One-year Outcomes of Biodegradable Polymer-coated Sirolimus-eluting Coronary Stent in Acute Coronary Syndrome - A Patient-level Pooled Analysis from Two Indian Registries.

INTRODUCTION: This pooled analysis was conducted to assess the clinical safety and performance of the Supra family (Sahajanand Medical Technologies Ltd., Surat, India) of sirolimus-eluting stents (SES) in patients with acute coronary syndromes (ACS) including ST segment elevation myocardial infarction (STEMI) from two real-world all-comers Indian registries at one-year. METHODS: We evaluated 1824 patients with ACS who underwent percutaneous coronary intervention with the Supra family of SES from two real-world Indian registries (891 patients from T-Flex registry and 933 patients from Tetriflex real-world registry). The primary endpoint was the incidence of target lesion failure (TLF) defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI), and target lesion revascularization (TLR) at one-year follow-up. The safety endpoint was stent thrombosis at one-year follow-up. RESULTS: Among a total of 1824 patients with ACS, 689 (37.8%) patients presented with STEMI. In ACS and STEMI groups, 47.6% and 41.8% patients had multi-vessel disease, respectively. Of 2128 lesions in ACS group, 76.7% lesions were type B2/C and 16.2% lesions were totally occluded. In the STEMI group, out of 784 treated lesions, 76.7% were type B2/C lesions and 21.9% were totally occluded. At one-year follow-up, incidence of TLF was 5.3% (cardiac death: 0.9%, TV-MI: 2.5%, TLR: 1.9%) in patients with ACS and 6.2% (cardiac death: 1.4%, TV-MI: 2.1%, TLR: 2.7%) in patients with STEMI. The one-year rate of definite/probable stent thrombosis were 0.3% and 0.7% in patients with ACS and STEMI, respectively. CONCLUSION: This patient-level pooled analysis provides evidence for the safe and effective use of the Supra family of SES in complex patient populations such as ACS and even in STEMI with favourable rates of TLF and stent thrombosis at one-year follow-up.

Ultrathin Strut Biodegradable Polymer-Coated Sirolimus-Eluting Coronary Stents: Patient-Level Pooled Analysis From Two Indian Registries.

Background Despite significant evolution in stent technology, female gender, and patients with diabetes mellitus, multivessel disease, total occlusions, long lesions, and small vessels represent the "Achilles' heel" of contemporary percutaneous coronary intervention (PCI). We performed a pooled analysis of high-risk subgroup on patient-level data from the T-Flex registry (1,203 patients) and a real-world Indian registry (1,269 patients), with the aim of assessing one-year safety and clinical performance of ultrathin strut biodegradable polymer-coated Supra family of sirolimus-eluting stents (SES) (Sahajanand Medical Technologies Limited, Surat, India) in the real-world, all-comer population. Method We pooled the following high-risk subgroups data from two all-comer registries: female gender (n=678), diabetes mellitus (n=852), multivessel disease (n=406), total occlusions (n=420), long lesions (≥28 mm) (n=1241), and small vessels (≤2.5 mm) (n=726). Both the registries included patients with coronary artery disease who underwent implantation of at least one SES belonging to the Supra family of stents from May 2016 until March 2018, irrespective of lesion complexity and comorbidities. The primary endpoint was the inci-dence of target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revas-cularization by percutaneous or surgical methods up to one year. The safety endpoint was stent thrombosis.  Results According to prespecified high-risk subgroups, one-year rates of TLF and overall stent thrombosis, respectively, were as follows: female gender (4.9% and 0.6%), diabetes mellitus (6.9% and 1.0%), multivessel disease (6.4% and 0.8%), total occlusions (5.2% and 0.5%), long lesions (≥28 mm) (6.6% and 0.8%), and small vessels (≤2.5 mm) (6.1% and 1.3%). Conclusion This present pooled analysis demonstrated the one-year safety and clinical performance of ultrathin strut biodegradable polymer-coated Supra family of SES in a real-world, all-comer population, with considerably low rates of TLF and stent thrombosis.

Twelve months clinical outcomes of ultrathin strut sirolimus-eluting stent in real-world Indian patients with coronary artery disease.

PURPOSE: Although the field of interventional cardiology has witnessed extraordinary progression, the search of an ideal coronary drug-eluting stent is still going on. Tetriflex (Sahajanand Medical Technologies Limited, Surat, India) is a latest generation biodegradable polymer-coated ultrathin (60 µm) sirolimus-eluting stent (SES) with unique Long Dual Z-link (LDZ) design. The present registry reports the 12 months clinical follow-up results of Tetriflex SES in unselected, real-world patients with coronary artery disease (CAD). METHODS: This was an investigator-initiated, retrospective, multi-center, single-arm, observational registry conducted in India between March-2017 and March-2018. The registry included 1269 consecutive patients with CAD who underwent implantation of at least one Tetriflex SES. The primary outcome was considered as target lesion failure (TLF), which was a composite of cardiac death, target-vessel myocardial infarction (TV-MI) and clinically-driven target lesion revascularisation (CD-TLR) at 12 months follow-up. The safety outcome, at 12 months follow-up, was stent thrombosis. RESULTS: Mean age of patients was 54.99±10.80 years. Among all, 36.6% patients had diabetes and 51.7% patients had multi-vessel disease. A total of 1515 lesions were treated with 1682 Tetriflex SES of which 73.2% lesions were complex B2/C type and 14.7% were totally occluded. At 12 months, the cumulative incidence of TLF was 5.75% comprising 0.8% cardiac death, 3.20% TV-MI and 1.72% CD-TLR. All the incidences of definite/probable stent thrombosis (n = 4, 0.32%) were reported within 30 days of the index procedure. Twelve-month cumulative incidence of TLF in diabetic subgroup was 7.10%. CONCLUSION: Twelve months clinical follow-up results of an ultrathin (60 µm), biodegradable polymer-coated Tetriflex SES, with unique LDZ-link, further clarify its safety and effectiveness in real-world, unselected Indian patients.

