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

radiation dose in the cath lab
News | Radiation Dose Management| May 02, 2016
May 2, 2016 — Starting at the Society for Cardiovascular Angiography and Interventions (SCAI) 2016 annual meeting May
microtubules, heartbeat mechanics, Perelman School of Medicine study

Microtubules in a cardiomyocyte at rest (top) and when compressed. Image courtesy of the lab of Ben Prosser, Ph.D., Perelman School of Medicine, University of Pennsylvania

News | EP Lab| April 29, 2016
Using new high-resolution microscopy, researchers have found that molecular struts called microtubules (MT) interact...
breast cancer, herceptin chemotherapy drug, heart damage, monitoring, Journal of Clinical Oncology study
News | Cardiac Diagnostics| April 28, 2016
April 28, 2016 — Breast cancer patients undergoing treatment with trastuzumab-containing regimens should be monitored
Feature | Business| April 28, 2016 | Dave Fornell
 
Technology | Stents Peripheral| April 27, 2016
Veniti Inc. announced the first successful treatment with the Vici Verto Venous Stent System of a patient suffering...
coronary CT angiography, CCTA, SCOT-HEART trial substudy, SCCT
News | Computed Tomography (CT)| April 26, 2016
The results of a secondary analysis of the SCOT-HEART trial show that coronary computed tomography angiography (CCTA)...
sleep patterns, metabolic syndrome, risk factors, ACC study
News | Cardiac Diagnostics| April 26, 2016
Taking long naps or being excessively tired during the day is associated with a higher risk for developing metabolic...
Auris Surgical Robotics, acquisition, Hansen Medical
News | Robotic Systems| April 26, 2016
Auris Surgical Robotics Inc. and Hansen Medical Inc. announced that they have signed a definitive merger agreement...
CABG, bypass surgery, heart failure, NHLBI study
News | Cardiovascular Surgery| April 25, 2016
Scientists have found that a greater number of patients with coronary artery disease may benefit from coronary artery...
Siemens Sensis Vibe, hemodyanamics system

Siemens released the Sensis Vibe hemodyanamics system at ACC.16. The newer system offers better integration of cath lab data into cath lab reports and the electronic medical record (EMR).

Feature | ACC| April 25, 2016 | Jon Brubaker, MBA, RCVT, Tom Watson, BS, RCVT, and Sabrina Newell MS, RCS
There were several trends seen in new cardiovascular technologies showcased on the expo floor at the 2016 American...
Overlay Init