Orlik Bartłomiej, Milewski Krzysztof, Derbisz Kamil, Jelonek Michał, Chrząszcz Patrycja, Beil Sonia, Młodziankowski Adam, Picheta Wojciech, Buszman Piotr P, Buszman Paweł E
Center for Cardiovascular Research and Development, American Heart of Poland, Katowice, Poland.
10 Department of Invasive Cardiology, Electrophysiology and Electrostimulation, Tychy, Poland.
Postepy Kardiol Interwencyjnej. 2018;14(2):149-156. doi: 10.5114/aic.2018.76406. Epub 2018 Jun 19.
Most clinical trials related to bioresorbable vascular scaffold (BVS) technology are limited to a highly selected patient population.
To evaluate early and long-term clinical outcomes of the Absorb everolimus-eluting BVS compared to the everolimus-eluting metallic XIENCE V stent in routine clinical practice.
This is a multicenter, retrospective propensity score-matched comparative study, comprising 76 patients treated with a bare metal stents (BMS) and 501 with a XIENCE stent. Patients included in the study had stable and unstable angina and both types of myocardial infarction (STEMI and NSTEMI) as an indication for intervention and at least one significant lesion in native coronary arteries. The primary endpoint was major adverse cardiovascular event (MACE), defined as death, myocardial infarction (MI), or target vessel revascularization (TVR).
Median follow-up was 400 days in both groups. After propensity score matching for patient baseline characteristics, only higher rate of predilatation, predominantly treated left anterior descending artery (LAD) and lower number of used stents in the BVS group remained statistically significant. After adjustment there was no difference in type of treated lesions. The MACE rate did not differ between BVS and drug-eluting stents (DES) groups (7.2% vs. 11.15%, respectively; = 0.17). The TVR was 2.9% in both groups. Except in the periprocedural period, there were no deaths or MI in the BVS group. There was no stent thrombosis in either studied group.
In routine clinical practice throughout long-term follow-up, clinical outcomes of patients who successfully received the Absorb BVS did not differ from those of patients who received the Xience stent. Longer follow-up data are required to determine whether these findings will persist beyond one year.
大多数与生物可吸收血管支架（BVS）技术相关的临床试验仅限于高度特定的患者群体。
在常规临床实践中，评估依维莫司洗脱生物可吸收血管支架（Absorb）与依维莫司洗脱金属XIENCE V支架相比的早期和长期临床结局。
这是一项多中心、回顾性倾向评分匹配的比较研究，包括76例接受裸金属支架（BMS）治疗的患者和501例接受XIENCE支架治疗的患者。纳入研究的患者患有稳定型和不稳定型心绞痛以及两种类型的心肌梗死（ST段抬高型心肌梗死和非ST段抬高型心肌梗死），作为干预指征，且在自身冠状动脉中至少有一处严重病变。主要终点是主要不良心血管事件（MACE），定义为死亡、心肌梗死（MI）或靶血管再血管化（TVR）。
两组的中位随访时间均为400天。在对患者基线特征进行倾向评分匹配后，仅BVS组较高的预扩张率、主要治疗的左前降支（LAD）以及使用支架数量较少仍具有统计学意义。调整后，治疗病变的类型没有差异。BVS组和药物洗脱支架（DES）组的MACE发生率没有差异（分别为7.2%和11.15%；P = 0.17）。两组的TVR均为2.9%。除围手术期外，BVS组没有死亡或心肌梗死病例。两个研究组均未发生支架血栓形成。
在长期随访的常规临床实践中，成功接受Absorb BVS的患者的临床结局与接受Xience支架的患者没有差异。需要更长时间的随访数据来确定这些发现是否会在一年后持续存在。
