal coating that leaves a polymer free stent after drug release enhances coverage of stent struts and prevents excess neo intimal proliferation. A retrospective data analysis was done to see safety and efficacy of Orsiro in patients treated with ultra-thin DES with Orsiro stents at Sunshine Hospitals, Hyderabad. A total of 331 patients with 525 lesions were treated with 506 Orsiro stents and the major adverse cardiac events (MACE) rate and stent thrombosis (ST) at 2 years’ follow-up were analysed. MACE rate was 1.6% for an average follow-up at 2 years. Out of 2 patients who developed ST, one presented with definite acute stent thrombosis and one with possible, late stent thrombosis and 1.8% non-cardiac death reported during the follow-up. Despite many patients with complex PCI in the ACS subset, Orsiro reduced significant reduction in MACE rate in all spectrum of coronary artery disease patients with excellent acute and long-term results similar to other established FDA-approved current generations stents.展开更多
Optical coherence tomography (OCT) is a new imaging modality with resolution of approximately 10 pm and can be employed to visualize intracoronary characteristics. Sirolimus-eluting stents (SES) are susceptible to...Optical coherence tomography (OCT) is a new imaging modality with resolution of approximately 10 pm and can be employed to visualize intracoronary characteristics. Sirolimus-eluting stents (SES) are susceptible to late thrombosis due to delayed reendothelialization over the stent struts, which may result in acute myocardial infarction or death. This study was designed to evaluate the re-endothelialization and neointimal coverage of SES with OCT 6 months and 12 months after implantation.Methods A total of 36 patients enrolled in the study underwent OCT examination 6 months (17 patients) and 12 months (19 patients) after SES implantation, The strut apposition to the vessel wall and neointimal coverage on SES struts were evaluated by OCT, Results Forty-six SES and 6561 struts were analyzed, At 6 months, 3041 struts (98.7%) were well-apposed and 39 struts (1,3%) were malapposed, At 12 months, 3434 struts (98,6%) were well-apposed and 47 struts (1,4%) were malapposed, Furthermore, only 4 SES at 6 months (18,2%) and 10 SES at 12 months (41,7%) were fully covered by neointimal growth, The average neointimal thicknesses covering the analyzed struts at 6 months and 12 months were (42±28) μm and (88±32) μm, respectively, There were 1989 struts at 6 months (72,1%) and 1461 struts at 12 months (45,6%) with neointimal thickness 〈100 μm, Conclusions OCT was able to visualize the strut apposition to the vessel wall and neointimal coverage on SES struts, At 6-month and 12-month follow-up examinations most struts were covered with thin neointima, but few of the entire SES showed full coverage. To prevent late-stent thrombosis in the presence of uncovered stent struts, longer dual antiplatelet drugs therapy should be recommended,展开更多
BACKGROUND With the development of percutaneous coronary intervention(PCI),the number of interventional procedures without implantation,such as bioresorbable stents(BRS)and drug-coated balloons,has increased annually....BACKGROUND With the development of percutaneous coronary intervention(PCI),the number of interventional procedures without implantation,such as bioresorbable stents(BRS)and drug-coated balloons,has increased annually.Metal drug-eluting stent unloading is one of the most common clinical complications.Comparatively,BRS detachment is more concealed and harmful,but has yet to be reported in clinical research.In this study,we report a case of BRS unloading and successful rescue.This is a case of a 59-year-old male with the following medical history:“Type 2 diabetes mellitus”for 2 years,maintained with metformin extended-release tablets,1 g PO BID;“hypertension”for 20 years,with long-term use of metoprolol sustained-release tablets,47.5 mg PO QD;“hyperlipidemia”for 20 years,without regular medication.He was admitted to the emergency department of our hospital due to intermittent chest pain lasting 18 hours,on February 20,2022 at 15:35.Electrocardiogram results showed sinus rhythm,ST-segment elevation in leads I and avL,and poor R-wave progression in leads V1–3.High-sensitivity troponin I level was 4.59 ng/mL,indicating an acute high lateral wall myocardial infarction.The patient’s family requested treatment with BRS,without implanta-tion.During PCI,the BRS became unloaded but was successfully rescued.The patient was followed up for 2 years;he had no episodes of angina pectoris and was in generally good condition.CONCLUSION We describe a case of a 59-year-old male experienced BRS unloading and successful rescue.By analyzing images,the causes of BRS unloading and the treatment plan are discussed to provide insights for BRS release operations.We discuss preventive measures for BRS unloading.展开更多
Objective:Double-J(DJ)ureteric stents are commonly placed perioperatively for semirigid or flexible ureteroscopic renal surgery.It is believed that lesser stent material within the bladder mitigates stent-related symp...Objective:Double-J(DJ)ureteric stents are commonly placed perioperatively for semirigid or flexible ureteroscopic renal surgery.It is believed that lesser stent material within the bladder mitigates stent-related symptoms.This study aimed to evaluate the J-Fil ureteral stent,a single pigtail suture stent compared with conventional DJ stent in relation to stent symptoms in an Asian population undergoing ureterorenal intervention.Methods:Based on internal audit committee recommendation approval,the records of 50 patients retrieved,available data of 41 patients who were prospectively enrolled into two groups(Group 1[J-Fil stent group],n=21 and Group 2[DJ stent group],n=20)between August 2020 to January 2021,were analysed.Parameters compared were nature of procedure,stone location and size,ease of deployment or removal,and complications.A modified universal stent symptom questionnaire was used to assess morbidity of stent symptoms within 48 h of insertion and at removal.Results:Both groups had similar median age,distribution in male to female ratio,and stone size.The overall median universal stent symptom questionnaire score at insertion was similar for bladder pain,flank or loin pain,and quality of life between Group 1 and 2;however,at removal Group 1 fared significantly better than Group 2,especially for flank or loin pain and pain at voiding.Both groups had similar ease in insertion with no hospital readmissions.Conclusion:Our audit favoured the single pigtail suture stent in Asian ureters in mitigating stent-related issues.It showed a good safety profile with easy deployment and removal.It promises a new standard in stenting.展开更多
