Severely calcified coronary stenosis poses a significant challenge for coronary angioplasty procedures. Modifying plaque before stenting is crucial to a successful intervention, since it will prevent the sub expansion associated to worse clinical outcomes at followup.
The tools employed to assess complex lesions include specialized balloons such as cutting, scoring, or high pressure balloons, as well as rotational (RA) and orbital atherectomy. The latter present limitation as regards deep plaque modification, with risk of periprocedural complications such as acute myocardial infarction (AMI), perforation, atrioventricular block, or no-reflow or slow flow phenomenon. Recently, intravascular lithotripsy (IVL) has been introduced, but there are still no randomized studies comparing RA to IVL for the treatment of severely calcified stenosis.
The aim of this prospective, randomized, multicenter, non-inferiority study, was to compare IVL against RA in terms of plaque modification, and stent and luminal areas, assessed with optimal computer tomography (OCT). Primary end point was end procedural minimal stent area (MSA), and secondary end points included several parameters such as stent diameter, minimal lumen diameter, minimal lumen area, lumen area, stent size, minimal stent diameter, stent expansion, eccentricity, fracture, malapposition, troponin levels, procedural time, contrast volume, radiation dose, target vessel failure (TVF), and in-hospital target vessel revascularization (TLR), at 1 and 6 month followup.
Read also: Is Coronary Lithotripsy as Effective as Rotational Atherectomy?
Seventy patients were enrolled between 2019 and 2021, randomized 1:1, mean age 73, mostly men. Stable coronary artery disease was the most common clinical presentation (82%), followed by NSTEMI (9.8%), unstable angina (3.3%) and STEMI (1.5%). The coronary artery was the most treated, with transradial approach in 65.6% of cases. Predilation was most often done in the IVL group (60%, p=0.04), with no significant differences in contrast, radiation dose and procedural time between the groups.
MSA resulted slightly lower for IVL patients (mean: 6.10 mm2, CI 95%: 5.32–6.87 mm2) vs. RA (mean: 6.60 mm2, CI 95%: 5.66–7.54 mm2). There were no differences in stent size and lumen, even though RA saw a trend towards larger stent area (9.52 ± 3.01 mm2 vs. 8.55 ± 2.31 mm2; p = 0.13). There were no differences in stent expansion, malapposition, tissue prolapse or fracture; and neither were there differences in clinical outcomes.
Conclusion
The use of IVL was shown non-inferior as regards MSA and stent expansion vs. RA, with a trend towards a larger stent area. Also, there were no significant differences in periprocedural myocardial damage induced by both techniques. Intracoronary lithotripsy seems to be an effective therapeutic alternative to treat severely calcified coronary artery lesions.
Dr. Andrés Rodríguez.
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 MD et al Catheter Cardiovasc Interv. 2023;1–11.
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