Feature | November 01, 2013

Radial Versus Femoral Access Benefits Women

Results of the SAFE-PCI trial presented at TCT 2013

radial access
November 1, 2013 — A clinical trial conducted exclusively in women suggests that an initial strategy of using the radial artery in the arm as the entry point for percutaneous coronary intervention (PCI) in women has potential for reducing bleeding complications. SAFE-PCI for Women is the first registry-based randomized trial in the United States and the first multicenter trial comparing radial with femoral access in the United States, and its primary findings were presented at the 25th annual Transcatheter Cardiovascular Therapeutics scientific symposium (TCT 2013).
The SAFE-PCI for Women Trial randomized 1,787 women undergoing elective PCI, urgent PCI or diagnostic catheterization with possible PCI to either a radial or femoral approach. In a novel approach designed to minimize trial costs, the trial used prospectively gathered data collection instruments based upon the existing National Cardiovascular Research Infrastructure (NCRI), a clinical trial infrastructure created through collaboration between the National Heart, Lung and Blood Institute (NHLBI), the American College of Cardiology (ACC) and the Duke Clinical Research Institute. It was also built on the NCDR CathPCI Registry, the largest ongoing PCI registry in the world. 
The primary efficacy endpoint was bleeding (BARC Types 2, 3 or 5) or vascular complications requiring intervention within 72 hours post-procedure or at hospital discharge, whichever came first. The primary feasibility endpoint was procedural failure defined as the inability to complete the PCI from the assigned access site.
After 1,120 patients had been randomized (446 had undergone PCI), review of data by the Data and Safety Monitoring Board (DSMB) showed that the primary efficacy event rate was markedly lower than expected. The DSMB recommended termination of the trial because the trial was unlikely to show a difference at the planned sample size. No harm was noted in either arm; therefore, the Steering Committee voted to continue the study until enrollment in a quality-of-life sub study was complete.
A total of 1,787 patients were randomized (893 to radial access, 894 to femoral access), 691 of those who underwent PCI (345 radial access and 346 femoral access). In the PCI group, bleeding and complication rates were 1.2 percent in the radial group compared to 2.9 percent in the femoral group (p = 0.12). When assessing the overall cohort of randomized patients (those receiving both diagnostic procedures alone as well as those receiving PCI), bleeding and complication rates were 0.6 percent versus 1.7 percent (p = 0.03). The overall procedural failure rate was 6.7 percent in the radial group and 1.9 percent in the femoral group (p < 0.001). Within the radial group, conversion to femoral access was often due to radial artery spasm (42.9 percent among the patients who converted).
“The SAFE-PCI for Women trial represents several ‘firsts.’ It is the first randomized trial of interventional strategies in women, the first multicenter randomized trial comparing radial with femoral access in the United States and the first registry-based randomized trial in the U.S. The treatment benefit of radial access over femoral access was larger than expected (~60 percent) in both the PCI group and total randomized cohorts,” said Sunil Rao, M.D., associate professor of medicine, Duke University Medical Center and lead investigator of the study.
“Findings suggest that an initial strategy of radial access is reasonable and may be preferred in women, with the recognition that a proportion of patients will require bailout to femoral access,” Rao added. 
Bleeding complications were very low in the trial. "I think overall, bleeding rates have come down because operators are doing a better job of reducing bleeding risks," Rao said. In addition, he said there is a large use today or vascular closure devices, bivalirudin, and more experience among operators. 
Innovation in Trial Model
This is the first trial to use the framework of the NCDR registry to significantly reduce the time needed to enter data for a trial. 
“As the first registry-based randomized trial in the United States, the SAFE-PCI for Women trial demonstrates a new paradigm shift for conducting efficient practical clinical trials using the National Cardiovascular Research Infrastructure. This trial construct is a promising approach for future clinical investigations,” Rao said. "This shows we can do efficient and pragmatic trials in the U.S."
For more information: www.crf.org

Related Content

News | Cath Lab| October 09, 2015
October 9, 2015 — Cardinal Health is launching its expanded portfolio in the cardiova
Shimadzu, MIX package, Trinias Cardiovascular suites, U.S. availability

Image courtesy of Shimadzu Medical Systems

Technology | Cath Lab| October 08, 2015
Shimadzu Medical Systems USA announced the availability of the MIX package for the Trinias Cardiovascular suites. Based...
ORSIF, radiation exposure for interventionalists, greater on left side of head, Ehtisham Mahmud
Feature | Radiation Dose Management| October 06, 2015
The results of a research study indicate that interventional cardiologists receive “very high” radiation exposure...
Synergy stent
Technology | October 05, 2015
October 5, 2015 — The U.S.
News | Heart Failure| October 02, 2015
Cyberonics Inc. announced results from the extension of the ANTHEM-HF clinical study (ENCORE Study). Results of the...
Tryton Side Branch Stent, clinical trial results, Catheterization and Cardiovascular Interventions

Tryton Side Branch Stent image courtesy of Tryton Medical

News | Stents Bifurcation| October 02, 2015
October 2, 2015 — Tryton Medical Inc.
Brilinta, 60 mg dose available, U.S. pharmacies
Technology | Antiplatelet and Anticoagulation Therapies| October 02, 2015
AstraZeneca announced that Brilinta (ticagrelor) 60-mg tablets are now available in U.S. pharmacies. On Sept. 3, 2015,...
Intact Vascular, TOBA II study, Tack Endovascular System

Image courtesy of Intact Vascular

News | Peripheral Arterial Disease (PAD)| October 01, 2015
Intact Vascular Inc. announced the U.S. Food and Drug Administration has granted conditional approval for a U.S. and...
Cook Medical, Zilver PTX, Japan PMS study, CIRSE 2015, two-year results

Image courtesy of Cook Medical

News | Stents Peripheral| October 01, 2015
Kimihiko Kichikawa, M.D., department of radiology at Nara Medical University in Japan, reported two-year results of the...
Stentys, CE Mark for self-apposing stent, lower limb artery disease, below-the-knee arteries, critical limb ischemia, PES BTK-70 trial

Image courtesy of Stentys

News | Stents Peripheral| October 01, 2015
Stentys announced that the company’s drug-eluting stent received CE Mark for treatment of below-the-knee (BTK) arteries...
Overlay Init