Objective:Ureteral stents are customarily inserted to facilitate urinary drainage,but they come with their own glitches of being forgotten and/or encrusted leading to serious consequences.The present study aimed to re...Objective:Ureteral stents are customarily inserted to facilitate urinary drainage,but they come with their own glitches of being forgotten and/or encrusted leading to serious consequences.The present study aimed to report the complications in patients with forgotten and encrusted stents according to the Clavien-Dindo system specific to urological procedures and identify the factors leading to high-grade(Clavien-Dindo Grade 4A or above)complications.Methods:The hospital records of patients with forgotten encrusted double-J stents over a period of 8 years were reviewed.The parameters recorded included patient demographics,indwelling time,need for percutaneous nephrostomy,hemodialysis,urine culture,blood culture,total blood counts,serum creatinine,radiologic findings,management techniques,number of surgical interventions,modified Clavien-Dindo complications,follow-up,and mortality,if any.Results:Forty patients were included in the study.The median age was 52(range 6-85)years.Of the total,25(62.5%)patients had a“significant”stent load;31(77.5%)had renal failure or acute kidney injury on presentation;19(47.5%)patients had sepsis at presentation.Among the patients presented with sepsis,11(57.9%)patients demonstrated a positive urine culture;and 7/11(63.6%)patients exhibited pan-resistant organisms.Twelve out of 40(30.0%)patients in our series developed high-grade Clavien-Dindo complications.On univariate analysis,sepsis at presentation(p=0.007),stent load(p=0.031),diabetes(p=0.023),positive urine culture(p=0.007),and stent indwelling time of more than 1 year(p=0.031)were found to be significant.On multivariate logistic regression analysis,sepsis at presentation(p=0.017)and positive urine culture(p=0.016)were significant predictors for high-grade complications.Conclusion:It is prudent to identify specific risk factors,namely sepsis at presentation and positive urine culture to triage and optimize these patients before surgical management.展开更多
Patients with malignant biliary obstruction,following endoscopic retrograde cholangiopancreatography(ERCP)failure could be referred for endoscopicultrasound-guided biliary drainage through electrocautery-enhanced(ECE)...Patients with malignant biliary obstruction,following endoscopic retrograde cholangiopancreatography(ERCP)failure could be referred for endoscopicultrasound-guided biliary drainage through electrocautery-enhanced(ECE)lumen-apposing metal stent(LAMS)placement.However,the efficacy and safety of ECE-LAMS in this scenario have remained debatable due to minimal scientific evidence.The current confirmed 91.0%clinical success,96.7%technical success,7.3%reintervention rate,and 17.5%adverse events,following the treatment of malignant biliary obstruction with ECE-LAMS delivery.Finally,ECE-LAMS proved to be a generalizable strategy for managing biliary obstruction for patients who were excluded from ERCP.展开更多
The role of endoscopy in pathologies of the bile duct and gallbladder has seen notable advancements over the past two decades.With advancements in stent technology,such as the development of lumen-apposing metal stent...The role of endoscopy in pathologies of the bile duct and gallbladder has seen notable advancements over the past two decades.With advancements in stent technology,such as the development of lumen-apposing metal stents,and adoption of endoscopic ultrasound and electrosurgical principles in therapeutic endoscopy,what was once considered endoscopic failure has transformed into failure of an approach that could be salvaged by a second-or third-line endoscopic strategy.Incorporation of these advancements in routine patient care will require formal training and multidisciplinary acceptance of established techniques and collaboration for advancement of experimental techniques to generate robust evidence that can be utilized to serve patients to the best of our ability.展开更多
BACKGROUND In severe cases of coronary artery disease,percutaneous coronary intervention provide promising results.The stent used could be a drug-eluting stent(DES)or a titanium-nitride-oxide coated stent(TiNOS).AIM T...BACKGROUND In severe cases of coronary artery disease,percutaneous coronary intervention provide promising results.The stent used could be a drug-eluting stent(DES)or a titanium-nitride-oxide coated stent(TiNOS).AIM To compare the 5-year effectiveness and safety of the two stent types.METHODS The following systematic review and meta-analysis was conducted in accordance with the preferred reporting items for systematic reviews and meta-analysis guidelines,and PubMed/MEDLINE,Scopus,and Cochrane Central were searched from inception till August 2023.Primary outcomes were major adverse cardiac events(MACE),cardiac death,myocardial infarction(MI),cardiac death or MI,and ischemia-driven total lesion revascularization(ID-TLR).RESULTS Four randomized controlled trials(RCT),which analyzed a sum total of 3045 patients with acute coronary syndrome(ACS)after a median follow-up time of 5 years were included.Though statistically insignificant,an increase in the ID-TLR was observed in patients receiving TiNOSs vs DESs.In addition,MI,cardiac death and MI,and definite stent thrombosis(DST)were significantly decreased in the TiNOS arm.Baseline analysis revealed no significant results with meta-regression presenting non-ST elevated MI(NSTEMI)as a statistically significant covariate in the outcome of MACE.CONCLUSION TiNOS was found to be superior to DES in terms of MI,cardiac death or MI,and DST outcomes,however,the effect of the two stent types on ID-TLR and MACE was not significant.A greater number of studies are required to establish an accurate comparison of patient outcomes in TiNOS and DES.展开更多
This editorial delves into Peng et al's article,published in the World Journal of Gastrointestinal Surgery.Peng et al's meta-analysis investigates the effectiveness of electrocautery-enhanced lumen-apposing me...This editorial delves into Peng et al's article,published in the World Journal of Gastrointestinal Surgery.Peng et al's meta-analysis investigates the effectiveness of electrocautery-enhanced lumen-apposing metal stents(ECE-LAMS)in ultrasound-guided biliary drainage for alleviating malignant biliary obstruction.Examining 14 studies encompassing 620 participants,the research underscores a robust technical success rate of 96.7%,highlighting the efficacy of ECE-LAMS,particularly in challenging cases which have failed endoscopic retrograde cholangio pancreatography.A clinical success rate of 91.0% underscores its impact on symptom alleviation,while a reasonably tolerable adverse event rate of 17.5% is observed.However,the 7.3% re-intervention rate stresses the need for post-procedural monitoring.Subgroup analyses validate consistent outcomes,bolstering the applicability of ECE-LAMS.These findings advocate for the adoption of ECELAMS as an appropriate approach for biliary palliation,urging further exploration in real-world clinical contexts.They offer valuable insights for optimizing interventions targeting malignant biliary obstruction management.展开更多
BACKGROUND Endoscopic management is the first-line therapy for post-liver-transplant anas-tomotic strictures.Although the optimal duration of treatment with plastic stents has been reported to be 8-12 months,data on s...BACKGROUND Endoscopic management is the first-line therapy for post-liver-transplant anas-tomotic strictures.Although the optimal duration of treatment with plastic stents has been reported to be 8-12 months,data on safety and duration for metal stents in this setting is scarce.Due to limited access to endoscopic retrograde cholan-giopancreatography(ERCP)during the coronavirus disease 2019 pandemic in our centre,there was a change in practice towards increased usage and length-of-stay of the Kaffes biliary intraductal self-expanding stent in patients with suitable anatomy.This was mainly due to the theoretical benefit of Kaffes stents allowing for longer indwelling periods compared to the traditional plastic stents.METHODS Adult liver transplant recipients aged 18 years and above who underwent ERCP were retrospectively identified during a 10-year period through a database query.Unplanned admissions post-Kaffes stent insertion were identified manually through electronic and scanned medical records.The main outcome was the incidence of complications when stents were left indwelling for 3 months vs 6 months.Stent efficacy was calculated via rates of stricture