Guidance

Recommendations for research

Recommendations for research

The Guideline Development Group has made the following recommendations for research, based on its review of evidence, to improve NICE guidance and patient care in the future.

1 Adding a newer anti-anginal drug to a calcium channel blocker

What is the clinical and cost effectiveness of adding a newer anti-anginal drug (nicorandil, ivabradine or ranolazine) to a calcium channel blocker for treating stable angina?

Why this is important

We do not know the long-term clinical and cost effectiveness of adding a newer anti-anginal drug to a calcium channel blocker in people with stable angina. We propose a double-blind placebo-controlled randomised trial comparing the addition of a newer anti-anginal drug to a calcium channel blocker with a calcium channel blocker alone in people with stable angina whose symptoms are not being controlled. Endpoints would include symptom severity, quality of life, long-term morbidity and mortality, and cost effectiveness. The results of the trial would influence clinical practice and inform future updates of key recommendations in this guideline.

2 Management of stable angina in people with evidence of ischaemia on non-invasive functional testing

Do people with stable angina and evidence of reversible ischaemia on non-invasive functional testing who are on optimal drug treatment benefit from routine coronary angiography with a view to revascularisation?

Why this is important

Revascularisation has traditionally been offered to people with stable angina who have evidence of reversible ischaemia on non-invasive functional testing. Recent trials in people with stable angina (COURAGE, BARI-2D, MASS II) have not shown survival benefit from revascularisation compared with drug treatment. In the nuclear substudy of COURAGE (n = 314), PCI was shown to be more effective in treating ischaemia than optimal drug treatment, and in multivariate analyses reduction of ischaemia was associated with greater event-free survival. It is unclear, however, whether people on optimal drug treatment who have evidence of inducible ischaemia on non-invasive functional testing should routinely have coronary angiography and revascularisation. This question is particularly relevant for people who have responded adequately (for example Canadian Cardiovascular Class 1 or 2) to optimal drug treatment and in whom, based on symptoms alone, revascularisation is not indicated. To answer this question we recommend a randomised trial of interventional management versus continued drug treatment in people with stable angina and myocardial ischaemia on non-invasive functional testing, with all-cause mortality and cardiovascular mortality as the primary endpoints.

3 Early revascularisation strategy for people with angina and multivessel disease

In people with stable angina and multivessel disease (including left main stem disease) whose symptoms are controlled with optimal drug treatment, would an initial treatment strategy of revascularisation be clinically and cost effective compared with continued drug treatment?

Why this is important

Research is needed to determine whether early investigation and revascularisation can improve longer term survival. People with stable angina may be disadvantaged if they do not have tests to identify whether they have a higher risk profile for early cardiac death, which could be reduced by revascularisation. This disadvantage could be magnified when people who are deemed to fall into very high risk groups (for example, left main stem stenosis > 50% in the MASS II trial) are excluded from randomised trials, resulting in the benefits of revascularisation being underestimated. We propose a randomised trial comparing an initial strategy of revascularisation (CABG or PCI) with an initial strategy of continued drug treatment in people with multivessel disease (including left main stem disease) in whom revascularisation is not needed for symptom relief. The trial should use drug-eluting stents and wider inclusion criteria than BARI-2D and COURAGE.

4 Cardiac rehabilitation

Is an 8-week, comprehensive, multidisciplinary, cardiac rehabilitation service more clinically and cost effective for managing stable angina than current clinical practice?

Why this is important

Cardiac rehabilitation programmes are an established treatment strategy for certain heart conditions, such as for people who have had a heart attack. However, there is no evidence to suggest that cardiac rehabilitation is clinically or cost effective for managing stable angina. Research to date has looked at short-term outcomes, such as a change in diet or exercise levels, but the effect on morbidity and mortality has not been studied. A randomised controlled trial is required to compare comprehensive cardiac rehabilitation with standard care in people with stable angina, with measures of angina severity (exercise capacity, angina frequency, use of a short-acting nitrate), and long-term morbidity and mortality as endpoints.

5 Patient self-management plans

What is the clinical and cost effectiveness of a self-management plan for people with stable angina?

Why this is important

Stable angina is a chronic condition. Evidence suggests that addressing people's beliefs and behaviours in relation to angina may improve quality of life, and reduce morbidity and use of resources. Self-management plans could include: educating people with stable angina about the role of psychological factors in pain and pain control; and teaching people self-management skills to modify cognitions, behaviours and affective responses in order to control chest pain. These skills may include pacing of physical activities, modifying stress using cognitive reframing and problem-solving techniques, and relaxation training or mindfulness techniques. The proposed study is a randomised controlled trial in primary care that would assess the clinical and cost effectiveness of self-management plans. This research would inform future updates of key recommendations in the guideline. Furthermore the research would be relevant to a national priority area (National service framework for coronary heart disease [NSF CHD] chapter 4: stable angina and chapter 7: cardiac rehabilitation) as well as the Coalition White Paper 2010 (Equity and excellence: liberating the NHS) that emphasise the importance of increasing people's choice and control in managing their condition.