Sirolimus-eluting stent fractures associated with aneurysm and very late stent thrombosis in the right coronary artery

Although the occurrence of coronary stent fracture is rare,recent reports showed that stent fracture after sirolimus-eluting stent(SES)implantation may be associated with neointimal hyperplasia and restenosis.We report two cases of stent fracture that occurred late after elective SES implantation into the right coronary artery(RCA)that were related to the aneurysm,restenosis,thrombosis,and vessel occlusion.……

Analysis of the effect of sirolimus-eluting stent on diabetes

Objective:To evaluate the effect of diabetes on outcome of sirolimus-eluting stent.Methods:From December 2002 to May 2005,262 diabetes and 262 non-diabetics treated with sirolimus-eluting stents were studied.The follow-up angiography was performed in 8-month.Major adverse cardiac events(MACE)defined as death,myocardial infarction,or target lesion revascularization and follow-up angiography were analyzed.Results:Successful rate of stent implantation was 100%.There was no death during the procedure,hospitalization,and follow-up period.Acute myocardial infarction occurred in 1 diabetic at 2 days after PCI,and in 2 non-diabetics at follow-up period.Angiographic follow up at 8 months showed that absolute late lumen loss was 0.06 vs 0.04mm(P>0.05),relative late lumen loss was 2.32% vs 1.63%,and TLR rate was 12.60% vs 9.92% in diabetic group and non-diabetic group respectively.Logistic regression analysis showed that reference vessel lumen and relative late lumen loss were significantly associated with restenosis.Conclusion:Cypher stent implantation in diabetes is safe and effective,while relative late lumen loss may be related to restenosis.In a word,diabetes with small vessel may be considered to be risk factor for restenosis after Cypher stents implantation.

Long-term effects of biodegradable versus durable polymercoated sirolimus-eluting stents on arterial wall morphology as assessed by virtual histology intravascular ultrasound

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.

All-Comers Study of Percutaneous Coronary Interventions with Ultrathin Strut Biodegradable-Polymer Sirolimus-Eluting Stents—ORSHINE Registry

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.

Clinical Performance of the Cobalt-Chromium Biodegradable Polymer Coated Sirolimus-Eluting Stent in an Unselected Real-World Population

OBJECTIVE: The primary objective of the S-CORE registry was to assess the safety and efficacy of the Supralimus-Core? sirolimus-eluting stent deployment for the treatment of coronary artery disease and event-free survival of patients treated with this coronary stent. METHODS: S-CORE Registry is an observational, single-arm, non-randomized, post-marketing surveillance multicenter registry in which 562 patients undergoing single or multi-vessel percutaneous coronary intervention were enrolled. The pre-specified primary outcome was the rate of major adverse cardiac events (MACE), defined as the composite of cardiac death, myocardial infarction (MI), target lesion revascularisation (TLR) and target vessel revascularisation (TVR) at 12-month post-procedure. Stent thrombosis (ST) served as the safety endpoint. RESULTS: A total of 640 lesions were treated in 562 enrolled patients (mean age 57.4 ± 10.7 years) with average stent length of 25.0 ± 9.0 mm. Stent delivery was successful in 99% cases. A total of 554 (98.6%) patients have been followed up to 12 months. The incidence of MACE at 30 days and 6 months was 7 (1.2%) and 12 (2.1%) respectively. The composite rate of MACE at a 12-month clinical follow-up was 19 (3.4%), consisting of 12 (2.1%) cardiac deaths, 0 (0%) MI, 6 (1.1%) TLR and 1 (0.2%) TVR. The long-term follow-up of this registry is going on to confirm safety and efficacy profiles. CONCLUSIONS: This multicenter registry demonstrated satisfactory safety and efficacy profiles, as evidenced by low rates of major adverse cardiac events up to 12 months, for the cobalt-chromium biodegradable polymer-based sirolimus-eluting Supralimus-Core? stent in a “real-world” setting.

