ArticleBMC cardiovascular disorders2024
Randomized evaluation of 5-month Ticagrelor monotherapy after 1-month dual-antiplatelet therapy in patients with acute coronary syndrome treated with drug-coated balloons: REC-CAGEFREE II trial rationale and design.
Article in BMC cardiovascular disorders, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04971356 (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), which is not on this map. Cited by 6 papers.
What it found
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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
Who cites it
6 citing papers in PubMed, 8 citations in OpenAlex.
- 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
- Beyond the Stent ("Leave-Nothing-Behind") Drug-Coated Balloons in Acute Coronary Syndrome: A Narrative Review.Journal of clinical medicine · 2026Review
- 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.BMJ (Clinical research ed.) · 2025Article
- Drug-coated balloons in percutaneous coronary interventions: existing evidence and emerging hopes.Cardiology journal · 2025Review
- Contemporary Use of Drug-Coated Balloons for Coronary Angioplasty: A Comprehensive Review.Journal of clinical medicine · 2024Review
- Current Management of In-Stent Restenosis.Journal of clinical medicine · 2024Review
Corrections and comments
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Authors and funding
16 authors at 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPatients treated with drug-coated balloons (DCB) have the theoretical advantage of adopting a low-intensity antiplatelet regimen due to the absence of struts and polymers. Nevertheless, the optimal antiplatelet strategy for patients undergoing DCB-only treatment remains a topic of debate and has not been investigated in randomized trials.
methodsThe REC-CAGEFREE II is an investigator-initiated, prospective, open-label, multi-center, randomized, non-inferiority trial aimed to enroll 1908 patients from ≥ 40 interventional cardiology centers in China to evaluate the non-inferiority of an antiplatelet regimen consisting of Aspirin plus Ticagrelor for one month, followed by five months Ticagrelor monotherapy, and then Aspirin monotherapy for six months (Experimental group) compared to the conventional treatment of Aspirin plus Ticagrelor for 12 months (Reference group) in patients with acute coronary syndrome (ACS) who have undergone percutaneous coronary intervention (PCI) using paclitaxel-coated balloons (DCB) exclusively. Participants will be randomly assigned to the Experimental or Reference group in a 1:1 ratio. The randomization will be stratified based on the center and the type of lesion being treated (De novo or in-stent restenosis). The primary endpoint is net adverse clinical events (NACE) within 12 months of PCI, which includes the composite of all-cause death, any stroke, any myocardial infarction, any revascularization and Bleeding Academic Research Consortium (BARC) defined type 3 or 5 bleeding. The secondary endpoint, any ischemic and bleeding event, which includes all-cause death, any stroke, MI, BARC-defined type 3 bleeding, any revascularization, and BARC-defined type 2 bleeding events, will be treated as having hierarchical clinical importance in the above order and analyzed using the win ratio method. DISCUSSION: The ongoing REC-CAGEFREE II trial aims to assess the efficacy and safety of a low-intensity antiplatelet approach among ACS patients with DCB. If non-inferiority is shown, the novel antiplatelet approach could provide an alternative treatment for ACS patients with DCB.
trial registrationClinicalTrials.gov identifier: NCT04971356.
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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.