ECLA ablation was performed at high energy during contrast injection and only within the underexpanded stent. The primary endpoint of successful laser dilatation was defined as an increase of at least 1 mm2 in minimal stent cross-sectional area (MSA) on IVUS or an increase of at least 20% in minimal stent diameter (MSD) by QCA, following redilatation with the same non-compliant balloon that had been unsuccessful prior to ELCA. Secondary endpoints were cardiac death, myocardial infarction (MI) and target lesion revascularization. Between June 2009 and November 2011, 28 patients with an underexpanded stent despite high-pressure balloon inflation were included. The mean laser catheter size was 1.2 卤 0.4 (range 0.9-2.0 mm) and a mean of 62 卤 12 mJ/mm2 at 62 卤 21hertz were required for optimal expansion. Laser-assisted stent dilatation was successful in 27 cases (96.4%), with an improvement in MSD by QCA (1.6 卤 0.6 mm at baseline to 2.6 卤 0.6 mm post-procedure) and MSA by IVUS (3.5 卤 1.1 mm2 to 7.1 卤 1.9 mm2). Periprocedural MI occurred in 7.1%, transient slow-flow in 3.6% and ST elevation in 3.6%. During follow-up, there were no MIs, there was 1 cardiac-death, and TLR occurred in 6.7%.
The ELLEMENT study confirms the feasibility of ELCA with contrast injection to improve stent underexpansion in undilatable stented lesions.