Objective It remains undetermined whether biodegradable polymer drug-eluting stents(BP-DES)are superior to second generation drugeluting stents(G2-DES)in patients with and without diabetes mellitus(DM).The study aims ...Objective It remains undetermined whether biodegradable polymer drug-eluting stents(BP-DES)are superior to second generation drugeluting stents(G2-DES)in patients with and without diabetes mellitus(DM).The study aims to evaluate the efficacy and safety of G2-DES and BP-DES in patients with and without DM in a high-volume cardiovascular center in China.展开更多
Background:There are few data comparing clinical outcomes of complex percutaneous coronary intervention(CPCI)when using biodegradable polymer drug-eluting stents(BP-DES)or second-generation durable polymer drug-elutin...Background:There are few data comparing clinical outcomes of complex percutaneous coronary intervention(CPCI)when using biodegradable polymer drug-eluting stents(BP-DES)or second-generation durable polymer drug-eluting stents(DP-DES).The purpose of this study was to investigate the safety and efficacy of BP-DES and compare that with DP-DES in patients with and without CPCI during a 5-year follow-up.Methods:Patients who exclusively underwent BP-DES or DP-DES implantation in 2013 at Fuwai Hospital were consecutively enrolled and stratified into two categories based on CPCI presence or absence.CPCI included at least one of the following features:unprotected left main lesion,≥2 lesions treated,≥2 stents implanted,total stent length>40 mm,moderate-to-severe calcified lesion,chronic total occlusion,or bifurcated target lesion.The primary endpoint was major adverse cardiac events(MACE)including all-cause death,recurrent myocardial infarction,and total coronary revascularization(target lesion revascularization,target vessel revascularization[TVR],and non-TVR)during the 5-year follow-up.The secondary endpoint was total coronary revascularization.Results:Among the 7712 patients included,4882(63.3%)underwent CPCI.Compared with non-CPCI patients,CPCI patients had higher 2-and 5-year incidences of MACE and total coronary revascularization.Following multivariable adjustment including stent type,CPCI was an independent predictor of MACE(adjusted hazard ratio[aHR]:1.151;95%confidence interval[CI]:1.017–1.303,P=0.026)and total coronary revascularization(aHR:1.199;95%CI:1.037–1.388,P=0.014)at 5 years.The results were consistent at the 2-year endpoints.In patients with CPCI,BP-DES use was associated with significantly higher MACE rates at 5 years(aHR:1.256;95%CI:1.078–1.462,P=0.003)and total coronary revascularization(aHR:1.257;95%CI:1.052–1.502,P=0.012)compared with that of DP-DES,but there was a similar risk at 2 years.However,BP-DES had comparable safety and efficacy profiles including MACE and total coronary revascularization compared with DP-DES in patients with non-CPCI at 2 and 5 years.Conclusions:Patients underwent CPCI remained at a higher risk of mid-to long-term adverse events regardless of the stent type.The effect of BP-DES compared with DP-DES on outcomes was similar in CPCI and non-CPCI patients at 2 years but had inconsistent effects at the 5-year clinical endpoints.展开更多
Background and Objective: In the contemporary practice, the use of drug-eluting stents is still associated with low mortality benefits, restenosis and stent thrombosis. To address these issues, newer generation, thin-...Background and Objective: In the contemporary practice, the use of drug-eluting stents is still associated with low mortality benefits, restenosis and stent thrombosis. To address these issues, newer generation, thin-strut, biodegradable polymer coated stents has been designed. Thus, the aim of the study is to assess the safety and clinical performance of the Everoflex (Sahajanand Medical Technologies Pvt. Ltd., Surat, India), a newer generation biodegradable polymer coated everolimus-eluting stent, in unselected “real-world” patients with coronary artery disease. Methods: It is a multicentre, retrospective, non-randomized, single-arm study enrolling all the consecutive patients who underwent implantation with the Everoflex for coronary artery disease from April 2014 to March 2016. The primary end-point of the study is 30-day major adverse cardiovascular events (MACE) rate, which consists of cardiac death, myocardial infarction, target lesion revascularization and target vessel revascularization. Stent thrombosis was also analyzed and reported. Results: A total of 340 patients were intervened successfully with 395 everolimus eluting stents (1.3 ± 0.6 