Arroyo Diego, Cook Stéphane, Puricel Serban
Department of Cardiology, University and Hospital Fribourg, Fribourg, Switzerland.
J Thorac Dis. 2016 Jun;8(6):E431-6. doi: 10.21037/jtd.2016.04.50.
The fully bioabsorbable vascular scaffold (BVS) has been developed to reduce late adverse events after coronary stenting such as device thrombosis. The device consists of polylactic acid, which is gradually absorbed within the first few years after its implantation. The initial experience with the device in low-risk patients presenting with simple lesions was satisfying and generated optimism among interventional cardiologists by promising better patient outcomes. However, the unrestricted use of the device in patients presenting with a higher baseline risk and more complex lesions came at the cost of alarmingly high rates of early device thrombosis. The performance of the device largely depends on an optimal implantation technique, which differs from that employed with metallic drug-eluting stents due to the device's distinct physical propensity. Mid-term outcomes in large-scale randomized clinical trial were disappointing. Although its non-inferiority compared to metallic everolimus-eluting stents was formally met, there was a clear trend towards an increased occurrence of myocardial infarction and device thrombosis during the first year after device implantation. However, the BVS's putative advantages are expected to manifest themselves at long-term, that is 3 to 5 years after the device has been implanted. Evidence pertaining to these long-term outcomes is eagerly awaited.
全生物可吸收血管支架(BVS)已被研发出来,以减少冠状动脉支架置入术后的晚期不良事件,如器械血栓形成。该器械由聚乳酸组成,在植入后的最初几年内会逐渐被吸收。在患有简单病变的低风险患者中使用该器械的初步经验令人满意,并通过承诺更好的患者预后在介入心脏病学家中产生了乐观情绪。然而,在基线风险较高和病变更复杂的患者中无限制地使用该器械,代价是早期器械血栓形成的发生率高得惊人。该器械的性能很大程度上取决于最佳植入技术,由于该器械独特的物理特性,其植入技术与金属药物洗脱支架不同。大规模随机临床试验的中期结果令人失望。尽管与金属依维莫司洗脱支架相比其非劣效性得到了正式验证,但在器械植入后的第一年,心肌梗死和器械血栓形成的发生率有明显上升趋势。然而,BVS的假定优势预计将在长期,即器械植入后3至5年显现出来。人们急切期待有关这些长期结果的证据。