大血管直径是否支持在初次经皮冠状动脉介入治疗中使用裸金属支架？
Does Large Vessel Size Justify Use of Bare-Metal Stents in Primary Percutaneous Coronary Intervention?
机构信息
Instituto Clínico Cardiovascular (ICCV), Hospital Clínic i Provincial de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Spain (F.C., S.A.P., E.F.-U., L.O.-P., M.S.).
Department of Clinical and Experimental Medicine, University of Messina, Italy (F.C.).
出版信息
Circ Cardiovasc Interv. 2019 Sep;12(9):e007705. doi: 10.1161/CIRCINTERVENTIONS.118.007705. Epub 2019 Aug 27.
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 (P=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.
背景
与金属裸支架（BMS）相比，药物洗脱支架（DES）显示出更好的疗效和安全性，国际指南建议将其作为一线治疗方法。然而，BMS 在实践中仍被广泛使用，特别是在大的冠状动脉中。我们旨在比较第二代 DES 与 BMS 在大冠状动脉罪犯 ST 段抬高型心肌梗死病变中的疗效和安全性。
方法
我们评估了在接受直接经皮冠状动脉介入治疗的 1498 例 ST 段抬高型心肌梗死患者中，大冠状动脉支架（最大直径≥3.50mm）或小支架（<3.50mm）的影响，这些患者随机分配至依维莫司洗脱 DES 或 EXAMINATION 试验（急性心肌梗死中 Xience-V 支架的临床评估试验）中同等 BMS 平台。评估了 5 年随访期间的临床事件。
结果
683 例患者（45.9%）使用了大冠状动脉支架。在 5 年随访时，大或小冠状动脉支架治疗患者的主要终点（全因死亡、任何心肌梗死或任何血运重建的复合终点）的粗发生率相似。DES 与 BMS 植入的影响在支架大小不同的情况下均一致，无论是主要终点（P=0.82）还是其他缺血性次要终点。在接受大支架治疗的患者中，DES 植入与靶病变（危险比，0.53；95%置信区间，0.27-1.02；P=0.05）和靶血管血运重建（危险比，0.60；95%置信区间，0.34-1.03；P=0.066）的降低趋势相关。
结论
我们的结果不支持对大血管病变患者优先使用 BMS。DES 可能在接受直接经皮冠状动脉介入治疗的患者中，无论支架大小如何，都能提高疗效。
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