A multitude of late-breaking trials are set to be unveiled at the Transcatheter Cardiovascular Therapeutics (TCT) conference this week. One of the first and featured trials of the day was the SAFE-PCI trial, evaluating radial vs. femoral vascular access in women undergoing diagnostic cardiac catheterization and PCI.
Results and Impact
This trial is only the most recent to support the use of radial artery access as the initial strategy in cardiac catheterization or PCI procedures; this access method is known to have patients on their feet and out of the hospital within hours, whereas with femoral access patients often are required to stay overnight. However, this trial is the first to focus solely on women, a subgroup that has historically seen higher rates of complications with this type of access. Nonetheless, results were positive: Dr. Sunil V. Rao, the study's principal investigator, reported similar results for bleeding and vascular complications for radial and femoral access in the subgroup of women undergoing PCI. Even more encouraging, in the larger sample of all women in the study, there was a significant reduction in complications, implying even greater benefits associated with radial access in diagnostic procedures.
Although radial artery access has seen wide adoption outside of the United States, it has lagged in this country, gaining some popularity only recently. This trial delivers yet another blow to the use of femoral access in coronary procedures, and may accelerate radial access adoption in the US. The shift towards the radial artery as the preferred access site in coronary angioplasty and interventions will impact many device categories, but the most significantly impacted will be the market for vascular closure devices in this market, the bulk of revenues are generated from higher-priced invasive devices used only in femoral access procedures.
A Trial of Firsts
In addition to being the first randomized trial comparing interventional approaches in women, this is also the first multicenter, randomized US-based trial investigating radial vs femoral access and the first registry-based trial using data from the NCDR (National Cardiovascular Data Registry). The use of NCDR data could pioneer a new method for lower-cost and faster enrolment in clinical trials in the future. This is also thought to help potentially reduce the so-called "innovation gap" in the US, helping innovative devices to reach the US market earlier.