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EuroCTO: Safety and Benefit at 3 Years

Chronic total occlusions (CTOs) account for approximately 15-20% of patients with stable coronary artery disease. This field has seen various advances regarding treatment, leading to an improvement in the success rate of procedures. According to registries and randomized studies, the main indication for percutaneous coronary intervention (PCI) of CTO should be based more on clinical symptoms than on the prognosis of chronic disease.

EuroCTO: seguridad y beneficios a los 3 años

The first phase of the EuroCTO study demonstrated the benefit of PCI for the symptomatic improvement of angina, compared with optimal medical treatment (OMT), with similar safety at one year. However, there are still no valid data on the long-term safety of PCI for CTO. The EuroCTO design included a 3-year follow-up, but it did not have enough power to detect differences in mortality. However, researchers expect to obtain data on the safety of PCI for CTO by analyzing its outcomes with those of other current and future randomized trials.

In this study, patients were treated according to randomization: those with CTO in a single artery (48.5%) and those with multivessel disease (51.5%) were included after at least 4 weeks since the completion of treatment of any other significant non-CTO lesion. Angiographic success was defined as residual stenosis <20% and TIMI 3 flow after drug-eluting stent (DES) implantation.

The primary safety endpoint (PSE) was the incidence of cardiovascular death or non-fatal myocardial infarction (MI) during the 3-year follow-up. Secondary endpoints (SEP) included changes in CCS classification (angina), major adverse cardiac events (MACE), stent thrombosis, cerebrovascular events, and cardiac hospitalization.

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The study included 396 patients with a 3-year follow-up, who were randomized 2:1 to receive PCI and OMT (n=259) or OMT alone (n=137). Recanalization was attempted in 254 patients in the PCI group. Success on the first attempt was achieved in 83.1% of cases, with additional attempts in 19 patients (final success rate: 86.6%). The rate for hospital complications was 2.9%, and these included pericardial tamponade (n=4), vascular surgical repair (n=2), and need for blood transfusion (n=5). There were no periprocedural deaths or emergency myocardial revascularization surgeries.

Angina according to CCS and NYHA functional class improved at 12 months, especially in the PCI group. In the first stage of the study, 81.8% of patients had CCS <2, compared with 65.7% (p<0.001) at 12 months, and 75.8% versus 53.3% (p<0.001) regarding NYHA <2. The number of anti-anginal drugs was significantly lower in the PCI group (1.4 versus 1.9; p<0.005).

During a follow-up of 37.4±7.7 months, there were no significant differences in cardiovascular mortality or non-fatal MI, with a rate of 3.7% in the OMT group and 6.2% in the PCI group (log-rank p=0.29). In the per-protocol analysis, 5.7% of patients in the OMT group and 4.7% in the PCI group (p=0.67) experienced events. During follow-up, the rate of spontaneous MI was 2.3% for patients in the PCI group and 1.5% for patients in the OMT group.

Read also: SCOPE I Results at 3 Years: ACURATE Neo vs. SAPIEN 3.

The rate of MACE was significantly higher in the OMT group, with 21.2% versus 11.2% in the PCI group, according to the intention-to-treat analysis (p=0.008). The difference was driven by ischemia-guided revascularization. The recurrence rate was 3.5%, with a need for another PCI during follow-up.

In patients treated with PCI, the incidence of the PSE was 3.6%, compared with 12.2% in patients with failed revascularization (p=0.03) and 5.7% in patients with OMT during follow-up.

When evaluating MACE, the rate was 8.6% compared with 15.2% in patients with failed percutaneous revascularization and 22.9% in patients with OMT.

Conclusions

The EuroCTO study demonstrated method safety with high procedural success rates and significant improvement in MACE. While it did not reduce mortality (as the design was not specifically intended for that purpose), it did reduce angina and the amount of medication needed for its treatment, which had a significant impact on patient quality of life.

Dr. Omar Tupayachi

Dr. Omar Tupayachi.
Member of the Editorial Board of SOLACI.org.

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

Reference: Werner GS, Hildick-Smith D, Martin Yuste V, Boudou N, Sianos G, Gelev V, Rumoroso  JR, Erglis A, Christiansen EH, Escaned J, di Mario C, Teruel L, Bufe A, Lauer B, Galassi AR, Louvard Y. Three-year outcomes of EuroCTO (A Randomized Multicentre Trial Comparing  Revascularization and Optimal Medical Therapy for Chronic Total Coronary Occlusions). EuroIntervention. 2023 Jul 21:EIJ-D-23-00312. doi: 10.4244/EIJ-D-23-00312. Epub ahead of  print. PMID: 37482940. 


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