Ultra-thin everolimus-eluting stents in atherosclerotic lesions: Three years follow-up with subgroup analysis of ultra-long stents.

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.

Safety and performance of everolimus-eluting stents comprising of biodegradable polymers with ultrathin stent platforms.

BACKGROUND: The registry investigated clinical outcomes after 12 months of implantation of ultra-thin strut (60 µm) biodegradable polymer-coated Tetrilimus everolimus-eluting stents (EES; Sahajanand Medical Technologies Pvt. Ltd., Surat, India) in patients with atherosclerotic coronary lesions. Additionally, sub-group analysis was performed to evaluate outcomes of ultra-long (44/48 mm) Tetrilimus EES in patients with long lesions. METHODS: This was an observational, single-center, single-arm and investigator-initiated retrospective registry. In this all-comers registry, patients who underwent implantation of Tetrilimus EES for treatment of coronary artery disease during routine clinical practice between February-2016 and August-2016 at tertiary care center of India were included. Primary endpoint was occurrence of any major adverse cardiac event (MACE) up to 12 months' follow-up. MACE was a composite of cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR). Similar endpoints were observed in sub-group patients. RESULTS: Total 766 stents were implanted to treat 695 lesions in 558 patients. Of treated lesions, 11.4% lesions were type B2 and 78.3% were type C lesions. In sub-group analysis of 143 patients, a total of 155 long coronary lesions were intervened successfully with only one stent been implanted per lesion. At 12 months' follow-up, four (0.7%) cases of cardiac death, eight (1.4%) of MI, and two (0.4%) of TLR were reported, resulting in a 2.5% rate of MACE. The MACE rate was 2.8% in sub-group patients. CONCLUSIONS: Twelve months' clinical data demonstrated favorable safety and excellent performance of Tetrilimus EES in high-risk patients and complex coronary lesions in routine clinical practice and also in patients with ultra-long lesions.

Impact of ultra-long sirolimus-eluting stents on coronary artery lesions: one-year results of real-world FLEX-LONG Study.

BACKGROUND: The FLEX-LONG study assessed the safety and clinical outcomes of ultra-long (44 mm/48 mm) biodegradable polymer-coated Supraflex (Sahajanand Medical Technology Pvt. Ltd., Surat, India) sirolimus-eluting stents (SES) in real-world patients with complex, long coronary artery lesions. METHODS: It was an investigator-initiated, retrospective, non-randomized, observational and single-center study, which evaluated one-year results of 141 patients who had undergone implantation of at least one ultra-long (44 mm/48 mm) Supraflex SES. The incidence of major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR), at one-year follow-up was considered as primary outcome. Stent thrombosis was analyzed as a safety outcome. RESULTS: The mean age of the study population was 56.2±9.6 years and 78.0% (110/141) patients were male. The study analyzed high risk patients, including 62 (44.0%) hypertensive and 60 (42.6%) diabetic patients. Total 147 target lesions were treated, including 25 (17.0%) total occlusions. Total 51 (34.7%) and 96 (65.3%) Supraflex SES of 44 mm and 48 mm were implanted, respectively. Average stent length and diameter were 46.6±1.9 mm and 3.4±0.2 mm, respectively. One-year follow-up was obtained in 100% of patients. There was one probable stent thrombosis after three weeks. At one-year follow-up, 99.3% of patients remained event free. CONCLUSIONS: The results of the FLEX-LONG study support the use of ultra-long (44 mm/48 mm) Supraflex SES, in the treatment of high-risk real-world patients. The stent appeared to be safe and effective at one-year with low clinical events in complex, long coronary artery lesions.

Local Intrasinus Thrombolysis for Cerebral Venous Sinus Thrombosis.

BACKGROUND: Cerebral venous strokes due to cerebral venous sinus thrombosis (CVST) have varied presentation and clinical outcome. Despite aggressive medical treatment with optimal anticoagulation, some patients develop progressive neurologic deterioration causing significant morbidity and mortality. The aim of the present series is to analyze the safety and efficacy of in situ thrombolysis in patients with cerebral venous sinus thrombosis in severe clinical grade and refractory to conventional medical management. MATERIALS AND METHODS: Twenty-nine patients with cerebral venous thrombosis who received in situ thrombolysis during a 3-year period (April 2013 to April 2016) were included in the study. Tissue plasminogen activator (tpa) was used in all the patients. The lytic agent was infused into the sinus via the micro catheter. Data regarding demographic, clinical, and radiologic features were analyzed in all the patients. RESULTS: Recanalization of the affected sinuses was achieved in all the cases. Twenty-four patients had good outcome (mRs 0 or1) and three patients had mild deficits (mRs 2). One patient had moderate disability (mRs 3). One patient succumbed due to increased hematoma causing midline shift and transtentorial herniation. At 3 months follow-up, 26 patients were asymptomatic and two patients had minor symptoms. CONCLUSION: Local intrasinus thrombolysis (LIST) is safe and effective method in patients with poor clinical grade and the present study highlights the benefit of thrombolysis, particularly in patients unresponsive to anticoagulation. The improved efficacy of this therapy depends on early recognition of worsening symptoms and timely intervention.