Lifespan Cardiovascular Institute, Rhode Island Hospital, Providence, RI, USA.
Mount Sinai St. Luke's and Mount Sinai West Hospitals, New York, NY, USA.
Eur Heart J Qual Care Clin Outcomes. 2020 Jan 1;6(1):81-88. doi: 10.1093/ehjqcco/qcz031.
The biodegradable polymer drug-eluting stents (BP-DES) offer controlled drug elution and complete degradation of the polymer over time, eventually lowering the risk for chronic inflammation and neoatherosclerosis, which can be particularly helpful in patients with diabetes. While BP-DES and durable polymer drug-eluting stents (DP-DES) have demonstrated comparable efficacy in all-comers population, their efficacy and safety in patients with diabetes remains uncertain.
Electronic databases were systematically searched for randomized controlled trials (RCTs) comparing BP-DES with contemporary DP-DES in patients with diabetes. Study investigators were contacted to obtain additional data. The primary outcome was efficacy in terms of target-vessel revascularization (TVR) and target-lesion revascularization (TLR). We also evaluated the following safety outcomes separately: all-cause mortality, cardiac mortality, myocardial infarction (MI), and definite or probable stent thrombosis. Eleven RCTs including 5190 diabetic patients were included. At the longest available follow-up (mean 2.7 years), there was no significant difference in TLR [relative risk (RR): 1.02, 95% confidence interval (CI): 0.85-1.24; P = 0.80] or TVR (RR: 1.04, 95% CI: 0.81-1.34; P = 0.76). Safety outcomes of all-cause mortality, cardiac mortality, and MI were similar between the two groups. Stent thrombosis rates were also similar between BP-DES and DP-DES groups (1.66% vs. 1.83%; RR: 0.84, 95% CI: 0.54-1.31; P = 0.45). The heterogeneity was low and fixed-effect model yielded similar results. Meta-regression analysis showed no relationship between insulin requiring diabetes and difference in TLR or stent thrombosis between BP-DES and DP-DES.
Overall, BP-DESs have similar safety and efficacy profiles compared to contemporary DP-DES in patients with diabetes.
可生物降解聚合物药物洗脱支架 (BP-DES) 可实现药物的控制释放，并随着时间的推移完全降解聚合物，从而最终降低慢性炎症和新生动脉粥样硬化的风险，这在糖尿病患者中尤为重要。虽然 BP-DES 和耐用聚合物药物洗脱支架 (DP-DES) 在所有患者中均显示出相当的疗效，但它们在糖尿病患者中的疗效和安全性仍不确定。
系统检索了电子数据库中比较糖尿病患者使用 BP-DES 与当代 DP-DES 的随机对照试验 (RCT)。联系研究人员以获取额外的数据。主要结局是靶血管血运重建 (TVR) 和靶病变血运重建 (TLR) 的疗效。我们还分别评估了以下安全性结局：全因死亡率、心源性死亡率、心肌梗死 (MI) 和确定或可能的支架血栓形成。纳入了 11 项 RCT，共 5190 例糖尿病患者。在最长的可获得随访（平均 2.7 年）中，TLR 无显著差异 [相对风险 (RR)：1.02，95%置信区间 (CI)：0.85-1.24；P=0.80] 或 TVR (RR：1.04，95% CI：0.81-1.34；P=0.76)。两组之间全因死亡率、心源性死亡率和 MI 的安全性结局相似。支架血栓形成率在 BP-DES 和 DP-DES 组之间也相似（1.66% vs. 1.83%；RR：0.84，95% CI：0.54-1.31；P=0.45）。异质性较低，固定效应模型得出了相似的结果。Meta 回归分析表明，需要胰岛素的糖尿病与 BP-DES 和 DP-DES 之间 TLR 或支架血栓形成的差异之间没有关系。
总体而言，BP-DES 在糖尿病患者中的安全性和疗效与当代 DP-DES 相当。
