Table 4 Adverse events in the six randomised studies of PFO closure in cryptogenic stroke

M

16.9

17.6

40.3

27.8

33.2

–

 Overall SAE (%)

C

16.6

21.1

36.0

23.1

35.7

–

P

0.90

0.37

0.17

0.22

0.56

–

 Atrial fibrillation or flutter (%)

M

0.7*

1.0

1.5

0.4*

0.9*

0

C

5.7*

2.9

3.0

6.6*

4.6*

3.3

P

<  0.001

0.17

0.13

<  0.0001

0.02

–

 Overall major bleeding (%)

M

1.1

1.4

0.2

2.7

2.1

4.9

C

2.6

0.5

0.6

1.8

0.8

0

P

0.11

0.62

0.6

0.57

0.28

0.15

M

0

0

0.6*

0.4

0

0

 Pulmonary embolism (%)

C

0

0

2.4*

0.5

0.4

0

P

–

–

0.034

1.0

–

–

 Atrial fibrillation or flutter (%)

C

3.5

0.5

1.4

5.4

4.2

3.0

 Bleeding (%)

C

2.5

1

0.6

0.9

0

0

 Pericardial tamponade (%)

C

0

0

0.4

0.2

0

0

 Cardiac thrombus (%)

C

1.1

0

0.2

0.5

0.4

0

 Cardiac perforation (%)

C

0.25

0

0.2

0

0

0

 Occluder embolisation (%)

C

0

0

0

0.7

0

0

 Rare complications classified as procedural or occluder-associated (%)

C

0.5^a

0

2.8^b

2.3^c

1.7^d

3.3^e