Coronary Artery Disease
Conditions
Keywords
CABG, LITA, graft patency, skeletonized vs. pedicled
Brief summary
Internal thoracic arteries can be harvested in skeletonized or pedicled technique. Latest research has posed a potential adverse effect of skeletonizing the internal thoracic arteries on graft patency rates and clinical outcome. Prospective, randomized, multi-centre trials are necessary to investigate the impact of harvesting technique of left internal thoracic artery (LITA) on graft patency rates and clinical outcome after coronary artery bypass grafting. The HARVITA trial compares skeletonized and pedicled harvesting technique of LITA regarding graft patency rates and patient survival.
Interventions
PROCEDUREskeletonized harvesting technique
In patients who are randomized to this treatment arm, the left internal thoracic artery will be harvested in skeletonized technique. Thereby, only the artery itself is harvested.
PROCEDUREpedicled harvesting technique
In patients who are randomized to this treatment arm, the left internal thoracic artery will be harvested in pedicled technique. Thereby, the artery will be harvested together with the accompanying veins, the endothoracic fascia and fatty tissue in order to create an 1-2 cm broad pedicle.
Sponsors
Medical University Innsbruck
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Primary isolated CABG patients with multi-vessel disease (defined as ≥70 % stenosis of the left anterior descending artery (LAD) and ≥50% stenosis of circumflex and right coronary territory, with or without a ≥50% stenosis of the left main artery).
Exclusion criteria
* Age \> 80 years * Planned CABG without LITA use * Preoperative mediastinal radiation therapy * Emergency operation * Minimal invasive coronary artery bypass surgery * Any concomitant cardiac or non-cardiac procedures * Previous cardiac surgery * Known contrast agent allergy * Severe stenosis of the left subclavian artery/ left-sided subclavian steal syndrome * Chronic kidney disease (GFR \<60ml/min/1.73m²) * Life expectancy of less than 5 years * Pregnancy * Hyperthyroidism * Iodine allergy Intraoperative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Death or LITA graft occlusion in cCTA or invasive angiography within 2 years (+/- 3 months) after surgery. | 2 years (+/- 3 months) after surgery | The primary endpoint will be compared between the two treatment groups using Kaplan-Meier graphs and a center stratified two sample log-rank test. In addition, Cox proportional hazards regression analysis adjusting for clinically relevant confounders will be performed. Hazard ratios and their 95% confidence intervals will be estimated. LITA graft occlusion is defined as the absence of contrast detection in the lumen of the graft indicating a 100% occlusion of LITA graft. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| composite outcome of all-cause death, myocardial infarction and repeated revascularization | 1 year, 2 years and 5 years after surgery | The composite outcome of all-cause death, myocardial infarction and repeated revascularization will be compared with Kaplan-Meier graphs together with log-rank testing. |
Countries
Austria, Germany, Switzerland
Contacts
Primary ContactHannes Abfalterer, Dr. med. univ.
Outcome results
None listed