Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05534698 |
Other study ID # |
H-21000675 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 2022 |
Est. completion date |
February 2033 |
Study information
Verified date |
September 2022 |
Source |
Danish Study Group |
Contact |
Lars V Køber, MD |
Phone |
31120540 |
Email |
lk[@]heart.dk |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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 (58.9% versus 66.1%; HR 0.84, 95%CI: 0.73-0.97; p = 0.02) over 9.8
years. Thus, these studies suggest that to offset the early operative risks of CABG, 10-year
survival is needed. As many patients with HF and/or 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.