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Purpose <p>This study aimed to compare directional atherectomy (DA) and plain old balloon angioplasty (POBA) for vessel preparation before drug-coated balloon (DCB) therapy in moderately to severely calcified peripheral artery disease.</p> Materials and Methods <p>This study is a sub-analysis of the Evolusion study. Inverse probability weighting was applied to balance the two groups. The primary endpoints were freedom from major adverse events (f-MAE), freedom from all-cause mortality (f-ACM), and major adverse limb events (MALE). Secondary endpoints included Rutherford classification improvement rate, bailout stent implantation rate, and bailout stent length.</p> Results <p>A total of 337 patients were included (254 in POBA group, 83 in DA group). POBA had higher bailout stent implantation rate (28.7% vs 16.9%, p = 0.004) and longer mean stent length (159.0 ± 78.8&#xa0;mm vs 119.3 ± 58.9&#xa0;mm, <i>p</i> &lt; 0.001); DA enabled larger-diameter DCBs (5.11 ± 0.69&#xa0;mm vs 4.73 ± 0.62&#xa0;mm, <i>p</i> &lt; 0.01). Over 24&#xa0;months, POBA had 43 deaths (41.9% cardiovascular) and 15 post-procedural reinterventions; DA had 4 deaths and 5 reinterventions. POBA also showed lower f-MAE (78.4% vs 85.4%, p = 0.027) and f-ACM (83.2% vs 92.7%, p = 0.0035), plus higher cumulative MALE (8.5% vs 4.8%, p = 0.006). DA had greater Rutherford category improvement, reaching 89.1% vs 71.3% at 24&#xa0;months.</p> Conclusion <p>In patients with calcified lesions, DA-based vessel preparation before DCB therapy was associated with superior clinical outcomes, including higher f-MAE and f-ACM, lower MALE rates, reduced bailout stenting, shorter stent length, and greater improvement in Rutherford category, compared with POBA.</p> Graphical Abstract <p></p>

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Directional Atherectomy Versus Plain Old Balloon Angioplasty for Vessel Preparation Before Drug-Coated Balloon Treatment in Moderate-to-Severe Calcified Lesions

  • 期刊论文

  • 发表日期：

    2026年5月6日

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  • Bing Wang,
  • Linjun Wang,
  • Zhengyuan Fang,
  • Chenyang Qiu,
  • Yiting Xu,
  • Xin Fang,
  • Zibo Feng,
  • Lianrui Guo,
  • Chunshui He,
  • Meng Ye,
  • Ziheng Wu

摘要

Purpose

This study aimed to compare directional atherectomy (DA) and plain old balloon angioplasty (POBA) for vessel preparation before drug-coated balloon (DCB) therapy in moderately to severely calcified peripheral artery disease.

Materials and Methods

This study is a sub-analysis of the Evolusion study. Inverse probability weighting was applied to balance the two groups. The primary endpoints were freedom from major adverse events (f-MAE), freedom from all-cause mortality (f-ACM), and major adverse limb events (MALE). Secondary endpoints included Rutherford classification improvement rate, bailout stent implantation rate, and bailout stent length.

Results

A total of 337 patients were included (254 in POBA group, 83 in DA group). POBA had higher bailout stent implantation rate (28.7% vs 16.9%, p = 0.004) and longer mean stent length (159.0 ± 78.8 mm vs 119.3 ± 58.9 mm, p < 0.001); DA enabled larger-diameter DCBs (5.11 ± 0.69 mm vs 4.73 ± 0.62 mm, p < 0.01). Over 24 months, POBA had 43 deaths (41.9% cardiovascular) and 15 post-procedural reinterventions; DA had 4 deaths and 5 reinterventions. POBA also showed lower f-MAE (78.4% vs 85.4%, p = 0.027) and f-ACM (83.2% vs 92.7%, p = 0.0035), plus higher cumulative MALE (8.5% vs 4.8%, p = 0.006). DA had greater Rutherford category improvement, reaching 89.1% vs 71.3% at 24 months.

Conclusion

In patients with calcified lesions, DA-based vessel preparation before DCB therapy was associated with superior clinical outcomes, including higher f-MAE and f-ACM, lower MALE rates, reduced bailout stenting, shorter stent length, and greater improvement in Rutherford category, compared with POBA.

Graphical Abstract