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Patients with MI, PCI on triple therapy show excess risk for bleeding
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Compared with dual antiplatelet therapy only, patients treated with dual antiplatelet therapy plus an oral anticoagulant had elevated risk for bleeding after PCI treatment for acute MI, according to new data from the TRANSLATE-ACS study.
Among patients on triple therapy, those assigned prasugrel (Effient, Daiichi Sankyo/Eli Lilly) had more self-reported bleeding than those assigned clopidogrel, researchers found.
Larry R. Jackson II, MD, from Duke Clinical Research Institute, Duke University School of Medicine, and colleagues evaluated bleeding rates in patients from the TRANSLATE-ACS study of patients who underwent PCI after acute MI.
The researchers compared 6-month adjusted risks for bleeding as assessed by the Bleeding Academic Research Consortium (BARC), and whether bleeding was associated with rehospitalization. The 11,756 patients were stratified into four groups: those discharged on aspirin, clopidogrel and an oral anticoagulant (4.5%); those on aspirin, prasugrel and an oral anticoagulant (0.8%); those on aspirin and clopidogrel (66%); and those on aspirin and prasugrel (29%).
More bleeding on triple therapy
Jackson and colleagues found that triple therapy was associated with greater frequency of BARC-defined bleeding at 6 months compared with DAPT. Compared with patients on aspirin and clopidogrel, those on aspirin, clopidogrel and an oral anticoagulant had a higher rate of bleeding (28.7% vs. 19.7%; adjusted incidence rate ratio [IRR] = 1.68; 95% CI, 1.29-2.18). Similarly, compared with those on aspirin and prasugrel, those on aspirin, prasugrel and an oral anticoagulant were more likely to bleed (38.5% vs. 26.7%; adjusted IRR = 1.88; 95% CI, 1.1-3.2).
Among those on triple therapy, those assigned prasugrel were more likely to bleed than those assigned clopidogrel (39% vs. 24.4%; adjusted IRR = 2.37; 95% CI, 1.36-4.15), according to the researchers.
For bleeding that required rehospitalization, triple therapy with clopidogrel conferred an increased risk compared with DAPT with clopidogrel (OR = 3.13; 95% CI, 1.97-4.96), and triple therapy with prasugrel conferred an increased risk compared with DAPT with prasugrel (OR = 4.91; 95% CI, 1.36-17.7), but there was no difference in odds of bleeding between triple therapy with prasugrel and triple therapy with clopidogrel (OR = 0.62; 95% CI, 0.2-1.93), Jackson and colleagues found.
For patient-reported bleeding, triple therapy with clopidogrel conferred an increased risk compared with DAPT with clopidogrel (OR = 1.4; 95% CI, 1.03-1.91), and triple therapy with prasugrel conferred an increased risk compared with triple therapy with clopidogrel (OR = 3.19; 95% CI, 1.52-6.66) but there was no difference in odds of bleeding between triple therapy with prasugrel and DAPT with prasugrel (OR = 1.56; 95% CI, 0.85-2.86).
Minimizing hemorrhagic risk
In a related editorial, Freek W.A. Verheugt, MD, PhD, wrote: “DAPT in warfarin-anticoagulated patients undergoing stent implantation increases bleeding risk. The use of novel antiplatelet therapy in this setting must be discouraged.”
Verheugt, from the department of cardiology, Heartcenter, Onze Lieve Vrouwe Gasthuis, Amsterdam, concluded that “the use of safer oral anticoagulants as well as omitting aspirin may be the means to achieve this goal” of minimizing hemorrhagic risk in this population. – by Erik Swain
Disclosure: The TRANSLATE-ACS study was sponsored by Daiichi Sankyo and Eli Lilly. Jackson reports no relevant financial disclosures. Please see the full study for a list of the other researchers’ relevant financial disclosures. Verheugt reports receiving consulting and speaking honoraria from AstraZeneca, Bayer Healthcare, Boehringer Ingelheim, Bristol-Myers Squibb/Pfizer, Daiichi Sankyo and Eli Lilly.
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