News | Antiplatelet and Anticoagulation Therapies | March 14, 2018

COMPASS Trial Shows Rivaroxaban and Aspirin Lowers Major Adverse Limb Events in Peripheral Artery Disease

The Xarelto booth at ACC.18

The Xarelto booth at the 2018 American College of Cardiology meeting. 

March 14, 2018 — A late-breaking analysis of the landmark COMPASS study presented at the American College of Cardiology (ACC) 2018 meeting this week showed rivaroxaban (Xarelto) combined with aspirin, compared to aspirin alone, significantly lowered the incidence of major adverse limb events (MALE) in people with peripheral artery disease (PAD). 

The combination of the anticoagulant and aspirin showed a 43 percent reduction in MALE events, which resulted in fewer amputations, death and hospitalizations (HR=0.57; 95% CI, 0.37 to 0.88; p=0.01). 

Additionally, COMPASS researchers confirmed the importance of preventing MALE in patients with PAD, noting the correlation between MALE and amputations, death and hospitalizations. Of note, MALE was associated with a three-fold increase in death and a 200-fold increase in amputation.

The COMPASS PAD analysis also identified several factors that were predictors of MALE in patients: prior revascularization (peripheral surgery or angioplasty), prior limb amputation, critical limb ischemia or randomization to aspirin therapy in the trial.

"This analysis reinforces the potential clinical benefit of Xarelto in this population and may offer additional insight into how physicians manage patients with PAD in the future,” said Dr. Peter DiBattiste, global development head, cardiovascular, Janssen Research and Development. 

PAD affects 10 million Americans and can signal that a more serious cardiovascular (CV) event, like heart attack or stroke, may occur. Untreated PAD may also lead to MALE, or severe limb ischemia, where blockage in the arteries of the lower extremities markedly reduces blood-flow.
 
Rivaroxaban is the only factor Xa inhibitor to be investigated in PAD and coronary artery disease (CAD). 

The COMPASS study was stopped about a year ahead of schedule due to efficacy, and primary results were published in The New England Journal of Medicine and presented at the 2017 ESC Congress. 

In December 2017, Janssen submitted a supplemental new drug application (sNDA) to the FDA for two new rivaroxaban vascular indications based on COMPASS. These include reducing the risk of major CV events such as CV death, heart attack or stroke in patients with chronic CAD and/or PAD, and for reducing the risk of acute limb ischemia in patients with PAD. 

Rivaroxaban is used to reduce the risk of stroke and blood clots in people with atrial fibrillation not caused by a heart valve problem. It is also a prescribed to treat deep vein thrombosis (DVT) and pulmonary embolism (PE), and to reduce the risk of blood clots happening again in people who continue to be at risk for DVT or PE after receiving treatment for blood clots for at least six months. It also has an indication to reduce the risk of forming a blood clot in the legs and lungs of people who have just had knee or hip replacement surgery.

 

For more information on late-breakering news at ACC.18, find links to stories at ACC 2018 Late-Breaking Trials.

 

Reference:

407-16 - High Mortality after Major Adverse Limb Events in Peripheral Artery Disease: Results from the COMPASS trial. ACC 2018 featured clinical research. Presented March 11, 2018. http://www.abstractsonline.com/pp8/#!/4496/presentation/41771

Related Content

American College of Cardiology Names Douglas Drachman Next Annual Scientific Session Vice Chair

Image courtesy of Massachusetts General Hospital

News | ACC | October 08, 2019
Douglas Drachman, M.D., FACC, has been selected as the next vice chair of the American College of Cardiology’s (ACC)...
SyncVision iFR Co-registration from Philips Healthcare maps pressure readings onto angiogram. Results from an international study presented at ACC 2019 indicates pressure readings obtained using iFR (instantaneous wave-free ratio, also referred to as instant wave-free ratio or instant flow reserve) in coronary arteries may localize stenoses that remain after interventions. FFR in the cath lab.

SyncVision iFR Co-registration from Philips Healthcare maps pressure readings onto angiogram. Results from an international study presented at ACC 2019 indicates pressure readings obtained using iFR (instantaneous wave-free ratio, also referred to as instant wave-free ratio or instant flow reserve) in coronary arteries may localize stenoses that remain after interventions.

Feature | ACC | March 27, 2019 | Greg Freiherr, Contributing Editor
The fingerprints of value-added medicine were all over products and works-in-progress on the exhibit floor of the a

The opening late-breaking trial at ACC 2019 is the Apple Heart Study, a large-scale, app-based study to identify atrial fibrillation using a smartwatch. Earlier, smaller trials showed this approach might be used in a population health application to proactively identify AFib patients earlier.

Feature | ACC | March 19, 2019
The American College of Cardiology (ACC) released a list of the late
A patient who received HeartMate III LVAD system at ACC.18. The HeartMate 3 was the topic of of the the key late-breaking trials at #ACC18

A patient who received the HeartMate III LVAD system showing off his external battery pack. He served as a patient ambassador in the Abbott booth at ACC.18. The HeartMate III, with its magnetic levitated pump, showed a big reduction in clotting over previous LVADs in a key late-breaking trial at this year's conference.

Feature | ACC | March 27, 2018 | Dave Fornell
There were several notable presentations of new data on cardiovascular technologies at the recent 2018 American Colle
Drug Stops Dangerous Bleeding in Patients Taking Factor Xa Inhibitors

Connolly 

News | ACC | March 22, 2018
March 22, 2018 — The experimental drug...
Videos | ACC | March 21, 2018
DAIC Editor Dave Fornell takes a tour of some of the most interesting new technologies on the expo floor at
ACC 2018 Late-Breaking Trials Announced
News | ACC | March 21, 2018
Here is a list of the American College of Cardiology (ACC) 2018 annual meeting late-breaking clinical trials presente
Inhaled Therapy Ineffective in Difficult-to-Treat Heart Failure at ACC 2018.

Image from presentation, "Inorganic Nitrite Delivery to Improve Exercise Capacity in HFpEF: The INDIE-HFpEF Trial," Borlaug

News | ACC | March 20, 2018
March 20, 2018 — Four weeks of treatment with a novel inhaled medication failed to improve exercise capacity, daily a
More Deaths, Strokes Seen with Perioperative Beta Blocker One Year After Surgery

Image from presentation, "1-Year outcomes of perioperative beta-blockade in patients undergoing noncardiac surgery," Devereaux 

News | ACC | March 20, 2018
March 20, 2018 — During the 12 months after undergoing noncardiac surgery, patients with or at risk for heart disease
Trial for Gout Drug Meets Primary Endpoint, Raises Safety Concerns, image shows a CT scan showing gout in the knees.
News | ACC | March 20, 2018
March 20, 2018 — Febuxostat, a gout dr...
Overlay Init