Author + information
- Jennifer Rymer,
- Lisa Kaltenbach,
- Ajar Kochar,
- Connie Hess,
- Mitchell Krucoff,
- Ian Gilchrist,
- John Messenger,
- Sanjit Jolly,
- Alice K. Jacobs,
- J. Abbott,
- Daniel Wojdyla and
- Sunil V. Rao
SAFE-PCI for Women, a RCT comparing radial and femoral access in women undergoing cath or PCI, was terminated early for lower than expected event rates. Whether this was due to patient selection or better access site practice among trial patients is unknown.
SAFE-PCI was conducted within the NCDR CathPCI registry. Using the NCRI ID, PCI date, and age, patients enrolled in SAFE-PCI were compared with trial-eligible unenrolled female registry patients 1 year before, during, and 1 year after SAFE-PCI enrollment (Table). Patient and procedure characteristics, predicted bleeding and mortality, and post-PCI bleeding were compared between groups.
At 57 SAFE-PCI sites, there were 24,958 eligible unenrolled registry patients 1 year before and after SAFE-PCI enrollment, and 15,904 registry patients during the SAFE-PCI trial enrollment. Trial patients were younger, less often had a history of prior MI, and had lower predicted bleeding and mortality compared with unenrolled registry patients treated at SAFE-PCI sites before, during, and after trial enrollment (Table). Trial patients also had lower rates of post-PCI bleeding within 72 hrs compared with registry patients.
Lower predicted risk of bleeding and mortality among SAFE-PCI patients compared with eligible unenrolled patients suggests that lower risk patients were selectively enrolled for the trial. These data underscore the value of a registry-based trial structure to address selection bias in real time.
Poster Hall, Hall A/B
Saturday, March 10, 2018, 3:45 p.m.-4:30 p.m.
Session Title: Outcomes After Myocardial Infarction and Percutaneous Coronary Intervention
Abstract Category: 15. Interventional Cardiology: ACS/AMI/Hemodynamics and Pharmacology
Presentation Number: 1155-274
- 2018 American College of Cardiology Foundation