Supplementary Material for: Three-Year Clinical Outcome of Patients with Coronary Disease and Increased Event Risk Treated with Newer-Generation Drug-Eluting Stents: From the Randomized DUTCH PEERS Trial

<b><i>Objective:</i></b> Limited data is available on the long-term outcome of patients with increased cardiovascular event risk, treated with newer-generation durable polymer drug-eluting stents (DES). <b><i>Methods:</i></b> We therefore assessed 3-year follow-up data of high-risk versus low- to intermediate-risk patients of the randomized DUTCH PEERS trial (NCT01331707). In both risk groups we also compared patients treated with Resolute Integrity versus Promus Element DES. Patients were categorized as “high-risk” if they met ≥1 of the following criteria: (1) diabetes (17.9%); (2) previous myocardial infarction (21.9%); (3) previous coronary revascularization (25.8%); (4) chronic renal failure (3.5%); (5) left ventricular ejection fraction ≤30% (1.5%); and (6) age ≥75 years (17.3%). <b><i>Results:</i></b> At the 3-year follow-up, the incidence of the composite endpoint target vessel failure (TVF) (13.2 vs. 7.5%; logrank <i>p</i> &lt; 0.001) and 2 of its components - cardiac death (4.7 vs. 1.5%; logrank <i>p</i> &lt; 0.001) and target vessel revascularization (7.3 vs. 4.7%; logrank <i>p</i> = 0.03) - was higher in high-risk (<i>n</i> = 957) versus low- to intermediate-risk patients (<i>n</i> = 854). Among high-risk patients, treatment with Resolute Integrity (<i>n</i> = 481) and Promus Element stents (<i>n</i> = 476) was similarly safe and efficacious (TVF: 13.3 vs. 13.1%; logrank <i>p</i> = 0.95; definite-or-probable stent thrombosis: 1.7 vs. 1.7%; logrank <i>p</i> = 1.00). <b><i>Conclusions:</i></b> The newer-generation Resolute Integrity and Promus Element stents showed similar results in terms of safety and efficacy for treating high-risk patients, who had significantly higher event rates than patients with low-to-intermediate risk.

**研究目标**：目前针对接受新一代永久聚合物药物洗脱支架（DES，drug-eluting stents）治疗的心血管事件风险升高患者，其长期预后相关数据较为有限。
**研究方法**：本研究对随机对照试验DUTCH PEERS（临床试验注册号NCT01331707）中高危与低至中危患者的3年随访数据展开分析，并在两个风险分层队列中，对比了接受Resolute Integrity支架与Promus Element支架治疗的患者预后。患者若符合以下≥1项判定标准，则被归类为“高危”：(1) 糖尿病（占比17.9%）；(2) 既往心肌梗死病史（占比21.9%）；(3) 既往冠状动脉血运重建史（占比25.8%）；(4) 慢性肾功能衰竭（占比3.5%）；(5) 左心室射血分数≤30%（占比1.5%）；(6) 年龄≥75岁（占比17.3%）。
**研究结果**：经3年随访后，高危患者组（n=957）的复合终点靶血管失败（TVF，target vessel failure）发生率（13.2% vs. 7.5%；log-rank检验p<0.001）及其两个组成组分——心源性死亡（4.7% vs. 1.5%；log-rank检验p<0.001）与靶血管血运重建（7.3% vs. 4.7%；log-rank检验p=0.03）——的发生率均显著高于低至中危患者组（n=854）。在高危患者亚组中，接受Resolute Integrity支架治疗者（n=481）与接受Promus Element支架治疗者（n=476）的安全性与疗效均无显著差异：靶血管失败率分别为13.3%与13.1%（log-rank检验p=0.95）；明确或可能的支架血栓发生率分别为1.7%与1.7%（log-rank检验p=1.00）。
**研究结论**：新一代Resolute Integrity与Promus Element支架在高危患者的治疗中展现出相当的安全性与疗效，且高危患者的不良事件发生率显著高于低至中危患者。