PMID- 37582169
OWN - NLM
STAT- MEDLINE
DCOM- 20230817
LR  - 20230817
IS  - 1941-7632 (Electronic)
IS  - 1941-7640 (Linking)
VI  - 16
IP  - 8
DP  - 2023 Aug
TI  - STICH3C: Rationale and Study Protocol.
PG  - e012527
LID - 10.1161/CIRCINTERVENTIONS.122.012527 [doi]
AB  - 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  approximately 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.
FAU - Fremes, Stephen E
AU  - Fremes SE
AUID- ORCID: 0000-0003-1723-3049
AD  - Schulich Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto, 
      Ontario, Canada (S.E.F., D.V., H.C.W.).
FAU - Marquis-Gravel, Guillaume
AU  - Marquis-Gravel G
AUID- ORCID: 0000-0003-2965-1504
AD  - Montreal Heart Institute, University of Montreal, Quebec, Canada (G.M.-G., 
      E.M.J., J.-L.R.).
FAU - Gaudino, Mario F L
AU  - Gaudino MFL
AUID- ORCID: 0000-0003-4680-0815
AD  - Department of Cardiothoracic Surgery (M.F.L.G.), Weill Cornell Medicine, New York 
      City, NY.
FAU - Jolicoeur, E Marc
AU  - Jolicoeur EM
AD  - Department of Cardiothoracic Surgery (M.F.L.G.), Weill Cornell Medicine, New York 
      City, NY.
FAU - Bedard, Sylvain
AU  - Bedard S
AUID- ORCID: 0000-0002-4403-3184
AD  - Centre d'excellence sur le partenariat avec les patients et le public, Montreal, 
      Quebec, Canada (S.B.).
FAU - Masterson Creber, Ruth
AU  - Masterson Creber R
AUID- ORCID: 0000-0002-4238-9902
AD  - Division of Health Informatics (R.M.C.), Weill Cornell Medicine, New York City, 
      NY.
FAU - Ruel, Marc
AU  - Ruel M
AUID- ORCID: 0000-0002-0487-1319
AD  - Division of Cardiac Surgery, University of Ottawa Heart Institute, Ontario, 
      Canada (M.R.).
FAU - Vervoort, Dominique
AU  - Vervoort D
AUID- ORCID: 0000-0002-3142-0388
AD  - Schulich Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto, 
      Ontario, Canada (S.E.F., D.V., H.C.W.).
FAU - Wijeysundera, Harindra C
AU  - Wijeysundera HC
AUID- ORCID: 0000-0001-8464-1080
AD  - Schulich Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto, 
      Ontario, Canada (S.E.F., D.V., H.C.W.).
FAU - Farkouh, Michael E
AU  - Farkouh ME
AD  - Division of Cardiology, Peter Munk Cardiac Centre, Toronto General Hospital, 
      Ontario, Canada (M.E.F.).
FAU - Rouleau, Jean-Lucien
AU  - Rouleau JL
AD  - Montreal Heart Institute, University of Montreal, Quebec, Canada (G.M.-G., 
      E.M.J., J.-L.R.).
CN  - STICH3C Study Investigators
LA  - eng
SI  - ClinicalTrials.gov/NCT05427370
GR  - 471008/CIHR/Canada
PT  - Clinical Trial Protocol
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20230815
PL  - United States
TA  - Circ Cardiovasc Interv
JT  - Circulation. Cardiovascular interventions
JID - 101499602
SB  - IM
MH  - Humans
MH  - Canada
MH  - *Coronary Artery Disease/diagnostic imaging/therapy
MH  - Multicenter Studies as Topic
MH  - *Percutaneous Coronary Intervention/adverse effects/methods
MH  - Prospective Studies
MH  - Stroke Volume
MH  - Treatment Outcome
MH  - *Ventricular Dysfunction, Left
MH  - Ventricular Function, Left
MH  - Randomized Controlled Trials as Topic
OTO - NOTNLM
OT  - coronary artery bypass
OT  - coronary disease
OT  - ischemic heart disease
OT  - percutaneous coronary intervention
OT  - ventricular dysfunction, left
COIS- Disclosures Dr Vervoort is supported by the Canadian Institutes of Health 
      Research Vanier Canada Graduate Scholarship. The other authors report no 
      conflicts.
FIR - Karkhanis, Reena
IR  - Karkhanis R
FIR - Arora, Rakesh
IR  - Arora R
FIR - Graham, Michelle
IR  - Graham M
FIR - Healey, Jeff
IR  - Healey J
FIR - Howlett, Jonathan
IR  - Howlett J
FIR - Kiss, Alex
IR  - Kiss A
FIR - Ko, Dennis
IR  - Ko D
FIR - Lee, Doug
IR  - Lee D
FIR - McGillion, Michael
IR  - McGillion M
FIR - Sun, Louise
IR  - Sun L
FIR - Swartz, Richard
IR  - Swartz R
FIR - Voisine, Pierre
IR  - Voisine P
FIR - Bax, Jeroen
IR  - Bax J
FIR - Crea, Filippo
IR  - Crea F
FIR - Doenst, Torsten
IR  - Doenst T
FIR - Jolly, Sanjit
IR  - Jolly S
FIR - Koeber, Lars V
IR  - Koeber LV
FIR - Lamy, Andre
IR  - Lamy A
FIR - Lansky, Alexandra
IR  - Lansky A
FIR - van der Meer, Peter
IR  - van der Meer P
FIR - Milojevic, Milan
IR  - Milojevic M
FIR - Omerovic, Elmir
IR  - Omerovic E
FIR - Petrie, Mark
IR  - Petrie M
FIR - Reid, Christopher
IR  - Reid C
FIR - Sandner, Sigrid
IR  - Sandner S
FIR - Sousa-Uva, Miguel
IR  - Sousa-Uva M
FIR - Velazquez, Eric
IR  - Velazquez E
FIR - Verma, Subodh
IR  - Verma S
FIR - Stone, Gregg W
IR  - Stone GW
FIR - Spertus, John
IR  - Spertus J
EDAT- 2023/08/15 18:42
MHDA- 2023/08/17 06:43
CRDT- 2023/08/15 14:04
PHST- 2023/08/17 06:43 [medline]
PHST- 2023/08/15 18:42 [pubmed]
PHST- 2023/08/15 14:04 [entrez]
AID - 10.1161/CIRCINTERVENTIONS.122.012527 [doi]
PST - ppublish
SO  - Circ Cardiovasc Interv. 2023 Aug;16(8):e012527. doi: 
      10.1161/CIRCINTERVENTIONS.122.012527. Epub 2023 Aug 15.