Pavasini Rita, Serenelli Matteo, Gallo Francesco, Bugani Giulia, Geraci Salvatore, Vicinelli Paolo, Campo Gianluca
Cardiology Unit, Azienda Ospedaliero-Universitaria di Ferrara, Ferrara, Italy.
Cardiology Unit, Ospedale S.Giovanni di Dio, Agrigento, Italy.
J Thorac Dis. 2017 Aug;9(Suppl 9):S887-S897. doi: 10.21037/jtd.2017.06.59.
In the last years bioresorbable vascular scaffold (BVS) become a new therapeutic option for interventional cardiologists, with the advantage of a scaffold inducing a possible vessel wall restoration. Nevertheless, several trials tried to prove the safety and efficacy profile of scaffolds, but with conflicting results.
A systematic review and meta-analysis was performed. The search was carried out in PubMed, Google Scholar, Biomed Central and Cochrane Library between January and March 2017. Inclusion criteria: randomized clinical trials (RCT) comparing the Absorb BVS versus durable polymer cobalt-chromium Everolimus Eluting Stent. The outcomes analysed were all-cause mortality, cardiac death, ischemia-driven target lesion revascularization, target vessel myocardial infarction (MI), target lesion failure (TLF)/device oriented composite endpoints (DOCE), and device thrombosis. Fixed-effect meta-analysis was performed. Data were expressed as odds ratio (OR).
Overall 5,674 patients were included (mean age 62.2±1.31 in drug eluting stents (DES) group 62±1,47 in BVS group; P=0.942). DOCE (OR 1.16, 95% CI: 0.90-1.48; P=0.259, I2=0%), cardiac death (OR 0.86, 95% CI: 0.52-1.40; P=0.537, I=0%) and all-cause death (OR 0.78, 95% CI: 0.53-1.15; P=0.205, I=15%) did not differ between BVS and DES. Conversely, ischemia-driven target lesion revascularization was more frequent in the BVS group (OR 1.32, 95% CI: 1.01-1.73; P=0.039, I=0%), as well as device thrombosis (2.2% 0.6%, OR 2.94, 95% CI: 1.71-5.05, P=0.0001, I=0%) and target-vessel MI (5.4% 3%, OR 1.66, 95% CI: 1.25-2.21, P=0.001, I=0%).
The implantation of BVS is associated with an increased risk of device thrombosis, ischemia-driven target lesion revascularization and target vessel MI. If longer follow-up or different implantation technique may change these findings should be addressed in future trials.
在过去几年中，生物可吸收血管支架（BVS）已成为介入心脏病学家的一种新的治疗选择，其优点是该支架可能诱导血管壁恢复。然而，多项试验试图证明支架的安全性和有效性，但结果相互矛盾。
进行了一项系统评价和荟萃分析。于2017年1月至3月在PubMed、谷歌学术、生物医学中心和考克兰图书馆进行检索。纳入标准：比较Absorb BVS与耐用聚合物钴铬依维莫司洗脱支架的随机临床试验（RCT）。分析的结局包括全因死亡率、心源性死亡、缺血驱动的靶病变血运重建、靶血管心肌梗死（MI）、靶病变失败（TLF）/器械相关复合终点（DOCE）以及器械血栓形成。采用固定效应荟萃分析。数据以比值比（OR）表示。
共纳入5674例患者（药物洗脱支架（DES）组平均年龄62.2±1.31岁，BVS组平均年龄62±1.47岁；P = 0.942）。BVS组和DES组在DOCE（OR 1.16，95%CI：0.90 - 1.48；P = 0.259，I² = 0%）、心源性死亡（OR 0.86，95%CI：0.52 - 1.40；P = 0.537，I² = 0%）和全因死亡（OR 0.78，95%CI：0.53 - 1.15；P = 0.205，I² = 15%）方面无差异。相反，BVS组缺血驱动的靶病变血运重建更为频繁（OR 1.32，95%CI：1.01 - 1.73；P = 0.039，I² = 0%），器械血栓形成（2.2%对0.6%，OR 2.94，95%CI：1.71 - 5.05，P = 0.0001，I² = 0%）以及靶血管MI（5.4%对3%，OR 1.66，95%CI：1.25 - 2.21，P = 0.001，I² = 0%）也是如此。
植入BVS与器械血栓形成、缺血驱动的靶病变血运重建和靶血管MI风险增加相关。更长时间的随访或不同的植入技术是否会改变这些结果，有待未来试验进一步探讨。
