SAFE-PCI for Women

Summary

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).

Conditions

• Percutaneous Coronary Intervention
• Ischemic Symptoms

Interventions

PROCEDURE

Transradial PCI

Transradial PCI

PROCEDURE

Transfemoral PCI

Transfemoral PCI

Sponsors & Collaborators

• American College of Cardiology

  collaborator OTHER

• Abbott Medical Devices

  collaborator INDUSTRY

• Lilly USA

  collaborator UNKNOWN

• Medtronic

  collaborator INDUSTRY

• Terumo Medical Corporation

  collaborator INDUSTRY

• The Medicines Company

  collaborator INDUSTRY

• Acist Medical Systems

  collaborator INDUSTRY

• Guerbet

  collaborator INDUSTRY

• Food and Drug Administration (FDA)

  collaborator FED

• Duke University

  lead OTHER

Principal Investigators

• Sunil V Rao, MD · Duke University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-08-31

Primary Completion

2013-09-30

Completion

2013-09-30