stents per patient). Out of total patients (58.7 ± 10.5 years), 77.9% were male and comorbidities like diabetes and hypertension were observed in 31.2% and 35.3% patients, respectively. According to ACC/AHA classification, there were 34.4% type B lesions and 53.2% type C lesions, indicating a higher proportion of complexity involved. Moreover, 57.9% patients had multivessel disease and there were 15.4% total occlusions. At 30 days, follow-up was completed in 100% patients. The MACE was found to be 1.5%, which is a composite of 1.2% cardiac death and 0.3% target lesion revascularization. Stent thrombosis at 30 days was found to be 0.3%. Conclusion: The low incidence of MACE and stent thrombosis clearly depicts excellent safety and clinical performance of the Everoflex in unselected real world patients with coronary artery disease.展开更多
Background Since permanent polymer is implicated in adverse events associated with delayed vessel healing after drug eluting stents （DES） implantation, great efforts have been made to develop more biocompatible DES ...Background Since permanent polymer is implicated in adverse events associated with delayed vessel healing after drug eluting stents （DES） implantation, great efforts have been made to develop more biocompatible DES with biodegradable polymer or without polymer. The present study aimed to evaluate the safety and efficacy of polymer free paclitaxel-eluting stents （PF-PES） in comparison with permanent polymer sirolimus-eluting stents （PP-SES） in patients with acute ST-segment elevation myocardial infarction （STEMI）. Methods Patients with STEMI were randomly assigned to receive PP-SES （n=55）, and PF-PES （n=50）. The 6-month angiographic and 1-year clinical outcomes were compared between the two groups. Target lesion failure （TLF） was defined as the composite of cardiac death, recurrent nonfatal myocardial infarction （Re-MI）, or target lesion revascularization （TLR）. Results Follow-up angiography at six months was performed in 72.7% of the PP-SES group and 70.0% of the PF-PES group （P=0.757）. The two groups had comparable angiographic outcomes including minimal luminal diameter, diameter stenosis, late loss and binary restenosis. All patients were clinically followed up to one year. The two groups had similar clinical outcomes with relatively low rates of target lesion failure （10.9% PP-SES vs. 12.0% PF-PES, P=0.861） and definite or probable stent thrombosis （1.8% PP-SES vs. 2.0% PF-PES, P=1.000） at one year. Conclusions The present study suggests that the safety and efficacy of PF-PES in the setting of STEMI are comparable to PP-SES. Further randomized trials with laraer study DODUlations are needed to net definite conclusions.展开更多
Objective::Data comparing the outcomes of MiStent(Micell Technologies,Durham,North Carolina,USA)microcrystalline biodegradable polymer(BP)drug-eluting stent(DES)and those of another post-marketing BP-DES,TIVOLI(EssenT...Objective::Data comparing the outcomes of MiStent(Micell Technologies,Durham,North Carolina,USA)microcrystalline biodegradable polymer(BP)drug-eluting stent(DES)and those of another post-marketing BP-DES,TIVOLI(EssenTech,Beijing,China)are rare.This study sought to compare the angiographic efficacy and clinical outcomes of the microcrystalline BP sirolimus-eluting stent(SES)system MiStent and those of TIVOLI BP-SES.Methods::The DESSOLVE-C trial was a prospective,single-blinded,multicenter,randomized trial(NCT02448524),which randomly assigned patients with de novo coronary lesions to receive MiStent or TIVOLI BP-SES by a 1:1 ratio.The primary endpoint was a non-inferiority comparison of in-stent late lumen loss(LLL)by quantitative coronary angiography at 9 months.The secondary endpoint was device-related clinical cardiovascular composite events(target lesion failure(TLF),composite of cardiac death,target vessel myocardial infarction(MI),and clinically driven target lesion revascularization)and 1-year outcomes.Results::A total of 428 patients(216 patients in the MiStent group and 212 patients in the TIVOLI group)were enrolled and included in an intention-to-treat analysis.MiStent was not only non-inferior but superior to TIVOLI for in-stent LLL at 9 months((0.23±0.37)mm vs.(0.34±0.48)mm,P for non-inferiority<0.001,P for superiority=0.02).Although without significant difference,the rate of TLF in MiStent was quantitatively lower than that in TIVOLI(3.70%vs.6.60%;P=0.17).Conclusion::Compared with TIVOLI BP-SES,the MiStent system was superior in in-stent LLL at 9 months and had a comparable clinical benefit at 1 year in de novo coronary lesions.