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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,350
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.
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 Graz
Graz, Austria
NOT_YET_RECRUITINGMedical University of Innsbruck
Innsbruck, Austria
RECRUITINGMedical University of Vienna
Vienna, Austria
NOT_YET_RECRUITINGUniversity of Duisburg-Essen
Essen, Germany
NOT_YET_RECRUITINGUniversity of Freiburg
Freiburg im Breisgau, Germany
NOT_YET_RECRUITINGUniversity Hospital Gießen
Giessen, Germany
NOT_YET_RECRUITINGUniversity of Jena
Jena, Germany
NOT_YET_RECRUITINGUniversity Hospital Bern
Bern, Switzerland
NOT_YET_RECRUITINGDeath 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.
Time frame: 2 years (+/- 3 months) after surgery
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.
Time frame: 1 year, 2 years and 5 years after surgery
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