Editorial articles

Managing patients with the various manifestations of coronary heart disease keeps cardiologists busy, whether in out-patients, the cardiac catheter lab or the coronary care unit. There is no doubt that the specialty of cardiology has benefited from drug regulation imposed and supervised by the Food and Drugs Administration and the Medicines and Healthcare Products Regulatory Agency – commercial sponsorship may have funded and, to some extent driven, the use of the ‘gold-standard’ double-blind, placebo-controlled, multi-centre clinical trial to test potentially useful drugs, but at least the evidence base for clinical practice is well-founded as a result.

After hundreds of thousands of patient-years of phase III clinical trials and of post-marketing surveillance to establish what works and what doesn’t, the development of ‘patient care pathways’ and ‘best practice’ guidelines, clinicians may have thought they knew how to treat patients with angina. Nevertheless, patients are voicing their concerns over the impact of coronary heart disease on daily life and the inadequacy of their treatment, according to a survey conducted by Izzat and Knight and reported in this issue of the British Journal of Cardiology (pages 191–4). This patient survey is a reminder that clinicians’ expectations of delivering improved mortality and morbidity and relief of symptoms does not completely coincide with patients’ expectations of an improved quality of life and perfect symptom control.

It is not clear if compliance was poor or whether the patient population was representative of the generality of patients, but the survey suggests that many were very dissatisfied with the treatment of angina. The most common complaints were the adverse impact of angina and associated drug treatment on the quality of daily life (especially sex life); symptoms occurring at least once per week, despite most having had surgical intervention; the adverse effect of medication, especially beta blockers causing symptoms of tiredness, lethargy, nightmares and impotence; and beta blockers prescribed despite concomitant chronic obstructive pulmonary disease.

The needs and aspirations of the UK’s junior doctors have not been far from the headlines since the Medical Training Application Service (MTAS)/Modernising Medical Careers (MMC) debacle unfolded. The results of this year’s British Junior Cardiologists Association (BJCA) survey of cardiology trainees therefore make fascinating reading (pages 134–36).

Our trainees are clearly both well informed and politically astute. Their views certainly deserve careful attention and at least four important issues emerge from this year’s survey.

A key component of the UK General Medical Services (GMS) contract, which was implemented in April 2004, is the quality and outcomes framework (QOF).

Practice-based commissioning (PBC) achieved universal coverage by the end of 2006 according to the Department of Health (DoH).1 So here we are well in to 2008 and I doubt if many cardiologists have seen any impact from PBC, and the latest DoH survey on PBC would suggest that the majority of general practitioners (GPs) feel that the scheme has yet to get off the ground. Having said that, 36% of practices say they have commissioned at least one new service through PBC.2

So will it die a natural death, or will it really make a difference to the way healthcare is commissioned? The DoH are saying that PBC remains central to world class commissioning, and the Conservative party are saying that, if they get in to power, they will give GPs real budgets. If we are to have payment by results, in a cash-limited service, we must have the balance of PBC. PBC aligns clinical and financial responsibility at the point of referral. It should also allow GPs to find new ways to deliver care closer to the patient, offer them real choice and drive up the quality of the care their patients receive. I cannot, therefore, see a future without some form of PBC and so it would make sense to come to terms with it and to make it work.

So now we know … drug-eluting stents (DES) are not to vanish from our armoury at the whim of a National Institute for Health and Clinical Excellence (NICE) appraisal committee containing not a single specialist in interventional cardiology. When the provisional guidance report was published in the fourth quarter of last year, stating “Drug-eluting stents are not recommended for use in PCI in patients with coronary artery disease” as point 1, paragraph 1, it was really difficult to comprehend how the committee had come to this ridiculous conclusion.

