依维莫司生物可吸收血管支架与药物洗脱金属支架在冠状动脉疾病应用中临床结局比较的meta分析（英文）

目的探讨生物可吸收血管支架(everolimus-eluting bioresorbable vascular scaffold,BVS)和依维莫司药物洗脱金属支架(everolimus-eluting metallic stents,EES)在冠状动脉疾病(coronary artery diseases,CAD)应用中的中长期临床结局的meta分析,为临床决策提供参考依据。方法系统地检阅了电子数据库以及最新国际心血管会议记录,检索时间截止至2018年1月8日,收集已公布相关临床研究的最新随访数据并采用stata 12.0软件进行统计分析。结果最终共纳入11项临床研究,包括7项随机对照试验,总计7 321位患者。meta分析结果显示,BVS组较EES组有更高的明确/极可能支架内血栓(stent/scaffold thrombosis,ST)发生率[比值比(OR)=3.08,95%CI:2.04-4.66,P0.01],其中早期(OR=2.26,95%CI:1.26-4.03,P=0.006)及极晚期ST(OR=4.46,95%CI:2.01-9.89,P0.01)发生率均显著高于EES组。BVS植入患者在靶病变失败(OR=1.34,95%CI:1.11 to 1.60,P0.01)、靶血管心肌梗死(OR=1.71,95%CI:1.31-2.23,P0.01)、有临床指征的靶病变血运重建(OR=1.51,95%CI:1.15-2.00,P0.01)以及总心肌梗死(OR=1.52,95%CI:1.22-1.90,P0.01)的发生率上均较EES组增多。然而,两组在面向患者的复合终点、心因死亡、全因死亡以及全血运重建等发生率上并无显著性差异。结论BVS在冠状动脉疾病应用中的中长期临床结局劣于EES,但仍需更多大型长期临床随机对照试验进一步论证。     

依维莫司药物洗脱支架和西罗莫司药物洗脱支架对冠心病疗效的Meta分析

目的比较依维莫司药物洗脱支架(everolimus-eluting stent,EES)与西罗莫司药物洗脱支架(sirolimuseluting stent,SES)治疗冠状动脉粥样硬化性心脏病(冠心病)的疗效。方法计算机检索Pub Med、MEDLINE、Cochrane Central Register of Controlled Trials、CNKI全文数据库,收集2007年1月至2013年12月公开发表的有关EES和SES疗效比较的随机对照试验(randomized controlled trials,RCT),手检已获文献的参考文献、会议摘要及相关网站。对文献质量进行严格评价后,对符合要求的RCTs进行资料提取并采用Rev Man4.2软件进行Meta分析。结果共纳入14项RCTs,Meta分析显示,EES组与SES组之间主要心血管事件(MACE)发生率(OR=0.94,95%CI:0.76~1.17,P=0.60)、心源性死亡发生率(OR=0.97,95%CI:0.74~1.27,P=0.81)、心肌梗死发生率(OR=1.03,95%CI:0.83~1.27,P=0.80)、血运重建发生率(OR=0.89,95%CI:0.76~1.04,P=0.15)均差异无统计学意义;但EES组确定或者可能的支架内血栓发生率低于SES组,差异有统计学意义(OR=0.65,95%CI:0.44~0.97,P=0.04)。结论在冠心病支架介入治疗中,EES能更显著降低支架术后的支架内血栓的发生率,但在主要心血管事件发生率、心源性死亡发生率、心肌梗死发生率、血运重建发生率与SES相似。     

