Brighton and Sussex University Hospitals National Health Service Trust, Brighton, England.
Hospital Marqués de Valdecilla, Santander, Spain.
J Am Coll Cardiol. 2014 Apr 15;63(14):1371-5. doi: 10.1016/j.jacc.2013.10.053. Epub 2013 Nov 21.
The aim of this study was to determine whether drug-eluting stents (DES) are superior to bare-metal stents (BMS) in octogenarian patients with angina.
Patients ≥80 years of age frequently have complex coronary disease warranting DES but have a higher risk of bleeding from prolonged dual antiplatelet therapy.
This multicenter randomized trial was conducted in 22 centers in the United Kingdom and Spain. Patients ≥80 years of age underwent stent placement for angina. The primary endpoint was a 1-year composite of death, myocardial infarction, cerebrovascular accident, target vessel revascularization, or major hemorrhage.
In total, 800 patients (83.5 ± 3.2 years of age) were randomized to BMS (n = 401) or DES (n = 399) for treatment of stable angina (32%) or acute coronary syndrome (68%). Procedural success did not differ between groups (97.7% for BMS vs. 95.4% for DES; p = 0.07). Thirty-eight percent of patients had ≥2-vessel percutaneous coronary intervention, and 66% underwent complete revascularization. Patients who received BMS had shorter stent implants (24.0 ± 13.4 mm vs. 26.6 ± 14.3 mm; p = 0.01). Rates of dual antiplatelet therapy at 1 year were 32.2% for patients in the BMS group and 94.0% for patients in the DES group. The primary endpoint occurred in 18.7% of patients in the BMS group versus 14.3% of patients in the DES group (p = 0.09). There was no difference in death (7.2% vs. 8.5%; p = 0.50), major hemorrhage (1.7% vs. 2.3%; p = 0.61), or cerebrovascular accident (1.2% vs. 1.5%; p = 0.77). Myocardial infarction (8.7% vs. 4.3%; p = 0.01) and target vessel revascularization (7.0% vs. 2.0%; p = 0.001) occurred more often in patients in the BMS group.
BMS and DES offer good clinical outcomes in this age group. DES were associated with a lower incidence of myocardial infarction and target vessel revascularization without increased incidence of major hemorrhage. (Xience or Vision Stent-Management of Angina in the Elderly [XIMA]; ISRCTN92243650).
本研究旨在确定对于心绞痛的 80 岁以上患者，药物洗脱支架（DES）是否优于金属裸支架（BMS）。
80 岁以上的患者常患有需要 DES 治疗的复杂冠状动脉疾病，但由于双联抗血小板治疗时间延长，出血风险更高。
这项多中心随机试验在英国和西班牙的 22 个中心进行。80 岁以上的患者因心绞痛接受支架置入术。主要终点是 1 年时的死亡、心肌梗死、卒中和靶血管血运重建或大出血的复合终点。
共有 800 例患者（83.5±3.2 岁）随机分为 BMS（n=401）或 DES（n=399）组，分别用于治疗稳定性心绞痛（32%）或急性冠状动脉综合征（68%）。两组的手术成功率无差异（BMS 组为 97.7%，DES 组为 95.4%；p=0.07）。38%的患者接受了≥2 支血管经皮冠状动脉介入治疗，66%的患者接受了完全血运重建。BMS 组的支架植入长度较短（24.0±13.4mm 比 26.6±14.3mm；p=0.01）。BMS 组 1 年时双联抗血小板治疗的比例为 32.2%，DES 组为 94.0%。BMS 组的主要终点发生率为 18.7%，DES 组为 14.3%（p=0.09）。两组之间死亡率（7.2%比 8.5%；p=0.50）、大出血（1.7%比 2.3%；p=0.61）或卒中等不良事件（1.2%比 1.5%；p=0.77）均无差异。心肌梗死（8.7%比 4.3%；p=0.01）和靶血管血运重建（7.0%比 2.0%；p=0.001）更常见于 BMS 组。
BMS 和 DES 在该年龄组均提供了良好的临床结果。DES 降低了心肌梗死和靶血管血运重建的发生率，且不增加大出血的发生率。
