Eur J Cardiothorac Surg 2004;26:528-534
© 2004 Elsevier Science NL
Feasibility and cost of treatment with drug eluting stents of surgical candidates with multi-vessel coronary disease
Huw Griffithsa,
Ameet Bakhaib,
Douglas Westc,
Mario Petrouc,
Tony De Souzac,
Neil Moatc,
John Pepperc*,
Carlo Di Marioa
a Department of Cardiology, Royal Brompton and Harefield NHS Trust, Sydney Street, London SW3 6NP, UK
b Clinical Trials and Evaluation Unit, Royal Brompton and Harefield NHS Trust, Sydney Street, London SW3 6NP, UK
c Department of Cardiac Surgery, Royal Brompton and Harefield NHS Trust, Sydney Street, London SW3 6NP, UK
Received 23 March 2004;
accepted 5 May 2004.
* Corresponding author. Tel./fax: +44-20-7351-8530
e-mail: j.pepper{at}rbh.nthames.nhs.uk
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Abstract
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Objective: To determine the feasibility and cost of treatment with drug eluting stents in patients with multi-vessel coronary disease referred currently for surgical revascularisation. Methods: Two experienced interventional cardiologists reviewed retrospectively the clinical records and pre-operative coronary angiograms of 209 patients who underwent their first coronary bypass operation for multi-vessel disease without other adjunctive surgical procedures at the Royal Brompton Hospital in 2002. They were classified according to the technical feasibility and completeness of percutaneous revascularisation. A cost decision-analysis model with a cost of drug eluting stents of 
2,100 and simulated 1-year costs was constructed. Results: Mean age was 64.6±8.9 years with 54 diabetics (25.8%). Each patient received at least 1 arterial graft and a mean of 3.0±0.8 distal anastomoses. Mean post-operative stay was 8.9±7.2 days and total cost 19,821±1,964. Percutaneous revascularisation was judged to be feasible in 158 (76%) cases. The contraindications were at least 1 unfavourable total occlusion subtending viable myocardium in 48 patients (23%) and extreme tortuosity or calcification in 4 patients (2%). Percutaneous revascularisation of grafted major epicardial vessels was anticipated to be complete in 138 (66%) patients and partial but acceptable in 19 (9.1%) patients. Stenting of the left main, of a ‘favourable’ total occlusion, of bifurcations or in an ostial location would have been required in 32 (20.4%), 60 (38.2%), 77 (49.0%) and 74 (47.1%), respectively, of cases treated. 3.6±1.4 drug eluting stents of total length 72.6±37.3 mm were required to treat 3.3±1.2 lesions per patient at an estimated cost of 17,266±2,850. When one year repeat revascularisation was modelled at a rate of 15% in the stent group there was no significant cost saving from stenting. Conclusions: Although percutaneous revascularisation is feasible in 76% of patients currently undergoing coronary artery bypass grafting for multi-vessel disease, such an approach will involve frequent treatment of complex lesions for which no long term results are available and is unlikely to provide appreciable economic savings.
Key Words: Coronary bypass grafting • Percutaneous coronary intervention • Drug eluting stents • Cost
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1. Introduction
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The enthusiasm generated by the very low restenosis rate observed after implantation of drug eluting stents (DES) has prompted many interventionists to declare the ‘end of coronary surgery’. These trials have, however, been conducted in highly selected patients with single vessel coronary disease [1,2]. The aim of the study was to evaluate the feasibility, technical complexity and cost of percutaneous treatment in an unselected cohort of patients who have recently undergone coronary artery bypass surgery.
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2. Methods
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In the year 2002, 780 coronary bypass operations were performed at the Royal Brompton Hospital. We performed a retrospective analysis including all patients with angiographically documented multi-vessel disease with the exception of those displaying the following exclusion criteria: previous cardiac surgery, concomitant valve repair or replacement, left ventricular resection or closure of ventricular septal defect, correction of congenital intracardiac defects or emergency treatment of acute myocardial infarction.
Of the remaining 389 patients, complete coronary angiograms which allowed screening for potential percutaneous revascularisation were available in 209 patients, the remainder having been catheterised by cardiologists based outside the Royal Brompton Hospital. Baseline clinical characteristics, operative and post-operative details were obtained from our surgical database. Two experienced interventionists (HG, CDM) analysed the Dicom images from the CD's of this cohort according to pre-determined criteria. In cases of disagreement during the first independent review, a conclusion was reached by consensus.
2.1. Definitions
2.1.1. Completeness
Expected completeness of percutaneous coronary revascularisation was assessed against the record of distal anastomoses fashioned during surgical treatment. Completeness was judged for each of the two categories of main vessels and major side branches. A major side branch was defined by an angiographic diameter >2.0 mm or an appearance suggesting a large territory of distribution (i.e. a long vessel). Equivalent completeness was defined as percutaneous revascularisation of all surgically grafted territories. Superior completeness was recorded when a diseased territory without a distal anastomosis could have been treated percutaneously. Incomplete but clinically adequate revascularisation was recorded when one or more surgically grafted territories were unsuitable for percutaneous treatment but these territories were non-viable. In cases where the territory of one or more surgically grafted main vessels was viable but could not be revascularised percutaneously, the patient was judged unsuitable for a percutaneous treatment strategy. Viability was assessed on the basis of wall motion during left ventriculography.
