Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Health Technology and Services Research, Faculty of Behavioural Management and Social Sciences, Technical Medical Centre, University of Twente, Enschede, the Netherlands.
Department of Health Technology and Services Research, Faculty of Behavioural Management and Social Sciences, Technical Medical Centre, University of Twente, Enschede, the Netherlands.
Am Heart J. 2020 Oct;228:109-115. doi: 10.1016/j.ahj.2020.07.003. Epub 2020 Jul 12.
Patients aged ≥80 years are often treated with new-generation drug-eluting stents (DES), but data from randomized studies are scarce owing to underrepresentation in most trials. We assessed 1-year clinical outcome of octogenarians treated with new-generation DES versus younger patients.
We pooled patient-level data of 9,204 participants in the TWENTE, DUTCH PEERS, BIO-RESORT, and BIONYX (TWENTE I-IV) randomized trials. The main clinical end point was target vessel failure (TVF), a composite of cardiac death, target vessel-related myocardial infarction (MI), or clinically indicated target vessel revascularization.
The 671 octogenarian trial participants had significantly more comorbidities. TVF was higher in octogenarians than in 8,533 patients <80 years (7.3% vs 5.3%, hazard ratio [HR]: 1.36, 95% CI: 1.0-1.83, P = .04). The cardiac death rate was higher in octogenarians (3.9% vs 0.8%, P < .001). There was no significant between-group difference in target vessel MI (2.3% vs 2.3%, P = .88) and repeat target vessel revascularization (1.9% vs 2.8%, P = .16). In multivariate analyses, age ≥ 80 years showed no independent association with TVF (adjusted HR: 1.04, 95% CI: 0.76-1.42), whereas the risk of cardiac death remained higher in octogenarians (adjusted HR: 3.38, 95% CI: 2.07-5.52, P < .001). In 6,002 trial participants, in whom data on major bleeding were recorded, octogenarians (n = 459) showed a higher major bleeding risk (5.9% vs 1.9%; HR: 3.08, 95% CI: 2.01-4.74, P < .001).
Octogenarian participants in 4 large-scale randomized DES trials had more comorbidities and a higher incidence of the main end point TVF. Cardiac mortality was higher in octogenarians, whereas there was no increase in MI or target vessel revascularization rates. Treatment of octogenarian patients with new-generation DES appears to be safe and effective.
≥80 岁的患者通常使用新一代药物洗脱支架（DES）进行治疗，但由于大多数试验中代表性不足，随机研究的数据很少。我们评估了接受新一代 DES 治疗的 80 岁以上患者与年轻患者的 1 年临床结局。
我们汇总了 TWENTE、DUTCH PEERS、BIO-RESORT 和 BIONYX（TWENTE I-IV）四项随机试验中 9204 名患者的个体患者数据。主要临床终点是靶血管失败（TVF），包括心源性死亡、靶血管相关心肌梗死（MI）或临床指征靶血管血运重建。
671 名 80 岁以上的试验参与者合并症明显更多。80 岁以上患者的 TVF 发生率高于 8533 名<80 岁患者（7.3%比 5.3%，风险比[HR]：1.36，95%CI：1.0-1.83，P=0.04）。80 岁以上患者的心脏死亡率更高（3.9%比 0.8%，P<0.001）。两组间靶血管 MI（2.3%比 2.3%，P=0.88）和重复靶血管血运重建（1.9%比 2.8%，P=0.16）发生率无显著差异。多变量分析显示，年龄≥80 岁与 TVF 无独立关联（校正 HR：1.04，95%CI：0.76-1.42），而 80 岁以上患者的心脏死亡风险仍然更高（校正 HR：3.38，95%CI：2.07-5.52，P<0.001）。在记录了大出血数据的 6002 名试验参与者中，80 岁以上患者（n=459）的大出血风险更高（5.9%比 1.9%；HR：3.08，95%CI：2.01-4.74，P<0.001）。
四项新一代 DES 大规模随机试验中的 80 岁以上参与者合并症更多，主要终点 TVF 的发生率更高。80 岁以上患者的心脏死亡率更高，而 MI 或靶血管血运重建的发生率没有增加。新一代 DES 治疗 80 岁以上患者似乎是安全有效的。
