ROTACUT Study: Rotational Atherectomy with Cutting Balloon for Stent Expansion Optimization

Approximately 30% of patients undergoing percutaneous coronary intervention (PCI) present moderate to severe calcified lesions, which presents a significant challenge involving a high incidence of major adverse cardiovascular events (MACE). Rotational atherectomy (RA) is used to modify these calcified lesions and facilitate balloon angioplasty followed by stent implantation. The combination of RA with other plaque prepping devices might improve outcomes in the long run.

Estudio ROTACUT: Aterectomía rotacional con ¨cutting balón¨para optimizar expansión del stent

The aim of this prospective randomized study was to look into whether the combination of RA with cutting balloon (RA + CBA) results in better stent expansion vs. RA followed by non-compliant balloon (RA + NCBA).

Primary end point was minimum stent area after intervention, assessed by IVUS. Secondary end point included segment minimal lumen area, stent expansion, any dissection and malapposition. Researchers looked at 30-day clinical outcomes, including all-cause mortality, acute myocardial infarction, target vessel revascularization, instent thrombosis, major bleeding and vascular complications.

60 patients were randomized: 29 were treated with RA + CBA and 31 with RA + NCBA. Mean age was 71, and they were mostly men. Baselines characteristics in both groups were similar, with close to 60% of patients presenting single vessel disease and close to 20% presenting triple vessel disease. The most treated artery was the anterior descending in most patients, followed by the right coronary.

As regards primary end point, minimum stent lumen area was similar in both groups, with 6.7 ± 1.7 mm2 for RA + CBA patients and 6.9 ± 1.8 mm2 for RA + NCBA patients (p=0.685). Also, there were no differences in secondary end point. As regards clinical complications, there were two AMIs and one target vessel revascularization among RA + CBA patients and one AMI in the RA + NCBA group.

Conclusion

In conclusion, the combination of RA with cutting balloon resulted in similar minimum stent area vs. RA followed by non-compliant balloons in patients with coronary lesions with moderate to severe calcification. RA followed by cutting balloon resulted safe, with few post procedural complications, and few adverse clinical events at 30 days.