Ignite Creation Date:
2024-05-06 @ 6:05 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05534698
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-09-15
First Post:
2022-09-06
Brief Title:
Coronary Artery Bypass Grafts or Percutaneous Coronary Intervention for High Risk Patients
Sponsor:
Danish Study Group
Organization:
Danish Study Group
Study Overview
Official Title:
Coronary Artery Bypass Grafts or Percutaneous Coronary Intervention for Revascularization in Moderate to Highs Risk Patients With Ischemic Heart Disease and Reduced Left Ventricular Ejection Fraction
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Most patients with Left Ventricular Systolic Dysfunction LVSD or heart failure HF have coronary artery disease CAD while some patients also have renal disease Life-saving revascularization is underperformed in patients with LVSD or HF due to CAD and especially if there is concomitant renal disease We hypothesize that PCI will be non-inferior to CABG for all-cause mortality and recurrent myocardial infarction MI stroke or hospitalization for HF To compare revascularization by PCI versus by CABG we will perform a multicentre open-label parallel randomized controlled trial in patients with severe CAD who belong to defined categories of moderate-to-high risk characteristics where guidelines acknowledge that both PCI and CABG are relevant treatment options
Detailed Description:
The STICH trial demonstrated a reduction in overall mortality after 10 years but the 5-year analyses did not show significant benefits of CABG versus medical therapy The extension of the STICH study the STICHES study established the superiority of CABG over medical therapy for all-cause mortality 589 versus 661 HR 084 95CI 073-097 p 002 over 98 years Thus these studies suggest that to offset the early operative risks of CABG 10-year survival is needed As many patients with HF andor LVSD are elderly both clinicians and patients are often unwilling to accept increased short-term risk even if they might eventually achieve long-term benefit and thus not favour CABG The available evidence suggest that PCI is feasible for patients with ischemic LVSD and that PCI may yield long-term mortality rates like CABG with lower short-term morbidity The planned trial is a multicentre open-label parallel randomized controlled trial comparing revascularization by CABG versus by PCI in patients with severe CAD and at high risk where guidelines accept both CABG and PCI as suitableand mortality High risk is defined as patients with LVEF 45 irrespectively of clinical HF and severe renal disease left anterior descending LAD disease in one- or two vessel disease three-vessel disease with a SYNTAX score of up to 22 and left main disease with a SYNTAX score of up to 32
The trial is powered for non-inferiorty
The trial is powered for non-inferiorty
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None