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Rapid Responses: Rapid Responses published:
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STENTS
- Wilson B James (28 March 2007)
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Coronary Artery Stents: time for a balanced view.
- Martyn R Thomas, Anthony Gershlick, Peter Ludman on behalf of BCIS council (9 April 2007)
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Stent versus surgery for coronary artery disease: A sterile debate
- Stephen Westaby, Keith M. Channon, Adrian P. Banning (5 July 2007)
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Let the Debate Continue, Let the Patient Decide
- David Paul Taggart (10 July 2007)
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Wilson B James, Retired Radiologist n/a
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Last week at a post lunch discussion with non-medical friends I was asked to explain the difference between "SHUNT" and "STENT" - which I did. I then remarked that I had never discovered the derivation of the term "STENT". I was informed by several of my friends -engineers- that "STENTING" was a technical term concerned with the stretching of fabric. It would seem likely that this is the origin of "STENT"- a device inserted into the lumen of a vessel in order to maintain patency usually after previous "stretching" by angioplasty. Competing interests: None declared |
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Martyn R Thomas, President of the British Cardiovascular Intervention Society (BCIS) Kings College Hospital, London, SE5 9RS, Anthony Gershlick, Peter Ludman on behalf of BCIS council
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Three papers were published in the 24 th March edition of the BMJ comparing the efficacy and cost efficacy of minimally invasive left anterior descending artery surgery with stenting and the cost efficacy comparison of stenting and surgery (1-3). In addition an editorial from a cardiac surgeon, Professor Taggart (4), accompanied these 3 papers. The “headline” comment from Professor Taggart was “surgery is effective on clinical and economic grounds, but stenting does not appear to be a cost effective procedure”. The “Times” on Friday March 24th reported that “Thousands of patients with heart disease may be being denied their best chance of long-term survival”. We would suggest that it should have reported that thousands of patients have been misled into thinking they are being offered inferior care, and have been exposed to unjustified and unwarranted anxiety engendered by the flawed data published in the BMJ. It is essential that the inaccuracies of this position are clearly explained, so that patients and purchasers can be reassured. This letter is designed to address these issues. We are disappointed that the opportunity to provide a balanced view of the 3 papers was not granted to the the British Cardiovascular Intervention Society (BCIS) following publication of the original articles. The British Cardiovascular Intervention Society had requested, and offered to provide, a “balanced” editorial process but this was denied. Many thousands of patients with coronary artery disease are treated by percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG) each year. In the majority of cases, the optimal strategy (angioplasty or surgery) is very clear cut, based on a synthesis of the literature and clinical acumen, interpreted in the context of the individual patient’s needs by both cardiologists and surgeons. We agree that all high risk patients should be discussed at a multidisciplinary meeting of surgeons and cardiologists and this is already standard practice in most UK Units. Within this setting a patient with left main stem disease or a diabetic with proximal 3 vessel disease and left ventricular dysfunction would usually, and appropriately, be advised to have CABG. There are, of course, significant gaps in the research base that can make definitive statements about the optimal strategy of some patients difficult. One of the problems is that the majority of patients requiring treatment would have been excluded from recruitment into the published trials. Thus there are many patients (particularly some of those presenting with an acute coronary syndrome) that are felt to be too high risk for CABG, and after discussion with our surgical colleagues are turned down for such an operation. Percutaneous coronary intervention in this context is the only option and its efficacy well documented. There is a smaller group of patients for whom the balance between these 2 revascularisation options is more finely tuned. There is debate and uncertainty about whether surgery or angioplasty might offer mortality benefits. The more important differences between the two techniques relate to differential morbidity. From the patient’s perspective, given similar