SAFE-PCI for Women

Study Overview
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Brief Summary
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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).

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

Conditions
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Percutaneous Coronary Intervention, Ischemic Symptoms

Intervention / Treatment
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* Procedure: Transradial PCI
* Procedure: Transfemoral PCI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Transradial PCI<br> | Procedure: Transradial PCI<br>* Transradial PCI<br>|
| Other: Transfemoral PCI<br> | Procedure: Transfemoral PCI<br>* Transfemoral PCI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Female, urgent or elective percutaneous coronary intervention, PCI, diagnostic angiography