Background In patients with three-vessel disease and/or left main disease, selecting revascularization strategy based on coronary com- and Aims puted tomography angiography (CCTA) has a high level of virtual agreement with treatment decisions based on invasive coronary angiography (ICA). Methods In this study, coronary artery bypass grafting (CABG) procedures were planned based on CCTA without knowledge of ICA. The CABG strategy was recommended by a central core laboratory assessing the anatomy and functionality of the coronary circulation. The primary feasibility endpoint was the percentage of operations performed without access to the ICA. The primary safety endpoint was graft patency on 30-day follow-up CCTA. Secondary endpoints included topographical adequacy of grafting, major adverse cardiac and cerebrovascular (MACCE), and major bleeding events at 30 days. The study was considered positive if the lower boundary of confidence intervals (CI) for feasibility was ≥75% (NCT04142021). Results The study enrolled 114 patients with a mean (standard deviation) anatomical SYNTAX score and Society of Thoracic Surgery score of 43.6 (15.3) and 0.81 (0.63), respectively. Unblinding ICA was required in one case yielding a feasibility of 99.1% (95% CI 95.2%–100%). The concordance and agreement in revascularization planning between the ICA- and CCTA-Heart Teams was 82.9% with a moderate kappa of 0.58 (95% CI 0.50–0.66) and between the CCTA-Heart Team and actual treatment was 83.7% with a substantial kappa of 0.61 (95% CI 0.53–0.68). The 30-day follow-up CCTA in 102 patients (91.9%) showed an anastomosis patency rate of 92.6%, whilst MACCE was 7.2% and major bleeding 2.7%. Conclusions CABG guided by CCTA is feasible and has an acceptable safety profile in a selected population of complex coronary artery disease.

Coronary bypass surgery guided by computed tomography in a low-risk population / P. W Serruys, S. Kageyama, G. Pompilio, D. Andreini, G. Pontone, S. Mushtaq, M. La Meir, K. Tanaka, T. Doenst, U. Teichgräber, U. Schneider, J. D Puskas, J. Narula, H. Gupta, V. Agarwal, J. Leipsic, S. Masuda, N. Kotoku, T. Tsai, S. Garg, M. Morel, Y. Onuma. - In: EUROPEAN HEART JOURNAL. - ISSN 0195-668X. - 45:20(2024 May 21), pp. 1804-1815. [10.1093/eurheartj/ehae199]

Coronary bypass surgery guided by computed tomography in a low-risk population

G. Pompilio;D. Andreini;G. Pontone;S. Mushtaq;
2024

Abstract

Background In patients with three-vessel disease and/or left main disease, selecting revascularization strategy based on coronary com- and Aims puted tomography angiography (CCTA) has a high level of virtual agreement with treatment decisions based on invasive coronary angiography (ICA). Methods In this study, coronary artery bypass grafting (CABG) procedures were planned based on CCTA without knowledge of ICA. The CABG strategy was recommended by a central core laboratory assessing the anatomy and functionality of the coronary circulation. The primary feasibility endpoint was the percentage of operations performed without access to the ICA. The primary safety endpoint was graft patency on 30-day follow-up CCTA. Secondary endpoints included topographical adequacy of grafting, major adverse cardiac and cerebrovascular (MACCE), and major bleeding events at 30 days. The study was considered positive if the lower boundary of confidence intervals (CI) for feasibility was ≥75% (NCT04142021). Results The study enrolled 114 patients with a mean (standard deviation) anatomical SYNTAX score and Society of Thoracic Surgery score of 43.6 (15.3) and 0.81 (0.63), respectively. Unblinding ICA was required in one case yielding a feasibility of 99.1% (95% CI 95.2%–100%). The concordance and agreement in revascularization planning between the ICA- and CCTA-Heart Teams was 82.9% with a moderate kappa of 0.58 (95% CI 0.50–0.66) and between the CCTA-Heart Team and actual treatment was 83.7% with a substantial kappa of 0.61 (95% CI 0.53–0.68). The 30-day follow-up CCTA in 102 patients (91.9%) showed an anastomosis patency rate of 92.6%, whilst MACCE was 7.2% and major bleeding 2.7%. Conclusions CABG guided by CCTA is feasible and has an acceptable safety profile in a selected population of complex coronary artery disease.
Coronary artery bypass grafting; Coronary computed tomography; Feasibility; First-in-human; Proof-of-concept; Safety;
Settore MED/11 - Malattie dell'Apparato Cardiovascolare
21-mag-2024
7-apr-2024
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/1059048
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