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

    Pothineni, Ramesh Babu / Ajmera, Prakash / Chawla, Kamal Kumar / Mantravadi, Sai Sudhakar / Pathak, Abhijit / Inamdar, Manohar K / Jariwala, Pankaj Vinod / Vijan, Vikrant / Vijan, Vinod / Potdar, Anil

    Cardiology

    2024  

    Abstract: 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) ... ...

    Abstract 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.
    Language English
    Publishing date 2024-05-07
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 80092-2
    ISSN 1421-9751 ; 0008-6312
    ISSN (online) 1421-9751
    ISSN 0008-6312
    DOI 10.1159/000538964
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: 3-Year Clinical Outcomes of Ultrathin Biodegradable Polymer-Coated Sirolimus-Eluting Stents: T-Flex Registry With High-Risk Subgroups.

    Pothineni, Ramesh Babu / Vijan, Vikrant / Potdar, Anil / Inamdar, Manohar K / Pathak, Abhijit / Mantravadi, Sai Sudhakar / Ajmera, Prakash

    JACC. Asia

    2022  Volume 2, Issue 6, Page(s) 784–785

    Language English
    Publishing date 2022-11-15
    Publishing country United States
    Document type Journal Article
    ISSN 2772-3747
    ISSN (online) 2772-3747
    DOI 10.1016/j.jacasi.2022.07.004
    Database MEDical Literature Analysis and Retrieval System OnLINE

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

    Babu Pothineni, Ramesh / Ajmera, Prakash / Chawla, Kamal Kumar / Mantravadi, Sai Sudhakar / Pathak, Abhijit / Inamdar, Manohar K / Jariwala, Pankaj V / Vijan, Vikrant / Vijan, Vinod / Potdar, Anil

    Cureus

    2023  Volume 15, Issue 7, Page(s) e41743

    Abstract: 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 ... ...

    Abstract 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.
    Language English
    Publishing date 2023-07-11
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2747273-5
    ISSN 2168-8184
    ISSN 2168-8184
    DOI 10.7759/cureus.41743
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: 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.

    Pothineni, Ramesh Babu / Vijan, Vikrant / Potdar, Anil / Inamdar, Manohar K / Pathak, Abhijit / Mantravadi, Sai Sudhakar / Ajmera, Prakash

    Anatolian journal of cardiology

    2021  Volume 25, Issue 10, Page(s) 706–715

    Abstract: 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 ... ...

    Abstract 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.
    MeSH term(s) Absorbable Implants ; Cardiovascular Agents ; Coronary Artery Disease/therapy ; Drug-Eluting Stents ; Humans ; Percutaneous Coronary Intervention ; Polymers ; Registries ; Retrospective Studies ; Risk Factors ; Sirolimus ; Treatment Outcome
    Chemical Substances Cardiovascular Agents ; Polymers ; Sirolimus (W36ZG6FT64)
    Language English
    Publishing date 2021-10-06
    Publishing country Turkey
    Document type Journal Article ; Multicenter Study
    ZDB-ID 2278670-3
    ISSN 2149-2271 ; 2149-2263
    ISSN (online) 2149-2271
    ISSN 2149-2263
    DOI 10.5152/AnatolJCardiol.2021.78291
    Database MEDical Literature Analysis and Retrieval System OnLINE

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