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New findings provide definitive management guidelines for patients on direct oral anticoagulants with atrial fibrillation undergoing elective procedures or surgeries

Feinstein Institutes for Medical Research.

Feinstein Institiutes' Dr. Alex C. Spyropoulos serves as co-principal investigator of perioperative management study

MANHASSET, NY —

Researchers have found that a simple standardized approach for atrial fibrillation (AF) patients undergoing surgery has led to improved outcomes, according to a study in the latest issue of JAMA Internal Medicine. Feinstein Institutes for Medical Research Professor Alex C. Spyropoulos, MD, was co-principal investigator for the study.

 One in six patients with AF require anticoagulant treatment and management around the time of surgery. From the time when direct oral anticoagulant (DOAC) for AF became available in 2010 until now, there were no studies done to inform health care professionals about specifics on managing DOAC treatment around the time of surgery. Dr. Spyropoulos, who also serves as system director of Northwell Health’s Anticoagulation and Clinical Thrombosis Services, found that AF patients on a DOAC undergoing surgery showed promising results.

“Dr. Spyropoulos and his co-investigators, with their recent discovery to improve perioperative management of patients living with atrial fibrillation, demonstrate how researchers are advancing our mission to produce knowledge to cure disease,” said Kevin J. Tracey, MD, president and CEO of the Feinstein Institutes.

It is common for patients living with AF – a quivering or irregular heartbeat that can lead to blood clots, stroke, and heart-related complications – to be treated with DOAC, new oral medications such as rivaroxaban or apixaban that have now supplanted warfarin to treat and prevent blood clots. They usually also require surgery.

Direct oral anticoagulant best practices

Researchers attempted to define best practices for management of DOAC around the time of surgery, also called perioperative management, which were previously unknown and could lead to unsubstantiated medical practices along with an increased risk of harm to patients. Some of the unknowns in perioperative management of DOAC were the timing of perioperative DOAC interruption and resumption, if heparin bridging should be given, and if preoperative coagulation function testing was needed.

Dr. Spyropoulos, along with James D. Douketis, MD, of McMaster University, a corresponding author of the JAMA paper, designed and conducted the Perioperative Anticoagulation Use for Surgery Evaluation (PAUSE) study to assess the safety of a simple, standardized perioperative DOAC management strategy. They found that managing patients without heparin bridging or coagulation function testing but simply using pharmacokinetic properties of the DOACs, surgical bleed risk, and a patient’s kidney function, was associated with very low rates of major bleeding and arterial thromboembolism, blood clots that are dislodged from the heart and block arteries.

“After treating atrial fibrillation patients who require surgery with DOACs for nearly 10 years without specific guidance on how to do this well, we now have a scientifically significant study that better informs medical professionals so that patient’s medical outcomes are improved,” said Dr. Spyropoulos, who conducts research at the Feinstein Institutes’s Institute of Health Innovations & Outcomes Research, led by Thomas McGinn, MD. “I am hopeful that our findings, if implemented by the medical community, will successfully minimize the risk of bleeding and clotting complications around the time of surgery for patients living with atrial fibrillation.”

Lower bleed rates for atrial fibrillation patients

PAUSE, a prospective management study, enrolled 3,007 patients with AF who were taking one of three DOACs – apixaban, dabigatran or rivaroxaban – and required anticoagulant interruption for an elective surgery or procedure. The study ultimately aimed to have the shortest duration of DOAC interruption before and after the surgery or procedure so as to minimize the risks for bleeding and thromboembolism. It also specified a simple interruption and resumption protocol for each DOAC based on surgical bleed risk and patient kidney function that would be easy to use by clinicians and easily understood by patients.

Findings show that in patients with AF who were receiving a DOAC (apixaban, dabigatran or rivaroxaban) and required anticoagulant interruption for an elective surgery/procedure, a simple standardized perioperative management strategy that did not require the use of heparin bridging or preoperative coagulation function testing could be used to safely manage patients, and was associated with low rates of perioperative major bleeding (less than 2 percent) and arterial thromboembolism (less than 1 percent). Furthermore, a high proportion of patients (more than 90 percent overall; 98.8 percent of those at high bleeding risk) had a minimal or no residual anticoagulant level at the time of the surgery/procedure