比较 SAFE-PCI 试验中女性患者入组前、入组时和入组后出血和血管并发症的发生率。
Comparison of Rates of Bleeding and Vascular Complications Before, During, and After Trial Enrollment in the SAFE-PCI Trial for Women.
机构信息
Department of Medicine, Duke University Medical Center, Durham, NC (J.A.R., A.K., M.W.K., S.V.R).
Division of Cardiology, Duke Clinical Research Institute, Durham, NC (L.A.K., D.M.W.).
出版信息
Circ Cardiovasc Interv. 2019 May;12(5):e007086. doi: 10.1161/CIRCINTERVENTIONS.118.007086.
BACKGROUND
SAFE-PCI for Women (Study of Access Site for Enhancement of PCI for Women), a randomized controlled trial comparing radial and femoral access in women undergoing cardiac catheterization or percutaneous coronary intervention (PCI), was terminated early for lower than expected event rates. Whether this was because of patient selection or better access site practice among trial patients is unknown.
METHODS AND RESULTS
SAFE-PCI was conducted within the National Cardiovascular Data Registry CathPCI registry. Using the National Cardiovascular Research Infrastructure Identification, PCI date, and age, patients enrolled in SAFE-PCI were compared with trial-eligible female CathPCI registry patients 1 year before, during, and 1 year after SAFE-PCI enrollment. Patient and procedure characteristics, predicted bleeding and mortality, and post-PCI bleeding were compared between groups. Enrolled SAFE-PCI patients and registry patients from the 3 time periods were linked to Centers for Medicare and Medicaid Services data to compare 30-day death and unplanned revascularization rates. At 54 SAFE-PCI sites, there were 496 SAFE-PCI trial patients with a PCI visit within the CathPCI registry. There were 24 958 registry patients from 1 year before and 1 year after SAFE-PCI enrollment and 15 904 trial-eligible registry patients during trial enrollment. Trial patients were younger, had lower predicted bleeding and mortality, and had lower rates of post-PCI bleeding within 72 hours compared with registry patients. Among 12 212 Centers for Medicare and Medicaid Services-linked patients, there were no significant differences in 30-day death and unplanned revascularization among the 4 groups.
CONCLUSIONS
Lower predicted risk of bleeding and mortality among SAFE-PCI trial patients compared with registry patients suggests that lower-risk patients were selectively enrolled for the trial. These data demonstrate how registry-based randomized trials may offer methods for enrollment feedback to curb selection bias in recruitment.
CLINICAL TRIAL REGISTRATION
URL: https://www.clinicaltrials.gov . Unique identifier: NCT01406236.
背景
SAFE-PCI for Women（女性经皮冠状动脉介入治疗入路安全性研究）是一项比较经桡动脉和股动脉入路在接受心导管检查或经皮冠状动脉介入治疗（PCI）的女性患者中的随机对照试验，因预期事件发生率较低而提前终止。尚不清楚这是由于患者选择还是试验患者更好的入路实践所致。
方法和结果
SAFE-PCI 是在全国心血管数据注册中心 CathPCI 注册中心进行的。使用国家心血管研究基础设施标识、PCI 日期和年龄，将 SAFE-PCI 入组患者与 SAFE-PCI 入组前 1 年、期间和入组后 1 年的试验合格女性 CathPCI 注册中心患者进行比较。比较两组患者和手术特征、预测出血和死亡率以及 PCI 后出血。将入组的 SAFE-PCI 患者和 3 个时期的注册中心患者与医疗保险和医疗补助服务中心数据相关联，以比较 30 天死亡率和计划外血运重建率。在 54 个 SAFE-PCI 站点中，有 496 名 SAFE-PCI 试验患者在 CathPCI 注册中心内进行了 PCI 就诊。在 SAFE-PCI 入组前 1 年和入组后 1 年有 24958 名注册中心患者，在试验入组期间有 15904 名符合试验条件的注册中心患者。与注册中心患者相比，试验患者年龄更小，预测出血和死亡率更低，PCI 后 72 小时内出血发生率更低。在与医疗保险和医疗补助服务中心相关联的 12212 名患者中，4 组患者在 30 天死亡率和计划外血运重建率方面无显著差异。
结论
与注册中心患者相比，SAFE-PCI 试验患者的出血和死亡率预测风险较低，表明低风险患者被选择性纳入试验。这些数据表明，基于注册中心的随机试验如何为入组反馈提供方法，以遏制招募中的选择偏倚。
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