recurrence between patients that had stenting courses for≤120 d or>120 d.RESULTS During the study period,a total of 66 ERCPs with Kaffes insertion were performed in 54 patients throughout their stenting course.In 33 ERCPs,the stent was removed or exchanged on a 3-month interval.No pancreatitis,perfor-ations or deaths occurred.Minor post-ERCP complications were similar between the 3-month(abdominal pain and intraductal migration)and 6-month(abdominal pain,septic shower and embedded stent)groups-6.1%vs 9.1%respectively,P=0.40.All strictures resolved at the end of the stenting course,but the stenting course was variable from 3 to 22 months.The recurrence rate for stenting courses lasting for up to 120 d was 71.4%and 21.4%for stenting courses of 121 d or over(P=0.03).There were 28 patients that were treated with a single ERCP with Kaffes,21 with removal after 120 d and 7 within 120 d.There was a significant improvement in stricture recurrence when the Kaffes was removed after 120 d when a single ERCP was used for the entire stenting course(71.0%vs 10.0%,P=0.01).CONCLUSION Utilising a single Kaffes intraductal fully-covered metal stent for at least 4 months is safe and efficacious for the management of post-transplant anastomotic strictures.展开更多
Objective To study the impact of the first national centralized procurement of coronary stents on patients’psychology,the economy of medical institutions,and the survival and development of the coronary stents indust...Objective To study the impact of the first national centralized procurement of coronary stents on patients’psychology,the economy of medical institutions,and the survival and development of the coronary stents industry,and to provide suggestions on perfecting procedures to better carry out the centralized procurement of coronary stents.Methods Literature analysis was used to investigate the results of the procurement of coronary stent in a province and a hospital.Results and Conclusion The centralized procurement of coronary stents has alleviated the economic pressure of patients,but it has many problems.Therefore,this paper proposes some suggestions,such as promoting the orderly development of the coronary stent industry,improving the evaluation link of the centralized procurement of coronary stents,adopting the accurate reporting model to ensure the quality of coronary stents and improving the standardization of clinical services.展开更多
Background Recent data have shown that sirolimus-eluting stents (SES) reduced not only the incidences of restenosis but also of target vessel revascularization (TVR). CYPHER and FIREBIRD stents are both widely use...Background Recent data have shown that sirolimus-eluting stents (SES) reduced not only the incidences of restenosis but also of target vessel revascularization (TVR). CYPHER and FIREBIRD stents are both widely used SES in China. However, comparative data concerning differences in long-term safety and efficacy regarding CYPHER and FIREBIRD stents in the Chinese population are still not available.展开更多
Background As a kind of sirolimus-eluting stent (SES) made in China, Firebird SES is more effective than bare metal stent (BMS) and not inferior to Cypher SES for short coronary lesions in terms of reduction of re...Background As a kind of sirolimus-eluting stent (SES) made in China, Firebird SES is more effective than bare metal stent (BMS) and not inferior to Cypher SES for short coronary lesions in terms of reduction of restenosis and revascularization. However, Firebird SES does not show any benefits in patients with a very long coronary lesion (VLCL). The present study was undertaken to evaluate the safety and efficacy of Firebird SES for VLCL by comparison of Cypher SES and BMS. Methods In this prospective, nonrandomized and comparative study, eligible patients with de novo coronary lesion (≥ 30 mm) between January 2005 and June 2006 were allocated into Firebird SES group, Cypher SES group or BMS group. They were subjected to an angiographic follow-up of 6 months and a clinical follow-up of 12 months. The primary endpoints constitute the in-stent and in-segment restenosis rates at 6 months. The secondary endpoint was defined as a major adverse cardiovascular event (MACE) that was a 12-month combined endpoint of all-cause deaths, reinfarction or in-stent thrombosis, and target-lesion revascularization. The 12-month in-stent thrombosis was also evaluated to address the safety of Firebird SES implantation exceptionally. Results A total of 468 patients were assessed for eligibility. Of 113 patients who were finally included according to the prior inclusion and exclusion criteria, 39 (41 lesions) were treated with Firebird SES, 37 (39 lesions) with Cypher SES, and 37 (37 lesions) with BMS. There were no significant differences in the baseline characteristics between the three groups; but there were longer lesions, more frequent use of overlapping stent in the Firebird SES group and the Cypher SES group. Angiographic follow-up showed that the rates of binary stenosis were similar between the Firebird SES group and the Cypher SES group (in-segment: 14.6% vs 12.8%, relative risk (RR)1.14, P=0.81; in-stent: 9.8% vs 10.3%, RR 0.95, P=0.94), and significantly lower than those in the BMS group (in-segment: vs 36.1%, RR 0.41 or 0.36, P=-0.04 or 0.03, respectively; in-stent: vs 30.6%, RR 0.32 or 0.34, P=0.03 or 0.04, respectively). The total MACE rate up to 12 months was also similar in both SES groups (7.7% vs 5.4%, P=1.000), and significantly lower than that in the BMS group (27.0%, P=0.034 or 0.024, respectively). The in-stent thrombosis rate in the follow-up period was 2.6% in the Firebird SES group, not higher in the Cypher SES and BMS groups (2.7% and 2.7%, respectively, P=1.000). Conclusions In the treatment of VLCL, Firebird SES would be safer and more effective than BMS. Firebird SES may be not inferior to Cypher SES in terms of restenosis and MACE.展开更多
Background Several clinical trials have shown that sirolimus-eluting stents significantly reduce the risk of restenosis after percutaneous coronary intervention (PCI). The FIREBIRD stent (coated with durable polyme...Background Several clinical trials have shown that sirolimus-eluting stents significantly reduce the risk of restenosis after percutaneous coronary intervention (PCI). The FIREBIRD stent (coated with durable polymer) and the EXCEL stent (coated with bioabsorbable polymer) are two different types of sirolimus-eluting stents made in China; both have been approved for clinical use in China by the State Food and Drug Administration. The mid-term (6-month) angiographic and clinical results of both stents have been confirmed exciting perspective outcomes. However, it is unclear whether there are differences in the long-term safety and efficacy between the two types of stents in daily practice.Methods All consecutive patients undergoing elective PCI with EXCEL or FIREBIRD stents between June 1,2006 and December 31, 2006 at Fu Wai Hospital in Beijing were included. Patients were classified from the index admission according to stent types (EXCEL or FIREBIRD) used. Clinical and procedural risk factors were collected prospectively. With propensity score matching without replacement, the frequency of major adverse cardiac events (MACE, a composite of death, myocardial infarction or target vessel revascularization) and stent thrombosis during a 2-year follow-up period were compared between the two groups.Results A total of 474 patients were treated with EXCEL, and 640 were treated with FIREBIRD. Three hundred and ninety-seven EXCEL patients were matched to 397 FIREBIRD patients, 2-year risk-adjusted MACE rates were 6.1% in EXCEL group and 7.6% in FIREBIRD group (HR 0.84, 95%CI0.50-1.43), whereas the respective rates for mortality, myocardial infarction and target-vessel revascularization were 2.3% vs 2.8% (HR 0.74, 95%CI0.30-0.85), 1.8% vs 1.3% (HR 1.41,95%CI 0.45-4.43) and 2.5% vs 4.0% (HR 0.62, 95%CI0.28-0.37), respectively. Cumulative incidence of stent thrombosis at 2 years was 1.8% in the EXCEL group vs 1.3% in the FIREBIRD group (P=0.5610), whereas the rate of very late stent thrombosis was 0.5% vs 1.3% (P=0.2550).Conclusions Results from this long-term, relatively large size, single-center study showed that both of the EXCEL and the FIREBIRD sirolimus-eluting stent had similar and lower incidence of MACE after PCI in daily practice.展开更多
