Literature DB >> 33583818

Ultrathin (60 μm), ultralong (≥40 mm) sirolimus-eluting stent: study of clinical and safety profiles among real-world patients.

Santosh Kumar Sinha1, Puneet Aggarwal2, Umeshwar Pandey1, Mahmodullah Razi1, Awdesh Kumar1, Vinay Krishna1.   

Abstract

OBJECTIVE: Although thin-strut drug-eluting stents (DES) with a more flexible design are easily obtainable, data regarding using ultralong DES (≥40 mm) for long coronary lesions are limited in the literature. Therefore, the current study assessed the safety and efficacy of an ultralong (≥40 mm) and ultrathin (60 μm) biodegradable polymer-coated sirolimus-eluting stent (SES), Supralimus Grace, with a unique Long Dual Z-link (LDZ-link) design (Sahajanand Medical Technologies Pvt. Ltd., Surat, India) in real-world patients with long coronary lesions.
METHODS: The assigned stents were implanted in 684 patients. The primary endpoint was target lesion failure (TLF), which is a composite of cardiovascular death, target vessel myocardial infarction (MI), and target lesion revascularization (TLR), whereas periprocedural secondary endpoints included device failure (failure of stent delivery, change of stent, and stent fracture) and patient-oriented composite endpoint (POCE), which is a composite of all deaths, any MI, and any revascularization, and stent thrombosis (ST). These outcomes were analyzed at one-year follow-up and during the procedure.
RESULTS: The patients' mean age was 52.7±15.9 years; 537 (78.5%) were males. 626 (91.5%) patients suffered from acute coronary syndrome and 58 (8.5%) patients from chronic coronary syndrome (CSS). 989 lesions were removed. The mean numbers of lesions and stents implanted per patient were 1.3±0.2 mm and 1.4±0.3 mm, respectively. TLF occurred in 42 (6.1%) as a result of cardiac death, target vessel MI, and TLR in 9 (1.3%), 20 (2.9%), and 13 (1.9%) patients, respectively. POCE was observed in 131 patients (19.1%) at one-year follow-up, mainly in 63 (9.2%) patients because of any revascularization. Stent failure was seen in 21 patients (3.1%) as a result of delivery failure (2.2%), edge dissection (0.8%), and fracture (0.1%). Definite and probable ST were observed in 8 (1.1%) and 9 (1.3%) patients, respectively.
CONCLUSION: Ultralong (≥40 mm), ultrathin (60 μm) Supralimus Grace stent can be safely implanted in vessels having long and multiple lesions.

Entities:  

Year:  2021        PMID: 33583818      PMCID: PMC8114648          DOI: 10.14744/AnatolJCardiol.2020.40909

Source DB:  PubMed          Journal:  Anatol J Cardiol        ISSN: 2149-2263            Impact factor:   1.596


  35 in total

1.  Myocardial infarction adjudication in contemporary all-comer stent trials: balancing sensitivity and specificity. Addendum to the historical MI definitions used in stent studies.

Authors:  Pascal Vranckx; Donald E Cutlip; Roxana Mehran; Peter-Paul Kint; Sigmund Silber; Stephan Windecker; Patrick W Serruys
Journal:  EuroIntervention       Date:  2010-02       Impact factor: 6.534

2.  Biodegradable polymer drug-eluting stents reduce the risk of stent thrombosis at 4 years in patients undergoing percutaneous coronary intervention: a pooled analysis of individual patient data from the ISAR-TEST 3, ISAR-TEST 4, and LEADERS randomized trials.

Authors:  Giulio G Stefanini; Robert A Byrne; Patrick W Serruys; Antoinette de Waha; Bernhard Meier; Steffen Massberg; Peter Jüni; Albert Schömig; Stephan Windecker; Adnan Kastrati
Journal:  Eur Heart J       Date:  2012-03-24       Impact factor: 29.983

