Godino Cosmo, Furuichi Shinichi, Latib Azeem, Morici Nuccia, Chieffo Alaide, Romagnoli Enrico, Tamburino Corrado, Barbagallo Rossella, Cera Michela, Antoniucci David, Goktekin Omer, Di Mario Carlo, Reimers Bernard, Grube Eberhard, Airoldi Flavio, Sangiorgi Giuseppe M, Colombo Antonio
Interventional Cardiology Unit, San Raffaele Institute, Milan, Italy.
Am J Cardiol. 2008 Oct 15;102(8):1002-8. doi: 10.1016/j.amjcard.2008.05.052. Epub 2008 Jul 26.
Several randomized trials have shown that sirolimus-eluting stents and paclitaxel-eluting stents (PES) are effective in reducing restenosis in respect to bare-metal stents, including the subset of small vessels. The objective of this study was to evaluate "real world" angiographic and clinical outcomes of a large series of patients enrolled in the TRUE registry and treated with PES for both small vessel and very small vessel lesions. A consecutive series of 675 patients (926 lesions) with reference vessel diameter <2.75 mm measured by quantitative coronary angiography analysis were analyzed. The primary end point was the rate of angiographic in-stent restenosis and 1-year major adverse cardiac events. In this study 390 lesions were identified as small vessel (reference vessel diameter >or=2.25 and <2.75 mm) and 536 lesions as very small vessel (reference vessel diameter <2.25 mm). Overall in-stent restenosis was 15.5% (n = 96). Compared with small vessel, the very small vessel lesions had more in-stent restenosis (21.7% vs 11.4%, p <0.001) and in-segment restenosis (29.3% vs 22.5%, p = 0.055). The majority of the restenotic lesions (n = 125) were focal (57%, n = 71). At 1 year, cardiac death was 1.6% (n = 11), acute myocardial infarction 0.5% (n = 4.), and the target lesion revascularization 12.8% (n = 86). Cumulative major adverse cardiac events rate was 17.3% (n = 119). The rate of definite and probable stent thrombosis was 0.9% (n = 8). In conclusion, in comparison with historical bare-metal stent controls, this large series of small vessel lesions treated with PES confirms previous results reporting the efficacy of PES in small vessels. The rate of subacute and late stent thrombosis was low in this subgroup of patients.
多项随机试验表明，与裸金属支架相比，包括小血管亚组在内，西罗莫司洗脱支架和紫杉醇洗脱支架（PES）在减少再狭窄方面是有效的。本研究的目的是评估纳入TRUE注册研究并接受PES治疗的大量小血管和极微小血管病变患者的“真实世界”血管造影和临床结局。通过定量冠状动脉造影分析对连续675例参考血管直径<2.75 mm的患者（926处病变）进行了分析。主要终点是血管造影支架内再狭窄率和1年主要不良心脏事件。在本研究中，390处病变被确定为小血管（参考血管直径≥2.25且<2.75 mm），536处病变为极微小血管（参考血管直径<2.25 mm）。总体支架内再狭窄率为15.5%（n = 96）。与小血管病变相比，极微小血管病变的支架内再狭窄更多（21.7%对11.4%，p<0.001），节段内再狭窄也更多（29.3%对22.5%，p = 0.055）。大多数再狭窄病变（n = 125）为局灶性（57%，n = 71）。1年时，心源性死亡为1.6%（n = 11），急性心肌梗死为0.5%（n = 4），靶病变血管重建为12.8%（n = 86）。累积主要不良心脏事件发生率为17.3%（n = 119）。明确和可能的支架血栓形成率为0.9%（n = 8）。总之，与既往裸金属支架对照相比，这一接受PES治疗的大量小血管病变系列证实了先前报道的PES在小血管中疗效的结果。该亚组患者亚急性和晚期支架血栓形成率较低。
