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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| skeletonized harvesting technique | Active Comparator | In skeletonized harvesting technique, only the left internal artery itself is harvested. |
|
| pedicled harvesting technique | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| skeletonized harvesting technique | Procedure | 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. |
| 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 |
| 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 |
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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:
Intraoperative exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hannes Abfalterer, Dr. med. univ. | Contact | 004351250482988 | hannes.abfalterer@i-med.ac.at |
| Name | Affiliation | Role |
|---|---|---|
| Hannes Abfalterer, Dr. med. univ. | Medical University Innsbruck | Principal Investigator |
| Nikolaos Bonaros, Univ. Prof. Dr. | Medical University Innsbruck | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz | Not yet recruiting | Graz | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34132753 | Background | 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. | |
| 34586338 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| pedicled harvesting technique | Procedure | 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. |
|
| Medical University of Innsbruck | Recruiting | Innsbruck | Austria |
|
| Medical University of Vienna | Not yet recruiting | Vienna | Austria |
|
| University of Duisburg-Essen | Not yet recruiting | Essen | Germany |
|
| University of Freiburg | Not yet recruiting | Freiburg im Breisgau | Germany |
|
| University Hospital Gießen | Not yet recruiting | Giessen | Germany |
|
| University of Jena | Not yet recruiting | Jena | Germany |
|
| University Hospital Bern | Not yet recruiting | Bern | Switzerland |
|
| Background |
| 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. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |