Trial reportJournal of the American Heart Association2020
Myocardial Injury After Balloon Predilatation Versus Direct Transcatheter Aortic Valve Replacement: Insights From the DIRECTAVI Trial.
Trial report in Journal of the American Heart Association, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
9 citing papers in PubMed, 14 citations in OpenAlex.
- Myocardial Injury After Balloon Predilatation Versus Direct Transcatheter Aortic Valve Replacement: Insights From the DIRECTAVI Trial.Journal of the American Heart Association · 2020Trial
- Time- and dose-dependent high-sensitivity cardiac troponin-T to improve outcome prediction after TAVI: a multicenter cohort study.Clinical research in cardiology : official journal of the German Cardiac Society · 2026Article
- Comparison of safety and efficiency of aortic balloon valvuloplasty performed in a free-standing catheterization laboratory and one with cardiac surgery backup.Postepy w kardiologii interwencyjnej = Advances in interventional cardiology · 2025Article
- The impact of myocardial injury on outcomes in TAVI patients.Clinical research in cardiology : official journal of the German Cardiac Society · 2025Article
- Predictors and Prognostic Effects of Perioperative Myocardial Injury After Transcatheter Aortic Valve Replacement According to VARC-3 Criteria.Clinical interventions in aging · 2025Article
- Renin-Angiotensin System Inhibition in Patients With Myocardial Injury Complicating Transcatheter Aortic Valve Replacement.JACC. Advances · 2024Article
- Roles of MDA-LDL/OX-LDL/LOX-1 and TNF-α/TLR4/NF-κB Signaling Pathways in Myocardial Damage by Implantations of Cardiac Pacemakers in Elderly Patients.Current vascular pharmacology · 2024Article
- Severe Aortic Valve Stenosis and Pulmonary Hypertension: A Systematic Review of Non-Invasive Ways of Risk Stratification, Especially in Patients Undergoing Transcatheter Aortic Valve Replacement.Journal of personalized medicine · 2022Review
- Vascular Complications in TAVR: Incidence, Clinical Impact, and Management.Journal of clinical medicine · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 7 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background Myocardial injury is associated with higher mortality after transcatheter aortic valve replacement (TAVR) and might be increased by prior balloon aortic valvuloplasty (BAV). We aimed to evaluate the impact of prior BAV versus direct prosthesis implantation on myocardial injury occurring after (TAVR) with balloon-expandable prostheses. Methods and Results The DIRECTAVI (Direct Transcatheter Aortic Valve Implantation) trial, an open-label randomized study, demonstrated noninferiority of TAVR without BAV (direct TAVR group) compared with systematic BAV (BAV group) with the Edwards SAPIEN 3 valve. High-sensitivity troponin was assessed before and the day after the procedure. Incidence of myocardial injury after the procedure (high-sensitivity troponin elevation >15× the upper reference limit [14 ng/L]) was the main end point. Impact of myocardial injury on 1-month adverse events (all-cause mortality, stroke, major bleeding, major vascular complications, transfusion, acute kidney injury, heart failure, pacemaker implantation, and aortic regurgitation) was evaluated. Preprocedure and postprocedure high-sensitivity troponin levels were available in 211 patients. The mean age of patients was 83 years (78-87 years), with 129 men (61.1%). Mean postprocedure high-sensitivity troponin was 124.9±81.4 ng/L in the direct TAVR group versus 170.4±127.7 ng/L in the BAV group (
Indexed as
Identifiers
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.