Isala Hospital, Zwolle, The Netherlands.
Cardiovascular Department, University of Trieste, Trieste, Italy.
Cardiovasc Diabetol. 2020 Oct 2;19(1):165. doi: 10.1186/s12933-020-01116-2.
Several studies compared everolimus-eluting bioresorbable scaffolds (EE-BRS) with everolimus-eluting stents (EES), but only few assessed these devices in patients with diabetes mellitus.
To evaluate the safety and efficacy outcomes of all-comer patients with diabetes mellitus up to 2 years after treatment with EE-BRS or EES.
We performed a post hoc pooled analysis of patient-level data in diabetic patients who were treated with EE-BRS or EES in 3 prospective clinical trials: The ABSORB DM Benelux Study (NTR5447), TWENTE (NTR1256/NCT01066650) and DUTCH PEERS (NTR2413/NCT01331707). Primary endpoint of the analysis was target lesion failure (TLF): a composite of cardiac death, target vessel myocardial infarction or clinically driven target lesion revascularization. Secondary endpoints included major adverse cardiac events (MACE): a composite of all-cause death, any myocardial infarction or clinically driven target vessel revascularization, as well as definite or probable device thrombosis (ST).
A total of 499 diabetic patients were assessed, of whom 150 received EE-BRS and 249 received EES. Total available follow-up was 222.6 patient years (PY) in the EE-BRS and 464.9 PY in the EES group. The adverse events rates were similar in both treatment groups for TLF (7.2 vs. 5.2 events per 100 PY, p = 0.39; adjusted hazard ratio (HR) = 1.48 (95% confidence interval (CI): 0.77-2.87), p = 0.24), MACE (9.1 vs. 8.3 per 100 PY, p = 0.83; adjusted HR = 1.23 (95% CI: 0.70-2.17), p = 0.47), and ST (0.9 vs. 0.6 per 100 PY, p > 0.99).
In this patient-level pooled analysis of patients with diabetes mellitus from 3 clinical trials, EE-BRS showed clinical outcomes that were quite similar to EES.
已有多项研究比较了依维莫司洗脱生物可吸收支架（EE-BRS）与依维莫司洗脱支架（EES），但仅有少数研究评估了这些器械在糖尿病患者中的应用。
评估所有糖尿病患者在接受 EE-BRS 或 EES 治疗后 2 年内的安全性和疗效结局。
我们对 3 项前瞻性临床试验中接受 EE-BRS 或 EES 治疗的糖尿病患者进行了患者水平数据的事后汇总分析：ABSORB DM 比荷卢研究（NTR5447）、TWENTE 研究（NTR1256/NCT01066650）和 DUTCH PEERS 研究（NTR2413/NCT01331707）。分析的主要终点为靶病变失败（TLF）：包括心源性死亡、靶血管心肌梗死或临床驱动的靶病变血运重建的复合终点。次要终点包括主要不良心脏事件（MACE）：包括全因死亡、任何心肌梗死或临床驱动的靶血管血运重建以及确定或可能的器械血栓形成（ST）的复合终点。
共评估了 499 例糖尿病患者，其中 150 例接受 EE-BRS 治疗，249 例接受 EES 治疗。EE-BRS 组和 EES 组的总随访时间分别为 222.6 患者年（PY）和 464.9 PY。两组的 TLF 不良事件发生率相似（每 100 PY 分别为 7.2 例和 5.2 例事件，p=0.39；校正后的危险比（HR）=1.48（95%可信区间（CI）：0.77-2.87），p=0.24）、MACE（每 100 PY 分别为 9.1 例和 8.3 例，p=0.83；校正 HR=1.23（95% CI：0.70-2.17），p=0.47）和 ST（每 100 PY 分别为 0.9 例和 0.6 例，p＞0.99）。
在这项来自 3 项临床试验的糖尿病患者的患者水平汇总分析中，EE-BRS 的临床结局与 EES 相当。