Most interventional cardiologists can understand that there is a need to audit the use of novel technologies in order to ensure the maintenance of patient safety and protect Department of Health (DoH) expenditure. Not only do we understand it, but we are committed to such a process. The preliminary judgement from this NICE group, however, was in my opinion, a significant low point in the process of appraisals. The fact that the final appraisal determination now states, “Drug-eluting stents are recommended for use in PCI for the treatment of coronary artery disease, within their instructions for use, only if: (a) the target artery to be treated has less than a 3 mm calibre or the lesion is longer than 15 mm, and (b) the price difference between DES and bare-metal stents is no more than £300”, is undoubtedly a relief if you are committed to patient care at the front line, although it raises questions about the appraisal mechanism.

There appear to be two schools of thought in relation to this latter issue. First, that the original analysis demonstrates that the process undertaken was fundamentally flawed in its design:

expert witnesses only contributed to the appraisal rather than being built in as a core component of it
there was a dependence upon health economists whose previous analyses betrayed an important degree of anti-DES, pro-coronary artery bypass graft (CABG) bias.
Such factors would allow the more cynical to predict a negative appraisal, even in the face of powerful randomised and observational data to support clinical benefit: data that was never disputed, and in fact clearly stated, in the preliminary document.

Second, by contrast, is that it is a triumph for the design of the appraisal process that there was such a substantial turnaround in the conclusion reached after the public consultation exercise. I am sure that NICE will claim vindication for the process based upon this argument.

In recent years, general practitioners (GPs) have been swamped by the burden of diabetes in the UK. The incidence has been growing almost as fast as our national waistlines, with the number of patients affected increasing from 800,000 to 1.8 million between 1980 and 2004, and the figure is predicted to increase to 3 million by 2010.

In addition, the landmark UK prospective diabetes study (UKPDS) has resulted in a gradual ‘rebranding’ of diabetes from a metabolic to a cardiometabolic disease. About 75–80% of patients with type 2 diabetes die, not from short-term complications of hyperglycaemia, but as a consequence of cardiovascular disease, which is more influenced by blood pressure and cholesterol management than by glycaemic control.1-3

Finally, far from being able to divert our energies from glycaemic control to tight control of blood pressure and cholesterol, we find glycaemic targets dropping ever lower. Poor glycaemic control is a major risk factor for microvascular complications, including diabetic retinopathy, peripheral neuropathy and nephropathy. While patients do not die of diabetic retinopathy, as the single most common cause of adult blindness it certainly causes huge morbidity. The burden of diabetic nephropathy is also increasing rapidly, with up to 45% of new cases of endstage renal failure accounted for by complications of diabetes.4 It is against this background that the National Institute for Health and Clinical Excellence (NICE) recommends a target glycosylated haemogloblin (HbA1c) of 6.5–7.5%, with a 6.5% target preferred, if feasible.5

The Second Scientific Meeting of the Cardiorenal Forum (CRF) was held recently at the Royal Pharmaceutical Society in London. This well-attended meeting highlighted the growing interest in this area. Here, the meeting organisers, Drs Paul Kalra, Philip Kalra and Henry Purcell, report highlights of the varied presentations made during the day.

The dramatic improvement in the management of cardiovascular disease over the past decade and the challenges that lie ahead were key elements of ‘Looking to the Future’, the 10th anniversary Annual Scientific Meeting of the Primary Care Cardiovascular Society held in London on 11th–13th October 2007. Over this period, the PCCS has grown from a small organisation to the influential body it is today. Medical journalist Rhonda Siddall reports from the meeting where an air of optimism embraced all the sessions, from celebration of past achievements to discussion of the future problems a new decade will bring.

Switching statins from on-patent to off-patent generic simvastatin is currently the focus of a major policy initiative by the Department of Health. In this context, an observational study of statin switching conducted by the manufacturer of an on-patent statin has already attracted considerable widespread media attention even before its publication within this issue of the British Journal of Cardiology (see pages 280-5). It is likely to stimulate considerable controversy and debate in the months ahead.

Huge changes are underway within the UK’s National Health Service (NHS). A far-reaching programme of marketing-orientated changes has resulted in “the emergence of a new NHS where increasingly care is delivered by an ‘alphabet soup’ of agencies and public and private providers”. These changes have affected both primary and secondary care and they continue to impact on the practice of medicine.