Study reports progress in preventing bleeding in atrial fibrillation

November 14, 2016

A new study led by clinician-researchers at Beth Israel Deaconess Medical Center (BIDMC) testing the safety and effectiveness of anticoagulant strategies for patients with atrial fibrillation who undergo stenting procedures has shown that therapies combining the anticoagulant drug rivaroxaban with either single or dual anti-platelet therapy (DAPT) were more effective in preventing bleeding complications than the current standard of care.

Principal Investigator C. Michael Gibson, MD, Chief of Clinical Research in the Division of Cardiovascular Medicine at BIDMC, reported the new research findings today online in The New England Journal of Medicine and simultaneously presented the findings at the American Heart Association's Scientific Sessions 2016 in New Orleans.

The PIONEER AF-PCI randomized clinical trial involved more than 2,100 patients at 430 sites in 26 countries.

Each year, nearly 1 million patients in the United States undergo (PCI) and are implanted with stents positioned to treat narrowed coronary arteries. Following PCI, patients receive dual anti-platelet therapy - a combination of aspirin and a second blood-thinning medication - to prevent the formation of blood clots in the stent. Approximately 5 to 8 percent of patients undergoing PCI have atrial fibrillation, the most common type of cardiac arrhythmia and an important risk factor for stroke. These patients typically take a blood thinner, such as warfarin (Coumadin), to prevent stroke.

"In managing the stented patient with atrial fibrillation, a pharmacologic strategy must carefully balance the risk of stent thrombosis, or blood clot, with the risk of bleeding complications," said Gibson, who is also Professor of Medicine at Harvard Medical School and chairman of the PERFUSE (Percutaneous/Pharmacologic Endoluminal Revascularization for Unstable Syndromes Evaluation) Study Group. "This trial, which tested two entirely new strategies, now provides us with data demonstrating that a combination of rivaroxaban with anti-platelet therapy is successful in minimizing bleeding while preventing clotting."

Current guidelines call for combining three drugs - DAPT plus a vitamin K antagonist (VKA) anticoagulant - in a strategy known as "triple therapy." But as the authors note, this approach may result in excess major bleeding rates of 4 to 12 percent within the first year of treatment.

The PIONEER AF-PCI trial studied men and women over age 18 with atrial fibrillation who had undergone a PCI procedure with stent placement. The study subjects were randomly assigned to one of three groups: Group 1 received reduced dose rivaroxaban plus a P2Y-12 inhibitor monotherapy; Group 2 received very low dose rivaroxaban plus DAPT; and Group 3 received VKA plus DAPT.

The findings showed that among patients with who underwent intracoronary stent placement, the administration of rivaroxaban in one of two dose strategies reduced the risk of clinically significant bleeding in about one out of every 10 to 11 as compared with triple therapy including a vitamin K antagonist. The risks of rehospitalization and death from all causes were also reduced in about one out of every 10 to 15 cases.

"This new treatment strategy benefits patient health as well as hospital finances," added Gibson.

Explore further: DAPT use variable in patients with A-fib at risk of stroke

Related Stories

DAPT use variable in patients with A-fib at risk of stroke

August 16, 2016
(HealthDay)—For patients with atrial fibrillation at moderate to high risk of stroke, dual antiplatelet therapy (DAPT) use is variable among those undergoing percutaneous coronary intervention (PCI), according to a study ...

How safe and effective are new drugs for stroke prevention?

October 3, 2016
For decades, warfarin was the only oral blood thinner available to reduce the risk of stroke for patients with atrial fibrillation. Warfarin use is cumbersome, because it requires ongoing blood test to monitor the effect ...

Enrollment completed for RE-DUAL PCI study of 2,700 atrial fibrillation patients

November 14, 2016
The Baim Institute has announced that patient enrollment into the international Phase IIIb RE-DUAL PCI study is complete. The study evaluates the safety and efficacy of dabigatran etexilate in atrial fibrillation (AF) patients ...

Peripheral arterial disease: Longer duration of dual antiplatelet therapy after stent placement improves outcomes

August 30, 2016
In a study published online by JAMA Cardiology, Marco Valgimigli, M.D., Ph.D., of Bern University Hospital, Bern, Switzerland, and colleagues assessed the efficacy and safety of prolonged (24 months) vs short (6 months or ...

Individualized treatment duration of blood thinning drugs after heart stent procedures

March 29, 2016
Nearly 1 million people in the United States receive coronary artery stents each year. Nearly all stent patients are expected to take dual antiplatelet therapy (DAPT) using the combination of aspirin and a second antiplatelet ...

New oral anticoagulants provide same stroke prevention as warfarin but cause less bleeding

August 27, 2016
The new oral anticoagulants provide the same stroke prevention as warfarin but cause less intracranial bleeding, reports an observational study in more than 43 000 patients presented at ESC Congress 2016 today by Dr Laila ...

Recommended for you

Researchers investigate the potential of spider silk protein for engineering artificial heart

August 18, 2017
Ever more people are suffering from cardiac insufficiency, despite significant advances in preventing and minimising damage to the heart. The main cause of reduced cardiac functionality lies in the irreversible loss of cardiac ...

Lasers used to detect risk of heart attack and stroke

August 18, 2017
Patients at risk of heart attacks and strokes may be spotted earlier thanks to a diagnosis tool that uses near-infrared light to identify high-risk arterial plaques, according to research carried out at WMG, University of ...

Cholesterol crystals are sure sign a heart attack may loom

August 17, 2017
A new Michigan State University study on 240 emergency room patients shows just how much of a role a person's cholesterol plays, when in a crystallized state, during a heart attack.

How Gata4 helps mend a broken heart

August 15, 2017
During a heart attack, blood stops flowing into the heart; starved for oxygen, part of the heart muscle dies. The heart muscle does not regenerate; instead it replaces dead tissue with scars made of cells called fibroblasts ...

Injectable tissue patch could help repair damaged organs

August 14, 2017
A team of U of T Engineering researchers is mending broken hearts with an expanding tissue bandage a little smaller than a postage stamp.

'Fat but fit' are at increased risk of heart disease

August 14, 2017
Carrying extra weight could raise your risk of heart attack by more than a quarter, even if you are otherwise healthy.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.