Background Previous studies indicated that long coronary lesions are one of the key predictors of drug-eluting stent (DES) failure. The purpose of this study was to evaluate the efficacy and the safety of the long l...Background Previous studies indicated that long coronary lesions are one of the key predictors of drug-eluting stent (DES) failure. The purpose of this study was to evaluate the efficacy and the safety of the long length FIREHAWK stent in long coronary artery disease. Methods The long cohort of TARGET I was a prospective, multicenter, single arm trial. It was planned to enroll 50 patients undergoing percutaneous coronary intervention (PCI) for the treatment of de novo long lesions in a native coronary artery. The major inclusion criteria of the trial was that patients were intended to undergo the treatment of a long target lesion(s) with diameter stenosis 〉70% and reference vessel diameter 2.5 mm to 4.0 mm by visual estimate, that needed to be covered by at least one 33 mm or 38 mm stent or multiple long stents overlapped. The angiographic follow-up was planned at 9-month and the clinical follow-up will be up to 5 years. The primary end point was in-stent late lumen loss at 9-month. Results Fifty patients (mean age (57.6±10.2) years) with 59 de novo long lesions (reference vessel diameter (2.85±0.44) mm, lesion length (35.2±9.4) mm, and stent length (41.8±11.3) mm) were enrolled. The angiographic follow-up rate was 92% at 9-month. The in-stent late loss was (0.16±0.16) mm. Proximal edge, distal edge and in-segment late loss (mm) were 0.21±0.35, 0.03±0.33, and 0.07±0.26, respectively. No in-segment binary restenosis was observed. At 1-year no death, Q wave myocardial infarction (MI), or stent thrombosis occurred. Non-Q-wave MI occurred in two patients (4%) due to procedural complications. Conclusions Treatment of long coronary lesions with the FIREHAWK stent is able to produce similar results as observed in the FIREHAWK~ FIM clinical trial. Based on this result, we are confident in the treatment prospect of the FIREHAWK for long coronary lesions.展开更多
Background The durable presence of polymer coating on drug-eluting stent (DES) surface may be one of the principal reasons for stent thrombosis. The long-term coronary arterial response to biodegradable polymer-coat...Background The durable presence of polymer coating on drug-eluting stent (DES) surface may be one of the principal reasons for stent thrombosis. The long-term coronary arterial response to biodegradable polymer-coated sirolimus-eluting stent (BSES) in vivo remained unclear.Methods Forty-one patients were enrolled in this study and virtual histology intravascular ultrasound (VH-IVUS) was performed to assess the native artery vascular responses to BSES compared with durable polymer-coated SES (DSES) during long-term follow-up (median: 8 months). The incidence of necrotic core abutting to the lumen was evaluated at follow-up.Results With similar in-stent late luminal loss (0.15 mm (0.06-0.30 mm) vs. 0.19 mm (0.03-0.30 mm), P=0.772), the overall incidence of necrotic core abutting to the lumen was significantly less in BSES group than in DSES group (44% vs.63%, P 〈0.05) (proximal 18%, stented site 14% and distal 12% in BSES group, proximal 19%, stented site 28% and distal 16% in DSES group). The DSES-treated segments had a significant higher incidence of necrotic core abutting to the lumen through the stent struts (73% vs. 36%, P 〈0.01). In addition, more multiple necrotic core abutting to the lumen was observed in DSES group (overall: 63% vs. 36%, P 〈0.05). Furthermore, when the stented segments with necrotic core abutting to the lumen had been taken into account only, DSES-treated lesions tended to contain more multiple necrotic core abutting to the lumen through the stent struts than BSES-treated lesions (74% vs. 33%), although there was no statistically significant difference between them (P=0.06).Conclusions By VH-IVUS analysis at follow-up, a greater frequency of stable lesion morphometry was shown in lesions treated with BSESs compared with lesions treated with DSESs. The major reason was BSES produced less toxicity to the arterial wall and facilitated neointimal healing as a result of polymer coating on DES surface biodegraded as time went by.展开更多
Background Restenosis of bare-metal stents (BMS) and drug-eluting stents (DES) has been increasingly treated with sirolimus-eluting stents (SES), but the long-term outcomes are unknown. Methods In our study, 388...Background Restenosis of bare-metal stents (BMS) and drug-eluting stents (DES) has been increasingly treated with sirolimus-eluting stents (SES), but the long-term outcomes are unknown. Methods In our study, 388 consecutive patients (144 DES restenosis and 244 BMS restenosis) with 400 lesions (147 DES restenosis and 253 BMS restenosis) treated with SES were included. The rates of target lesion revascularization (TLR) and major adverse cardiac events (MACE) at 42 months were analyzed. Results At the mean follow-up of 42 months, the rates of death (3.5% vs. 3.3%, P=1.000) and myocardial infarction (2.8% vs. 1.2%, P=0.431) in the DES group and BMS group were comparable. Compared with the BMS group, ischemia-driven TLR occurred with a higher frequency in the DES group (18.8% vs.10.7%, P=0.024). This translated into an increased rate of MACE in the DES group (22.2% vs. 14.0%, P=0.034). Stent thrombosis occurred with a similar frequency in both groups (2.8% vs. 1.6%, P=0.475). Multivariate analysis showed that DES restenosis (OR=1.907, 95% Cl 1.108-3.285, P=0.020) and smoking (OR=2.069; 95% Cl 1.188-3.605; P=0.010) were independent predictors of MACE.展开更多
The role of drug-eluting stent (DES), which prevents acute or subacute recoil and elutes drugs to prevent smooth muscle cell proliferation, is temporary and limited within a few weeks after its implantation. Beyond ...The role of drug-eluting stent (DES), which prevents acute or subacute recoil and elutes drugs to prevent smooth muscle cell proliferation, is temporary and limited within a few weeks after its implantation. Beyond that, there is no utility or advantages but only limitations just like foreign materials in patients' body. All of these problems can be solved with the use of fully bioabsorbable stent (BAS),展开更多
