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Survival at 30 days similar by access site in PCI for STEMI
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.
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
Reference:
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.
Perspective
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SAFARI-STEMI is a bold study and the investigators should be congratulated for doing this challenging study. It is the largest dedicated STEMI transradial vs. transfemoral trial performed, even though it stopped well short of its planned sample size.
This study showed how challenging doing trials in the radial and STEMI spaces can be. It did reiterate that TIMI bleeding is probably not the correct bleeding metric to use for vascular access site strategy trials (RIVAL also showed no difference between transradial and transfemoral with respect to TIMI bleeding). It also showed that when bleeding is measured, transfemoral performance improves significantly.
In the STEMI setting, time is still of the essence, so until operators become proficient with transradial access, they should use whatever access site they are comfortable with. However, since the total body of data still supports transradial access, interventional cardiologists and cath lab staff should become proficient with the transradial approach for non-urgent cases and eventually adopt a “radial first” approach for primary PCI for STEMI as well.
One important thing that Dr. Le May showed in his presentation was that even if you include SAFARI-STEMI, the pooled data still support transradial access for STEMI PCI.