Key result
Initial CTO-PCI did not significantly reduce 10-year death, MI, stroke, or revascularization vs no CTO-PCI (33.9% vs 37.4%; risk difference -3.5%; 95% CI -10.4 to 3.3; P=0.32).
Why the study?
The long-term clinical effects of PCI for chronic total occlusion remained uncertain, prompting a 10-year comparison of initial CTO-PCI versus no CTO-PCI strategies in the DECISION-CTO trial.
Does an initial strategy of CTO-PCI reduce the 10-year composite outcome of all-cause death, myocardial infarction, stroke, or any revascularization compared with no CTO-PCI in patients with chronic total occlusion?
RCT (n=834)
Open-label
Randomly assigned
Yes
Does an initial strategy of CTO-PCI reduce the 10-year composite outcome of all-cause death, myocardial infarction, stroke, or any revascularization compared with no CTO-PCI in patients with chronic total occlusion?
Answers are grounded in this paper and cite their sources.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“This study suggested that optimal medical therapy could be a reasonable initial treatment strategy for coronary CTO compared with CTO PCI.”
“Two stents in the OMT arm is not really medical therapy. They found a benefit—all the patients profited—but there was no difference between the two treatment arms in DECISION-CTO because they did a lot of PCI in the conservative arm.”
“What people didn’t realize so much about DECISION-CTO was exactly as they say: the non-CTO PCI confounded the treatment effect.”
At 10 years of extended follow-up in the DECISION-CTO trial, an initial CTO-PCI strategy showed no significant difference in major cardiovascular events or all-cause mortality compared with medical therapy and non-CTO PCI alone, though wide confidence intervals prevent definitive conclusions.
BACKGROUND The long-term clinical effects of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) remain uncertain. OBJECTIVES This study aimed to compare 10-year clinical outcomes between initial CTO-PCI and no CTO-PCI strategies in the extended follow-up of the DECISION-CTO trial. METHODS The DECISION-CTO trial was an open-label, multicenter, randomized trial conducted at 19 centers in 5 Asian countries. Patients were randomly assigned to an initial strategy of CTO-PCI or no CTO-PCI, with guideline-directed medical therapy in both groups and PCI of obstructive non-CTO lesions encouraged in both groups. The primary endpoint was a composite of death from any cause, myocardial infarction, stroke, or any revascularization at 10 years, analyzed in the modified intention-to-treat population. RESULTS Between March 2010 and October 2016, 834 patients were randomly assigned, of whom 804 were included in the modified intention-to-treat analysis (413 CTO-PCI, 391 no CTO-PCI). Clinical follow-up at 10 years was complete in 688 patients (85.6%), without a significant between-group difference (P = 0.69). At 10 years, the primary endpoint had occurred in 134 patients in the CTO-PCI group and 138 patients in the no CTO-PCI group (Kaplan-Meier estimates: 33.9% vs 37.4%; risk difference: −3.5 percentage points; 95% confidence interval [CI]: −10.4 to 3.3; *P =* 0.32). Restricted mean event-free survival time at 10 years was also similar between groups (7.52 vs 7.53 years; difference: −0.01 years; 95% CI: −0.54 to 0.52; *P* = 0.97). Death from any cause did not differ significantly between groups (12.7% vs 16.5%; hazard ratio: 0.76; 95% CI: 0.52-1.12; *P =* 0.16). CONCLUSIONS Over 10 years, an initial strategy of CTO-PCI was not associated with a significant difference in the primary endpoint or all-cause mortality compared with an initial strategy of no CTO-PCI. However, the wide confidence intervals preclude definitive conclusions regarding the potential benefit or harm of an initial CTO-PCI strategy.
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Kim et al. (2026) conducted an RCT in Chronic total occlusion (n=834). Initial strategy of CTO-PCI with guideline-directed medical therapy and PCI of obstructive non-CTO lesions vs. Initial strategy of no CTO-PCI with guideline-directed medical therapy and PCI of obstructive non-CTO lesions was evaluated on Composite of death from any cause, myocardial infarction, stroke, or any revascularization at 10 years (Risk difference -3.5 percentage points, 95% CI -10.4 to 3.3, p=0.32). Initial CTO-PCI did not significantly reduce 10-year death, MI, stroke, or revascularization vs no CTO-PCI (33.9% vs 37.4%; risk difference -3.5%; 95% CI -10.4 to 3.3; P=0.32).
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