News | May 21, 2015

VENTURE-AF Trial Data Supports Rivaroxaban for Atrial Fibrillation Patients Undergoing Catheter Ablation

Xarelto group displays no major bleeds, ischemic strokes or vascular deaths

rivaroxaban, Xarelto, VENTURE-AF, VKA, atrial fibrillation, Heart Rhythm 2015

May 21, 2015 — Janssen Pharmaceuticals Inc. and its development partner Bayer HealthCare 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., FACC, FHRS, FESC, executive medical director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, Texas, 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 clinical development program, other completed and ongoing clinical trials, investigative registries and non-interventional studies.

For more information:

Related Content

DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Heart Failure Market to Surpass $16 Billion by 2026
News | Heart Failure| September 19, 2017
The heart failure space across the seven key markets of the U.S., France, Germany, Italy, Spain, the U.K. and Japan is...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Marijuana Associated With Three-Fold Risk of Death From Hypertension
News | Hypertension| September 14, 2017
Marijuana use is associated with a three-fold risk of death from hypertension, according to research published recently...
Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Feature | Cath Lab| September 14, 2017
September 14, 2017 — Here are quick summaries for all the key late-breaking vascular and endovascular clinical trials
Medtronic Announces Japanese Regulatory Approval for In.Pact Admiral Drug-Coated Balloon
News | Drug-Eluting Balloons| September 13, 2017
Medtronic plc announced that the In.Pact Admiral Drug-Coated Balloon (DCB) received approval from the Japanese Ministry...
Overlay Init