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WASHINGTON -- Patients with chronic total occlusion (CTO) were no worse off getting optimal medical therapy (OMT) alone in lieu of stenting, according to the first trial to compare the two strategies.

The DECISION-CTO investigators randomized patients to OMT with or without percutaneous coronary intervention (PCI). On intention-to-treat analysis, OMT was non-inferior to stenting when it came to 3-year rates of combined all-cause death, MI, stroke, and repeat revascularization (19.6% for OMT vs 20.6% for PCI, P=0.008 for non-inferiority).

Adverse event rates stayed indistinguishable between OMT and PCI through 5-year follow-up (25.1% vs 26.3%, adjusted HR 0.91, 95% CI 0.68-1.23), reported , of the Asan Medical Center in Seoul, at the American College of Cardiology (ACC) annual meeting.

"This study suggested that OMT could be a reasonable initial treatment strategy for coronary CTO compared with CTO-PCI," he stated.

Park's group found no differences for the individual components of the endpoints or quality of life. Comparable outcomes were observed across major subgroups.

"Until today no such randomized trial had been performed," said ACC discussant , of the Piedmont Heart Institute in Atlanta.

However, he noted that over the 6 years that the study took, it was "troubling" that over 3-year follow-up, only half of patients were represented in the Kaplan-Meier analyses.

"Nevertheless, the trial is ambitious because CTOs are the most complex lesions in interventional cardiology," he stated. "Acknowledging that crossover, as in clinical practice, may be produced, the DECISION-CTO trial may be considered as a strategy trial in stable patients with angina and CTO instead of one that discounts the merits of CTO revascularization."

"I'd say this reinforces a strategy rather than provide a roadmap of an optimal therapy," agreed , of Hoag Hospital in Newport Beach, Calif., who was not part of the study. "Anything that's good, you get a taste, you want more. You can do OMT and take those patients with ischemic symptoms and try to do a revascularization."

"Hopefully this will slow down the [proliferation of] CTO centers," she said at an ACC press conference.

DECISION-CTO is a prospective, open-label trial that enrolled patients with silent ischemia, stable angina, or acute coronary syndrome from at 19 centers in Asia. Participants had to have a de novo CTO located in a proximal-to-mid epicardial coronary artery with a reference diameter of at least 2.5 mm. Park's group excluded those with severe comorbidity and left ventricular ejection fractions under 30%.

Importantly, the trial was terminated early because of sluggish enrollment: 834 patients were enrolled instead of the expected 1,284.

Patients in the PCI arm had drug-eluting stents placed. In case of procedural failure, additional attempts at stenting were allowed within 30 days of the index procedure. Overall CTO PCI success was 91.1%.

There was no difference in baseline characteristics between those randomized to OMT (n=398) and PCI (n=417), besides the greater use of clopidogrel (Plavix) with PCI. Three-quarters of the study cohort presented with stable angina and another three-quarters had multivessel disease (operators were directed to perform complete revascularization for multivessel disease).

After some crossover between groups, the OMT group had slightly fewer stents placed (2.0 vs 2.4, P<0.001) and short total stent lengths (53.6 mm vs 71.2 mm, P<0.001).

The non-inferiority of OMT was lost in predefined per-protocol (22.3% OMT vs 19.0% PCI, P=0.15 f0r non-inferiority) and as-treat analyses (23.1% vs 17.4%, P=0.35 for non-inferiority).

Through 5 years, however, event rates remained similar between arms.

, of San Raffaele Scientific Institute in Milan, suggested that patient selection was probably at play in the trial. "The conclusion should be more tempered," he said.

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