Jennifer A Rymer1, Lisa A Kaltenbach2, Ajar Kochar1, Connie N Hess3, Ian C Gilchrist4, John C Messenger3, Robert A Harrington5, Sanjit S Jolly6, Alice K Jacobs7, J Dawn Abbott8, Daniel M Wojdyla2, Mitchell W Krucoff1, Sunil V Rao1. 1. Department of Medicine, Duke University Medical Center, Durham, NC (J.A.R., A.K., M.W.K., S.V.R). 2. Division of Cardiology, Duke Clinical Research Institute, Durham, NC (L.A.K., D.M.W.). 3. Division of Cardiology, University of Colorado School of Medicine, Aurora (C.N.H., J.C.M.). 4. Department of Medicine, Penn State University, Hershey, PA (I.C.G.). 5. Department of Medicine, Stanford University, CA (R.A.H.). 6. Department of Medicine, McMaster University, Hamilton, ON (S.S.J.). 7. Department of Medicine, Boston University, MA (A.K.J.). 8. Division of Cardiovascular Medicine, Warren Alpert Medical School of Brown University and Lifespan Cardiovascular Institute, Providence, RI (J.D.A.).
Abstract
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.
RCT Entities:
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.
Entities:
Keywords:
cardiac catheterization; patient selection; percutaneous coronary intervention; risk; women
Authors: Andrija Matetic; Warkaa Shamkhani; Muhammad Rashid; Annabelle Santos Volgman; Harriette G C Van Spall; Thais Coutinho; Laxmi S Mehta; Garima Sharma; Purvi Parwani; Mohamed Osama Mohamed; Mamas A Mamas Journal: CJC Open Date: 2021-07-01