Eliano P Navarese1, Mariusz Kowalewski2, Bernardo Cortese3, David Kandzari4, Sofia Dias5, Wojtek Wojakowski6, Antonino Buffon7, Alexandra Lansky8, Paolo Angelini9, Rebecca Torguson10, Jacek Kubica11, Malte Kelm12, Menko-Jan de Boer13, Ron Waksman10, Harry Suryapranata13. 1. Department of Cardiology, Radboud University Medical Center, Nijmegen, The Netherlands; Systematic Investigation and Research on Interventions and Outcomes (SIRIO) MEDICINE Research Network. Electronic address: eliano.navarese@alice.it. 2. 10th Military Research Hospital and Polyclinic, Bydgoszcz, Poland; Systematic Investigation and Research on Interventions and Outcomes (SIRIO) MEDICINE Research Network. 3. Interventional Cardiology Unit, Ospedale Fatebenefratelli, Milan, Italy. 4. Department of Cardiology, Piedmont Heart Institute, Atlanta, GA, USA. 5. University of Bristol, School of Social and Community Medicine, Bristol, UK. 6. Department of Cardiology, Medical University of Silesia, Katowice, Poland. 7. Department of Cardiovascular Sciences, Catholic University of the Sacred Heart, Rome, Italy. 8. Department of Cardiology, Yale Medical School, New Haven, CT, USA. 9. Department of Cardiology, Texas Heart Institute of St. Luke's Episcopal Hospital, Houston, TX, USA. 10. Department of Cardiology, MedStar Washington Hospital Center, Washington, DC, USA. 11. Department of Cardiology and Internal Medicine, Ludwik Rydygier Collegium Medicum, Nicolaus Copenicus University, Bydgoszcz, Poland; Systematic Investigation and Research on Interventions and Outcomes (SIRIO) MEDICINE Research Network. 12. Department of Internal Medicine, Division of Cardiology, Pulmonology and Vascular Medicine, Heinrich-Heine-University, Düsseldorf, Germany. 13. Department of Cardiology, Radboud University Medical Center, Nijmegen, The Netherlands.
Abstract
BACKGROUND: The efficacy and safety of polymer-free drug-eluting stents (DESs) in clinical practice is currently subject of debate; randomized trials (RCTs) conducted so far provided conflicting results or were underpowered to definitively address this question; we aimed to investigate the efficacy and safety profile of polymer-free vs. durable polymer DES by a comprehensive meta-analysis of RCTs. METHODS: MEDLINE, Google Scholar, EMBASE and Cochrane databases were searched for RCTs comparing polymer-free to durable polymer DES. Safety endpoints at short-term (≤ 1 year) and long-term follow-up (>1-year) were: death, myocardial infarction (MI) and stent thrombosis (ST); main efficacy endpoints were: target lesion revascularization (TLR) and target vessel revascularization (TVR). RESULTS: Eight RCTs including 6178 patients were included. No significant differences in mortality were observed between polymer-free and durable polymer DESs at both short- and long-follow up (OR [95% CI] = 0.79 [0.58-1.08], p = 0.14; and 0.80 [0.58-1.10], p = 0.17 respectively); polymer free and durable polymer DESs provided comparable short and long-term MI rates; at short-term: OR [95% CI] = 1.13 [0.83-1.54], p = 0.44 and at long-term: OR [95% CI] = 1.27 [0.87-1.85], p = 0.22. Similarly, these two different devices proved equally effective in regards to ST, TLR and TVR over the short and long follow-up period. CONCLUSIONS: Polymer-free DESs are as safe and effective as durable polymer DES; however, there is no evidence of any additional benefits provided by this new technology.
BACKGROUND: The efficacy and safety of polymer-free drug-eluting stents (DESs) in clinical practice is currently subject of debate; randomized trials (RCTs) conducted so far provided conflicting results or were underpowered to definitively address this question; we aimed to investigate the efficacy and safety profile of polymer-free vs. durable polymer DES by a comprehensive meta-analysis of RCTs. METHODS: MEDLINE, Google Scholar, EMBASE and Cochrane databases were searched for RCTs comparing polymer-free to durable polymer DES. Safety endpoints at short-term (≤ 1 year) and long-term follow-up (>1-year) were: death, myocardial infarction (MI) and stent thrombosis (ST); main efficacy endpoints were: target lesion revascularization (TLR) and target vessel revascularization (TVR). RESULTS: Eight RCTs including 6178 patients were included. No significant differences in mortality were observed between polymer-free and durable polymer DESs at both short- and long-follow up (OR [95% CI] = 0.79 [0.58-1.08], p = 0.14; and 0.80 [0.58-1.10], p = 0.17 respectively); polymer free and durable polymer DESs provided comparable short and long-term MI rates; at short-term: OR [95% CI] = 1.13 [0.83-1.54], p = 0.44 and at long-term: OR [95% CI] = 1.27 [0.87-1.85], p = 0.22. Similarly, these two different devices proved equally effective in regards to ST, TLR and TVR over the short and long follow-up period. CONCLUSIONS:Polymer-free DESs are as safe and effective as durable polymer DES; however, there is no evidence of any additional benefits provided by this new technology.
Authors: Endrin Koni; Wojciech Wanha; Jakub Ratajczak; Zhongheng Zhang; Przemysław Podhajski; Rita L. Musci; Giuseppe M. Sangiorgi; Maciej Kaźmierski; Antonio Buffon; Jacek Kubica; Wojciech Wojakowski; Eliano P. Navarese Journal: J Clin Med Date: 2021-03-19 Impact factor: 4.241