Heart Center; department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
The Department of Cardiology, Medical Center Leeuwarden, Leeuwarden, The Netherlands.
Catheter Cardiovasc Interv. 2021 Oct;98(4):713-720. doi: 10.1002/ccd.29329. Epub 2020 Oct 29.
In this prespecified AIDA-trial sub-study we investigate the clinical performance of absorb bioresorbable vascular scaffold (BVS) compared to Xience everolimus-eluting stent (EES) in routine percutaneous coronary intervention (PCI) in patients with diabetes mellitus (DM) at complete 3-year follow-up.
All 1,845 randomized patients were subdivided by medical history with DM or without DM. Of the 924 Absorb BVS patients, 171 (18.5%) patients had DM, of which 65 (38.0%) were treated with insulin (iTDM). Of the 921 Xience EES patients, 153 (16.6%) patients had DM, of which 45 (29.4%) were insulin-treated diabetes mellitus (iTDM). Target vessel failure (TVF), composite of cardiac death, target vessel myocardial infarction, and target vessel revascularization, occurred in 18.7% of diabetic patients treated with Absorb patients versus in 18.0% patients treated with Xience EES (p = .840). In nondiabetics the rates of TVF were 12.3% in Absorb BVS versus 11.0% in Xience EES (p = .391). Definite/probable device thrombosis occurred more frequently in Absorb BVS compared to Xience EES in both diabetic and nondiabetic patients (4.8% versus 0.7%; p = .028 and 3.2% vs. 0.5%; p < .001, respectively).
In routine PCI practice, both Absorb BVS and Xience EES have worse clinical outcomes in diabetic patients as compared to nondiabetic patients. Throughout all clinical presentations, Absorb BVS was associated with higher rates of device thrombosis at 3-year follow-up.
在这项预先指定的 AIDA 试验子研究中，我们在完整的 3 年随访中调查了在常规经皮冠状动脉介入治疗 (PCI) 中患有糖尿病 (DM) 的患者中，可吸收生物可吸收血管支架 (BVS) 与依维莫司洗脱支架 (EES) 的临床性能。
所有 1845 名随机患者按是否有 DM 病史进行了细分。在 924 名 Absorb BVS 患者中，171 名（18.5%）患者患有 DM，其中 65 名（38.0%）接受胰岛素治疗（iTDM）。在 921 名 Xience EES 患者中，153 名（16.6%）患者患有 DM，其中 45 名（29.4%）接受胰岛素治疗糖尿病（iTDM）。在接受 Absorb 治疗的糖尿病患者中，靶血管失败（TVF），包括心源性死亡、靶血管心肌梗死和靶血管血运重建，发生率为 18.7%，而接受 Xience EES 治疗的患者为 18.0%（p=0.840）。在非糖尿病患者中，Absorb BVS 的 TVF 发生率为 12.3%，而 Xience EES 为 11.0%（p=0.391）。在糖尿病和非糖尿病患者中，与 Xience EES 相比，Absorb BVS 发生明确/可能的器械血栓的频率更高（4.8%比 0.7%；p=0.028 和 3.2%比 0.5%；p<0.001）。
在常规 PCI 实践中，与非糖尿病患者相比，Absorb BVS 和 Xience EES 在糖尿病患者中的临床结局更差。在所有临床表现中，Absorb BVS 在 3 年随访时与更高的器械血栓形成率相关。
