Deutsches Herzzentrum Munchen, Technische Universität München, Munich, Germany.
EuroIntervention. 2020 Mar 20;15(16):1451-1457. doi: 10.4244/EIJ-D-18-01080.
Bioresorbable scaffolds (BRS) were conceived to ensure transient coronary artery support during antiproliferative drug delivery. However, the Absorb everolimus-eluting bioresorbable scaffold was found to be inferior to everolimus-eluting metallic stents (EES) in moderately complex coronary anatomies. We sought to investigate whether the Absorb represents a valuable option for the percutaneous treatment of patients with ST-elevation myocardial infarction (STEMI).
We pooled the individual patient data of two randomised trials specifically designed to investigate the performance of Absorb versus EES in patients with acute myocardial infarction (MI). The primary outcome was lesion (in-segment) diameter stenosis at angiographic follow-up. The main secondary outcome was the device-oriented composite endpoint (DOCE) of cardiac death, target vessel MI and target lesion revascularisation at one year. A total of 388 patients with STEMI were allocated to Absorb (n=227) or EES (n=161). Angiographic follow-up at one year was available for 332 (85.6%) patients. Lesion diameter stenosis was comparable between Absorb and EES (22.8±9.8% versus 23.6±11.2%; mean difference -0.8%, 95% confidence interval [CI]: -3.18-1.48, p=0.47). DOCE occurred in 21 patients at one year, with similar distribution between the Absorb and EES groups (5.3% versus 5.6%; hazard ratio 0.95, 95% CI: 0.40-2.26, p=0.91).
This pooled analysis provides evidence for a comparable angiographic performance and suggests similar clinical performance of Absorb and EES in STEMI patients undergoing percutaneous revascularisation. The long-term durability of Absorb and the extent to which newer BRS platforms might have a potential role in STEMI deserve further investigation. Both trials were registered at www.clinicaltrials.gov (NCT01942070 and NCT01986803).
生物可吸收支架（BRS）的设计初衷是在药物输送期间为冠状动脉提供短暂的支持。然而，Absorb 依维莫司洗脱生物可吸收支架在中度复杂的冠状动脉解剖结构中表现不如依维莫司洗脱金属支架（EES）。我们试图研究 Absorb 是否为急性 ST 段抬高型心肌梗死（STEMI）患者的经皮治疗提供了有价值的选择。
我们汇集了两项专门设计用于研究 Absorb 与 EES 在急性心肌梗死（MI）患者中表现的随机试验的个体患者数据。主要终点是血管造影随访时的病变（节段内）直径狭窄。主要次要终点是一年时的器械定向复合终点（DOCE），包括心脏死亡、靶血管心肌梗死和靶病变血运重建。共有 388 例 STEMI 患者被分配至 Absorb（n=227）或 EES（n=161）。332 例（85.6%）患者可进行一年时的血管造影随访。Absorb 和 EES 之间的病变直径狭窄相似（22.8±9.8%与 23.6±11.2%；平均差异-0.8%，95%置信区间[CI]：-3.18-1.48，p=0.47）。一年时，21 例患者发生 DOCE，Absorb 和 EES 组的分布相似（5.3%与 5.6%；风险比 0.95，95%CI：0.40-2.26，p=0.91）。
这项汇总分析提供了可比较的血管造影表现的证据，并表明 Absorb 和 EES 在接受经皮血运重建的 STEMI 患者中具有相似的临床表现。Absorb 的长期耐久性以及更新的 BRS 平台在 STEMI 中的潜在作用程度值得进一步研究。两项试验均在 www.clinicaltrials.gov 注册（NCT01942070 和 NCT01986803）。
