瑞士伯尔尼大学医院的Marco Valgimigli研究小组在研究中取得进展。他们研究了用于经皮冠状动脉介入治疗的药物洗脱支架或裸金属支架，进行了随机临床试验的系统回顾和个体患者数据荟萃分析（meta分析）。 2019年5月2日出版的《柳叶刀》发表了这项成果。

该研究组对随机临床试验的个体患者数据进行了荟萃分析分析，比较了在新一代药物洗脱支架(DES)或裸金属支架(BMS)植入后，对经皮冠状动脉介入治疗患者的疗效。 研究的主要结果是基于心脏死亡或心肌梗死数据，这些数据汇集在一个单阶段随机效应荟萃分析，并在最大随访时和时间满一年时进行检测，风险评估报告为95%置信区间的危险比(HRs)。 课题组获得了26个人的数据20个随机试验中的616名患者。平均随访3·2年(SD 1·8)。 与BMS患者相比(HR 0·84,95% CI 0·78-0·90,p < 0·001)，DES患者的主要结局风险降低，原因是心肌梗死风险降低(0·79,0·71-0·88,p < 0·001)，并且可能有轻微但不显著的心脏死亡率(0·89,0·78-1·01,p=0·075)。 全因死亡未受影响(HR为DES 0·96,95% CI 0·88-1·05,p=0·358)，但明确支架血栓形成(0·63,0·50-0·80,p < 0·001)和靶血管再通(0·55,0·50-0·60,p < 0·001)的风险降低。 课题组观察到一个时间依赖的治疗效果，DES与植入后1年的原发性结局风险比BMS低。 虽然该效应在较长时间内保持不变，1年后与BMS无进一步差异。新一代DES植入后第一年的表现意味着BMS不再是安全的黄金标准。 进一步发展DES技术的目标应该是改善1年后的临床结果。

新一代药物洗脱支架(DES)大多在针对早期药物洗脱支架的面对面非劣效性试验中进行了研究，具有相似的疗效和较高的安全性。 新一代DES与裸金属支架(BMS)的安全性比较尚不清楚。

附：英文原文

Title: Drug-eluting or bare-metal stents for percutaneous coronary intervention: a systematic review and individual patient data meta-analysis of randomised clinical trials

Author: Raffaele Piccolo, MD Prof Kaare H Bonaa, MD Orestis Efthimiou, PhD Olivier Varenne, MD Andrea Baldo, MD Philip Urban, MD Prof Christoph Kaiser, MD Wouter Remkes, MD Lorenz Räber, MD Prof Adam de Belder, MD Prof Arnoud W J van 't Hof, MD Goran Stankovic, MD Pedro A Lemos, MD Tom Wilsgaard, PhD Jörg Reifart, MD Prof Alfredo E Rodriguez, MD Prof Expedito E Ribeiro, MD Prof Patrick W J C Serruys, MD Alex Abizaid, MD Prof Manel Sabaté, MD Robert A Byrne, PhD Jose M de la Torre Hernandez, MD Prof William Wijns, MD Prof Peter Jüni, MD Prof Stephan Windecker, MD Prof Marco Valgimigli, MD

Issue&Volume: Volume 393,Number 10190,2019

Abstract:Background New-generation drug-eluting stents (DES) have mostly been investigated in head-to-head non-inferiority trials against early-generation DES and have typically shown similar efficacy and superior safety. How the safety profile of new-generation DES compares with that of bare-metal stents (BMS) is less clear.

Methods We did an individual patient data meta-analysis of randomised clinical trials to compare outcomes after implantation of new-generation DES or BMS among patients undergoing percutaneous coronary intervention. The primary outcome was the composite of cardiac death or myocardial infarction. Data were pooled in a one-stage random-effects meta-analysis and examined at maximum follow-up and a 1-year landmark. Risk estimates are reported as hazard ratios (HRs) with 95% CIs. This study is registered in PROSPERO, number CRD42017060520.

Findings We obtained individual data for 26?616 patients in 20 randomised trials. Mean follow-up was 3·2 (SD 1·8) years. The risk of the primary outcome was reduced in DES recipients compared with BMS recipients (HR 0·84, 95% CI 0·78–0·90, p<0·001) owing to a reduced risk of myocardial infarction (0·79, 0·71–0·88, p<0·001) and a possible slight but non-significant cardiac mortality benefit (0·89, 0·78–1·01, p=0·075). All-cause death was unaffected (HR with DES 0·96, 95% CI 0·88–1·05, p=0·358), but risk was lowered for definite stent thrombosis (0·63, 0·50–0·80, p<0·001) and target-vessel revascularisation (0·55, 0·50–0·60, p<0·001). We saw a time-dependent treatment effect, with DES being associated with lower risk of the primary outcome than BMS up to 1 year after placement. While the effect was maintained in the longer term, there was no further divergence from BMS after 1 year.

Interpretation The performance of new-generation DES in the first year after implantation means that BMS should no longer be considered the gold standard for safety. Further development of DES technology should target improvements in clinical outcomes beyond 1 year.

DOI: https://doi.org/10.1016/S0140-6736(19)30474-X

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)30474-X/fulltext#