1. Physical Counterpressure Maneuver (PC) Trial
Presented at
The American College of Cardiology
Scientific Session 2006
Presented by Dr. N. van Dijk

2. PC-Trial: Background
This trial set out to evaluate treatment with physical counterpressure manoeuvres (PCM) compared with optimal conventional therapy among patients with recurrent vasovagal syncope
Presented at ACC 2006

3. PC-Trial: Study Design
223 patients age years with recurrent vasovagal syncope and recognizable prodromal symptoms
Randomized.
Mean follow-up 14 months
Physical counterpressure maneuvers using biofeedback in addition to optimal conventional therapy
n=98
PCM included: leg crossing with tensing of leg muscles, hand grasping, and arm tensing
Optimal conventional therapy alone
n=101
Primary Endpoint: Total syncopal burden
Secondary Endpoint: Time to first recurrent syncopal episode
Presented at ACC 2006

4. PC-Trial: Primary Endpoint
Syncopal Recurrence Episode (%)
p<0.01
A syncopal recurrence episode occurred less frequently in the PCM group compared with the control group (32% vs. 51%; p<0.01)
Presented at ACC 2006

5. PC-Trial: Secondary Endpoints
Median Reduction in Yearly Syncope-Burden
p<0.01
Median yearly syncope-burden during follow-up was significantly lower in the PCM group compared with the control group (0.0 vs. 0.6; p<0.01)
Presented at ACC 2006

6. PC-Trial: Secondary Endpoints (cont.)
Pre-Syncope Recurrence (%)
p=0.12
There was no difference in pre-syncope recurrence for the PCM group and the control group (82.7% vs. 74%; p=0.12)
Presented at ACC 2006

7. PC-Trial: Secondary Endpoints (cont.)
Interquartile range [IQ] for yearly syncope-burden during follow-up was for the PCM group and for the control group
Recurrence-free survival was longer in the treatment group (hazard ratio 0.59; log rank p=0.018)
No adverse events were reported
Presented at ACC 2006

8. PC-Trial: Limitations
Few treatment options are available for patients with syncopal recurrence.
PCM had previously been demonstrated to abort vasovagal episodes in the laboratory setting, but the present trial is the first randomized study to evaluate PCM in a real world setting.
Presented at ACC 2006

9. PC-Trial: Summary
Among patients with recurrent vasovagal syncope, treatment with physical counterpressure manoeuvres using biofeedback in addition to optimal conventional therapy was associated with a reduction in syncopal recurrence compared with optimal conventional therapy alone.
Presented at ACC 2006