A case of very late stent thrombosis after sirolimus-eluting stent implantation in a patient with provoked severe coronary spasm

A 73-year-old male patient suffered from very late stent thrombosis occurred 6 years after sirolimuseluting stent (SES) implantation in the ostial and proximal left anterior descending coronary artery (LAD). He presented emergently with cardiogenic shock and emergent coronary angiography showed thombus in the ostial stent and in the ostial left circumflex artery. Optical coherence tomography found delayed healing on the ostial stent. Acetylcholine provocation test had also shown severe provoked coronary spasm in all coronary arteries 28 months after SES implantation which suggested the association of severe coronary endothelial dysfunction as a potential mechanism of very late stent thrombosis.

Safety evaluation of the biodegradable polymer-based sirolimus-eluting stent with faster drug eluting rate and polymer absorption kinetics in complex patient and lesion subgroup

Background and Objective Previous reports from PANDA III trial had proven that BuMA biodegradable polymer(BP)sirolimus-elutingstents(SES),with faster drug eluting rate and polymer absorption kinetics,was non-inferior to the Excel SES in an all-comers population for 1-year target lesion failure(TLF),with a lower incidence of stent thrombosis(ST).The aim of the present study was to perform a safety evaluation of BuMA SES in the complex patient and lesion subgroup.

Optimized sirolimus-eluting stent by coating asymmetrically with biodegradable and cytocompatible polymers

Since the approval of the first stent by the US Food and Drug Administration,stents have been developed from bare metal stents to advanced forms such as drug-eluting stent(DES).However,after being inserted into damaged coronary arteries,even modern DES still has some problems such as late thrombosis or irregular drug release[1,2].

Sirolimus-eluting stent fractures associated with aneurysm and very late stent thrombosis in the right coronary artery

Although the occurrence of coronary stent fracture is rare, recent reports showed that stent fracture after sirolimus-eluting stent (SES) implantation may be associated with neointimal hyperplasia and restenosis. We report two cases of stent fracture that occurred late after elective SES implantation into the right coronary artery (RCA) that were related to the aneurysm, restenosis, thrombosis, and vessel occlusion.

Sirolimus-eluting Stent for the Treatment of Small Coronary Artery Lesions:Comparison between Cypher and Firebird Stent

Objectives To evaluate the effectiveness of firebird stent for the treatment of coronary de novo lesion compared with cypher stent. Methods Ninety-one consecutive patients with 156 lesions who underwent coronary cypher (n = 68 lesions) and firebird (n = 88 lesions) implantation, quantitative coronary angiography (QCA) was performed at the time of stent implantation and subsequently at 8 months post-stenting. Small vessel disease was defined as ≤2.5 mm of reference vessel diameter measured by QCA. Major adverse cardiac events (MACE) including death, thrombosis, nonfatal myocardial infarction and target lesion revascularization (TLR) were compared between the two groups. Results Baseline clinical characteristics and angiographic parameters were similar between the two groups. Seven-month angiographic follow-up, the late loss was not different between the two groups (0.14 ± 0.38 mm vs 0.13 ± 0.17 mm, P > 0.05). Similarly, overall thrombosis rate were similar in both groups (1.5% vs 1.1%, P > 0.05). However, in-stent restenosis as well as in-segment restenosis rate were significantly higher in cypher group than that in firebird group (4.4% vs 0% and 19.1% vs 3.4%, P = 0.047 and P = 0.001 respectively). TLR was also higher in the cypher group (10.3% vs 2.3%, P = 0.033) compared with firebird group. Conclusions In this small sample size, non-randomized study, the data indicated that implantation of firebird stent for the treatment of small coronary lesion showed more favorable results in respective of restenosis compared with cypher stent implantation. A multi-center, large-sample size, randomized study, therefore, may be warranted.

A novel biodegradable polymer-coated sirolimus-eluting stent:1-year results of the HELIOS registry

