Coronary Artery Disease
Conditions
Keywords
Coronary Artery Disease, Statins, Coronary Artery Bypass Grafting, Cardiac Surgery
Brief summary
Patients with coronary artery disease requiring coronary artery bypass grafting (CABG) are at risk for postoperative complications after surgery. The StaRT-CABG trial is the first large-scale (2,630 patients) that will investigate whether an additional treatment with statins (lipid-lowering medication) in high doses before CABG surgery can reduce the incidence of major post-surgery complications including death, myocardial infarction and stroke. The StaRT-CABG trial will be recruiting patients from 8 cardiac surgery centres in Germany and is expected to provide relevant clinical data on the efficacy of this novel treatment in order to optimize the care for all patients undergoing CABG.
Detailed description
Patients with coronary artery disease (CAD) requiring coronary artery bypass grafting (CABG) are still at significant risk for postoperative major adverse cardiocerebral events (≈15% MACCE rate), with ≈3% of patients dying within 30 days of surgery. Recent clinical evidence shows that cardioprotection in patients receiving chronic statin treatment can be further improved by a high-dose statin 'recapture' therapy given shortly before an ischemia-reperfusion sequence, resulting in a 61% risk reduction for MACE at 30 days in patients undergoing PCI. Evaluation of this novel approach in the setting of CABG seems particularly promising, as myocardial injury, surgery-related inflammation and pre-existing patients' comorbidities play a pivotal role for poor clinical outcomes after CABG that may be improved by an acute statin recapture therapy. The StaRT-CABG trial is the first large-scale (n=2,630 CABG patients), multicentre (8 cardiac surgery centres), randomised, double-blind and placebo-controlled trial that aims to test whether an acute high-dose statin recapture therapy given shortly before CABG reduces the incidence of MACCE at 30 days after surgery (composite primary outcome: all-cause mortality; non-fatal myocardial infarction and cerebrovascular events). The StaRT-CABG trial is expected to provide highly relevant clinical data on the efficacy of this novel therapeutic approach in order to optimize the care for all CAD patients undergoing CABG with broad clinical implications on current clinical practice and existing guidelines.
Interventions
DRUGStatin Recapture Therapy
Given 12h and 2h before CABG
DRUGPlacebo
Given 12h and 2h before CABG.
Sponsors
German Federal Ministry of Education and Research
University of Cologne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients on chronic statin treatment (\>30 days) scheduled for isolated CABG, including on- or off-pump or repeat (redo's) revascularisation procedures 2. Stable or unstable angina, including non ST-segment-elevation acute coronary syndrome (NSTE-ACS) 3. Age ≥ 18 years 4. Written informed consent
Exclusion criteria
1. Any concomitant cardiovascular procedure to CABG (i.e. valve, aortic or carotid surgery) 2. Acute ST-segment-elevation myocardial infarction (STEMI) 3. NSTE-ACS with cardiogenic shock warranting emergent salvage surgery within 12 hrs from hospital admission 4. History of atrial fibrillation or muscle disease (myopathy) 5. Current renal (creatinine\>2x upper limit of normal (ULN), dialysis, kidney transplant) or hepatic dysfunction (AST/ALT\>2x ULN, liver transplant or neoplasm) 6. Inability of oral drug intake
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiocerebral events (MACCE) within 30 days after CABG. | 30 days after Surgery | Composite endpoint consisting of (1) all-cause mortality, (2) non-fatal myocardial infarction (MI) and (3) non-fatal cerebrovascular event (stroke or TIA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay | within the first 15 days after surgery (plus or minus 5 days) | Length of stay on intensive care unit (ICU) and hospital |
| Repeat coronary revascularisation | 30 days after surgery | Repeat coronary revascularisation (PCI or CABG) |
| Major adverse cardiac events | 30 days after Surgery | Composite outcome consisting cardiac mortality and non-fatal MI within 30 days after surgery. |
| Wound Infections | 30 days after surgery | Surgical site wound infections. |
| Atrial fibrillation | within the first 15 days after surgery (plus or minus 5 days) | New-onset postoperative atrial fibrillation |
| Mortality at 12 months | 12 months after surgery | All-cause mortality at 12 months |
Countries
Germany
Outcome results
None listed