Long-term clopidogrel confers less MACCE, bleeding events vs. aspirin after PCI
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ATLANTA — Clopidogrel monotherapy after 12 months of event free post-PCI dual antiplatelet therapy was associated with fewer MACCE and bleeding events vs. aspirin monotherapy in high bleeding risk patients, a speaker reported.
Data presented at the Society for Cardiovascular Angiography and Interventions Scientific Sessions, showed that, at 30 months post-PCI, patients taking the P2Y12 inhibitor clopidogrel, as monotherapy experienced nearly half the risk for all-cause death, MI, definite/probable stent thrombosis, stroke or Bleeding Academic Research Consortium type 2, 3 or 5 bleeding compared with those taking aspirin monotherapy.
“Trials of early aspirin cessation were not designed to evaluate the effects of these strategies on the endpoints the medications are intended to influence, such as myocardial infarction, stent thrombosis and stroke, and that scarce information is available beyond 1 year,” Hao-Yu Wang, MD, of Fuwai Hospital, State Key Laboratory of Cardiovascular Disease, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College in Beijing, said during a presentation. “
Prior studies, such as HOST-EXAM, evaluated the use of clopidogrel or aspirin monotherapy after 6 to 18 months of dual antiplatelet therapy following PCI.
As Healio previously reported, the HOST-EXAM primary endpoint of all-cause death, nonfatal MI, ischemic stroke, readmission for ACS or Bleeding Academic Research Consortium (BARC) bleeding type 3 or greater at 24 months was less frequent among patients taking clopidogrel compared with aspirin.
However, Wang said, “Optimal antiplatelet monotherapy during the chronic maintenance period beyond 12 months after PCI with drug-eluting stents in high-risk patients in real-world settings remains unclear.”
Utilizing the Fuwai PCI Registry, researchers identified 5,664 high-risk patients (mean age, 58 years; 76% men; 65% who had PCI for ACS; 17% at high bleeding risk) who were event-free during the initial 12 months of DAPT following PCI and were subsequently switched to either aspirin monotherapy (n = 3,690) or clopidogrel (n = 1,974).
The primary endpoint was a composite of all-cause death, MI, definite/probable stent thrombosis, stroke, or BARC bleeding type 2, 3 or 5, from 12 to 30 months. Secondary endpoints included MACCE, defined as all-cause death, MI, definite/probable stent thrombosis or stroke; and BARC bleeding type 2, 3 or 5.
At 30 months post-PCI, Wang and colleagues observed that 5% of patients taking aspirin monotherapy during the maintenance period experienced the primary composite endpoint compared with 2.5% of the clopidogrel cohort (HR = 0.557; 95% CI, 0.397-0.781; log-rank P = .001).
Over the same period, 3.1% of patients taking aspirin monotherapy experienced the secondary composite endpoint of MACCE compared with 1% of those taking clopidogrel (HR = 0.442; 95% CI, 0.275-0.71; log-rank P = .001).
BARC bleeding type 2, 3 or 5 occurred in 2.1% of the aspirin group at 30 months compared with 1.5% of the clopidogrel arm (HR = 0.732; 95% CI, 0.454-1.181; log-rank P = .199).
Multivariable adjustment did not change the results, and the results did not vary according to prespecified subgroups.
“In this real-world study, clopidogrel monotherapy has effects on all-cause and cardiovascular mortality, as well as stroke, compared with aspirin monotherapy,” Wang said during the presentation. “Therefore, this strategy might be an effective alternative to aspirin for secondary prevention of cardiovascular disease.”
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Srihari S. Naidu, MD, FACC, FAHA, FSCAI
This trial is interesting because its talking about secondary prevention after a stent. We know that from TWILIGHT and what Roxana Mehran, MD, FACC, FACP, FCCP, FESC, FAHA, FSCAI, has done, it does seem like the field is moving towards ticagrelor (Brilinta, AstraZeneca) monotherapy after PCI, and there might be a good risk-benefit ratio of ischemic and bleeding complications in those patients. What we don't know is what clopidogrel does. Is clopidogrel a good alternative to that, and what do you do after the first year?
Wang and colleagues looked at a large cohort of patients, almost 7,000, that had PCI, and they selected those patients who were higher risk for bleeding and ischemic complications. Then they looked to see which patients got aspirin monotherapy and which got clopidogrel monotherapy at the 1-year mark, and they followed those patients up to 30 months. At 30 months, the patients who got clopidogrel had a reduction in ischemic endpoints, as well as no signal of increased bleeding. In fact, the bleeding rates were the same, or even numerically lower in the clopidogrel group. This is interesting because clopidogrel is generic; we have some old data from CAPRI that this might be a good alternative, but we really haven't done that before. Now with everything going on with aspirin monotherapy in primary prevention, what do you do with secondary prevention? The question is, is clopidogrel better in that situation and should we really just get rid of aspirin altogether?
I think this trial is going to have some implications. Obviously, it's not a randomized trial, but it has a large number of patients and the groups seem equally balanced based on the populations tested, but there is more to come on that.
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Wang HY, et al. Featured Clinical Research: Part 2. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 19-22, 2022; Atlanta.
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