依维莫司药物洗脱支架与西罗莫司药物洗脱支架治疗冠心病疗效的Meta分析

目的 比较依维莫司药物洗脱支架（everolimus-eluting stent,EES）与西罗莫司药物洗脱支架（sirolimus-eluting stent,SES）治疗冠心病的疗效与安全性.方法 计算机检索PubMed、MEDLINE、Cochrane Central Register of Controlled Trials、CNKI全文数据库,收集2007年1月至2012年12月公开发表的有关EES和SES疗效和安全性比较的随机对照试验（RCT）,同时辅以手检纳入文献的参考文献.对文献质量进行严格评价后,符合要求的RCTs进行资料提取及采用RevMen5.1软件进行Meta分析.结果 共纳入7项RCTs,Meta分析显示：EES组与SES组之间病死率（OR=0.98,95%CI：0.85～1.12,P=0.75）、心源性病死率（OR=1.05,95%CI：0.88～1.25,P=0.57）、靶病变血运重建（TLR）率（OR=0.92,95%CI：0.65～1.31,P=0.65）、主要心脏不良事件（MACE）发生率（OR=0.95,95%CI：0.77～1.18,P=0.66）、支架内血栓发生率（OR=0.80,95%CI：0.49～1.32,P=0.39）、支架内再狭窄发生率（OR=0.89,95%CI：0.26～3.04,P=0.85）均无统计学差异,但EES组心肌梗死发生率低于SES组（OR=0.66,95%CI：0.53～0.80,P＜0.001）有统计学差异.结论 在冠心病支架介入治疗中,EES能更显著降低支架术后的心肌梗死的发生率,但在病死率,心源性病死率,TLR、MACE、支架内血栓和支架内再狭窄的发生率方面,与SES相似.     

经皮冠状动脉介入治疗术中应用生物可吸收支架的安全性和有效性的系统评价

目的以随机对照试验(RCT)为依据,比较生物可吸收支架(BVS)对比依维莫司洗脱支架(EES)在冠状动脉粥样硬化性心脏病(冠心病)介入治疗中的安全性和有效性。方法计算机检索数据库PubMed、Embase、Web of Science和Cochrane Library,并追踪获取文献,查询时间从2008年1月至2017年9月,根据改良Jadad量表评价文献质量并提取资料,运用Review Manager 5.3软件进行Meta分析。结果通过检索共纳入7项对比BVS及EES的RCT,随访时间从9个月～3年,共5546例患者,其中BVS组3241例、EES组2305例。Meta分析结果显示,应用BVS的患者发生心肌梗死(OR=1.55,95%CI:1.22～1.96,P=0.0003)、靶血管心肌梗死(OR=1.73,95%CI:1.32～2.27,P0.0001)、支架内血栓(OR=3.62,95%CI:2.12～6.18,P0.0001)的风险高于应用EES患者,但在全因死亡(P=0.1)、心源性死亡(P=0.42)、所有血运重建(P=0.10)、靶病变血运重建(P=0.06)对比中两组差异无统计学意义。同时,在各项复合终点的对比中,BVS组的主要心血管不良事件(OR=1.37,P=0.0003)、面向患者的复合终点(OR=1.21,P=0.005)、面向装置的复合终点(OR=1.41,P=0.002)、靶病变失败(OR=1.44,P0.0001)的发生率均高于EES组。结论在目前的冠心病介入治疗随访中,BVS的安全性和有效性无论是短期还是长期均不优于EES。临床应用BVS应当更加谨慎,在新一代BVS投入应用之前,现行的治疗方案仍需大量的、更长时间的随访来验证。     

生物可吸收支架与依维莫斯洗脱支架在经皮冠状动脉介入治疗中的安全性和有效性Meta分析

目的:系统评价生物可吸收支架(BVS)与依维莫司洗脱支架(EES)在经皮冠状动脉介入治疗(PCI)中的安全性和有效性。方法:计算机检索Pub Med、MEDILINE、EMBASE、Cochrane library、知网、万方等数据库,检索时限从建库到2017-10。同时查阅会议摘要和相关网站,收集已公布随访数据的有关随机对照试验。根据改良Jadad量表评价文献质量并提取资料,运用Review Manager 5.3软件进行Meta分析。主要的有效性终点和安全性终点为靶病变失败和支架内血栓形成。结果:共纳入9篇随机对照研究,共包含6 721例患者,其中BVS组3 670例,EES组3 051例。随访时间为6~36个月。Meta分析结果:BVS组靶病变失败(RR=1.31,95%CI:1.08~1.58,P=0.005)、支架内血栓形成(RR=2.89,CI:1.85~4.53,P0.0001)、缺血驱动靶病变血运重建(RR=1.44,95%CI:1.12~1.86,P=0.005)、靶血管心肌梗死(RR=1.74,95%CI:1.33~2.27,P0.0001)及所有心肌梗死(RR=1.49,95%CI:1.16~1.91,P=0.002)均高于EES组;全因死亡(RR=0.87,95%CI:0.57~1.33,P=0.520),心原性死亡(RR=0.78,95%CI:0.54~1.11,P=0.160)及患者相关的复合终点(RR=1.10,95%CI:0.95~1.27,P=0.210),两组差异均无统计学意义。结论:在PCI中BVS与EES相比安全性和有效性较低。BVS的安全性和有效性仍然需要更长时间的、大量的临床研究来论证。     

