Each year, nearly one million patients in the United States undergo
percutaneous coronary intervention (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 5-8% 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.
‘Therapies combining the anticoagulant drug rivaroxaban with either single or dual anti-platelet therapy (DAPT) were more effective in preventing bleeding complications in atrial fibrillation.’
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, Chief of Clinical
Research in the Division of Cardiovascular Medicine at BIDMC, reported
the new research findings 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.
"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
randomized clinical trial 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
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 atrial fibrillation 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 patients 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.