outcomes, a day case or overnight procedure through a 2mm arterial puncture is usually preferred even to a ‘minimally’ invasive surgical approach. In this context it is unfortunate that the recent publication in the BMJ of 3 papers and accompanying editorial presented such a one sided view that it may have erroneously led readers to believe that surgery had been shown to be a superior strategy. The 3 trials published in the BMJ do not help inform this debate because of significant limitations which we will explore. So what of the 3 published papers? The paper by Griffin (3) appears not to be about the cost efficacy of stenting versus surgery but on the on cost efficacy of clinically appropriate decisions for stenting or surgery. The paper is somewhat difficult to understand. It appears not to be about real patients who had a real procedure but about a nine member consensus panel who rated the clinical “appropriateness” of surgery or stenting in hypothetical patients in the 1996-1997 era. Consensus on “appropriateness” has certainly changed since this time as intervention is undertaken in more complex lesions and following the introduction of drug eluting stents (DES). Some aspects of this paper therefore appear “dated”. Most patients had “chronic coronary disease” in this paper whereas in modern practice the majority of patients receiving PCI are treated in the setting of unstable coronary syndromes including acute myocardial infarction. Critically (in contradiction to the media speculation) there was no reported difference in mortality between PCI and CABG; indeed, in patients considered suitable only for surgical management, medical management (rather than PCI) was associated with an increased mortality. Quality of life surgical advantage is presumably therefore driven by further angioplasty. This would be dramatically reduced in the current era because of the use of DES. One important aspect that needs addressing is the issue of changes in revascularisation efficiency over time. Readers will have been given the impression that when considering CABG versus PCI, the former improves over time whereas unfortunately in reality graft failure increases over time. In one recent trial, PREVENT IV (5), the 18 month graft failure rate was 46%! For PCI with DES while there is a potentially very small (0.26% per annum) risk of very late stent thrombosis beyond one year, this does not translate into an increased incidence of death or myocardial infarction in the reported series. Restenosis requiring a repeat procedure after DES occurs in approximately 5% of patients and is 80% reduced compared to bare metal stents. By far the majority of this restenosis occurs in the first 9 -12 months at most. Therefore we would argue that convergence of the two techniques occurs with time rather than there being any increased longitudinal benefit of CABG. The other two papers (1,2) on minimally invasive surgery are interesting but unfortunately flawed also. The individual trial numbers are small and hence the need for a meta-analysis (1). Only 6 of the 12 trials are randomised studies and although these data are re-presented separately this is not patient level data, merely a review of publications. Given that sample sizes are small, the apparent superiority of CABG is driven exclusively by need for repeat revascularisation (and the surrogate outcome of recurrence of angina). Long term MI or mortality shows no difference (in statistical terms) and indeed trends in favour of PCI. Again these studies were without the use of DES and therefore outdated in the modern era. Finally readers should not think the surgery practiced in this paper is “standard” CABG. Minimally invasive internal thoracic artery bypass surgery to the left anterior descending coronary artery is a performed relatively infrequently by a minority of surgical enthusiasts. The data on cost efficacy comparing minimally invasive surgery versus PCI (2) also merits comment. We interpret this paper as showing that the cost effective data does not favour CABG on any level. We are surprised at the costly figure of £6317.07 for stenting. This is purported to be a report on single vessel stenting, without use of expensive adjunctive pharmacology (Glycoprotein IIbIIIa inhibitors for example). These procedures are increasingly performed as a “day case” in most interventional units in the country. The national tariff for elective angioplasty set by the Department of Health (based on historical reference costs) for 2007-2008 will be £3,752 (40% less than the costs used in this paper!!). In their paper the authors provide very little follow up data and that which is provided shows PCI dominates over CABG during the first 2 years. It is difficult to understand the pathological mechanism whereby the surgical procedure could become increasingly cost dominant over the subsequent few years as we have previously