Background

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 balloons (MB) strategy. We aimed to  investigate the impact of calcified lesion complexity on the treatment effect with either MB or RA.

Methods

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; p_interaction=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.