Clin Res Cardiol (2022). https://doi.org/10.1007/s00392-022-02002-5

Randomized comparison of intracoronary lithoplasty and rotablation for the treatment of severely calcified vessels – ROTA.shock trial
F. Blachutzik1, S. Schlattner2, M. Weissner3, T. Gori4, H. Ullrich4, L. Gaede5, S. Achenbach6, H. Möllmann7, J. Blumenstein7, A. Aksoy8, G. Nickenig8, M. Weferling3, O. Dörr1, N. F. Boeder1, M. Bayer1, C. W. Hamm1, H. Nef1
1Medizinische Klinik I - Kardiologie und Angiologie, Universitätsklinikum Gießen und Marburg GmbH, Gießen; 2Medizinische Klinik I - Kardiologie und Angiologie, Universitätsklinikum Giessen und Marburg GmbH, Gießen; 3Abteilung für Kardiologie, Kerckhoff Klinik GmbH, Bad Nauheim; 4Zentrum für Kardiologie, Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz; 5Medizinische Klinik 2, Friedrich-Alexander Universität Erlangen-Nürnberg, Erlangen; 6Med. Klinik 2 - Kardiologie, Angiologie, Universitätsklinikum Erlangen, Erlangen; 7Klinik für Innere Medizin I, St.-Johannes-Hospital Dortmund, Dortmund; 8Medizinische Klinik und Poliklinik II, Universitätsklinikum Bonn, Bonn;

Background: Severely calcified coronary lesions provide a particular challenge for percutaneous coronary intervention (PCI). Intracoronary lithoplasty has been recently introduced for plaque modulation of these lesions. Rotablation is the current gold-standard treatment for severely calcified lesions, but it is usually associated with higher procedural risks. The aim of this ongoing study is to show the non-inferiority of coronary lithoplasty compared to rotablation in the treatment of severely calcified coronary lesions regarding minimal stent area. 

Methods: Coronary lithoplasty or rotablation were performed randomly in 30 patients with severe lesion calcification. Optical coherence tomography (OCT) was performed pre-procedurally as well as immediately post-procedurally to compare lumen/stent areas, plaque mass, and vessel wall configuration. The results of 30 patients are available so far and are the basis of this abstract. Until the congress takes place, the data of all 70 patients will probably be available.  

Results: The mean patient age was 76±6 years. All patients were symptomatic with stable angina. There was a trend towards a shorter procedure time when comparing lithoplasty with rotablation (61.9±23.1min vs. 74.7±44.7min; p=0.31). Pre-procedural minimal lumen area was 2.82±1.26 mm2 and mean lumen area was 5.33±1.20 mm2 as determined by OCT. Mean and minimum stent areas were larger after lithoplasty than after rotablation (9.55±2.62 mm2 vs. 8.84±3.34 mm2; p=0.62 and 6.82±2.44 mm2 vs. 5.89±2.32 mm2; p=0.41), but did not differ significantly. There were no differences in stent symmetry (eccentricity index after lithoplasty 0.65±0.08 vs. rotablation 0.64±0.10; p=0.82) or strut malapposition (mean malapposition area 1.02±0.51 mmvs. 0.80±0.69 mm2; p=0.88) between lithoplasty and rotablation. Troponine I levels were lower after lithoplasty as after rotablation (0.38±0.43ng/ml vs. 0.88±0.90ng/ml; p=0.11). There were no periprocedural adverse events.

Conclusion: Coronary lithoplasty is a promising treatment option for severely calcified coronary lesions and seems to be associated with a larger mean and minimum stent area as well as an excellent safety profile. 

 

This study is funded by the Else Kröner-Fresenius-Stiftung


https://dgk.org/kongress_programme/jt2022/aV140.html