Smaller Superficial Femoral Artery is Associated with Worse Outcomes after Percutaneous Transluminal Angioplasty for De Novo Atherosclerotic Disease.

Background: With the exponential increase in the use of endovascular techniques in the treatment of peripheral artery disease, our understanding of factors that affect intervention failures continues to grow. We sought to assess the outcomes of percutaneous transluminal angioplasty for isolated de novo superficial femoral artery (SFA) disease based on balloon diameter.

Methods: The Vascular Quality Initiative database was queried for patients undergoing percutaneous balloon angioplasty for isolated de novo atherosclerotic SFA disease. Based on the diameter of the angioplasty balloon as a surrogate measure of arterial diameter, patients were stratified into 2 groups: group 1, balloon diameter <5 mm (354 patients) and group 2, balloon diameter ≥5 mm (1,550 patients). The primary patency and major adverse limb event (MALE) were estimated by the Kaplan-Meier method and compared with the log-rank test, based on vessel diameter. Multivariable Cox regression analysis was used to determine factors associated with the primary patency.

Results: From January 2010 through December 2018, a total of 1,904 patients met criteria for analysis, with a mean follow-up of 13.3 ± 4.5 months. The mean balloon diameters were 3.92 ± 0.26 mm and 5.47 ± 0.55 mm in group 1 and 2, respectively (P < 0.001). The mean length of treatment and distribution of TASC lesions were not statistically different between the groups. Primary patency at 18 months was significantly lower in group 1, compared with group 2 (55% vs. 67%; log-rank P < 0.001). The MALE rate was higher in group 1 than group 2 (33% vs. 26%; log-rank P < 0.001). Among patients with claudication, there was no significant difference in the primary patency (61% vs 68%; log-rank P = 0.073) and MALE (27% vs. 22%; log-rank P = 0.176) at 18 months between groups 1 and 2, respectively. However, in patients with CLTI, group 1 had significantly lower 18-month primary patency (47% vs. 64%; log-rank P < 0.014) and higher MALE rates (41% vs. 35%; log-rank P = 0.012) than group 2. Cox proportional hazard analysis confirmed that balloon diameter < 5 mm was independently associated with increased risks of primary patency loss (HR 1.35; 95% CI, 1.04-1.72; P = 0.021) and MALE (HR 1.29; 95% CI, 1-1.67; P = 0.048) at 18-months.

Conclusions: In patients undergoing isolated SFA balloon angioplasty for CLTI, smaller SFA (<5 mm) was associated with worse primary patency and MALE. Using balloon size as a surrogate, our findings suggest that patients with a smaller SFA diameter appear to be at increased risk for treatment failure and warrant closer surveillance. Furthermore, these patients may also be considered for alternative approaches, including open revascularization.