In the Journals

SAFARI-STEMI: 30-day survival after PCI for STEMI similar by access site

Michel Le May

There were no significant differences for survival or other clinical endpoints at 30 days among patients with STEMI who underwent PCI via radial access compared with femoral access, according to results of the SAFARI-STEMI trial published in JAMA Cardiology.

This trial was originally presented at the American College of Cardiology Scientific Session in 2019.

“Although the SAFARI-STEMI trial was terminated early, our results suggested that experienced operators practicing in high-volume PCI centers may achieve equally good survival outcomes using either access site for primary PCI,” Michel Le May, MD, director of the STEMI program at the University of Ottawa Heart Institute, and colleagues wrote.

Study design

Researchers analyzed data from patients with STEMI who were referred for primary PCI at five centers in Canada between July 2011 and December 2018. Recruitment was stopped early for futility in December 2018 after 2,292 patients (mean age, 62 years; 78% men) were enrolled. Patients were assigned radial access (n = 1,136) or femoral access (n = 1,156).

The primary outcome was originally bleeding but was then modified to 30-day all-cause mortality based on a recommendation from the granting agency. Secondary outcomes were defined as stroke, recurrent MI and TIMI-defined major or minor bleeding.

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).

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.

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 = 1.33; 95% CI, 0.65-2.73) or any metric of bleeding, according to the researchers.

“The 2017 European Society of Cardiology STEMI Guidelines give a class IA recommendation for radial access over femoral access,” Le May and colleagues wrote. “Given the shortcomings of previous trials, some authors have questioned this recommendation. Furthermore, this recommendation may not be applicable for all patients, institutions and cardiologists. Proficiency at performing PCI via either access would provide flexibility and help ensure better outcomes. Therefore, it is important that educational programs for trainees aim to ensure competency using the two approaches.”

Remaining questions

In a related editorial, Ranya N. Sweis, MD, MS, associate professor of medicine (cardiology) at Northwestern University Feinberg School of Medicine, wrote: “No single study, including SAFARI-STEMI, will be the last word on PCI access, and it remains to be seen if its results can be generalized to lower-volume centers and less experienced operators. For now, the weight of the evidence continues to favor a radial-first approach. However, circumstances requiring a femoral approach will always exist, particularly in the current era of large-bore access for structural heart interventions and mechanical support devices.” – by Darlene Dobkowski, with additional reporting from Erik Swain

Disclosures: Le May reports he received grants from the Canadian Institutes of Health. Sweis reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.

Michel Le May

There were no significant differences for survival or other clinical endpoints at 30 days among patients with STEMI who underwent PCI via radial access compared with femoral access, according to results of the SAFARI-STEMI trial published in JAMA Cardiology.

This trial was originally presented at the American College of Cardiology Scientific Session in 2019.

“Although the SAFARI-STEMI trial was terminated early, our results suggested that experienced operators practicing in high-volume PCI centers may achieve equally good survival outcomes using either access site for primary PCI,” Michel Le May, MD, director of the STEMI program at the University of Ottawa Heart Institute, and colleagues wrote.

Study design

Researchers analyzed data from patients with STEMI who were referred for primary PCI at five centers in Canada between July 2011 and December 2018. Recruitment was stopped early for futility in December 2018 after 2,292 patients (mean age, 62 years; 78% men) were enrolled. Patients were assigned radial access (n = 1,136) or femoral access (n = 1,156).

The primary outcome was originally bleeding but was then modified to 30-day all-cause mortality based on a recommendation from the granting agency. Secondary outcomes were defined as stroke, recurrent MI and TIMI-defined major or minor bleeding.

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).

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.

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 = 1.33; 95% CI, 0.65-2.73) or any metric of bleeding, according to the researchers.

“The 2017 European Society of Cardiology STEMI Guidelines give a class IA recommendation for radial access over femoral access,” Le May and colleagues wrote. “Given the shortcomings of previous trials, some authors have questioned this recommendation. Furthermore, this recommendation may not be applicable for all patients, institutions and cardiologists. Proficiency at performing PCI via either access would provide flexibility and help ensure better outcomes. Therefore, it is important that educational programs for trainees aim to ensure competency using the two approaches.”

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Remaining questions

In a related editorial, Ranya N. Sweis, MD, MS, associate professor of medicine (cardiology) at Northwestern University Feinberg School of Medicine, wrote: “No single study, including SAFARI-STEMI, will be the last word on PCI access, and it remains to be seen if its results can be generalized to lower-volume centers and less experienced operators. For now, the weight of the evidence continues to favor a radial-first approach. However, circumstances requiring a femoral approach will always exist, particularly in the current era of large-bore access for structural heart interventions and mechanical support devices.” – by Darlene Dobkowski, with additional reporting from Erik Swain

Disclosures: Le May reports he received grants from the Canadian Institutes of Health. Sweis reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.