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Valid consent requires that patients should have every opportunity to be fully involved in the decision making process. In most instances this means that patients need to be informed about all the available treatment options before making a decision about the best treatment for themselves and their carers. This is simple when there are only 2 alternatives, such as treatment A or no treatment. It is also simple when one therapy has a significantly better chance of improving life expectancy than another.

For long term conditions with many possible evidence based treatments (A, B, C, D and E) the situation is much more complex. Unless a patient elects to hand over responsibility to her doctor to decide what is best then it is necessary for the doctor to explain in understandable terms what each treatment involves, its risks and potential benefits. Failure to do so might invalidate the consent process. A patient could claim that they consented to treatment B because they thought they had no alternative and did not know that treatments C, D and E were available.

At the National Refractory Angina Centre we follow the NHS DoH and BMA best practice guidelines. However we have developed an innovative improvement in approaching consent (see BMJ 2003 Nov 15;327: 1159-61 Making consent patient centred). In our model patients define their objectives at the outset. This enables us to focus on the therapies that can realistically achieve their objectives. In our experience patients are often willing to compromise. They will often settle for mild angina at negligible risk rather than no angina if that involves high risk of death or serious complications. Unless they are aware of the low risk alternatives such compromises are impossible and the patient may consent to the high risk strategy in the mistaken believe that it is that or nothing.

When we set up NRAC in 1996, we decided to make no assumptions. We knew what traditional were like, from a doctors’ perspective. We recognised that our patients had extensive experience of what it was like to be a patient in traditional clinics. From the outset, we worked very hard to put patients at ease so they felt comfortable to share with us what aspects of traditional clinics they liked and what irritated or annoyed them. Engaging patients and carers in the design of NRAC gave them the confidence to put forward suggestions for improvements and offer constructive criticism when our implementation of their suggestions didn’t quite work. Working with our patients in his way enabled us to continuously improve the service to the point when we expect patients to be delighted with the service. By 2009, NRAC had become the most advanced patient centred angina service anywhere in the country.

Virtual Angina employs NRAC’s tried and tested and multi award winning, user engagement model in the training and maintenance of other patient centred angina clinics. Quality control is an essential part of Virtual Angina’s service redesign package. It involves regular mentorship/coaching supported by biannual site visits in the first year follow by annual review. Active staff and patient engagement is assessed using standard industry measures and ‘customer’ feedback is assessed using a range of established methods. Only clinics who have completed a full patient-centred training programme and have satisfied quality control are included in the patient-centred angina clinic list.

* Excludes angioplasty on-costs: follow up clinics, further investigations, repeat procedures, long term anti platelet therapy etc
† Assuming 45% of UK angioplasty are scheduled (www.BCIS.org.uk)
‡ 2008/9 NHS tariff for scheduled angioplasty £3,752 ; scheduled bypass £7,375 

RITA II trial The results largest UK study of PCI versus continued medical therapy was published in 1997 and demonstrated that angioplasty was associated with a 78% increase in cardiovascular risk and with only a small and transient improvement in angina achieved at considerable additional cost (1,2) 

COURAGE trial. The largest study to date, called “COURAGE” tested the hypothesis that angioplasty is superior to optimal medical treatment in preventing heart attacks (3). The result mirrored the earlier RITA-2 trial and showed that at best angioplasty temporarily improved quality of life (1,2). The cost effectiveness analysis completed recently and showed that the small overall benefit was so costly ($150,000 to $300,000 per QALY) that it exceeded the NICE cost effectiveness barrier ($50,000 per QALY) by between three and six fold (4).  This is consistent with an earlier UK study that showed PCI cost per QALY was over £50,000 and raised questions over the health economic justification for continuing to fund angioplasty for stable angina (5). 