Background Sirolimus-eluting stents (SES) are reported to be associated with reduced late lumen loss (LLL), resulting in less frequent restenosis when compared to bare-metal stent. The current study aimed to asses...Background Sirolimus-eluting stents (SES) are reported to be associated with reduced late lumen loss (LLL), resulting in less frequent restenosis when compared to bare-metal stent. The current study aimed to assess the difference in LLL between SES with biodegradable and with permanent polymer. Methods From March 2010 to June 2011, 300 consecutive patients having only biodegradable polymers or permanent polymer SES for all diseased vessels were included. Serial quantitative coronary analysis was performed on both the "in-stent" and "segment" area, including the stented segment, as well as both five mm margins proximal and distal to the stent. The primary endpoint was the LLL defined as the minimal lumen diameter (MLD) post-stenting minus the MLD at nine-month after the indexed procedure. Results LLL was comparable between the two stents. Importantly, LLL for the distal segment (median 0.05 mm, interquartile 0 to 0.09 mm) was less severe compared with in-stent (median 0.13 mm, interquartile 0.08 to 0.18 mm) and proximal segment LLL (median 0.12 mm, interquartile 0.06 to 0.14 mm, all P 〈0.001 ). In general, the LLL was associated with the post-procedure MLD (b=0.28, P=0.002), hyperlipidemia (b=0.14, P=0.021), and calcified lesions (b=0.58, P=-0.001). The R2 and Radj of the multiple regression model were 0.651 and 0.625, respectively. Conclusions SES with either biodegradable or permanent polymer had lower value of LLL. The small amount of LLL at the distal segment possibly contributed to the less distal edge stenosis.展开更多
文摘Objectives To assess long-term coronary arterial response to biodegradable polymer-coated sirolimus-eluting stent(BSES) in vivo by using virtual histology intravascular ultrasound(VH-IVUS).Methods 41 patients were enrolled in this study and VH-IVUS was performed to assess the native artery vascular responses to BSES compared with durable polymer-coated SES(DSES) during long-term follow-up(median =8 months).The presence of necrotic core abutting to the lumen was evaluated at follow-up.Results With similar in-stent late luminal loss(0.15[0.06,0.30]vs 0.19[0.03, 0.30]mm,P=0.772),the overall incidence of necrotic core abutting to the lumen was significantly less in BSES than DSES group(44%vs.63%,P=0.019)(proximal 18%,stented site 14%and distal 12%in BSES group,proximal 19%, stented site 28%and distal 16%in DSES group).Compared with stented segments each other,the DSES -treated segments had a significant higher incidence of necrotic core abutting to the lumen through the stent struts(73%vs.36%, P=0.005).In addition,more multiple necrotic core abutting to the lumen was observed in DSES group(overall:63%vs. 36%,P=0.015).Furthermore,among the total number of stented segments with necrotic core abutting to the lumen, DSES -treated lesions had more multiple necrotic core abutting to the lumen through the stent struts than BSES -treated lesions in evidence(74%vs.33%,P=0.027).Conclusions By VH-IVUS analysis at follow-up,a greater frequency of stable lesion morphometry was shown in lesions treated with BSESs compared with lesions treated with DSESs.The major reason was BSES produced less toxicity to the arterial wall and facilitated neointimal healing as a result of polymer coating on drug-eluting stent(DES) surface biodegraded as time went by.
文摘Current new generation stent technology has made remarkable progress in stent design, structure, and component material to improve its performance in reducing stent thrombosis, and restenosis compared to earlier DES and BMS. Orsiro-Sirolimus eluting stent is new generation ultra-thin strut stent with biodegradable abluminal coating that leaves a polymer free stent after drug release enhances coverage of stent struts and prevents excess neo intimal proliferation. A retrospective data analysis was done to see safety and efficacy of Orsiro in patients treated with ultra-thin DES with Orsiro stents at Sunshine Hospitals, Hyderabad. A total of 331 patients with 525 lesions were treated with 506 Orsiro stents and the major adverse cardiac events (MACE) rate and stent thrombosis (ST) at 2 years’ follow-up were analysed. MACE rate was 1.6% for an average follow-up at 2 years. Out of 2 patients who developed ST, one presented with definite acute stent thrombosis and one with possible, late stent thrombosis and 1.8% non-cardiac death reported during the follow-up. Despite many patients with complex PCI in the ACS subset, Orsiro reduced significant reduction in MACE rate in all spectrum of coronary artery disease patients with excellent acute and long-term results similar to other established FDA-approved current generations stents.
文摘Optical coherence tomography (OCT) is a new imaging modality with resolution of approximately 10 pm and can be employed to visualize intracoronary characteristics. Sirolimus-eluting stents (SES) are susceptible to late thrombosis due to delayed reendothelialization over the stent struts, which may result in acute myocardial infarction or death. This study was designed to evaluate the re-endothelialization and neointimal coverage of SES with OCT 6 months and 12 months after implantation.Methods A total of 36 patients enrolled in the study underwent OCT examination 6 months (17 patients) and 12 months (19 patients) after SES implantation, The strut apposition to the vessel wall and neointimal coverage on SES struts were evaluated by OCT, Results Forty-six SES and 6561 struts were analyzed, At 6 months, 3041 struts (98.7%) were well-apposed and 39 struts (1,3%) were malapposed, At 12 months, 3434 struts (98,6%) were well-apposed and 47 struts (1,4%) were malapposed, Furthermore, only 4 SES at 6 months (18,2%) and 10 SES at 12 months (41,7%) were fully covered by neointimal growth, The average neointimal thicknesses covering the analyzed struts at 6 months and 12 months were (42±28) μm and (88±32) μm, respectively, There were 1989 struts at 6 months (72,1%) and 1461 struts at 12 months (45,6%) with neointimal thickness 〈100 μm, Conclusions OCT was able to visualize the strut apposition to the vessel wall and neointimal coverage on SES struts, At 6-month and 12-month follow-up examinations most struts were covered with thin neointima, but few of the entire SES showed full coverage. To prevent late-stent thrombosis in the presence of uncovered stent struts, longer dual antiplatelet drugs therapy should be recommended,
基金Supported by Health Commission of Hunan Province,No.202203014389Chinese Medicine Research Project of Hunan Province,No.A2023051the Natural Science Foundation of Hunan Province,No.2024JJ9414.
文摘BACKGROUND With the development of percutaneous coronary intervention(PCI),the number of interventional procedures without implantation,such as bioresorbable stents(BRS)and drug-coated balloons,has increased annually.Metal drug-eluting stent unloading is one of the most common clinical complications.Comparatively,BRS detachment is more concealed and harmful,but has yet to be reported in clinical research.In this study,we report a case of BRS unloading and successful rescue.This is a case of a 59-year-old male with the following medical history:“Type 2 diabetes mellitus”for 2 years,maintained with metformin extended-release tablets,1 g PO BID;“hypertension”for 20 years,with long-term use of metoprolol sustained-release tablets,47.5 mg PO QD;“hyperlipidemia”for 20 years,without regular medication.He was admitted to the emergency department of our hospital due to intermittent chest pain lasting 18 hours,on February 20,2022 at 15:35.Electrocardiogram results showed sinus rhythm,ST-segment elevation in leads I and avL,and poor R-wave progression in leads V1–3.High-sensitivity troponin I level was 4.59 ng/mL,indicating an acute high lateral wall myocardial infarction.The patient’s family requested treatment with BRS,without implanta-tion.During PCI,the BRS became unloaded but was successfully rescued.The patient was followed up for 2 years;he had no episodes of angina pectoris and was in generally good condition.CONCLUSION We describe a case of a 59-year-old male experienced BRS unloading and successful rescue.By analyzing images,the causes of BRS unloading and the treatment plan are discussed to provide insights for BRS release operations.We discuss preventive measures for BRS unloading.
