Successful CTO PCI Significantly Improves Health Status in Registry Study
High technical success rates were achieved with chronic total occlusion (CTO) PCI and significant health status benefits were realized in patients with successful CTO PCI, in a prospective, multicenter registry study, concluded James Sapontis, MD, et al., in a paper published August 7 in JACC: Cardiovascular Interventions.
The OPEN-CTO study was a comprehensive registry of consecutive patients undergoing hybrid CTO PCI. Technical success was defined as the positioning of the guidewire in the distal true lumen of the first CTO attempted, deployment of a balloon or stent with final antegrade TIMI flow grade 2 or 3, residual stenosis <50 percent and no significant side branch occlusion. Patients were followed-up at one month. Health status was evaluated using the Seattle Angina Questionnaire (SAQ), Rose Dyspnea Scale and Patient Health Questionnaire (PHQ) 8.
A total of 1,054 CTO lesions were attempted in 1,000 enrolled patients. The most common indication for CTO PCI was symptom relief. The technical success rate was 86 percent using the core-lab definition of success and 90 percent when determined by the operator without core lab data. The in-hospital death rate was 0.9 percent. Complications included perforations (8.8 percent), periprocedural myocardial infarction (2.6 percent), in-hospital repeat PCI (0.1 percent), referral for emergent surgery (0.7 percent), acute kidney injury (0.8 percent) and major bleeding events (0.3 percent).
Among the 991 patients discharged alive, 890 had complete baseline and one-month health status data. After CTO-PCI, improvements at one month (mean ± SEM) were observed in SAQ quality of life (QOL) (49.4 ± 0.9 to 75.0 ± 0.7; p < 0.01), Rose Dyspnea Scale (2.0 ± 0.1 to 1.1 ± 0.1; p < 0.01) and PHQ-8 (6.2 ± 0.2 to 3.5 ± 0.1; p < 0.01). Patients with successful CTO PCI had greater health status improvement than those with unsuccessful procedures. After adjusting for baseline differences, the SAQ QOL was improved by 10.8 points in the successful vs. unsuccessful CTO-PCI group (95 percent confidence interval, 6.3-15.3; p < 0.001).
CTO-PCI operators achieved high technical success rates but complication rates were higher than described for non-CTO PCI. Patients with successful CTO had significant health status benefits at one month. The authors concluded that clarification of the success rates, risks and benefits of CTO PCI will help appropriately selected patients to more effectively share in the decision to pursue PCI or other therapies.
In a related editorial, Carlo Di Mario, MD, PhD, FACC, et al., noted that the DECISION-CTO and EXPLORE randomized trials reported no advantage to CTO PCI vs. optimal medical therapy. They attributed the difference in results to possible selection bias in the randomized trials and the lack of discrimination between clinical improvement from PCI in general and CTO PCI in patients with multivessel disease (OPEN-CTO baseline observation was done after non-CTO PCI). Although the claim that CTO PCI saves lives is not supported by randomized trials, they concluded, “There is no doubt, however, that QOL is improved by CTO recanalization.” While the price to pay is higher for non-CTO PCI, “complications, especially perforations, are successfully handled in most cases without surgery.”
Keywords: Selection Bias, Constriction, Pathologic, Confidence Intervals, Quality of Life, Prospective Studies, Myocardial Infarction, Angina Pectoris, Registries, Hospital Mortality, Stents, Acute Kidney Injury, Dyspnea, Referral and Consultation, Risk Assessment
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