{
  "abstract": "BACKGROUNDThe optimal antiplatelet regimen in patients with acute coronary syndrome (ACS) and multivessel disease undergoing drug-coated balloon (DCB) angioplasty remains unclear.\n\nMETHODSThis was a prespecified subgroup analysis of the REC-CAGEFREE II trial, which was conducted at 41 sites in China and randomized 1948 exclusively DCB-treated participants with ACS to stepwise dual antiplatelet therapy (DAPT) de-escalation or standard DAPT. The primary endpoint was net adverse clinical events (NACE; including all-cause death, stroke, myocardial infarction, revascularization, and BARC type 3 or 5 bleeding) at 12 months. Participants were stratified into multivessel and single-vessel subgroups according to angiographic characteristics.\n\nRESULTSOverall, 720/1948 (37.0%) patients had multivessel disease. The multivessel subgroup was associated with a significantly higher risk of NACE compared with the single-vessel subgroup (12.5% versus 6.7%, HRIPTW:1.84, 95%CI:1.35-2.51, P<0.001). No significant interaction was observed between vessel status (multivessel or single-vessel) and treatment allocation with respect to NACE (Pinteraction=0.542). In the multivessel subgroup, NACE occurred in 44/368 (12.1%) and 45/352 (12.9%) in the stepwise de-escalation and standard DAPT groups (HRIPTW:0.95, 95%CI:0.62-1.75, P=0.818), respectively. In the single-vessel subgroup, NACE occurred in 43/607 (7.1%) and 39/621 (6.3%) in the stepwise de-escalation and standard groups (HRIPTW:1.12, 95%CI:0.72-1.70, P=0.611), respectively. For the prespecified hierarchical secondary endpoint, win ratio analyses yielded more wins for stepwise de-escalation in both subgroups.\n\nCONCLUSIONSAmong patients with ACS undergoing DCB-only angioplasty, those with multivessel disease were associated with a higher risk of NACE than those with single-vessel disease. Stepwise DAPT de-escalation and standard DAPT exhibited similar risk-benefit profiles in both subgroups.\n\nRegistration InformationClinicalTrials.gov identifier: NCT04971356\n\nCLINICAL PERSPECTIVEO_ST_ABSWhat Is New?C_ST_ABSO_LIThis is the first prespecified subgroup analysis that evaluated the efficacy and safety of a stepwise DAPT de-escalation strategy versus standard DAPT among ACS patients with multivessel disease undergoing DCB-only treatment. C_LIO_LIOur findings suggested that stepwise de-escalation was associated with a numerically similar risk of NACE in both multivessel and single-vessel subgroups compared with standard DAPT. C_LI\n\nWhat Are the Clinical Implications?O_LIFor ACS patients undergoing DCB-only angioplasty, stepwise DAPT de-escalation provides similar ischemic protection while reducing bleeding risk irrespective of coronary disease burden. These findings suggest that the stepwise DAPT de-escalation strategy may be considered for this high ischemic risk population. C_LI",
  "abstract_shown": true,
  "affiliations": [
    "The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China"
  ],
  "article_type": "PUBLISHAHEADOFPRINT",
  "arxiv": null,
  "author_total": 23,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "C. Gao"
    },
    {
      "name": "Y. Zhang"
    },
    {
      "name": "X. He"
    },
    {
      "name": "M. Yuan"
    },
    {
      "name": "F. Mou"
    },
    {
      "name": "J. Zhou"
    },
    {
      "name": "H. Chen"
    },
    {
      "name": "H. Wang"
    },
    {
      "name": "W. Guo"
    },
    {
      "name": "Y. Wei"
    },
    {
      "name": "Z. Zhang"
    },
    {
      "name": "T. Yin"
    },
    {
      "name": "C. Zhang"
    },
    {
      "name": "Z. Lian"
    },
    {
      "name": "B. Zhu"
    },
    {
      "name": "J. Liu"
    },
    {
      "name": "R. Zhang"
    },
    {
      "name": "G. Fu"
    },
    {
      "name": "Y. Onuma"
    },
    {
      "name": "D. Wang"
    },
    {
      "name": "P. W. Serruys"
    },
    {
      "name": "F. Yi"
    },
    {
      "name": "L. Tao"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/bw6vwqm0pkens.bib",
  "cited_by": 0,
  "doi": "10.64898/2026.08.31.26361869",
  "fulltext_url": "https://www.medrxiv.org/content/10.64898/2026.08.31.26361869v1.full",
  "id": "bw6vwqm0pkens",
  "issns": [],
  "landing_url": "https://www.medrxiv.org/content/10.64898/2026.08.31.26361869v1",
  "language": null,
  "licence": "CC-BY-NC-ND",
  "licence_label": "CC BY-NC-ND",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by-nc-nd/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "medrxiv",
      "cardiovascular medicine"
    ],
    [
      "openalex",
      "2705|Antiplatelet Therapy and Cardiovascular Diseases"
    ]
  ],
  "openalex": "W7206153383",
  "pdf_url": "https://www.medrxiv.org/content/10.64898/2026.08.31.26361869v1.full.pdf",
  "pmcid": null,
  "pmid": null,
  "published": "2026-08-31",
  "publisher": null,
  "ris": "https://research.draconitic.com/paper/bw6vwqm0pkens.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:17:35Z",
      "native_id": "10.64898/2026.08.31.26361869",
      "source": "medrxiv",
      "url": "https://www.medrxiv.org/content/10.64898/2026.08.31.26361869v1"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "medrxiv:cardiovascular medicine",
      "subfield": "cardiovascular"
    }
  ],
  "title": "Impact of stepwise dual antiplatelet therapy de-escalation in patients with multivessel disease undergoing drug-coated balloon angioplasty: insights from the REC-CAGEFREE II trial",
  "title_text": "Impact of stepwise dual antiplatelet therapy de-escalation in patients with multivessel disease undergoing drug-coated balloon angioplasty: insights from the REC-CAGEFREE II trial",
  "type": "preprint",
  "updated_at": "2026-10-30T12:17:35Z",
  "url": "https://research.draconitic.com/paper/bw6vwqm0pkens",
  "venue": "medRxiv",
  "versions": []
}