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Background <p>The efficacy of drug-coated balloons (DCB) for the treatment of de novo, non-small coronary lesions remains uncertain. This study aimed to evaluate the real-world performance of DCB-only angioplasty in this setting.</p> Methods <p>Patients with de novo, non-small coronary lesions (≥ 2.5 mm) treated exclusively with either drug-eluting stents (DES) or DCB were included from the DCB registry and two DES registries. The primary endpoint was the device-oriented composite endpoint (DoCE), including cardiovascular death, non-fatal target vessel myocardial infarction (TV-MI), and target lesion revascularization (TLR). Differences between cohorts were compared and adjusted by inverse probability of treatment weighting (IPTW).</p> Results <p>The study included 4621 patients, with 3780 in the DES group and 841 in the DCB group. At 3 years, the primary endpoint occurred in 51 (6.1%) patients receiving DCB and 143 (3.8%) patients with DES (HR<sub>IPTW</sub>: 1.87, 95% CI: 1.04–3.36, <i>P</i> = 0.039). Cardiovascular death occurred in 12 (1.4%) patients in the DCB group and 88 (2.3%) patients in the DES group (HR<sub>IPTW</sub>: 1.24, 95% CI: 0.34–4.48), non-fatal TV-MI occurred in 5 (0.6%) patients in the DCB group and 18 (0.5%) patients in the DES group (HR<sub>IPTW</sub>: 1.21, 95% CI: 0.33–4.38), and TLR occurred in 34 (4.0%) patients in the DCB group and 45 (1.2%) in the DES group (HR<sub>IPTW</sub>: 2.94, 95% CI: 1.72–5.01).</p> Conclusions <p>DCB-only angioplasty is associated with a higher rate of DoCE and TLR compared with DES group in patients with de novo coronary lesions which were ≥ 2.5 mm in diameter.</p> Trial registration <p>Registered on clinicaltrials.gov (NCT02929030, NCT03916432, and NCT05133921).</p>

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Mid-term outcomes of paclitaxel-coated balloon for de novo non-small coronary lesions: a pooled analysis

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年10月31日

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  • Xingqiang He,
  • Yi Liu,
  • Zhiyong Yin,
  • Fei Li,
  • Robert-Jan van Geuns,
  • Scot Garg,
  • Yoshinobu Onuma,
  • Patrick W. Serruys,
  • Chao Gao,
  • Ling Tao

摘要

Background

The efficacy of drug-coated balloons (DCB) for the treatment of de novo, non-small coronary lesions remains uncertain. This study aimed to evaluate the real-world performance of DCB-only angioplasty in this setting.

Methods

Patients with de novo, non-small coronary lesions (≥ 2.5 mm) treated exclusively with either drug-eluting stents (DES) or DCB were included from the DCB registry and two DES registries. The primary endpoint was the device-oriented composite endpoint (DoCE), including cardiovascular death, non-fatal target vessel myocardial infarction (TV-MI), and target lesion revascularization (TLR). Differences between cohorts were compared and adjusted by inverse probability of treatment weighting (IPTW).

Results

The study included 4621 patients, with 3780 in the DES group and 841 in the DCB group. At 3 years, the primary endpoint occurred in 51 (6.1%) patients receiving DCB and 143 (3.8%) patients with DES (HRIPTW: 1.87, 95% CI: 1.04–3.36, P = 0.039). Cardiovascular death occurred in 12 (1.4%) patients in the DCB group and 88 (2.3%) patients in the DES group (HRIPTW: 1.24, 95% CI: 0.34–4.48), non-fatal TV-MI occurred in 5 (0.6%) patients in the DCB group and 18 (0.5%) patients in the DES group (HRIPTW: 1.21, 95% CI: 0.33–4.38), and TLR occurred in 34 (4.0%) patients in the DCB group and 45 (1.2%) in the DES group (HRIPTW: 2.94, 95% CI: 1.72–5.01).

Conclusions

DCB-only angioplasty is associated with a higher rate of DoCE and TLR compared with DES group in patients with de novo coronary lesions which were ≥ 2.5 mm in diameter.

Trial registration

Registered on clinicaltrials.gov (NCT02929030, NCT03916432, and NCT05133921).