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

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physical counterpressure maneuver pc trial

Physical Counterpressure Maneuver (PC) Trial

Presented at

The American College of Cardiology

Scientific Session 2006

Presented by Dr. N. van Dijk

pc trial background
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

pc trial study design
PC-Trial: Study Design

223 patients age 16-70 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

pc trial primary endpoint
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

pc trial secondary endpoints
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

pc trial secondary endpoints cont
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

pc trial secondary endpoints cont7
PC-Trial: Secondary Endpoints (cont.)
  • Interquartile range [IQ] for yearly syncope-burden during follow-up was 0.0-0.7 for the PCM group and 0.0-1.3 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

pc trial limitations
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

pc trial summary
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