Rotational atherectomy with cutting balloon to optimize stent expansion in calcified lesions: The ROTACUT randomized trial

DOI: 10.4244/EIJ-D-23-00811

Samin Sharma
Samin K. Sharma1, MD; Roxana Mehran1, MD; Birgit Vogel1, MD; Amit Hooda1, MD; Samantha Sartori1, PhD; Regina Hanstein1, PhD; Yihan Feng1, MS; Richard A. Shlofmitz2, MD; Allen Jeremias2, MD; Alessandro Spirito1, MD; Davide Cao1, MD; Evan Shlofmitz2, DO; Ziad A. Ali2, MD, DPhil; Keisuke Yasumura1, MD; Shingo Minatoguchi1, MD; Yuliya Vengrenyuk1, PhD; Annapoorna Kini1, MD; Jeffrey W. Moses2, MD
1. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA; 2. St. Francis Hospital & Heart Center, Roslyn, New York, USA

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Background: Percutaneous coronary intervention (PCI) of calcific lesions remains challenging for interventionalists.

Aims: To investigate whether combining rotational atherectomy (RA) with cutting balloon angioplasty (RA+CBA) results in more optimal stent expansion compared with RA followed by non-compliant balloon post-dilatation (RA+NCBA).

Methods: ROTACUT is a prospective multicenter randomized trial of 60 patients with coronary artery disease undergoing PCI of moderately or severely calcified lesions with drug-eluting stent implantation. Patients were randomized 1:1 to either RA+CBA or RA+NCBA. The primary endpoint was the minimum stent area on intravascular ultrasound (IVUS). Secondary endpoints included minimum lumen area and stent expansion assessed by IVUS and acute lumen gain, final residual diameter stenosis and minimum lumen diameter assessed by angiography. Clinical endpoints were obtained at 30 days.

Results: The mean age was 71.1±9.4 years and 22% were women. Procedural details of RA were similar between groups, as were procedure duration and contrast used. Minimum stent area was similar with RA+CBA versus RA+NCBA (6.7±1.7 mm2 versus 6.9±1.8 mm2; p=0.685). Furthermore, there were no significant differences regarding the other IVUS and angiographic endpoints. Procedural complications were rare and 30-day clinical events included 2 myocardial infarctions and 1 target vessel revascularization in the RA+CBA and 1 myocardial infarction in the RA+NCBA group.

Conclusions: Combining RA with CBA resulted in similar minimum stent area compared with RA followed by NCBA in patients undergoing PCI of moderately or severely calcified lesions. RA followed by CBA was safe with rare procedural complications and few clinical adverse events at 30 days.

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