Clinical outcomes of ultrathin biodegradable polymer-coated sirolimus-eluting stents in an all-comer population: One-year results from the T-FLEX registry including high-risk subgroups.

OBJECTIVE: T-Flex registry was designed to investigate the safety and clinical performance of the ultrathin (60 µm) strut biodegradable polymer-coated sirolimus-eluting stent (SES) with a unique long dual Z (LDZ) link design on a cobalt-chromium stent platform (Sahajanand Medical Technologies Pvt. Ltd., Surat, India) in a real-world all-comer population including high-risk subgroups. METHODS: This was an observational, multicenter, single-arm, and investigator-initiated retrospective registry. A total of 1,203 patients treated with an ultrathin biodegradable polymer-coated SES, irrespective of lesion complexity, comorbidities, and acute presentation were analyzed from May 2016 to January 2017. The primary endpoint was the one-year incidence of target lesion failure (TLF), a composite of cardiac death, target-vessel myocardial infarction (TV-MI), and clinically-indicated target lesion revascularization (CI-TLR). Stent thrombosis was assessed as an additional safety endpoint. RESULTS: At the one-year follow-up, TLF was observed in 3.8% [95% confidence interval (CI) 2.9-5.1] patients, composed of 0.6% (95% CI: 0.3-1.3) cardiac death, 1.3% (95% CI: 0.8-2.2) TV-MI, and 1.9% (95% CI: 1.3-2.9) CI-TLR. In the high-risk subgroups, TLF at one-year was 6.8% (95% CI: 4.6-9.8) in patients with diabetes, 5.2% (95% CI: 3.4-8) in patients with small-vessel disease, 6.1% (95% CI: 3.9-9.6) in patients with ST-elevation myocardial infarction, and 4.5% (95% CI: 2.4-8.3) in patients with total occlusion. During follow-up, stent thrombosis was reported in 0.8% (95% CI: 0.4-1.5) patients in the overall population. CONCLUSION: Low event rates of TLF and stent thrombosis at one-year follow-up indicate that this ultrathin biodegradable polymer-coated SES has encouraging safety and clinical performance in real-world all-comer populations as well as in high-risk subgroups.

Real-World Use Of Ultrathin-Strut Biodegradable Polymer-Coated Sirolimus-Eluting Stents In Patients With Coronary Artery Disease: 6-Month Clinical Outcomes.

BACKGROUND: Although a number of drug-eluting stents have been developed with different design, composition, and polymers, the search for an ideal drug-eluting stent is ongoing. The Tetriflex (Sahajanand Medical Technology, Surat, India) is a newer-generation, ultrathin (60 µm) biodegradable polymer-coated sirolimus-eluting stent (SES) designed with a unique long dual Z-link on a cobalt-chromium alloy. The present registry aimed to evaluate the safety and clinical outcomes of the Tetriflex SES at 6-month post-implantation. METHODS: This was an investigator-initiated, retrospective, multicenter, single-arm, observational registry conducted at five tertiary-care centers in India. A total of 1,269 consecutive patients with coronary artery disease who underwent implantation of at least one Tetriflex SES between March 2017 and March 2018 were included. The primary outcome was considered a composite of cardiac death, myocardial infarction and target-lesion revascularization (TLR) at 6-month follow-up. Stent thrombosis was evaluated as a safety outcome at 6-month follow-up. RESULTS: The mean age of patients was 54.99±10.80 years. Among 1,515 lesions treated with 1,682 Tetriflex SES, 58.3% were type C lesions. Six-month follow-up was done for 1,245 of 1,269 (98.1%) patients. At 6 months, composite events had occurred in 31 (2.5%) patients, consisting of ten (0.8%) cardiac deaths, 16 (1.3%) myocardial infarctions, and five (0.4%) TLRs. Stent thrombosis was observed in seven (0.56%) cases at 6 months. A subgroup analysis between diabetic and nondiabetic patients did not reveal any statistically significant difference for clinical outcomes at 6-month follow-up. CONCLUSION: The results of the current registry outline the safety and effectiveness of the Tetriflex SES in real-world patients, as it displayed favorable clinical outcomes at 6-month follow-up, with low incidence of TLR and stent thrombosis.