Objective:
To assess the safety and efficacy of Novel tapered (BioMime™ Morph) sirolimus-eluting stent (SES) for left main PCI in a real-world scenario.
Background:
Currently no data is available on clinical usefulness of tapered ultrathin stents in left main PCI.
Methods:
This was a prospective, non-randomised, single centre study carried out between February 2018 and May 2020 at a tertiary cardiac care centre in southern India. The study included patients treated with BioMime Morph tapered stent for distal de novo LMB lesion or ostial LAD/LCX lesions with significant size disparity between reference segments based on the eligibility criteria. Primary endpoint of the study was the cumulative incidence of major adverse cardiovascular events (MACE) composed of cardiac death, myocardial infraction, and clinically driven target-lesion revascularisation at follow-up.
Results:
A total of 41 patients (average age of 54.83±9.81 years) were included in the study. Average SS-2 score was 23.17±5.42. Majority of the lesions (n=31; 75.61%) were of medina class (0.1.0). Provisional single stent strategy was adopted for treatment of LMB lesions. TIMI flow-3 was achieved in 40 patients (97.56%). Median clinical follow-up was 20 months (range 6-34 months) There was no periprocedural complication or MACE during follow-up.
Can the CROSS protocol be safely implemented in real world scenario with broader eligibility criteria? Experience from a tertiary care centre in India
