Stone Gregg W, Ellis Stephen G, Colombo Antonio, Dawkins Keith D, Grube Eberhard, Cutlip Donald E, Friedman Mark, Baim Donald S, Koglin Joerg
Columbia University Medical Center, The Cardiovascular Research Foundation, 111 E 59th St, 11th Floor, New York, NY 10022, USA.
Circulation. 2007 Jun 5;115(22):2842-7. doi: 10.1161/CIRCULATIONAHA.106.687186. Epub 2007 May 21.
Drug-eluting stents compared with bare metal stents (BMS) may increase late stent thrombosis (ST), although an accompanying increase in the rates of death and myocardial infarction (MI) has not been observed. We hypothesized that the prevention of restenosis-related adverse events by drug-eluting stents might offset some or all of the excess risk from ST.
We analyzed a pooled patient-level database from 4 prospective, double-blind trials in which 3445 patients were randomized to paclitaxel-eluting stents or BMS. The occurrence of death or MI within 7 days of ST or target lesion revascularization was assessed. With a median follow-up of 3.2 years, ST occurred in 34 patients (1.0%), 31 (91.1%) of whom sustained death or MI within 7 days. Target lesion revascularization was performed in 425 patients (12.3%), 15 (3.5%) of whom died or had MI within 7 days. ST occurred in 14 BMS and 20 paclitaxel-eluting stent patients, resulting in 12 and 19 deaths or MIs within 7 days, respectively. Target lesion revascularization was performed in 290 BMS and 135 paclitaxel-eluting stent patients, resulting in 11 and 4 deaths or MI events within 7 days, respectively. In total, 23 patients in both the BMS and paclitaxel-eluting stents groups died or had an MI event within 7 days of either ST or target lesion revascularization.
ST, although infrequent, results in a high incident rate of death and MI, whereas the more frequent occurrence of target lesion revascularization is associated with a finite but lower rate of death and MI. The marked reduction in restenosis with drug-eluting stents compared with BMS may counterbalance the potential excess risk from late ST with drug-eluting stents.
与裸金属支架（BMS）相比，药物洗脱支架可能会增加晚期支架血栓形成（ST），尽管尚未观察到死亡和心肌梗死（MI）发生率随之增加。我们推测，药物洗脱支架预防再狭窄相关不良事件的作用可能会抵消ST带来的部分或全部额外风险。
我们分析了来自4项前瞻性双盲试验的汇总患者水平数据库，其中3445例患者被随机分配至紫杉醇洗脱支架组或BMS组。评估ST或靶病变血管重建术后7天内死亡或MI的发生情况。中位随访3.2年，34例患者（1.0%）发生ST，其中31例（91.1%）在7天内发生死亡或MI。425例患者（12.3%）接受了靶病变血管重建，其中15例（3.5%）在7天内死亡或发生MI。14例BMS患者和20例紫杉醇洗脱支架患者发生ST，分别导致12例和19例在7天内死亡或发生MI。290例BMS患者和135例紫杉醇洗脱支架患者接受了靶病变血管重建，分别导致11例和4例在7天内死亡或发生MI事件。总体而言，BMS组和紫杉醇洗脱支架组共有23例患者在ST或靶病变血管重建术后7天内死亡或发生MI事件。
ST虽不常见，但导致死亡和MI的发生率较高，而更频繁发生的靶病变血管重建与有限但较低的死亡和MI发生率相关。与BMS相比，药物洗脱支架使再狭窄显著减少，这可能会抵消药物洗脱支架晚期ST带来的潜在额外风险。