3.  Third universal definition of myocardial infarction.

Authors:  Kristian Thygesen; Joseph S Alpert; Allan S Jaffe; Maarten L Simoons; Bernard R Chaitman; Harvey D White; Kristian Thygesen; Joseph S Alpert; Harvey D White; Allan S Jaffe; Hugo A Katus; Fred S Apple; Bertil Lindahl; David A Morrow; Bernard R Chaitman; Peter M Clemmensen; Per Johanson; Hanoch Hod; Richard Underwood; Jeroen J Bax; Jeroen J Bonow; Fausto Pinto; Raymond J Gibbons; Keith A Fox; Dan Atar; L Kristin Newby; Marcello Galvani; Christian W Hamm; Barry F Uretsky; Ph Gabriel Steg; William Wijns; Jean-Pierre Bassand; Phillippe Menasche; Jan Ravkilde; E Magnus Ohman; Elliott M Antman; Lars C Wallentin; Paul W Armstrong; Maarten L Simoons; James L Januzzi; Markku S Nieminen; Mihai Gheorghiade; Gerasimos Filippatos; Russell V Luepker; Stephen P Fortmann; Wayne D Rosamond; Dan Levy; David Wood; Sidney C Smith; Dayi Hu; Jose-Luis Lopez-Sendon; Rose Marie Robertson; Douglas Weaver; Michal Tendera; Alfred A Bove; Alexander N Parkhomenko; Elena J Vasilieva; Shanti Mendis; Jeroen J Bax; Helmut Baumgartner; Claudio Ceconi; Veronica Dean; Christi Deaton; Robert Fagard; Christian Funck-Brentano; David Hasdai; Arno Hoes; Paulus Kirchhof; Juhani Knuuti; Philippe Kolh; Theresa McDonagh; Cyril Moulin; Bogdan A Popescu; Zeljko Reiner; Udo Sechtem; Per Anton Sirnes; Michal Tendera; Adam Torbicki; Alec Vahanian; Stephan Windecker; Joao Morais; Carlos Aguiar; Wael Almahmeed; David O Arnar; Fabio Barili; Kenneth D Bloch; Ann F Bolger; Hans Erik Botker; Biykem Bozkurt; Raffaele Bugiardini; Christopher Cannon; James de Lemos; Franz R Eberli; Edgardo Escobar; Mark Hlatky; Stefan James; Karl B Kern; David J Moliterno; Christian Mueller; Aleksandar N Neskovic; Burkert Mathias Pieske; Steven P Schulman; Robert F Storey; Kathryn A Taubert; Pascal Vranckx; Daniel R Wagner
Journal:  J Am Coll Cardiol       Date:  2012-09-05       Impact factor: 24.094

4.  A prospective multicentre randomised all-comers trial to assess the safety and effectiveness of the thin-strut sirolimus-eluting coronary stent SUPRAFLEX: rationale and design of the Thin Strut Sirolimus-eluting Stent in All Comers Population vs Everolimus-eluting Stent (TALENT) trial.

Authors:  Rodrigo Modolo; Ply Chichareon; Norihiro Kogame; Taku Asano; Chun-Chin Chang; Robbert J de Winter; Upendra Kaul; Azfar Zaman; Ernest Spitzer; Kuniaki Takahashi; Yuki Katagiri; Osama I I Soliman; Gerrit A van Es; Marie-Angèle Morel; Yoshinobu Onuma; Patrick W Serruys
Journal:  EuroIntervention       Date:  2019-07-20       Impact factor: 6.534

5.  Outcomes in Patients Treated With Thin-Strut, Very Thin-Strut, or Ultrathin-Strut Drug-Eluting Stents in Small Coronary Vessels: A Prespecified Analysis of the Randomized BIO-RESORT Trial.

Authors:  Rosaly A Buiten; Eline H Ploumen; Paolo Zocca; Carine J M Doggen; Liefke C van der Heijden; Marlies M Kok; Peter W Danse; Carl E Schotborgh; Martijn Scholte; Frits H A F de Man; Gerard C M Linssen; Clemens von Birgelen
Journal:  JAMA Cardiol       Date:  2019-07-01       Impact factor: 14.676

6.  Implications of small reference vessel diameter in patients undergoing percutaneous coronary revascularization.

Authors:  H Schunkert; L Harrell; I F Palacios
Journal:  J Am Coll Cardiol       Date:  1999-07       Impact factor: 24.094

7.  Long-term (8 year) outcomes and predictors of major adverse cardiac events after full metal jacket drug-eluting stent implantation.

Authors:  Cheol Whan Lee; Jung-Min Ahn; Jong-Young Lee; Won-Jang Kim; Duk-Woo Park; Soo-Jin Kang; Seung-Whan Lee; Young-Hak Kim; Seong-Wook Park; Seung-Jung Park
Journal:  Catheter Cardiovasc Interv       Date:  2014-04-21       Impact factor: 2.692

8.  Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial.

Authors:  David E Kandzari; Laura Mauri; Jacques J Koolen; Joseph M Massaro; Gheorghe Doros; Hector M Garcia-Garcia; Johan Bennett; Ariel Roguin; Elie G Gharib; Donald E Cutlip; Ron Waksman
Journal:  Lancet       Date:  2017-08-26       Impact factor: 79.321

Review 9.  Cardiovascular Diseases in India: Current Epidemiology and Future Directions.

Authors:  Dorairaj Prabhakaran; Panniyammakal Jeemon; Ambuj Roy
Journal:  Circulation       Date:  2016-04-19       Impact factor: 29.690

10.  Small-vessel treatment with contemporary newer-generation drug-eluting coronary stents in all-comers: Insights from 2-year DUTCH PEERS (TWENTE II) randomized trial.

Authors:  Liefke C van der Heijden; Marlies M Kok; Peter W Danse; Alexander R Schramm; Marc Hartmann; Marije M Löwik; Gerard C M Linssen; Martin G Stoel; Carine J M Doggen; Clemens von Birgelen
Journal:  Am Heart J       Date:  2016-03-17       Impact factor: 4.749

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