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Randomized Controlled Trial
. 2024 Jan 1;20(1):75-84.
doi: 10.4244/EIJ-D-23-00811.

Rotational atherectomy combined with cutting balloon to optimise stent expansion in calcified lesions: the ROTA-CUT randomised trial

Samin K Sharma  1 , Roxana Mehran  1 , Birgit Vogel  1 , Amit Hooda  1 , Samantha Sartori  1 , Regina Hanstein  1 , Yihan Feng  1 , Richard A Shlofmitz  2 , Allen Jeremias  2 , Alessandro Spirito  1 , Davide Cao  1 , Evan Shlofmitz  2 , Ziad A Ali  2 , Keisuke Yasumura  2 , Shingo Minatoguchi  1 , Yuliya Vengrenyuk  1 , Annapoorna Kini  1 , Jeffrey W Moses  2
Affiliations
Randomized Controlled Trial

Rotational atherectomy combined with cutting balloon to optimise stent expansion in calcified lesions: the ROTA-CUT randomised trial

Samin K Sharma et al. EuroIntervention. .

Abstract

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

Aims: We aimed 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 angioplasty (RA+NCBA).

Methods: ROTA-CUT is a prospective, multicentre, randomised trial of 60 patients with coronary artery disease undergoing PCI of moderately or severely calcified lesions with drug-eluting stent implantation. Patients were randomised 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. The procedural details of RA were similar between groups, as were procedure duration and contrast use. Minimum stent area was similar with RA+CBA versus RA+NCBA (6.7±1.7 mm2 vs 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 revascularisation in the RA+CBA group and 1 myocardial infarction in the RA+NCBA group.

Conclusions: Combining RA with CBA resulted in a 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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Conflict of interest statement

R. Mehran reports institutional research payments from Abbott, Abiomed, Affluent Medical, Alleviant Medical, Amgen, AM-Pharma, Applied Therapeutics, Arena, AstraZeneca, AtriCure, Biosensors, Biotronik, Boston Scientific, Bristol-Myers Squibb, CardiaWave, CeloNova, Chiesi, Concept Medical, CSL Behring, CytoSorbents, Daiichi Sankyo, Duke, Element Science, Faraday, Humacyte, Idorsia, I-Laser, Janssen, Magenta Medical, MedAlliance, Medscape, MediaSphere Medical, Medtelligence, Medtronic, MJH Healthcare, Novartis, OrbusNeich, Penumbra, PhaseBio, Philips, Pi-Cardia, PLx Pharma, Protembis, RenalPro, RM Global, Shockwave Medical, Transverse Medical, Vivasure Medical, and ZOLL Medical; personal fees from Affluent Medical, Cardiovascular Research Foundation (CRF), Daiichi Sankyo Brasil, E.R. Squibb & Sons, Esperion Science, Innovative BioPharma, Europa Group, Boston Scientific, Gaffney Events, Educational Trust, Ionis Pharmaceuticals, jCalc, Novartis, Novo Nordisk, Vectura, Voxmedia LLC, IQVIA, McVeigh Global Meetings and Events, Overcome, Primer Healthcare of New Jersey, Radcliffe, SL Solutions, Tarsus Cardiology, and WebMD; equity <1% in Applied Therapeutics, Elixir Medical, Stel Life, and ControlRad (spouse); no fees from AMA (Scientific Advisory Board), or SCAI (Women in Innovations Committee Member); faculty member of CRF; and honoraria from JAMA Cardiology (Associate Editor) and ACC (BOT Member, SC Member CTR Program). Z.A. Ali reports institutional grant support from Abbott, Abiomed, ACIST Medical, Amgen, Boston Scientific, CathWorks, Canon, Conavi Medical, HeartFlow, Inari Medical, Medtronic, National Institute of Health, Nipro, OpSens Medical, Medis, Philips, Shockwave Medical, Siemens, SpectraWAVE, and Teleflex; consulting fees from Abiomed, AstraZeneca, Boston Scientific, CathWorks, OpSens, Philips, and Shockwave Medical; and equity in Elucid, Lifelink, SpectraWAVE, Shockwave Medical, and VitalConnect. The other authors have no conflicts of interest to declare.

Figures

Central illustration
Central illustration. Design and primary outcome of the ROTA-CUT trial.
A total of 60 patients were randomised to either rotational atherectomy (RA) followed by cutting balloon angioplasty (RA+CBA) or RA followed by non-compliant balloon angioplasty (RA+NCBA). Coronary angiography for offline quantitative coronary angiography (QCA) was performed at baseline, after RA, after RA+CBA/RA+NCBA, and at the end of the procedure. Intravascular ultrasound (IVUS) runs were performed at baseline (if possible), after lesion preparation defined as RA+CBA or RA+NCBA, and at the end of the procedure. The primary endpoint of the study was minimum stent area (in mm2) on IVUS. Clinical endpoints were collected at 30 days. *p-value for comparison of means±SD. † p-value for comparison of medians (IQR). Angio: angiography; DES: drug-eluting stent; IQR: interquartile range; MACE: major adverse cardiac events; PCI: percutaneous coronary intervention; SD: standard deviation
See this image and copyright information in PMC

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