生物可吸收支架与药物洗脱支架在急性心肌梗死治疗中的安全性和有效性Meta分析

目的系统评价生物可吸收支架(BVS)与药物洗脱支架(DES)在治疗急性心肌梗死(AMI)中的安全性和有效性。方法计算机检索PubMed、Cochrane Library、Embase、Web of Science及相关网站(www.clinicaltrials.gov)。纳入2006年1月至2020年1月关于BVS与DES治疗AMI安全性与有效性的研究。主要有效终点为靶病变血运重建,主要安全终点为明确/可能的支架内血栓形成。由两名研究者按照纳入与排除标准筛选文献,提取资料和评价文献质量。采用Stata 12.0统计软件进行Meta分析。结果最终纳入4个临床研究,其中2个为随机对照研究,2个为观察性研究,共1335例患者,其中BVS组709例,DES组626例。随访时间为12~36个月。Meta分析结果:BVS组与DES组靶病变血运重建(RR 1.59,95%CI 0.82~3.10,P=0.337)、明确/可能的支架内血栓形成(RR 1.56,95%CI 0.70~3.46,P=0.685)的差异均无统计学意义。两组靶血管心肌梗死(RR 1.05,95%CI 0.41~2.67,P=0.667)、全因死亡(RR 1.35,95%CI 0.52~3.45,P=0.871)、心原性死亡(RR 1.29,95%CI 0.59~2.80,P=0.778)、设备相关的复合终点(RR 1.37,95%CI 0.87~2.16,P=0.425)的差异均无统计学意义。结论BVS治疗AMI的安全性与有效性可能不劣于DES。     

生物可吸收支架与钴铬合金依维莫司洗脱支架治疗冠心病的Meta分析

目的:系统评价Absorb生物可吸收支架(BVS)对比钴铬合金依维莫司洗脱支架(cobalt chromium-everolimus eluting stent,CoCr-EES)在冠心病介入治疗中的安全性和有效性。方法:计算机检索Pub Med、Embase、Cochrane图书馆、CNKI和万方数据库,检索年限为2008-01至2015-10,同时查阅会议摘要和相关网站,收集已公布随访数据的有关随机对照试验。根据改良Jadad量表评价文献质量并提取资料,运用STATA 12.0软件进行Meta分析。结果:最终纳入4项随机对照研究,共包含3 389例患者(Absorb BVS组2 164例,CoCr-EES组1 225例)。在平均1.1年的随访时间内,Absorb BVS组与CoCr-EES组患者在临床终点靶病变失败[比值比(OR)=1.29,95%可信区间(CI):0.95~1.74,P=0.10]、全因死亡(OR=1.31,95%CI:0.60~2.87,P=0.50)、心原性死亡(OR=1.38,95%CI:0.45~4.24,P=0.57)、心肌梗死(OR=1.30,95%CI:0.93~1.80,P=0.12)、确定的或极有可能的支架内血栓(OR=2.08,95%CI:0.95~4.54,P=0.07)、再次血运重建(OR=1.03,95%CI:0.80~1.33,P=0.81)、靶病变血运重建(OR=1.06,95%CI:0.67~1.66,P=0.81)和患者相关的复合终点(OR=0.95,95%CI:0.66~1.35,P=0.76)差异均无统计学意义。结论:在心绞痛和无症状性心肌缺血的中、低危冠心病患者中,AbsorbBVS与CoCr-EES具有相似的安全性和有效性。Absorb BVS应用于治疗冠心病患者的疗效仍有待更长的随访时间、更多的大型随机对照试验证实。     