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 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 Several clinical trials have shown that rapamycin-eluting stents significantly reduce the risk of restenosis after percutaneous coronary intervention （PCI）. The Firebird stent and the Excel stent （coated...Background Several clinical trials have shown that rapamycin-eluting stents significantly reduce the risk of restenosis after percutaneous coronary intervention （PCI）. The Firebird stent and the Excel stent （coated with bioabsorbable polymer） are two different types of rapamycin-eluUng stents made in China, both have been recently approved for clinical use in China by State Food and Drug Administration. However, it is unclear whether there are differences in safety and efficacy between the two types of stents in daily practice. Methods In the month of June 2006, a total of 190 consecutive patients were treated exclusively with Firebird stents （n=93, Firebird group） or Excel stents （n=97, Excel group） in our center and were included in this study. The frequency of major adverse cardiac events （MACE, a composite of death, myocardial infarction or target lesion revascularization）, binary restenosis, and late lumen loss and stent thrombosis dudng a six-month follow-up period were compared between the two groups. Results Patient and lesion characteristics were comparable between the groups. Major adverse cardiac event rates were low in hospital and at 6 months （2.1% in the Excel group and 0% in the Firebird group, P〉 0.05）. The 6-month angiographic in-stent restenosis rate was 0% in both groups, with an associated late loss of （0.15 ± 0.21） mm versus （0.14 ± 0.20） mm （P=0.858） and the in-segment restenosis rate was also 0% for the Excel group and the Firebird group. There was no definite stent thrombosis identified in either group during the six-month follow-up period and only one patient in the Excel group had probable stent thrombosis in hospital. Conclusions Results from this mid-term, single-center study showed that both of the Firebird and the Excel rapamycin eluUng stent had similar effects on reducing the incidence of MACE and the risk of restenosis （both in-stent and in-segment binary restenosis） after PCI in daily practice.展开更多
Background Drug-eluting stents（DES） with durable polymer have significantly reduced restenosis and target vessel revascularization compared with bare metal stents. Durable polymer has been linked with persistent inf...Background Drug-eluting stents（DES） with durable polymer have significantly reduced restenosis and target vessel revascularization compared with bare metal stents. Durable polymer has been linked with persistent inflammation of vessel wall and delayed endothelial healing that may increase the risk of late and very late stent thrombosis. This study sought to evaluate the efficacy and safety of HELLOS completed biodegradable polymer sirolimus-eluting stent （SES） in de novo coronary lesions.Methods Totally, 287 patients with one or two de novo coronary lesions （lesion length ≤38 mm and reference vessel diameter 2.5-4.0 mm） were enrolled in the HOPE study, a prospective, multicenter, randomized, non-inferiority trial. Patients were randomized to treatment either with HELIOS completed biodegradable polymer SES （n=142） or PARTNER durable polymer SES （n=145）. The primary endpoint was angiographic in-stent late lumen loss （LLL） at 9-month follow-up. The secondary endpoint included stent thrombosis and major adverse cardiac events including cardiac death, myocardial infarction （MI） and target lesion revascularization （TLR）.Results The 9-month in-stent LLL in the HELIOS group was similar to the PARTNER group, （0.16±0.22） mm vs. （0.19±0.30） mm （P=0.28）. The difference and 95% confidence interval were -0.03 （-0.09, 0.04）, and the P value for non-inferiority 〈0.01. Major adverse cardiovascular event （MACE） occurred in 7.9% vs. 8.2%, MI in 2.4% vs. 3.0%, TLR in 5.5% vs. 3.0%, and stent thrombosis in 0 vs. 1.5%; and events were comparable between the HELIOS group and PARTNER aroup at three-year follow-up （all P 〉0.05）. The three-year cardiac death was lower in the HELIOS group, butwith no significant difference, 0 vs. 3.0% （P=0.12）. Conclusions In the HOPE trial, the novel completed biodegradable polymer SES HELIOS was non-inferior to the durable polymer SES PARTNER with respect to nine-month in-stent LLL in de novo coronary lesions. The incidence of other clinical endpoints was low for both of the stents in three-year follow-up.展开更多
