Randomized Multicentre Trial to Compare Revascularization With Optimal Medical Therapy for the Treatment of Chronic Total Occlusions - EUROCTO

Sep 28, 2019
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Biosensors Europe SA, and ASAHI Intecc Co. Ltd.
Date Presented:
09/28/2019
Date Published:
05/02/2018
Date Updated:
09/28/2019
Original Posted Date:
05/09/2018
References

Contribution To Literature:

The EUROCTO trial showed that PCI was effective at improving some measures of health status.

Description:

The goal of the trial was to evaluate percutaneous coronary intervention (PCI) plus optimal medical therapy compared with optimal medical therapy alone among patients with stable angina due to chronic total occlusion (CTO).

Study Design

  • Randomized
  • Parallel

Patients with stable angina due to CTO were randomized to PCI with a biolimus-eluting stent plus optimal medical therapy (n = 259) versus optimal medical therapy alone (n = 137). Patients with multivessel nonocclusive disease underwent revascularization of those lesions >4 weeks prior to randomization. If CTO-PCI was unsuccessful, a reattempt could be performed. The primary outcome was components of the Seattle Angina Questionnaire.

  • Total number of enrollees: 396
  • Duration of follow-up: median 19 months
  • Mean patient age: 65 years
  • Percentage female: 16%
  • Percentage with diabetes: 27%

Inclusion criteria:

  • At least one CTO in a vessel at least 2.5 mm in diameter
  • Age of CTO estimated >3 months

Exclusion criteria:

  • Inability to tolerate dual antiplatelet therapy
  • Need for elective noncardiac surgery within 6 months

Other salient features/characteristics:

Of the 259 patients randomized to PCI, five did not undergo PCI, and 34 had unsuccessful PCI (one of these patients was referred for coronary artery bypass grafting). The overall success rate for PCI was 87%. The retrograde approach was used in 36%. There were no procedural deaths; however, four patients had tamponade and five patients received blood transfusion.

Of the 137 patients randomized to optimal medical therapy, 10 crossed over to receive PCI.

Principal Findings:

For the primary efficacy endpoint at 12 months, the angina frequency score (p = 0.003) and the quality-of-life score (p = 0.007) had improved for PCI compared with optimal medical therapy (intention to treat). There was no improvement in the other domains (physical limitation, angina stability, and treatment satisfaction) for PCI compared with optimal medical therapy.

For the primary safety endpoint at 3 years, cardiovascular death or myocardial infarction occurred in 5.0% of the PCI group vs. 2.9% of the optimal medical therapy group (p = 0.32).

Secondary outcomes:

  • Major cardiovascular and cerebrovascular events: 5.2% for PCI vs. 6.7% for optimal medical therapy (p = 0.55)
  • Ischemia-driven revascularization: 2.0% for PCI vs. 6.7% for optimal medical therapy (p = 0.04)
  • Complete freedom from angina: 71.6% for PCI vs. 57.8% for optimal medical therapy (p = 0.008)
  • Any major adverse cardiac or cerebrovascular event at 3 years: 10.7% for PCI vs. 20.1% for optimal medical therapy (p = 0.019)

Interpretation:

Among patients with stable angina due to CTO, PCI improved some, but not all measures of health status (angina frequency and quality of life). There was a higher frequency of complete relief from angina in the PCI group. There were no periprocedural deaths in the PCI group, although four tamponades occurred. Major adverse cardiovascular and cerebrovascular events were low and similar between treatment groups at 12 months. At 3 years, cardiovascular death or myocardial infarction was similar between treatment groups, while major adverse cardiovascular and cerebrovascular events were lower in the PCI group vs. optimal medical therapy. This was driven by a reduction in ischemia-driven revascularization in the PCI group.

This trial is different from DECISION-CTO (found no benefit for PCI vs. optimal medical therapy) by treating non-CTO lesions before randomization. Accordingly, EUROCTO was a truer assessment of the potential benefit of CTO revascularization.

References:

Presented by Dr. Gerald S. Werner at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2019), San Francisco, CA, September 28, 2019.

Werner GS, Martin-Yuste V, Hildick-Smith D, et al. A randomized multicentre trial to compare revascularization with optimal medical therapy for the treatment of chronic total occlusions. Eur Heart J 2018;39:2484-93.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Pericardial Disease, Stable Ischemic Heart Disease, Aortic Surgery, Cardiac Surgery and SIHD, Chronic Angina

Keywords: Angina, Stable, Blood Transfusion, Cardiac Tamponade, Coronary Occlusion, Drug-Eluting Stents, Intention to Treat Analysis, Myocardial Infarction, Myocardial Ischemia, Myocardial Revascularization, Percutaneous Coronary Intervention, Personal Satisfaction, Quality of Life, Transcatheter Cardiovascular Therapeutics, TCT19


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