Background:The HELIOS stent is a sirolimus-eluting stent with a biodegradable polymer and titanium oxide film as the tie-layer.The study aimed to evaluate the safety and efficacy of HELIOS stent in a real-world setting.Methods:The HELIOS registry is a prospective,multicenter,cohort study conducted at 38 centers across China between November 2018 and December 2019.A total of 3060 consecutive patients were enrolled after application of minimal inclusion and exclusion criteria.The primary endpoint was target lesion failure(TLF),defined as a composite of cardiac death,non-fatal target vessel myocardial infarction(MI),and clinically indicated target lesion revascularization(TLR)at 1-year follow-up.Kaplan-Meier methods were used to estimate the cumulative incidence of clinical events and construct survival curves.Results:A total of 2998(98.0%)patients completed the 1-year follow-up.The 1-year incidence of TLF was 3.10%(94/2998,95%closed interval:2.54-3.78%).The rates of cardiac death,non-fatal target vessel MI and clinically indicated TLR were 2.33%(70/2998),0.20%(6/2998),and 0.70%(21/2998),respectively.The rate of stent thrombosis was 0.33%(10/2998).Age≥60 years,diabetes mellitus,family history of coronary artery disease,acute myocardial infarction at admission,and device success were independent predictors of TLF at 1 year.Conclusion:The 1-year incidence rates of TLF and stent thrombosis were 3.10%and 0.33%,respectively,in patients treated with HELIOS stents.Our results provide clinical evidence for interventional cardiologists and policymakers to evaluate HELIOS stent.Clinical trial registration:ClinicalTrials.gov,NCT03916432.

A Randomized Controlled Trial of a Biodegradable Polymer,Microcrystalline Sirolimus-Eluting Stent(MiStent)versus Another Biodegradable Polymer Sirolimus-Eluting Stent(TIVOLI):The DESSOLVE-C Trial

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.

Efficacy and safety of Firebird sirolimus-eluting stent in treatment of complex coronary lesions in Chinese patients： one-year clinical and eight-month angiographic outcomes from the FIREMAN registry

Background Off-label application of drug-eluting stents （DES） during percutaneous coronary intervention （PCI） was not uncommon in daily practice, however DES in treating Chinese patients with complex lesion subset was under-investigated. The primary objective of the FIREMAN registry was to evaluate the long term efficacy and safety of the Firebird sirolimus-eluting stent （SES） in treating patients with complex coronary lesions. Here we report the mid-term of one-year clinical outcomes and eight-month angiographic follow-up results of FIREMAN registry.Methods The FIREMAN registry was a prospective multi-center registry, which included 1029 consecutive patients undergoing PCI with Firebird SES implantation between September 2006 and July 2007 in 45 centers in China. The clinical follow-up was designed to be performed at 1, 6, 12, 18, 24, 30 and 36 months post index procedure, and non-mandatory angiographic follow-up at 8 months was planned. One hundred percent site monitoring was conducted.Results Long lesions （59.2%）, multi-vessel disease （50.4%）, and small vessel disease （31.6%） were mostly found in angiography. Major adverse cardiac events （MACE） occurred in 51 （5.1%） patients at 1 year clinical follow-up,including cardiac mortality in 6 （0.6%）, non-fatal myocardial infarction in 11 （1.1%）, and target lesion revascularization in 36 （3.5%） of the patients. Definite and probable stent thrombosis （ST） by Academic Research Consortium （ARC） definition occurred in 12 （1.36%） patients at one-year clinical follow-up. The 8-month binary restenosis rate was 5.7% in-segment and 4.3% in-stent, respectively. Late lumen loss was （0.21±0.40） mm in-segment and （0.23±0.36） mm in-stent, respectively. Furthermore, Cox regression analysis revealed that diabetes, small vessel diameter, and chronic total occlusion were independent predictors of ST.Conclusions The results showed that the Firebird SES was effective and safe in treating Chinese patients with complex coronary lesions and occurrence of ST rate at one-year clinical follow-up was acceptable, however further long-term follow-up was still necessary. （NCT00552656）

Nine-month angiographic and two-year clinical follow-up of polymer-free sirolimus-eluting stent versus durable-polymer sirolimus-eluting stent for coronary artery disease： the Nano randomized trial

