ROTA.shock Outcomes: Intravascular Lithotripsy vs. Rotational Atherectomy

At present, severe calcified coronary stenosis poses a significant challenge for PCI. A successful intervention will require plaque modification prior stenting, seeing as sub-expansion has been associated with worse clinical outcomes at followup.

The tools normally used to treat these complex lesions include specialized balloons such as cutting, scoring, and high pressure balloons, as well as rotational (RA) and orbital atherectomy. However, these last two methods have limited effect in deep calcifications and have been associated with periprocedural complications, such as MI, perforation, atrioventricular blockage and no reflow or slow flow phenomenon.

Intravascular Lithotripsy (IVL) has been recently introduced as an additional therapeutic alternative. To date, there are no randomized studies to compare RA vs IVL in the treatment of calcified coronary lesions.

The aim of this prospective, multicenter, non-inferiority study was to compare IVL against RA in terms of plaque modification, stent area and lumen gain, assessed by optical coherence tomography (OCT).

Primary end point was post procedural minimal stent area (MSA). Secondary end points included mean stent diameter, minimal lumen diameter, mean lumen diameter, minimal lumen area, mean lumen area, mean stent area, minimal stent diameter, stent expansion, eccentricity, fracture, malapposition, troponin levels, procedural time, contrast consumption, radiation dose, target vessel failure (TLF) and target lesion revascularization (TLR) both inhospital and at 1 and 6 month followup.

In total, the study included 70 patients between 2019 and 2021, who were randomized 1:1. Mean age was 73, and most were men. Stable coronary heart disease was the most common clinical presentation (82%), followed by non ST elevation MI (9.8%), unstable angina (3.3%) and ST acute MI (1.5%). The right coronary artery was treated most often. The transradial was the most used access site (65.6% while the femoral was used in 37.7% of cases). Predilation was most frequently done in the IVL arm (60% of cases, P= 0.04). There were no significant differences between groups as regards contrast consumption, radiation dose and procedural time.

Primary end point of MSA resulted similar between groups, though slightly lower in IVL patients (mean: 6.10 mm2, 95% CI: 5.32–6.87 mm2) vs. RA (mean: 6.60 mm2, 95% CI: 5.66–7.54 mm2).

Also, there were no significant differences as regards stent dimension and lumen. However, there was a tendency towards larger stent area with RA vs. IVL (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. Lastly, there were no differences in clinical outcomes.

Conclusion

The use of IVL was shown non-inferior in terms of MSA and stent expansion vs. RA. Also, there were no significant differences in technique induced periprocedural myocardial damage. IVL appears to be an effective therapeutic alternative to approach severely calcified coronary lesions.