Background First generation drug-eluting stents （DESs） were based on 316L stainless steel and coated with a permanent polymer. The vessel wall of these DESs was inflammatory and late in-stent thrombosis was reported...Background First generation drug-eluting stents （DESs） were based on 316L stainless steel and coated with a permanent polymer. The vessel wall of these DESs was inflammatory and late in-stent thrombosis was reported. Hence, cobalt chromium based DES coated with a bioabsorbable polymer was an alternate choice. Methods Cobalt chromium based DES with bioabsorbable polymer （Simrex stent） as well as control stents （Polymer stent and EXCELTM stent） were implanted into porcine arteries. At a designated time, angiography, quantitative coronary angiography （QCA） analysis, histomorphometry, and electron-microscopical follow-up were performed. Results A total of 98 stents of all the three groups were harvested. At week 24, percent diameter stenosis （%DS）, late loss （LL）, and percent area stenosis （%AS） of Simrex was （12.9±0.4）%, （0.35±0.02） mm, and （24.5±4.2）%, respectively, without significant difference in comparison to commercialized EXCELTM stent. Slight inflammatory reaction was seen around the stent strut of Simrex, just as in the other two groups. Electron-microscopical follow-up suggested that it might take 4-12 weeks for Simrex to complete its re-endothelialization process. Conclusions Cobalt chromium based, bioabsorbable polymer coated sirolimus-eluting stent showed excellent biocompatibility. During 24 weeks observation in porcine model, it was proved that this novel DES system successfully inhibited neointima hyperplasia and decreased in-stent stenosis. It is feasible to launch a clinical evaluation to improve the current prognosis of DES implantation.展开更多
Background Stent-based delivery of sirolimus has been shown to reduce neointimal hyperplasia significantly. However, the long-term effect of the polymer is thought to initiate and sustain an inflammatory response and ...Background Stent-based delivery of sirolimus has been shown to reduce neointimal hyperplasia significantly. However, the long-term effect of the polymer is thought to initiate and sustain an inflammatory response and contribute to the occurrence of late complications. Our study aimed to evaluate the efficacy and safety of the BuMA biodegradable drug-coated sirolimus-eluting stent （BSES） for inhibiting neointimal hyperplasia in a porcine coronary model. Methods Four types of stents were implanted at random in different coronary arteries of the same pig： BSES （n=24）, bare metal stent （BMS） （n=24）, biodegradable polymer coated stent without drug （PCS） （n=24） and only poly （n-butyl methacrylate） base layer coated stent （EGS） （n=23）. In total, 26 animals underwent successful random placement of 95 oversized stents in the coronary arteries. Coronary angiography was performed after 28 days, 90 days and 240 days of stent implantation. After 14 days, 28 days, 90 days and 240 days, 6 animals at each timepoint were sacrificed for histomorphologic analysis. Results The 28-day, 90-day and 240-day results of quantitative coronary angiography （QCA） showed reduction in luminal loss （LL） in the BSES group when compared with the BMS group; （0.20±0.35） mm vs. （0.82±0.51） mm （P=-0.035）, （0.20±0.30） mm vs. （0.93±0.51） mm （P=-0.013）, and （0.18±0.16） mm vs. （0.19±0.24） mm （P=0.889）, respectively. By 28-day, 90-day and 240-day histomorphomeric analysis results, there was also a corresponding significant reduction in neointimal tissue proliferation with similar injury scores of BSES compared with the BMS control; average neointimal area （0.90±0.49） mm2 vs. （2.16±1.29） mm2 （P=0.049）, （1.53±0.84） mm2 vs. （3.41±1.55） mm2 （P=-0.026）, and （2.43±0.95） mm2 vs. （3.12±1.16） mm2 （P=0.228）, respectively. High magnification histomorphologic examination revealed similar inflammation scores and endothelialization scores in both the BSES and BMS groups. Conclusions The BuMA biodegradable drug-coated sirolimus-eluting stents can significantly reduce neointimal hyperplasia and in-stent restenosis. Re-endothelialization of the BuMA stent is as good as that of the BMS in the porcine coronary model due to the reduced inflammation response to the BuMA stent.展开更多
文摘Objective It remains undetermined whether biodegradable polymer drug-eluting stents(BP-DES)are superior to second generation drugeluting stents(G2-DES)in patients with and without diabetes mellitus(DM).The study aims to evaluate the efficacy and safety of G2-DES and BP-DES in patients with and without DM in a high-volume cardiovascular center in China.
