Radial access should be the initial choice for percutaneous coronary intervention (PCI), saving femoral access for bailout, according to a consensus document from the European Society of Cardiology (ESC).
The radial approach leads to less bleeding and improved survival, especially in ST-elevation myocardial infarction (STEMI) patients, according to Martial Harmon, MD, of the University of Caen in Normandy, France, and co-authors.
However, it is still necessary for interventional cardiologists to maintain proficiency in the femoral approach, "which is indispensable in a variety of procedures, like intra-aortic counter pulsation and complex structural heart disease procedures ... as well as when radial access fails," they wrote online in EuroIntervention.
Action Points
- This consensus document points out that compared to femoral access, radial access for percutaneous coronary intervention has been shown to cause fewer complications at the vascular access site, allow more rapid ambulation, to offer greater post-procedural comfort for the patient, and to be cost effective.
- For these reasons, radial access should be the initial choice for percutaneous coronary intervention, saving femoral access for bailout, according to this consensus document from the European Society of Cardiology.
The radial approach has historically been used more frequently in Europe (50% of cases) than in the U.S. (11%), but even in Europe, there are countries with a low adoption rate, such as Germany (10%), according to the consensus statement.
It was therefore necessary for the ESC to develop this document so that all European countries can utilize radial access and improve quality and outcomes, they said.
"The femoral approach is easier for the doctor, but it's not as easy for the patient," William O'Neill, MD, medical director for the Center for Structural Heart Disease at Henry Ford Hospital in Detroit, told . "I can only recall one patient out of the hundreds that I've done that actually preferred the femoral approach." O'Neill was not involved in developing the consensus statement.
The statement authors pointed to recent studies that demonstrated the radial approach's safety and effectiveness.
The randomized RIVAL and RIFLE-STEACS trials, for example, found no statistical differences in 30-day rate of death, MI, stroke, or major bleeding unrelated to coronary artery bypass grafting (CABG) between radial and femoral access. RIVAL included patients with acute coronary syndrome, while RIFLE-STEACS included patients with a STEMI acute coronary syndrome (ACS).
"It is now clear after the RIFLE-STEACS and RIVAL trials that radial access reduces major bleeding at the vascular access site and as a consequence improves patient outcomes, including survival, especially in STEMI patients," Harmon said in a statement.
One recommendation from the document is that an aggressive antithrombotic regimen can be used in high-risk groups, such as women and those with ACS, because of the bleeding safety profile that has been shown in trials. However, more studies on non-access site bleeding are necessary, they said.
Although studies have not found a difference in the rate of stroke -- both silent and symptomatic -- between the two approaches, Harmon and colleagues advised caution because of the longer duration of radial versus femoral access, especially during the learning curve.
Another aspect of the radial approach that is influenced by operator experience is radiation exposure. The authors pointed to a substudy of RIVAL that showed a correlation between radiation exposure and operators and centers with the lowest volume of PCIs performed using the radial approach.
The radial approach is a more demanding technique, the authors noted, with 80 cases per year being associated with fewer access failures and a reduction in procedure time.
"However, no threshold has been identified above which the volume of radial access procedures is no longer associated with enhanced success," they wrote.
They therefore recommended that operators and facilities aim for "over 50% radial access in routine practice with a minimum of 80 procedures/year per operator (including diagnostic and interventional procedures)." But these baseline metrics apply only after the learning curve has been completed.
The document has a section detailing the equipment necessary to develop a radial access program. In particular, smaller sheaths are available commercially that have "progressive tapering and better lubricated coating ... to reduce the risk of arterial spasm."
Operators also can avoid catheter exchanges by using specially designed catheters that allow for cannulation of both coronary ostia and even ventriculography with the same catheter.
Harmon and colleagues recommend starting out with 5 French (Fr) sheaths and catheters for diagnostic angiography, then switching to 5 or 6 Fr equipment for PCI. They said operators should begin with uncomplicated PCI cases, gradually taking on more complex cases.
Also during the learning curve, operators should strive to perform the radial approach in consecutive patients.
"From a patient perspective, radial access offers significantly less discomfort and significantly improved quality of life as compared with femoral access," they concluded.
From the American Heart Association:
Disclosures
One author reported receiving Kimny catheter sales royalties from Boston Scientific. The other authors had no conflicts of interest to declare.
Primary Source
EuroIntervention
Harmon M, et al "Consensus document on the radial approach in percutaneous cardiovascular interventions: position paper by the European Association of Percutaneous Cardiovascular Interventions and Working Groups on Acute Coronary Care and Thrombosis of the European Society of Cardiology" EuroIntervention 2013.