佐他莫司药物洗脱支架和依维莫司药物洗脱支架二年临床疗效比较

目的:比较佐他莫司药物洗脱支架(ZES)和依维莫司药物洗脱支架(EES)的2年临床疗效。方法:纳入2013年在中国医学科学院阜外医院初次行经皮冠状动脉介入治疗(PCI)的患者2655例,根据支架类型分为两组:ZES组(n=1637)和EES组(n=1018)。2年随访的主要终点为主要不良心血管事件(MACE),包括死亡、非致死性心肌梗死和靶血管血运重建。结果:两组患者的人口学特征、危险因素和既往史、实验室检查结果以及药物应用方面均相似(P均>0.05)。在冠状动脉病变和介入治疗方面,与EES组相比,ZES组SYNTAX积分更高,左主干病变、B2/C型病变的比例更高,置入的支架直径更大、长度更长(P均<0.05)。2年随访结果显示,ZES组与EES组中MACE(5.4%vs 4.9%)以及各独立终点事件的发生率差异均无统计学意义(P均>0.05)。结论:以ZES和EES为代表的新一代药物洗脱支架临床应用安全、有效;2年随访结果显示,两种支架MACE发生率差异无统计学意义。     

急性ST段抬高心肌梗死的最佳支架植入时机:即刻与延迟植入比较的Meta分析

目的:收集比较有关发生急性ST段抬高心肌梗死(STEMI)时即刻植入支架(IS)和延迟植入支架(DS)的随机对照和队列研究,对其结果进行系统评价和Meta分析,比较IS和DS的安全性和有效性。方法:在PubMed、Cochrane Library、中国知网3大数据库检索2017年5月前关于比较IS和DS安全性和有效性的文章,将IS患者作为实验组(IS组),DS患者组作为对照组(DS组),以主要心脏不良事件(MACE)发生率、慢血流/无复流发生率、远端栓塞发生率、靶病变血管开通率(TIMI 3级)、靶血管再次血运重建(TVR)率、主要出血发生率、再次心肌梗死发生率作为观察指标,使用Review Manager 5.3软件进行Meta分析,计算对应的OR值和95%CI,并分析异质性及其来源。结果:最终有8篇文献纳入Meta分析,包括2 181例患者,其中IS组1 262例,DS组919例。与IS相比,DS能够显著降低慢血流/无复流发生率(OR=4.55,95%CI:2.14~9.68)、远端栓塞发生率(OR=9.14,95%CI:3.47~24.10),提高靶病变血管开通率(TIMI 3级)(OR=0.22,95%CI:0.12~0.43);然而两组在MACE发生率、TVR率、再次心肌梗死发生率、主要出血发生率方面相比无明显差异。结论:在STEMI患者中,DS与IS在MACE发生率、TVR、再次心肌梗死发生率与主要出血发生率方面无明显差异;DS慢血流/无复流发生率与远端栓塞发生率均较IS低,靶病变血管开通率(TIMI 3级)较IS高。     

生物可吸收支架在急性冠状动脉综合征中应用的Meta分析

目的评价生物可吸收支架(bioresorbable vascular scaffold,BVS)在急性冠状动脉综合征(acute coronary syndrome,ACS)患者中临床应用的有效性和安全性。方法在线检索Pub Med、EMBase及the Cochrane library等数据库和美国心脏病学院、美国心脏协会及欧洲心脏病学会相关会议论文或摘要,以及一些相关专业网址(www.tctmd.com,www.crtonline.org和www.clinicaltrial.gov)等。根据纳入标准与排除标准筛选文献。结果的处理和统计分析通过Stata12.0软件实现。结果共提取7个研究,计2206例患者在相应的随访期间里可提取有效的临床终点事件数据。统计分析显示,BVS组与药物洗脱支架(drug eluting stent,DES)组相比,两组患者主要不良心血管事件(major adverse cardiovascular events,MACE)发生情况在随访时间分别为6个月、≥12个月、24个月时的差异均无统计学意义;心源性死亡率在随访时间分别为6个月、≥12个月、24个月时的差异均无统计学意义;两组间全因死亡、心肌梗死及靶病变再次血运重建发生率比较,差异均无统计学意义;BVS组总体血栓发生率与DES组相比,差异有统计学意义(2.1%比1.0%,RR 2.02,95%CI 1.01~4.06,P=0.034)。结论在ACS患者中置入BVS,与目前广泛使用的DES相比,MACE发生率、死亡率(心源性死亡及全因死亡)、心肌梗死及靶病变再次血运重建发生率均相当,但是BVS组血栓事件的发生率较高。受纳入研究数量和质量的限制,上述结论尚需开展更多高质量随机对照试验予以验证。     

