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DCBs not beneficial in below-the-knee lesions

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Compared with plain balloons, drug-coated balloons did not improve patency and were associated with worse 12-month rates of amputation-free survival in patients with below-the-knee lesions, according to an investigator-initiated study presented at the Society of Interventional Radiology Annual Scientific Meeting.

The researchers conducted a randomized controlled trial of 138 patients with critical limb ischemia (mean age, 63 years; 93 men; 94.2% with diabetes; 52.9% with end-stage renal failure) who had below-the-knee lesions treated with a DCB or a plain balloon.

Mean lesion length was 90.3 mm for the DCB group and 81.8 mm for the plain balloon group (difference, 8.5 mm; 95% CI, –16.2 to 33.2).

The primary endpoint was primary patency as determined by angiography at 6 months.

The 6-month primary patency rates were 41.9% in the DCB group and 37.8% in the plain balloon group (risk difference, 6.2%; 95% CI, –11 to 3.4), Kiang Hiong Tay, MD, FRCR, FSIR, FCIRSE, from the department of vascular and interventional radiology at Singapore General Hospital, said during a presentation.
Limb salvage rates were also similar between the groups at 6 months (DCB group, 77.9%; plain balloon group, 84.8%; risk difference, 8.8%; 95% CI, –21.7 to 4.7), according to the researchers.

Compared with plain balloons, drug-coated balloons did not improve patency and were associated with worse 12-month rates of amputation-free survival in patients with below-the-knee lesions, according to an investigator-initiated study presented at the Society of Interventional Radiology Annual Scientific Meeting.

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Amputation-free survival was numerically higher at 6 months in the plain balloon group (69.6% vs. 80.3%; log-rank P = .161), and the difference reached statistical significance at 12 months (P = .03), Tay said. – by Erik Swain

Reference:

Tay KH, et al. Abstract 857. Presented at: Society of Interventional Radiology Annual Scientific Meeting; March 23-28, 2019; Austin, Texas.

Disclosure: Cardiology Today’s Intervention could not confirm relevant financial disclosures at the time of publication.

Editor’s Note: This article was updated on April 1, 2019 to clarify that amputation-free survival was numerically higher at 6 months in the plain balloon group. The Editors regret the error.