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

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: 5 months
• 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 vessels CTOs in any location. two proximal CTOs in a 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: 2.3
• 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 20.6% vs. 19.6%, p for noninferiority 0.008.

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

• 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 was 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. 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 recently published 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%.