DCBs may be superior to bare-metal stents in patients with femoropopliteal artery disease
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In patients with femoropopliteal artery disease amenable to treatment with drug-coated balloons or bare-metal stents, DCBs appear to be the better option, according to an analysis presented at VIVA 22.
Mehdi H. Shishehbor, DO, MPH, PhD, president of University Hospitals Harrington Heart & Vascular Institute, Cleveland, and Angela and James Hambrick Chair in Innovation, and colleagues conducted a patient-level pooled analysis of 771 patients with femoropopliteal artery disease who participated in the IN.PACT SFA I/II or INPACT.SFA Japan randomized controlled trials (n = 288) of a DCB (IN.PACT Admiral, Medtronic) or the Complete SE and DURABILITY single-arm studies of BMS (n = 483).
While it is known that DCBs provide better outcomes than percutaneous transluminal angioplasty in this population, “what’s unknown is the safety and efficacy of DCB vs. BMS in patients that are amenable to both treatments,” Shishehbor said during a presentation. “We know that rates of reocclusion or reoperation is about 40% (with BMS) in long lesions. Stents are also associated with stent fractures that can lead to restenosis, thrombosis and occasionally pseudoaneurysms. The question was ... whether we could identify a group of patients that would benefit from DCB over bare-metal stents.”
All patients (mean age, 69 years; 65% men) had Rutherford class 2 to 4 femoropopliteal artery disease and all studies the analysis was derived from had core laboratory adjudication.
The researchers compared outcomes using inverse probability of treatment weighting. The outcomes of interest were primary patency at 12 months, clinically driven target lesion revascularization at 36 months and major adverse events at 36 months. The results were simultaneously published in the Journal of the American College of Cardiology.
At 12 months, primary patency was achieved in 90.4% of the patients treated with DCB and 80.9% of the patients treated with BMS (log-rank P = .007), the researchers found.
At 36 months, the DCB group had a higher rate of freedom from clinically driven TLR (85.6% vs. 73.7%; log-rank P = .001) and a lower rate of major adverse events (25.3% vs. 38.8%; log-rank P < .001), according to the researchers.
There were no differences between patients treated with DCB and those treated with BMS in all-cause mortality, target major limb amputation or thrombosis at 36 months, Shishehbor said during the presentation.
Excluding patients from the DCB group who had provisional stenting did not change the results, he said.
“This analysis supports the use of DCB vs. bare-metal stenting in moderately complex femoropopliteal lesions which are amenable to both treatments,” Shishehbor said during the presentation.
Reference:
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Shishehbor MH, et al. Late-Breaking Clinical Trials. Presented at: VIVA 22; Oct. 31-Nov. 3, 2022; Las Vegas (hybrid meeting).
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