We studied 531 limbs of 432 Japanese patients (HD +, n = 107; HD −, n = 325) who received BSNS implantation to FP lesions between 2004 and 2014. Patients were followed-up for an average of 44.3 ± 33.6 months. We compared the long-term results between HD + and HD − patients using the Cox-proportional hazard model with adjustment for inverse probability treatment weight (IPTW) of PS, which was calculated for covariates with HD as a dependent variable.
PP rate in HD + vs. HD − patients at 9 years after the procedure was 19.1% vs. 47.9%, with a freedom from TLR rate of 47.6% vs. 62.9%, respectively. Adjusted HRs in HD + patients with 95% confidence intervals (CIs) were as follows: loss of PP: HR 1.64, 95% CI 1.052–2.557, P = 0.03; TLR: HR 1.862, 95% CI 1.104–3.139, P = 0.02.
The present study suggests that HD + patients have an increased risk for loss of PP and need for TLR after BSNS implantation to FP lesions.