Previous studies have assessed the health status benefits associated with CTO-PCI.4,5 Most recently, the OPEN CTO study showed significant improvement in health status in 1000 consecutive patients undergoing CTO-PCI in 12 experienced U.S. centers.6 Similarly, in a Canadian registry, revascularization of CTO was associated with greater health status benefit compared to medical therapy alone.4 However, these studies compared CTO-PCI success to failure, rather than to medical therapy.
In this context, Werner and colleagues investigated the value of PCI versus OMT for CTO by performing a well-designed randomized clinical trial in patients with CTO by assessing their health status with the SAQ.7 The SAQ is a 19-item questionnaire with a 4-week recall period that measures 5 domains of health status in patients with coronary artery disease (CAD).8,9 Scores in each domain range from 0 to 100, with higher scores indicating fewer symptoms and better quality of life. The SAQ has undergone extensive reliability and validity testing and is associated with long-term survival and health care utilization among patients with chronic CAD.10,11 At 12 months follow-up, patients who underwent CTO-PCI had greater improvement in SAQ subscales, including angina frequency and quality of life, reaching the pre-specified significance level of 0.01. There was also numerical improvement in physical limitation (P = 0.02)
The strengths of this current study include the randomized design and the careful treatment of non-CTO- PCI lesions before enrollment into the study. These non-CTO lesions were treated before the baseline health status assessment so that the additional health status benefit of non-CTO-PCI would not affect the results. This was one of multiple major limitations of the recently presented DECISION-CTO trial, as the non-CTO lesions were treated after the randomization and baseline assessment, leading to inaccurate comparison between medical therapy and CTO-PCI.12
Another interesting point of the current study is the patient selection. Since the treatment sites included were all expert centers in Europe, many patients who were referred to their institution for CTO-PCI were excluded from the study. For example, among the 1980 patients with screening log, 1381 were excluded because they were referred for CTO-PCI and 122 were excluded because they were “too symptomatic.” This suggests that the population studied were less symptomatic than the overall symptomatic CTO population from previous registries, as evidenced by about 40% of patients having Canadian Cardiovascular Society (CCS) class I/II angina at baseline. In the recent consecutively enrolled OPEN CTO registry, only 26% of patients reported CCS class I/II angina at baseline.6 These observations likely represent biases to the null, and thus one can reasonably speculate that the impact among unselected patients would be greater. Degree of baseline angina has been reported to be a predictor in patients with stable angina.13 Moreover, the degree of health status improvement is significantly larger in patients with refractory angina undergoing CTO- PCI.14
In this study, the success rate of CTO PCI was 83.1% at the initial attempt and 86.6% at the final attempt. The in-hospital complication rate was 2.9%, which included pericardial tamponade, vascular surgical repair, and need for blood transfusion. The success rate and complication rates were consistent with previous observational studies from expert centers.1,6
Applications for Clinical Practice
In patients presenting with stable angina with CTO, the health status improvement is larger with CTO-PCI plus medical therapy compared to medical therapy alone. CTO-PCI should be offered to symptomatic patients in conjunction with OMT.
—Taishi Hirai, MD, and J. Aaron Grantham, MD, St. Luke’s Mid America Heart Institute, Kansas City, MO