Werner GS, et al. - The impact of percutaneous coronary intervention (PCI) vs optimal medical therapy (OMT) on the health status in patients with at least one coronary total occlusion (CTO) was evaluated. Relative to those who received OMT alone, a significant improvement in health status was seen in patients with stable angina and a CTO who underwent PCI.

Methods

• In this prospective randomized, multicenter, open-label, and controlled clinical trial, 396 patients were enrolled and treatment by PCI was compared with OMT via a 2:1 randomization ratio.
• Using the Seattle angina questionnaire (SAQ), the observed change in health status between baseline and 12 months follow-up was the primary endpoint.

Results

• Multi-vessel disease was present in 52% of patients; all significant non-occlusive lesions were treated before randomization.
• Including 13.4% failed procedures in the PCI group and 7.3% cross-overs in the OMT group, an intention-to-treat analysis was carried out.
• With PCI vs OMT, a greater improvement of SAQ subscales for angina frequency (5.23, 95% confidence interval [CI] 1.75; 8.71; P=0.003), and quality of life (6.62, 95% CI 1.78–11.46; P=0.007) was noted at 12 months, reaching the prespecified significance level of 0.01 for the primary endpoint.
• The PCI group also showed improvement in physical limitation (P=0.02).
• With PCI vs OMT, complete freedom from angina was more frequent (71.6% vs 57.8% [P=0.008]).
• No periprocedural death or myocardial infarction was reported; the two groups had comparable rates of major adverse cardiac events at 12 months.