基金supported by the National Key Research and Development Program of China(Nos.2016YFC1301300 and 2016YFC1301301)National Clinical Research Center for Cardiovascular Diseases,Fuwai Hospital,Chinese Academy of Medical Sciences(No.NCRC2020013)+1 种基金Chinese Academy of Medical Sciences(CAMS)Innovation Fund for Medical Sciences(CIFMS)(No.2020-I2M-C&T-B-049)the National Natural Science Foundation for Young Scholars of China(No.81900323).
文摘Background:There are few data comparing clinical outcomes of complex percutaneous coronary intervention(CPCI)when using biodegradable polymer drug-eluting stents(BP-DES)or second-generation durable polymer drug-eluting stents(DP-DES).The purpose of this study was to investigate the safety and efficacy of BP-DES and compare that with DP-DES in patients with and without CPCI during a 5-year follow-up.Methods:Patients who exclusively underwent BP-DES or DP-DES implantation in 2013 at Fuwai Hospital were consecutively enrolled and stratified into two categories based on CPCI presence or absence.CPCI included at least one of the following features:unprotected left main lesion,≥2 lesions treated,≥2 stents implanted,total stent length>40 mm,moderate-to-severe calcified lesion,chronic total occlusion,or bifurcated target lesion.The primary endpoint was major adverse cardiac events(MACE)including all-cause death,recurrent myocardial infarction,and total coronary revascularization(target lesion revascularization,target vessel revascularization[TVR],and non-TVR)during the 5-year follow-up.The secondary endpoint was total coronary revascularization.Results:Among the 7712 patients included,4882(63.3%)underwent CPCI.Compared with non-CPCI patients,CPCI patients had higher 2-and 5-year incidences of MACE and total coronary revascularization.Following multivariable adjustment including stent type,CPCI was an independent predictor of MACE(adjusted hazard ratio[aHR]:1.151;95%confidence interval[CI]:1.017–1.303,P=0.026)and total coronary revascularization(aHR:1.199;95%CI:1.037–1.388,P=0.014)at 5 years.The results were consistent at the 2-year endpoints.In patients with CPCI,BP-DES use was associated with significantly higher MACE rates at 5 years(aHR:1.256;95%CI:1.078–1.462,P=0.003)and total coronary revascularization(aHR:1.257;95%CI:1.052–1.502,P=0.012)compared with that of DP-DES,but there was a similar risk at 2 years.However,BP-DES had comparable safety and efficacy profiles including MACE and total coronary revascularization compared with DP-DES in patients with non-CPCI at 2 and 5 years.Conclusions:Patients underwent CPCI remained at a higher risk of mid-to long-term adverse events regardless of the stent type.The effect of BP-DES compared with DP-DES on outcomes was similar in CPCI and non-CPCI patients at 2 years but had inconsistent effects at the 5-year clinical endpoints.
