SAFE-PCI for Women

Duke University

Status

Terminated

Conditions

Percutaneous Coronary Intervention

Ischemic Symptoms

Treatments

Procedure: Transfemoral PCI

Procedure: Transradial PCI

Study type

Interventional

Funder types

Other

Industry

Other U.S. Federal agency

Identifiers

NCT01406236

Pro00030109

Details and patient eligibility

About

The hypothesis of the SAFE-PCI for women trial is that, compared with transfemoral PCI, transradial PCI will result in a significant reduction in bleeding and vascular complications. The primary objective is to compare the efficacy and feasibility of the transradial approach to percutaneous coronary intervention (PCI) in women compared with the transfemoral approach.

This study is a multicenter, randomized, open-label active controlled study. Three thousand women undergoing urgent or elective PCI from at least 50 centers will be randomized to either transradial or transfemoral PCI. Patients who are enrolled at sites performing ad hoc PCI will be randomized before diagnostic angiography. A total of approximately 3000 women will be randomized to obtain a cohort of approximately 1800 patients undergoing PCI.

The Data Safety Monitoring Board has alerted us that the bleeding event rate overall in our trial is very low, making it unlikely that there will be statistical power to show a difference between the randomized arms in the SAFE PCI for Women study using the BARC bleeding definition per protocol. Based on this statistical futility, the DSMB has recommended stopping enrollment. They also noted, however, that as this is not based on any safety issues, and since there are a variety of key secondary endpoints (contrast and radiation exposure, quality of life) that are of clinical and scientific interest, the DSMB left it to the discretion of the Steering Committee to continue enrollment to meet sufficient power for these outcomes. On March 1, 2013, the Steering Committee met to discuss these issues and voted to continue enrollment until the planned sample size for the Quality of Life substudy was met (300 patients).

Enrollment

1,787 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Have the capacity to understand and sign an informed consent form
Age ≥ 18 years
Female patient undergoing urgent or elective PCI or undergoing diagnostic angiography to evaluate ischemic symptoms with the possibility of PCI

Exclusion criteria

Peripheral arterial disease that prohibits vascular access
Bilateral abnormal Barbeau tests
Hemodialysis access (arteriovenous fistula or graft) in the arm to be used for PCI in case of assignment to radial approach (note that the opposite arm may be used for radial access in case a dialysis graft is present in one arm provided that the opposite arm has a normal Barbeau test)
International normalized ratio (INR) ≥ 1.5 in a patient treated with oral vitamin K antagonists (i.e., warfarin).
Receipt of oral Factor Xa or IIa inhibitors ≤ 24 hours prior to the procedure
Planned staged PCI within 30 days of index procedure
Valvular heart disease requiring valve surgery
Planned right-heart catheterization
Primary PCI for ST-segment elevation myocardial infarction
Presence of bilateral internal mammary artery coronary bypass grafts
Unable to provide informed consent
Participation in any investigational drug or device study currently or within 30 days prior to enrollment