Department of Cardiology, Swiss Cardiovascular Center, University Hospital, Bern, Switzerland.
Institute of Social and Preventive Medicine and Clinical Trials Unit, Bern University Hospital, Bern, Switzerland.
Lancet. 2014 Dec 13;384(9960):2111-22. doi: 10.1016/S0140-6736(14)61038-2. Epub 2014 Sep 1.
Refinements in stent design affecting strut thickness, surface polymer, and drug release have improved clinical outcomes of drug-eluting stents. We aimed to compare the safety and efficacy of a novel, ultrathin strut cobalt-chromium stent releasing sirolimus from a biodegradable polymer with a thin strut durable polymer everolimus-eluting stent.
We did a randomised, single-blind, non-inferiority trial with minimum exclusion criteria at nine hospitals in Switzerland. We randomly assigned (1:1) patients aged 18 years or older with chronic stable coronary artery disease or acute coronary syndromes undergoing percutaneous coronary intervention to treatment with biodegradable polymer sirolimus-eluting stents or durable polymer everolimus-eluting stents. Randomisation was via a central web-based system and stratified by centre and presence of ST segment elevation myocardial infarction. Patients and outcome assessors were masked to treatment allocation, but treating physicians were not. The primary endpoint, target lesion failure, was a composite of cardiac death, target vessel myocardial infarction, and clinically-indicated target lesion revascularisation at 12 months. A margin of 3·5% was defined for non-inferiority of the biodegradable polymer sirolimus-eluting stent compared with the durable polymer everolimus-eluting stent. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT01443104.
Between Feb 24, 2012, and May 22, 2013, we randomly assigned 2119 patients with 3139 lesions to treatment with sirolimus-eluting stents (1063 patients, 1594 lesions) or everolimus-eluting stents (1056 patients, 1545 lesions). 407 (19%) patients presented with ST-segment elevation myocardial infarction. Target lesion failure with biodegradable polymer sirolimus-eluting stents (69 cases; 6·5%) was non-inferior to durable polymer everolimus-eluting stents (70 cases; 6·6%) at 12 months (absolute risk difference -0·14%, upper limit of one-sided 95% CI 1·97%, p for non-inferiority <0·0004). No significant differences were noted in rates of definite stent thrombosis (9 [0·9%] vs 4 [0·4%], rate ratio [RR] 2·26, 95% CI 0·70-7·33, p=0·16). In pre-specified stratified analyses of the primary endpoint, biodegradable polymer sirolimus-eluting stents were associated with improved outcome compared with durable polymer everolimus-eluting stents in the subgroup of patients with ST-segment elevation myocardial infarction (7 [3·3%] vs 17 [8·7%], RR 0·38, 95% CI 0·16-0·91, p=0·024, p for interaction=0·014).
In a patient population with minimum exclusion criteria and high adherence to dual antiplatelet therapy, biodegradable polymer sirolimus-eluting stents were non-inferior to durable polymer everolimus-eluting stents for the combined safety and efficacy outcome target lesion failure at 12 months. The noted benefit in the subgroup of patients with ST-segment elevation myocardial infarction needs further study.
Clinical Trials Unit, University of Bern, and Biotronik, Bülach, Switzerland.
影响支架厚度、表面聚合物和药物释放的支架设计的改进提高了药物洗脱支架的临床疗效。我们旨在比较一种新型超薄支架的安全性和疗效，该支架由可生物降解聚合物释放西罗莫司，具有薄支架耐用聚合物依维莫司洗脱支架。
我们在瑞士的 9 家医院进行了一项随机、单盲、非劣效性试验，最低排除标准为 18 岁或以上患有慢性稳定型冠状动脉疾病或急性冠状动脉综合征并接受经皮冠状动脉介入治疗的患者。将患者随机（1:1）分为使用可生物降解聚合物西罗莫司洗脱支架或耐用聚合物依维莫司洗脱支架治疗的两组。随机分配通过中央网络系统进行，并按中心和 ST 段抬高心肌梗死的存在进行分层。患者和结果评估者对治疗分配进行了盲法，但治疗医生没有。主要终点是 12 个月时的心脏死亡、靶血管心肌梗死和临床指示的靶病变血运重建的复合终点。与耐用聚合物依维莫司洗脱支架相比，可生物降解聚合物西罗莫司洗脱支架的非劣效性定义为 3.5%。分析采用意向治疗。该试验在 ClinicalTrials.gov 上注册，编号为 NCT01443104。
在 2012 年 2 月 24 日至 2013 年 5 月 22 日期间，我们随机分配了 2119 例患者（3139 个病变）接受西罗莫司洗脱支架（1063 例患者，1594 个病变）或依维莫司洗脱支架（1056 例患者，1545 个病变）治疗。407 例（19%）患者出现 ST 段抬高型心肌梗死。使用可生物降解聚合物西罗莫司洗脱支架的靶病变失败率（69 例；6.5%）与耐用聚合物依维莫司洗脱支架（70 例；6.6%）在 12 个月时无差异（绝对风险差异-0.14%，单侧 95%CI 的上限为 1.97%，p<0.0004 表示非劣效性）。未观察到明确的支架血栓形成（9 例[0.9%] vs 4 例[0.4%]，率比[RR]2.26，95%CI 0.70-7.33，p=0.16）。在主要终点的预先指定分层分析中，与耐用聚合物依维莫司洗脱支架相比，可生物降解聚合物西罗莫司洗脱支架与 ST 段抬高型心肌梗死亚组患者的预后改善相关（7 例[3.3%] vs 17 例[8.7%]，RR 0.38，95%CI 0.16-0.91，p=0.024，p 为交互作用=0.014）。
在最低排除标准和高双联抗血小板治疗依从性的患者人群中，可生物降解聚合物西罗莫司洗脱支架与耐用聚合物依维莫司洗脱支架相比，12 个月时的联合安全性和疗效终点靶病变失败率无差异。ST 段抬高型心肌梗死亚组的注意到的益处需要进一步研究。
伯尔尼大学临床研究单位和瑞士比罗特克公司。
