After reading some of the posts here misunderstanding the importance or terminology of msb's announcement I would like to muse a bit and write down my thoughts
1. Mortality vs symptomatic reliefA reduction in mortality means less people dying during the trial period, as such meaning the treatment allows individuals to live for longer. As a kaplan-meier curve, this can be seen as a flatter and less steep downward trajectory.
NB: This graph is not relevant at all to the current issue at hand, moreso just an example of what I am talking about.
On the other hand, palliation refers to symptomatic relief. Chronic CHF can be well managed with medication and as long as nothing changes patients may experience minimal symptoms. However from time to time they may experience a "decompensation" - meaning an acute exacerbation of symptoms. In CHF these symptoms can include dyspnoea, orthopnea, paroxysmal nocturnal dyspnoea, productive cough, syncopal and presyncopal episodes, palpitations, oedema and severe fatigue which can all have a significant impact on patients quality of life.
The primary endpoint of the trial was aimed at reducing the occurrence of decompensatory events rather than mortality modification
2. The rarity of mortality modifying treatments in CHFA standard CHF treatment regimen consists of numerous drugs:
ACEII inhibitor or ARB (spironolactone), beta blockers, diuretics (often frusemide), nitroglycerin, hydralazine, digoxin and supplementary oxygen.
Yet out of all these treatments, the only ones which actually reduce mortality and promote increased survival are the first two classes (ACEII/ARB and Beta blockers), the rest of the treatments simply help to palliate symptoms.
NOW, even out of ACEII Inhib's and Beta blockers, they only reduce mortality by 35% and 23% respectively vs revascor's trial of 60%(see Brophy JM, Joseph L, Rouleau JL. Beta-blockers in congestive heart failure. A Bayesian metaanalysis. Ann Intern Med. 2001; 134(7): 550-60.and
Garg R, Yusuf S, Bussmann W, et al. Overview of randomized trials of angiotensin-converting enzyme inhibitors on mortality and morbidity in patients with heart failure. JAMA. 1995; 273(18):1450-6.)
3. Why did SI choose acute decompensations as the primary endpoint?Well hopefully it is clear just how rare mortality modifying treatments are in CHF, and my guess is that this is why SI aimed low towards these as opposed to taking the risk of hoping for mortality reduction. Yet with these current results it seems we may have struck gold while mining for silver. Mortality improving treatments are far and few between and the magnitude of Revascor's effect surely demonstrates its ability to revolutionise CHF treatment in the future.
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