Percutaneous coronary intervention versus optimal medical therapy for chronic total occlusion: an updated meta-analysis of randomized controlled trials comparing clinical and health status outcomes

Abstract

Abstract Background The prevalence of coronary chronic total occlusion (CTO) varies widely from 18-52% in patients with stable ischemic heart disease. Despite recent advances in operator techniques and improving operator experience, percutaneous coronary intervention (PCI) for CTO still poses a major challenge. While several observational studies have demonstrated superior outcomes for CTO-PCI, the overall benefit of CTO intervention remains controversial. Purpose We aimed to compare the clinical endpoints and health status outcomes in all randomized controlled trials (RCT's) to evaluate safety and efficacy of PCI as compared to optimal medical therapy (OMT). Methods We queried PubMed/MEDLINE, Cochrane Library and EMBASE for RCT’s that compared CTO-PCI with OMT. The primary endpoint was all-cause mortality. Secondary outcomes included cardiac mortality, major adverse cardiac and cerebrovascular events (MACCE), myocardial infarction (MI), target vessel revascularization (TLR), stent thrombosis, left ventricle ejection fraction (LVEF) changes and health status outcomes. Risk ratios (RR’s) and their corresponding 95% confidence intervals (CIs) were calculated using the random-effects model. Results We included a total of 6 RCT’s (1890 total patients, mean age 61.8±3.6, and 84.6 % male) Follow-up ranged from 4 to 48 months. All-cause mortality and cardiac mortality were comparable between CTO-PCI and OMT groups (RR 0.83; 95% CI 0.47 – 1.48; p = 0.53 and RR 0.98; 95% CI 0.24 – 4.07; p = 0.98, respectively). There was no significant difference between PCI or medical therapy with regards to MACCE (RR 0.85; 95% CI 0.50 – 1.45; p = 0.55) and TLR at follow-up (RR 0.50, 95% CI 0.24 – 1.06; p = 0.07). Moreover, the risk for MI (RR 1.36; 95% CI 0.91 – 2.-2; p = 0.13), stent thrombosis (RR 1.74; 95% CI 0.36 – 8.40; p = 0.49), and stroke at follow-up (RR 0.57; 95% CI 0.24 – 1.38; p = 0.21) was comparable between the two groups. Health status outcomes such as angina frequency (RR 4.05; 95% CI –1.95 – 10.05; p = 0.19), physical limitations (RR 3.83; 95% CI –0.75 – 8.41; p = 0.10), quality of life (RR 6.25; 95% CI –1.54 – 14.03; p = 0.12), and treatment satisfaction (RR 2.60; 95% CI –1.15 – 6.35; p = 0.17), were comparable between the two groups. Conclusion Pooled data from RCT does not support an advantage to CTO PCI in terms of a reduction in cardiovascular events or improved quality of life. Further adequately powered and long-term trials are required to identify the best management strategy for patients with coronary CTO.Figure 1Figure 2