{
  "abstract": "Introduction: While drug-coated balloons (DCB) have demonstrated efficacy for coronary small vessel disease, comparative data between DCB and drug-eluting stents (DES) in de novo coronary lesions remain limited.\n\nAim: This study hypothesized that a DCB-only strategy would be non-inferior to DES for angiographic outcomes in de novo small vessel coronary lesions.\n\nMaterial and methods: This prospective randomized controlled trial (RCT) enrolled 228 patients with de novo (≥ 70% stenosis), non-complex coronary lesions from January 2022 to January 2024. Participants were randomized 1 : 1 to paclitaxel-coated balloon or rapamycin-eluting stent (DES). The primary endpoint was late lumen loss (LLL) at 6 and 12 months post-procedure, with a non-inferiority margin of 0.15 mm. Baseline clinical characteristics were compared between groups, with 12-month follow-up assessments including cardiac function, major adverse cardiovascular events (MACE), post-procedural angina, and bleeding events. Quantitative coronary angiography was used to evaluate minimal lumen diameter, percent stenosis, and LLL. Kaplan-Meier analysis was used to assess cumulative survival rates.\n\nResults: Baseline clinical characteristics were similar between groups (p > 0.05). The DCB group had more Mehran Type I lesions (p < 0.05). Both groups reduced thrombogenic potential (p < 0.05). There were no significant differences in angiographic outcomes, MACE, or BARC ≥ 3 bleeding (p > 0.05). At 6 and 12 months, the 95% CI upper limits for LLL difference were below 0.15 mm (p for non-inferiority < 0.001). DCB had lower post-procedural angina frequency (p < 0.05) but similar episode duration. Survival rates did not differ significantly (p > 0.05).\n\nConclusions: For de novo, non-complex small coronary vessel disease, DCB monotherapy demonstrates comparable long-term efficacy to DES, meeting non-inferiority criteria.",
  "abstract_shown": true,
  "affiliations": [
    "Department of Cardiology, Fuwai Yunnan Hospital, Chinese Academy of Medical Sciences, Kunming City, China"
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 6,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "XiaoYu Xu"
    },
    {
      "affs": [
        0
      ],
      "name": "Yi Xiang"
    },
    {
      "affs": [
        0
      ],
      "name": "KangHui Ge"
    },
    {
      "affs": [
        0
      ],
      "name": "HaoTian Shi"
    },
    {
      "affs": [
        0
      ],
      "name": "ZiWei Zhang"
    },
    {
      "affs": [
        0
      ],
      "name": "JiaLin Zheng"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/b8p1b9wh7dw4q.bib",
  "cited_by": 0,
  "doi": "10.5114/aic.2026.164688",
  "fulltext_url": "https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13721081/?tool=EBI",
  "id": "b8p1b9wh7dw4q",
  "issns": [
    "1734-9338",
    "1897-4295"
  ],
  "landing_url": "https://europepmc.org/article/PMC/PMC13721081",
  "language": "eng",
  "licence": "CC-BY-NC-SA",
  "licence_label": "CC BY-NC-SA",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by-nc-sa/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "heading",
      "Original Paper"
    ],
    [
      "openalex",
      "2746|Coronary Interventions and Diagnostics"
    ]
  ],
  "openalex": "W7213307253",
  "pdf_url": "https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13721081/pdf/?tool=EBI",
  "pmcid": "PMC13721081",
  "pmid": "42965038",
  "published": "2026-09-01",
  "publisher": "Termedia Publishing",
  "ris": "https://research.draconitic.com/paper/b8p1b9wh7dw4q.ris",
  "sources": [
    {
      "first_seen": "2026-10-31T12:21:37Z",
      "native_id": "PMC:PMC13721081",
      "source": "europepmc",
      "url": "https://europepmc.org/article/PMC/PMC13721081"
    },
    {
      "first_seen": "2026-11-03T12:21:50Z",
      "native_id": "PMC13721081",
      "source": "pmc",
      "url": "https://doi.org/10.5114/aic.2026.164688"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2746|Coronary Interventions and Diagnostics",
      "subfield": "surgery"
    }
  ],
  "title": "Non-inferiority of a paclitaxel-coated balloon versus a rapamycin-eluting metal stent for de novo non-complex small coronary vessel disease: a prospective randomized controlled trial",
  "title_text": "Non-inferiority of a paclitaxel-coated balloon versus a rapamycin-eluting metal stent for de novo non-complex small coronary vessel disease: a prospective randomized controlled trial",
  "type": "peer-reviewed",
  "updated_at": "2026-11-03T12:21:50Z",
  "url": "https://research.draconitic.com/paper/b8p1b9wh7dw4q",
  "venue": "Postepy w kardiologii interwencyjnej = Advances in interventional cardiology",
  "versions": []
}