Efficacy of Percutaneous Coronary Intervention on Health Related Quality of Life in Optimally-Treated Stable Coronary Patients - Electronic Supplement

Weintraub WS, Spertus JA, Kolm P, Maron DJ, Zhang Z, Jurkovitz C, Zhang W, Hartigan PM, Lewis C, Veledar E, Bowen J, Dunbar SB, Deaton C, Kaufman S, O'Rourke RA, Goeree R, Barnett PG, Teo KK, Boden WE, for the COURAGE Trial Research Group

N Engl J Med 2008;359:677-87 (electronic supplement)

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Clinically Significant Increases from Baseline In SAQ Scores

Increases in SAQ and RAND-36 scores from baseline were calculated for 1, 3, 6, 12, 24 and 36 months of follow-up. For the SAQ, those with increases greater than or equal to 8 for Physical Limitation, 20 for angina frequency, 16 for quality of life and 10 for angina stability and treatment satisfaction were considered clinically significant. Contingency table analysis (chi-square) was used to compare PCI + OMT and OMT differences. Multivariable logistic regression was used to adjust for age, gender, race, previous MI, diabetes, baseline CCS score, and previous CABG.

Table 2 in the manuscript presents the percentages of PCI + OMT and OMT patients with clinically significant increases in SAQ scores. There was a significantly greater percentage of PCI + OMT patients with greater increases in physical limitation and quality of life scores at 1, 3 and 6 months from baseline. Thereafter, there were no significant differences between PCI + OMT and OMT. Although the nonsignificant p values at 12 months and following could be attributed to decreasing sample sizes (and thus power), the observed differences in percentages between PCI and OMT became smaller with increasing follow-up.

Differences in angina frequency favored PCI + OMT over all 36 months of follow-up. For angina stability, there was only a significant difference between PCI + OMT and OMT at 1 month. Differences in treatment satisfaction were virtually the same except at 24 months with OMT percentage greater than PCI + OMT.

Adjustment for age, gender, race, previous MI, diabetes, baseline CCS score, and previous CABG made little impact on differences between observed and predicted proportions of patients with clinically significant increases in scores, differing in only the second and third decimal places. Consequently, the magnitude of p values of PCI + OMT vs. OMT differences changed only slightly.