Støttrup Nicolaj Brejnholt, Christiansen Evald Høj, Raungaard Bent, Kahlert Johnny, Terkelsen Christian Juhl, Kristensen Steen Dalby, Thim Troels, Jakobsen Lars, Jensen Rebekka Vibjerg, Eftekhari Ashkan, Freeman Phillip, Jensen Svend Eggert, Veien Karsten Tange, Jensen Lisette Okkels, Maeng Michael, For Randomized Trials With Clinical Outcome Sort Out For The Scandinavian Organization
Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
Department of Clinical Medicine, Health, Aarhus University, Aarhus, Denmark.
EuroIntervention. 2025 Jun 2;21(11):e629-e638. doi: 10.4244/EIJ-D-24-00763.
Long-term outcomes following implantation of drug-eluting coronary stents are necessary to determine safety and efficacy.
We aimed to report the 5-year outcomes of the SYNERGY thin-strut biodegradable-polymer everolimus-eluting platinum-chromium stent (EES) versus the BioMatrix NeoFlex biodegradable-polymer biolimus-eluting stainless-steel stent (BES).
This randomised, multicentre, all-comer, non-inferiority trial was undertaken at three sites in Western Denmark. Patients with a clinical indication for percutaneous coronary intervention were eligible for inclusion. Patients were randomly assigned (1:1) to either EES or BES. Outcomes included target lesion failure (TLF: cardiac death, myocardial infarction not clearly attributable to a non-target lesion, or target lesion revascularisation), all myocardial infarctions, and very late stent thrombosis at 5-year follow-up.
We included 2,764 patients and randomly assigned 1,385 patients to treatment with EES and 1,379 patients to treatment with BES. TLF occurred in 150 patients (10.8%) assigned to the EES and in 165 (12.0%) assigned to the BES (rate ratio [RR] 0.88, 95% confidence interval [CI]: 0.71-1.10). The incidence of myocardial infarction was lower in the EES group (EES: n=85 [6.1%], BES: n=116 [8.4%]; RR 0.71, 95% CI: 0.54-0.95), while very late stent thrombosis was rare for both stent types (EES: n=12 [0.9%], BES: n=9 [0.7%]; RR 1.32, 95% CI: 0.56-3.14).
At 5-year follow-up, TLF was comparable for EES and BES. The incidence of myocardial infarction, however, was lower in patients randomised to EES versus BES implantation.
植入药物洗脱冠状动脉支架后的长期预后对于确定安全性和有效性至关重要。
我们旨在报告SYNERGY薄支柱生物可降解聚合物依维莫司洗脱铂铬合金支架（EES）与BioMatrix NeoFlex生物可降解聚合物生物雷帕霉素洗脱不锈钢支架（BES）的5年预后情况。
这项随机、多中心、针对所有患者的非劣效性试验在丹麦西部的三个地点进行。有经皮冠状动脉介入治疗临床指征的患者符合纳入标准。患者被随机分配（1:1）接受EES或BES治疗。预后指标包括靶病变失败（TLF：心源性死亡、不能明确归因于非靶病变的心肌梗死或靶病变血运重建）、所有心肌梗死以及5年随访时的极晚期支架血栓形成。
我们纳入了2764例患者，随机分配1385例患者接受EES治疗，1379例患者接受BES治疗。分配至EES组的150例患者（10.8%）发生了TLF，分配至BES组的165例患者（12.0%）发生了TLF（率比[RR]0.88，95%置信区间[CI]：0.71 - 1.10）。EES组心肌梗死的发生率较低（EES组：n = 85 [6.1%]，BES组：n = 116 [8.4%]；RR 0.71，95% CI：0.54 - 0.95），而两种支架类型的极晚期支架血栓形成均较少见（EES组：n = 12 [0.9%]，BES组：n = 9 [0.7%]；RR 1.32，95% CI：0.56 - 3.14）。
在5年随访时，EES和BES的TLF情况相当。然而，随机接受EES植入的患者心肌梗死发生率低于接受BES植入的患者。
