Randomized Comparison of Skeletonized Versus Pedicled Left Internal Thoracic Artery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: skeletonized harvesting technique, pedicled harvesting technique.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria, Germany, Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Randomized Comparison of HARVesting the Left Internal Thoracic Artery in a Skeletonized Versus Pedicled Technique: the HARVITA Trial
Overview
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
- 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. - 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.
Primary outcome measures
- Death or LITA graft occlusion in cCTA or invasive angiography within 2 years (+/- 3 months) after surgery. [Time frame: 2 years (+/- 3 months) after surgery]
Secondary outcome measures (1)
- composite outcome of all-cause death, myocardial infarction and repeated revascularization [Time frame: 1 year, 2 years and 5 years after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Germany · 4 centers
- University of Duisburg-Essen — Essen
- University of Freiburg — Freiburg im Breisgau
- University Hospital Gießen — Giessen
- University of Jena — Jena
Austria · 3 centers
- Medical University of Graz — Graz
- Medical University of Innsbruck — Innsbruck
- Medical University of Vienna — Vienna
Switzerland · 1 center
- University Hospital Bern — Bern
Publications
- 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. PMID 34132753
- 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. PMID 34586338
Identifiers
NCT: NCT05931783 · 1135/2023