Key result
Implantation of the Tetrilimus everolimus-eluting stent in patients with coronary artery disease demonstrated a 3-year major adverse cardiac event rate of 9.1% and a stent thrombosis rate of 1.0%.
Why the study?
The long-term safety and efficacy of the Tetrilimus everolimus-eluting stent, including the outcomes of ultra-long stents in patients with long coronary lesions, required evaluation.
Observational (n=558)
No
Everolimus-eluting stents demonstrated favorable long-term safety and efficacy at 3 years in patients with coronary artery disease, including those requiring ultra-long stents for complex lesions.
Favorable EES outcomes in complex lesions may inform real-world decisions; leaves open need for RCTs to confirm ultra-long stent use.
OBJECTIVES: To assess the long-term (3 years) safety and efficacy of Tetrilimus everolimus-eluting stent (EES) and subgroup analysis of outcomes of ultra-long (44/48 mm) Tetrilimus EES implantation in patients with long coronary lesions. MATERIAL AND METHODS: In this observational, single-centre, single-arm, investigator-initiated registry, 558 patients who underwent implantation of Tetrilimus EES for the treatment of coronary artery disease were retrospectively included. The primary endpoint was occurrence of any major adverse cardiac event (MACE) at 12 months follow-up (composite of cardiac death, myocardial infarction [MI], and target lesion revascularization [TLR]) and we hereby report 3 years follow-up data. Stent thrombosis was assessed as a safety endpoint. A subgroup analysis of patients with long coronary lesions is also reported. RESULTS: A total of 558 patients (57.0 ± 10.2 years) received 766 Tetrilimus EES (1.3 ± 0.5 stents/patient) to treat 695 coronary lesions. In subgroup analysis of 143 patients implanted with ultra-long EES, 155 lesions were intervened successfully with only one Tetrilimus EES (44/48 mm) implanted per lesion. At 3 years, event rates of 9.1% MACE with predominance of MI (4.4%), followed by 2.9% TLR and 1.7% cardiac death, and only 1.0% stent thrombosis were reported in overall population, while in a subgroup of patients implanted with ultra-long EES, 10.4% MACE and 1.5% stent thrombosis were reported. CONCLUSIONS: Three years clinical outcomes showed favourable long-term safety and excellent performance of Tetrilimus EES in high-risk patients and complex coronary lesions in routine clinical practice, including a subgroup of patients with long coronary lesions, with acceptable primary and safety endpoints.
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Polavarapu et al. (2023) conducted an observational in coronary artery disease (n=558). Tetrilimus everolimus-eluting stent (EES) was evaluated on Major adverse cardiac event (MACE) (composite of cardiac death, myocardial infarction, and target lesion revascularization). Implantation of the Tetrilimus everolimus-eluting stent in patients with coronary artery disease demonstrated a 3-year major adverse cardiac event rate of 9.1% and a stent thrombosis rate of 1.0%.
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