Velazquez Eric J, Samad Zainab, Al-Khalidi Hussein R, Sangli Chithra, Grayburn Paul A, Massaro Joseph M, Stevens Susanna R, Feldman Ted E, Krucoff Mitchell W
Duke Clinical Research Institute, Duke University Medical Center, Durham, NC; Division of Cardiology, Duke University Medical Center, Durham, NC.
Division of Cardiology, Duke University Medical Center, Durham, NC.
Am Heart J. 2015 Nov;170(5):1050-1059.e3. doi: 10.1016/j.ahj.2015.08.004. Epub 2015 Aug 12.
We compared 30-day and 1-year survival among high-risk mitral regurgitation (MR) patients treated with the MitraClip (Abbott Vascular, Abbott Park, IL) with matched non-surgically treated patients from the Duke Echocardiography Laboratory Database (DELD).
High-risk patients with 3+/4+ MR managed non-surgically between years 2000 and 2010 in the longitudinal DELD were matched to high-risk MitraClip patients. Patient matching was performed using the method of nearest available Mahalanobis distance metric within calipers defined by the propensity score. Kaplan-Meier estimates and stratified Cox proportional hazards models were used to compare survival at 30 days and 1 year. Among 953 high-risk DELD patients available for matching, 30-day and 1-year mortality were 6.5% and 26.2%. Close matches were obtained for 239 of the 351 MitraClip patients. The 30-day mortality in MitraClip patients was lower (4.2%) when compared with matched DELD patients (7.2%). The 1-year relative risk of mortality of the MitraClip compared with non-surgical treatment was 0.64 (95% CI 0.45-0.91; log-rank P = .013). These results in favor of the MitraClip remained significant upon further adjustment for baseline differences between groups (P = .043).
This matched comparison of severe MR patients at high surgical risk supports the safety of the MitraClip relative to medical therapy at 30 days and a survival benefit at 1 year.
我们比较了使用MitraClip(雅培血管,雅培公园,伊利诺伊州)治疗的高危二尖瓣反流(MR)患者与来自杜克超声心动图实验室数据库(DELD)的匹配非手术治疗患者的30天和1年生存率。
在纵向DELD中,2000年至2010年间非手术治疗的3+/4+级高危MR患者与高危MitraClip患者进行匹配。使用倾向评分定义的卡尺内最近可用马氏距离度量法进行患者匹配。采用Kaplan-Meier估计和分层Cox比例风险模型比较30天和1年时的生存率。在953例可用于匹配的高危DELD患者中,30天和1年死亡率分别为6.5%和26.2%。351例MitraClip患者中有239例获得了紧密匹配。与匹配的DELD患者(7.2%)相比,MitraClip患者的30天死亡率更低(4.2%)。与非手术治疗相比,MitraClip的1年死亡相对风险为0.64(95%CI 0.45-0.91;对数秩检验P=.013)。在对组间基线差异进行进一步调整后,这些支持MitraClip的结果仍然显著(P=.043)。
这种对高手术风险的重度MR患者进行的匹配比较支持了MitraClip相对于药物治疗在30天时的安全性以及在1年时的生存获益。