van der Heijden Liefke C, Kok Marlies M, Löwik Marije M, Danse Peter W, Jessurun Gillian A J, Hartmann Marc, Stoel Martin G, van Houwelingen K Gert, Hautvast Raymond W M, Linssen Gerard C, Doggen Carine J M, von Birgelen Clemens
Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, The Netherlands.
Cardiology. 2017;137(4):207-217. doi: 10.1159/000464320. Epub 2017 Apr 27.
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).
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%).
At the 3-year follow-up, the incidence of the composite endpoint target vessel failure (TVF) (13.2 vs. 7.5%; logrank p < 0.001) and 2 of its components - cardiac death (4.7 vs. 1.5%; logrank p < 0.001) and target vessel revascularization (7.3 vs. 4.7%; logrank p = 0.03) - was higher in high-risk (n = 957) versus low- to intermediate-risk patients (n = 854). Among high-risk patients, treatment with Resolute Integrity (n = 481) and Promus Element stents (n = 476) was similarly safe and efficacious (TVF: 13.3 vs. 13.1%; logrank p = 0.95; definite-or-probable stent thrombosis: 1.7 vs. 1.7%; logrank p = 1.00).
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.
关于心血管事件风险增加的患者接受新一代耐用聚合物药物洗脱支架（DES）治疗的长期预后，可用数据有限。
因此，我们评估了随机化荷兰PEERS试验（NCT01331707）中高危患者与低至中危患者的3年随访数据。在两个风险组中，我们还比较了接受Resolute Integrity与Promus Element DES治疗的患者。如果患者符合以下标准中的≥1条，则被分类为“高危”：（1）糖尿病（17.9%）；（2）既往心肌梗死（21.9%）；（3）既往冠状动脉血运重建（25.8%）；（4）慢性肾衰竭（3.5%）；（5）左心室射血分数≤30%（1.5%）；以及（6）年龄≥75岁（17.3%）。
在3年随访时，高危患者（n = 957）的复合终点靶血管失败（TVF）发生率（13.2%对7.5%；对数秩检验p < 0.001）及其两个组成部分——心源性死亡（4.7%对1.5%；对数秩检验p < 0.001）和靶血管血运重建（7.3%对4.7%；对数秩检验p = 0.03）——高于低至中危患者（n = 854）。在高危患者中，接受Resolute Integrity治疗的患者（n = 481）和接受Promus Element支架治疗的患者（n = 476）在安全性和有效性方面相似（TVF：13.3%对13.1%；对数秩检验p = 0.95；明确或可能的支架血栓形成：1.7%对1.7%；对数秩检验p = 1.00）。
新一代Resolute Integrity和Promus Element支架在治疗高危患者方面，在安全性和有效性方面显示出相似的结果，高危患者的事件发生率明显高于低至中危患者。