Background First generation drug-eluting stents （DES） were associated with a high incidence of late stent thrombosis （ST）,mainly due to delayed healing and re-endothelization by the durable polymer coating.This study sought to assess the safety and efficacy of the Nano polymer-free sirolimus-eluting stent （SES） in the treatment of patients with de novo coronary artery lesions.Methods The Nano trial is the first randomized trial designed to compare the safety and efficacy of the Nano polymer-free SES and Partner durable-polymer SES （Lepu Medical Technology,Beijing,China） in the treatment of patients with de novo native coronary lesions.The primary endpoint was in-stent late lumen loss （LLL） at 9-month follow-up.The secondary endpoint was major adverse cardiac events （MACE）,a composite of cardiac death,myocardial infarction or target lesion revascularization.Results A total of 291 patients （Nano group：n=143,Partner group：n=148） were enrolled in this trial from 19 Chinese centers.The Nano polymer-free SES was non-inferior to the Partner durable-polymer DES at the primary endpoint of 9 months （P 〈0.001）.The 9-month in-segment LLL of the polymer-free Nano SES was comparable to the Partner SES （0.34±0.42） mm vs.（0.30±0.48） mm,P=0.21）.The incidence of MACE in the Nano group were 7.6% compared to the Partner group of 5.9% （P=0.75） at 2 years follow-up.The frequency of cardiac death and stent thrombosis was low for both Nano and Partner SES （0.8% vs.0.7%,0.8% vs.1.5%,both P=1.00）.Conclusions In this multicenter randomized Nano trial,the Nano polymer-free SES showed similar safety and efficacy compared with the Partner SES in the treatment of patients with de novo coronary artery lesions.Trials in patients with complex lesions and longer term follow-up are necessary to confirm the clinical performance of this novel Nano polymer-free SES.

Six-month clinical outcomes of Firebird 2TM sirolimus-eluting stent implantation in real-world patients with coronary artery diseases

Background The Firebird 2TM sirolimus-eluting stent （Firebird 2 stent） is a second-generation sirolimus-eluting stent which has a cobalt-chromium alloy stent platform, a brand new bracket structure, and two layers of styrene-butylenes-styrene polymer coatings with better biocompatibility. The Firebird 2TM cObalt-Chromium alloy sirolimus-elUting Stent registry （FOCUS registry） aimed to evaluate the safety and efficacy of the Firebird 2 stent in patients with coronary artery disease in daily practice.Methods The FOCUS registry is a prospective, non-randomized, international multi-center, single-arm clinical registry.Between March 2009 and February 2010, 5084 patients receiving at least 1 Firebird 2 stent during daily clinical practice at 83 medical centers were enrolled.Results Of the 5084 patients enrolled in the registry, 5077 and 5058 were respectively available for 30 days and 6 months follow-up. The 30-day rate of major adverse cardiac events （MACE） was 1.20%, including 13 cardiac deaths, 46 non-fatal myocardial infarction （MI）, and 6 target vessel revascularization （TVR）. At 6 months follow-up, the rate of MACE was 1.80%. There were 32 cardiac deaths, 48 non-fatal MI, and 15 TVR. According to the Academic Research Consortium definition, definite/probable stent thrombosis （ST） occurred in 0.43% （22/5058） of patients, including 8 cases of acute ST, 11 subacute ST, and 3 late ST.Conclusion The Firebird 2 stent showed the promising efficacy and safety at 30 days and 6 months in a real-world population of patients with coronary artery diseases.

Influence of insulin resistance on long-term outcomes in patients with coronary artery disease after sirolimus-eluting stent implantation

Background Insulin resistance（IR）is significantly associated with coronary artery disease and cardiovascular events in patients with or without type 2 diabetes mellitus.This study aimed to evaluate the influence of IR on long-term outcomes of patients undergoing percutaneous coronary intervention（PCI）with sirolimus-eluting stent（SES）implantation.Methods A total of 467 consecutive patients undergoing SES-based PCI were divided into lR group（n=104）and non-IR group（n=363）.The patients were followed up for one year.The rate of major adverse cardiac events（MACEs） including death, non-fatal myocardial infarction and recurrent angina pectoris was compared by the log-rank test,and the independent risk factors were identified by the Cox regression analysis.Results MACEs occurred more frequently,and cumulative survival rate was lower in the IR group than in the non-IR group during the follow-up （all P〈0.05）.IR was an independent risk factor for the occurrence of cardiac death and non-fatal myocardial infarction（OR=2176,95% CI=1.35-5.47,P=0.034）.Old age,diabetes,and multi-vessel disease were determinants for recurrent angina pectoris after PCI（P〈0.05）.Subgroup analysis revealed that IR（OR=3.35,95% CI=1.07-13.59,P=0.013）and multi-vessel disease（OR=2.19,95%CI=1.01-5.14,P=0.044）were independent risk predictors for recurrent angina pectoris in patients with diabetes after PCI.Conclusions IR is associated with reduced MACE-free survival and remains an independent predictor for recurrent angina pectoris after PCI with SES implantation.

