Randomized Comparison of Skeletonized Versus Pedicled Left Internal Thoracic Artery

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Comparison of HARVesting the Left Internal Thoracic Artery in a Skeletonized Versus Pedicled Technique: the HARVITA Trial

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: skeletonized harvesting technique
* Procedure: pedicled harvesting technique


Participation Criteria
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Eligibility Criteria
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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 exclusion criteria: Y/T graft off the LITA graft LITA sequential grafting LITA target vessel other than LAD

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: skeletonized harvesting technique<br>In skeletonized harvesting technique, only the left internal artery itself is harvested. | Procedure: skeletonized harvesting technique<br>* 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.<br>|
| Active Comparator: pedicled harvesting technique<br>In pedicled harvesting technique the left internal thoracic artery, it's accompanying veins and parts of the endothoracic fascia is harvested, creating a 1-2 cm broad pedicle. | Procedure: pedicled harvesting technique<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death or LITA graft occlusion in cCTA or invasive angiography within 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. | 2 years (+/- 3 months) after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite outcome of all-cause death, myocardial infarction and repeated revascularization | The composite outcome of all-cause death, myocardial infarction and repeated revascularization will be compared with Kaplan-Meier graphs together with log-rank testing. | 1 year, 2 years and 5 years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CABG, LITA, graft patency, skeletonized vs. pedicled