BACKGROUND Drug-eluting stents (DES) showed improved efficacy and safety compared with bare-metal stents (BMS), and international guidelines recommend their use as first line treatment. Yet, BMS are still widely used in practice, especially in large coronary vessels. We aimed to compare efficacy and safety of second-generation DES over BMS in large coronary culprit ST-segment elevated myocardial infarction lesions. METHODS We evaluated impact of large coronary stents (maximum size ≥3.50 mm) or smaller stents (<3.50 mm), among 1498 patients with ST-segment elevated myocardial infarction undergoing primary percutaneous coronary intervention, randomly allocated to everolimus-eluting DES or to an equivalent BMS platform in the EXAMINATION trial (Clinical Evaluation of the Xience-V Stent in Acute Myocardial Infarction Trial). Clinical events up to 5 years of follow-up were evaluated. RESULTS Large coronary stents were used in 683 patients (45.9%). At 5-year follow-up, the crude rate of the primary end point, a composite of all-cause death, any myocardial infarction, or any revascularization, was similar among patients treated with large or smaller coronary stents. The impact of DES versus BMS implantation was consistent irrespective of the stent size both for the primary end point (Pint=0.82) and other secondary ischemic end points. Within patients treated with bigger stents, DES implantation was associated to a trend toward a reduction of target lesion (hazard ratio, 0.53; 95% CI, 0.27-1.02; P=0.05) and target vessel revascularization (hazard ratio, 0.60; 95% CI, 0.34-1.03; P=0.066). CONCLUSIONS Our results do not support the preferential use of BMS for patients with large coronary vessels. DES may warrant improved efficacy irrespective of stent size among patients undergoing primary percutaneous coronary intervention. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT00828087.

中文翻译：

---

大血管尺寸是否证明在原发性经皮冠状动脉介入治疗中使用裸金属支架是合理的？

背景技术与裸金属支架（BMS）相比，药物洗脱支架（DES）表现出更高的功效和安全性，国际指南建议将其用作一线治疗。然而，BMS在实践中仍被广泛使用，特别是在大型冠状血管中。我们旨在比较第二代DES对BMS在大型冠状动脉ST段抬高的心肌梗塞病变中的疗效和安全性。方法我们评估了1498例ST段抬高型心肌梗死的初次经皮冠状动脉介入治疗的大型冠状动脉支架（最大尺寸≥3.50mm）或较小的支架（<3.50 mm）的影响，这些患者随机分配至依维莫司洗脱的DES或EXAMINATION试验中的等效BMS平台（急性心肌梗死试验中Xience-V支架的临床评估）。评估了长达5年的随访的临床事件。结果683例患者使用了较大的冠状动脉支架（45.9％）。在5年的随访中，使用较大或较小的冠状动脉支架治疗的患者的主要终点，所有原因死亡，任何心肌梗塞或任何血运重建的总发生率相似。DES与BMS植入的影响是一致的，而不论主要终点（Pint = 0.82）和其他次要缺血终点的支架大小如何。在使用较大支架治疗的患者中，DES植入与目标病变减少（危险比，0.53； 95％CI，0.27-1.02； P = 0.05）和目标血管血运重建（危险比，0.60； 95％）的趋势相关。 CI，0.34-1.03； P ＝ 0.066）。结论我们的结果不支持对大冠状动脉患者优先使用BMS。不论初次经皮冠状动脉介入治疗的患者支架大小如何，DES均可保证疗效的提高。临床试验注册网址：https：//www.clinicaltrials.gov。唯一标识符：NCT00828087。