Patients with ACS who were treated with dual antiplatelet therapy plus a newer oral anticoagulant had an increased risk for clinically significant bleeding, according to a meta-analysis published in The American Journal of Cardiology.
The rate of major adverse CV events was modestly reduced with this treatment.
Safi U. Khan, MD, internal medicine resident at Guthrie Clinic/Robert Packer Hospital in Sayre, Pennsylvania, and colleagues analyzed data from 31,574 patients with ACS from seven randomized controlled trials that investigated apixaban (Eliquis, Bristol-Myers Squibb/Pfizer), rivaroxaban (Xarelto, Janssen) and dabigatran (Pradaxa, Boehringer Ingelheim). Five trials investigated newer oral anticoagulants in patients with recent ACS and two trials assessed the safety of rivaroxaban and dabigatran in patients with atrial fibrillation who underwent PCI.
The primary safety outcome of interest was clinically significant bleeding. The secondary efficacy endpoint of interest was major adverse CV events, which was a composite of stroke, MI and all-cause mortality.
The studies had significant heterogeneity (78%; P < .001).
Single antiplatelet therapy plus a newer oral anticoagulant did not increase the risk for clinically significant bleeding (HR = 0.82; 95% CI, 0.56-1.2) and did not have a benefit on major adverse CV events (HR = 0.82; 95% CI, 0.66-1.04).
When new oral anticoagulants were combined with DAPT into so-called triple therapy, patients had a modest reduction in major adverse CV events (HR = 0.86; 95% CI, 0.78-0.93), but an increased risk for bleeding (HR = 2.24; 95% CI, 1.75-2.87).
Subgroup analyses found that dabigatran with single antiplatelet therapy was a safer treatment option compared with control (HR = 0.51; 95% CI, 0.42-0.61). Rivaroxaban with DAPT reduced major adverse CV events by 17%.
“Until the fog clears from this active investigative domain of antithrombotic therapy, the practitioner should carefully weigh the thrombotic and bleeding risk before suggesting an antithrombotic regimen to the individual patient,” Khan and colleagues wrote. “This discussion should include dosing and duration of the drugs and the required monitoring of the possible adverse events.” – by Darlene Dobkowski
One author reports he is a speaker and consultant for Bristol-Myers Squibb, Daiichi Sankyo, Janssen and Pfizer.