文摘Background and Objective: In the contemporary practice, the use of drug-eluting stents is still associated with low mortality benefits, restenosis and stent thrombosis. To address these issues, newer generation, thin-strut, biodegradable polymer coated stents has been designed. Thus, the aim of the study is to assess the safety and clinical performance of the Everoflex (Sahajanand Medical Technologies Pvt. Ltd., Surat, India), a newer generation biodegradable polymer coated everolimus-eluting stent, in unselected “real-world” patients with coronary artery disease. Methods: It is a multicentre, retrospective, non-randomized, single-arm study enrolling all the consecutive patients who underwent implantation with the Everoflex for coronary artery disease from April 2014 to March 2016. The primary end-point of the study is 30-day major adverse cardiovascular events (MACE) rate, which consists of cardiac death, myocardial infarction, target lesion revascularization and target vessel revascularization. Stent thrombosis was also analyzed and reported. Results: A total of 340 patients were intervened successfully with 395 everolimus eluting stents (1.3 ± 0.6 stents per patient). Out of total patients (58.7 ± 10.5 years), 77.9% were male and comorbidities like diabetes and hypertension were observed in 31.2% and 35.3% patients, respectively. According to ACC/AHA classification, there were 34.4% type B lesions and 53.2% type C lesions, indicating a higher proportion of complexity involved. Moreover, 57.9% patients had multivessel disease and there were 15.4% total occlusions. At 30 days, follow-up was completed in 100% patients. The MACE was found to be 1.5%, which is a composite of 1.2% cardiac death and 0.3% target lesion revascularization. Stent thrombosis at 30 days was found to be 0.3%. Conclusion: The low incidence of MACE and stent thrombosis clearly depicts excellent safety and clinical performance of the Everoflex in unselected real world patients with coronary artery disease.
文摘Background Since permanent polymer is implicated in adverse events associated with delayed vessel healing after drug eluting stents （DES） implantation, great efforts have been made to develop more biocompatible DES with biodegradable polymer or without polymer. The present study aimed to evaluate the safety and efficacy of polymer free paclitaxel-eluting stents （PF-PES） in comparison with permanent polymer sirolimus-eluting stents （PP-SES） in patients with acute ST-segment elevation myocardial infarction （STEMI）. Methods Patients with STEMI were randomly assigned to receive PP-SES （n=55）, and PF-PES （n=50）. The 6-month angiographic and 1-year clinical outcomes were compared between the two groups. Target lesion failure （TLF） was defined as the composite of cardiac death, recurrent nonfatal myocardial infarction （Re-MI）, or target lesion revascularization （TLR）. Results Follow-up angiography at six months was performed in 72.7% of the PP-SES group and 70.0% of the PF-PES group （P=0.757）. The two groups had comparable angiographic outcomes including minimal luminal diameter, diameter stenosis, late loss and binary restenosis. All patients were clinically followed up to one year. The two groups had similar clinical outcomes with relatively low rates of target lesion failure （10.9% PP-SES vs. 12.0% PF-PES, P=0.861） and definite or probable stent thrombosis （1.8% PP-SES vs. 2.0% PF-PES, P=1.000） at one year. Conclusions The present study suggests that the safety and efficacy of PF-PES in the setting of STEMI are comparable to PP-SES. Further randomized trials with laraer study DODUlations are needed to net definite conclusions.
文摘Objective::Data comparing the outcomes of MiStent(Micell Technologies,Durham,North Carolina,USA)microcrystalline biodegradable polymer(BP)drug-eluting stent(DES)and those of another post-marketing BP-DES,TIVOLI(EssenTech,Beijing,China)are rare.This study sought to compare the angiographic efficacy and clinical outcomes of the microcrystalline BP sirolimus-eluting stent(SES)system MiStent and those of TIVOLI BP-SES.Methods::The DESSOLVE-C trial was a prospective,single-blinded,multicenter,randomized trial(NCT02448524),which randomly assigned patients with de novo coronary lesions to receive MiStent or TIVOLI BP-SES by a 1:1 ratio.The primary endpoint was a non-inferiority comparison of in-stent late lumen loss(LLL)by quantitative coronary angiography at 9 months.The secondary endpoint was device-related clinical cardiovascular composite events(target lesion failure(TLF),composite of cardiac death,target vessel myocardial infarction(MI),and clinically driven target lesion revascularization)and 1-year outcomes.Results::A total of 428 patients(216 patients in the MiStent group and 212 patients in the TIVOLI group)were enrolled and included in an intention-to-treat analysis.MiStent was not only non-inferior but superior to TIVOLI for in-stent LLL at 9 months((0.23±0.37)mm vs.(0.34±0.48)mm,P for non-inferiority<0.001,P for superiority=0.02).Although without significant difference,the rate of TLF in MiStent was quantitatively lower than that in TIVOLI(3.70%vs.6.60%;P=0.17).Conclusion::Compared with TIVOLI BP-SES,the MiStent system was superior in in-stent LLL at 9 months and had a comparable clinical benefit at 1 year in de novo coronary lesions.
