Severely calcified lesions currently pose a significant challenge, as they require adequate preparation through non-compliant balloons or cutting balloons to achieve effective stent expansion. Another option is the use of orbital or rotational atherectomy (RA), but this carries the risk of complications such as slow/no reflow, perforations, dissections, peri-procedural infarction, or guidewire rupture.
Despite the lack of comparative randomized studies between strategies, intravascular lithotripsy (IVL) has shown benefits in various analyses of severely calcified lesions.
The ROTA.shock study randomized 61 patients with severely calcified lesions and ischemia. Of these, 31 underwent RA, and 28 underwent IVL. Optical coherence tomography (OCT) was performed at the end of the procedure. The primary endpoint (PEP) was the minimal lumen area (MLA) for the stent at the end of the procedure.
The mean participant age was 73 years old and most of the subjects were men. Overall, 22 patients had diabetes, 58% had hypertension, 41 had a history of myocardial infarction, and 5 of them were smokers. The average ejection fraction was 55%, and 50 patients presented stable coronary syndrome, 2 had unstable angina, 6 experienced non-ST-segment elevation myocardial infarction (NSTEMI), and 1 had an ST-segment elevation myocardial infarction (STEMI).
Predilation was more common in those who underwent IVL. There were no differences in the OCT performed before percutaneous coronary intervention (PCI), with similar levels of calcification and lumen. The maximum calcification angle was 270 degrees, with a thickness of 0.61 mm and a length of 16 mm.
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The PEP was lower but not statistically inferior with IVL (mean: 6.10 mm², 95% confidence interval [CI]: 5.32–6.87 mm²) compared with RA (6.60 mm², 95% CI: 5.66–7.54 mm²; difference in MLA: −0.50 mm², 95% CI: −1.52–0.52 mm²; non-inferiority margin: −1.60 mm²). Stent expansion was similar (0.82 vs. 0.83, p=0.79) for IVL and RA, respectively, and there were no differences in contrast volume, received radiation, and procedure time.
Conclusion
In conclusion, coronary lithotripsy did not prove to be inferior in terms of the minimum lumen area for the stent, achieving similar expansion compared with rotational atherectomy. Additionally, there were no significant differences in procedure time, contrast volume, or received radiation.
Dr. Carlos Fava.
Member of the Editorial Board of SOLACI.org.
Original Title: Coronary intravascular lithotripsy and rotational atherectomy for severely calcified stenosis: Results from the ROTA.shock trial.
Reference: F. Blachutzik, et al. Catheter Cardiovasc Interv. 2023;102:823–833.
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