Optimal Medical Therapy With or Without Stenting For Coronary Chronic Total Occlusion - DECISION-CTO

May 31, 2019
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Presenter/Author:
Seung-Jung Park, MD, PhD, FACC
Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
CardioVascular Research Foundation Korea
Date Presented:
03/18/2017
Date Published:
04/02/2019
Date Updated:
05/31/2019
Original Posted Date:
03/18/2017
References

Contribution To Literature:

The DECISION-CTO trial showed that routine CTO-PCI + OMT is not superior to OMT alone in reducing cardiovascular outcomes among patients with at least one CTO.

Description:

The goal of the trial was to assess the safety and efficacy of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) compared with optimal medical therapy (OMT) among patients with at least one CTO.

Study Design

Patients were randomized to CTO-PCI + OMT (n = 417) or OMT (n = 398). The trial had to be stopped early due to slow enrollment. In the PCI arm, revascularization for all significant non-CTO lesions within a vessel diameter of ≥2.5 mm for patients with multivessel coronary artery disease was recommended. PCI had to be completed within 30 days of randomization. All patients were prescribed guideline-derived OMT.

  • Total number of enrollees: 834
  • Duration of follow-up: 4 years
  • Mean patient age: 62.5 years
  • Percentage female: 18%

Inclusion criteria:

  • Silent ischemia, stable angina, or acute coronary syndrome
  • De novo CTO located in a proximal to mid epicardial coronary artery with a reference diameter of ≥2.5 mm
  • CTO was defined as a coronary artery obstruction with TIMI flow grade 0 of at least 3 months’ duration based on patient history.

Exclusion criteria:

  • CTO located in the distal coronary artery, three different vessel CTOs in any location. two proximal CTOs in separate coronary artery, left main segment, in-stent restenosis, or graft vessel
  • Left ventricular ejection fraction (LVEF) <30%
  • Severe comorbidity

Other salient features:

  • Previous PCI: 17%, chronic kidney disease: 1.4%
  • Mean LVEF: 57%
  • Stable angina presentation: 73%
  • Multivessel disease: 73%
  • Location of CTO: LAD 43%, RCA 46%
  • J-CTO score: 2.1
  • Overall SYNTAX score: 20.8
  • CTO PCI success: 91%, retrograde approach 24%
  • Statin use at 1 year: 92%

Principal Findings:

The primary endpoint for CTO-PCI + OMT vs. OMT, major adverse cardiac events (MACE) at 3 years (all-cause mortality, MI, stroke, repeat revascularization), was 22.3% vs. 22.4%, p for noninferiority 0.014, p for superiority = 0.86.

Secondary outcomes for CTO-PCI + OMT vs. OMT:

  • Death at 4 years: 3.6% vs. 5.3%, p = 0.3
  • MI: 11.3% vs. 8.5%, p = 0.14
  • Any revascularization: 11.0% vs. 10.6%, p = 0.55
  • MACE at 5 years: 26.3% vs. 25.1%, p = 0.67
  • MACE at 5 years on per-protocol analysis: 25.0% vs. 29.0%, p = 0.3
  • Cardiovascular mortality at 5 years: 1.9% vs. 3.6%, p = 0.22
  • Spontaneous MI at 5 years: 1.8% vs. 1.8%, p = 0.93
  • Repeat revascularization at 5 years: 14.0% vs. 11.8%, p = 0.38
  • Quality of life measures, including Seattle Angina Questionnaire for angina, were similar

Interpretation:

The results of this trial indicate that routine CTO-PCI + OMT is not superior to OMT alone in reducing cardiovascular outcomes among patients with at least one CTO. One limitation is the high rate of crossover of nearly 20%. Although negative, this is a landmark trial for the field of CTO PCI. It is one of the first to systematically compare the two therapies.

EXPLORE was another CTO-PCI trial that focused on patients with STEMI undergoing primary PCI with a coexistent CTO, and showed no improvement in LV function with CTO-PCI. Further analyses will be important to see if there are certain scenarios (e.g., high ischemic burden) where CTO-PCI might be beneficial. It is interesting to note that with contemporary expertise and techniques, the success for CTO-PCI is >90%.

References:

Lee SW, Lee PH, Ahn JM, et al. Randomized Trial Evaluating Percutaneous Coronary Intervention for the Treatment of Chronic Total Occlusion: The DECISION-CTO Trial. Circulation 2019;139:1674-83.

Editorial: Brilakis ES, Mashayekhi K, Burke MN. How DECISION-CTO Can Help Guide the Decision to Perform Chronic Total Occlusion Percutaneous Coronary Intervention. Circulation 2019;139:1684-7.

Presented by Dr. Seung-Jung Park at the American College of Cardiology Annual Scientific Session (ACC 2017), Washington, DC, March 18, 2017.

Keywords: ACC17, ACC Annual Scientific Session, Acute Coronary Syndrome, Angina, Stable, Drug-Eluting Stents, Myocardial Infarction, Percutaneous Coronary Intervention, Quality of Life, Random Allocation, Stroke, Coronary Occlusion


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