Effectiveness and safety of coronary Laser in UnDIlatable or unCrOssable lesions: The LUDICO study.

Excimer laser coronary atherectomy (ELCA) is increasingly used in complex percutaneous coronary intervention (PCI). In balloon-failure scenarios (uncrossable [UCL] and undilatable lesions [UDL]) uniform procedural endpoints have been applied despite their different mechanisms of failure. To evaluate the effectiveness and safety of ELCA in balloon-failure lesions using lesion-specific endpoints. Prospective, multicentre, single-arm observational study including patients undergoing PCI for UCL, UDL, or combined balloon-failure lesions (CBFL [UCL + UDL]) treated with ELCA. UDL was defined as < 80% expansion with a non-compliant balloon at burst pressure; UCL as inability to cross with a < 1.5 mm balloon despite successful wiring and adequate support. Intracoronary imaging was recommended and analysed in a central core laboratory. Lesion specific ELCA success, procedural success, imaging-based success, complications, and 1-year outcomes were assessed. 254 lesions (230 patients) were included. Lesions were classified as UCL (n = 109), UDL (n = 99), or CBFL (n = 46). Most UDL were in-stent lesions (38.4%), whereas UCL were chronic total occlusions (20.2%). Intracoronary imaging was used in 44.4%. ELCA success was 83.9%, with a trend toward lower success in CBFL (UCL 88.1%, UDL 83.8%, CBFL 73.9% p = 0.09). Procedural success was similar between groups (UCL 81.6%, UDL 81.2%, CBFL 84.8% p = 0.9). Imaging-based success rate was 88.1% (52/59 evaluable lesions). Additional plaque modification was required in 13.4%. Severe ELCA-related complications were 1.9%, all successfully managed. An initial ELCA-based approach is safe and effective for the treatment of selected balloon-failure lesions. CBFL represents the most complex subset showing a trend toward lower ELCA success and frequently requiring additional plaque-modification techniques.