STICH3C: Rationale and Study Protocol.
coronary artery bypass
coronary disease
ischemic heart disease
percutaneous coronary intervention
ventricular dysfunction, left
Journal
Circulation. Cardiovascular interventions
ISSN: 1941-7632
Titre abrégé: Circ Cardiovasc Interv
Pays: United States
ID NLM: 101499602
Informations de publication
Date de publication:
08 2023
08 2023
Historique:
medline:
17
8
2023
pubmed:
15
8
2023
entrez:
15
8
2023
Statut:
ppublish
Résumé
Coronary artery bypass grafting (CABG) is the recommended mode of revascularization in patients with ischemic left ventricular dysfunction (iLVSD) and multivessel disease. However, contemporary percutaneous coronary intervention (PCI) outcomes have improved with the integration of novel technologies and refinement of revascularization strategies, and PCI is often used in clinical practice in this population. There is a lack of evidence from randomized trials comparing contemporary state-of-the-art PCI versus CABG for the treatment of iLVSD and multivessel disease. This was the impetus for the STICH3C trial (Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy), described here. The STICH3C trial is a prospective, unblinded, international, multicenter trial with an expected sample size of 754 participants from ≈45 centers. Patients with multivessel/left main coronary artery disease and iLVSD with left ventricular ejection fraction ≤40% considered by the local Heart Team appropriate for and amenable to revascularization by both modes of revascularization will be randomized in a 1:1 ratio to state-of-the-art PCI or CABG. The primary end point is the composite of death from any cause, stroke, spontaneous myocardial infarction, urgent repeat revascularization, or heart failure readmission, summarized as a time-to-event outcome. The key hierarchical end point is time to death and frequency of hospitalizations for heart failure. The key safety outcome is a composite of major adverse events. Disease-specific quality-of-life and health economics measures will be compared between groups. Participants will be followed for a median of 5 years, with a minimum follow-up of 4 years. STICH3C will directly inform patients, clinicians, and international practice guidelines about the efficacy and safety of CABG versus PCI in patients with iLVSD. The results will provide novel and broad evidence, including clinical events, health status, and economic assessments, to guide care for patients with iLVSD and severe coronary artery disease. URL: https://clinicaltrials.gov/; Unique identifier: NCT05427370.
Sections du résumé
BACKGROUND
Coronary artery bypass grafting (CABG) is the recommended mode of revascularization in patients with ischemic left ventricular dysfunction (iLVSD) and multivessel disease. However, contemporary percutaneous coronary intervention (PCI) outcomes have improved with the integration of novel technologies and refinement of revascularization strategies, and PCI is often used in clinical practice in this population. There is a lack of evidence from randomized trials comparing contemporary state-of-the-art PCI versus CABG for the treatment of iLVSD and multivessel disease. This was the impetus for the STICH3C trial (Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy), described here.
METHODS
The STICH3C trial is a prospective, unblinded, international, multicenter trial with an expected sample size of 754 participants from ≈45 centers. Patients with multivessel/left main coronary artery disease and iLVSD with left ventricular ejection fraction ≤40% considered by the local Heart Team appropriate for and amenable to revascularization by both modes of revascularization will be randomized in a 1:1 ratio to state-of-the-art PCI or CABG.
RESULTS
The primary end point is the composite of death from any cause, stroke, spontaneous myocardial infarction, urgent repeat revascularization, or heart failure readmission, summarized as a time-to-event outcome. The key hierarchical end point is time to death and frequency of hospitalizations for heart failure. The key safety outcome is a composite of major adverse events. Disease-specific quality-of-life and health economics measures will be compared between groups. Participants will be followed for a median of 5 years, with a minimum follow-up of 4 years.
CONCLUSIONS
STICH3C will directly inform patients, clinicians, and international practice guidelines about the efficacy and safety of CABG versus PCI in patients with iLVSD. The results will provide novel and broad evidence, including clinical events, health status, and economic assessments, to guide care for patients with iLVSD and severe coronary artery disease.
REGISTRATION
URL: https://clinicaltrials.gov/; Unique identifier: NCT05427370.
Identifiants
pubmed: 37582169
doi: 10.1161/CIRCINTERVENTIONS.122.012527
doi:
Banques de données
ClinicalTrials.gov
['NCT05427370']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e012527Subventions
Organisme : CIHR
ID : 471008
Pays : Canada
Investigateurs
Reena Karkhanis
(R)
Rakesh Arora
(R)
Michelle Graham
(M)
Jeff Healey
(J)
Jonathan Howlett
(J)
Alex Kiss
(A)
Dennis Ko
(D)
Doug Lee
(D)
Michael McGillion
(M)
Louise Sun
(L)
Richard Swartz
(R)
Pierre Voisine
(P)
Jeroen Bax
(J)
Filippo Crea
(F)
Torsten Doenst
(T)
Sanjit Jolly
(S)
Lars V Koeber
(LV)
Andre Lamy
(A)
Alexandra Lansky
(A)
Peter van der Meer
(P)
Milan Milojevic
(M)
Elmir Omerovic
(E)
Mark Petrie
(M)
Christopher Reid
(C)
Sigrid Sandner
(S)
Miguel Sousa-Uva
(M)
Eric Velazquez
(E)
Subodh Verma
(S)
Gregg W Stone
(GW)
John Spertus
(J)