Abstract Background/Introduction The adoption of drug coated balloons (DCB) for treatment of coronary lesions is rapidly expanding. Along with this trend comes an increasing lesion complexity being treated with DCBs. In this context, optimal lesion preparation, permitting not only good luminal gain, but also preserving vascular integrity and limiting flow limiting dissection, is key. Yet sufficient information about the safety and efficacy of intravascular lithotripsy (IVL) for management of coronary lesions treated with DCBs is lacking. Purpose To assess the safety and efficacy of intravascular lithotripsy (IVL) in the treatment of coronary lesions managed with drug-coated balloons (DCBs). Material and Methods Consecutive patients undergoing lesion preparation with IVL for treatment of calcified coronary lesions with contemporary DCBs were analyzed from the prospective SIROOP Registry (NCT04988685). Outcomes of interest included, among others, periprocedural complications and target lesion failure (TLF). Angiograms and outcomes were independently adjudicated. Results Overall, 41 patients and 43 lesions underwent DCB-PCI involving Shockwave. The patient’s mean age was 73.2±7 years, 37 patients (90.2%) were males. Regarding lesion characteristics, 26 (60.5%) cases involved instent restenosis (ISR), 4 (9.3%) of which were chronic total occlusions (CTO), and only 17 (39.5%) were native lesions. Hybrid treatment, requiring additional stent implantation, was performed in 15 (35%) lesions, the remainder was treated with a "DCB-only" approach. There were no flow-limiting dissections requiring bail-out stent implantation as well as no coronary artery perforations. After a mean follow-up time of 12±3 months, TLF occurred in 12 (27.9%) lesions, TVR was required in 17 (39.5%) vessels. Of note, TLF and TVR were mostly attributable to recurrent ISR in previously implanted metallic stent. Conclusion IVL seems to be a safe and effective preparation strategy for management of calcified coronary lesions undergoing DCB-PCI. Nonetheless, we also encountered an unexpectedly high rate of recurrent ISR, despite aggressive lesion preparation and use of contemporary DCBs. More research is warranted to define optimal lesion preparation, especially in calcified lesions, undergoing DCB-PCI.
Paugsch et al. (Sat,) studied this question.