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- Cardiovascular disease
- randomised controlled trial
- cardiac rehabilitation
- coronary artery disease
The RAMIT trial was funded in 1997 to randomise 8000 patients to cardiac rehabilitation (CR) or routine care and would have provided sufficient power to demonstrate the effect of CR on mortality in a single trial. Despite the efforts of the investigators, the study sponsors (NHS Research and Development Programme), requested early closure due to low recruitment. Given the level of all cause mortality in the control group (84/910, 9.2%) the trial would have needed around 3100 patients in each arm, to detect a 20% reduction at 80% power. In fact the study had <1000 in each arm of the trial. Despite that, over the last 10 years, the ‘negative result’ from RAMIT has been discussed widely. This is the first published account and we welcome the discussion it is provoking (see page 637).
What RAMIT tells us about the efficacy of CR
RAMIT was not designed as a trial of ‘efficacy’, that is, to demonstrate whether or not CR ‘works’ but as a pragmatic trial of its effectiveness as provided ‘in real life’. The results showed no benefit for survival, psychosocial status or HRQOL. In addition the CR group was less likely to be physically active at 12 months than the control group. These results are opposite to those produced by the Cochrane Collaboration Systematic Review and meta-analyses of CR,1 2 all of the reviews of CR by authoritative bodies around the world, from the American Heart Association3 to the WHO4 and is contrary to established clinical guidance5 along with insurance remuneration agreements, in most countries of the world.
Since RAMIT was published the Cochrane CR group has included its data alongside the existing 47 RCTs. This resulted in a slight fall in the estimated, relative, all cause mortality benefit for CR from 13% …