explained. As far as cost efficacy over this short medium term we would point the reader to appropriate randomised trials that track patient level data over time such as that by Weintraub (6). Studies like this have very consistent findings: PCI is cheaper for the in-hospital phase and to 1 or 2 year follow-up. Any CABG advantage in terms of angina symptoms (and hence quality of life) cannot be justified on cost [for example > 1 million pounds per QUALY in the SoS trial (6)]. In Professor Taggart’s editorial he uses registry data to support the use of surgery versus stenting in multi-vessel disease on the basis of survival. It is from this speculation that the media reporting of patients getting the “wrong” treatment arises. No randomised trial has ever shown a mortality advantage in surgical patients and Professor Taggart appears to agree with this, stating in a previous editorial “ten randomised trials have compared percutaneous coronary intervention and coronary artery bypass grafting in patients with multi-vessel ischaemic heart disease. Overall, the trials broadly agreed that survival was similar” (7). The practice of most cardiologists and surgeons is based on randomised trials. The SYNTAX trial (8) is a randomised trial of DES versus CABG in the setting of 3 vessel coronary disease or left main stem disease. We believe this trial will shed appropriate scientific light on the issues of morbidity and mortality, associated with the two treatment modalities, in the modern revascularisation era in patients with severe coronary artery disease. When this study is published we will all, as evidence enlightened physicians, adjust our practice accordingly. In summary, we believe, the 3 papers are flawed and the Editorial is premature and predicated on selected registries and questionable data. For the vast majority of patients in whom revascularization is required, these papers present little useful additional data that moves the debate of optimal revascularisation strategy forward. These papers should not be misinterpreted, and should not cause patients who have been treated by PCI to feel that they have received an inferior therapy. Of equal concern to BCIS is the implication that the reason that stenting is so popular is a billion dollar industry, and that interventionists are somehow influenced by this. It should of course be pointed out that all of the important DES trials had an independent Data and Safety Monitoring Boards (many of whom were not interventionalists). We strongly believe that this rather “easy” hint at inappropriate behaviour by the interventional community should be backed up by fact especially when this appears in an editorial in an important medical journal. We are grateful to the BMJ for allowing us to provide a balanced view on how best to treat patients who need coronary revascularisation. (1) Aziz O, Rao C, Panesar SS, Jones C, Morris S, Darzi A, Anthanasiou T. Meta-analysis of minimally invasive internatl thoracic artery bypass versus percuataneous revascularisation for isolated lesions of the left anterior descending artery. BMJ 2007;334:617-21. (2) Rao C, Aziz O, Panesar SS, Jones C, Morris S, Darzi A, Anthanasiou T.# Cost effectiveness analysis of minimally invasive internal thoracic artery bypass versus percutaneous revascularisation for isolated lesions ofthe left anterior descending artery. BMJ 2007;334:621-4. (3) Griffin SC, Barber JA, Manca A, Sculpher MJ, Thompson SG, Buxton MJ, Hemingway H. Cost effectiveness of clinically appropriate decisions on alternative treatments for angina pectoris: prospective observational study. BMJ 2007;334:624-8. (4) Taggart DP. Coronary revascularisation. BMJ 2007;334:593-594. (5) Goyal A, Alexander JH, Hafley GE, Graham SH, Mehta RH, Mack MJ, Wolf RK, Cohn LH, Kouchoukos NT, Harrington RA, Gennevois D, Gibson CM, Califf RM, Ferguson TB Jr, Peterson ED; PREVENT IV Inveestigators. Outcomes associated with the use of secondary prevention medications after coronary artery bypass surgery. Ann Thorac Surg 2007 Mar;83(3):993-1001. (6) Weintraub WS, Mahoney EM, Zhang Z, Chu H, Hutton J, Buxton M et al One year comparison of costs of coronary surgery versus percutaneous coronary intervention in the stent or surgery trial Heart 2004 Jul;90(7):782-8 (7) Taggart DP Surgery is the best intervention for severe coronary artery disease. BMJ Apr 2005;330:785-786. (8) Ong AT, Serruys PW, Mohr FW, Morice MC, Kappetein AP, Holmes DR Jr, Mack MJ, van den Brand M, Morel MA, van Es GA, Kleijne J, Koglin J, Russell ME. The SYNery between percutaneous coronary intervention with TAXus and cardiac surgery (SYNTAX) study: design, rationale, and run-in phase. Am Heart J 2006 Jun;151(6):1194-204 Competing interests: None declared |
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Stephen Westaby, Consultant Cardiac Surgeon John Radcliffe Hospital, Oxford OX3 9DU, Keith M. Channon, Adrian P. Banning
