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The scientific evidence for cardiac rehabilitation is strong with reductions in total and cardiac mortality of 13% and 26% respectively in randomised controlled trials comparing rehabilitation to usual care.1 However, this evidence largely pre-dates acute revascularisation, initially by thrombolysis and then angioplasty, and the widespread use of cardioprotective medications, also reducing total mortality.2 So RAMIT (Rehabilitation after myocardial infarction trial) asked the seminal question does cardiac rehabilitation, as provided by the NHS, further reduce total mortality and morbidity and improve health related quality of life in the context of cardiology practice in the late 90s?3 It did not (see page 637).
In this multicentre parallel group trial hospitals already running a cardiac rehabilitation programme, fourteen of them, agreed to randomise patients following myocardial infarction to their own programme or to usual care. These programmes reportedly conformed to guidelines issued by the British Association for Cardiac Rehabilitation and comprised exercise training, health education about heart disease, risk factors and treatment, counselling for recovery and advice for long term secondary prevention.4 Exercise training was described as the largest component using equipment in physiotherapy gyms. The primary endpoint was total mortality at 2 years and a sample size of 8000 patients was required to detect a 20% RR reduction compared to usual care. In the event only 1813 patients were randomised between 1997 and 2000, before the money ran out, with 903 allocated to rehabilitation and 910 to usual care. Baseline characteristics were almost identical. With less than a quarter of patients recruited out of the total originally planned the trial was far too weak to assess the primary endpoint. At 2 years the number of deaths in cardiac rehabilitation and usual care were almost identical. So this complete cohort of trial patients was carefully followed up for all cause mortality, for up to 9 years, and vital status was determined in 99.4% of randomised patients. The primary endpoint was analysed on an intention to treat basis. There was still no difference: 245 deaths in rehabilitation compared to 243 in usual care; RR 0.99 (95% CI 0.85 to 1.15). The description of results from two non-randomised comparator groups in the report is a distraction and serves no purpose in interpreting an otherwise valid trial.
The null result for the primary endpoint, a statistically legitimate analysis, even though performed many years after the trial finished, is not the point. It is hardly surprising there was no difference in all cause mortality as these so called ‘comprehensive’ programmes did not achieve any benefit whatsoever at 1 year compared to usual care. The prevalence of smoking was almost identical, diet in terms of fresh fruit consumption was similar, and paradoxically physical exercise (>100 kcal/day) was significantly lower in the cardiac rehabilitation arm. Alcohol consumption in terms of moderate and heavy drinking was identical. Surprisingly, the management of blood pressure, lipids and glucose was not even reported given the apparent emphasis on secondary prevention. Importantly, the use of aspirin, B-blockers, ACE inhibitors and statins was almost identical in the two arms and for a comprehensive programme this was less than optimal; only 59% of patients were taking a statin and 45% an ACE inhibitor despite recommendations for these drug therapies following a myocardial infarction.5
What this trial really demonstrates is these rehabilitation programmes were not fit for purpose. If all 8000 patients had been randomised total and cardiovascular mortality would still have been the same in both arms. This is because these programmes achieved no added benefit in terms of lifestyle, risk factor and therapeutic management compared to usual care. So to expect any favourable impact on subsequent clinical events is completely unrealistic. The central question this trial raises is about the quality of participating programmes and their claim to be comprehensive. Whatever the nature of their intervention, and remember this was all delivered in the name of cardiac rehabilitation, it was insufficient to reduce the prevalence of smoking, improve dietary habits or increase physical activity. In contrast the EUROACTION trial of a nurse-led, multidisciplinary, preventive cardiology programme compared 1 year outcomes for 1589 coronary patients offered this new prevention programme with 1499 coronary patients receiving usual care.6 The EUROACTION programme prevented some relapse in smokers who had stopped after their coronary event, and for all patients there was a significant reduction in saturated fat consumption, a substantial increase in the intake of fresh fruit and vegetables, and oily fish was also consumed more frequently at 1 year compared to usual care. A substantially higher proportion of patients achieved the physical activity target, an absolute difference of 34% between intervention and usual care, and the same direction of lifestyle change for diet and physical activity was seen in partners. These lifestyle changes impacted favourably on blood pressure control, significantly better in intervention than usual care, for all patients combined and separately for those with diabetes, and all without any increase in anti-hypertensive drugs. EUROACTION was a truly comprehensive programme with corresponding 1 year outcomes, unlike RAMIT, and the principles of this model are now embodied in the MyAction community based preventive cardiology programme for the NHS.7
