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药物洗脱支架与裸金属支架用于经皮冠状动脉分叉病变治疗的长期比较。

A long-term comparison of drug-eluting versus bare metal stents for the percutaneous treatment of coronary bifurcation lesions.

作者信息

Colombo Francesco, Biondi-Zoccai Giuseppe, Infantino Vincenzo, Omedé Pierluigi, Moretti Claudio, Sciuto Filippo, Siliquini Roberta, Chiadò Simone, Trevi Gian Paolo, Sheiban Imad

机构信息

Division of Cardiology, University of Turin, S. Giovanni Battista Molinette Hospital, Turin, Italy.

出版信息

Acta Cardiol. 2009 Oct;64(5):583-8. doi: 10.2143/AC.64.5.2042686.

Abstract

BACKGROUND

After the first exciting results on drug-eluting stents (DES), many concerns have been raised on their potential risk for late stent thrombosis. Whereas DES appear beneficial at early and mid-term for coronary bifurcation lesions, no data are available on their long-term safety in this setting in comparison to bare metal stents (BMS). We thus aimed to appraise the long-term (> 2 years) outcomes of patients with bifurcation lesions treated with DES vs. BMS.

METHODS

We abstracted baseline, procedural and follow-up data on all patients with bifurcation coronary lesions (both branches with reference vessel diameter > 2.0 mm) treated with stent implantation at our centre. The primary end-point was the long-term (> 2 years) rate of major adverse cardiac events (MACE, i.e. cardiac death, myocardial infarction, coronary artery bypass grafting and target vessel revascularization).

RESULTS

A total of 315 patients and 334 lesions were included, 84.4% treated with DES, and 15.6% treated with BMS. The side branch was stented in 108 cases, according to a provisional T in 76 (22.7%), crushing in 15 (4.5%),V in 14 (4.2%), and culottes in 1 (0.3%). In-hospital MACE occurred in 4 (1.5%) patients of the DES group and 2 (4.1%) of the BMS group (P = 0.22). After 35.8 +/- 12.9 months, MACE were 72 (27.1%) vs. 24 (49%), respectively (P = 0.002), with cardiac death in 7 (2.6%) patients vs. 3 (6.1%, P = 0.20), myocardial infarction in 12 (4.5%) vs. 6 (12.2%, P = 0.42), coronary artery bypass grafting in 5 (1.9%) vs. 1 (2%, P = 0.93), target lesion revascularization in 30 (11.3%) vs. 13 (26.5%, P = 0.0042), and target vessel revascularization in 48 (18%) vs. 13 (26.5%, P = 0.16). Definite stent thrombosis occurred in 2 (0.75%) patients in the DES group vs. 1 (2%, P = 0.93) in the BMS group, whereas probable stent thrombosis was adjudicated in 5 (1.9%) vs. 2 (4%, P = 0.93).

CONCLUSION

This cohort study, reporting for the first time on the long-term outlook of patients treated with DES vs. BMS for coronary bifurcation lesions, supports the overall safety and efficacy of DES in comparison to BMS. Specifically, even after several years of follow-up, repeat revascularizations appeared significantly lower with DES, and stent thromboses occurred with equivalent frequency in both DES and BMS groups.

摘要

背景

在药物洗脱支架(DES)取得首批令人振奋的成果之后,人们对其晚期支架血栓形成的潜在风险提出了诸多担忧。尽管DES在冠状动脉分叉病变的早期和中期似乎有益,但与裸金属支架(BMS)相比,尚无关于其在此情况下长期安全性的数据。因此,我们旨在评估接受DES与BMS治疗的分叉病变患者的长期(>2年)结局。

方法

我们提取了在本中心接受支架植入治疗的所有冠状动脉分叉病变患者(两个分支的参考血管直径>2.0 mm)的基线、手术和随访数据。主要终点是长期(>2年)主要不良心脏事件(MACE,即心源性死亡、心肌梗死、冠状动脉搭桥术和靶血管血运重建)发生率。

结果

共纳入315例患者和334处病变,其中84.4%接受DES治疗,15.6%接受BMS治疗。108例患者的分支血管植入了支架,其中76例(22.7%)采用临时T型技术,15例(4.5%)采用挤压技术,14例(4.2%)采用V型技术,1例(0.3%)采用裤裙式技术。DES组4例(1.5%)患者和BMS组2例(4.1%)患者发生院内MACE(P = 0.22)。35.8±12.9个月后,MACE发生率分别为72例(27.1%)和24例(49%)(P = 0.002),心源性死亡分别为7例(2.6%)和3例(6.1%,P = 0.20),心肌梗死分别为12例(4.5%)和6例(12.2%,P = 0.42),冠状动脉搭桥术分别为5例(1.9%)和1例(2%,P = 0.93),靶病变血运重建分别为30例(11.3%)和13例(26.5%,P = 0.0042),靶血管血运重建分别为48例(18%)和13例(26.5%,P = 0.16)。DES组2例(0.75%)患者发生明确的支架血栓形成,BMS组1例(2%,P = 0.93);而可能的支架血栓形成经判定分别为5例(1.9%)和2例(4%,P = 0.93)。

结论

这项队列研究首次报告了接受DES与BMS治疗的冠状动脉分叉病变患者的长期预后,支持DES与BMS相比具有总体安全性和有效性。具体而言,即使经过数年随访,DES组的再次血运重建率明显更低,且DES组和BMS组的支架血栓形成发生率相当。

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