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Cardiologists and cardiac surgeons collaborate daily to manage coronary artery disease. In most patients selection of the optimal revascularisation strategy is straightforward. For patients with intrusive exertional angina, contemporary percutaneous coronary intervention (PCI) is a minimally invasive, largely day case procedure performed under local anaesthetic. Deaths are rare and most patients return to full activity rapidly. In contrast, coronary artery bypass (CABG) with or without cardiopulmonary bypass (CPB) is a major operation. Complications include death, stroke, cognitive dysfunction, renal failure, blood transfusion, and wound infection. Recovery typically requires 24 hours intensive care, 5 further days in hospital and 3 months off work. In a contest between the two is it reasonable to compare one PCI with one CABG operation? Perhaps it may be more reasonable to equate 3 or more PCIs with one CABG. Inevitably, their relative merits cannot be debated without bias by those whose livelihoods depend on revascularisation. Conflict of interest statements have missed this point. Did the recent BMJ articles (24 March 2007) provide evidence for CABG superiority over PCI, as claimed?1-3 The featured MIDCAB operation for isolated left anterior descending disease accounted for <0.5% of 24,000 CABG procedures in the UK in 20051,2. Equally, the economic arguments were outdated, based on hospital costs 10 years ago3. At that time PCI strategies were limited, first generation stents were more expensive and 2 -3 days in hospital were routine. Changes in surgical practice have not significantly improved cost effectiveness or outcomes4. Off-pump CABG uses more expensive equipment than CPB, but fewer grafts tend to be performed, with inferior patency rates 5. We believe that public reporting of surgical mortality and league tables have changed revascularisation practice in tertiary centres6. In a well publicised “before and after” study, Bridgewater suggests that media reporting of CABG mortality statistics (since 2001) has not caused risk averse behaviour in surgeons7. This was unconvincing, counterintuitive, and presented no real evidence that the numbers of high-risk patients were unchanged after 2001. Data reporting practices changed at this time. Before then, few surgeons understood scoring systems. Afterwards public scrutiny inevitably caused surgeons to maximise Euroscore and avoid deaths. CABG mortality fell as did the number of cases with left ventricular ejection fraction <30% (only 5.5%). Without a “surgical breakthrough” this implies modification of patient selection. The relative merits of PCI versus CABG in complex multi-vessel disease are addressed by the Synergy between PCI with Taxus and cardiac surgery (SYNTAX) trial, which recently completed recruitment of 1800 patients12. We anticipate that SYNTAX will provide much clear guidance to support one revascularisation approach over the other. Even so, many less sanguine patients will still choose one or more PCIs first, knowing that CABG is possible should symptoms return. Careful, informed discussion with the patient remains central to revascularisation decisions. Cooperation between interventionalists and surgeons will ensure that PCI and CABG are considered complementary rather than competitive therapies. References 1. Aziz O, Rao C, Panesar SS, Jones C, Morris S, Darzi A, Athanasio T Meta analysis of minimally invasive internal thoracic artery bypass versus percutaneous revascularisation for isolated lesions of the left anterior descending artery. BMJ 2007; 334:617-621 2. Rao C, Aziz O, Panesar SS, Jons C, Morris S, Darzi A, Athanasiou T Cost effectiveness analysis of minimally invasive internal thoracic artery bypass versus percutaneous revascularisation for isolated lesions of the left anterior descending artery BMJ 2007; 334:621-624 3. Griffin SC, Barber JA, Manca A, Sculpher MJ, Thomson SG, Buxton MJ, Hemingway H Cost effectiveness of clinically appropriate decisions on alternative treatments for angina pectoris: prospective observational study BMJ 2007; 334:624-628 4. Karolak W, Hirsch G, Buth K, Legare JF Medium-term outcomes of coronary artery bypass graft surgery on pump versus off pump: results from a randomized controlled trial Am Heart J 2007; 153(4):689-95 5. Khan NE, De Souza A, Mister R, Flather M, Clague J, Davies S, Collins P, Wang D, Sigwart U, Pepper J A randomized comparison of off-pump and on-pump multivessel coronary- artery bypass surgery N Engl J Med 2004; 350(1):21-8 6. Turi TG The big chill: the deleterious effects of public reporting on access to health care for the sickest patients J Am Coll Cardiol 2005; 45(11):1766-8 7. Bridgewater B, Grayson A, Brooks N, Grotte G, Fabri B, Au J, Hooper T, Jones M, Keogh B Has the publication of cardiac surgery outcome data been associated with changes in practice in Northwest England? An analysis of 25,730 patients undergoing CABG surgery under 30 surgeons over 8 years. Heart May 2007; doi 10.11.36/hrt 2006.106393 Competing interests: The authors, a cardiac surgeon and two interventional cardiologists, perform CABG or PCI as major parts of their NHS clinical work, are SYNTAX trial investigators and undertake private practice in myocardial revascularisation. |
