Cadrenal Therapeutics highlighted a key opinion leader presentation at the European Association for Cardio-thoracic Surgery (EACTS) Mechanical Circulatory Support Summit, featuring tecarfarin data and the company's proposed clinical trial protocol for patients with the Abbott HeartMate3 (HM3) left ventricular assist device (LVAD). The presentation, titled Tec arfarin and H emocompatibility with LVAD Therapy (TECH-LVAD), outlined Cadrenal's clinical trial protocol recently submitted to the U.S. Food and Drug Administration (FDA).
TECH-LVAD Trial Design and Rationale
The TECH-LVAD trial, presented by Dr. Mandeep R. Mehra, aims to study tecarfarin as a new vitamin K antagonist (VKA) option to reduce bleeding events associated with HM3 LVAD use in advanced heart failure patients. Dr. Mehra emphasized the inverse relationship between bleeding rates and TTR in HM3 patients, highlighting data suggesting tecarfarin's potential to improve TTR compared to warfarin.
Tecarfarin's Potential Benefits in LVAD Patients
One of the critical differentiators for tecarfarin is its consistent exposure in patients with end-stage kidney disease (ESKD), a common comorbidity among LVAD recipients. Data from prior trials indicate that ESKD does not alter tecarfarin exposure, whereas warfarin exposure is increased in these patients. This pharmacokinetic advantage could lead to more stable anticoagulation and reduced bleeding risk in LVAD patients with renal impairment.
Expert Commentary
Dr. Mehra, who also chaired Abbott's ARIES-HM3 study, stated, "In the proposed TECH-LVAD trial, we plan to study a much-needed VKA option with the expectation of reducing bleeding events that accompany use of the HM3 LVAD in advanced heart failure. Tecarfarin could potentially be an important therapy for patients with LVADs who all require chronic anticoagulation."
Cadrenal's Perspective
Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics, noted, "As our team progresses discussions with the FDA and Abbott about a tecarfarin study in LVAD patients, increasing tecarfarin data visibility will help us to continue accelerating our development as we plan for investigator outreach and patient recruitment for our tecarfarin trial."
About Tecarfarin
Tecarfarin is a novel vitamin K antagonist (VKA) being developed by Cadrenal Therapeutics as a safer, more effective chronic anticoagulation option for patients with implanted cardiac devices or rare cardiovascular conditions. The company anticipates that tecarfarin will result in fewer adverse events compared to warfarin, particularly in patients for whom direct oral anticoagulants (DOACs) are not recommended. Tecarfarin has received orphan drug designation for advanced heart failure patients with LVADs and for ESKD patients with atrial fibrillation.
