MARC details
000 -LEADER |
fixed length control field |
05208nam a22006737a 4500 |
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
fixed length control field |
2401116s20232023 xxu||||| |||| 00| 0 eng d |
022 ## - INTERNATIONAL STANDARD SERIAL NUMBER |
International Standard Serial Number |
0098-7484 |
024 ## - OTHER STANDARD IDENTIFIER |
Standard number or code |
10.1001/jama.2023.23204 [doi] |
024 ## - OTHER STANDARD IDENTIFIER |
Standard number or code |
2811936 [pii] |
024 ## - OTHER STANDARD IDENTIFIER |
Standard number or code |
PMC10640705 [pmc] |
040 ## - CATALOGING SOURCE |
Original cataloging agency |
Ovid MEDLINE(R) |
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC) |
PMID |
37950897 |
245 ## - TITLE STATEMENT |
Title |
Aspirin and Hemocompatibility Events With a Left Ventricular Assist Device in Advanced Heart Failure: The ARIES-HM3 Randomized Clinical Trial. |
251 ## - Source |
Source |
JAMA. 330(22):2171-2181, 2023 12 12. |
252 ## - Abbreviated Source |
Abbreviated source |
JAMA. 330(22):2171-2181, 2023 12 12. |
253 ## - Journal Name |
Journal name |
JAMA |
260 ## - PUBLICATION, DISTRIBUTION, ETC. |
Year |
2023 |
260 ## - PUBLICATION, DISTRIBUTION, ETC. |
Manufacturer |
FY2024 |
260 ## - PUBLICATION, DISTRIBUTION, ETC. |
Publication date |
2023 12 12 |
265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE] |
Publication status |
ppublish |
265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE] |
Medline status |
PubMed-not-MEDLINE |
266 ## - Date added to catalog |
Date added to catalog |
2024-01-16 |
520 ## - SUMMARY, ETC. |
Abstract |
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. |
520 ## - SUMMARY, ETC. |
Abstract |
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. |
520 ## - SUMMARY, ETC. |
Abstract |
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. |
520 ## - SUMMARY, ETC. |
Abstract |
Intervention: Patients were randomized in a 1:1 ratio to receive aspirin (100 mg/d) or placebo in addition to an antithrombotic regimen. |
520 ## - SUMMARY, ETC. |
Abstract |
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. |
520 ## - SUMMARY, ETC. |
Abstract |
OBJECTIVE: To determine whether excluding aspirin as part of the antithrombotic regimen with a fully magnetically levitated LVAD is safe and decreases bleeding. |
520 ## - SUMMARY, ETC. |
Abstract |
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. |
520 ## - SUMMARY, ETC. |
Abstract |
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04069156. |
546 ## - LANGUAGE NOTE |
Language note |
English |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
*Heart Failure |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
*Heart-Assist Devices |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
*Stroke |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
*Thromboembolism |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Aspirin/ae [Adverse Effects] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Double-Blind Method |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Female |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Fibrinolytic Agents/ae [Adverse Effects] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Heart Failure/pp [Physiopathology] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Heart-Assist Devices/ae [Adverse Effects] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Hemorrhage/et [Etiology] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Humans |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Male |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Platelet Aggregation Inhibitors/ae [Adverse Effects] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Stroke/dt [Drug Therapy] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Stroke/et [Etiology] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Stroke/pc [Prevention & Control] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Thromboembolism/et [Etiology] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Thromboembolism/pc [Prevention & Control] |
651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME |
Institution |
MedStar Heart & Vascular Institute |
657 ## - INDEX TERM--FUNCTION |
Medline publication type |
Comment |
657 ## - INDEX TERM--FUNCTION |
Medline publication type |
Journal Article |
657 ## - INDEX TERM--FUNCTION |
Medline publication type |
Research Support, Non-U.S. Gov't |
700 ## - ADDED ENTRY--PERSONAL NAME |
Local Authors |
Sheikh, Farooq H |
Institution Code |
MHVI |
790 ## - Authors |
All authors |
Mehra MR, Netuka I, Uriel N, Katz JN, Pagani FD, Jorde UP, Gustafsson F, Connors JM, Ivak P, Cowger J, Ransom J, Bansal A, Takeda K, Agarwal R, Byku M, Givertz MM, Bitar A, Hall S, Zimpfer D, Vega JD, Kanwar MK, Saeed O, Goldstein DJ, Cogswell R, Sheikh FH, Danter M, Pya Y, Phancao A, Henderson J, Crandall DL, Sundareswaran K, Soltesz E, Estep JD |
856 ## - ELECTRONIC LOCATION AND ACCESS |
DOI |
<a href="https://dx.doi.org/10.1001/jama.2023.23204">https://dx.doi.org/10.1001/jama.2023.23204</a> |
942 ## - ADDED ENTRY ELEMENTS (KOHA) |
Koha item type |
Journal Article |
Item type description |
Article |