Outcomes following drug-coated balloons and drug-eluting stents in patients with peripheral arterial disease.

BACKGROUND

Drug-coated balloons and drug-eluting stents (DCB/DES) have shown promise in improving outcomes for patients with peripheral artery disease (PAD); however, more real-world analyses are needed to better understand the role of this technology within current practice. As such, we compared our institution's experience with DCB/DES vs percutaneous transluminal angioplasty with or without stenting (PTA/S) for the treatment of PAD.

METHODS

All patients undergoing an infrainguinal endovascular intervention for PAD at our institution between 2016 and 2022 were reviewed retrospectively. Patients undergoing isolated supra-inguinal or tibial interventions were excluded. Outcomes included primary patency, freedom from major adverse limb events (MALE), limb salvage, and amputation-free survival. To account for baseline differences, one-to-one propensity score matching was performed between DCB/DES and PTA/S groups. Outcomes were further evaluated using χ, Kaplan-Meier analyses, and Cox regression analyses.

RESULTS

Between 2016 and 2022, 800 patients underwent an endovascular infrainguinal intervention for PAD: 224 DCB/DES and 576 PTA/S. Before matching, DCB/DES patients were younger (69 vs 72 years), more often male (72% vs 65%), non-White (58%, vs 34%), had a history of smoking (77% vs 64%), were more likely to have had a prior ipsilateral intervention (45% vs 10%), and more often presented with claudication (44% vs 18%) (all P < .05). After matching, 211 patients were included in each group, where the only remaining difference between DCB/DES and PTA/S was prior ipsilateral intervention (40% vs 15%; P < .001). After DCB/DES, Kaplan-Meier analyses demonstrated higher rates of primary patency (65% vs 54%; P < .01) and higher freedom from MALE (3-year rates: 84% vs 75%; P = .04), correlating with a 38% lower event risk in both outcomes (hazard ratio [HR], 0.62 [95% confidence interval, 0.44-0.89] and hazard ratio, 0.62 [0.39-0.99], respectively). No differences were noted in rates of limb salvage (3-year rates: 94% vs 90%; P = .63) or amputation-free survival (3-year rates: 78% vs 71%; P = .13). When stratifying by indication, DCB/DES demonstrated higher rates of freedom from MALE among patients with chronic limb-threatening ischemia (3-year rates: 85% vs 66%; P = .02).

CONCLUSIONS

Among a matched cohort of patients with PAD undergoing endovascular intervention, DCB/DES, as compared with PTA/S, demonstrated higher rates of primary patency and freedom from MALE, the former treatment effect remaining notable among patients with claudication and the latter among patients with chronic limb-threatening ischemia. These data demonstrate the importance of further analyses on this evolving technology.