Chronic Total Occlusion Vessel
Conditions
Keywords
Coronary ChronicTotal Occlusion, Coronary Angioplasty, Reduced Ejection Fraction
Brief summary
The investigators studied the effect of CTO-PCI on left ventricular function and clinical parameters in patients with HFrEF.
Detailed description
Observational studies have shown that chronic total coronary occlusion percutaneous intervention (CTO-PCI) improves angina, left ventricular ejection fraction (LVEF), and survival. None of these studies aimed to assess the benefits in populations with heart failure with reduced ejection fraction (HFrEF). The investigators studied the effect of CTO-PCI on left ventricular function and clinical parameters in patients with HFrEF. Using cardiac magnetic resonance (CMR), the investigators studied 29 patients with HFrEF and evidence of viability and/or ischemia in the territory supplied by an occluded vessel who were successfully treated with CTO-PCI. Non-CTO PCI was also performed in patients with multi-vessel disease, . Imaging parameters, clinical status, and brain natriuretic peptide (BNP) levels were evaluated before and six months after CTO-PCI.
Interventions
PROCEDUREchronic total coronary occlusion percutaneous intervention
Percutaneous intervention of chronic total coronary occlusion with stent implantation
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* At least one chronic total coronary occlusion * LVEF ≤40% by CMR * Evidence of myocardial viability and/or ischemia in at least two contiguous segments subtended by the occluded vessel.
Exclusion criteria
* Women of childbearing age or pregnant * Claustrophobia * Admission to hospital within the previous 90 days due to decompensated heart failure, myocardial infarction or unstable angina. * Severe valvulopathy * Pacemaker or implantable cardioverter defibrillator * Indication for coronary artery bypass surgery * Heart transplantation waiting list * Follow-up not feasible * Life expectancy shorter than 12 months. * Iodine contrast or gadolinium allergy * Aspirin or clopidogrel allergy * Asthma * NYHA IV class * Liver cirrosis * Noncompliance with medical treatment * Chronic kidney disease with serum creatinine levels ≥ 2.5 mg/dl or glomerular filtration rate ≤30 ml/min/1.73m2 * Evidence of active bleeding * High risk of bleeding * CTO distal vessel not visible through collateral circulation * CTO distal vessel diameter \<2mm * Absence of acceptable vascular access
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular ejection fraction (%) | 6 months | Evaluate changes in left ventricular function by cardiac magnetic resonance imaging 6 months after CTO PCI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NYHA functional class (I-V) | 6 months | Evaluate changes in NYHA functional class 6 months after CTO PCI |
| Myocardial ischemia | 6 months | Evaluate changes in number of segments with induced ischemia by cardiac magnetic resonance imaging 6 months after CTO PCI |
| Brain Natriuretic Peptide (pg/ml) | 6 months | Evaluate changes in brain natriuretic peptide 6 months after CTO PCI |
| Incidence of in-hospital CTO PCI major adverse events | 6 months | Safety evaluation of CTO PCI in patients with HFrEF (periprocedural mortality, periprocedural STEMI or need for urgent myocardial revascularization surgery) |
Outcome results
None listed