In patients with CAD, P2Y12 inhibitors best aspirin for secondary prevention
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Among patients with CAD, P2Y12 monotherapy was superior to aspirin monotherapy for prevention of CV death, MI and stroke, according to an individual patient data meta-analysis presented at the European Society of Cardiology Congress.
Marco Valgimigli, MD, FESC, deputy chief of interventional cardiology at Cardiocentro Ticino Institute, Lugano, Switzerland, and colleagues conducted an individual patient data meta-analysis of seven randomized trials of 24,325 patients with CAD (mean age, 64 years; 22% women). Among those assigned to P2Y12 inhibitor monotherapy, 62% received clopidogrel and 38% received ticagrelor (Brilinta, AstraZeneca).
“The key message is that based on all available randomized evidence, long-term P2Y12 inhibitor [monotherapy] may be warranted instead of long-term aspirin monotherapy for secondary prevention in patients with coronary artery disease,” Valgimigli said during a press conference.
The primary endpoint was CV death, MI and stroke. The key secondary endpoints were major bleeding, defined as Bleeding Academic Research Consortium (BARC) type 3 or 5 if available and TIMI major bleeding or a trial-specific definition if not, and net adverse clinical events, defined as CV death, MI, stroke or major bleeding. Median treatment duration was 557 days.
During the study period, the primary endpoint occurred in 5.5% of patients in the P2Y12 inhibitor group and 6.3% of patients in the aspirin group (HR = 0.88; 95% CI, 0.79-0.97; P = .014; number needed to treat for benefit = 123), Valgimigli said during the press conference.
Net adverse clinical events also favored the P2Y12 inhibitor group (6.4% vs. 7.2%; HR = 0.89; 95% CI, 0.81-0.98; P = .02), Valgimigli said.
The rates of major bleeding were 1.2% in the P2Y12 inhibitor group and 1.4% in the aspirin group (HR = 0.87; 95% CI, 0.7-1.09; P = .23), he said.
The results were driven by MI (HR = 0.77; 95% CI, 0.66-0.9; P < .001), Valgimigli said, noting that compared with the aspirin group, the P2Y12 inhibitor group also had lower rates of hemorrhagic stroke (HR = 0.32; 95% CI, 0.14-0.75; P = .009), definite stent thrombosis (HR = 0.42; 95% CI, 0.19-0.97; P = .041), definite or probable stent thrombosis (HR = 0.46; 95% CI, 0.23-0.92; P = .028) and gastrointestinal bleeding (HR = 0.75; 95% CI, 0.57-0.97; P = .027).
“The incidence of major bleeding did not differ, but gastrointestinal bleeding, the most frequent bleeding complication, and hemorrhagic stroke, the worst bleeding complication, were both lower with P2Y12 inhibitor monotherapy,” Valgimigli said during the press conference, noting that the hemorrhagic stroke finding was unexpected.
He said the results do not necessarily mean that aspirin therapy should be ended in this population.
"I don’t think it’s the end of aspirin; I think it’s the rise of an available alternative to aspirin,” he said during the press conference. “The guidelines say aspirin is first line, but if aspirin is contraindicated, then the second option is a P2Y12 inhibitor. Within Europe, the guidelines have been inconsistent in suggesting that clopidogrel could be a first-line option in patients with [peripheral artery disease]. Now, we have two at least equally effective alternatives. To take aspirin out of the picture completely would require additional studies. It has been there for 125 years."
Instead, Valgimigli told Healio, aspirin should now be considered second-line therapy, and P2Y12 inhibitors first-line therapy, for secondary prevention in patients with CAD.
Perspective
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Edward T.A. Fry, MD, FACC, FSCAI
These results are applicable to day-to-day practice, in the context of recognizing what to do after stopping dual antiplatelet therapy, as stopping DAPT lowers overall bleeding risks long term. They also provide reassurance that P2Y12 inhibitors enable fewer ischemic events long term compared with aspirin, going back as far as 25 years ago in the CAPRI trial, without giving anything up in terms of bleeding, especially [gastrointestinal] bleeding and intracranial bleeding.
Most practitioners have already switched to P2Y12 inhibitors in this population because of the idea that aspirin has direct [gastrointestinal] effects.
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Valgimigli M, et al. Hot Line 9. Presented at: European Society of Cardiology Congress; Aug. 26-29, 2022; Barcelona, Spain (hybrid meeting).
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