Comparison of in vivo acute stent recoil between the bioabsorbable everolimus-eluting coronary stent and the everolimus-eluting cobalt chromium coronary stent: insights from the ABSORB and SPIRIT trials.

OBJECTIVES: This study sought to evaluate and compare in vivo acute stent recoil of a novel bioabsorbable stent and a metallic stent. BACKGROUND: The bioabsorbable everolimus-eluting coronary stent (BVS) is composed of a poly-L-lactic acid backbone, coated with a bioabsorbable polymer containing the antiproliferative drug, everolimus, and expected to be totally metabolized and absorbed in the human body. Because the BVS is made from polymer, it may have more acute recoil than metallic stents in vivo. METHODS: A total of 54 patients, who underwent elective stent implantation for single de novo native coronary artery lesions, were enrolled: 27 patients treated with the BVS and 27 patients treated with the everolimus-eluting cobalt chromium stent (EES). Acute absolute recoil, assessed by quantitative coronary angiography, was defined as the difference between mean diameter of the last inflated balloon at the highest pressure (X) and mean lumen diameter of the stent immediately after the last balloon deflation (Y). Acute percent recoil was defined as (X - Y)/X and expressed as a percentage. RESULTS: Acute absolute recoil of the BVS and EES was 0.20 +/- 0.21 mm and 0.13 +/- 0.21 mm, respectively (P = 0.32). Acute percent recoil was 6.9% +/- 7.0% in the BVS group and 4.3% +/- 7.1% in the EES group (P = 0.25). CONCLUSIONS: In vivo acute stent recoil of the BVS is slightly larger but insignificantly different from that of the EES, implying that the BVS may have good radial strength similar to the metallic stent.     

Outcomes after unrestricted use of everolimus-eluting stent compared to paclitaxel- and sirolimus-eluting stents

Compared to paclitaxel-eluting stents (PESs) and sirolimus-eluting stents (SESs), a paucity of data exists regarding the clinical outcome of everolimus-eluting stents (EESs) in unselected patients with the entire spectrum of obstructive coronary artery disease. The present study cohort included 6,615 consecutive patients at Washington Hospital Center who underwent coronary artery stent implantation with EESs (n = 519), PESs (n = 2,036), or SESs (n = 4,060). Patients who received bare metal stents, zotarolimus-eluting stents, or 2 different drug-eluting stent types were excluded. The analyzed clinical end points were death, death or Q-wave myocardial infarction, target lesion revascularization (TLR), target vessel revascularization, definite stent thrombosis, and major adverse cardiac events, defined as the composite of death, Q-wave myocardial infarction, or TLR at 1 year. The groups were well matched for the conventional risk factors for coronary artery disease, except for systemic hypertension, which differed among the groups. The unadjusted end points for EESs and PESs were death (4.5% vs 7.1%; p = 0.03), TLR (3.4% vs 4.6%; p = 0.24), target vessel revascularization (5.6% vs 7.1%; p = 0.46), death or Q-wave myocardial infarction (4.5% vs 7.4%; p = 0.02), and definite stent thrombosis (0.0% vs 0.7%; p = 0.09). The unadjusted end points for EES and SES were death (4.5% vs 5.2%; p = 0.45), TLR (3.4% vs 5.8%; p = 0.3), target vessel revascularization (5.6% vs 8.6%; p = 0.05), death or Q-wave myocardial infarction (4.5% vs 5.4%; p = 0.39), and definite stent thrombosis (0.0% vs 1.08%; p = 0.003). The rates of major adverse cardiac events were similar among the 3 groups. After multivariate analysis, the rate of death or Q-wave myocardial infarction between the EES and PES groups was no longer significant (hazard ratio 1.14, 95% confidence interval 0.59 to 2.20, p = 0.70). In conclusion, the results of the present study suggest the use of EES in routine clinical practice is both safe and effective but offers no clinically relevant advantage in terms of hard end points compared to PES or SES.     

