Meeting NewsPerspective

Prasugrel, ticagrelor yield similar 1-year outcomes; switch to clopidogrel safe in STEMI

ANAHEIM, Calif. — Patients who underwent PCI for STEMI had similar outcomes at 1 year regardless of assignment to prasugrel or ticagrelor, according to a follow-up study of the PRAGUE-18 trial. Moreover, patients who switched from either antiplatelet therapy to clopidogrel after discharge because of out-of-pocket cost had no increased risk for ischemic events.

As Cardiology Today’s Intervention previously reported, PRAGUE-18, the first randomized, head-to-head comparison of prasugrel (Effient, Daiichi Sankyo/Eli Lilly) vs. ticagrelor (Brilinta, AstraZeneca), showed no difference in outcomes between the therapies at 7 days and 30 days.

Zuzana Motovska, MD, PhD, from Cardiocentre, Third Faculty of Medicine, Charles University and University Hospital Kralovske Vinohrady, Prague, presented 1-year results from the study of 1,230 patients with STEMI (mean age, 62 years; 24% women) who were randomly assigned upon arrival to a PCI center to prasugrel 60 mg followed by 10 mg per day for 1 year (5 mg per day for patients aged 75 years or older or weight under 60 kg) or ticagrelor 180 mg followed by 90 mg twice daily for 1 year.

Patients were informed before discharge of the cost of the medications and the risks and benefits of clopidogrel vs. prasugrel and ticagrelor, and were allowed at any time between discharge and 1 year to switch to clopidogrel, which is generic and fully reimbursed at no cost to the patient in the Czech Republic, Motovska said.

At 1 year, the endpoint of CV death, MI and stroke occurred in 6.6% of those assigned prasugrel vs. 5.7% of those assigned ticagrelor (HR = 1.167; 95% CI, 0.742-1.835), Motovska said.

There was also no difference at 1 year between the groups in CV death (prasugrel, 3.3%; ticagrelor, 3%; P = .769), MI (prasugrel, 3%; ticagrelor, 2.5%; P = .611), stroke (prasugrel, 1.1%; ticagrelor, 0.7%; P = .423), all-cause mortality (prasugrel, 4.7%; ticagrelor, 4.2%; P = .654), definite stent thrombosis (prasugrel, 1.1%; ticagrelor, 1.5%; P = .535), all bleeding (prasugrel, 10.9%; ticagrelor, 11.1%; P = .999) and TIMI major bleeding (prasugrel, 0.9%; ticagrelor, 0.7%; P = .754), she said.

A switch to clopidogrel was made in 34.1% of those assigned prasugrel and 44.4% of those assigned ticagrelor (P = .003), with most switches occurring soon after discharge, according to the researchers.

Patients who switched therapies because of cost sharing for study drugs had less frequent bundle branch block or acute heart failure at admission, and also had less frequent presence of left main disease and fewer cases of failed PCI than those who did not switch, Motovska said.

In addition, those who switched medications for economic reasons had lower risk for CV death, MI and stroke (HR = 0.433; 95% CI, 0.21–0.894) and bleeding (HR = 0.514; 95% CI, 0.35-0.7455) compared with those who did not switch.

The results were simultaneously published in the Journal of the American College of Cardiology.

Roxana Mehran

“Prasugrel and ticagrelor are similarly effective and safe at 1 year after MI treated with primary PCI,” Motovska said. “Switching to clopidogrel, when approved by treating physicians, was not associated with increased risk of ischemic endpoints.”

During a discussion of the results, Roxana Mehran, MD, associate medical editor of Cardiology Today’s Intervention and professor of medicine and director of interventional cardiovascular research and clinical trials at the Zena and Michael A. Weiner Cardiovascular Institute at Icahn School of Medicine at Mount Sinai, said the data must be considered observational. A more definitive answer requires “a large, randomized trial to evaluate the safety and efficacy of switching, specifically de-escalation, in this high-risk patient population of STEMI undergoing percutaneous coronary intervention for the next year after their procedure,” Mehran said. – by Erik Swain

References:

Motovska Z, et al. LBS.05 – New Insights into the Risks, Benefits and Costs of Antithrombotic Therapy. Presented at: American Heart Association Scientific Sessions; Nov. 11-15, 2017; Anaheim, California.

Motovska Z, et al. J Am Coll Cardiol. 2017;doi:10.1016/j.jacc.2017.11.008.

Disclosures: Motovska reports she receives honoraria from AstraZeneca. Mehran reports she has financial ties with multiple pharmaceutical and device companies.

 

Editor’s Note: This article was updated on Nov. 16, 2017 to reflect updated data and add additional information about drug costs to patients.

ANAHEIM, Calif. — Patients who underwent PCI for STEMI had similar outcomes at 1 year regardless of assignment to prasugrel or ticagrelor, according to a follow-up study of the PRAGUE-18 trial. Moreover, patients who switched from either antiplatelet therapy to clopidogrel after discharge because of out-of-pocket cost had no increased risk for ischemic events.

As Cardiology Today’s Intervention previously reported, PRAGUE-18, the first randomized, head-to-head comparison of prasugrel (Effient, Daiichi Sankyo/Eli Lilly) vs. ticagrelor (Brilinta, AstraZeneca), showed no difference in outcomes between the therapies at 7 days and 30 days.

