Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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Coronary Angioplasty in used to treat angina!
- Martyn R Thomas (6 April 2007)
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The Emperor’s New Clothes: the President of the Dry Cleaners Defends the Bill
- Michael R Chester (8 April 2007)
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Relevance of the COURAGE trial - what if anything did it really tell us
- Anthony H Gershlick (8 April 2007)
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Why angina patients are miserable
- Austin A Leach (20 April 2007)
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Who will consider hemoglobinopathies?
- Celine M Aranjo (21 April 2007)
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Martyn R Thomas, President of the British Cardiovascular Intervention Society (BCIS) Kings College Hospital, London, SE5 9RS
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The COURAGE trial results show that patients with significant stable coronary artery disease who have a good quality of life on medical therapy do not require an angioplasty. This is not news and will not effect the use of coronary angioplasty in the UK. Coronary angioplasty in the UK is generally used to treat stable patients who have angina while on medical therapy. This trial therefore has little relevance to UK practice. It is important to note that 43% of patients randomised had little or no angina. In addition 1/3 of patients in the "optimal medical treatment" arm had an angioplasty by 4.6 years presumeably because of angina while on optimal medical therapy. It would be interesting to know how many of these patients started the trial with important (class II or III) angina. The trial may actually show that the majority of patients with class II or III angina will require an angioplasty within 5 years because optimal medical therapy will not control thier symptoms! The primary end point of death or non-fatal myocardial infarction is perculiar and was designed to see angioplasty fail. Interventional cardiologists have never argued that angioplasty effects mortality or reduces the incidence of myocardial infarction. Indeed the only patients where angioplasty may have a chance of producing this effect; those with left main or severely reduced LV function were excluded from the trial. This would strongly suggest that if the trial was repeated, but with surgery as the method of revascularisation, there would also have been no mortality benefit as the only patients for which there is a real mortality benefit from revascularisation are excluded from the trial. It is interesting to note that the BMJ chose to ask a cardiac surgeon to comment on the results. The reason for this is unclear to me. Perhaps the BMJ will ask an interventional cardiologist to comment on the next randomised trial of surgery versus angioplasty which, yet again, shows no difference in mortality between the two treatment arms. Finally, it is important to state that the majority of coronary angioplasty in the UK is used to treat patients with unstable syndromes, including acute myocardial infarction, rather than patients with stable angina. Therefore, the COURAGE trial has little relevance to coronary angioplasty as performed in the UK and will have little effect on its practice. Interventional cardiologists in the UK will continue to use optimal medical therapy as we have always done and angioplasty will remain the dominant mode of revascularisation for the foreseeable future. Competing interests: None declared |
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Michael R Chester, Consultant Cardiologist & Director National Refractory Angina Centre NRAC, Royal Liverpool & Broadgeen University Hospital NHS Trust, Liverpool. L14 3PE
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COURAGE (1) is an important study that comes hard on the heels of the recent cost effectiveness analysis that showed that the huge costs of angioplasty compared to medical therapy could not be justified (2). The study confirms the extant research that angioplasty does not improve prognosis in stable angina patients and this should clarify a common misunderstanding in the minds of commissioners and patients (3). Dr Thomas suggests that it is important to note that 43% of patients in the COURAGE study had little or no angina. It is indeed worrying that such patients should have been exposed to risk of harm inherent in palliative angioplasty but Dr Thomas should recall that the proportion of patients randomised to palliative angioplasty in the landmark RITA trial (in which Dr Thomas participated) was 45% (4). This suggests that poor patient selection is not the sole preserve of our American colleagues. The finding that one third of the COURAGE patients randomised to medical therapy later underwent angioplasty should be balanced by the fact that 20% of the angioplasty group also underwent further angioplasty during follow up. Given the common practice of recommending angioplasty to patients who do not have significant angina it is highly likely that a high proportion of these patients had little or no angina. Dr Thomas states that COURAGE ‘will not effect the use of coronary angioplasty in the UK,’ arguing that the majority of angioplasty procedures in the UK are used to treat patients with unstable syndromes. As member of the British Cardiovascular Intervention Society (BCIS) monitoring group, he will know that the national audit data presented to the 2006 annual meeting (available to download from www.bcis.org.uk) showed that 56% of the 70,142 angioplasty procedures in 2005 were for stable angina. COURAGE (1) and the data provided by Griffin et al., (2) combine to suggest that most of these were a costly waste. I suggest that in the current value for money climate driven by Practice Based Commissioning, Primary Care Trusts will be obliged to look much more carefully at the resources they commit to the 40,000 or so palliative angioplasty procedures presently undertaken (5). In assessing the validity of Dr Thomas's defence of current UK angioplasty practice, readers may wish to take into account the substantial financial support that the organisation over which he presides has received from angioplasty equipment manufacturers over the past 10 years (6). References 1. NEJM, doi:10.1056/NEJMoa070829 (published 27 March 2007) 2. BMJ, doi:10.1136/bmj.39129.442164.55 (published 5 March 2007) 3. Bridson J, Hammond C, Leach A, Chester MR. Making consent patient centred BMJ 2003;327;1159-1161 4. 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 5. Chester MR and Kingsland J. Timely fillip for Practice Based Commissioning http://www.bmj.com/cgi/eletters/334/7594/624#162274 6. http://www.bcis.org.uk/bcia Competing interests: NRAC provides advice and training to commissioners who want to rationalise palliative revascularisation costs |
