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Randomized Controlled Trial
. 2023 Sep 18;19(7):571-579.
doi: 10.4244/EIJ-D-23-00312.

Three-year outcomes of A Randomized Multicentre Trial Comparing Revascularization and Optimal Medical Therapy for Chronic Total Coronary Occlusions (EuroCTO)

Gerald S Werner  1 , David Hildick-Smith  2 , Victoria Martin Yuste  3 , Nicolas Boudou  4 , Georgios Sianos  5 , Valery Gelev  6 , Jose Ramon Rumoroso  7 , Andrejs Erglis  8 , Evald Hoj Christiansen  9 , Javier Escaned  10 , Carlo Di Mario  11 , Luis Teruel  12 , Alexander Bufe  13 , Bernward Lauer  14 , Alfredo Ruggero Galassi  15 , Yves Louvard  16
Affiliations
Randomized Controlled Trial

Three-year outcomes of A Randomized Multicentre Trial Comparing Revascularization and Optimal Medical Therapy for Chronic Total Coronary Occlusions (EuroCTO)

Gerald S Werner et al. EuroIntervention. .

Abstract

Background: Percutaneous coronary intervention (PCI) for chronic total coronary occlusions (CTO) improves clinical symptoms and quality of life. The longer-term safety of PCI compared to optimal medical therapy (OMT) remains uncertain.

Aims: We sought to evaluate the long-term safety of PCI for CTO in a randomised trial as compared to OMT.

Methods: A total of 396 patients with a symptomatic CTO were enrolled into a randomised, multicentre clinical trial comparing PCI and OMT. Half of the patients had a single CTO; the others had multivessel disease. Non-CTO lesions were treated prior to randomisation (2:1 ratio). During follow-up, crossover from OMT to PCI occurred in 7.3% (1 year) and 17.5% (3 years) of patients.

Results: At 3 years, the incidence of cardiovascular death or nonfatal myocardial infarction was not significantly different between the groups (OMT 3.7% vs PCI 6.2%; p=0.29). By per-protocol analysis, the difference remained non-significant (OMT 5.7% vs PCI 4.7%; p=0.67). Overall, major adverse cardiovascular events (MACE) were more frequent with OMT (OMT 21.2% vs PCI 11.2%), largely because of ischaemia-driven revascularisation. The rates of stroke or hospitalisation for bleeding were not different between the groups.

Conclusions: At 3 years there was no difference in the rate of cardiovascular death or myocardial infarction between PCI or OMT among patients with a remaining single coronary CTO. The MACE rate was higher in the OMT group due largely to ischaemia-driven revascularisation. CTO PCI appears to be a safe option for patients with a single remaining significant coronary CTO. CinicalTrials.gov: NCT01760083.

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Conflict of interest statement

G. Werner reports speaker honoraria from Asahi Intecc, Abbott Vascular, Daiichi Sankyo, OrbusNeich, Philips/Volcano, Siemens, and Terumo. J. Escaned reports speaker honoraria from Abbott and Boston Scientific; and received honoraria from Philips. A. Erglis reports speaker fees from Biosensors, Biotronik, and Boston Scientific. E.H. Christiansen received research grants from Asahi Intecc and Biosensors.C. Di Mario reports institutional grants from Abbott Vascular, Amgen, Chiesi, Daiichi Sankyo, Edwards Lifesciences, Medtronic, Philips, and Shockwave; and personal speaker honoraria from Shockwave and Philips/Volcano. A. Bufe reports speaker honoraria from Biotronik. B. Lauer reports speaker honoraria from Daiichi Sankyo, Amgen, Nicolai, Asahi Intecc, Abbott, and Abiomed. The other authors have no conflict of interest to declare.

Figures

Central illustration
Central illustration. Study plan and 3-year outcome of the EuroCTO trial.
At 3 years, there was no difference in the rate of cardiovascular death or non-fatal myocardial infarction between PCI or OMT among patients with a coronary CTO, while the MACE rate was higher with OMT. c/o: crossed over from 1 group to the other; ITT: intention-to-treat; MACE: major adverse cardiac events; MI: myocardial infarction; OMT: optimal medical therapy; PCI: percutaneous coronary intervention; PP: per protocol
Figure 1
Figure 1. Overview of enrolment, treatment assignment and crossover of study patients during 3 years of follow-up.
*1 patient crossed over to CABG directly. CABG: coronary artery bypass graft; c/o: crossed over from 1 group to the other; FUP: follow-up; ITT: intention-to-treat; OMT: optimal medical therapy; PCI: percutaneous coronary intervention; PP: per protocol
Figure 2
Figure 2. Kaplan-Meier survival plot, free of cardiovascular death and non-fatal MI, in patients assigned to PCI or OMT for a minimum follow-up of 3 years.
A) Intention-to-treat analysis. B) Per-protocol analysis. ITT: intention-to-treat; OMT: optimal medical therapy; PCI: percutaneous coronary intervention; PP: per protocol
Figure 3
Figure 3. Kaplan-Meier survival plot, free of major adverse cardiac events (MACE) in patients assigned to PCI or OMT for a minimum follow-up of 3 years.
A) Intention-to-treat analysis. B) Per-protocol analysis. ITT: intention-to-treat; OMT: optimal medical therapy; PCI: percutaneous coronary intervention; PP: per protocol
See this image and copyright information in PMC

Comment in

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