ASJC Scopus subject areas
- Pulmonary and Respiratory Medicine
- Cardiology and Cardiovascular Medicine
Access to Document
Other files and links
PREVENTion of non-surgical bleeding by management of HeartMate II patients without anti-platelet therapy (PREVENT II) trial. / PREVENT II study investigators.In: Journal of Heart and Lung Transplantation, Vol. 39, No. 8, 08.2020, p. 838-840.
Research output: Contribution to journal › Letter › peer-review
TY - JOUR
T1 - PREVENTion of non-surgical bleeding by management of HeartMate II patients without anti-platelet therapy (PREVENT II) trial
AU - PREVENT II study investigators
AU - Jorde, Ulrich P.
AU - Katz, Jason N.
AU - Colombo, Paolo C.
AU - Stulak, John
AU - Saeed, Omar
AU - Egnaczyk, Gregory
AU - Haeusslein, Ernest
AU - McCann, Patrick
AU - Crandall, Daniel
AU - Franke, Abi
AU - Adamson, Robert
N1 - Funding Information: Results from the Study of Reduced Anti-Coagulation/Anti-platelEt Therapy in Patients with the HeartMate II LVAS (Tirapazamine-Radiation and Cisplatin Evaluation [TRACE], NCT01477528), United States experience for example, revealed a stroke rate of 0.07 events per patient-year and device thrombosis rate of 0.08 events per patient-year among patients in whom anti-thrombotic therapies had been reduced in response to bleeding. 4 Similarly, the TRACE study investigators in Europe demonstrated a comparable thrombosis risk using an a priori aspirin (ASA)-free, vitamin K antagonist‒only regimen. 5 PREVENTion of non-surgical bleeding by management of HMII patients without anti-platelet therapy (PREVENT II) (refer to Supplementary Table S1 available online at www.jhltonline.org ) was a prospective, multicenter, randomized, double-blinded, placebo-controlled trial of ASA 81 mg vs placebo daily in subjects ≥50 years of age receiving warfarin after initial implantation of an HMII. PREVENT II (NCT02836652) was sponsored and funded by Abbott. See Supplementary Table S2 online for full inclusion–exclusion criteria. Investigators were asked to implant and manage subjects in accordance with the original PREVENT-recommended practices ( Supplementary Tables S3 and S4 online) aimed at reducing pump thrombosis, with the exception of the use of anti-platelet therapy. 6 The PREVENT-recommended practices have 3 objectives: maximizing flow through the pump, reducing the risk of cannula malpositioning, and ensuring adequate anti-coagulation while on LVAD support, with the overall goal of reducing pump thrombosis events. Participants were placed on the study drug once bleeding had subsided and hemodynamic stability achieved, no later than post-operative Day 15 ( Supplementary Figure S1 online). PREVENT II aimed to enroll up to 350 subjects to demonstrate, with 80% power, the non-inferiority of the primary safety and the superiority of the primary efficacy end-point; one-sided α of 0.025. The primary efficacy end-point was the composite incidence of non-surgical bleeding and primary hemorrhagic stroke at 6 months. The primary safety end-point was the composite incidence of pump thrombosis and thromboembolic stroke at 6 months after initial implantation. Descriptive end-points included hemocompatibility-related adverse events during the 12 months of follow-up. Details of the study end-points and statistical analysis are available in the Supplementary Appendix online. The study was terminated on April 9, 2018, owing to futility of enrollment, given the concurrent Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HM3 trial. Of the 72 subjects enrolled within 48 hours of HMII implant, 65 (31 placebo, 34 ASA) met the criteria for initiation of the study drug. Ischemic heart failure and bleeding history were more prevalent in patients on ASA (detailed demographics can be found in Supplementary Table S5 online). At 6 and 12 months, 47 and 35 subjects, respectively, remained on study drug. Funding Information: Dr Jorde reports other fees from Abbott, outside of the submitted work. Dr Katz reports grants from and consultancy (no Honoraria) at Abbott, outside of the submitted work. Dr Colombo reports research grants from Abbott and consultant (non-financial support) for Abbott, outside of the submitted work. Drs Egnaczyk, McCann, and Adamson report personal fees from Abbott, outside of the submitted work. Dr Saeed is supported by the National Institute of Health (K23HL145140, UL1TR001073). Drs Crandall and Franke are employees of Abbott during the conduct of the study.
PY - 2020/8
Y1 - 2020/8
UR - http://www.scopus.com/inward/record.url?scp=85088640831&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85088640831&partnerID=8YFLogxK
U2 - 10.1016/j.healun.2020.05.003
DO - 10.1016/j.healun.2020.05.003
M3 - Letter
C2 - 32571737
AN - SCOPUS:85088640831
VL - 39
SP - 838
EP - 840
JO - Journal of Heart and Lung Transplantation
JF - Journal of Heart and Lung Transplantation
SN - 1053-2498
IS - 8