Comparison of Everolimus-Eluting and Sirolimus-Eluting Coronary Stents: 1-Year Outcomes from the Randomized Evaluation of Sirolimus-Eluting Versus Everolimus-Eluting Stent Trial (RESET)

BACKGROUND: Several recent randomized trials comparing everolimus-eluting stent (EES) and sirolimus-eluting stent (SES) reported similar outcomes. However, only 1 trial was powered for a clinical end point, and no trial was powered for evaluating target-lesion revascularization. METHODS AND RESULTS: Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial is a prospective multicenter randomized open-label trial comparing EES with SES in Japan. The trial was powered for evaluating noninferiority of EES relative to SES in terms of target-lesion revascularization. From February and July 2010, 3197 patients were randomly assigned to receive either EES (1597 patients) or SES (1600 patients). At 1 year, the primary efficacy end point of target-lesion revascularization occurred in 65 patients (4.3%) in the EES group and in 76 patients (5.0%) in the SES group, demonstrating noninferiority of EES to SES (P(noninferiority)<0.0001, and P(superiority)=0.34). Cumulative incidence of definite stent thrombosis was low and similar between the 2 groups (0.32% versus 0.38%, P=0.77). An angiographic substudy enrolling 571 patients (EES, 285 patients and SES, 286 patients) demonstrated noninferiority of EES relative to SES regarding the primary angiographic end point of in-segment late loss (0.06±0.37 mm versus 0.02±0.46 mm, P(noninferiority)<0.0001, and P(superiority)=0.24) at 278±63 days after index stent implantation. CONCLUSIONS: One-year clinical and angiographic outcome after EES implantation was noninferior to and not different from that after SES implantation in a stable coronary artery disease population with relatively less complex coronary anatomy. One-year clinical outcome after both EES and SES use was excellent with a low rate of target-lesion revascularization and a very low rate of stent thrombosis. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01035450.     

Preventable effects of bare-metal stent on restenosis after everolimus-eluting stent deployment

This case report describes a patient who underwent implantation of a bare-metal stent (BMS) for the treatment of everolimus-eluting stent (EES) restenosis caused by chronic stent recoil, and the BMS successfully escaped from duplicate restenosis and target lesion revascularization (TLR).     

Long-term (three-year) safety and efficacy of everolimus-eluting stents compared to paclitaxel-eluting stents (from the SPIRIT III Trial)

The safety and efficacy of the XIENCE V everolimus-eluting stent (EES) compared to the Taxus Express(2) paclitaxel-eluting stent (PES) has been demonstrated through 2 years in the SPIRIT II and III randomized clinical trials, but limited longer-term data have been reported. In the SPIRIT III trial, 1,002 patients with up to 2 lesions in 2 coronary arteries were randomized 2:1 to EESs versus PESs at 65 United States sites. At completion of 3-year follow-up, treatment with EES compared to PES resulted in a significant 30% decrease in the primary clinical end point of target vessel failure (cardiac death, myocardial infarction, or ischemic-driven target vessel revascularization, 13.5% vs 19.2%, hazard ratio 0.70, 95% confidence interval 0.50 to 0.96, p = 0.03) and a 43% decrease in major adverse cardiovascular events, cardiac death, myocardial infarction, or ischemic-driven target lesion revascularization (9.1% vs 15.7%, hazard ratio 0.57, 95% confidence interval 0.39 to 0.83, p = 0.003). In a landmark analysis, major adverse cardiovascular events were decreased to a similar extent with EES compared to PES 0 through 1 year and 1 year through 3 years (hazard ratio 0.56, 95% confidence interval 0.35 to 0.90; hazard ratio 0.59, 95% confidence interval 0.31 to 1.11, respectively). In conclusion, patients treated with EES rather than PES in the SPIRIT III trial had significantly improved event-free survival at 3 years. From 1 year to 3 years hazard curves continued to diverge in favor of EES, consistent with an improving long-term safety and efficacy profile of EES compared to PES, with no evidence of late catchup.     