文摘Objective:Double-J(DJ)ureteric stents are commonly placed perioperatively for semirigid or flexible ureteroscopic renal surgery.It is believed that lesser stent material within the bladder mitigates stent-related symptoms.This study aimed to evaluate the J-Fil ureteral stent,a single pigtail suture stent compared with conventional DJ stent in relation to stent symptoms in an Asian population undergoing ureterorenal intervention.Methods:Based on internal audit committee recommendation approval,the records of 50 patients retrieved,available data of 41 patients who were prospectively enrolled into two groups(Group 1[J-Fil stent group],n=21 and Group 2[DJ stent group],n=20)between August 2020 to January 2021,were analysed.Parameters compared were nature of procedure,stone location and size,ease of deployment or removal,and complications.A modified universal stent symptom questionnaire was used to assess morbidity of stent symptoms within 48 h of insertion and at removal.Results:Both groups had similar median age,distribution in male to female ratio,and stone size.The overall median universal stent symptom questionnaire score at insertion was similar for bladder pain,flank or loin pain,and quality of life between Group 1 and 2;however,at removal Group 1 fared significantly better than Group 2,especially for flank or loin pain and pain at voiding.Both groups had similar ease in insertion with no hospital readmissions.Conclusion:Our audit favoured the single pigtail suture stent in Asian ureters in mitigating stent-related issues.It showed a good safety profile with easy deployment and removal.It promises a new standard in stenting.
文摘Objective:Ureteral stents are customarily inserted to facilitate urinary drainage,but they come with their own glitches of being forgotten and/or encrusted leading to serious consequences.The present study aimed to report the complications in patients with forgotten and encrusted stents according to the Clavien-Dindo system specific to urological procedures and identify the factors leading to high-grade(Clavien-Dindo Grade 4A or above)complications.Methods:The hospital records of patients with forgotten encrusted double-J stents over a period of 8 years were reviewed.The parameters recorded included patient demographics,indwelling time,need for percutaneous nephrostomy,hemodialysis,urine culture,blood culture,total blood counts,serum creatinine,radiologic findings,management techniques,number of surgical interventions,modified Clavien-Dindo complications,follow-up,and mortality,if any.Results:Forty patients were included in the study.The median age was 52(range 6-85)years.Of the total,25(62.5%)patients had a“significant”stent load;31(77.5%)had renal failure or acute kidney injury on presentation;19(47.5%)patients had sepsis at presentation.Among the patients presented with sepsis,11(57.9%)patients demonstrated a positive urine culture;and 7/11(63.6%)patients exhibited pan-resistant organisms.Twelve out of 40(30.0%)patients in our series developed high-grade Clavien-Dindo complications.On univariate analysis,sepsis at presentation(p=0.007),stent load(p=0.031),diabetes(p=0.023),positive urine culture(p=0.007),and stent indwelling time of more than 1 year(p=0.031)were found to be significant.On multivariate logistic regression analysis,sepsis at presentation(p=0.017)and positive urine culture(p=0.016)were significant predictors for high-grade complications.Conclusion:It is prudent to identify specific risk factors,namely sepsis at presentation and positive urine culture to triage and optimize these patients before surgical management.
文摘Patients with malignant biliary obstruction,following endoscopic retrograde cholangiopancreatography(ERCP)failure could be referred for endoscopicultrasound-guided biliary drainage through electrocautery-enhanced(ECE)lumen-apposing metal stent(LAMS)placement.However,the efficacy and safety of ECE-LAMS in this scenario have remained debatable due to minimal scientific evidence.The current confirmed 91.0%clinical success,96.7%technical success,7.3%reintervention rate,and 17.5%adverse events,following the treatment of malignant biliary obstruction with ECE-LAMS delivery.Finally,ECE-LAMS proved to be a generalizable strategy for managing biliary obstruction for patients who were excluded from ERCP.
文摘The role of endoscopy in pathologies of the bile duct and gallbladder has seen notable advancements over the past two decades.With advancements in stent technology,such as the development of lumen-apposing metal stents,and adoption of endoscopic ultrasound and electrosurgical principles in therapeutic endoscopy,what was once considered endoscopic failure has transformed into failure of an approach that could be salvaged by a second-or third-line endoscopic strategy.Incorporation of these advancements in routine patient care will require formal training and multidisciplinary acceptance of established techniques and collaboration for advancement of experimental techniques to generate robust evidence that can be utilized to serve patients to the best of our ability.
文摘BACKGROUND In severe cases of coronary artery disease,percutaneous coronary intervention provide promising results.The stent used could be a drug-eluting stent(DES)or a titanium-nitride-oxide coated stent(TiNOS).AIM To compare the 5-year effectiveness and safety of the two stent types.METHODS The following systematic review and meta-analysis was conducted in accordance with the preferred reporting items for systematic reviews and meta-analysis guidelines,and PubMed/MEDLINE,Scopus,and Cochrane Central were searched from inception till August 2023.Primary outcomes were major adverse cardiac events(MACE),cardiac death,myocardial infarction(MI),cardiac death or MI,and ischemia-driven total lesion revascularization(ID-TLR).RESULTS Four randomized controlled trials(RCT),which analyzed a sum total of 3045 patients with acute coronary syndrome(ACS)after a median follow-up time of 5 years were included.Though statistically insignificant,an increase in the ID-TLR was observed in patients receiving TiNOSs vs DESs.In addition,MI,cardiac death and MI,and definite stent thrombosis(DST)were significantly decreased in the TiNOS arm.Baseline analysis revealed no significant results with meta-regression presenting non-ST elevated MI(NSTEMI)as a statistically significant covariate in the outcome of MACE.CONCLUSION TiNOS was found to be superior to DES in terms of MI,cardiac death or MI,and DST outcomes,however,the effect of the two stent types on ID-TLR and MACE was not significant.A greater number of studies are required to establish an accurate comparison of patient outcomes in TiNOS and DES.
文摘This editorial delves into Peng et al's article,published in the World Journal of Gastrointestinal Surgery.Peng et al's meta-analysis investigates the effectiveness of electrocautery-enhanced lumen-apposing metal stents(ECE-LAMS)in ultrasound-guided biliary drainage for alleviating malignant biliary obstruction.Examining 14 studies encompassing 620 participants,the research underscores a robust technical success rate of 96.7%,highlighting the efficacy of ECE-LAMS,particularly in challenging cases which have failed endoscopic retrograde cholangio pancreatography.A clinical success rate of 91.0% underscores its impact on symptom alleviation,while a reasonably tolerable adverse event rate of 17.5% is observed.However,the 7.3% re-intervention rate stresses the need for post-procedural monitoring.Subgroup analyses validate consistent outcomes,bolstering the applicability of ECE-LAMS.These findings advocate for the adoption of ECELAMS as an appropriate approach for biliary palliation,urging further exploration in real-world clinical contexts.They offer valuable insights for optimizing interventions targeting malignant biliary obstruction management.
