Comparison of a Contemporary Sirolimus-eluting Stent (ihtDEStiny®) With Another Everolimus-eluting Stent (Xience™), Both With Permanent Polymers, in Patients With Acute Coronary Syndrome and de Novo Coronary Artery Lesions

Official title

Comparison of a Contemporary Sirolimus-eluting Stent (ihtDEStiny®) With Another Everolimus-eluting Stent (Xience™), Both With Permanent Polymers, in Patients With Acute Coronary Syndrome and de Novo Coronary Artery Lesions (DestinACSion Study)

Overview

To evaluate the efficacy of the two DES (Drug Eluting Stent) used in terms of device-related adverse events at 12 months after PCI (Percutaneous Coronary Intervention). To compare the clinical safety and efficacy by comparing net clinical events (defined as the combination of ischemic and hemorrhagic events) of the two DES used at 12 months after PCI.

Detailed description

To evaluate the efficacy of the two DES (Drug Eluting Stent) used in terms of device-related adverse events at 12 months after PCI (Percutaneous Coronary Intervention).

To compare the clinical safety and efficacy by comparing net clinical events (defined as the combination of ischemic and hemorrhagic events) of the two DES used at 12 months after PCI.

Interventions

• Device ihtDEStiny® DES implanted
  ihtDEStiny® DES implanted
• Device Xience™ DES implanted
  Xience™ DES implanted

Primary outcome measures

• EFFICACY: Device-oriented Composite Endpoint (DoCE) [Time frame: 12 months]
• NACE [Time frame: 12 months]

Secondary outcome measures (12)

• All-Cause Death Rate at 12 months [Time frame: 12 months]
• All-Cause Death Rate at 24 months [Time frame: 12 months]
• Cardiac Death Rate at 12 months [Time frame: 12 months]
• Cardiac Death Rate at 24 months [Time frame: 12 months]
• Myocardial Infarction Rate at 12 months [Time frame: 12 months]
• Myocardial Infarction Rate at 24 months [Time frame: 12 months]
• Periprocedural myocardial infarction Rate [Time frame: PCI procedure]
• Definite/Probable stent thrombosis rate at 12 months [Time frame: 12 months]
• Definite/Probable stent thrombosis rate at 24 months [Time frame: 24 months]
• Any stroke at 12 months [Time frame: 12 months]
• Any stroke at 24 months [Time frame: 12 months]
• BARC type 2 ,3 or 5 bleeding events at 12 months [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

Patients who meet ALL inclusion criteria will be included:

• Patients aged ≥18 years, and
• Patients diagnosed with an acute coronary syndrome (ACS), either SCASEST (Acute Coronary Syndrome without Persistent ST-Segment Elevation) or IAMCEST (Acute Myocardial Infarction with Persistent ST-Segment Elevation), for which they will undergo PCI, and
• Patients with de novo lesions in vessels with a reference diameter of ≥2.25 mm and ≤4.5 mm in whom implantation of one or more DES is clinically indicated, and
• Patients who have been informed of the characteristics of the study and have provided written informed consent.

Exclusion criteria

Patients must not meet any of the following exclusion criteria:

• Patients in cardiogenic shock according to the severity criteria defined by the Society of Cardiovascular Angiography and Interventions (SCAI): "C" (Classic Shock), "D" (Deteriorating) and "E" (Extremis).
• Patients unable to provide informed consent.
• Patients with a known hypersensitivity or allergy to aspirin or any P2Y12 receptor inhibitor (clopidogrel, prasugrel, ticagrelor), heparin, contrast agents, or any of the components of DES.
• Patients with active bleeding at the time of PCI requiring medical attention.
• Patients with planned surgery within the next 3 months.
• Patients with any medical condition that limits a life expectancy of less than 12 months.
• Patients participating in another clinical trial in which the primary endpoint was not met.
• Pregnant or breastfeeding women of childbearing potential with a positive pregnancy test.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Spain · 19 centers

• Hospital Universitario San Juan Alicante — Alicante
• Hospital Universitari Germans Trias I Pujol — Badalona
• Hospital Universitario de Cruces — Barakaldo
• Hospital Universitari Vall d'Hebron — Barcelona
• Hospital Clínic de Barcelona — Barcelona
• Hospital General Universitario de Castellon — Castelló
• Hospital Universitario de Donostia — Donostia / San Sebastian
• Hospital Universitario Virgen de La Arrixaca — El Palmar
• … and 11 more centers

Publications

• de la Torre Hernandez JM, Otaegui I, Subinas A, Gomez-Menchero A, Moreno R, Rondan J, Munoz-Garcia E, Sainz-Laso F, Garcia Del Blanco B, Rumoroso JR, Diaz JF, Berenguer A, Gomez-Lara J, Zueco J. First-in-Man Evaluation of a Sirolimus-Eluting Stent With Abluminal Fluoropolymeric/Triflusal Coating With Ultrathin Struts by OCT at 9 Months' Follow-Up: The PROMETHEUS Study. Cardiovasc Revasc Med. 2021 PMID 33386256
• Ploumen EH, von Birgelen C. Novel DES Aims at Full Thromboresistance: Another Promising Player on the Field? Cardiovasc Revasc Med. 2021 Nov;32:25-26. doi: 10.1016/j.carrev.2021.07.029. Epub 2021 Aug 11. No abstract available. PMID 34391680
• Linares Vicente JA, Sainz Laso F, Casanova Sandoval JM, Rumoroso Cueva JR, Gomez Menchero A, Gomez Hospital JA, Perez Guerrero A, Santos Martinez S, Fernandez Portales J, Romani S, Garcia Del Blanco B, Ocaranza Sanchez R, Urbano Carrillo C, Garcia San Roman K, Vinhas H, Cid Alvarez B, Sanchis Fores J, Telleria Arrieta M, Torres Bosco A, Pinar Bermudez E, Mendez Castro JJ, Lozano Ruiz de Poveda F, PMID 40713212
• Zaman A, de Winter RJ, Kogame N, Chang CC, Modolo R, Spitzer E, Tonino P, Hofma S, Zurakowski A, Smits PC, Prokopczuk J, Moreno R, Choudhury A, Petrov I, Cequier A, Kukreja N, Hoye A, Iniguez A, Ungi I, Serra A, Gil RJ, Walsh S, Tonev G, Mathur A, Merkely B, Colombo A, Ijsselmuiden S, Soliman O, Kaul U, Onuma Y, Serruys PW; TALENT trial investigators. Safety and efficacy of a sirolimus-eluting cor PMID 30827782
• Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Circulation. 2018 Jun 12;137(24):2635-2 PMID 29891620

Identifiers

NCT: NCT07190690 · EPIC45-DestinACSion

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