Biodegradable polymer stents vs second generation drug eluting stents:A meta-analysis and systematic review of randomized controlled trials

AIM: To evaluate the premise, that biodegradable polymer drug eluting stents(BD-DES) could improve clinical outcomes compared to second generation permanent polymer drug eluting stents(PP-DES), we pooled the data from all the available randomized control trials(RCT) comparing the clinical performance of both these stents.METHODS: A systematic literature search of Pub Med, Cochrane, Google scholar databases, EMBASE, MEDLINE and SCOPUS was performed during time period of January 2001 to April 2015 for RCT and comparing safety and efficacy of BD-DES vs second generation PP-DES. The primary outcomes of interest were definite stent thrombosis, target lesion revascularization, myocardial infarction, cardiac deaths and total deaths during the study period. RESULTS: A total of 11 RCT's with a total of 12644 patients were included in the meta-analysis, with 6598 patients in BD-DES vs 6046 patients in second generation PP-DES. The mean follow up period was 16 mo. Pooled analysis showed non-inferiority of BD-DES, comparing events of stent thrombosis(OR = 1.42, 95%CI: 0.79-2.52, P = 0.24), target lesion revascularization(OR = 0.99, 95%CI: 0.84-1.17, P = 0.92), myocardial infarction(OR = 1.06, 95%CI: 0.86-1.29, P = 0.92), cardiac deaths(OR = 1.07, 95%CI 0.82-1.41, P = 0.94) and total deaths(OR = 0.96, 95%CI: 0.80-1.17, P = 0.71).CONCLUSION: BD-DES, when compared to second generation PP-DES, showed no significant advantage and the outcomes were comparable between both the groups.     

The Pt-Cr everolimus-eluting stent with bioabsorbable polymer in the treatment of patients with acute coronary syndromes. Results from the SYNERGY ACS registry

ObjectivesWe investigated the safety and efficacy of the bioabsorbable polymer-coated, everolimus-eluting coronary stent (SYNERGY) stent in a real-world study population with acute coronary syndromes (ACS).BackgroundA number of clinical trials support the overall efficacy and safety of the SYNERGY stent. However, a recent trial (TIDES-ACS) in the context of ACS reported worrying figures of infarction and definite/probable stent thrombosis in the SYNERGY control arm.MethodsThis is a multicenter registry (10 centers) including consecutive patients with ACS (unstable angina, non-ST elevated myocardial infarction, ST elevated myocardial infarction) who underwent percutaneous revascularization with the implantation of SYNERGY stent. The primary endpoint was the composite of cardiac death, myocardial infarction and target lesion revascularization at 12 months.ResultsA total of 1008 patients were included with age 65.4 ± 14.8 years, 23.8% females and a 24.5% diabetics. Regarding presentation, a 15.2% with unstable angina, 43% with non-ST elevated myocardial infarction and 41.8% with ST elevated myocardial infarction. Primary outcome was met in 3% (7% in SYNERGY TIDES-ACS arm, P superiority <0.01 and 6.3% in OPTIMAX TIDES-ACS arm, P superiority <0.01). Cardiac death was 1.3% (1.6%, p = 0.8 and 0.5%, P superiority =0.1 respectively). Myocardial infarction was 1.6% (4.6%, p < 0.01 and 1.8%, P superiority = 0.9 respectively). Target lesion revascularization was 1% (3.4%, p < 0.01 and 5.4%, P superiority <0.01 respectively). Definite or probable thrombosis was 0.9% (2.8%, p ≤ 0.01 and 1.1%, P superiority = 0.8 respectively).ConclusionsThe results of this registry show a very good safety and efficacy profile at 12 months for the SYNERGY stent in patients with ACS.SummaryA recent trial (TIDES-ACS) in the context of acute coronary syndromes (ACS) reported worrying figures of infarction and definite/probable stent thrombosis in the SYNERGY stent control arm. We investigated the safety of SYNERGY stent in a real-world study population with ACS applying the same inclusion/exclusion criteria as used in the TIDES-ACS trial. Primary endpoint was the composite of cardiac death, myocardial infarction and TLR at 12 months. A total of 1008 patients have been included. Primary outcome was met in 3% (7% in SYNERGY TIDES-ACS arm, P superiority <0.01 and 6.3% in OPTIMAX TIDES-ACS arm, P superiority <0.01).     

