Assessment of Recurrence Patterns and Treatment Strategies for Reintervention after Paclitaxel-Coated Balloon Angioplasty in Femoropopliteal Artery Diseases: Results of the ASTRA Study.

AIMS: Data on recurrence and its patterns after paclitaxel-coated balloon (PCB) angioplasty for femoropopliteal artery disease are limited. We evaluated the incidence and predictors of re-recurrence according to the retreatment strategy (PCB or scaffold) and recurrence pattern (restenosis or reocclusion) in patients with recurrence after primary PCB therapy.

METHODS

This multicenter retrospective study included 276 limbs of 246 patients who underwent repeat endovascular therapy (EVT) using either PCB (PCB group, n = 217) or a scaffold (scaffold group, n = 59) for primary PCB recurrence. The primary endpoint was 1-year freedom from re-recurrence, and secondary analyses identified the predictors of re-recurrence.

RESULTS

In the PCB group, 174 restenotic and 43 reoccluded lesions were treated with PCBs. In the scaffold group, 32 restenotic and 27 reoccluded lesions were treated with scaffolds. In both groups, reoccluded lesions had significantly lower freedom from re-recurrence rates than restenotic lesions (PCB: 43.0% vs. 68.6%, p＜0.001; scaffold: 52.6% vs. 81.5%, p = 0.033). Freedom from re-reocclusion was also significantly lower in reoccluded lesions than in restenotic lesions (PCB: 48.5% vs. 88.6%, p＜0.001; scaffold: 65.8% vs. 93.2%, p = 0.033). The independent predictors of re-recurrence after PCB treatment were male sex (hazard ratio [HR] 2.01, p = 0.010), reoccluded lesions (HR 2.71, p = 0.001), poor BK run-off (HR 1.97, p = 0.020), use of first-generation low-dose PCB (HR 2.32, p = 0.017), and residual stenosis ＞30% (HR 2.60, p = 0.009). After scaffold treatment, reoccluded lesions were also identified as a significant predictor of re-recurrence (HR 2.99, p = 0.043).

CONCLUSION

Reocclusion after PCB therapy was strongly associated with subsequent re-recurrence, including re-reocclusion, regardless of the retreatment strategy.