Douglas Pamela S, Brennan J Matthew, Anstrom Kevin J, Sedrakyan Art, Eisenstein Eric L, Haque Ghazala, Dai David, Kong David F, Hammill Bradley, Curtis Lesley, Matchar David, Brindis Ralph, Peterson Eric D
Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina, USA.
J Am Coll Cardiol. 2009 May 5;53(18):1629-41. doi: 10.1016/j.jacc.2009.03.005.
The aim of this study was to compare outcomes in older individuals receiving drug-eluting stents (DES) and bare-metal stents (BMS).
Comparative effectiveness of DES relative to BMS remains unclear.
Outcomes were evaluated in 262,700 patients from 650 National Cardiovascular Data Registry sites during 2004 to 2006 with procedural registry data linked to Medicare claims for follow-up. Outcomes including death, myocardial infarction (MI), revascularization, major bleeding, stroke, death or MI, death or MI or revascularization, and death or MI or stroke were compared with estimated cumulative incidence rates with inverse probability weighted estimators and Cox proportional hazards ratios.
The DES were implanted in 217,675 patients and BMS were implanted in 45,025. At 30 months, DES patients had lower unadjusted rates of death (12.9% vs. 17.9%), MI (7.3 of 100 patients vs. 10.0 of 100 patients), and revascularization (23.0 of 100 patients vs. 24.5 of 100 patients) with no difference in stroke or bleeding. After adjustment, DES patients had lower rates of death (13.5% vs. 16.5%, hazard ratio [HR]: 0.75, 95% confidence interval [CI]: 0.72 to 0.79, p < 0.001) and MI (7.5 of 100 patients vs. 8.9 of 100 patients, HR: 0.77, 95% CI: 0.72 to 0.81, p < 0.001), with minimal difference in revascularization (23.5 of 100 patients vs. 23.4 of 100 patients; HR: 0.91, 95% CI: 0.87 to 0.96), stroke (3.1 of 100 patients vs. 2.7 of 100 patients, HR: 0.97, 95% CI: 0.88 to 1.07), or bleeding (3.4 of 100 patients vs. 3.6 of 100 patients, HR: 0.91, 95% CI: 0.84 to 1.00). The DES survival benefit was observed in all subgroups analyzed and persisted throughout 30 months of follow-up.
In this largest ever real-world study, patients receiving DES had significantly better clinical outcomes than their BMS counterparts, without an associated increase in bleeding or stroke, throughout 30 months of follow-up and across all pre-specified subgroups.
本研究旨在比较接受药物洗脱支架(DES)和裸金属支架(BMS)的老年患者的治疗结果。
DES相对于BMS的比较有效性仍不明确。
对2004年至2006年期间来自650个国家心血管数据注册中心的262,700例患者的结果进行评估,将手术注册数据与医疗保险索赔数据相链接以进行随访。通过逆概率加权估计器和Cox比例风险比,比较包括死亡、心肌梗死(MI)、血运重建、大出血、中风、死亡或MI、死亡或MI或血运重建以及死亡或MI或中风等结果的估计累积发生率。
217,675例患者植入了DES,45,025例患者植入了BMS。在30个月时,DES组患者未经调整的死亡率(12.9%对17.9%)、MI发生率(每100例患者中7.3例对10.0例)和血运重建率(每100例患者中23.0例对24.5例)较低,中风或出血方面无差异。调整后,DES组患者的死亡率(13.5%对16.5%,风险比[HR]:0.75,95%置信区间[CI]:0.72至0.79,p<0.001)和MI发生率(每100例患者中7.5例对8.9例,HR:0.77,95%CI:0.72至0.81,p<0.001)较低,血运重建(每100例患者中分别为23.5例和23.4例;HR:0.91,95%CI:0.87至0.96)、中风(每100例患者中3.1例对2.7例,HR:0.97,95%CI:0.88至1.07)或出血(每100例患者中3.4例对3.6例,HR:0.91,95%CI:0.84至1.00)方面差异最小。在所有分析的亚组中均观察到DES的生存获益,且在整个30个月的随访期内持续存在。
在这项有史以来最大规模的真实世界研究中,接受DES的患者在整个30个月的随访期内以及所有预先指定的亚组中,临床结果均显著优于接受BMS的患者,且未伴随出血或中风增加。