DECISION CTO Compares PCI With Optimal Medical Therapy
March 18, 2017—The American College of Cardiology announced the presentation of data from the DECISION CTO randomized trial by lead investigator Seung-Jung Park, MD, at the ACC 66th annual scientific sessions in Washington, DC. The study is evaluating a drug-eluting stent versus optimal medical therapy in patients with coronary chronic total occlusion (CTO). The data showed that treatment with medications alone was found to be equal to percutaneous coronary intervention (PCI) in terms of major adverse events over 3 years, reported the ACC.
As summarized in the ACC announcement, in the trial's composite primary endpoint, approximately 20% of patients died or experienced a nonfatal heart attack, stroke, or subsequent revascularization procedure within 3 years after enrolling in the study. This proportion was not significantly different for patients randomly assigned to receive PCI compared with those assigned to receive only drugs, which included aspirin, a beta-blocker, a calcium channel blocker, and a statin.
The ACC announcement noted that the findings are in line with evidence from previous studies suggesting that PCI does not improve long-term patient outcomes compared with medications alone in patients with coronary heart disease who have not experienced a sudden change in symptoms. This is the first study to compare clinical outcomes from the two treatment approaches in patients with CTO.
Dr. Park, a cardiologist at Asan Medical Center in Seoul, South Korea, commented in the ACC press release, “PCI is not the only solution to treat CTO, and in terms of patient outcomes, cost versus benefit, and other considerations, it is not beneficial to use PCI for all CTO lesions. The size of the ischemia, patient symptoms and cardiac function must be taken into account prior to the decision to perform PCI.”
In DECISION-CTO trial, the investigators enrolled 815 patients with CTO at 19 cardiac centers in Asia. They randomly assigned 417 patients to receive PCI plus drugs and 398 patients to receive drugs alone. After tracking outcomes for 3 years, the results showed no significant differences in the composite primary endpoint and no differences in rates of death, heart attack, stroke, and subsequent revascularization procedures considered separately. Measures of health-related quality of life, assessed by the Seattle Angina Questionnaire, also did not differ significantly between the two groups throughout the follow-up period.
The investigators also advised that the findings suggest that it is not always necessary to open blocked arteries using PCI, which substantially increases costs and can increase the risk of a heart attack around the time of the procedure.
Dr. Park stated in the announcement, “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.”
Dr. Park suggested two potential reasons why patients with CTO might not benefit from opening the blockage: if a blockage builds up over a long period of time, sometimes a patient will develop new blood vessels that allow blood to circumvent the blockage, akin to a natural bypass; or, it is also possible that a total blockage actually carries a lower risk of heart attack or stroke compared with a partial blockage. Because no blood is flowing through the blockage, it may be less likely to rupture and travel through the bloodstream to the heart or brain compared with plaque that lines, but does not block, the artery.
According to the ACC, DECISION CTO was designed to enroll 1,284 patients, but stopped after 815 patients because of slow enrollment. Dr. Park said interventional cardiologists may have been reluctant to enroll patients because of the predominant view that blocked arteries should be opened, despite a lack of evidence for long-term benefits of the intervention in these patients. Nevertheless, statisticians determined that the study was sufficiently large to show statistically valid results. A large, global, multicenter study would allow investigators to further validate the study findings, advised Dr. Park.