Neointimal coverage of sirolimus-eluting stents 6 months and 12 months after implantation： evaluation by optical coherence tomography

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,

Comparison of long-term clinical outcome after successful implantation of FIREBIRD and CYPHER sirolimus-eluting stents in daily clinical practice： analysis of a large single-center registry

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.

Acute coronary syndrome is an independent risk factor for late incomplete stent apposition after sirolimus-eluting stent implantation

Background Late incomplete stent apposition （ISA） may occur after drug-eluting stent implantation, affecting long-term clinical outcomes. This study aimed to evaluate the impact of clinical presentations of coronary artery disease on late ISA after percutaneous coronary intervention （PCI） with sirolimus-eluting stents （SES） by means of three-dimensional volumetric intravascular ultrasound （IVUS） analyses. Methods One hundred and thirty-seven patients with coronary artery disease received SES implantation during PCI and had repeat angiography with IVUS examination. All patients were followed up one year after the procedure. Results In overall 219 treated lesions （137 patients）, late ISA was identified in 25 lesions （16 patients）. Clinical diagnosis of acute coronary syndrome （ACS） and use of long stents were more common in patients with than in those without late ISA. Patients with late ISA had greater external elastic membrane （EEM） area in stented segment （（15.34±5.44） vs （13.83±4.51） mm^2, P=0.026）, stented-to-reference segment EEM area ratio （1.13±0.22 vs 1.02±0.18, P 〈0.001）, and plaque and media area （（8.43±3.93） vs （7.01±2.93） mm^2, P =0.002） than in those without late ISA. Multivariate Logistic regression analysis showed that clinical diagnosis of ACS and use of long stents were independent risk factors for late ISA （OR 6.477, 95%CI 2.297-18.263, P 〈0.001; OR 3.680, 95%Cl 1.181-11.469, P =0.025; respectively）. During one-year follow-up after IVUS examination, the rate of very late stent thrombosis tended to be higher in patients with than in those without late ISA （18.7% vs 3.3%, P =0.051）. Conclusions The occurrence of late ISA after SES implantation may be related to clinical status, use of long stents, and marked positive vessel remodeling. Late ISA tended to increase the rate of very late stent thrombosis during follow-up, highlighting the importance of long-term dual antiplatelet therapy for these patients.

A randomized, prospective, two-center comparison of sirolimus-eluting stent and zotarolimus-eluting stent in acute ST-elevation myocardial infarction： The SEZE trial

Background The zotarolimus-eluting stent has shown larger in-stent late lumen loss compared to sirolimus-eluting stents in previous studies. However, this has not been thoroughly evaluated in ST elevation myocardial infarction. Methods This was a prospective, randomized, controlled trial evaluating angiographic outcomes in patients presenting with ST elevation myocardial infarction, treated with zotarolimus-eluting stents or sirolimus-eluting stents. From March 2007 to February 2009, 122 patients were randomized to zotarolimus-eluting stents or sirolimus-eluting stents in a 1：1 fashion. The primary endpoint was 9-month in-stent late lumen loss confirmed by coronary angiography, and secondary endpoints were percent diameter stenosis, binary restenosis rate, major adverse cardiac events （a composite of cardiac death, non-fatal myocardial infarction, and target vessel revascularization）, and late-acquired incomplete stent apposition. Results Angiographic in-stent late lumen loss was significantly higher in the zotarolimus-eluting stent group compared to the sirolimus-eluting stent group （（0.49±0.65） mm vs. （0.10±0.46） mm, P=0.001）. Percent diameter stenosis at 9-month follow-up was also larger in the zotarolimus-eluting stent group （（30.0±17.9）% vs. （17.6±14.0）%, P 〈0.001）. In-segment analysis showed similar findings. There were no significant differences in binary restenosis rate, major adverse cardiac events, and late-acquired incomplete stent apposition. Conclusions Compared to sirolimus-eluting stents, the zotarolimus-eluting stent is associated with significantly higher in-stent late lumen loss at 9-month angiographic follow-up in the treatment of ST elevation myocardial infarction. Although there was no significant difference in 1-year clinical outcomes, the clinical implication of increased late lumen loss should be further studied.