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生物可吸收血管支架与依维莫司洗脱金属支架治疗小血管疾病的比较:COMPARE II、RAI和MAASSTAD-ABSORB研究的倾向匹配分析

Absorb bioresorbable vascular scaffold vs. everolimus-eluting metallic stent in small vessel disease: A propensity matched analysis of COMPARE II, RAI, and MAASSTAD-ABSORB studies.

作者信息

Tarantini Giuseppe, Masiero Giulia, Barioli Alberto, Paradies Valeria, Vlachojannis Georgios, Tellaroli Paola, Cortese Bernardo, di Palma Gaetano, Varricchio Attilio, Ielasi Alfonso, Loi Bruno, Steffenino Giuseppe, Ueshima Daisuke, Mojoli Marco, Smits Pieter

机构信息

Department of Cardiac, Thoracic and Vascular Sciences, University of Padua Medical School, Padua, Italy.

Maastad Ziekenhuis, Rotterdam, Netherlands.

出版信息

Catheter Cardiovasc Interv. 2018 Aug 1;92(2):E115-E124. doi: 10.1002/ccd.27522. Epub 2018 Mar 7.

Abstract

BACKGROUND

Patients with small vessel disease (SVD) are at higher risk of adverse events after PCI compared to non-SVD patients. In this subset, the use of bioresorbable vascular scaffolds (BVS) has raised particular concern.

OBJECTIVE

We aimed to compare outcomes of Absorb BVS versus a 2nd-generation metallic everolimus-eluting stents (EES) in the SVD setting, by pooling patients from three large, prospective studies.

METHODS

Patients with SVD (reference vessel diameter ≤2.75 mm by QCA) and treated with Absorb BVS were identified in the Italian RAI and the MAASSTAD-Absorb registries. EES controls were identified in the COMPARE II Trial. We performed a propensity-score matching using several clinical and angiographic variables. Implantation technique was not object of matching, being device-specific.

RESULTS

Out of 4635 enrolled subjects, 1147 belonged to the SVD population. After matching, we obtained 337 pairs of patients. High clinical and angiographic complexity was found in both groups. Predilation and postdilation rates were significantly higher in BVS patients. No differences were found in terms of the device-oriented composite end-point at 1-year (HR = 1.08, 95%CI 0.5-2.3, P = .8) and 2-years (HR = 1.28, 95% CI: 0.68-2.43, P = .5). Notwithstanding, higher incidence of definite/probable stent thrombosis was observed in the BVS group at 1 year (HR 4.7, 95%CI 0.8-31.4, P = .08) and 2-years (HR = 8.34 95%CI 1.1-60.2, P = .04).

CONCLUSION

In this propensity-matched analysis pooling SVD patients of three large prospective studies, incidence of composite device-related events was comparable between BVS and EES up to 2 years follow-up. However, higher rates of stent thrombosis were found in the BVS group.

摘要

背景

与非小血管疾病(SVD)患者相比,SVD患者在接受经皮冠状动脉介入治疗(PCI)后发生不良事件的风险更高。在这一亚组患者中,生物可吸收血管支架(BVS)的使用引发了特别关注。

目的

我们旨在通过汇总三项大型前瞻性研究的患者,比较在SVD情况下Absorb BVS与第二代金属依维莫司洗脱支架(EES)的治疗结果。

方法

在意大利RAI和MAASSTAD-Absorb注册研究中确定患有SVD(定量冠状动脉造影测定参考血管直径≤2.75 mm)并接受Absorb BVS治疗的患者。在COMPARE II试验中确定EES对照组。我们使用多个临床和血管造影变量进行倾向评分匹配。植入技术不是匹配对象,因为它是特定于设备的。

结果

在4635名入组受试者中,1147名属于SVD人群。匹配后,我们获得了337对患者。两组均发现临床和血管造影复杂性较高。BVS患者的预扩张和后扩张率明显更高。在1年(HR = 1.08,95%CI 0.5 - 2.3,P = 0.8)和2年(HR = 1.28,95%CI:0.68 - 2.43,P = 0.5)时,在以设备为导向的复合终点方面未发现差异。尽管如此,BVS组在1年(HR 4.7,95%CI 0.8 - 31.4,P = 0.08)和2年(HR = 8.34,95%CI 1.1 - 60.2,P = 0.04)时观察到明确/可能的支架血栓形成发生率更高。

结论

在这项汇总三项大型前瞻性研究的SVD患者的倾向匹配分析中, 在长达2年的随访中,BVS和EES之间与设备相关的复合事件发生率相当。然而,BVS组的支架血栓形成率更高。

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