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 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 Several clinical trials have shown that rapamycin-eluting stents significantly reduce the risk of restenosis after percutaneous coronary intervention （PCI）. The Firebird stent and the Excel stent （coated with bioabsorbable polymer） are two different types of rapamycin-eluUng stents made in China, both have been recently approved for clinical use in China by State Food and Drug Administration. However, it is unclear whether there are differences in safety and efficacy between the two types of stents in daily practice. Methods In the month of June 2006, a total of 190 consecutive patients were treated exclusively with Firebird stents （n=93, Firebird group） or Excel stents （n=97, Excel group） in our center and were included in this study. The frequency of major adverse cardiac events （MACE, a composite of death, myocardial infarction or target lesion revascularization）, binary restenosis, and late lumen loss and stent thrombosis dudng a six-month follow-up period were compared between the two groups. Results Patient and lesion characteristics were comparable between the groups. Major adverse cardiac event rates were low in hospital and at 6 months （2.1% in the Excel group and 0% in the Firebird group, P〉 0.05）. The 6-month angiographic in-stent restenosis rate was 0% in both groups, with an associated late loss of （0.15 ± 0.21） mm versus （0.14 ± 0.20） mm （P=0.858） and the in-segment restenosis rate was also 0% for the Excel group and the Firebird group. There was no definite stent thrombosis identified in either group during the six-month follow-up period and only one patient in the Excel group had probable stent thrombosis in hospital. Conclusions Results from this mid-term, single-center study showed that both of the Firebird and the Excel rapamycin eluUng stent had similar effects on reducing the incidence of MACE and the risk of restenosis （both in-stent and in-segment binary restenosis） after PCI in daily practice.
文摘Background Drug-eluting stents（DES） with durable polymer have significantly reduced restenosis and target vessel revascularization compared with bare metal stents. Durable polymer has been linked with persistent inflammation of vessel wall and delayed endothelial healing that may increase the risk of late and very late stent thrombosis. This study sought to evaluate the efficacy and safety of HELLOS completed biodegradable polymer sirolimus-eluting stent （SES） in de novo coronary lesions.Methods Totally, 287 patients with one or two de novo coronary lesions （lesion length ≤38 mm and reference vessel diameter 2.5-4.0 mm） were enrolled in the HOPE study, a prospective, multicenter, randomized, non-inferiority trial. Patients were randomized to treatment either with HELIOS completed biodegradable polymer SES （n=142） or PARTNER durable polymer SES （n=145）. The primary endpoint was angiographic in-stent late lumen loss （LLL） at 9-month follow-up. The secondary endpoint included stent thrombosis and major adverse cardiac events including cardiac death, myocardial infarction （MI） and target lesion revascularization （TLR）.Results The 9-month in-stent LLL in the HELIOS group was similar to the PARTNER group, （0.16±0.22） mm vs. （0.19±0.30） mm （P=0.28）. The difference and 95% confidence interval were -0.03 （-0.09, 0.04）, and the P value for non-inferiority 〈0.01. Major adverse cardiovascular event （MACE） occurred in 7.9% vs. 8.2%, MI in 2.4% vs. 3.0%, TLR in 5.5% vs. 3.0%, and stent thrombosis in 0 vs. 1.5%; and events were comparable between the HELIOS group and PARTNER aroup at three-year follow-up （all P 〉0.05）. The three-year cardiac death was lower in the HELIOS group, butwith no significant difference, 0 vs. 3.0% （P=0.12）. Conclusions In the HOPE trial, the novel completed biodegradable polymer SES HELIOS was non-inferior to the durable polymer SES PARTNER with respect to nine-month in-stent LLL in de novo coronary lesions. The incidence of other clinical endpoints was low for both of the stents in three-year follow-up.
