ABSTRACT
BACKGROUND/PURPOSE: In the randomized PREPARE-CALC trial, lesion preparation of calcified lesions with upfront rotational atherectomy (RA) prior to drug-eluting stent (DES) implantation resulted in higher acute success as compared to a provisional modified balloon (MB) strategy. We aimed to investigate the impact of calcified lesion complexity on the treatment effect with either MB or RA. METHODS/MATERIALS: Two hundred patients were randomized to lesion preparation with either MB or RA. The study population was stratified according to lesion complexity into at least one type-C lesion or into exclusively non-type-C lesions. Endpoints were strategy success, need for bail-out RA, acute lumen gain, and late lumen loss (LLL) at 9 months. RESULTS: In total, 143 patients were graded as type-C (45% patients were allocated to MB), whereas 57 patients were graded as non-type-C (61% patients were allocated to MB). In patients with at least one type-C lesion, strategy success with RA was higher than with MB (97% vs 72%, p < 0.001), but superiority of RA was not observed in patients with non-type-C lesions (100% vs 97%, p = 1.00; pinteraction = 0.001). The need for bail-out RA was higher in patients with type-C lesions (n = 15) as compared with non-type-C lesions (n = 1). Acute lumen gain, LLL, and target lesion revascularization at 9 months were not dependent on lesion complexity and upfront lesion preparation strategy. CONCLUSIONS: In patients with calcified non-type-C lesions, the treatment strategy with RA or MB before DES implantation results in comparable success rates, whereas in type-C lesions upfront RA appears to be the superior upfront strategy.
