Polymer-free stents for percutaneous coronary intervention in diabetic patients: a systematic review and meta-analysis

Aim: To compare the efficacy of polymer-free drug-eluting stents (PF-DES) versus other stents in diabetic patients with coronary artery disease undergoing percutaneous coronary interventions. Materials & methods: A systematic review and meta-analysis were performed to identify pertinent randomized controlled trials. The primary end point was the occurrence of target lesion failure. Results: Eight randomized controlled trials were included for a total of 4854 subjects. The PF-DES group experienced a trend in favor of a lower rate of target lesion failure (Incidence rate ratio = 0.91; p = 0.11) and a significantly lower rate of cardiac mortality, as compared with the control group (Incidence rate ratio = 0.82; p = 0.04). However, statistical significance was lost if bare-metal stent patients were excluded and a trend in favor of the PF-DES strategy was reported only for cardiac mortality. Conclusion: PF-DES could be a valuable strategy in diabetic patients with coronary artery disease undergoing percutaneous coronary interventions. Polymer-free drug-eluting stents (PF-DES) are a novel type of coronary stent with potential benefits in terms of chronic coronary inflammation. This is a comprehensive, up-to-date, systematic review and meta-analysis of randomized controlled trials comparing the efficacy of PF-DES versus other stents in diabetic patients with coronary artery disease undergoing percutaneous coronary intervention. Patients treated with PF-DES experienced similar prognosis, with a trend toward better outcomes, as compared with conventional stents. PF-DES could represent a novel and effective strategy for treating coronary artery disease in diabetic patients. Polymer-free drug-eluting stents could be a valuable strategy in diabetic patients with coronary artery disease undergoing percutaneous coronary intervention. Graphical summary of the study. IRR: Incidence rate ratio. Polymer-free drug-eluting stents (PF-DES) allow for antiproliferative agent release without the presence of polymers, which leads to chronic coronary inflammation and delayed endothelialization of stent struts. Whether PF-DES could provide prognostic benefits as compared with other types of stents in diabetic populations undergoing percutaneous coronary intervention (PCI) is controversial to date. This study was a comprehensive, up-to-date, systematic review and meta-analysis aimed to compare the efficacy of PF-DES versus other stents in diabetic patients undergoing PCI. A total of eight randomized controlled trials for a total of 4854 subjects were included in the analysis. There was a trend in favor of PF-DES in the primary end point of target lesion failure (IRR = 0.91, [95% CI: 0.81–1.02]; p = 0.11). PF-DES group experienced a significantly lower rate of cardiac mortality, as compared with the control group (IRR = 0.82, [95% CI: 0.68–0.99]; p = 0.04). PF-DES could be a valuable strategy in diabetic patients with coronary artery disease (CAD) undergoing PCI. The pathophysiology underlying these results remains to be addressed. Future larger randomized controlled trials are warranted to address DM subpopulations that could gain more benefit from PF-DES revascularization.目的：对比无聚合物药物洗脱支架（polymer-free drug-eluting stents, PF-DES）与其他支架在接受经皮冠状动脉介入治疗（percutaneous coronary intervention, PCI）的冠状动脉疾病（coronary artery disease, CAD）糖尿病患者中的疗效。材料与方法：本研究采用系统评价（systematic review）与荟萃分析（meta-analysis）方法，检索符合纳入标准的随机对照试验（randomized controlled trial, RCT），主要终点为靶病变失败（target lesion failure）事件的发生情况。结果：共纳入8项随机对照试验，涉及4854名受试者。与对照组相比，无聚合物药物洗脱支架组的靶病变失败率呈降低趋势（发病率比（Incidence rate ratio, IRR）=0.91；P=0.11），且心脏死亡率（cardiac mortality）显著降低（发病率比=0.82；P=0.04）。但若排除裸金属支架（bare-metal stent）受试者，则该统计学差异消失，仅在心脏死亡率方面仍呈有利于无聚合物药物洗脱支架的趋势。结论：无聚合物药物洗脱支架可为接受经皮冠状动脉介入治疗的冠状动脉疾病糖尿病患者提供一种有价值的治疗策略。无聚合物药物洗脱支架是一类新型冠状动脉支架，有望在慢性冠状动脉炎症方面带来获益。本研究为对比无聚合物药物洗脱支架与其他支架在接受经皮冠状动脉介入治疗的冠状动脉疾病糖尿病患者中疗效的全面、最新系统评价与荟萃分析。与传统支架相比，接受无聚合物药物洗脱支架治疗的患者预后相近，但呈向好趋势。无聚合物药物洗脱支架可作为冠状动脉疾病糖尿病患者治疗的新型有效策略。无聚合物药物洗脱支架可为接受经皮冠状动脉介入治疗的冠状动脉疾病糖尿病患者提供有价值的治疗方案。本研究附图形摘要。IRR：发病率比（Incidence rate ratio）。无聚合物药物洗脱支架可在无需聚合物载体的情况下释放抗增殖药物（antiproliferative agent），但既往观点认为这可能引发慢性冠状动脉炎症及支架支撑杆内皮化（endothelialization）延迟。截至目前，在接受经皮冠状动脉介入治疗的糖尿病人群中，无聚合物药物洗脱支架相较其他类型支架是否能带来预后获益仍存在争议。本研究为一项全面、最新的系统评价与荟萃分析，旨在对比无聚合物药物洗脱支架与其他支架在接受PCI的糖尿病患者中的疗效。本分析共纳入8项随机对照试验，涉及4854名受试者。在主要终点靶病变失败率方面，无聚合物药物洗脱支架组呈获益趋势（IRR=0.91，95%CI：0.81~1.02；P=0.11）。与对照组相比，无聚合物药物洗脱支架组的心脏死亡率显著降低（IRR=0.82，95%CI：0.68~0.99；P=0.04）。无聚合物药物洗脱支架可为接受PCI的冠状动脉疾病糖尿病患者提供有价值的治疗策略。上述结果的病理生理学机制尚待阐明。未来需开展更大样本量的随机对照试验，以明确可从无聚合物药物洗脱支架血运重建（revascularization）中获益更多的糖尿病亚群。