Michel Le May
NEW ORLEANS — Among patients who underwent PCI for STEMI, there was no difference in 30-day survival between those who had their procedure with transradial access and those who had it with transfemoral access, according to data from the SAFARI-STEMI trial.
“Our findings suggest that adequately trained operators should be able to achieve similar results using either radial or femoral access for primary PCI,” Michel Le May, MD, director of the STEMI program at the University of Ottawa Heart Institute, said during a presentation at the American College of Cardiology Scientific Session.
For the investigator-initiated trial, Le May and colleagues randomly assigned patients with STEMI referred for primary PCI less than 12 hours after symptom onset to PCI with transradial access or transfemoral access.
The primary outcome was 30-day mortality. Secondary outcomes included stroke, reinfarction, stent thrombosis and bleeding.
Recruitment was stopped early for futility in December 2018 after 2,292 patients (mean age, 62 years; 78% men) were enrolled, Le May said.
Compared with the transfemoral group, the transradial group had longer door-to-balloon time (47 minutes vs. 44 minutes; P = .007), cath lab-to-balloon time (20 minutes vs. 18 minutes; P < .0001) and lidocaine-to-balloon time (13 minutes vs. 11 minutes; P < .0001), as well as longer fluoroscopy time (9.4 minutes vs. 8.2 minutes, P < .0001), Le May said.
Among patients who underwent PCI for STEMI, there was no difference in 30-day survival between those who had their procedure with transradial access and those who had it with transfemoral access, according to data from the SAFARI-STEMI trial.
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The rates of 30-day mortality were similar in both groups (transradial, 1.5%; transfemoral, 1.3%; RR = 1.15; 95% CI, 0.58-2.3), and did not vary by age, sex, administration of bivalirudin, preloading with ticagrelor (Brilinta, AstraZeneca), BMI, creatinine clearance or diabetes status, Le May said.
There were also no differences between the groups in reinfarction (RR = 1.07; 95% CI, 0.57-2), stroke (RR = 2.24; 95% CI, 0.78-6.42), death/reinfarction/stroke (RR = 1.17; 95% CI, 0.77-1.79), stent thrombosis (RR = 1.07; 95% CI, 0.57-2) or any metric of bleeding, according to the researchers.
“It will be important for medical training programs to emphasize the need to be proficient at both the radial and femoral access,” Le May said in a press release. “It is possible to become deskilled at doing one of the procedures, and a consistent emphasis on one approach over the other can lead to an increase in complications.” – by Erik Swain
Le May M, et al. Late-Breaking Clinical Trials V. Presented at: American College of Cardiology Scientific Session; March 16-18, 2019; New Orleans.
Disclosure: Le May reports he receives consultant fees/honoraria from AstraZeneca and Bayer Canada and research grants from AstraZeneca, Bayer Canada, Eisai, Sanofi Canada and Wells Fargo Canada.