背景:长期随访对于评估药物洗脱支架(DES)中聚合物降解的影响至关重要。
目的:我们旨在在3年的随访中比较耐久聚合物DES(DP-DES)和可生物降解聚合物DES(BP-DES),以评估整个时期的聚合物分辨率(之前,during,和降解后)。
方法:HOSTREDUCEPOLYTECHRCT试验是一项随机临床试验,纳入急性冠脉综合征(ACS)患者,并比较DP-DES和BP-DES的疗效和安全性。主要结局是以患者为导向的复合结局(POCO),关键次要结局是面向装置的复合结局(DOCO).
结果:总共3,413名ACS患者被随机分为DP-DES组(1,713名患者)或BP-DES组(1,700名患者)。在3年的随访中,DP-DES组和BP-DES组的POCO风险相似(14.8%vs15.4%,风险比[HR]0.96,95%置信区间[CI]:0.80-1.14;p=0.613)。然而,DP-DES组的DOCO风险较低(6.0%vs8.0%,HR0.73,95%CI:0.57-0.95;p=0.020)。在具有里程碑意义的分析中,在经皮冠状动脉介入治疗(PCI)后从早期到晚期的过渡期间,DP-DES组的DOCO风险较低(PCI后8至16个月;1.8%vs3.3%,HR0.54,95%CI:0.34-0.84;p=0.007),这主要是由于靶病变血运重建的风险降低。
结论:在ACS患者中,DP-DES在长达3年的POCO方面显示出与BP-DES相似的结果。对于DOCO来说,DP-DES优于BP-DES;这是由于在聚合物降解期间较高的事件率。
BACKGROUND: Long-term follow-up is essential to evaluate the impact of polymer degradation in drug-eluting stents (DES).
OBJECTIVE: We aimed to compare durable-polymer DES (DP-DES) and biodegradable-polymer DES (BP-DES) during a 3-year follow-up to evaluate the entire period of polymer resolution (before, during, and after degradation).
METHODS: The HOST REDUCE POLYTECH RCT
Trial was a randomised clinical
trial enrolling patients with acute coronary syndrome (ACS) and comparing the efficacy and safety of DP-DES and BP-DES. The primary outcome was a patient-oriented composite outcome (POCO), and the key secondary outcome was a device-oriented composite outcome (DOCO).
RESULTS: A total of 3,413 ACS patients were randomised to either the DP-DES (1,713 patients) or BP-DES (1,700 patients) group. During the 3-year follow-up, the risk of the POCO was similar between the DP-DES and BP-DES groups (14.8% vs 15.4%, hazard ratio [HR] 0.96, 95% confidence interval [CI]: 0.80-1.14; p=0.613). However, the risk of the DOCO was lower in the DP-DES group (6.0% vs 8.0%, HR 0.73, 95% CI: 0.57-0.95; p=0.020). In a landmark analysis, the lower risk of the DOCO for the DP-DES group was evident during the transition from the early to the late period after percutaneous coronary intervention (PCI) (from 8 to 16 months post-PCI; 1.8% vs 3.3%, HR 0.54, 95% CI: 0.34-0.84; p=0.007), which was mainly driven by a risk reduction of target lesion revascularisation.
CONCLUSIONS: In ACS patients, DP-DES showed similar results to BP-DES regarding the POCO up to 3 years. For the DOCO, DP-DES were superior to BP-DES; this was due to the higher event rate during the period of polymer degradation.