open access

Vol 30, No 4 (2023)
Original Article
Submitted: 2021-06-28
Accepted: 2021-07-30
Published online: 2021-10-18
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Feasibility and outcome of the Rotapro system in treating severely calcified coronary lesions: The Rotapro study

Mohamed Ayoub1, Peter Tajti21, Miroslaw Ferenc1, Ibrahim Akin3, Michael Behnes3, Franz-Josef Neumann1, Kambis Mashayekhi1
DOI: 10.5603/CJ.a2021.0128
·
Pubmed: 34671968
·
Cardiol J 2023;30(4):526-533.
Affiliations
  1. Division of Cardiology and Angiology II, University Heart Center Freiburg, Bad Krozingen, Germany
  2. Gottsegen György Hungarian Institute of Cardiology, Budapest, Hungary
  3. First Department of Medicine, University Medical Centre Mannheim (UMM), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany

open access

Vol 30, No 4 (2023)
Original articles — Interventional cardiology
Submitted: 2021-06-28
Accepted: 2021-07-30
Published online: 2021-10-18

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.

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.

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Keywords

percutaneous coronary intervention, rotational atherectomy, coronary artery disease

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About this article
Title

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

Journal

Cardiology Journal

Issue

Vol 30, No 4 (2023)

Article type

Original Article

Pages

526-533

Published online

2021-10-18

Page views

2279

Article views/downloads

719

DOI

10.5603/CJ.a2021.0128

Pubmed

34671968

Bibliographic record

Cardiol J 2023;30(4):526-533.

Keywords

percutaneous coronary intervention
rotational atherectomy
coronary artery disease

Authors

Mohamed Ayoub
Peter Tajti
Miroslaw Ferenc
Ibrahim Akin
Michael Behnes
Franz-Josef Neumann
Kambis Mashayekhi

References (14)
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  2. Reifart N, Vandormael M, Krajcar M, et al. Randomized comparison of angioplasty of complex coronary lesions at a single center. Excimer Laser, Rotational Atherectomy, and Balloon Angioplasty Comparison (ERBAC) Study. Circulation. 1997; 96(1): 91–98.
  3. Onuma Y, Tanimoto S, Ruygrok P, et al. Efficacy of everolimus eluting stent implantation in patients with calcified coronary culprit lesions: two-year angiographic and three-year clinical results from the SPIRIT II study. Catheter Cardiovasc Interv. 2010; 76(5): 634–642.
  4. Rathore S, Matsuo H, Terashima M, et al. Rotational atherectomy for fibro-calcific coronary artery disease in drug eluting stent era: procedural outcomes and angiographic follow-up results. Catheter Cardiovasc Interv. 2010; 75(6): 919–927.
  5. Abdel-Wahab M, Richardt G, Joachim Büttner H, et al. High-speed rotational atherectomy before paclitaxel-eluting stent implantation in complex calcified coronary lesions: the randomized ROTAXUS (Rotational Atherectomy Prior to Taxus Stent Treatment for Complex Native Coronary Artery Disease) trial. JACC Cardiovasc Interv. 2013; 6(1): 10–19.
  6. Abdel-Wahab M, Toelg R, Byrne RA, et al. High-Speed rotational atherectomy versus modified balloons prior to drug-eluting stent implantation in severely calcified coronary lesions. Circ Cardiovasc Interv. 2018; 11(10): e007415.
  7. Mintz GS, Popma JJ, Pichard AD, et al. Patterns of calcification in coronary artery disease. A statistical analysis of intravascular ultrasound and coronary angiography in 1155 lesions. Circulation. 1995; 91(7): 1959–1965.
  8. Barbato E, Carrié D, Dardas P, et al. European Association of Percutaneous Cardiovascular Interventions. European expert consensus on rotational atherectomy. EuroIntervention. 2015; 11(1): 30–36.
  9. Safian RD, Feldman T, Muller DW, et al. Coronary angioplasty and Rotablator atherectomy trial (CARAT): immediate and late results of a prospective multicenter randomized trial. Catheter Cardiovasc Interv. 2001; 53(2): 213–220.
  10. Thygesen K, Alpert JS, Jaffe AS, et al. Third universal definition of myocardial infarction. J Am Coll Cardiol. 2012; 60: 1581–98.
  11. Lee MS, Yang T, Lasala J, et al. Impact of coronary artery calcification in percutaneous coronary intervention with paclitaxel-eluting stents: Two-year clinical outcomes of paclitaxel-eluting stents in patients from the ARRIVE program. Catheter Cardiovasc Interv. 2016; 88(6): 891–897.
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  13. Oei HHS, Vliegenthart R, Hofman A, et al. Risk factors for coronary calcification in older subjects. The Rotterdam Coronary Calcification Study. Eur Heart J. 2004; 25(1): 48–55.
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