SWITCH: Apixaban vs Vitamin K in HM3

Официальное название

The SWITCH Trial: A Randomized Controlled Study of Apixaban Versus Vitamin K Antagonists in Patients With HeartMate 3 Left Ventricular Assist Devices

Обзор

This study is being done to learn the safety and efficacy of a new anticoagulant therapy with apixaban as compared to warfarin to prevent thrombotic events while protecting from bleeding complications in patients with advanced heart failure who are chronically supported by a HeartMate 3 Left Ventricular Assist Device for 3 months.

Подробное описание

Heart failure is a global epidemic, and Left Ventricular Assist Devices (LVADs) - particularly the HeartMate 3 (HM3) - are increasingly used due to their survival benefit over medical therapy. Despite advances, hemocompatibility-related adverse events (HRAEs) like thrombosis and bleeding remain significant causes of morbidity and mortality.

Direct Oral Anticoagulants (DOACs) have shown superiority over warfarin in heart failure patients, with lower rates of embolic and intracranial bleeding. Reduced-dose DOACs also appear to reduce major bleeding without increasing thrombotic risk. However, data on their use in LVAD patients is limited, consisting mainly of case reports, small series, retrospective analyses, and a few small randomized clinical trials.

Some reports suggest apixaban may reduce bleeding in high-risk LVAD patients, though cases of pump thrombosis and stroke have occurred. Early studies comparing DOACs to warfarin in patients with HeartMate II (HMII), HeartWare™ HVAD™ System, and The Abbott HeartMate 3 (HM3) show no significant differences in outcomes, with a trend toward less bleeding with apixaban. Two small randomized clinical trials in HM3 patients (The DOAC LVAD Study and The DOT-HM3 Study) found similar results.

This prospective, randomized, controlled, non-inferiority trial will evaluate the safety and efficacy of apixaban versus vitamin K antagonists in HM3 patients more than 3 months post-implant.

Вмешательства

• Препарат Warfarin
  Warfarin dose titrated for an International Normalized Ratio (INR) \>= 1.8
• Препарат Apixaban
  Apixaban 5 mg bid (twice a day)

Первичные конечные точки

• Survival free of major hemocompatibility related adverse event [Срок оценки: 12 months]

Вторичные конечные точки (7)

• Non-surgical Major Hemorrhagic Events [Срок оценки: 12 months]
• Non-surgical Major Thrombotic Events [Срок оценки: 12 months]
• Survival [Срок оценки: 12 months]
• Stroke Rates [Срок оценки: 12 months]
• Pump Thrombosis Rates [Срок оценки: 12 months]
• Bleeding Rates [Срок оценки: 12 months]
• Rates of listing for Heart Transplant [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Participants will have HeartMate3 LVAD implanted > 3 months before enrollment
• ≥ 18 years old
• Treated with WARFARIN SODIUM
• Participant must provide written informed consent prior to any clinical investigation related procedure
• In female participants of childbearing capability, not currently pregnant and on appropriate contraception

Критерии исключения

• Participation in any other clinical investigation(s) involving a Mechanical Circulatory Support (MCS) device, or interventional investigation(s) likely to confound study results or affect study outcome
• Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results
• Known allergy to Apixaban
• Bridge to transplant
• Severe renal dysfunction Estimated Glomerular Filtration Rate (eGFR) <20
• History of major bleeding event with subsequent reduction of INR goal to < 1.8
• Apixaban dose reduction criteria (Age ≥80 years, weight ≤60 kg, creatinine ≥1.5 mg/dL)
• Aortic root thrombus

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Netuka I, Tucanova Z, Ivak P, Gregor S, Kolesar DM, Marek T, Melenovsky V, Binova J, Dorazilova Z, Hegarova M, Podolec M, Riha H, Connors JM, Mehra MR. A Prospective Randomized Trial of Direct Oral Anticoagulant Therapy With a Fully Magnetically Levitated LVAD: The DOT-HM3 Study. Circulation. 2024 Aug 6;150(6):509-511. doi: 10.1161/CIRCULATIONAHA.124.069726. Epub 2024 Apr 9. No abstract available. PMID 38594972
• Shah P, Looby M, Dimond M, Bagchi P, Shah B, Isseh I, Rollins AT, Abdul-Aziz AA, Kennedy J, Tang DG, Klein KM, Casselman S, Vermeulen C, Sheaffer W, Snipes M, Sinha SS, O'Connor CM. Evaluation of the Hemocompatibility of the Direct Oral Anticoagulant Apixaban in Left Ventricular Assist Devices: The DOAC LVAD Study. JACC Heart Fail. 2024 Sep;12(9):1540-1549. doi: 10.1016/j.jchf.2024.04.013. Epub 20 PMID 38795110

Идентификаторы

NCT: NCT07471139 · AAAV9532

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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