Abstract | OBJECTIVES: BACKGROUND: A number of clinical trials support the overall efficacy and safety of the SYNERGY stent. However, a recent trial (TIDES-ACS) in the context of ACS reported worrying figures of infarction and definite/probable stent thrombosis in the SYNERGY control arm. METHODS: RESULTS: A total of 1008 patients were included with age 65.4 ± 14.8 years, 23.8% females and a 24.5% diabetics. Regarding presentation, a 15.2% with unstable angina, 43% with non-ST elevated myocardial infarction and 41.8% with ST elevated myocardial infarction. Primary outcome was met in 3% (7% in SYNERGY TIDES-ACS arm, P superiority <0.01 and 6.3% in OPTIMAX TIDES-ACS arm, P superiority <0.01). Cardiac death was 1.3% (1.6%, p = 0.8 and 0.5%, P superiority =0.1 respectively). Myocardial infarction was 1.6% (4.6%, p < 0.01 and 1.8%, P superiority = 0.9 respectively). Target lesion revascularization was 1% (3.4%, p < 0.01 and 5.4%, P superiority <0.01 respectively). Definite or probable thrombosis was 0.9% (2.8%, p ≤ 0.01 and 1.1%, P superiority = 0.8 respectively). CONCLUSIONS: The results of this registry show a very good safety and efficacy profile at 12 months for the SYNERGY stent in patients with ACS. SUMMARY: A recent trial (TIDES-ACS) in the context of acute coronary syndromes (ACS) reported worrying figures of infarction and definite/probable stent thrombosis in the SYNERGY stent control arm. We investigated the safety of SYNERGY stent in a real-world study population with ACS applying the same inclusion/exclusion criteria as used in the TIDES-ACS trial. Primary endpoint was the composite of cardiac death, myocardial infarction and TLR at 12 months. A total of 1008 patients have been included. Primary outcome was met in 3% (7% in SYNERGY TIDES-ACS arm, P superiority <0.01 and 6.3% in OPTIMAX TIDES-ACS arm, P superiority <0.01).
|
Authors | Jose M de la Torre Hernandez, Raul Moreno, Nieves Gonzalo, Ricardo Rivera, Jose A Linares, Gabriela Veiga Fernandez, Antonio Gomez Menchero, Bruno Garcia Del Blanco, Felipe Hernandez, Tomas Benito Gonzalez, Asier Subinas, Javier Escaned |
Journal | Cardiovascular revascularization medicine : including molecular interventions
(Cardiovasc Revasc Med)
Vol. 20
Issue 8
Pg. 705-710
(08 2019)
ISSN: 1878-0938 [Electronic] United States |
PMID | 30414798
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Observational Study)
|
Copyright | Copyright © 2018 Elsevier Inc. All rights reserved. |
Chemical References |
- Cardiovascular Agents
- Chromium
- Platinum
- Everolimus
|
Topics |
- Absorbable Implants
- Acute Coronary Syndrome
(diagnostic imaging, mortality, therapy)
- Aged
- Aged, 80 and over
- Angina, Unstable
(diagnostic imaging, mortality, therapy)
- Cardiovascular Agents
(administration & dosage, adverse effects)
- Chromium
- Coronary Thrombosis
(etiology)
- Drug-Eluting Stents
- Everolimus
(administration & dosage, adverse effects)
- Female
- Humans
- Male
- Middle Aged
- Non-ST Elevated Myocardial Infarction
(diagnostic imaging, mortality, therapy)
- Percutaneous Coronary Intervention
(adverse effects, instrumentation, mortality)
- Platinum
- Prosthesis Design
- Recurrence
- Registries
- Retrospective Studies
- Risk Factors
- ST Elevation Myocardial Infarction
(diagnostic imaging, mortality, therapy)
- Spain
- Time Factors
- Treatment Outcome
|