BEST-CLI, BEST-CLI QOL, PREVENT-HD, IMPROVE: Prevention of Limb Loss Through Vascular Interventions and Venous Therapies

Preventing limb loss through vascular interventions and venous therapies were the focus of the BEST-CLI, BEST-CLI QOL, PREVENT-HD and the IMPROVE trials presented Nov. 7 during AHA 2022 in Chicago.

In BEST-CLI, researchers compared the clinical, safety, quality of life and cost outcomes in more than 1,800 patients with chronic limb-threatening ischemia (CLTI) and infrainguinal peripheral artery disease (PAD) in two parallel-cohort trials. Patients with a single segment of great saphenous vein that could be used for surgery were assigned to cohort 1 (n=1,434), while patients who needed an alternative bypass conduit were assigned to cohort 2 (n=396). Once assigned to cohorts, those in cohort 1 were randomly assigned by their treatment team to undergo either bypass surgery or an endovascular procedure. Those in cohort 2 were randomly assigned to undergo either bypass surgery using an arm vein or artificial blood vessel or an endovascular procedure. The primary outcome was a composite of a major adverse limb event or death from any cause.

Overall results, which were also published in the New England Journal of Medicine, found that patients in cohort 1 assigned to bypass surgery had a significantly lower incidence of a major adverse limb event or death compared with those assigned to the endovascular procedure. Among patients in cohort 2, the outcomes between the surgery and endovascular subgroups were similar.

"The results we found within [cohort 1] are interesting in that there were significantly fewer amputations and major reoperations performed in the people who had bypass surgery, and there was no difference between the treatment groups in the number of patient deaths," said Alik Farber, MD, MBA. "This information debunks the idea that CLTI patients who need revascularization should have an endovascular procedure first due to concern that bypass surgery may be potentially more dangerous. In this group of people, who were at acceptable risk for surgery and had a good vein available, we determined that surgical bypass led to better outcomes."

BEST-QOL findings complemented the BEST-CLI clinical findings. Researchers surveyed participants at the beginning of the BEST-CLI study and at six follow-up visits over a median of four years, asking about pain, daily living activities, disease symptoms and severity, physical activity level and mental health. Overall results found that quality-of-life scores were low at the beginning of the study and pain levels were high, but pain scores decreased substantially and quality-of-life scores increased for all participants across all measures used for assessment post-surgery or procedure, driven in part by decreased leg pain.

"We anticipated low levels of quality of life at the beginning of the study," said Menard. "Improvement in health-related quality-of-life measures regardless of the type of procedure is very encouraging and highlights the importance of timely restoration of blood flow to the leg and foot."

In PREVENT-HD, early initiation of rivaroxaban, prescribed for 35 days in non-hospitalized patients with symptomatic COVID-19 at-risk for thrombosis, was not found to reduce a composite endpoint of venous and arterial thrombotic events, hospitalization, and death. However, in presenting the findings, Gregory Piazza, MD, MS, FACC, said a significant reduction in venous and arterial thrombotic events was observed. He also noted that bleeding overall was low and generally consistent with the known safety profile of rivaroxaban.

"With the caveat that the trial was underpowered to provide a definitive conclusion, these data do not support routine antithrombotic prophylaxis in non-hospitalized patients with symptomatic COVID-19," he said.

In IMPROVE, researchers said their findings are the first to show that a universal electronic health record (EHR)-integrated clinical decision-support tool using a validated venous thromboembolism (VTE) risk model (IMPROVE-DD) significantly increased rates of in-hospital appropriate thromboprophylaxis and significantly reduced major thromboembolic events without an increase in major bleeding at 30 days post-discharge compared with usual medical care.

Specifically, an approximate 50% increase was observed in appropriate thromboprophylaxis (72.5% vs. 80.1%) and researchers noted a roughly two-fold increase in appropriate at-discharge extended thromboprophylaxis (7.5% vs. 13.6%). There was also a 20% reduction in VTE, 65% reduction in arterial thromboembolism (ATE), and 29% reduction in total thromboembolic events (VTE + ATE: 4.0% vs. 2.9%)

"The relatively high baseline rate of appropriate in-hospital and at discharge thromboprophylaxis in academic control hospitals suggests potential for greater benefit in nonacademic/community/rural hospitals," said Alex C. Spyropoulos, MD, FACC, in presenting the findings.

Clinical Topics: Anticoagulation Management, Vascular Medicine, Atherosclerotic Disease (CAD/PAD)

Keywords: AHA Annual Scientific Sessions, AHA22, Peripheral Arterial Disease, Ischemia, Enoxaparin, Factor Xa Inhibitors, Rivaroxaban

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