文摘BACKGROUND Endoscopic management is the first-line therapy for post-liver-transplant anas-tomotic strictures.Although the optimal duration of treatment with plastic stents has been reported to be 8-12 months,data on safety and duration for metal stents in this setting is scarce.Due to limited access to endoscopic retrograde cholan-giopancreatography(ERCP)during the coronavirus disease 2019 pandemic in our centre,there was a change in practice towards increased usage and length-of-stay of the Kaffes biliary intraductal self-expanding stent in patients with suitable anatomy.This was mainly due to the theoretical benefit of Kaffes stents allowing for longer indwelling periods compared to the traditional plastic stents.METHODS Adult liver transplant recipients aged 18 years and above who underwent ERCP were retrospectively identified during a 10-year period through a database query.Unplanned admissions post-Kaffes stent insertion were identified manually through electronic and scanned medical records.The main outcome was the incidence of complications when stents were left indwelling for 3 months vs 6 months.Stent efficacy was calculated via rates of stricture recurrence between patients that had stenting courses for≤120 d or>120 d.RESULTS During the study period,a total of 66 ERCPs with Kaffes insertion were performed in 54 patients throughout their stenting course.In 33 ERCPs,the stent was removed or exchanged on a 3-month interval.No pancreatitis,perfor-ations or deaths occurred.Minor post-ERCP complications were similar between the 3-month(abdominal pain and intraductal migration)and 6-month(abdominal pain,septic shower and embedded stent)groups-6.1%vs 9.1%respectively,P=0.40.All strictures resolved at the end of the stenting course,but the stenting course was variable from 3 to 22 months.The recurrence rate for stenting courses lasting for up to 120 d was 71.4%and 21.4%for stenting courses of 121 d or over(P=0.03).There were 28 patients that were treated with a single ERCP with Kaffes,21 with removal after 120 d and 7 within 120 d.There was a significant improvement in stricture recurrence when the Kaffes was removed after 120 d when a single ERCP was used for the entire stenting course(71.0%vs 10.0%,P=0.01).CONCLUSION Utilising a single Kaffes intraductal fully-covered metal stent for at least 4 months is safe and efficacious for the management of post-transplant anastomotic strictures.
基金2022 Discipline Construction Project of School of Business Administration,Shenyang Pharmaceutical University(2022-SYGSXK-05).
文摘Objective To study the impact of the first national centralized procurement of coronary stents on patients’psychology,the economy of medical institutions,and the survival and development of the coronary stents industry,and to provide suggestions on perfecting procedures to better carry out the centralized procurement of coronary stents.Methods Literature analysis was used to investigate the results of the procurement of coronary stent in a province and a hospital.Results and Conclusion The centralized procurement of coronary stents has alleviated the economic pressure of patients,but it has many problems.Therefore,this paper proposes some suggestions,such as promoting the orderly development of the coronary stent industry,improving the evaluation link of the centralized procurement of coronary stents,adopting the accurate reporting model to ensure the quality of coronary stents and improving the standardization of clinical services.
文摘Background Recent data have shown that sirolimus-eluting stents (SES) reduced not only the incidences of restenosis but also of target vessel revascularization (TVR). CYPHER and FIREBIRD stents are both widely used SES in China. However, comparative data concerning differences in long-term safety and efficacy regarding CYPHER and FIREBIRD stents in the Chinese population are still not available.
文摘Background As a kind of sirolimus-eluting stent (SES) made in China, Firebird SES is more effective than bare metal stent (BMS) and not inferior to Cypher SES for short coronary lesions in terms of reduction of restenosis and revascularization. However, Firebird SES does not show any benefits in patients with a very long coronary lesion (VLCL). The present study was undertaken to evaluate the safety and efficacy of Firebird SES for VLCL by comparison of Cypher SES and BMS. Methods In this prospective, nonrandomized and comparative study, eligible patients with de novo coronary lesion (≥ 30 mm) between January 2005 and June 2006 were allocated into Firebird SES group, Cypher SES group or BMS group. They were subjected to an angiographic follow-up of 6 months and a clinical follow-up of 12 months. The primary endpoints constitute the in-stent and in-segment restenosis rates at 6 months. The secondary endpoint was defined as a major adverse cardiovascular event (MACE) that was a 12-month combined endpoint of all-cause deaths, reinfarction or in-stent thrombosis, and target-lesion revascularization. The 12-month in-stent thrombosis was also evaluated to address the safety of Firebird SES implantation exceptionally. Results A total of 468 patients were assessed for eligibility. Of 113 patients who were finally included according to the prior inclusion and exclusion criteria, 39 (41 lesions) were treated with Firebird SES, 37 (39 lesions) with Cypher SES, and 37 (37 lesions) with BMS. There were no significant differences in the baseline characteristics between the three groups; but there were longer lesions, more frequent use of overlapping stent in the Firebird SES group and the Cypher SES group. Angiographic follow-up showed that the rates of binary stenosis were similar between the Firebird SES group and the Cypher SES group (in-segment: 14.6% vs 12.8%, relative risk (RR)1.14, P=0.81; in-stent: 9.8% vs 10.3%, RR 0.95, P=0.94), and significantly lower than those in the BMS group (in-segment: vs 36.1%, RR 0.41 or 0.36, P=-0.04 or 0.03, respectively; in-stent: vs 30.6%, RR 0.32 or 0.34, P=0.03 or 0.04, respectively). The total MACE rate up to 12 months was also similar in both SES groups (7.7% vs 5.4%, P=1.000), and significantly lower than that in the BMS group (27.0%, P=0.034 or 0.024, respectively). The in-stent thrombosis rate in the follow-up period was 2.6% in the Firebird SES group, not higher in the Cypher SES and BMS groups (2.7% and 2.7%, respectively, P=1.000). Conclusions In the treatment of VLCL, Firebird SES would be safer and more effective than BMS. Firebird SES may be not inferior to Cypher SES in terms of restenosis and MACE.
文摘Background Several clinical trials have shown that sirolimus-eluting stents significantly reduce the risk of restenosis after percutaneous coronary intervention (PCI). The FIREBIRD stent (coated with durable polymer) and the EXCEL stent (coated with bioabsorbable polymer) are two different types of sirolimus-eluting stents made in China; both have been approved for clinical use in China by the State Food and Drug Administration. The mid-term (6-month) angiographic and clinical results of both stents have been confirmed exciting perspective outcomes. However, it is unclear whether there are differences in the long-term safety and efficacy between the two types of stents in daily practice.Methods All consecutive patients undergoing elective PCI with EXCEL or FIREBIRD stents between June 1,2006 and December 31, 2006 at Fu Wai Hospital in Beijing were included. Patients were classified from the index admission according to stent types (EXCEL or FIREBIRD) used. Clinical and procedural risk factors were collected prospectively. With propensity score matching without replacement, the frequency of major adverse cardiac events (MACE, a composite of death, myocardial infarction or target vessel revascularization) and stent thrombosis during a 2-year follow-up period were compared between the two groups.Results A total of 474 patients were treated with EXCEL, and 640 were treated with FIREBIRD. Three hundred and ninety-seven EXCEL patients were matched to 397 FIREBIRD patients, 2-year risk-adjusted MACE rates were 6.1% in EXCEL group and 7.6% in FIREBIRD group (HR 0.84, 95%CI0.50-1.43), whereas the respective rates for mortality, myocardial infarction and target-vessel revascularization were 2.3% vs 2.8% (HR 0.74, 95%CI0.30-0.85), 1.8% vs 1.3% (HR 1.41,95%CI 0.45-4.43) and 2.5% vs 4.0% (HR 0.62, 95%CI0.28-0.37), respectively. Cumulative incidence of stent thrombosis at 2 years was 1.8% in the EXCEL group vs 1.3% in the FIREBIRD group (P=0.5610), whereas the rate of very late stent thrombosis was 0.5% vs 1.3% (P=0.2550).Conclusions Results from this long-term, relatively large size, single-center study showed that both of the EXCEL and the FIREBIRD sirolimus-eluting stent had similar and lower incidence of MACE after PCI in daily practice.
