Key result
Long-tapered sirolimus-eluting stents show high deliverability and no significant device-related MACE at 12 months.
Why the study?
There is a lack of data about the treatment of long diffuse coronary lesions using single or multiple stent strategies and the impact of overlap reduction with long-tapered drug-eluting stents.
Does the BioMime Morph long-tapered sirolimus-eluting stent provide safe clinical outcomes and acceptable deliverability in patients with very long coronary atherosclerotic lesions?
Cohort (n=32)
No
Does the BioMime Morph long-tapered sirolimus-eluting stent provide safe clinical outcomes and acceptable deliverability in patients with very long coronary atherosclerotic lesions?
The use of a novel long-tapered sirolimus-eluting stent for very long coronary lesions appears safe and feasible, minimizing the need for complex overlapping stent techniques.
May support tapered stent use in long lesions; leaves open need for randomized trials to confirm outcomes.
INTRODUCTION: Long lesions contribute to a significant number of percutaneous coronary interventions. AIM: To assess the efficacy and safety of a novel long-tapered drug-eluting stent (DES) at a 12-month follow-up (FU) in patients with long coronary atherosclerotic lesions. MATERIAL AND METHODS: A prospective clinical cohort study was conducted in 32 patients who underwent percutaneous coronary intervention using a BioMime Morph tapered stent (Meril Life Sciences, India). The patients were followed for 3, 6, and 12 months. The safety endpoints were death, myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), and MACE and/or major bleeding. RESULTS: Mean lesion length was 48 mm (range: 35-70 mm) measured via quantitative coronary analysis (QCA). In most cases, the target lesion was located in the LAD (68.75%). A GuideLiner catheter (Vascular Solutions Inc., MN, USA) was used in 12.5% of procedures; buddy-wire technique in 9.4% of cases. Bifurcation lesions were treated in 40.6% of cases. Additional stent implantation was needed in 56% of the procedures (25% of cases due to proximal or distal dissection, or due to insufficient stent length in 31% of cases). On 12-month FU we observed 1 TLR (3.1%), 1 TVR (3.1%), and 1 non-cardiovascular death. CONCLUSIONS: The long sirolimus-eluting stent with tapered structure was characterized by good deliverability in long coronary lesions, although in some cases "buddy wire" or extension microcatheter use was necessary. Follow-up at 3, 6, and 12 months showed no significant major adverse cardiovascular events related to the device.
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Podolec et al. (2019) conducted a cohort in Long coronary atherosclerotic lesions (n=32). BioMime Morph long-tapered sirolimus-eluting stent was evaluated on Safety endpoints (death, myocardial infarction, target lesion revascularization, target vessel revascularization, MACE and/or major bleeding at 12 months). In patients with long coronary lesions, implantation of a long-tapered sirolimus-eluting stent demonstrated good deliverability with no significant device-related major adverse cardiovascular events at 12-month follow-up.
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