Among the nearly 3,000 patients randomized to either rivaroxaban with aspirin or aspirin alone, the absolute risk reduction of any major vascular event was 4.2% at 30 months with the rivaroxaban-aspirin combination, according to the report published in JAMA Cardiology.
"Patients with peripheral artery disease suffer a high risk of future cardiovascular and limb outcomes such as heart attack, stroke, acute limb ischemia, amputation and death," said study coauthor Dr. Sonia Anand, a professor of medicine and epidemiology and a senior scientist at the Population Health Research Institute at McMaster University in Hamilton, Canada.
"You can identify the highest risk PAD patients by their history of prior limb revascularization surgery including amputation, and continuing leg pain at rest OR by the presence of risk factors such as diabetes, heart failure, concomitant CAD, or renal insufficiency," Dr. Anand said in an email. "PAD patients with any of these features benefit significantly with rivaroxaban and aspirin treatment."
Dr. Anand hopes the study will remind physicians to ask about PAD.
"A lot of clinicians tend to forget to inquire about PAD symptoms or history, or do not think of PAD as a high-risk vascular condition," Dr. Anand said. "This study provides an easy way for clinicians to risk stratify their PAD patients and then they can move forward with aggressive medical treatment to lower risk."
The new research is a subanalysis of a previously reported subgroup of patients with symptomatic LE-PAD who were enrolled in a large double-blind placebo-controlled randomized clinical trial, the Cardiovascular Outcomes for People Using Anticoagulation Strategies study (COMPASS), which included 602 centers in 33 countries from March 2013 to January 2020 and was funded and sponsored by Bayer AG.
The COMPASS trial enrolled 4,129 patients with symptomatic LE-PAD, whose average age was 66.8. Among those patients, the 30-month Kaplan-Meier incidence risk of major adverse cardiac events (MACE) or major adverse limb events (MALE), including major amputation was 22.6% in those with prior amputation, 17.6% in those with Fontaine III or IV symptoms, and 11.8% in those with previous peripheral artery revascularization.
The 4,129 patients were randomized to three groups: rivaroxaban, 2.5 mg, twice a day, plus aspirin, 81 mg; rivaroxaban, 5 mg, twice a day; or aspirin, 81 mg, once a day.
The 30-month incidence of MACE or MALE, including major amputation was 14.1% in those with kidney dysfunction, 13.5% in those with heart failure, 13.4% in those with diabetes, and 12.8% in those with polyvascular disease.
Among patients with either high-risk limb presentations or high-risk comorbidities, treatment with rivaroxaban and aspirin compared with aspirin alone was associated with an estimated 4.2% absolute risk reduction for MACE or MALE, including major amputation, at 30 months. Absolute risk reduction was 2.7% for MACE and 2.1% for MALE.
While the increase in absolute risk for major bleeding in those treated with the combination therapy was greater than with aspirin alone, the researchers note, they found that for patients with high-risk limb presentation or high-risk comorbidity, the estimated absolute risk of fatal or critical organ bleeding was low at 0.4% in this group, leading to a net clinical benefit of 3.2%.
"This study is incredibly exciting for those of us who are caregivers of patients (with LE-PAD)," said Dr. Prakash Krishnan, an associate professor of medicine and radiology at the Icahn School of Medicine at Mount Sinai and director of endovascular Interventions at the Mount Sinai Hospital in New York City. "The researchers showed that patients with high risk factors can be treated medically."
The new study found a substantial treatment benefit in patients at high risk, said Dr. John Pacella, an associate professor of medicine and interventional cardiology at the University of Pittsburgh School of Medicine.
"This should open the eyes of clinicians to really consider this additional therapy for those who don't have a high risk of bleeding," Dr. Pacella said. "It really makes a difference for these folks."
By Linda Carroll
SOURCE: https://bit.ly/2EPUNta JAMA Cardiology, online September 30, 2020.
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