文摘Background Previous studies indicated that long coronary lesions are one of the key predictors of drug-eluting stent (DES) failure. The purpose of this study was to evaluate the efficacy and the safety of the long length FIREHAWK stent in long coronary artery disease. Methods The long cohort of TARGET I was a prospective, multicenter, single arm trial. It was planned to enroll 50 patients undergoing percutaneous coronary intervention (PCI) for the treatment of de novo long lesions in a native coronary artery. The major inclusion criteria of the trial was that patients were intended to undergo the treatment of a long target lesion(s) with diameter stenosis 〉70% and reference vessel diameter 2.5 mm to 4.0 mm by visual estimate, that needed to be covered by at least one 33 mm or 38 mm stent or multiple long stents overlapped. The angiographic follow-up was planned at 9-month and the clinical follow-up will be up to 5 years. The primary end point was in-stent late lumen loss at 9-month. Results Fifty patients (mean age (57.6±10.2) years) with 59 de novo long lesions (reference vessel diameter (2.85±0.44) mm, lesion length (35.2±9.4) mm, and stent length (41.8±11.3) mm) were enrolled. The angiographic follow-up rate was 92% at 9-month. The in-stent late loss was (0.16±0.16) mm. Proximal edge, distal edge and in-segment late loss (mm) were 0.21±0.35, 0.03±0.33, and 0.07±0.26, respectively. No in-segment binary restenosis was observed. At 1-year no death, Q wave myocardial infarction (MI), or stent thrombosis occurred. Non-Q-wave MI occurred in two patients (4%) due to procedural complications. Conclusions Treatment of long coronary lesions with the FIREHAWK stent is able to produce similar results as observed in the FIREHAWK~ FIM clinical trial. Based on this result, we are confident in the treatment prospect of the FIREHAWK for long coronary lesions.
文摘Background The durable presence of polymer coating on drug-eluting stent (DES) surface may be one of the principal reasons for stent thrombosis. The long-term coronary arterial response to biodegradable polymer-coated sirolimus-eluting stent (BSES) in vivo remained unclear.Methods Forty-one patients were enrolled in this study and virtual histology intravascular ultrasound (VH-IVUS) was performed to assess the native artery vascular responses to BSES compared with durable polymer-coated SES (DSES) during long-term follow-up (median: 8 months). The incidence of necrotic core abutting to the lumen was evaluated at follow-up.Results With similar in-stent late luminal loss (0.15 mm (0.06-0.30 mm) vs. 0.19 mm (0.03-0.30 mm), P=0.772), the overall incidence of necrotic core abutting to the lumen was significantly less in BSES group than in DSES group (44% vs.63%, P 〈0.05) (proximal 18%, stented site 14% and distal 12% in BSES group, proximal 19%, stented site 28% and distal 16% in DSES group). The DSES-treated segments had a significant higher incidence of necrotic core abutting to the lumen through the stent struts (73% vs. 36%, P 〈0.01). In addition, more multiple necrotic core abutting to the lumen was observed in DSES group (overall: 63% vs. 36%, P 〈0.05). Furthermore, when the stented segments with necrotic core abutting to the lumen had been taken into account only, DSES-treated lesions tended to contain more multiple necrotic core abutting to the lumen through the stent struts than BSES-treated lesions (74% vs. 33%), although there was no statistically significant difference between them (P=0.06).Conclusions By VH-IVUS analysis at follow-up, a greater frequency of stable lesion morphometry was shown in lesions treated with BSESs compared with lesions treated with DSESs. The major reason was BSES produced less toxicity to the arterial wall and facilitated neointimal healing as a result of polymer coating on DES surface biodegraded as time went by.
文摘Background Restenosis of bare-metal stents (BMS) and drug-eluting stents (DES) has been increasingly treated with sirolimus-eluting stents (SES), but the long-term outcomes are unknown. Methods In our study, 388 consecutive patients (144 DES restenosis and 244 BMS restenosis) with 400 lesions (147 DES restenosis and 253 BMS restenosis) treated with SES were included. The rates of target lesion revascularization (TLR) and major adverse cardiac events (MACE) at 42 months were analyzed. Results At the mean follow-up of 42 months, the rates of death (3.5% vs. 3.3%, P=1.000) and myocardial infarction (2.8% vs. 1.2%, P=0.431) in the DES group and BMS group were comparable. Compared with the BMS group, ischemia-driven TLR occurred with a higher frequency in the DES group (18.8% vs.10.7%, P=0.024). This translated into an increased rate of MACE in the DES group (22.2% vs. 14.0%, P=0.034). Stent thrombosis occurred with a similar frequency in both groups (2.8% vs. 1.6%, P=0.475). Multivariate analysis showed that DES restenosis (OR=1.907, 95% Cl 1.108-3.285, P=0.020) and smoking (OR=2.069; 95% Cl 1.188-3.605; P=0.010) were independent predictors of MACE.
文摘The role of drug-eluting stent (DES), which prevents acute or subacute recoil and elutes drugs to prevent smooth muscle cell proliferation, is temporary and limited within a few weeks after its implantation. Beyond that, there is no utility or advantages but only limitations just like foreign materials in patients' body. All of these problems can be solved with the use of fully bioabsorbable stent (BAS),
文摘Background Sirolimus-eluting stents (SES) are reported to be associated with reduced late lumen loss (LLL), resulting in less frequent restenosis when compared to bare-metal stent. The current study aimed to assess the difference in LLL between SES with biodegradable and with permanent polymer. Methods From March 2010 to June 2011, 300 consecutive patients having only biodegradable polymers or permanent polymer SES for all diseased vessels were included. Serial quantitative coronary analysis was performed on both the "in-stent" and "segment" area, including the stented segment, as well as both five mm margins proximal and distal to the stent. The primary endpoint was the LLL defined as the minimal lumen diameter (MLD) post-stenting minus the MLD at nine-month after the indexed procedure. Results LLL was comparable between the two stents. Importantly, LLL for the distal segment (median 0.05 mm, interquartile 0 to 0.09 mm) was less severe compared with in-stent (median 0.13 mm, interquartile 0.08 to 0.18 mm) and proximal segment LLL (median 0.12 mm, interquartile 0.06 to 0.14 mm, all P 〈0.001 ). In general, the LLL was associated with the post-procedure MLD (b=0.28, P=0.002), hyperlipidemia (b=0.14, P=0.021), and calcified lesions (b=0.58, P=-0.001). The R2 and Radj of the multiple regression model were 0.651 and 0.625, respectively. Conclusions SES with either biodegradable or permanent polymer had lower value of LLL. The small amount of LLL at the distal segment possibly contributed to the less distal edge stenosis.