BAT-VTE

Best Antithrombotic Therapy in patients with acute Venous ThromboEmbolism while taking antiplatelets: the BAT-VTE randomised-controlled trial

Cardiovascular diseases are the leading cause of death and disability in Europe. Among them, venous thromboembolism (VTE) and atherosclerotic cardiovascular disease (ACVD) frequently coexist, requiring treatments with potentially conflicting effects. Anticoagulants (AC) are essential for managing the acute phase and preventing VTE recurrence, while antiplatelets (AP) reduce the risk of major adverse cardiovascular and cerebrovascular events in ACVD patients. However, combining AC and AP significantly heightens bleeding risk, making anticoagulant-related bleeding the leading cause of emergency admissions for adverse drug reactions.

Up to one in three patients treated for VTE receive concomitant AP therapy, yet evidence remains conflicting: some studies suggest a threefold bleeding risk increase, while others report improved cardiovascular protection. These discrepancies likely reflect confounding factors such as AP type, indication, or duration— leaving clinicians uncertain about the optimal benefit-risk balance in VTE patients with ACVD and leading to inconsistent practices.

Because VTE treatment protocols differ from those for atrial fibrillation—requiring DOAC loading followed by full-dose for at least six months—existing ESC guidelines cannot be extrapolated. Clinicians are thus left choosing between two strategies: continuing combined AC+AP therapy or switching to AC monotherapy. 

Given the lack of dedicated studies, a randomised trial is urgently needed to address this common clinical scenario. A de-escalation strategy appears feasible and of particular interest in patients with low arterial risk, and particularly in patients at high bleeding risk. We propose a randomized trial testing whether full-dose AC monotherapy reduces bleeding and improves net clinical benefit—defined as a composite outcome including clinically relevant bleeding, recurrent VTE, and major ischemic cardiovascular and cerebrovascular events—compared to combined AC+AP.

Population: Adult | Intervention type: Interventional