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

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.