Patients with chronic total occlusions (CTOs) had similar results whether they underwent PCIs or received optimal medical treatment, according to a prospective, open-label, randomized trial.

At 3 years, 20.6 percent of patients in the PCI group and 19.6 percent of patients in the optimal medical therapy group reached the primary endpoint, which was a composite of all-cause mortality, MI, stroke or any repeat revascularization. At 5 years, the rates were 26.3 percent and 25.1 percent, respectively.

The health-related quality of life measures were similar, as well.

Lead researcher Seung-Jung Park, MD, PhD, of Asan Medical Center in Seoul, South Korea, presented results of the DECISION CTO study in a late-breaking clinical trial session at the ACC scientific session on March 18 in Washington, D.C.

“PCI is not the only solution to treat chronic total occlusion, and in terms of patient outcomes, cost versus benefit, and other considerations, it is not beneficial to use PCI for all chronic total occlusion lesions,” Park said in a news release. “The size of the ischemia, patient symptoms and cardiac function must be taken into account prior to the decision to perform PCI.”

In this study, patients had silent ischemia, stable angina or acute coronary syndrome and a de novo CTO located in a proximal to mid epicardial coronary artery with a reference diameter of at least 2.5 mm. The researchers defined a CTO as a coronary artery obstruction with TIMI flow grade 0 of at least three months in duration.

Between March 22, 2010, and Oct. 10, 2016, the researchers randomized 834 patients at 19 centers in Asia to receive optimal medical treatment or CTO-PCI using drug-eluting stents within 30 days. If patients had a failed CTO-PCI, operators could attempt additional procedures within 30 days of the index procedure. Operators could choose the type of drug-eluting stent they used.

Patients in the optimal medical treatment received guideline-directed therapies, including aspirin, P2Y12 receptor inhibitors, beta blockers, calcium channel blockers, nitrate, ACE inhibitors, ARBs and statins. The researchers recommend that operators perform revascularization for all significant non-CTO lesions within a vessel diameter of 2.5 mm for patients with multi-vessel coronary artery disease.

The study stopped enrollment due to slower than anticipated enrollment, but the sponsor and study leaders were not aware of results at that time.

At baseline, the groups were well balanced. The mean age was approximately 62 years old, and more than 80 percent of patients were males.

More than 91 percent of the attempted CTO PCI procedures were successful, and 73.9 percent of patients received the single wire CTO technique and 24.6 percent received the retrograde approach.

At 3 years, the all-cause mortality rates were 4.4 percent in the optimal medical therapy group and 3 percent in the PCI group. At 5 years, the rates were 7.9 percent and 4.5 percent, respectively.

In addition, at 3 years, 10.7 percent of patients in the PCI group and 8.4 percent of patients in the optimal medical therapy group had an MI. At 5 years, the rates were 11.9 percent and 9.4 percent, respectively.

Meanwhile, the 3-year stroke rates were 1.3 percent in the optimal medical therapy group and 1 percent in the PCI group, while the 5-year stroke rates were 5 percent and 1 percent, respectively.

Further, the repeat revascularization rates at 3 years were 10.4 percent in the PCI group and 8.6 percent in the optimal medical therapy group, while the 5-year repeat revascularization rates were 14.0 percent and 11.8 percent, respectively.

"If patients suffer from a large ischemic burden, PCI is crucial to open the lesion, but for small occlusions, optimal medical treatment [with drugs alone] is sufficient,” Park said in a news release.

Dipti Itchhaporia, MD, of Hoag Memorial Hospital in Newport Beach, California, said during a news conference that interventional cardiologists have been seeking a randomized trial comparing PCIs to optimal medical treatment in CTO patients.

“We probably do need more clinical trials that address this issue because I think we’re still left with some questions,” she said. “I think [DECISION CTO] sort of reinforced the strategy more than really giving you a roadmap of what the optimal therapy is.”