Evaluation of SAFE-PCI for Women Trial Offers Clues to Better Recruitment
May 6, 2019—An analysis of the SAFE-PCI for Women study sought to determine whether the study's lower-than-expected event rates were because of patient selection or better access site practice among trial patients. Jennifer A. Rymer, MD, et al published the findings online in Circulation: Cardiovascular Interventions.
SAFE-PCI for Women was a randomized controlled trial intended to study access site for enhancement of percutaneous coronary intervention (PCI) in women. The trial compared radial and femoral access in women undergoing PCI but was terminated early for lower than expected event rates. The study was conducted within the National Cardiovascular Data Registry CathPCI registry.
As summarized in Circulation: Cardiovascular Interventions, the investigators compared the patients enrolled in SAFE-PCI with trial-eligible women from the CathPCI registry 1 year before, during, and 1 year after SAFE-PCI enrollment. The comparison was made using the National Cardiovascular Research Infrastructure Identification, the PCI date, and age.
Investigators compared the two groups in terms of patient and procedure characteristics, predicted bleeding and mortality, and post-PCI bleeding. Patients enrolled in SAFE-PCI and patients enrolled in a registry from the three 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 four groups.
In Circulation: Cardiovascular Interventions, the investigators concluded that the 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. They advised that these data demonstrate how registry-based randomized trials may offer methods for enrollment feedback to curb selection bias in recruitment.