Dual therapy may confer less major bleeding vs. triple therapy in AF, PCI
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A meta-analysis of randomized controlled trials published in the Annals of Internal Medicine showed that dual therapy was associated with lower risk for major bleeding in patients with nonvalvular atrial fibrillation after PCI compared with triple therapy.
Researchers assessed four trials that compared dual therapy (direct oral anticoagulants plus P2Y12 inhibitors) with triple therapy (vitamin K antagonist plus dual antiplatelet therapy), and reported bleeding, mortality and ischemic outcomes.
Researchers found that dual therapy was associated with reduced risk for major bleeding compared with triple therapy (risk difference [RD], –0.013; 95% CI, –0.025 to –0.002; I2 = 0%).
Inconclusive outcomes
In contrast, the effects of dual therapy compared with triple therapy on other outcomes were inconclusive:
- all-cause mortality (RD, 0.004; 95% CI, –0.01 to 0.017; I2 = 0%);
- CV mortality (RD, 0.001; 95% CI, –0.011 to 0.013; I2 = 0%);
- MI (RD, 0.003; 95% CI, –0.01 to 0.017; I2 = 0%);
- stent thrombosis (RD, 0.003; 95% CI, –0.005 to 0.01; I2 = 0%); and
- stroke (RD, –0.003; 95% CI, –0.01 to 0.005; I2 = 0%).
However, the upper bounds of the CIs may be compatible with increased risks with dual therapy, the researchers wrote.
“Our meta-analysis shows high-certainty evidence that supports the use of direct oral anticoagulant-based dual therapy over vitamin K antagonist-based triple therapy for reducing bleeding risk in patients with AF who received PCI,” Safi U. Khan, MD, assistant professor in the department of medicine at West Virginia University, and colleagues wrote. “The use of dual therapy vs. triple therapy had an inconclusive effect on risks for death and ischemic outcomes. The certainty of this evidence was low, and upper bounds of CIs signaled a possible increased risk for the ischemic endpoints.”
The four trials chosen for this analysis included 7,953 adults with nonvalvular AF who underwent PCI.
“The totality of evidence favors dual antithrombotic therapy for consistently showing the safety in terms of bleeding,” Khan told Healio. “However, there is room for further evidence to examine the effects of these antithrombotic regimes on ischemic endpoints and mortality.
“The clinicians should have strong confidence in prescribing dual antithrombotic therapy to their patients, based on a significant body of evidence favoring dual thrombotic therapy in reducing the risk of bleeding,” Khan said in an interview. “However, a potential risk of worsening higher ischemic outcomes cannot be ignored.”
Navigating risks remains a challenge
“Are these separate meta-analyses compatible, and did Khan and colleagues get it right? I believe that the answer to both questions is yes,” John U. Doherty, MD, professor of cardiology and electrophysiology at the Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, wrote in a related editorial. “Because bleeding events are much more frequent than thrombotic events, even after pooling data from four trials, it is difficult to know definitively whether and to what extent thrombotic events are increased with dual antithrombotic therapy.
“Where does this leave us today as we face the hazard of bleeding on one side and thrombosis on the other? Lesion complexity, patient-specific bleeding risk, and whether stenting is elective or emergent are factors to weigh in determining the duration and intensity of combined anticoagulant and antiplatelet therapy. Navigating the competing risks remains a challenge. Stent technology is maturing, and which P2Y12 inhibitor to prescribe remains a question, especially when treatment with clopidogrel is unsuccessful. Stay tuned, because practice will surely continue to evolve.” – by Scott Buzby
Disclosures: The study authors report no relevant financial disclosures. Doherty reports he consulted for Bristol-Myers Squibb and received honoraria from Bayer.
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