文摘Background First generation drug-eluting stents （DESs） were based on 316L stainless steel and coated with a permanent polymer. The vessel wall of these DESs was inflammatory and late in-stent thrombosis was reported. Hence, cobalt chromium based DES coated with a bioabsorbable polymer was an alternate choice. Methods Cobalt chromium based DES with bioabsorbable polymer （Simrex stent） as well as control stents （Polymer stent and EXCELTM stent） were implanted into porcine arteries. At a designated time, angiography, quantitative coronary angiography （QCA） analysis, histomorphometry, and electron-microscopical follow-up were performed. Results A total of 98 stents of all the three groups were harvested. At week 24, percent diameter stenosis （%DS）, late loss （LL）, and percent area stenosis （%AS） of Simrex was （12.9±0.4）%, （0.35±0.02） mm, and （24.5±4.2）%, respectively, without significant difference in comparison to commercialized EXCELTM stent. Slight inflammatory reaction was seen around the stent strut of Simrex, just as in the other two groups. Electron-microscopical follow-up suggested that it might take 4-12 weeks for Simrex to complete its re-endothelialization process. Conclusions Cobalt chromium based, bioabsorbable polymer coated sirolimus-eluting stent showed excellent biocompatibility. During 24 weeks observation in porcine model, it was proved that this novel DES system successfully inhibited neointima hyperplasia and decreased in-stent stenosis. It is feasible to launch a clinical evaluation to improve the current prognosis of DES implantation.
文摘Background Stent-based delivery of sirolimus has been shown to reduce neointimal hyperplasia significantly. However, the long-term effect of the polymer is thought to initiate and sustain an inflammatory response and contribute to the occurrence of late complications. Our study aimed to evaluate the efficacy and safety of the BuMA biodegradable drug-coated sirolimus-eluting stent （BSES） for inhibiting neointimal hyperplasia in a porcine coronary model. Methods Four types of stents were implanted at random in different coronary arteries of the same pig： BSES （n=24）, bare metal stent （BMS） （n=24）, biodegradable polymer coated stent without drug （PCS） （n=24） and only poly （n-butyl methacrylate） base layer coated stent （EGS） （n=23）. In total, 26 animals underwent successful random placement of 95 oversized stents in the coronary arteries. Coronary angiography was performed after 28 days, 90 days and 240 days of stent implantation. After 14 days, 28 days, 90 days and 240 days, 6 animals at each timepoint were sacrificed for histomorphologic analysis. Results The 28-day, 90-day and 240-day results of quantitative coronary angiography （QCA） showed reduction in luminal loss （LL） in the BSES group when compared with the BMS group; （0.20±0.35） mm vs. （0.82±0.51） mm （P=-0.035）, （0.20±0.30） mm vs. （0.93±0.51） mm （P=-0.013）, and （0.18±0.16） mm vs. （0.19±0.24） mm （P=0.889）, respectively. By 28-day, 90-day and 240-day histomorphomeric analysis results, there was also a corresponding significant reduction in neointimal tissue proliferation with similar injury scores of BSES compared with the BMS control; average neointimal area （0.90±0.49） mm2 vs. （2.16±1.29） mm2 （P=0.049）, （1.53±0.84） mm2 vs. （3.41±1.55） mm2 （P=-0.026）, and （2.43±0.95） mm2 vs. （3.12±1.16） mm2 （P=0.228）, respectively. High magnification histomorphologic examination revealed similar inflammation scores and endothelialization scores in both the BSES and BMS groups. Conclusions The BuMA biodegradable drug-coated sirolimus-eluting stents can significantly reduce neointimal hyperplasia and in-stent restenosis. Re-endothelialization of the BuMA stent is as good as that of the BMS in the porcine coronary model due to the reduced inflammation response to the BuMA stent.
