Saia Francesco, Piovaccari Giancarlo, Manari Antonio, Guastaroba Paolo, Vignali Luigi, Varani Elisabetta, Santarelli Andrea, Benassi Alberto, Liso Armando, Campo Gianluca, Tondi Stefano, Tarantino Fabio, De Palma Rossana, Marzocchi Antonio
Istituto di Cardiologia, Università di Bologna, Policlinico S. Orsola-Malpighi, Italy.
EuroIntervention. 2009 May;5(1):57-66. doi: 10.4244/eijv5i1a10.
To evaluate the long-term clinical outcome after drug-eluting stents (DES) implantation, and to test if patient selection could enhance their net clinical benefit.
We assessed the incidence of major adverse cardiac events (MACE=death, acute myocardial infarction, and target vessel revascularisation, TVR) and angiographic stent thrombosis (ST) during 3-year follow-up in a prospective multicentre registry. Propensity-score analysis to adjust for different clinical, angiographic and procedural characteristics was performed. Overall, 14,115 patients enrolled in the registry received solely BMS (n=9,565) or DES (n=4,550). The incidence of definite ST was 0.6% for BMS and 1.3% for DES (p=0.003). The propensity-score adjusted incidence of cardiac death and myocardial infarction was similar between the two groups (DES 11.9% vs. BMS 12.1%, HR 0.90, 95% CI 0.77-1.04), whereas DES were associated with lower rates of TVR (DES 11.6% vs. BMS 15.2%, HR 0.67, 95% CI 0.59-0.76). The efficacy of DES in reducing TVR increased with increasing likelihood of TVR at baseline.
The beneficial effect of DES in reducing new revascularisations compared to BMS extends out to three years without a significantly worse overall safety profile. The benefit seems more evident in patients with the highest baseline risk of clinical restenosis.
评估药物洗脱支架(DES)植入后的长期临床结局,并测试患者选择是否能提高其净临床获益。
我们在一项前瞻性多中心注册研究中评估了3年随访期间主要不良心脏事件(MACE=死亡、急性心肌梗死和靶血管血运重建,TVR)及血管造影支架血栓形成(ST)的发生率。进行倾向评分分析以调整不同的临床、血管造影和手术特征。总体而言,注册研究中的14115例患者仅接受了裸金属支架(BMS,n=9565)或DES(n=4550)。BMS组明确ST的发生率为0.6%,DES组为1.3%(p=0.003)。两组间倾向评分调整后的心脏死亡和心肌梗死发生率相似(DES为11.9%,BMS为12.1%,HR 0.90,95%CI 0.77-1.04),而DES与较低的TVR发生率相关(DES为11.6%,BMS为15.2%,HR 0.67,95%CI 0.59-0.76)。DES降低TVR的疗效随基线时TVR可能性的增加而提高。
与BMS相比,DES在减少新的血运重建方面的有益作用可延续至三年,且总体安全性无明显更差。这种益处似乎在临床再狭窄基线风险最高的患者中更为明显。