IMPORTANCE: Left ventricular assist devices (LVADs) enhance quality and duration of life in advanced heart failure. The burden of nonsurgical bleeding events is a leading morbidity. Aspirin as an antiplatelet agent is mandated along with vitamin K antagonists (VKAs) with continuous-flow LVADs without conclusive evidence of efficacy and safety. OBJECTIVE: To determine whether excluding aspirin as part of the antithrombotic regimen with a fully magnetically levitated LVAD is safe and decreases bleeding. DESIGN, SETTING, AND PARTICIPANTS: This international, randomized, double-blind, placebo-controlled study of aspirin (100 mg/d) vs placebo with VKA therapy in patients with advanced heart failure with an LVAD was conducted across 51 centers with expertise in treating patients with advanced heart failure across 9 countries. The randomized population included 628 patients with advanced heart failure implanted with a fully magnetically levitated LVAD (314 in the placebo group and 314 in the aspirin group), of whom 296 patients in the placebo group and 293 in the aspirin group were in the primary analysis population, which informed the primary end point analysis. The study enrolled patients from July 2020 to September 2022; median follow-up was 14 months. INTERVENTION: Patients were randomized in a 1:1 ratio to receive aspirin (100 mg/d) or placebo in addition to an antithrombotic regimen. MAIN OUTCOMES AND MEASURES: The composite primary end point, assessed for noninferiority (-10% margin) of placebo, was survival free of a major nonsurgical (>14 days after implant) hemocompatibility-related adverse events (including stroke, pump thrombosis, major bleeding, or arterial peripheral thromboembolism) at 12 months. The principal secondary end point was nonsurgical bleeding events. RESULTS: Of the 589 analyzed patients, 77% were men; one-third were Black and 61% were White. More patients were alive and free of hemocompatibility events at 12 months in the placebo group (74%) vs those taking aspirin (68%). Noninferiority of placebo was demonstrated (absolute between-group difference, 6.0% improvement in event-free survival with placebo [lower 1-sided 97.5% CI, -1.6%]; P < .001). Aspirin avoidance was associated with reduced nonsurgical bleeding events (relative risk, 0.66 [95% confidence limit, 0.51-0.85]; P = .002) with no increase in stroke or other thromboembolic events, a finding consistent among diverse subgroups of patient characteristics. CONCLUSIONS AND RELEVANCE: In patients with advanced heart failure treated with a fully magnetically levitated LVAD, avoidance of aspirin as part of an antithrombotic regimen, which includes VKA, is not inferior to a regimen containing aspirin, does not increase thromboembolism risk, and is associated with a reduction in bleeding events. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04069156.
- MeSH
- Aspirin škodlivé účinky MeSH
- cévní mozková příhoda * etiologie prevence a kontrola farmakoterapie MeSH
- dvojitá slepá metoda MeSH
- fibrinolytika škodlivé účinky MeSH
- inhibitory agregace trombocytů škodlivé účinky MeSH
- krvácení etiologie MeSH
- lidé MeSH
- podpůrné srdeční systémy * škodlivé účinky MeSH
- srdeční selhání * patofyziologie MeSH
- tromboembolie * etiologie prevence a kontrola MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- komentáře MeSH
- práce podpořená grantem MeSH
- Názvy látek
- Aspirin MeSH
- fibrinolytika MeSH
- inhibitory agregace trombocytů MeSH
- MeSH
- lidé MeSH
- podpůrné srdeční systémy * MeSH
- srdce MeSH
- srdeční selhání * chirurgie MeSH
- transplantace plic * MeSH
- transplantace srdce * MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- směrnice pro lékařskou praxi MeSH
As the prevalence of advanced heart failure continues to rise, treatment strategies for select patients include heart transplantation or durable left ventricular assist device (LVAD) support, both of which improve quality of life and extend survival. Recently, the HeartMate 3 has been incorporated into clinical practice, the United Network for Organ Sharing donor heart allocation system was revised, and the management of LVAD-related complications has evolved. Contemporary LVAD recipients have greater preoperative illness severity, but survival is higher and adverse event rates are lower compared with prior eras. This is driven by advances in device design, patient selection, surgical techniques, and long-term management. However, bleeding, infection, neurologic events, and right ventricular failure continue to limit broader implementation of LVAD support. Ongoing efforts to optimize management of patients implanted with current devices and parallel development of next-generation devices are likely to further improve outcomes for patients with advanced heart failure.
- Klíčová slova
- advanced heart failure, hemocompatibility-related adverse events, left ventricular assist device, mechanical circulatory support,
- MeSH
- dárci tkání MeSH
- kvalita života MeSH
- lidé MeSH
- podpůrné srdeční systémy * škodlivé účinky MeSH
- srdeční selhání * MeSH
- transplantace srdce * škodlivé účinky MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
- Research Support, N.I.H., Extramural MeSH