Professional guidance on appropriateness. Aside from the increasingly dubious health economic case for PCI in stable angina, the assumption that all revascularisation procedures are clinically appropriate was recently called into question by a collaboration of American cardiac societies. The American Heart Association and American College of Cardiology recently produced a report on clinically relevant scenarios where coronary revascularisation procedures are performed and determined whether revascularisation was appropriate, inappropriate or of uncertain value (6).  Of one hundred and forty four stable angina scenarios, revascularisation was deemed inappropriate in 15%, of uncertain value in 32% and in 2% the scenario was too difficult to rule on. According to the cardiac Czar, the most up to date UK audit shows that 8% of procedures performed in the UK in 2008 were in the ‘inappropriate’ category. This means that each year the NHS carries out around 4,000 inappropriate revascularisation procedures (mostly angioplasty). 

The report advises against assuming that the remaining 92% were medically necessary: “Appropriateness also does not equate to medical necessity. Shared physician/patient decision making for many scenarios would be expected and may result in the patient deferring coronary revascularization while maintaining medical therapy”.  

In December 2002 the director of specialist services commissioning for Cheshire and Merseyside reviewed NRAC’s patient-centred angina service and wrote to the regional cardiothoracic centre chief executive to say that: 

“NRAC’s patient-centred treatment approach presents a real alternative to other forms of treatment including revascularisation, catheterisation and other invasive procedures including the use of high-cost treatments such as drug eluting stents”.  

Research on avoiding revascularisation.

Several separate research groups have shown that outpatient rehabilitation-based programmes are a safe and affective alternative to revascularisation in the majority of patients. 

Courage, the largest trial to date, showed that patients with stable angina may safely choose not to have angioplasty. Although some patients eventually decided to have a procedure, the majority of patients in the COURAGE trial who chose to try optimal conservative treatment first, were able to avoid going through an angioplasty procedure (2). 

Lewin and colleagues found that the majority of eighty four patients awaiting bypass surgery decided not to proceed after attending a group CBT programme (7). 

Ornish trained healthcare professionals to deliver an NRAC-like service to 194 patients with stable coronary artery disease in whom revascularisation was deemed ‘appropriate’ and funding was agreed. Over a three year follow up period 29% proceeded to revascularisation. In other words 71% of patients were able to avoid revascularisation. A control group of 133 patients who had already undergone ‘successful’ revascularisation were the control group. Over the three year follow up period 25% of these patients underwent a second procedure. In other words the availability of a NRAC service could reduce palliative revascularisation by 95% (8) 

We have show that it is possible to train primary care colleagues to deliver optimal conservative care. Go to Virtual Angina. 

1. RITA-2 Trial Participants. Coronary angioplasty versus medical therapy for angina: the second Randomised Intervention Treatment of Angina (RITA-2) trial. Lancet 1997;350:461–468
2. Sculpher MJ, Smith DH, Clayton T, Henderson R, Buxton MJ, Pocock SJ, et al. Coronary angioplasty versus medical therapy for angina. Eur Heart J 2002;23:1291-300.
3. Boden et al. Optimal Medical Therapy with or without PCI for Stable Coronary Disease.  N Engl J Med 2007; 356:1503-1516
4. Weintraub et al. Cost-Effectiveness of Percutaneous Coronary Intervention in Optimally Treated Stable Coronary Patients.  http://circoutcomes.ahajournals.org/cgi/content/full/1/1/12
5. Griffin et al. Cost effectiveness of clinically appropriate decisions on alternative treatments for angina pectoris: prospective observational study.  BMJ 2007;334:624 (24 March)
6. ACCF/SCAI/STS/AATS/AHA/ASNC 2009 Appropriateness Criteria for Coronary Revascularization http://content.onlinejacc.org/cgi/content/full/j.jacc.2008.10.005v1
7. Lewin B, Cay E, Todd I, Soryal I, Goodfield N, Bloomfield P, Elton R  The angina management programme: a rehabilitation treatment.  British Journal of Cardiology 1995; 2(8): 221-226
8. Ornish D. Avoiding revascularization with lifestyle changes: The Multicenter Lifestyle Demonstration Project. Am J Cardiol. 1998 Nov 26;82(10B):72T-76T.

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