An optimal approach to treating femoropopliteal lesions

An optimal approach to treating femoropopliteal lesions

New research published in the Journal of the American College of Cardiology shows that the use of drug-coated balloons is an optimal approach in the treatment of femoropopliteal lesions compared to bare metal stents.

In the publication titled “Drug-coated Balloons versus Bare Metal Stents in Femoropopliteal Lesions: Three-Year Results of Prospective, Multicenter Studies,” researchers reported the results of testing drug-coated balloons (DCB) versus bare metal stents (BMS) in a tilt-corrected, pooled analysis of four prospective, multicenter studies.

“While stents provide immediate scaffolding and excellent periprocedural lumen gain for femoropopliteal artery lesions, in-stent restenosis can worsen outcomes and challenge subsequent treatment,” said lead author Mehdi Shishehbor, DO, MPH, PhD, president of the Harrington Heart & Vascular Institute at University Hospitals, and Angela and James Hambrick Chair in Innovation.

Endovascular treatment of femoropopliteal artery disease has shifted to drug-eluting balloons, but not much data has been available on the safety and effectiveness of this approach compared to bare metal stents.”

Mehdi Shishehbor, President, Harrington Heart & Vascular Institute, University Hospitals Cleveland Medical Center

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The primary analysis included 771 patients, of whom 288 were treated with DCB and 483 with BMS. The IPTW-adjusted Kaplan-Meier estimates of 12-month primary patency were 90 percent for DCB and 80 percent for BMS. DCB performs better at 85 percent for clinically guided revascularization of target lesions compared to 73 percent with BMS. DCB had a 25 percent cumulative incidence of serious adverse events (MAEs) at 36 months, while BMS had 38 percent. No statistically significant differences were observed in all-cause mortality, major target limb amputation, or thrombosis over 36 months.

With significantly higher 12-month patency and freedom from 36-month clinically driven reintervention and MAE and no statistically significant differences in 36-month all-cause mortality, amputation, or thrombosis observed, these results support the use of DCB over BMS for femoropopliteal lesions amenable to either treatment.

"This research clearly shows which approach will have the most success with our patients, and that's what we wanted to find out," said Dr. Shishehbor.

“Drug-coated Balloons versus Bare Metal Stents in Femoropopliteal Lesions: Three-Year Results of Prospective, Multicenter Studies” can be read in full in the November 1, 2022 online edition of the Journal of the American College of Cardiology.

Source:

University Hospitals Cleveland Medical Center

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