Implantable Left Ventricular Assist Devices
Patients with left ventricular assist devices rely on lifelong anticoagulation to prevent pump thrombosis and stroke, yet bleeding complications remain common and often severe. Safer, more stable therapies are needed to improve outcomes and quality of life.
Implantable LVAD therapy is used to improve quality of life, alleviate symptoms, and extend survival rates in patients with advanced heart failure, irrespective of eligibility for cardiac transplant. Patients with LVADs require life-long chronic anticoagulation to reduce the risk of pump thrombosis and thromboembolic complications; however despite a very low incidence of thrombotic events they still commonly experience bleeding complications.
There are approximately 15,000 patients in the U.S. with LVADs, with about 4,000 new LVADs implanted annually. These patients all require life-long chronic anticoagulation to reduce the risk of pump thrombosis and thromboembolic complications, but anticoagulation management in LVAD patients remains a challenge.
The Problem
A Narrow Therapeutic Window with Too Much at Stake
VKAs are the accepted standard in general practice, but are used off-label. A great deal of attention is directed at keeping LVAD patients within the target INR range, given the very high thrombotic risk in these patients and the narrow therapeutic range. Recent randomized controlled trials in LVAD patients have shown that warfarin can also be associated with relatively poor-quality anticoagulation as reflected by the time in therapeutic range (TTR), despite efforts to manage anticoagulation tightly in clinical trials. Patients and their clinicians face the daily challenge of balancing the need for adequate anticoagulation with the bleeding risks associated with excessive anticoagulation. Warfarin, despite all its limitations, is the only available oral anticoagulant for all currently available LVADs.
There is a need for a new, superior and safer VKA anticoagulant for LVAD patients that improves outcomes and relieves patients and their healthcare providers from some of warfarin’s most significant challenges. Recent data in LVAD patients have highlighted the need for a next-generation VKA anticoagulant. An analysis of the ARIES-HM3 study, a carefully controlled and monitored study sponsored by Abbott to evaluate the need for chronic aspirin treatment in LVAD patients, showed that the average TTR was only 56% with warfarin, far below the benchmark for well-controlled anticoagulation of 70%.
Our Solution
Tecarfarin: Redefining VKA Therapy with a Distinct Metabolic Pathway
Our new vitamin K antagonist anticoagulant, tecarfarin, is designed to overcome the challenges of warfarin, including its prevalent serious side effects and cumbersome dosing, and provide superior and safer anticoagulation. Tecarfarin is metabolized via a different pathway than warfarin, and data show that its efficacy is unaffected by common drug-drug interactions or kidney impairment, which are common in these patients.
Direct oral anticoagulants (DOACs) are not recommended for patients with implanted cardiac devices, leaving tecarfarin the only new anticoagulant being studied for these underserved patients. Phase 2/3 clinical trials show that tecarfarin, compared to warfarin, may offer superior stability and time in therapeutic range that inversely correlates with major events.
In 2024, tecarfarin was granted ODD by the FDA for the prevention of thrombosis and thromboembolism (blood clots) in patients with an implanted mechanical circulatory support device, including left ventricular assist devices.