ArticleBMJ (Clinical research ed.)2025
Stepwise dual antiplatelet therapy de-escalation in patients after drug coated balloon angioplasty (REC-CAGEFREE II): multicentre, randomised, open label, assessor blind, non-inferiority trial.
Article in BMJ (Clinical research ed.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 16 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.
Aspirin Plus Ticagrelor for 1 Month Followed by 5 Months Ticagrelor Monotherapy Versus Aspirin Plus Ticagrelor for 12 Months in Acute Coronary Syndrome Patients With Drug-coated Balloon: a Multicentre, Randomized, Non-inferiority Trial
An Investigator-initiated, Multicenter, Open-label, Randomized Controlled Non-inferiority Trial to Assess the Single vs. Dual Antiplatelet Therapy in the Chronic Coronary Syndrome (CCS) and Stable Acute Coronary Syndrome (S-ACS) Patients Undergoing Percutaneous Intervention With Drug-coated Balloons (DCB)-Only Strategy (KONG-FREEDOM-I)
Who cites it
16 citing papers in PubMed.
- Drug-Coated Balloons Versus Drug-Eluting Stents for Patients With Long De Novo Coronary Artery Lesions: Insights From the REC-CAGEFREE I Trial.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2026Trial
- Abbreviated dual antiplatelet therapy after percutaneous coronary intervention with drug coated balloons in acute coronary syndromes: insights from the SWEDEHEART registry.European heart journal. Cardiovascular pharmacotherapy · 2026Observational
- Evaluation of Graphene as a Novel Bioactive Stent Coating: Comparative Performance and Vascular Response in Porcine Coronary Arteries.Journal of functional biomaterials · 2026Article
- Drug-coated balloon angioplasty in coronary artery disease: state of the art review.NPJ cardiovascular health · 2026Review
- Clinical outcomes of drug-coated balloonsCardiovascular diagnosis and therapy · 2026Article
- CVIT expert consensus document on primary percutaneous coronary intervention (PCI) for acute coronary syndromes (ACS) in 2026.Cardiovascular intervention and therapeutics · 2026Article
- Drug-coated balloons in complex large-vessel coronary artery disease: a comprehensive review of current evidence and future perspectives.Frontiers in cardiovascular medicine · 2026Review
- When means and standard deviations are an incomplete summary of a continuous variable: problems, solutions, and utilising the reference ranges to check normality.BMJ medicine · 2026Article
- Contemporary Percutaneous Coronary Intervention in Diabetic Patients.Reviews in cardiovascular medicine · 2025Review
- Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9): The Multifaceted Biology, Diseases, and Pharmaceutical Interventions.MedComm · 2025Review
- Mid-term outcomes of paclitaxel-coated balloon for de novo non-small coronary lesions: a pooled analysis.BMC medicine · 2025Observational
- Blended Coronary Revascularization with Drug-Coated Balloon and Drug-Eluting Stent: A Narrative Review on Rationale, Clinical Evidence, and Future Perspectives.Journal of clinical medicine · 2025Review
- Consensus Statement on Drug-Coated Balloons in Coronary Artery Disease from the Cardiovascular Intervention Association of Thailand.Journal of clinical medicine · 2025Review
- Drug-Coated Balloons Versus Drug-Eluting Stents for Large Vessel Coronary Artery Disease: A Meta-Analysis.Journal of cardiovascular development and disease · 2025Review
- Antiplatelet Monotherapies for Long-Term Secondary Prevention Following Percutaneous Coronary Intervention.Journal of clinical medicine · 2025Review
- Advances in Clinical Cardiology 2024: A Summary of Key Clinical Trials.Advances in therapy · 2025Review
Corrections and comments
- Erratum issued
Authors and funding
30 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo investigate whether a less intense antiplatelet regimen could be used for people receiving drug coated balloons.
designMulticentre, randomised, open label, assessor blind, non-inferiority trial (REC-CAGEFREE II).
setting41 hospitals in China between 27 November 2021 and 21 January 2023.
participants1948 adults (18-80 years) with acute coronary syndrome who received treatment exclusively with paclitaxel-coated balloons according to the international drug coated balloon consensus.
interventionsParticipants were randomly assigned (1:1) to either the stepwise dual antiplatelet therapy (DAPT) de-escalation group (n=975) consisting of aspirin plus ticagrelor for one month, followed by five months of ticagrelor monotherapy, and then six months of aspirin monotherapy, or to the standard DAPT group (n=973) consisting of aspirin plus ticagrelor for 12 months.
main outcome measuresThe primary endpoint was net adverse clinical events (all cause death, stroke, myocardial infarction, revascularisation, and Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding) at 12 months in the intention-to-treat population. Non-inferiority was established if the upper limit of the one sided 95% confidence interval (CI) for the absolute risk difference was smaller than 3.2%.
resultsThe mean age of participants was 59.2 years, 74.9% were men, 30.5% had diabetes, and 20.6% were at high bleeding risk. 60.9% of treated lesions were in small vessels, and 17.8% were in-stent restenosis. The mean drug coated balloon diameter was 2.72 mm (standard deviation 0.49). At 12 months, the primary endpoint occurred in 87 (8.9%) participants in the stepwise de-escalation group and 84 (8.6%) in the standard group (difference 0.36%; upper boundary of the one sided 95% CI 2.47%; P
conclusionsAmong participants with acute coronary syndrome who could be treated by drug coated balloons exclusively, a stepwise DAPT de-escalation was non-inferior to 12 month DAPT for net adverse clinical events.
trial registrationClinicaltrials.gov NCT04971356.
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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 Socratic graph.