ARRIVE: Aspirin does not reduce initial vascular events in low-to-moderate risk population
MUNICH — In a moderate-risk population with low event rates, aspirin did not significantly reduce initial vascular events, according to the ARRIVE study presented at the European Society of Cardiology Congress.
Among 12,546 patients randomly assigned to receive enteric-coated aspirin (Bayer) 100 mg daily or placebo and followed for a median of 60 months, the primary efficacy endpoint of time to first occurrence of CV death, MI, unstable angina, stroke or transient ischemic attack occurred in 4.29% of the aspirin group vs. 4.48% of the placebo group (HR = 0.96; 95% CI, 0.81-1.13), according to results of an intention-to-treat analysis.
“ARRIVE attempted to address the issue of aspirin for primary prevention in subjects at moderate risk for cardiovascular disease in a pragmatic, primary-care-based study,” J. Michael Gaziano, MD, MPH, chief of the division of aging at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, said during a press conference. “We ended up with a lower-risk population than we had intended. The results showed that aspirin did not significantly reduce a composite of vascular events in the intention-to-treat population. The effects of aspirin tended to be the same as in other primary prevention studies.”
All patients enrolled in the ARRIVE study were considered to be at moderate risk based on number of risk factors and were free from diabetes and elevated bleeding risk. Patients enrolled had a mean age of 64 years and 30% were women. Men were aged at least 55 years and women were aged at least 60 years. Enrollment occurred at 501 centers in seven countries.
In other results presented here, gastrointestinal bleeding events were mostly mild, but occurred approximately twice as often in the aspirin group (0.97% vs. 0.46%; HR = 2.11; 95% CI, 1.36-3.28), according to the researchers.
Serious adverse events occurred in 20.19% of the aspirin group vs. 20.89% in the placebo group, while overall adverse events occurred in 82.01% of the aspirin group vs. 81.72% of the placebo group.
Treatment-related adverse events were higher in the aspirin group (16.75% vs. 13.54%; P < .0001), but death rates were nearly identical in the intention-to-treat population (aspirin group, 2.55%; placebo group, 2.57%; HR = 0.99; 95% CI, 0.8-1.24), according to the researchers.
Rates of MI did not differ in the intention-to-treat population, but favored the aspirin group in the per-protocol population (HR = 0.53; 95% CI, 0.36-0.79).
“The use of aspirin remains a decision that should involve a thoughtful discussion between a clinician and a patient that requires a need to weigh the cardiovascular and cancer benefits against the bleeding risks,” Gaziano said during a press conference.
The data were simultaneously published in The Lancet.
Davide Capodanno, MD, from the division of cardiology, AOU “Policlinico Vittorio Emanuele,” Catania, Italy, and Cardiology Today’s Intervention Editorial Board Member Dominick J. Angiolillo, MD, PhD, medical director of the Cardiovascular Research Program, program director of the Interventional Cardiology Fellowship Program and professor of medicine at the University of Florida College of Medicine – Jacksonville, discussed the findings in a related editorial also published in The Lancet.
“Overall, the consistent trend in negative results from trials of aspirin in primary prevention, particularly in patients without diabetes, suggests that new avenues of research are needed for the prevention of cardiovascular events.” – by Erik Swain
Gaziano JM, et al. Hot Line Session 1. Presented at: European Society of Cardiology Congress; Aug. 25-29, 2018; Munich.
Disclosures: The study was funded by Bayer. Gaziano reports receiving personal fees from Bayer. Please see the study for the other authors’ relevant financial disclosures. Angiolillo reports financial ties with multiple pharmaceutical and device companies. Capodanno reports he received speaker’s and consultant honoraria from AstraZeneca and Bayer.