Zuzana Motovska, MD, PhD, from Cardiocentre, Third Faculty of Medicine, Charles University and University Hospital Kralovske Vinohrady, Prague, presented 1-year results from the study of 1,230 patients with STEMI (mean age, 62 years; 24% women) who were randomly assigned upon arrival to a PCI center to prasugrel 60 mg followed by 10 mg per day for 1 year (5 mg per day for patients aged 75 years or older or weight under 60 kg) or ticagrelor 180 mg followed by 90 mg twice daily for 1 year.

Patients were informed before discharge of the cost of the medications and the risks and benefits of clopidogrel vs. prasugrel and ticagrelor, and were allowed at any time between discharge and 1 year to switch to clopidogrel, which is generic and fully reimbursed at no cost to the patient in the Czech Republic, Motovska said.

At 1 year, the endpoint of CV death, MI and stroke occurred in 6.6% of those assigned prasugrel vs. 5.7% of those assigned ticagrelor (HR = 1.167; 95% CI, 0.742-1.835), Motovska said.

There was also no difference at 1 year between the groups in CV death (prasugrel, 3.3%; ticagrelor, 3%; P = .769), MI (prasugrel, 3%; ticagrelor, 2.5%; P = .611), stroke (prasugrel, 1.1%; ticagrelor, 0.7%; P = .423), all-cause mortality (prasugrel, 4.7%; ticagrelor, 4.2%; P = .654), definite stent thrombosis (prasugrel, 1.1%; ticagrelor, 1.5%; P = .535), all bleeding (prasugrel, 10.9%; ticagrelor, 11.1%; P = .999) and TIMI major bleeding (prasugrel, 0.9%; ticagrelor, 0.7%; P = .754), she said.

A switch to clopidogrel was made in 34.1% of those assigned prasugrel and 44.4% of those assigned ticagrelor (P = .003), with most switches occurring soon after discharge, according to the researchers.

Patients who switched therapies because of cost sharing for study drugs had less frequent bundle branch block or acute heart failure at admission, and also had less frequent presence of left main disease and fewer cases of failed PCI than those who did not switch, Motovska said.

In addition, those who switched medications for economic reasons had lower risk for CV death, MI and stroke (HR = 0.433; 95% CI, 0.21–0.894) and bleeding (HR = 0.514; 95% CI, 0.35-0.7455) compared with those who did not switch.

The results were simultaneously published in the Journal of the American College of Cardiology.

PAGE BREAK
Roxana Mehran

“Prasugrel and ticagrelor are similarly effective and safe at 1 year after MI treated with primary PCI,” Motovska said. “Switching to clopidogrel, when approved by treating physicians, was not associated with increased risk of ischemic endpoints.”

During a discussion of the results, Roxana Mehran, MD, associate medical editor of Cardiology Today’s Intervention and professor of medicine and director of interventional cardiovascular research and clinical trials at the Zena and Michael A. Weiner Cardiovascular Institute at Icahn School of Medicine at Mount Sinai, said the data must be considered observational. A more definitive answer requires “a large, randomized trial to evaluate the safety and efficacy of switching, specifically de-escalation, in this high-risk patient population of STEMI undergoing percutaneous coronary intervention for the next year after their procedure,” Mehran said. – by Erik Swain

References:

Motovska Z, et al. LBS.05 – New Insights into the Risks, Benefits and Costs of Antithrombotic Therapy. Presented at: American Heart Association Scientific Sessions; Nov. 11-15, 2017; Anaheim, California.

Motovska Z, et al. J Am Coll Cardiol. 2017;doi:10.1016/j.jacc.2017.11.008.

Disclosures: Motovska reports she receives honoraria from AstraZeneca. Mehran reports she has financial ties with multiple pharmaceutical and device companies.

 

Editor’s Note: This article was updated on Nov. 16, 2017 to reflect updated data and add additional information about drug costs to patients.

    Perspective

    C. Michael Valentine

    Between one-third and one-half of all patients changed to clopidogrel later in the course of their recovery from STEMI, purely because of cost, with no significant impact in their outcomes at 1 year. That makes this become much more of a real-world study, because so many of our patients end up changing drugs or becoming noncompliant because of cost issues. This suggests that after the acute phase of prasugrel or ticagrelor, changing to clopidogrel, a generic drug, later in the course does not significantly affect 1-year outcomes.

    This could change clinical practice, and also may validate current clinical practice, in that many clinicians are forced to change drugs to maintain patient compliance, because our patients tell us that they can’t afford the brand-name medicines and want to stop them. This issue affects me every day, when my patients walk in and say they can’t afford their drug anymore, so I tell them I will change them to generic clopidogrel, but I have no idea if that is a good strategy. This gives me confidence that I may not be impacting long-term outcomes by changing to clopidogrel later in the course.

    • C. Michael Valentine, MD, FACC
    • Cardiologist, Stroobants Cardiovascular Center
      Centra Health, Lynchburg, Virginia
      Vice President, American College of Cardiology

    Disclosures: Valentine reports no relevant financial disclosures.

    See more from American Heart Association Scientific Sessions