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Anthony H Gershlick, Consultant Interventional Cardiologist University Hospitals of Leicester LE3pQP
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The recent publication of the COURAGE trial has perhaps not surprisingly generated a lot of interest in the medical and lay press, not least the sort of provocative title to this report (“Drugs are as good as PCI in stable coronary artery disease, study shows” . It has some important messages and these need to be clarified and the trial needs to be placed in the context of current clinical practice –something one would have hoped from the commentator 1. The trial would seem to imply to those not acquainted with an understanding of the design and nature of the study (which unfortunately would seem to apply to the commentator in the report) that anyone with chest pain will tend to undergo percutaneous coronary angioplasty (PCI) whereas they could really have been managed with pharmacology alone. This is far from the truth and as such COURAGE is not a study that can or should be regarded as applicable into UK practice. In the UK patients with chest pain undergo screening tests to ensure they have ischaemic heart disease as a cause of their chest pain and they are then treated medically and thereafter if still symptomatic will proceed to angiography. The angiogram remains an excellent test for confirming diagnosis and assessing prognosis. The results of the angiogram will be discussed and revascularisation offered if appropriate (i.e if the patient is still having symptoms). Admittedly in the COURAGE trial all patients had evidence of reversible ischaemia but we have little idea of who had settled and so would not therefore have even got to angiography in the UK and even if had would have merely been monitored. 2. The trial patients were randomised after angiography so bias could easily have crept in... if for example an operator saw a significant lesion in the left anterior descending artery then they may have pre- formed bias that such patients do better with re vascularisation and they may well have excluded that patient from being included in the study even before it began. Thus the trial design could bias toward lower risk lesions (for example including distal circumflex lesions) 3. Only 2.6% of patients received drug eluting stents (they only became available in the last 6 months of the trial) as compared to the UK level of ~ 50% which may have influenced the incidence of acute ischaemic follow up events. 4. In any case PCI has never made any claim regarding mortality benefit in the sort of lesions making up the COURAGE trial - The trial reinforces information that we have already known for almost 2 decades. For patients with chronic stable angina, the rate of death or myocardial infarction is low - particularly in patients with single-vessel disease where the 5-year mortality rate is less than 2 percent on medical therapy. PCI does not offer a mortality benefit in these patients. In patients with higher risk lesions there is currently no data regarding mortality benefit for PCI – the trials just have not been done. However what successful PCI does do in those patients with ongoing symptoms after medical therapy is to deal with the often underestimated misery that angina is. It is too frequently forgotten how debilitating and socially incapacitating (work issues for example) ischaemic heart disease can be. 5. Any comparison between coronary artery bypass grafting (CABG) and medical treatment for the sorts of patients included in COURAGE would also have shown no mortality benefit and incontrovertibly would have been cost/ineffective both in terms of what the patient would have needed to go through and the financial cost. Even for the high risk condition of left main stem disease where surgery has been shown to be better than medical therapy, those patients with normal left ventricular function did no better at 15 years whether they had CABG or medical therapy (CASS data Circulation 1995). 6 There have been no published randomised trials of CABG versus PCI for higher risk lesions (multi-vessel disease, left main stem disease)- it doesn’t mean CABG may not be better - it just has never been shown in a randomised trial. Of course there have been some dated (ie non stent) registry data which suggest benefit, but any self respecting statician or clinical scientist should be able to understand the limitations of such studies, as for example applying propensity analyses in such trials when the groups are so dissimilar. 7. It is bizarre therefore that the BMJ should choose a cardiac surgeon as their commentator for COURAGE, a trial of PCI versus medical therapy in low risk stable angina patients. Professor Taggart has on more than one occasion used the BMJ as an outlet, inappropriately to advocate CABG over PCI based on the sort of unsubstantiated evidence highlighted in the last paragraph. In his Editorial in BMJ in 2005 he sates " Overall, the trials broadly agreed that survival was similar with both interventions but that surgery greatly reduced the need for further intervention (from 20% with percutaneous coronary intervention to 5% with coronary artery bypass grafting)". Of course now we have drug eluting stents revascularisation need after PCI is reduced by 80%. The only randomised trial (SYNTAX) that compares surgery and drug eluting stents in higher risk (3 vessel disease/ left main stem disease) is awaited - it is interesting that Professor Taggart felt unable to include his patients in this important study. Once we have the answer then most will be in a better position to advise patients. The point is that rather than this be an attack on the personal beliefs of Professor Taggart it would have been more sound and have made more sense and have more relevance for the BMJ readership to ask a Cardiologist or an Interventionist to comment on a trial comparing PCI with medical therapy. 