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David Paul Taggart, Professor of Cardiovascular Surgery University of Oxford John Radcliffe Hospital, Oxford, OX3 9DU
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The assertion by doctors Westaby and colleagues that ‘cardiologists and cardiac surgeons collaborate daily to manage coronary artery disease’ is somewhat misleading as it applies to only a very small proportion of patients undergoing interventions for coronary artery disease. Indeed the latest data from the British Cardiac Society show an exponential growth in percutaneous coronary interventions over the last decade to a current ratio approaching 3 to 1 against CABG [1]; many of these patients who would have benefited at least as much from surgery have had no opportunity to discuss that option. It is therefore disappointing that doctors Westaby and colleagues appear to have missed the central tenet of my accompanying editorial [2] which simply argued that where there are alternative interventions, with different risks and benefits over both the short and long term, a multidisciplinary team approach is the surest way to ensure that patients receive the best and most balanced advice. So while stenting is undoubtedly a less invasive procedure, with lower early mortality and morbidity than surgery, the implication that it offers the same survival benefit and freedom from repeat interventions over the longer term is quite erroneous [2]. And despite the long list of potential adverse consequences of surgery listed by doctors Westaby et al they ignore the fact in lower risk patients, typical of the majority of those who undergo stenting, that the risk of surgery is also remarkably low eg the one year mortality in 500 surgery patients in the Stent or Surgery trial was 0.8% [3]. Furthermore, the contention that the economic arguments favouring surgery are outdated, seems oblivious of a considerable body of data showing that the newer generation of much more expensive drug eluting stents not only have no survival benefit or freedom from further myocardial infarction than earlier generation stents [4] but that they also increase the risk of potentially lethal stent thrombosis mandating prolonged dual antiplatelet medication with its associated bleeding complications and financial costs [5]. So while some patients may indeed favour the less invasive approach of stents others may prefer the superior long term survival and freedom from repeat interventions offered with surgery. The issue is not that of a ‘turf war’ between different specialists practicing stenting or surgery but rather one of patient choice and appropriately informed consent. Indeed when Westaby and colleagues state that the ‘relative merits cannot be debated without bias by those whose livelihoods depend on revascularisation’ they emphasize the very danger, highlighted in my editorial, of the individual clinician making recommendations for a particular intervention. And until the multidisciplinary team rather than the individual clinician is accepted as the ‘minimum standard of care’, to ensure that patients are offered the most appropriate choices, let the debate continue. 1. Dawkins KD, Gershlick T, de Belder M, et al; Joint Working Group on Percutaneous Coronary Intervention of the British Cardiovascular Intervention Society and the British Cardiac Society. Percutaneous coronary intervention: recommendations for good practice and training. Heart. 2005 Dec;91 Suppl 6:vi1-27. 2. Taggart DP. Coronary revascularisation. BMJ 2007;334:593-4. 3. SoS Investigators. Coronary artery bypass surgery versus percutaneous coronary intervention with stent implantation in patients with multivessel coronary artery disease (the Stent or Surgery trial): a randomised controlled trial. Lancet 2002;360:965-70. 4. Kastrati A, Mehilli J, Pache J, et al. Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med 2007;356:1030-9. 5. Grines CL, Bonow RO, Casey DE Jr, et al. Prevention of premature discontinuation of dual antiplatelet therapy in patients with coronary artery stents: a science advisory from the American Heart Association, American College of Cardiology, Society for Cardiovascular Angiography and Interventions, American College of Surgeons, and American Dental Association, with representation from the American College of Physicians. J Am Coll Cardiol 2007;49:734-9. . Competing interests: None declared |
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