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Table 2 Adverse events *

From: Clinical and cost-effectiveness analysis of an open label, single-centre, randomised trial of spinal cord stimulation (SCS) versus percutaneous myocardial laser revascularisation (PMR) in patients with refractory angina pectoris: The SPiRiT trial

 

Months 0–12 post-

procedure

Months 13–24 post-

procedure

 

SCS

PMR

SCS

PMR

Disease-related

    

   Unstable angina

16 (10)

16 (7)

7 (5)

12 (4)

   Myocardial infarction

4 (3)

1 (1)

1 (1)

1 (1)

   Loss of pain relief/angina worse

5 (5)

3 (2)

3 (3)

8 (6)

Total disease related

25 (18)

20 (10)

11 (9)

21 (11)

SCS related: Infection of SCS system

0

NA

0

2 (2)

Undesirable change in stimulation

7 (5)

NA

5 (5)

2 (1)

Pain at neurostimulator site

5 (3)

NA

0

0

Neurostimulator migration

2 (2)

NA

1 (1)

0

Lead migration

1 (1)

NA

0

0

PMR related: Femoral pseudoaneurysm

0

1 (1)

0

0

Groin haematoma

1 (1)

2 (2)

0

0

Other

4 (3)

7 (7)

7 (5)

4 (4)

Total

45 (17)

30 (15)

24 (18)

29 (12)

Total excluding SCS/PMR related

29 (14)

27 (14)

18 (12)

25 (11)

Severity

    

Mild

2 (2)

2 (2)

0

0

Moderate

5 (5)

0

0

3 (2)

Severe**

38 (15)

28 (15)

24 (18)

26 (11)

Total

45 (17)

30 (15)

24 (18)

29 (12)

  1. *Data are number of events (number of patients), NA means Not Applicable.
  2. **Severe included events which: required hospital admission and/or surgery, prolonged hospital stay, or were life-threatening or fatal.