NEW ORLEANS – , Michel R. Le May, MD, reported at the annual meeting of the American College of Cardiology.
Our findings suggest that adequately trained operators should be able to achieve similar results using either radial or femoral access for primary PCI,” declared Dr. Le May, professor of medicine at the University of Ottawa Heart Institute.
This is a controversial issue. European cardiologists have led a strong push for preferential use of radial access, citing reduced bleeding risk and an associated reduction in 30-day mortality. And this movement has spread to North America. But the evidence doesn’t convincingly support this position, the cardiologist said. He noted that of nine prior RCTs of radial versus the more traditional femoral access for primary PCI in STEMI, seven showed no difference in mortality. Nor did SAFARI-STEMI, which at 2,292 randomized STEMI patients was the second-largest trial to date.
SAFARI-STEMI was conducted at five high-volume Canadian PCI centers. Participating interventional cardiologists averaged 250 PCIs per year and were proficient in both access approaches. The study plan was to enroll 5,000 STEMI patients, but the trial was stopped after results were in for the first 2,292 because outcomes in the two study arms were so similar that the trial’s data safety monitoring board deemed it futile to continue.
The primary outcome was 30-day mortality. The rate was 1.5% in the radial access group and 1.3% in the femoral access group, with no differences among various subgroups.
Nor were there any between-group significant difference in the secondary endpoints of reinfarction (1.8% with radial, 1.6% with femoral), stroke (1.0% versus 0.4%), or the composite of death, reinfarction, or stroke, which occurred in 4.0% of the radial access group and 3.4% of the femoral group. Rates of non-CABG TIMI major or minor bleeding at 30 days were closely similar, as was need for transfusion. Definite or probable stent thrombosis occurred in 1.5% of the radial and 1.1% of the femoral groups.
Time from arrival at the PCI center to first balloon inflation was 47 minutes in the radial access group and significantly shorter at 44 minutes with femoral access, a noteworthy finding in the setting of STEMI, where time is myocardium. Fluoroscopy time was 1.2 minutes shorter in the femoral access group as well.
The reaction
Discussant Jacqueline E. Tamis-Holland, MD, said that, although she recently switched over to a radial access-first approach, her take away from SAFARI-STEMI is “It’s okay to do femoral.
“I think it’s comforting to the femoralists who are struggling to say, ‘I do a good femoral job and I don’t necessarily want to transition my STEMI patients to radial,’ ” said Dr. Tamis-Holland, associate director for the Mount Sinai St. Luke’s cardiac cath labs in New York.
Session cochair Martin B. Leon, MD, embraced the SAFARI-STEMI results with gusto.
“I’ve been tortured over the past 5 years by my junior interventional colleagues saying that, unless you’re doing transradial for STEMIs, that you’re not only out of step with the modern era of PCI, but you’re really moving against the evidence. And this study brings it back to a center position, where if you do a very-high-quality transfemoral approach, it is no different from transradial, not just from the standpoint of mortality but also bleeding complications. So I think we should aspire to be better transfemoral interventionalists, and if we do then there probably isn’t that much of a difference,” said Dr. Leon, professor of medicine at Columbia University in New York.
But discussant Sunil V. Rao, MD, who has championed radial access in the United States, was skeptical. “I think the results you achieved with femoral access in this trial are quite remarkable. We know from the registry data that those results are difficult to achieve in clinical practice.
“I would caution that the trial was stopped early, so I think it’s very challenging to try to apply this so as to influence our practice definitively,” said Dr. Rao of Duke University, Durham, N.C.
He asked Dr. Le May what advice he could give to femoralists in community practice to up their game and achieve results comparable to those in SAFARI-STEMI.
“We have to pay attention to their puncture,” Dr. Le May replied. “We use fluoroscopic guidance, and there are others who use ultrasound. We pay attention to the anticoagulation and antiplatelet therapy we use for these patients. We use GP IIb/IIIa inhibitors less today, and smaller sheaths. More than 90% of patients got ticagrelor before going to the cath lab. We’ve borrowed some of the techniques that the radial access people use.”
At a postpresentation ACC press conference, he indicated that it was difficult to recruit patients for the trial in the current strongly pro–radial access climate.
“I think there are people who think that, seriously, the horse is out of the barn, and it’s game over for the femoral. There is a mindset out there where people think that it’s just wrong to do a femoral approach,” said Dr. Le May. “We had comments that it’s not even ethical to randomize such patients.”
In fact, the issue is “very debatable,” he asserted, noting that radial artery occlusion is emerging as an important complication. And he suspects that cardiologists who strive to do 80%-90% of their percutaneous coronary interventions via the transradial route may become deskilled at using the femoral approach. That becomes a real concern when there is a problem in accessing the radial artery or need arises for a device that requires femoral access.
“I am of the school of thought that, given the results of our trial, we should teach people that you’re not a femoralist or a radialist. You should be an interventionalist that can do either and flip from one side to the other and be comfortable in doing that,” Dr. Le May concluded.
He reported having no conflicts regarding the study, funded by the Canadian Institutes of Health Research.