De Luca Giuseppe, Valgimigli Marco, Spaulding Christian, Menichelli Maurizio, Brunner-La Rocca Hans Peter, van der Hoeven Bas L, Di Lorenzo Emilio, Diaz de la Llera Luis-S, Pasceri Vincenzo, Pittl Undine, Percoco Gianfranco, Violini Roberto, Stone Gregg W
Division of Cardiology, Ospedale Maggiore della Carità, Eastern Piedmont University, Novara, Italy.
J Thromb Thrombolysis. 2009 Aug;28(2):200-10. doi: 10.1007/s11239-009-0305-7. Epub 2009 Feb 4.
Recent concerns have emerged on the potential higher risk of stent thrombosis after DES implantation, that might be even more pronounced among STEMI patients. The aim of the current study was to perform a meta-analysis to evaluate the benefits and safety of Sirolimus-Eluting Stent (SES) as compared to BMS in patients undergoing primary angioplasty for STEMI.
The literature was scanned by formal searches of electronic databases (MEDLINE and CENTRAL). We examined all completed randomized trials of DES for STEMI. The following keywords were used for study selection: randomized trial, myocardial infarction, reperfusion, primary angioplasty, stenting, DES, sirolimus-eluting stent (SES), Cypher. Information on study design, type of stent, inclusion and exclusion criteria, primary endpoint, number of patients, angiographic and clinical outcome, were extracted by two investigators. Disagreements were resolved by consensus.
A total of 9 trials were included in the meta-analysis, involving 2,769 patients (1389 or 50.2% randomized to DES and 1,380 or 49.8% randomized to BMS). At 12 months follow-up, SES was associated with a significant reduction in TVR (4.9% vs. 13.6%, p < 0.0001), with a trend in benefits in mortality (2.9% vs. 4.2%, p = 0.08) and reinfarction (3.0% vs. 4.3%, p = 0.06), without any significant difference in stent thrombosis (1.9% vs. 2.5%, p = 0.36). Safety and efficacy of DES were confirmed at 2-3 years follow-up (data available from 4 trials including 569 patients).
This meta-analysis shows that among selected STEMI patients undergoing primary angioplasty, SES as compared to BMS is safe and associated with a significant reduction in TVR at 1 and 2-3 years follow-up.
近期人们开始关注药物洗脱支架(DES)植入术后支架血栓形成风险可能更高,这在ST段抬高型心肌梗死(STEMI)患者中可能更为明显。本研究的目的是进行一项荟萃分析,以评估与裸金属支架(BMS)相比,西罗莫司洗脱支架(SES)在接受直接经皮冠状动脉腔内血管成形术(primary angioplasty)治疗的STEMI患者中的获益和安全性。
通过正式检索电子数据库(MEDLINE和CENTRAL)来筛选文献。我们审查了所有已完成的针对STEMI的DES随机试验。以下关键词用于研究选择:随机试验、心肌梗死、再灌注、直接经皮冠状动脉腔内血管成形术、支架置入术、DES、西罗莫司洗脱支架(SES)、Cypher。两名研究人员提取了有关研究设计、支架类型、纳入和排除标准、主要终点、患者数量、血管造影和临床结果的信息。分歧通过协商解决。
荟萃分析共纳入9项试验,涉及2769例患者(1389例或50.2%随机分配至DES组,1380例或49.8%随机分配至BMS组)。在12个月的随访中,SES与靶病变血管重建(TVR)显著降低相关(4.9%对13.6%,p<0.0001),在死亡率(2.9%对4.2%,p=0.08)和再梗死率(3.0%对4.3%,p=0.06)方面有获益趋势,而在支架血栓形成方面无显著差异(1.9%对2.5%,p=0.36)。在2至3年的随访中证实了DES的安全性和有效性(数据来自4项试验,包括569例患者)。
这项荟萃分析表明,在接受直接经皮冠状动脉腔内血管成形术的特定STEMI患者中,与BMS相比,SES在1年以及2至3年随访时是安全的,并且与TVR显著降低相关。