The trial is the difference between the treatment arm and the control arm for HF related events. Non HF related events.
My assessment of the picture on treating the desperately HF sick on available evidence is (see other posts)
At interim roughly 100 patients enrolled in each arm
Treatment Arm:-
20% non related to HF events
= Study treatment population now 80.
80% success rate of remaining 80
= 64 patients who received significant benefit from C-Pulse
Of which 25% i.e.. 16 patients.(very conservative) are symptom free.
Control Arm.
20% non related to HF events
=Study control population now 80
4 against trend improvers i.e.. people who just get better for no apparent reason.
= leaves 74
30% exit rate due to worsening HF every 2 months.
Leaves around 18 desperately ill people at the end of the 12 month follow up plus 4 people not so ill.
Say you get a weird distribution that slants this 25% you still end up with around 50% benefit for treatment arm v no benefit for control arm. P values would not seem a problem??
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