Novel supreme drug-eluting stents with early synchronized antiproliferative drug delivery to inhibit smooth muscle cell proliferation after drug-eluting stents implantation in coronary artery disease: Results of the PIONEER III randomized clinical trial
| Autor: | Ovidiu Dressler, Angel Cequier, Joanna J. Wykrzykowska, David Brogno, Guy N. Piegari, Edouard Benit, Ozgu Issever, Dean J. Kereiakes, Anthony Mathur, Brent T. McLaurin, Yasin Hussain, Pieter C. Smits, Barry D. Bertolet, Shigeru Saito, Sjoerd H. Hofma, Michael Curtis, James P. Zidar, Andreas Baumbach, Salvatore Brugaletta, Cody Pietras, Jacques Berland, Alexandra J. Lansky, Victor Alfonso Jimenez Diaz, Stephan Windecker, Martin B. Leon, Nabil Dib |
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| Přispěvatelé: | Cardiology, ACS - Atherosclerosis & ischemic syndromes, ACS - Heart failure & arrhythmias, Baumbach, A, Curtis, M, McLaurin, B, Mathur, A, Windecker, S, Wykrzykowska, J, Cequier, A, Brogno, D, Issever, O, Hofma, S, Saito, S, Hussain, Y, Leon, MB, Brugaletta, S, Smits, PC, Piegari, G, Pietras, C, Diaz, VAJ, Lansky, AJ, BENIT, Edouard, Zidar, JP, Kereiakes, DJ, Dressler, O, Dib, N, Bertolet, B, Berland, J |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Male
FOCUSED UPDATE Coronary Artery Disease 030204 cardiovascular system & hematology Pharmacology law.invention Coronary artery disease Drug Delivery Systems 0302 clinical medicine Randomized controlled trial Smooth muscle law Medicine 030212 general & internal medicine 610 Medicine & health Drug-eluting stents media_common Aged 80 and over DUAL ANTIPLATELET THERAPY Single-blind method Middle Aged Treatment Outcome GUIDELINE Drug delivery Female Stents Acute coronary syndrome Cardiology and Cardiovascular Medicine INTERVENTION Adult Drug Inflammatory response media_common.quotation_subject ULTRATHIN Article POOLED ANALYSIS Young Adult 03 medical and health sciences Physiology (medical) Humans Aged Cell Proliferation DURABLE-POLYMER business.industry Cell growth medicine.disease THROMBOSIS BARE-METAL BIODEGRADABLE-POLYMER business |
| Zdroj: | Circulation, 143(22), 2143-2154. Lippincott Williams and Wilkins Circulation, 143(22), 2143-2154. LIPPINCOTT WILLIAMS & WILKINS Circulation |
| ISSN: | 0009-7322 |
| Popis: | Background: Accelerated endothelial healing after targeted antiproliferative drug delivery may limit the long-term inflammatory response of drug-eluting stents (DESs). The novel Supreme DES is designed to synchronize early drug delivery within 4 to 6 weeks of implantation, leaving behind a prohealing permanent base layer. Whether the Supreme DES is safe and effective in the short term and can improve long-term clinical outcomes is not known. Methods: In an international, 2:1 randomized, single-blind trial, we compared treatment with Supreme DES to durable polymer everolimus-eluting stents (DP-EES) in patients with acute and chronic coronary syndromes. The primary end point was target lesion failure—a composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. The trial was designed to demonstrate noninferiority (margin of 3.58%) of the Supreme DES at 12 months compared with DP-EES (URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03168776). Results: From October 2017 to July 2019, a total of 1629 patients were randomly assigned (2:1) to the Supreme DES (N=1086) or DP-EES (N=543). At 12 months, target lesion failure occurred in 57 of 1057 patients (5.4%) in the Supreme DES group and in 27 of 532 patients (5.1%) in the DP-EES group (absolute risk difference, 0.32% [95% CI, −1.87 to 2.5]; P non inferiority =0.002]. There were no significant differences in rates of device success, clinically driven target lesion revascularization, or stent thrombosis at 12 months, and the safety composite of cardiovascular death and target vessel myocardial infarction was 3.5% versus 4.6% (hazard ratio, 0.76 [95% CI, 0.46–1.25]) with Supreme DES compared with DP-EES, although rates of combined clinically and non–clinically driven target lesion revascularization at 12 months were higher with Supreme DES. Conclusions: Among patients with acute and chronic coronary syndromes undergoing percutaneous coronary intervention, the Supreme DES proved to be noninferior to the standard DP-EES. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03168776. |
| Databáze: | OpenAIRE |
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