The RAMIT study asked a simple question. Does cardiac rehabilitation offer any added value, as delivered at that time, to the management of myocardial infarction in the late 90s? The trial was well conducted, with comparable patient characteristics in rehabilitation and usual care, and there were no differences in any programme outcomes at 12 months and therefore no impact on total or cardiovascular mortality could be expected. They didn't even achieve improved quality of life. However, a majority of patients reported their programmes ‘very or fairly helpful’, as most programmes claim today: good patient satisfaction. But satisfaction will not guarantee a better life, either in quality or years. So the answer to the question posed by RAMIT is clearly no. Cardiac rehabilitation as delivered then did not provide any added value over usual care. By comparison with the BACR standards of the time these programmes were not fit for purpose.
Since then the cardiac rehabilitation community has evolved, taking a more comprehensive approach to this specialty by integrating prevention and rehabilitation, as defined in the new BACR Standards published in 2007. This major revision, which defined the core components of a prevention and rehabilitation programme, underpinned the Department of Health Commissioning Pack on Cardiac Rehabilitation.9 10 Although the title of the pack eschewed the word prevention, it strongly advocated the need for truly comprehensive programmes: lifestyle, risk factor management, cardioprotective drug therapy, psychosocial status and quality of life, education and long-term management. The leadership of the newly named British Association for Cardiovascular Prevention and Rehabilitation has also clearly signalled the need for programmes to forge prevention and rehabilitation, and be all embracing. But the reality of every day service delivery falls far short of these national standards.
The reports of the National Audit of Cardiac Rehabilitation (NACR) reveal daunting challenges every year for current NHS programmes, most of which are inadequately staffed and resourced.9 Only 42% of coronary patients following a myocardial infarction access them, and those with angina or other atherosclerotic vascular disease are largely ignored. Median waiting time to joining a programme is an astounding 9 weeks following a myocardial infarction, and even longer after surgery, thus missing the early opportunities following diagnosis to help patients understand their disease and its treatment, address anxiety and depression, and reduce their overall cardiovascular risk. The range of disciplines has significantly declined over the last 3 years—specifically dieticians, physiotherapists and psychologists—making these programmes less multidisciplinary and comprehensive. Exercise physiologists are the exception, with numbers increasing, but exercise is only one part of a truly comprehensive programme. Group based interventions, rather than individualised care, are still the norm and this is one explanation for poorer outcomes, both in terms of lifestyle change and the totality of risk factor management. And those outcomes reported by NACR at 1 year offer substantial scope for improvement in terms of smoking cessation, diet and weight management, risk factor reduction and so on, and these UK results are entirely consistent with a European wide audit of 1 year outcomes of cardiac rehabilitation across 22 countries in 2008, almost a decade after RAMIT started.11 Given insufficient patient access, protracted delays in joining programmes, the decline in disciplines making programmes less comprehensive the question posed by RAMIT maybe as relevant today. Is cardiac rehabilitation as currently delivered in the NHS fit for purpose—maybe not for many programmes by comparison with national standards.
The results of RAMIT should be a wakeup call to all cardiac rehabilitation programmes to look at themselves, the service they provide and quantitative outcomes achieved. Patient appreciation, however heartfelt, is not enough. If programmes are not fit for purpose they need to change. This will mean reconfiguring services to implement a modern preventive cardiology programme, based on the totality of scientific evidence, which requires a cultural change among hard working professionals across all disciplines and investment by the NHS.