8. PCI has an important role to play in patients with coronary artery disease, and the COURAGE trial should not detract from that. More than 50% of patients undergoing this procedure are not stable patients (unstable angina, non-ST segment elevation MI or ST-segment elevation MI). 9. One of the most important messages from COURAGE was the importance and value of secondary prevention (an aspect which also seems to have slipped past Professor Taggart) Those who are confirmed as having ischaemic heart disease should be appropriately assessed, started on secondary preventative measures and if still symptomatic or have silent ischaemia on medical therapy, be offered angiography. The results will be discussed with the patient and most opt for PCI (in 2005 approximately 73,000 PCIs AND 22,000 CAGBG were undertaken). For patients with higher risk lesions discussions with interventional and surgical colleagues at an MDT (Multi-disciplinary Team) meeting or other such similar format undoubtedly should, and does occur. 10. COURAGE was an interesting but largely irrelevant to trial to UK practice. It reminded us however of the importance of secondary prevention. Low risk patients who settle on medical therapy will continue on it and those with ongoing symptoms be offered re-vascularisation. We await comparative trials of re vascularisation in patients with higher risk disease to determine the place of PCI and CABG in the coming years. Competing interests: None declared |
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Austin A Leach, Consultant in Pain Medicine National Refractory Angina Centre, Royal Liverpool University Hospital, Liverpool L14 3PE
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Dr Gershlick refers to "the often underestimated misery that angina is", and makes extravagant claims for UK interventionists' ability to abolish this misery using percutaneous coronary interventions (PCI) where US practitioners demonstrably cannot. Readers may wish to reflect on some of the reasons why angina can make people's lives so miserable. The misery to which Dr Gershlick refers is most often a direct result of the fear that accompanies an episode of angina because of an array of mistaken beliefs. This leads to inappropriate behavioural responses borne of the lack of vitally relevant information that should have been delivered early in the relationship between patient and cardiologist. Predominant among the views expressed by patients is the belief that angina represents ongoing damage to the myocardium, which results from the "furring up" process (patients' words) within the coronary arteries. Moreover, many patients (and non-cardiologist healthcare professionals) remain under the mistaken impression that PCI in stable angina reduces myocardial infarction and improves prognosis. The American Heart Association (1) and European Society of Cardiology (2) guidelines recognize that psychological distress resulting from misconceptions about stable angina play a major role in the pathogenesis of angina and the “often underestimated misery” associated with this condition. It is for this reason that both authorities recommend that misconceptions are identified and the condition itself demystified as an ongoing and integral part of high quality care. However it is widely recognized that this critically important aspect of high quality care is often neglected (1). Current GMC Good Practice guidelines now emphasise the importance of the "doctor-patient partnership" that explicitly requires doctors to assess patients' understanding about their condition and provide them with appropriate education so that they are full and active partners in the decision-making process (3). Well-informed patients are less anxious, have less angina, and have fewer hospital admissions (4,5). Having acquired the necessary information patients tell us that they prefer to avoid transiently palliative invasive procedures, such as PCI, with only a weak evidence base in their favour. Stable angina sufferers, and the taxpayer, may be better served if cardiologists spent more time listening and explaining and less time in the catheter lab. (1) ACC/AHA 2002 guideline update for the management of patients with stable angina. Available from www.americanheart.org (2) European Society of Cardiology. Guidelines on the management of stable angina pectoris: executive summary. Eur Heart J 2006; 27:1341-1387. Available from www.escardio.org (3) GMC: the doctor-patient relationship (para 2a; 4; 7; 21e; 21f). Available from www.GMC-uk.org (4) Moore R et al. A brief cognitive-behavioural intervention reduces hospital admissions in refractory angina patients. J Pain and Symptom Manage 2007; 33:310-316 (5) Furze G et al. Does it matter what patients think? The relationship between changes in patients’ beliefs about angina and their psychological and functional status. J Psychosom Res 2005; 59: 323-329 Competing interests: None declared |
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Celine M Aranjo, Senior G.P. NSW, Australia 2208
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I agree with the COURAGE study. When there is coronary artery disease with occasional mild angina, medical treatment is definitely safer than PCI, because of *the hemoglobinopathy, (as in Beta-thalassaemia minor) and *related iron-deficiency and *hemolytic episodes, (iron deficiency in itself a potential cause of angina)and also *possible other genetic deficiencies like Inborn Errors of Metabolism, which could manifest only after Surgical Invention, PCI,a.s.o. The studies show that beta-thalassaemia minor is an inherited deficiency, not to be taken heed of except for genetic counselling for before marriage; * studies also show that this so-called mild condition is a variety of Hemolytic anaemia and as such, PCIs, extensive Cardiac Surgery,Valve replacement,....carry the risk of causing Hemolysis. What then when hemolysis occurs? Competing interests: None declared |
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