SAFE-PCI for Women (SAFE-PCI)

Study of Access Site for Enhancement of PCI for Women (SAFE-PCI for Women)

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).

Study Overview

• Status: Terminated
• Conditions: Percutaneous Coronary Intervention; Ischemic Symptoms
• Intervention / Treatment: Procedure: Transradial PCI; Procedure: Transfemoral PCI

• Study Type: Interventional
• Enrollment (Actual): 1787
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Transradial PCI	Procedure: Transradial PCI; Transradial PCI
Other: Transfemoral PCI	Procedure: Transfemoral PCI; Transfemoral PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Primary Efficacy Endpoint: Composite of BARC Types 2, 3, and 5 bleeding or vascular complications.	From first arterial access post-randomization to 72 hours or hospital discharge, whichever occurs first.
Primary Feasibility Endpoint: Procedural failure, defined as inability to complete the procedure from the assigned vascular access site.	From first arterial access post-randomization to 72 hours or hospital discharge, whichever occurs first.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure Duration, total radiation dose and total contrast volume	To determine the effect of transradial PCI on procedure time, total radiation dose, and total contrast volume.	72 hours post randomization or hospital discharge (whichever occurs first)
Resource Use, patient preferences and quality of life	To determine the effect of transradial PCI on resource use, patient preferences, and quality of life.	Baseline, 72 hours post randomization or hospital discharge (whichever occurs first), 30 day
30-day death, vascular complications, or repeat revascularization	To determine the effect of transradial PCI on 30-day death, vascular complications, or repeat revascularization.	30 day

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Food and Drug Administration (FDA); Medtronic; Abbott Medical Devices; The Medicines Company; Guerbet; Terumo Medical Corporation; Acist Medical Systems; American College of Cardiology; Lilly USA
• Investigators: Principal Investigator: Sunil V Rao, MD, Duke University

Publications and helpful links

General Publications

• Rymer JA, Kaltenbach LA, Kochar A, Hess CN, Gilchrist IC, Messenger JC, Harrington RA, Jolly SS, Jacobs AK, Abbott JD, Wojdyla DM, Krucoff MW, Rao SV. Comparison of Rates of Bleeding and Vascular Complications Before, During, and After Trial Enrollment in the SAFE-PCI Trial for Women. Circ Cardiovasc Interv. 2019 May;12(5):e007086. doi: 10.1161/CIRCINTERVENTIONS.118.007086.
• Rao SV, Hess CN, Barham B, Aberle LH, Anstrom KJ, Patel TB, Jorgensen JP, Mazzaferri EL Jr, Jolly SS, Jacobs A, Newby LK, Gibson CM, Kong DF, Mehran R, Waksman R, Gilchrist IC, McCourt BJ, Messenger JC, Peterson ED, Harrington RA, Krucoff MW. A registry-based randomized trial comparing radial and femoral approaches in women undergoing percutaneous coronary intervention: the SAFE-PCI for Women (Study of Access Site for Enhancement of PCI for Women) trial. JACC Cardiovasc Interv. 2014 Aug;7(8):857-67. doi: 10.1016/j.jcin.2014.04.007.
• Hess CN, Rao SV, Kong DF, Aberle LH, Anstrom KJ, Gibson CM, Gilchrist IC, Jacobs AK, Jolly SS, Mehran R, Messenger JC, Newby LK, Waksman R, Krucoff MW. Embedding a randomized clinical trial into an ongoing registry infrastructure: unique opportunities for efficiency in design of the Study of Access site For Enhancement of Percutaneous Coronary Intervention for Women (SAFE-PCI for Women). Am Heart J. 2013 Sep;166(3):421-8. doi: 10.1016/j.ahj.2013.06.013. Epub 2013 Jul 23.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: June 20, 2011
• First Submitted That Met QC Criteria: July 29, 2011
• First Posted (Estimate): August 1, 2011

Study Record Updates

• Last Update Posted (Estimate): January 21, 2015
• Last Update Submitted That Met QC Criteria: January 16, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: PCI; Female; urgent or elective percutaneous coronary intervention; diagnostic angiography
• Other Study ID Numbers: Pro00030109