Tel-Aviv Medical Center.
Sackler Faculty of Medicine, Tel-Aviv, Israel.
Coron Artery Dis. 2022 Aug 1;33(5):354-361. doi: 10.1097/MCA.0000000000001143. Epub 2022 Mar 8.
Implantation of drug eluting stents (DES) is the mainstay treatment for patients requiring percutaneous coronary intervention (PCI). The polymer coating of DES has been associated with inflammatory response, increased arterial injury and long-term in-stent restenosis and thrombosis. Polymer-free stents (PFS) were designed to overcome limitations of polymer-coated stents (PCS). Our aim was to compare clinical outcomes of patients undergoing PCI with PFS versus contemporary PCS.
This is a prospective, open-label registry study enrolling consecutive all-comers patients admitted to a single center and undergoing PCI using contemporary DES. Clinical outcomes were compared between patients treated with PFS and PCS. The primary endpoint was target lesion revascularization (TLR) at 12 months. Subgroup analyses were conducted for diabetic and nondiabetic patients.
Overall, 1664 patients were included: 928 (55.8%) of which were treated with PFS and 736 (44.2%) with PCS for 2046 and 1462 lesions, respectively. At 12 months, TLR rates were not significantly different between the groups (1.7% vs. 2.3% for PFS and PCS, respectively, P = 0.48). The use of PFS did not improve clinical outcomes among diabetic patients in comparison with PCS. Target vessel revascularization and major adverse cardiac events rates were also similar between groups, regardless of diabetes status.
Newer generation DES offer excellent results in diabetic and nondiabetic patients without significant differences in outcomes between PCS and PFS.
药物洗脱支架（DES）的植入是经皮冠状动脉介入治疗（PCI）患者的主要治疗方法。DES 的聚合物涂层与炎症反应、动脉损伤增加以及支架内再狭窄和血栓形成的长期风险相关。无聚合物支架（PFS）旨在克服聚合物涂层支架（PCS）的局限性。我们的目的是比较接受 PFS 和当代 PCS 行 PCI 的患者的临床结果。
这是一项前瞻性、开放标签的注册研究，纳入了一家中心连续收治的所有接受 PCI 的患者，且使用了当代 DES。比较了接受 PFS 和 PCS 治疗的患者的临床结果。主要终点是 12 个月时的靶病变血运重建（TLR）。对糖尿病和非糖尿病患者进行了亚组分析。
共有 1664 例患者纳入研究：928 例（55.8%）接受 PFS 治疗，736 例（44.2%）接受 PCS 治疗，分别用于治疗 2046 处和 1462 处病变。12 个月时，两组之间 TLR 发生率无显著差异（分别为 PFS 和 PCS 的 1.7%和 2.3%，P=0.48）。与 PCS 相比，PFS 的使用并不能改善糖尿病患者的临床结果。无论糖尿病状态如何，两组之间靶血管血运重建和主要不良心脏事件的发生率也相似。
新一代 DES 在糖尿病和非糖尿病患者中提供了出色的结果，PCS 和 PFS 之间的结局无显著差异。
