Table 2.
Change in endpoints before and after apheresis and sham
| Variable | Apheresis | Sham | Treatment effect | P |
|---|---|---|---|---|
| Parametric Test: Mean (95% CI) | ||||
| Primary Outcome | ||||
| MPR | 0.47 (0.31, 0.63) | −0.16 (−0.33, 0.02) | 0.63 (0.37, 0.89) | 0.0001 |
| Secondary Outcomes | ||||
| Rest myocardial perfusion mL/min/g | 0.002 (−0.09, 0.10) | 0.06 (−0.05, 0.17) | −0.06 (−0.05, 0.18) | 0.42 |
| LVEF % | 1.50 (−0.78, 3.76) | 0.70 (−3.52, 3.92) | 0.80 (−2.96, 4.56) | 0.66 |
| Left carotid distensibility % | 4.90 (0.60, 9.20) | −0.80 (−4.40, 2.80) | 5.70 (0.44, 10.98) | 0.035 |
| Right carotid distensibility % | 7.10 (3.30, 10.90) | −0.80 (−3.80, 2.10) | 7.90 (2.48, 13.47) | 0.007 |
| EndoPat LnRHI | −0.05 (−0.08, 0.19) | −0.03 (−0.18, 0.11) | 0.08 (−0.03, 0.21) | 0.14 |
| SAQ—Angina stability | 17.50 (6.70, 28.30) | −1.75 (−17.10, 9.55) | 21.25 (4.58, 37.92) | 0.016 |
| SAQ—QoL | 25.80 (17.50, 34.10) | 4.60 (−6.10, 15.30) | 21.20 (7.08, 35.42) | 0.005 |
| SF-36—Mental component score (MCS) | 6.40 (2.50, 16.20) | 1.60 (−3.80, 7.00) | 4.80 (−2.63, 6.99) | 0.19 |
| HDL cholesterol mmol/L | −0.12 (−0.21, −0.04) | −0.002 (−0.08, 0.07) | −0.12 (−0.21, −0.04) | 0.006 |
| Triglycerides mmol/L | −0.28 (−0.49, −0.07) | 0.18 (−0.02, 0.37) | −0.46 (−0.77, −0.14) | 0.007 |
| Apolipoprotein A (g/L) | −0.09 (−0.17, −0.00) | −0.01 (−0.06, 0.04) | −0.08 (−0.16, −0.008) | 0.074 |
| Apolipoprotein B (g/L) | −0.41 (−0.47, −0.34) | −0.04 (−0.11, 0.03) | −0.37 (−0.45, −0.29) | <0.0001 |
| Non-parametric test: median [IQR] | ||||
| Stress myocardial perfusion mL/min/g | 0.44 [0.18, 0.67] | −0.07 [−0.14, 0.09] | 0.45 (0.28, 0.64) | 0.0004 |
| Total carotid wall volume (left & right) mm3 | −335 [−423, −247] | 127.35 [72.2, 183] | −564 (−729, −416) | <0.0001 |
| Total carotid wall volume (left) mm3 | −200 [−268, −133] | 93.40 [40.0, 147] | −337 (−487, −218) | <0.0001 |
| Total carotid wall volume (right) mm3 | −135 [−187, −81.8] | 34.0 [−19.3, 87.2] | −249 (−349, −141) | 0.0004 |
| 6MWT distance m | 70.5 [41.5, 105.5] | 3.5 [–15.1, 30.8] | 70.6 (39.0, 150) | 0.001 |
| SAQ—Physical limitation | 27.8 [16.7, 43.1] | −4.2 [−11.1, 6.9] | 28.5 (19.4, 40.3) | 0.003 |
| SAQ—Angina frequency | 35.0 [20.0, 50.0] | −5.0 [−20.0, 5.0] | 30.0 (15.0, 55.0) | 0.005 |
| SAQ—Treatment satisfaction | 6.25 [0.0, 18.75] | 0 [−3.125, 6.25] | 6.25 (0.0, 18.80) | 0.14 |
| SF-36—Physical component score (PCS) | 7.5 [5.0, 13.0] | −2.0 [−4.5, 1.0] | 11.0 (7.0, 14.0) | 0.001 |
| Lp(a) mg/L | −679.5 [−1102, −453] | −5.5 [−48.85, 51.5] | −912 (−1381, −597) | 0.0001 |
| LDL cholesterol mmol/L | −1.55 [−1.90, −1.17] | −0.03 [−0.04, 0.07] | −1.42 (−1.80, −1.15) | 0.0001 |
Data are mean (lower 95% CI, upper 95% CI) or median [lower quartile, upper quartile].
LVEF, left ventricular ejection fraction; 6MWT, 6-min walk test; LnRHI, natural logarithm of reactive hyperaemia index; SAQ, Seattle angina questionnaire; SF-36, short form-36 questionnaire; Lp(a), lipoprotein (a); LDL, low-density lipoprotein; HDL, high-density lipoprotein.