Department of Cardiology, Fuwai Hospital, National Clinical Research Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China.
Department of Cardiology, Cardiovascular Research Institute, General Hospital of Northern Theatre Command, Shenyang, Liaoning 110016, China.
Chin Med J (Engl). 2023 Feb 5;136(3):322-330. doi: 10.1097/CM9.0000000000002450.
There are few data comparing clinical outcomes of complex percutaneous coronary intervention (CPCI) when using biodegradable polymer drug-eluting stents (BP-DES) or second-generation durable polymer drug-eluting stents (DP-DES). The purpose of this study was to investigate the safety and efficacy of BP-DES and compare that with DP-DES in patients with and without CPCI during a 5-year follow-up.
Patients who exclusively underwent BP-DES or DP-DES implantation in 2013 at Fuwai Hospital were consecutively enrolled and stratified into two categories based on CPCI presence or absence. CPCI included at least one of the following features: unprotected left main lesion, ≥2 lesions treated, ≥2 stents implanted, total stent length >40 mm, moderate-to-severe calcified lesion, chronic total occlusion, or bifurcated target lesion. The primary endpoint was major adverse cardiac events (MACE) including all-cause death, recurrent myocardial infarction, and total coronary revascularization (target lesion revascularization, target vessel revascularization [TVR], and non-TVR) during the 5-year follow-up. The secondary endpoint was total coronary revascularization.
Among the 7712 patients included, 4882 (63.3%) underwent CPCI. Compared with non-CPCI patients, CPCI patients had higher 2- and 5-year incidences of MACE and total coronary revascularization. Following multivariable adjustment including stent type, CPCI was an independent predictor of MACE (adjusted hazard ratio [aHR]: 1.151; 95% confidence interval [CI]: 1.017-1.303, P = 0.026) and total coronary revascularization (aHR: 1.199; 95% CI: 1.037-1.388, P = 0.014) at 5 years. The results were consistent at the 2-year endpoints. In patients with CPCI, BP-DES use was associated with significantly higher MACE rates at 5 years (aHR: 1.256; 95% CI: 1.078-1.462, P = 0.003) and total coronary revascularization (aHR: 1.257; 95% CI: 1.052-1.502, P = 0.012) compared with that of DP-DES, but there was a similar risk at 2 years. However, BP-DES had comparable safety and efficacy profiles including MACE and total coronary revascularization compared with DP-DES in patients with non-CPCI at 2 and 5 years.
Patients underwent CPCI remained at a higher risk of mid- to long-term adverse events regardless of the stent type. The effect of BP-DES compared with DP-DES on outcomes was similar in CPCI and non-CPCI patients at 2 years but had inconsistent effects at the 5-year clinical endpoints.
目前鲜有研究比较使用可降解聚合物药物洗脱支架（BP-DES）和第二代持久性聚合物药物洗脱支架（DP-DES）行复杂经皮冠状动脉介入治疗（CPCI）的临床结局。本研究旨在探讨 5 年随访期间 BP-DES 和 DP-DES 在有和无 CPCI 患者中的安全性和有效性。
2013 年，阜外医院连续入选单纯行 BP-DES 或 DP-DES 植入术的患者，并根据是否存在 CPCI 进行分层。CPCI 包括以下至少一项特征：无保护左主干病变、≥2 处病变、≥2 个支架植入、总支架长度＞40mm、中重度钙化病变、慢性完全闭塞或分叉靶病变。主要终点为全因死亡、复发性心肌梗死和总冠状动脉血运重建（靶病变血运重建、靶血管血运重建[TVR]和非 TVR）的 5 年随访期间的主要不良心脏事件（MACE）。次要终点为总冠状动脉血运重建。
在纳入的 7712 例患者中，4882 例（63.3%）行 CPCI。与无 CPCI 患者相比，CPCI 患者的 2 年和 5 年 MACE 和总冠状动脉血运重建发生率更高。多变量调整包括支架类型后，CPCI 是 MACE（调整后的危险比[aHR]：1.151；95%置信区间[CI]：1.017-1.303，P=0.026）和总冠状动脉血运重建（aHR：1.199；95%CI：1.037-1.388，P=0.014）的独立预测因素。5 年终点时结果一致。在 CPCI 患者中，与 DP-DES 相比，BP-DES 治疗的 5 年 MACE 发生率显著更高（aHR：1.256；95%CI：1.078-1.462，P=0.003）和总冠状动脉血运重建（aHR：1.257；95%CI：1.052-1.502，P=0.012），但 2 年时风险相似。然而，BP-DES 在有和无 CPCI 的患者中，2 年和 5 年的 MACE 和总冠状动脉血运重建安全性和有效性与 DP-DES 相当。
无论支架类型如何，行 CPCI 的患者仍处于中期至长期不良事件的高风险中。在 2 年时，与 DP-DES 相比，BP-DES 对 CPCI 和非 CPCI 患者的结局影响相似，但在 5 年临床终点时效果不一致。
