TriHealth Heart & Vascular Institute Participates in Landmark Clinical Trial

TriHealth, Cincinnati’s nationally recognized healthcare system, is pleased to have played a vital role in a landmark clinical trial that will immediately impact how patients are treated after receiving a WATCHMAN cardiac device.

The WATCHMAN device is designed to reduce the risk of stroke related to atrial fibrillation (AFib) without the need for long-term, full-dose blood thinners. Historically, after the device is successfully inserted into the heart, patients have been prescribed an aggressive, six-month regimen of two medications to prevent blood clots during the initial healing phase. However, these intensive drug regimens carry a substantial risk of serious bleeding, presenting a persistent clinical challenge particularly for older patients.

To solve this dilemma, a group of national researchers, including TriHealth electrophysiologist Dr. Gaurang Gandhi, conducted the SIMPLAAFY trial. Supported by clinicians at the TriHealth Heart & Vascular Institute and TriHealth’s Hatton Research Institute at Bethesda North Hospital in Cincinnati, Ohio, the national U.S. study randomized 1,857 patients across 86 sites.

The SIMPLAAFY study concluded that the traditional use of a two-drug regimen is not required. Instead, the trial proved that simpler, single-drug therapies, such as aspirin alone or a reduced dose of a blood thinner, achieved excellent results, successfully protecting patients from blood clots while drastically reducing bleeding risks.

The landmark findings were published this week in JAMA, one of the world's leading peer-reviewed medical journals. TriHealth was the lone Cincinnati-area health system selected to participate in the study.

“These results are a major victory for patient safety and will immediately simplify how we deliver post-procedure care,” said Dr. Gandhi (Chair, Department of Cardiology and Director of Electrophysiology Labs at Bethesda North). “We are constantly looking for ways to mitigate procedural risks for our cardiac patients, especially older individuals who face multiple compounding health factors. The SIMPLAAFY data show we can successfully protect patients from stroke while simultaneously shielding them from the unnecessary dangers of severe bleeding. Our experience with this trial will have immediate beneficial effects for our patients.”