How anticoagulants may impact a patient’s risk of gastrointestinal bleeding after TAVR
Patients with prevalent or incident atrial fibrillation (AFib) after undergoing a successful transcatheter aortic valve replacement (TAVR) procedure could face an increased risk of major gastrointestinal bleeding (MGIB) if given edoxaban instead of a vitamin K antagonist (VKAs), according to new research published in the Journal of the American Heart Association.[1]
Non–vitamin K oral anticoagulants (NOACs) such as edoxaban have previously been linked to multiple benefits over VKAs for some AFib patients. In addition, the ENVISAGE‐TAVI AF randomized trial found that edoxaban was noninferior to VKAs in terms of adverse clinical events in patients with AFib following successful TAVR.[2] In this subanalysis of ENVISAGE-TAVI AF, researchers focused specifically on MGIB to learn more about the different risks associated with each treatment strategy.
Researchers tracked data from more than 1,300 ENVISAGE-TAVI AF patients who presented with AFib after a successful TAVR from April 2017 to January 2020. MGIB was reported in 6% of patients, and 67.5% of those patients had been part of the group randomized to receive edoxaban. The other 32.5% received a VKA.
Patients who did and did not experience MGIB had comparable mean ages and a similar percentage were women. In addition, the rates of most comorbidities were comparable for the two groups. A history of carotid artery disease, however, was seen in 13.3% of patients with MGIB and 6.6% of patients without MGIB.
One key takeaway from the group’s analysis was the fact that patients who had undergone percutaneous coronary intervention less than 30 days before TAVR had a significantly higher MGIB rate (9.6%) than patients who did not (4.2%). This was likely due to the fact that these patients were on additional antiplatelet therapies, the group noted.
“Patients with a recent PCI are at a higher risk of MGIB due to use of antiplatelet therapy on top of oral anticoagulant therapy, so physicians may need to tailor oral anticoagulant therapy to each patient,” wrote first author George D. Dangas, MD, PhD, an interventional cardiologist and director of cardiovascular innovation at Mount Sinai Hospital and chief of cardiology at Mount Sinai Queens, and colleagues.
Smoking was another independent predictors of MGIB in these patients, which comes as no surprise.
“Smoking is a well‐known risk factor for both stroke and cardiovascular death,” the authors wrote. “Smoking status is also associated with a number of adverse events in patients with AFib, including major bleeding and MGIB, irrespective of use of oral anticoagulation.”
Reviewing these findings, Dangas et al. emphasized the importance of learning as much as possible about a patient’s risks prior to treatment.
“Given its impact on morbidity and death, a prior identification of predictors of MGIB may help with the optimization of TAVR outcomes,” they wrote.
The group also noted that it remains unclear how the resumption of oral anticoagulation after MGIB impacts a patient’s bleeding risks. This will require additional research.