Drugs were as effective in CTO patients as PCI, Korean study found.
Patients with a complete blockage in a coronary artery did as well with drugs and they did with percutaneous coronary intervention (PCI), researchers said today at ACC Scientific Sessions.
Reporting on a study called DECISION CTO Seung-Jung Park, MD, (photo) a cardiologist as Asan Medical Center in Seoul said results in 798 patients with chronic total occlusion (CTO) showed no significant differences in outcomes when they were randomized to get PCI plus drugs or drugs alone.
After three years, the primary end point (death or major cardiac event) had occurred in 19% of the medical therapy group and in 21.4% of those who had PCI. The P value for non-inferiority was 0.007.
In the medication-only group the death rate was 5.2% vs 3.2% in the PCI group. Rates of myocardial infarction were 8.8% in the medication group and 11.2% in the PCI group.
Measures of health-related quality of life did not differ significantly in the two groups over time.
Drugs included aspirin, a beta-blocker, a calcium channel blocker, and a statin.
The findings reinforce those of earlier studies showing that PCI does not improve long-term patient outcomes any better than medications in patients with coronary heart disease, Park said.
Commenting on Park’s study at a panel discussion today, Dipti Itchhaporia, MD, a cardiologist at Hoag Hospital in Orange County, CA said, “CTOs are a particular problem for interventionist, and this is the first randomized controlled trial to address it.
The data were useful, she added, “But we probably need more studies because we are still left with questions.”
The issue is that drugs can ease symptoms and reduce the risk of adverse events but they do not remove the blockage. Park said that may not be necessary.
“If patients suffer from a large ischemic burden, PCI is crucial to open the lesion,but for small occlusions, optimal medical treatment is enough.”
The study was supposed to enroll 1,284 patients but enrollment was halted early. Park said he though interventional cardiologists were convinced that only PCI would be effective treatment and were overly reluctant to allow patients to take part in the research.
But statisticians determined the sample was large enough to proceed.
The trial was funded by the CardioVascular Research Foundation in South Korea. 2