ArticleJournal of the American College of Cardiology2018
Anticoagulation and Antiplatelet Strategies After On-X Mechanical Aortic Valve Replacement.
Article in Journal of the American College of Cardiology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 37 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT)
A Prospective, Randomized, Active (Warfarin) Controlled, Parallel-arm Clinical Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely and Effectively on Apixaban
Who cites it
37 citing papers in PubMed, 1 synthesis or guideline pooled it, 134 citations in OpenAlex.
- Antithrombotic Treatment After Surgical and Transcatheter Heart Valve Repair and Replacement.Frontiers in cardiovascular medicine · 2021Pooled it
- Effect of Music Therapy on the Chronic Pain and Midterm Quality of Life of Patients after Mechanical Valve Replacement.Annals of thoracic and cardiovascular surgery : official journal of the Association of Thoracic and Cardiovascular Surgeons of Asia · 2020Trial
- Strain Energy Minimization Technique to Design a Surgical Heart Valve Using a Novel Polymer.Annals of biomedical engineering · 2026Article
- Risks of bleedingThe British journal of cardiology · 2026Article
- Safety of parenteral anticoagulation as a bridge to warfarin in patients undergoing mechanical aortic valve replacement.JTCVS open · 2025Article
- Article
- Chronic kidney disease and valvular heart disease: State of the art.Physiological reports · 2025Review
- Major Bleeding and Thromboembolic Events with the On-X Mechanical Aortic Valve Prosthesis: A SWEDEHEART Study.Interdisciplinary cardiovascular and thoracic surgery · 2025Article
- Management of patients with congenital bleeding disorders and cardiac indications for antithrombotic therapy.European heart journal. Cardiovascular pharmacotherapy · 2025Review
- The Ross Operation in Young Patients—A Single-Center, Long-Term Follow-Up Study.Deutsches Arzteblatt international · 2024Article
- Decellularized aortic homografts versus mechanical composite grafts for aortic root replacement.European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery · 2024Article
- Mechanical Aortic Valve Thrombosis During Anticoagulation Using Oral Rivaroxaban: A Case Report.Cureus · 2024Article
- Mechanical Valves: Past, Present, and Future-A Review.Journal of clinical medicine · 2024Review
- Twenty-year experience following aortic valve replacement in patients younger than 60 years of age.Journal of cardiothoracic surgery · 2024Article
- On-X aortic valve replacement patients treated with low-dose warfarin and low-dose aspirin.European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery · 2024Observational
- Modern Treatment of Valvulopathies in Patients with Congenital Hemophilia.Life (Basel, Switzerland) · 2024Review
- Pregnancy outcomes in women with a mitral valve prosthesis: A systematic review and meta-analysis.JTCVS open · 2023Article
- Grafts and Patches: Optimized but Not Optimal Materials for Congenital Heart Surgery.Pediatric cardiology · 2023Review
- Aortic Root Surgery in Adults: An Unsolved Problem.Aorta (Stamford, Conn.) · 2023Article
- Evolving technology: the TRIFLO tri-leaflet mechanical valve without oral anticoagulation: a potential major innovation in valve surgery.Frontiers in cardiovascular medicine · 2023Review
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Authors and funding
30 authors at 20 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe burden oral anticoagulation is a limitation of mechanical valve prostheses.
objectivesThe aim of this study was to test whether patients could be safely managed with dual-antiplatelet therapy (DAPT) (aspirin 325 mg and clopidogrel 75 mg) or lower warfarin after On-X mechanical aortic valve replacement (mAVR).
methodsPROACT (Prospective Randomized On-X Anticoagulation Trial) (n = 576) is a multicenter (41 sites) noninferiority trial. From June 2006 through February 2014, 201 patients ≥18 years of age without thromboembolic risk factors undergoing mAVR were randomized to receive DAPT (n = 99) or standard warfarin plus aspirin (n = 102) 3 months after mAVR (low-risk arm). From June 2006 through October 2009, 375 patients with 1 or more thromboembolic risk factors were also randomized to lower intensity warfarin plus aspirin (international normalized ratio 1.5 to 2.0; n = 185) or standard warfarin plus aspirin (international normalized ratio 2.0 to 3.0; n = 190) 3 months after mAVR (high-risk arm).
resultsThe low-risk arm was terminated for excess cerebral thromboembolic events (3.12% per patient-year vs. 0.29% per patient-year, p = 0.02) in the DAPT group at up to 8.8-year follow-up (631.6 patient-years), with no differences in bleeding or all-cause mortality. High-risk arm patients experienced significantly lower major (1.59% per patient-year vs. 3.94% per patient-year, p = 0.002) and minor (1.27% per patient-year vs. 3.49% per patient-year, p = 0.002) bleeding up to 8.7-year follow-up (2,035.2 patient-years), with no differences in thromboembolism (0.42% per patient-year vs. 0.09% per patient-year, p = 0.20) and all-cause mortality.
conclusionsDAPT was associated with higher rates of thromboembolism and valve thrombosis compared with control in the low-risk arm. International normalized ratios were safely maintained at 1.5 to 2.0 in high-risk patients, without differences in mortality or thromboembolic complications. (Randomized On-X Anticoagulation Trial [PROACT]; NCT00291525).
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.