OMT + CSWT group | OMT + sham procedure group | |||||
---|---|---|---|---|---|---|
Baseline | 3- month | 6- month | Baseline | 3- month | 6- month | |
Primary endpoints | ||||||
WMSI at stress during DSE | 1.6 ± 0.4 | 1.4 ± 0.4* | 1.4 ± 0.3* | 1.6 ± 0.4 | 1.5 ± 0.3 | 1.4 ± 0.3* |
SDS during SPECT# | 5.5 [3.3; 7.0] | – | 3.0 [0; 5.0]*, & | 4.0 [3.0; 9.0]) | – | 5.0 [3.0; 8.0] |
Secondary endpoints | ||||||
WMS at stress during DSE | 26.8 ± 7.0 | 24.2 ± 7.3* | 23.1 ± 5.8* | 26.3 ± 6.5 | 25.0 ± 5.7 | 23.5 ± 5.1* |
LVEF at stress during DSE, % | 49.8 ± 11.2 | 54.1 ± 12.3* | 56.8 ± 9.4* | 51.6 ± 11.0 | 53.4 ± 11.6 | 53.7 ± 9.7 |
Number of patients with at least moderate ischemia in DSE, n (%) | 17 (57) | 6 (21)* | 5 (18)* | 14 (48) | 10 (36) | 9 (35) |
Number of patients with at least moderate ischemia in SPECT, n (%) | 22 (73) | – | 12 (46)* | 21 (72.4) | – | 17 (68) |
ECG changes during stress DSE, n (%) | 22 (73) | 13 (46)*, & | 13 (46)* | 19 (66) | 21 (75) | 16 (62) |
Angina during stress DSE, n (%) | 23 (77) | 12 (43)* | 10 (36)* | 18 (62) | 13 (46) | 11 (42)* |
Global PSS at stress during DSE, % | −15.0 ± 3.2 | −13.7 ± 3.0 | −14.0 ± 2.3 | −15.1 ± 4.5 | − 13.7 ± 3.6 | −13.6 ± 2.4 |
Summed stress score (SSS) during SPECT# | 8.5 [5.3; 12.8] | – | 5.0 [2.0; 12.0]* | 10.0 [4.0; 15.0] | – | 8.0 [3.0; 14.0] |
TPD at stress during SPECT, %# | 13.0 [6.3; 18.8] | – | 7.0 [3.0; 17.5]* | 15.0 [6.0; 22.0] | – | 12.0 [4.0; 20.0] |
TPD at rest during SPECT, %# | 2.0 [0; 7.8] | – | 0 [0; 7.0]) | 2.0 [0; 10.0]) | – | 3.0 [0; 9.0] |
TPD difference during SPECT, % | 7.0 [4.3; 11.0] | – | 4.0 [0; 7.0]*,& | 7.0 [5.0; 13.0] | – | 7.0 [4.0; 12.0] |
Other tests characteristics | ||||||
WMS at rest during DSE | 23.4 ± 7.8 | 23.6 ± 7.8 | 22.6 ± 6.4 | 23.8 ± 7.0 | 24.3 ± 6.9 | 22.8 ± 5.7 |
WMSI at rest during DSE | 1.4 ± 0.5 | 1.4 ± 0.5 | 1.3 ± 0.4 | 1.4 ± 0.4 | 1.4 ± 0.4 | 1.3 ± 0.3 |
LVEF at rest during DSE, % | 46.5 ± 10.6 | 47.3 ± 11.0 | 49.8 ± 8.6* | 48.5 ± 9.0 | 48.2 ± 8.6 | 48.5 ± 8.1 |
Number of positive DSE tests, n (%) | 21 (70) | 10 (36)* | 8 (29)* | 20 (69) | 13 (46) | 11 (4) |
Number of positive SPECT tests, n (%) | 28 (93) | – | 18 (69)* | 28 (96) | – | 21 (84) |
Global PSS at rest, % | −14.8 ± 3.4 | −13.2 ± 3.8 | −13.9 ± 2.7 | −14.1 ± 2.2 | −13.5 ± 2.6 | −13.0 ± 1.9 |
SRS during SPECT# | 1.0 [0; 5.8] | – | 0 [0; 5.0] | 2.0 [0; 7.0] | 2.0 [0; 6.0] |