摘要
背景:支架血栓形成是药物洗脱支架安全性方面应考虑的一个问题。有关置入此类支架1年之后的支架血栓形成情况知之甚少。方法:2002年4月至2005年12月间,共8146例患者在两所学术医院接受了经皮冠状动脉介入治疗,分别接受西罗莫司洗脱支架(SES;n=3823)或紫杉醇洗脱支架(PES;n=4323)置入。对该组资料进行评估以确定支架血栓形成的发生率、病程及相关因素,并比较SES与PES以及早期(0～30d)与晚期(】30d)支架血栓形成方面的差异。结果:152例患者经血管造影证实有支架血栓形成(发病密度为1.3例/100人年,3年累积发病率为2.9%);其中91例患者(60%)为早期支架血栓形成,61例(40%)为晚期支架血栓形成。晚期支架血栓形成的发病率较稳定,至支架置入后3年其年发病率保持在0.6%
Background: Stent thrombosis is a safety concern associated with use of drug-eluting stents. Little is known about occurrence of stent thrombosis more than 1 year after implantation of such stents. Methods: Between April, 2002, and Dec, 2005, 8146 patients underwent percutaneous coronary intervention with sirolimus-eluting stents(SES; n=3823) or paclitaxel-eluting stents(PES; n=4323)at two academic hospitals. We assessed data from this group to ascertain the incidence, time course, and correlates of stent thrombosis, and the differences between early(0- 30 days) and late( >30 days) stent thrombosis and between SES and PES. Findings: Angiographically documented stent thrombosis occurred in 152 patients(incidence density 1.3 per 100 person-years; cumulative incidence at 3 years 2.9% ). Early stent thrombosis was noted in 91(60% ) patients, and late stent thrombosis in 61(40% ) patients. Late stent thrombosis occurred steadily at a constant rate of 0.6% per year up to 3 years after stent implantation. Incidence of early stent thrombosis was similar for SES(1.1% ) and PES(1.3% ), but late stent thrombosis was more frequent with PES(1.8% ) than with SES(1.4% ; p=0.031). At the time of stent thrombosis, dual antiplatelet therapy was being taken by 87% (early) and 23% (late) of patients(p< 0.0001). Independent predictors of overall stent thrombosis were acute coronary syndrome at presentation(hazard ratio 2.28, 95% CI 1.29- 4.03) and diabetes(2.03, 1.07- 3.83). Interpretation: Late stent thrombosis was encountered steadily with no evidence of diminution up to 3 years of follow-up. Early and late stent thrombosis were observed with SES and with PES. Acute coronary syndrome at presentation and diabetes were independent predictors of stent thrombosis.
