Long-term follow-up of patients with chronic total coronary artery occlusion previously randomized to treatment with optimal drug therapy or percutaneous revascularization of chronic total occlusion (COMET-CTO)

Stefan A Juricic; Sinisa M Stojkovic; Alfredo R Galassi; Goran R Stankovic; Dejan N Orlic; Vladan D Vukcevic; Dejan G Milasinovic; Srdjan B Aleksandric; Miloje V Tomasevic; Milan R Dobric; Milan A Nedeljkovic; Branko D Beleslin; Miodrag P Dikic; Marko D Banovic; Miodrag C Ostojic; Milorad B Tesic

doi:10.3389/fcvm.2022.1014664

Long-term follow-up of patients with chronic total coronary artery occlusion previously randomized to treatment with optimal drug therapy or percutaneous revascularization of chronic total occlusion (COMET-CTO)

Front Cardiovasc Med. 2023 Jan 9:9:1014664. doi: 10.3389/fcvm.2022.1014664. eCollection 2022.

Authors

Stefan A Juricic¹, Sinisa M Stojkovic^{1

2}, Alfredo R Galassi^{3

4}, Goran R Stankovic^{1

2

5}, Dejan N Orlic^{1

2}, Vladan D Vukcevic^{1

2}, Dejan G Milasinovic^{1

2}, Srdjan B Aleksandric^{1

2}, Miloje V Tomasevic^{1

6}, Milan R Dobric^{2

7}, Milan A Nedeljkovic^{1

2}, Branko D Beleslin^{1

2}, Miodrag P Dikic¹, Marko D Banovic^{1

2}, Miodrag C Ostojic^{2

5}, Milorad B Tesic^{1

2}

Affiliations

¹ Clinic for Cardiology, University Clinical Center of Serbia, Belgrade, Serbia.
² School of Medicine, University of Belgrade, Belgrade, Serbia.
³ Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties (ProMISE), University of Palermo, Palermo, Italy.
⁴ Royal Brompton & Harefield NHS Foundation Trust, London, United Kingdom.
⁵ Serbian Academy of Sciences and Arts, Belgrade, Serbia.
⁶ Department of Internal Medicine, Faculty of Medical Sciences, University of Kragujevac, Kragujevac, Serbia.
⁷ Dedinje Cardiovascular Institute, Belgrade, Serbia.

Abstract

Background: The COMET-CTO trial was a randomized prospective study that assessed long-term follow-up in patients with chronic total occlusion (CTO) in coronary arteries treated with percutaneous coronary intervention (PCI) or with optimal medical therapy (OMT). During the 9-month follow-up, the incidence of major adverse cardiac events (MACE) did not differ between the two groups; no death or myocardial infarction (MI) was observed. There was a significant difference in quality of life (QoL), assessed by the Seattle Angina Questionnaire (SAQ), in favor of the PCI group. Here we report long-term follow-up results (56 ± 12 months).

Methods: Between October 2015 and May 2017, a total of 100 patients with CTO were randomized into two groups of 50 patients: PCI CTO or OMT group. The primary endpoint of the current study was the incidence of MACE defined as cardiac death, MI, and revascularization [PCI or coronary artery bypass graft (CABG)]. As the secondary exploratory outcome, we analyzed all the cause-mortality rate.

Results: Out of 100 randomized patients, 92 were available for long-term follow-up (44 in the PCI group and 48 in the OMT group). The incidence of MACE did not differ significantly between the two groups (p = 0.363). Individual components of MACE were distributed, respectively: cardiac death (OMT vs. PCI group, 6 vs. 3, p = 0.489), MI (OMT vs. PCI group, 1 vs. 0, p = 1), and revascularization (PCI: OMT vs. PCI group, 2 vs. 2, p = 1; CABG: OMT vs. PCI group, 1 vs. 1, p = 1). There was no significant difference between the two groups regarding the individual component of MACE. Six patients died from non-cardiac causes [five deaths were reported in the OMT group and one death in the PCI group (p = 0.206)]. Kaplan-Meier survival curves for MACE did not differ significantly between the study groups (log-rank 0.804, p = 0.370). Regarding the secondary exploratory outcome, a total of 15 patients died at 56 ± 12 months (11 in the OMT and 4 in the PCI group) (p = 0.093). The Kaplan-Meier survival curves for all-cause mortality rates did not differ significantly between the two groups (log rank 3.404, p = 0.065). There were no statistically significant differences between OMT and PCI groups in all five SAQ domains. There was a significant improvement in three SAQ domains in the PCI group: PL (p < 0.001), AF (p = 0.007), and QoL (p = 0.001).

Conclusion: After 56 ± 12 months of follow-up, the incidence of MACE, as well as QoL measured by SAQ, did not differ significantly between the PCI and OMT groups.

Keywords: chronic total occlusion; long-term follow-up; optimal medical therapy; outcomes; percutaneous coronary intervention.