FACTOR Trial Studies Health Status Benefits of CTO Recanalization
April 13, 2010—J. Aaron Grantham, MD, et al published results from the FACTOR (FlowCardia’s Approach to Chronic Total Occlusion [CTO] Recanalization) trial, which is seeking to quantify the early health status benefits of successful CTO recanalization. The FACTOR pivotal study was designed to assess the safety and efficacy of the Crosser catheter (FlowCardia, Inc., Sunnyvale, CA) in chronically occluded coronary arteries. The findings were published online ahead of print in Circulation: Cardiovascular Quality and Outcomes
The FACTOR investigators concluded that successful CTO recanalization is associated with significant early improvements in patient symptoms, function, and quality of life (QOL) but only among symptomatic patients. Percutaneous treatment of a CTO offers the potential to provide significant health status benefits in symptomatic patients.
In the FACTOR trial, patients (n = 125) completed the Seattle Angina Questionnaire (SAQ) at baseline and 1 month after percutaneous coronary intervention (PCI). One-month health status outcomes were compared by multivariable analysis, adjusting for group differences between patients whose CTO was successfully and unsuccessfully recanalized. These changes were also analyzed according to baseline symptoms. Procedural success was 55% (n = 64) and independently associated with angina relief (difference between those with successful and unsuccessful PCI [Δ] in SAQ angina frequency, 9.5 points; 95% confidence interval [CI], 1.6–17.5; P = .019), improved physical function (Δ in SAQ physical limitation, 13.1 points; 95% CI, 5.1–21.1; P = .001), and enhanced QOL (Δ in SAQ QOL, 20.3 points; 95% CI, 11.9–28.6; P < .001). The benefit of successful PCI was greatest in symptomatic patients as compared with asymptomatic patients, although statistically significantly so only for QOL (Δ SAQ angina frequency domain, 10.3 vs 4.3 points; P = .51; Δ physical limitation, 15.9 vs 6.3 points; P = .25; Δ QOL, 27.3 vs 8.5 points; P = .047), the investigators reported.