Janssen Pharmaceuticals, Inc. and its development partner, Bayer HealthCare, today announced results from the VENTURE-AF trial. The study explored the potential of once-daily Xarelto (rivaroxaban) as an alternative to vitamin K antagonists (VKA), used to reduce the risk of blood clots, in people with non-valvular atrial fibrillation (NVAF) undergoing catheter ablation, a frequently used interventional procedure to remove abnormal tissue in the heart that is causing the irregular heartbeat. The results were presented at Heart Rhythm 2015, the Heart Rhythm Society’s 36th Annual Scientific Sessions, and published in the European Heart Journal.
Over the past decade, the number of catheter ablation procedures has risen dramatically in the United States, with more than 93,000 procedures performed from 2000-2010. Current guidelines recommend uninterrupted anticoagulation before, during and after the procedure to help prevent life-threatening blood clots. The VENTURE-AF study is the first global, prospective, randomized trial of any novel oral anticoagulant (NOAC) in this high-risk patient population.
VENTURE-AF was a 248-patient, Phase 3b trial. For patients treated during or after the catheter ablation procedure, there was one major bleed in the VKA group, as defined by the ISTH scale, compared to zero for rivaroxaban. There were no major bleeds in either group using GUSTO- and TIMI-defined scales. The majority of bleeding that occurred in the study was mild or insignificant. There was one ischemic stroke and one vascular death in the VKA arm compared to none for rivaroxaban. Serious adverse events were comparable between both treatment strategies with 17 in the rivaroxaban group and 20 in the VKA group. VENTURE-AF was intentionally designed as an exploratory study and thus no formal statistical superiority or non-inferiority analysis was planned.
“The VENTURE-AF study results provide physicians with additional insights that may help them manage non-valvular atrial fibrillation patients who are scheduled for catheter ablation,” said Andrea Natale, M.D., F.A.C.C., F.H.R.S., F.E.S.C., Executive Medical Director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, TX, and lead investigator of VENTURE-AF. “Given the dose adjustments often needed for patients on vitamin K antagonists, such as warfarin, to ensure the medicine is working effectively, rivaroxaban may offer a simpler approach in this setting.”
VENTURE-AF is a part of the EXPLORER global cardiovascular research program for XARELTO®. The EXPLORER program includes 11 trials assessing the safety and efficacy of XARELTO® in high-risk patient populations, including those with chronic heart failure, coronary artery disease, peripheral artery disease, acute coronary syndrome and embolic stroke of undetermined source. By the time of its completion, more than 275,000 patients will have participated in the XARELTO® clinical development program, other completed and ongoing clinical trials, investigative registries, and non-interventional studies.
“The VENTURE-AF results build on the promising data observed in a sub-analysis of the landmark ROCKET-AF trial,” said Paul Burton, M.D., Ph.D., Vice President, Medical Affairs, Janssen. “Through our work on the EXPLORER global cardiovascular research program, that includes six indication-seeking programs currently underway, we will continue to evaluate the full potential of XARELTO® in addressing unmet medical needs for patients.”
Source: Janssen Pharmaceuticals
Filed Under: Drug Discovery