The procedural success rates for were 84.4% for the R2/3 group, 76.9% for the R4/5 group, and 70.2% for the R6 group. Almost all of those in the R2/3 and R4/5 groups were discharged immediately after treatment. In the R6 group, approximately 25% of patients were held for complications or additional care.
At 18 months of follow-up, freedom from major adverse events, defined as death, major amputation, or a target vessel revascularization, was achieved by 76.9% of those in the R2/3 group, 68.2% of those in the R4/5 group, and 52.8% of those in the R6 group. The analysis also looked at specific events: The rates for freedom from amputation were 99.3%, 95.3%, and 81.7% in the R2/3, R4/5, and R6 groups, respectively; the freedom from death was 93.9%, 85.5%, and 76.2%; and the freedom from target vessel revascularization was 77.5%, 70.6%, ad 65.7%.
Those in R2/3 maintained the improvement in Rutherford classification observed at 30 days for the subsequent 12 months. Those in R2/3 and R4/5 showed continued improvement in Rutherford classification. For example, R4 represented approximately 50% of the patients in R3/4 classification at baseline but less than 20% of this group at 18 months.
The change in Rutherford classification was reflected in quality of life (QOL) analyses. As far as total QOL scores, the R6 group, which had lower scores at baseline, was no longer significantly different at 18 months from the R4/5 group. On the pain subdomain QOL score, which was incrementally worse at baseline for increased PAD severity, there were no differences at 18 months after improvements in all groups.