Cardiovascular Division, Brigham and Women's Hospital, Boston, MA 02115, USA.
Circ Cardiovasc Interv. 2009 Jun;2(3):178-87. doi: 10.1161/CIRCINTERVENTIONS.109.855221. Epub 2009 Jun 2.
Although drug-eluting stents have become a mainstay of percutaneous coronary intervention, information about drug-eluting stents outcomes in elderly patients is limited. Data from the paclitaxel-eluting stent (PES) trials and registries were pooled to assess PES benefits relative to advancing patient age, including comparison with bare-metal stents.
Data from 5 randomized trials (2271 patients with PES, 1397 patients with bare-metal stents) and from 2 postmarket registries (7492 patients with PES) were pooled separately. Each dataset was stratified into age groups: <60, 60 to 70, and >70 years. At baseline, patients aged >70 years in both datasets had significantly more adverse characteristics than younger patients. Through 5 years, trial data showed that patients aged >70 years had higher death rates, but comparable rates of myocardial infarction, stent thrombosis, and target lesion revascularization with younger patients. Compared with patients with bare-metal stents, patients with PES aged >70 years had comparable rates of death, myocardial infarction, and stent thrombosis but a significantly lower target lesion revascularization rate (22.2 versus 10.2, P<0.001). These findings were echoed in the registry data through 2 years that showed that PES patients aged >70 years had significantly higher death rates, but lower myocardial infarction, stent thrombosis, and target lesion revascularization rates, compared with younger patients. Although the mortality rates of patients aged >70 years were higher than those of younger patients, they were comparable with those of age- and gender-matched norms in the general population.
This analysis of almost 10 000 patients demonstrated that percutaneous coronary intervention with PES is a safe and an effective treatment option that should not be withheld based on age.
尽管药物洗脱支架已成为经皮冠状动脉介入治疗的主要手段，但有关老年患者药物洗脱支架治疗结果的信息有限。本研究对紫杉醇洗脱支架（PES）试验和注册研究的数据进行了汇总分析，以评估与患者年龄增长相关的 PES 治疗优势，包括与裸金属支架的比较。
分别对 5 项随机试验（2271 例 PES 患者，1397 例裸金属支架患者）和 2 项上市后注册研究（7492 例 PES 患者）的数据进行了汇总。每个数据集均按年龄组分层：<60 岁、60 至 70 岁和>70 岁。在基线时，两个数据集年龄>70 岁的患者与年轻患者相比，具有更多的不良特征。5 年随访结果显示，年龄>70 岁的患者死亡率较高，但与年轻患者相比，心肌梗死、支架血栓和靶病变血运重建的发生率相似。与裸金属支架相比，年龄>70 岁的 PES 患者死亡率、心肌梗死和支架血栓发生率相似，但靶病变血运重建发生率显著降低（22.2%比 10.2%，P<0.001）。2 年的注册研究数据也证实了这一结果，年龄>70 岁的 PES 患者死亡率显著升高，但心肌梗死、支架血栓和靶病变血运重建发生率均显著降低。尽管年龄>70 岁患者的死亡率高于年轻患者，但与一般人群中年龄和性别匹配的标准相比，死亡率相似。
这项对近 10000 例患者的分析表明，经皮冠状动脉介入治疗中应用 PES 是一种安全有效的治疗选择，不应因其年龄而被拒绝。