Absorb Bioresorbable Scaffold Versus Xience Metallic Stent for Prevention of Restenosis Following Percutaneous Coronary Intervention in Patients at High Risk of Restenosis: Rationale and Design of the COMPARE ABSORB Trial

BackgroundThe advent of bioresorbable vascular scaffolds (BVS) was considered as a potential improvement in percutaneous coronary intervention (PCI) after the groundbreaking development of drug eluting stents (DES). However, the clinical performance, long-term safety and efficacy of BVS in complex coronary lesions remain uncertain. COMPARE ABSORB, a multicenter, single blind, prospective randomized trial, aims to compare the clinical outcomes between the Absorb BVS and Xience everolimus-eluting metallic stent (EES) in patients with coronary artery disease and a high risk of restenosis.DesignCOMPARE ABSORB is designed to enroll 2100 patients at up to 45 European sites. Enrolled patients will possess high risk for restenosis due to clinical profile or coronary lesion complexity and will undergo elective or emergent PCI. Once included in the study, patients will receive either Absorb BVS or Xience EES. Specific advice on implantation technique including mandatory pre-dilatation, sizing and post-dilatation (PSP), will be used in the Absorb BVS arm. The primary endpoint is target lesion failure (TLF), a device-oriented composite endpoint (cardiac death, target vessel myocardial infarction and clinically-indicated target lesion revascularization). The trial is powered to assess non-inferiority of Absorb BVS compared with Xience EES with a predetermined non-inferiority margin of 4.5% at 1 year after index procedure. The clinical follow-up will continue for 7 years.ConclusionsThe prospective COMPARE ABSORB randomized trial (ClinicalTrials.gov NCT02486068) will help to assess the long-term safety and efficacy of Absorb BVS compared with Xience EES in the treatments of patients with complex coronary artery disease and a high attendant risk of restenosis.     

Occurrence of late acquired peri-stent contrast staining: comparison between sirolimus-eluting stents and everolimus-eluting stents

Peri-stent contrast staining (PSS) is an abnormal angiographic finding following drug-eluting stent implantation which suggests the presence of a space outside the stent struts. PSS has been reported to be associated with very late stent thrombosis (VLST). The aims of this study were to compare the occurrence rate of late acquired PSS between sirolimus-eluting stent (SES) and everolimus-eluting stent (EES) implantation, and to identify clinical characteristics associated with PSS. The percutaneous coronary intervention (PCI) database of our hospital was queried to identify patients meeting the following criteria: (i) patients who received SES or EES in de novo coronary artery lesions; and (ii) patients who had angiographic follow-up between 3 and 15 months after stent implantation. There were 221 patients with 249 lesions treated with SES, and 173 patients with 212 lesions treated with EES. The occurrence of PSS was evaluated and compared between SES and EES implantation on a patient and lesion basis. The occurrence rate of late acquired PSS with EES was lower than that with SES. (On a patient basis; 1.2% versus 4.5%, P = 0.045, on a lesion basis; 0.9% versus 4.0%, P = 0.043). Among the clinical characteristics, chronic total occlusion (CTO) lesions were associated with PSS. The occurrence of late acquired PSS in EES was lower than that in SES. In conclusion, the occurrence rate of late acquired PSS with EES was lower than that with SES, however, it remains to be determined whether this difference translates to the difference in the rate of VLST.