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. 2023;30(4):526-533.
doi: 10.5603/CJ.a2021.0128. Epub 2021 Oct 21.

Feasibility and outcome of the Rotapro system in treating severely calcified coronary lesions: The Rotapro study

Mohamed Ayoub  1 , Peter Tajti  2   1 , Miroslaw Ferenc  1 , Ibrahim Akin  3 , Michael Behnes  3 , Franz-Josef Neumann  1 , Kambis Mashayekhi  4
Affiliations

Feasibility and outcome of the Rotapro system in treating severely calcified coronary lesions: The Rotapro study

Mohamed Ayoub et al. Cardiol J. 2023.

Abstract

Background: The Rotapro study was conducted to evaluate the safety and feasibility of the new Rotapro rotational atherectomy system (RAS) for lesion preparation in calcified coronary artery stenosis.

Methods: Between 2015 and 2019 consecutive patients undergoing rotational atherectomy (RA) with the new Rotapro system and the conventional rotablator (Rotablator) were included from the Bad Krozingen Rotablation Registry. The primary endpoint was the incidence of in-hospital major adverse cardiovascular and cerebral event (MACCE) rate.

Results: Rotablation was performed in 3.6% of all patients (n = 597) treated by percutaneous coronary intervention. Procedural outcomes were compared according to the applied RAS (n = 246 Rotapro vs. n = 351 Rotablator). Overall technical success was achieved in 98.3% of patients. The primary endpoint of in-hospital MACCE was comparable between the Rotapro- and the Rotablator-group (3.7% vs. 5.7%, respectively, p = 0.254). The Rotapro group was associated with significant reductions of fluoroscopy time (30 vs. 38 min, p < 0.0001), procedural time (82.5 vs. 96 min, p = 0.0003), applied contrast volume (210 vs. 290 mL, p < 0.0001) and radiation dose (6129 vs. 9827 cGy*cm2, p < 0.0001) compared to the Rotablator group.

Conclusions: The present study demonstrates the safety and efficacy of the new Rotapro system. Inhospital MACCE rates were comparable between both RAS, whereas Rotapro was associated with less fluoroscopy time, radiation dose as well as contrast use.

Keywords: coronary artery disease; percutaneous coronary intervention; rotational atherectomy.

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Conflict of interest statement

Conflict of interest: Mohamed Ayoub, MD: reports consulting/speaker/proctoring honoraria honoraria from Boston Scientific, Ashai Intecc, Medtronic, Terumo; Miroslaw Ferenc, MD: reports consulting honoraria from Boston Scientific; Franz-Josef Neumann reports lectures fees paid to his institution from Amgen, Bayer Healthcare, Biotronic, Boehringer Ingelheim, Boston Scientific, Daiichi Sankyo, Edwards Lifesciences, Ferrer, Pfizer, Novartis, consultancy fees paid to his institution from Boehringer Ingelheim and grant support from Bayer Healthcare, Boston Scientific, Biotronic, Edwars Lifesciences, GlaxoSmithKline, Medtronic, Pfizer, Abbot Vascular; Kambis Mashayekhi reports consulting/speaker/proctoring honoraria from Abbott Vascular, Ashai Intecc, AstraZeneca, Biotronik, Boston Scientific, Cardinal Health, Daiichi Sankyo, Medtronic, Teleflex, Terumo.

Figures

Figure 1
Figure 1
Components of the primary endpoint of in-hospital major adverse cardiovascular and cerebral events (MACCE) including pericardiocentesis during in the conventional Rotablator and Rotapro groups; MI — myocardial infarction; TVR — target vessel revascularization.
See this image and copyright information in PMC

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