PARIS (FRONTLINE MEDICAL NEWS) – The first randomized clinical trial to evaluate quality of life and clinical symptoms as the primary efficacy outcome in patients with coronary chronic total occlusion (CTO) showed a clear advantage for percutaneous revascularization over optimal medical therapy.
At 12 months’ follow-up in the 26-site, 396-patient EuroCTO trial, patients randomized to PCI with drug-eluting stents had significantly less angina and physical limitations coupled with greater improvement in quality of life than the optimal medical therapy (OMT) group on subscales of the Seattle Angina Questionnaire. On the angina frequency subscale, for example, the PCI group improved from a mean baseline score of 77.2 to 91.4 at 12 months, a significantly better result than the OMT group improvement from 80.6 to 87.5.
The PCI group also experienced greater mobility, better activity status, and less pain and discomfort as assessed by the EuroQOL five dimensions questionnaire ( EQ-5D ), Gerald S. Werner, MD , reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
“PCI of a CTO should be considered as a primary option in symptomatic patients. It is a safe and effective treatment option in expert hands,” said Dr. Werner, director of cardiology and nonsurgical intensive care at the Darmstadt (Ger.) Clinic.
He emphasized the point about “expert hands,” drawing attention to the stellar 86.3% successful revascularization rate in the EuroCTO trial, even though these were often complex procedures. Indeed, in 36% of the CTO PCIs, a retrograde approach was used.
“CTO is a special field. Just like not everybody in every hospital will do a transcatheter aortic valve replacement, not everybody should do a CTO. It can be done safely and to the benefit of the patient, but it needs to be done by someone with expertise,” the cardiologist said.
Study participants were evenly split between those with single- and multivessel disease. Patients with additional nonocclusive disease had those lesions treated by PCI before the 2:1 randomization to CTO PCI or OMT.
The periprocedural complication rate was low at 2.9%, a figure that included a 1.5% incidence of pericardial tamponade as well as vascular repairs. There were no periprocedural MIs or deaths. The 1-year major adverse cardiac event rate was roughly 6% in both study arms.
The PCI group received 6-12 months of dual-antiplatelet therapy with clopidogrel and aspirin. So did roughly 40% of the OMT group because of prior PCI.
Both study arms had comparably high rates of guideline-directed medical therapy, including statins, beta-blockers, and ACE inhibitors. However, the PCI group made significantly less use of nitrates than the OMT group during follow-up, reflecting their greater reduction in angina frequency. The crossover rate from OMT to PCI because of ongoing angina was 7.3%.
The long-term safety and durability of the two treatment strategies will be assessed at 3 years of follow-up.
The EuroCTO trial was originally planned for 600 patients. The investigators eventually settled for less because of slow enrollment. Many interventionalists who are skilled in treating CTOs proved reluctant to randomize the patients.
Dr. Werner contrasted the positive EuroCTO findings regarding clinical symptoms and quality of life to the negative results of the Korean DECISION CTO trial presented at the 2017 meeting of the American College of Cardiology. DECISION CTO found that PCI plus OMT wasn’t superior to OMT alone in reducing MI and other major adverse cardiac events in patients with at least one CTO. In Dr. Werner’s view, the Korean investigators chose the wrong endpoint.
“The quality of life improvement we’ve shown after PCI in EuroCTO is a valid clinical goal in treating stable coronary artery disease. I don’t think we can aim at improving prognosis,” according to Dr. Werner.
The impetus for EuroCTO was a recognition that CTOs are common and seriously undertreated. CTOs account for 16%-18% of all coronary lesions in patients with stable coronary artery disease, yet U.S. national data indicate only 5% of PCIs are performed to treat CTOs.
The EuroCTO trial was sponsored by the Euro CTO Club and supported by research grants from Biosensors and Asahi.