Endovascular management of superficial femoral artery chronic total occlusions: Influence of lesion complexity and popliteal access on the efficacy of rotational atherectomy plus drug-coated balloon versus drug-coated balloon alone

Objectives: This study aimed to compare the safety and efficacy of rotational atherectomy combined with drug-coated balloon angioplasty (RA+DCB) versus DCB alone in patients with superficial femoral artery chronic total occlusions (SFA CTOs) and to evaluate the influence of lesion complexity and vascular access site (femoral or popliteal) on procedural success and 12-month clinical outcomes. Material and Methods: This single-center retrospective cohort included 98 consecutive patients (117 SFA CTOs) treated between December 2022 and January 2024. All patients presented with lifestyle-limiting claudication or chronic limb-threatening ischemia (Rutherford 3–6). The primary outcome was 12-month primary patency on duplex ultrasound; secondary outcomes were technical success and freedom from target-lesion revascularization (TLR). Multivariable logistic regression identified predictors of loss of primary patency and TLR, and Kaplan– Meier analysis compared patency across treatment groups and access sites. Results: Successful lesion crossing was achieved in 109 of 117 CTOs (93.2%). Technical success was similar for RA + DCB (94.3%) and DCB alone (94.6%). At 12 months, primary patency (67.3% vs. 50%, p = 0.16) and freedom from TLR (70.2% vs. 54.2%, p = 0.26) did not differ between treatment modalities, nor between femoral and popliteal access. Diabetes mellitus independently reduced the odds of primary patency (odds ratio [OR], 0.30, 95% confidence interval [CI], 0.11–0.88) and TLR-free survival (OR, 0.28, 95% CI, 0.09–0.86). Longer occlusion length predicted crossing failure ( p = 0.008) but not loss of patency. No procedure-related major adverse limb events occurred. Conclusion: Routine addition of RA to DCB angioplasty for all SFA CTOs is not supported. RA-facilitated DCB may confer benefit only in selected heavily calcified lesions. Mid-term outcomes are driven primarily by diabetes and lesion length, rather than the access route, underscoring the importance of a risk-adapted, lesion-specific treatment strategy.