Balloon angioplasty versus Shockwave intravascular lithotripsy in calcified coronary arteries: the BASIL study.

Abstract

Objectives: Severe coronary calcification is a predictor for procedural failure during percutaneous coronary intervention (PCI). Intravascular lithotripsy (IVL) delivers acoustic pressure waves to modify coronary calcification to optimize stent results. The efficacy of IVL compared to conventional balloon angioplasty (BA) prior to drug-eluting stent (DES) implantation is largely unknown. This study aimed to compare pretreatment with IVL vs BA for severely calcified coronary lesions prior to DES implantation.

Methods: A total of 60 patients with severely calcified coronary disease undergoing PCI were randomly assigned (1:1 ratio) to conventional BA or IVL pretreatment groups. The primary efficacy endpoint was procedural success (successful stent implantation without bailout calcium modification devices, no major angiographic complications, and residual stenosis less than 20%). The primary safety endpoint was freedom from in-hospital major adverse cardiovascular events (MACE) including death, periprocedural myocardial infarction, stroke, and target vessel revascularization/target lesion failure.

Results: Procedural success was achieved in 15 (55.6%) patients in the BA group and 24 (72.7%) patients in the IVL group (P = .165). Requirement for bailout calcium modification was higher in the BA group (22.2% vs 0.0%; P = .004). The primary safety endpoint was achieved in 26 (96.3%) patients in the BA group and 30 (90.9%) patients in the IVL group (P = .405).

Conclusions: In PCI of severely calcified coronary disease, no significant differences in procedural success or in-hospital MACE were identified when comparing IVL to conventional BA pretreatment. There was a higher need for additional dedicated calcium modification observed with conventional BA.