Bailout stenting strategy in complex femoropopliteal lesions: mid-term outcomes with drug-eluting versus bare-metal stents.

Background

The aim of this study was to compare mid-term outcomes of drug-eluting stents (DES) versus bare-metal stents (BMS) when used as a bailout strategy for complex femoropopliteal lesions in real-world practice.

Methods

Single-center, retrospective cohort (January 2018 - February 2025) including patients requiring bailout stenting after suboptimal angioplasty. Primary endpoints included primary patency, freedom from clinically driven target lesion revascularization (cdTLR). Secondary endpoints were considered the limb loss, freedom from major adverse limb events (MALE) and all-cause mortality rate. Time-to-event outcomes were analyzed by Kaplan-Meier and log-rank testing up to 36 months; hazard ratios (HRs) with 95% confidence intervals (CIs) were estimated. A multivariable Cox model explored predictors of statistically significant outcomes.

Results

A total of 141 patients were included (BMS 65; DES 76). Compared with DES, the BMS group had higher rates of diabetes (58.5% vs. 40.8, P=0.036), CKD (70.8% vs. 40.8, P<0.001), dialysis (12.3% vs. 1.3, P=0.008), CLTI (89.2% vs. 75.0, P=0.030), Rutherford 5-6 (69.2% vs. 52.6, P=0.045), and ASA ≥3 (100% vs. 89.5, P=0.007). Kaplan-Meier analyses showed no significant between-group differences for primary patency (log-rank χ2 0.0011, P=0.973; HR 0.99, 95% CI 0.43-2.27), freedom from cdTLR (χ2 1.6318, P=0.2015; HR 0.52, 0.19-1.41), limb loss (χ2 2.37, P=0.124; HR 4.03, 0.68-23.76), or freedom from MALE (χ2 0.68, P=0.409; HR 1.48, 0.58-3.79). The all-cause mortality rate in the unadjusted analysis resulted higher in the BMS group (log-rank χ2 13.09, P<0.0003); (HR 2.75; 95% CI 1.59-4.76). In multivariable analysis, mortality was independently associated with CKD (HR 3.43, P=0.001), dialysis (HR 2.70, P=0.012), tissue loss/Rutherford 5-6 (HR 2.54, P=0.006), and history for neoplasia (HR 1.96, P=0.028); stent type was not an independent predictor (BMS vs. DES HR 0.54, P=0.063).

Conclusions

In bailout setting for long, complex femoropopliteal disease, stent type did not influence the outcomes post revascularization at 36 months. The overall all-cause mortality rate was driven by baseline clinical status rather than the device.