Harjai Kishore J, Orshaw Pamela, Boura Judith, Sporn Daniel
Guthrie Clinic, Sayre, Pennsylvania, USA.
Am J Cardiol. 2009 Jun 1;103(11):1537-45. doi: 10.1016/j.amjcard.2009.02.017. Epub 2009 Apr 22.
Previous studies have shown impressive short- and medium-term outcomes from drug-eluting stent (DES) implantation in coronary artery disease. We assessed long-term outcomes from DES versus bare metal stent (BMS) implantation in standard and off-label lesions. In 2,345 patients who survived event-free for > or = 30 days after stent implantation for standard (n = 1,540, 66%) or off-label (805, 34%) lesions, we assessed time to occurrence of death, myocardial infarction (MI), death or MI, stent thrombosis, target vessel revascularization (TVR), and major adverse cardiovascular events (defined as composite of all study outcomes). Comparisons were made between standard and off-label lesion subsets and between DES and BMS in lesion subsets. Multivariable differences in outcomes between DES versus BMS were assessed using propensity-adjusted proportional hazards regression. Median follow-up duration was 3.4 years. Stenting of off-label lesions was associated with uniformly worse outcomes than stenting of standard lesions. After adjustment for lesion classification, propensity to receive DES, and baseline differences, DES implantation was associated with statistically significant decreases in death (adjusted hazard ratio 0.71, 95% confidence interval 0.51 to 0.98), TVR (hazard ratio 0.58, 95% confidence interval 0.39 to 0.85 for off-label subset; hazard ratio 0.33, 95% confidence interval 0.24 to 0.46 for standard subset), and major adverse cardiovascular events (hazard ratio 0.51, 95% confidence interval 0.42 to 0.61), without increase in MI, death/MI, or stent thrombosis. Elective TVR occurred in 272 patients and resulted in only 1 early death. In conclusion, compared with BMS, use of DES is associated with clinical benefit in standard and off-label lesions at late follow-up. Decrease in elective TVR does not explain the apparent mortality benefit from DES implantation.
既往研究显示，药物洗脱支架（DES）植入治疗冠状动脉疾病的近期和中期疗效令人印象深刻。我们评估了DES与裸金属支架（BMS）植入标准病变和非标准病变的长期疗效。在2345例支架植入标准病变（n = 1540，66%）或非标准病变（805例，34%）后无事件生存≥30天的患者中，我们评估了死亡、心肌梗死（MI）、死亡或MI、支架血栓形成、靶血管重建（TVR）以及主要不良心血管事件（定义为所有研究结局的复合事件）的发生时间。对标准病变亚组和非标准病变亚组以及病变亚组中的DES和BMS进行了比较。使用倾向调整比例风险回归评估DES与BMS之间结局的多变量差异。中位随访时间为3.4年。非标准病变支架植入的结局普遍比标准病变支架植入的结局差。在调整病变分类、接受DES的倾向和基线差异后，DES植入与死亡（调整后风险比0.71，95%置信区间0.51至0.98）、TVR（非标准亚组风险比0.58，95%置信区间0.39至0.85；标准亚组风险比0.33，95%置信区间0.24至0.46）和主要不良心血管事件（风险比0.51，95%置信区间0.42至0.61）的统计学显著降低相关，且MI、死亡/MI或支架血栓形成无增加。272例患者发生了择期TVR，仅导致1例早期死亡。总之，与BMS相比，DES的使用在晚期随访中对标准病变和非标准病变均具有临床益处。择期TVR的减少并不能解释DES植入带来的明显死亡率益处。
