Clinical trial NCT05931783: Randomized Comparison of Skeletonized Versus Pedicled Left Internal Thoracic Artery
Official title: Randomized Comparison of HARVesting the Left Internal Thoracic Artery in a Skeletonized Versus Pedicled Technique: the HARVITA Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Keywords: CABG
LITA
graft patency
skeletonized vs. pedicled
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 1350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 HARVITA trial compares skeletonized and pedicled harvesting technique of LITA regarding graft patency rates and patient survival.


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

Primary outcomes:
measure: Death or LITA graft occlusion in cCTA or invasive angiography within 2 years (+/- 3 months) after surgery.
timeFrame: 2 years (+/- 3 months) after surgery
Secondary outcomes:
measure: composite outcome of all-cause death, myocardial infarction and repeated revascularization
timeFrame: 1 year, 2 years and 5 years after surgery
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Essen
country: Germany
facility: University of Duisburg-Essen
city: Freiburg
country: Germany
facility: University of Freiburg
city: Gießen
country: Germany
facility: University Hospital Gießen
city: Jena
country: Germany
facility: University of Jena
city: Bern
country: Switzerland
facility: University Hospital Bern
Study officials:
affiliation: Medical University Innsbruck
name: Hannes Abfalterer, Dr. med. univ.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University Innsbruck
name: Nikolaos Bonaros, Univ. Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.