HARVITA: Randomized Comparison of Skeletonized Versus Pedicled Left Internal Thoracic Artery
Study Details
Study Description
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 primary aim of our study is to provide a prospective, randomized, multi-centre trial to evaluate the impact of harvesting technique of LITA on graft patency rates of LITA grafts at 2 years after surgery.
Secondary aim of our study is to provide a prospective, randomized, multi-centre trial to evaluate the impact of harvesting technique of LITA on short-term and mid-term clinical outcome parameters.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: skeletonized harvesting technique In skeletonized harvesting technique, only the left internal artery itself is harvested. |
Procedure: skeletonized 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.
|
| Active Comparator: pedicled harvesting technique 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
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.
|
Outcome Measures
Primary Outcome Measures
- LITA graft occlusion/dysfunction in coronary CT angiography or invasive angiography [2 years (+/- 3 months) after surgery]
The primary endpoint (LITA graft occlusion/dysfunction in coronary CT angiography or invasive angiography at 2 years (+/- 3 months) after surgery) will be compared between the two treatment groups (skeletonized or pedicled harvesting technique) using a 2-sided Chi-square test. Coronary CT angiography will be performed to assess the status of LITA grafts. LITA graft occlusion is defined as the absence of contrast detection in the lumen of the graft indicating a 100% occlusion of LITA graft. LITA graft dysfunction is defined as the suspicion of LITA graft dysfunction: either anatomical (anatomical stenosis ≥ 50% (for example due to plaques, stricture) at anastomotic site or in the course of the graft), functional (due to competitive flow) or unclear (diffuse small sized vessel without clear anatomical obstruction)
Secondary Outcome Measures
- composite outcome of all-cause death, myocardial infarction and repeated [1 year, 2 years and 5 years after surgery]
The composite outcome of all-cause death, myocardial infarction and repeated revascularisation will be compared with Kaplan-Meier graphs together with log-rank testing.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Primary isolated CABG patients with multi-vessel disease (defined as ≥70 % stenosis of major coronary vessels including the left anterior descending artery (LAD) 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical University of Graz | Graz | Austria | ||
| 2 | Medical University of Innsbruck | Innsbruck | Austria | ||
| 3 | Medical University of Vienna | Vienna | Austria | ||
| 4 | University of Duisburg-Essen | Essen | Germany | ||
| 5 | University of Freiburg | Freiburg | Germany | ||
| 6 | University Hospital Gießen | Gießen | Germany | ||
| 7 | University of Jena | Jena | Germany |
Sponsors and Collaborators
- Medical University Innsbruck
Investigators
- Principal Investigator: Hannes Abfalterer, Dr. med. univ., Medical University Innsbruck
Study Documents (Full-Text)
None provided.More Information
Publications
- Gaudino M, Audisio K, Rahouma M, Chadow D, Cancelli G, Soletti GJ, Gray A, Lees B, Gerry S, Benedetto U, Flather M, Taggart DP; ART Investigators. Comparison of Long-term Clinical Outcomes of Skeletonized vs Pedicled Internal Thoracic Artery Harvesting Techniques in the Arterial Revascularization Trial. JAMA Cardiol. 2021 Dec 1;6(12):1380-1386. doi: 10.1001/jamacardio.2021.3866.
- Lamy A, Browne A, Sheth T, Zheng Z, Dagenais F, Noiseux N, Chen X, Bakaeen FG, Brtko M, Stevens LM, Alboom M, Lee SF, Copland I, Salim Y, Eikelboom J; COMPASS Investigators. Skeletonized vs Pedicled Internal Mammary Artery Graft Harvesting in Coronary Artery Bypass Surgery: A Post Hoc Analysis From the COMPASS Trial. JAMA Cardiol. 2021 Sep 1;6(9):1042-1049. doi: 10.1001/jamacardio.2021.1686. Erratum In: JAMA Cardiol. 2021 Aug 18;:null.
- 1135/2023