Table 4 Summary of safety outcomes – number of patient events

Follow up

13.8 months

6-weeks

4 weeks

2-years

1-year

SCS-related complication

Infection

NR

0/13

NR

1/57

0/34

Lead migration/fracture

6/34

0/13

NR

3/57

1/34

Mortality/morbidity

Non fatal MI

1/12

NR

NR

SCS 7/53

CABG 3/53, P = 0.18

SCS 4/34

PMR 1/34, P = 0.16

Total mortality

2/12

NR

NR

SCS 5/53

CABG 10/53, P = 0.16

SCS 4/34

PMR 2/34, P = 0.73

Cardiac mortality

2/12

NR

NR

SCS 3/53

CABG 5/53, P = 0.54

SCS 2/34

PMR 1/34, P = 0.52

Other outcomes

Treatment cross over

NR

NR

NR

6-months

SCS 3/53

CABG 3/51

SCS 1/34

PMR 0/33