Randomized Comparison of Skeletonized Versus Pedicled Left Internal Thoracic Artery

Coronary Artery Disease Clinical Trial

— HARVITA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05931783
• Other study ID #: 1135/2023
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2024
• Est. completion date: October 1, 2031

Study information

• Verified date: June 2023
• Source: Medical University Innsbruck
• Contact: Hannes Abfalterer, Dr. med. univ.
• Phone: 004351250482988
• Email: hannes.abfalterer[@]i-med.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1350
• Est. completion date: October 1, 2031
• Est. primary completion date: October 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz
Austria	Medical University of Innsbruck	Innsbruck
Austria	Medical University of Vienna	Vienna
Germany	University of Duisburg-Essen	Essen
Germany	University of Freiburg	Freiburg
Germany	University Hospital Gießen	Gießen
Germany	University of Jena	Jena
Switzerland	University Hospital Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Countries where clinical trial is conducted

Austria,  Germany,  Switzerland, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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