2.1.2. Complexity
Eligibility for inclusion in the ARTS or SoS trials of coronary stenting vs. coronary surgery was recorded based on their inclusion and exclusion criteria [3,4]. An example of a surgical patient who might have been a possible candidate for percutaneous treatment despite the presence of complex multiple lesions including involvement of the left main coronary artery is shown in Fig. 1
. For cases in which percutaneous revascularisation was judged to be technically feasible, the requirement to treat the following lesion sub-types was assessed. Stenting the left main coronary artery was recorded as mandatory when >50% diameter stenosis was present. Possible involvement was defined as the presence of an ostial stenosis of either the left anterior descending or the left circumflex arteries with irregularity of the left main raising the possibility of plaque shift or retrograde dissection. Ostial stenosis was defined as the presence of a lesion within 3 mm of the following locations: the aorto-ostial junction, the origin from the left main coronary artery of the left anterior descending or left circumflex artery, the origin from a main vessel of a major (>2.0 mm) diagonal, marginal or postero-lateral side branch. A bifurcation lesion was defined as a lesion >50% diameter involving the main vessel at a distance of <5 mm from a major coronary bifurcation, with a side branch of reference diameter >2.0 mm, with or without involvement of one or both of the coronary ostia of the daughter vessels. In the absence of significant involvement of the main parent vessel, >50% diameter stenosis of both ostial daughter vessels was also defined as a bifurcation lesion. Total occlusion was defined as obstruction of a native coronary artery with no luminal continuity and with Thrombolysis In Myocardial Infarction (TIMI) flow grade 0 or 1. Total occlusion was classified as ‘favourable’ in the presence of a vessel stump, adequate visualisation of the distal vessel, the absence of tortuosity of the segment of access and an occluded segment length <15 mm. These features equate to a >70% probability of successful percutaneous recanalisation [5]. The contraindications to percutaneous revascularisation were the presence of one or more unfavourable chronic total occlusions in a main vessel or extreme tortuosity or calcification of the diseased segment with anticipated impossibility of wire, balloon or stent insertion or expansion. An example of a patient considered unsuitable for percutaneous revascularisation because of the presence of an unfavourable chronic total occlusion subtending a large area of viable myocardium is shown in Fig. 2
. The frequency of lesion sub-type matching those treated in the RAVEL and SIRIUS trials of drug eluting vs. bare metal stenting in single vessel disease was recorded [1,2]. The total number of DES required and the length of stented segments was calculated based on the lengths available for the Sirolimus coated CypherTM stent (8,13,18,23,28, and 33 mm). Availability of stents allowing treatment of vessels with a diameter between 2.25 and 5.5 mm was assumed. The need to cover the likely site of distal graft anastomosis in one or more of the major coronary arteries was reported. A strategy was adopted of covering lesions from normal to normal segments rather than that of spot stenting and a kissing stent strategy was assumed for all true bifurcation lesions.
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Fig. 1. Pre-operative coronary angiogram of a patient suitable potentially for percutaneous revascularisation with the use of drug eluting stents. (A) The lesion involvement of the left main coronary artery and of the proximal left anterior descending (LAD), intermediate branch and left circumflex (LCX) requires the use of at least 4 stents and raises doubts about the long term efficacy of covering a large trifurcation with DES. (B) The RAO caudal view of the left coronary artery demonstrates the need for an additional stent in the mid LCX. (C) Treatment of the right coronary artery (RCA) appears less challenging but still requires 3 more long DES for a total number of 7 stents and a total length of stented segment of 182 mm (allowing 3 mm overlapping of contiguous stents).
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Fig. 2. Pre-operative coronary angiogram of a patient considered unsuitable for percutaneous revascularisation. Despite the presence of a short lesion in the mid RCA, the flush occlusion of the ostial LAD with poor distal collateralisation in a patient with no previous myocardial infarction and only mild hypokenesia of the anterior wall predicts a very low probability of complete percutaneous revascularisation.
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2.2. Cost analysis
Costs were assigned using local costs and also from the national schedule of reference costs for the UK. The local costs were able to take into account actual lengths of stay and ward type for the surgical patients and were based on costs that would be charged to private insurers or patients paying from personal funds. The national reference costs assign a single health resource group (HRG) cost for patients undergoing either coronary artery bypass grafting or percutaneous coronary intervention (PCI). The national costs include 1.8 bare metal stents used in 86% of cases and we subtracted this cost before adjusting for DES use. The costs of bare metal stents and DES were assigned at 532 and 2,100, respectively, in line with the cost of DES in the RAVEL analysis [6]. The cost of clopidogrel for 90 days and abciximab for all patients was included in the economic analysis using British National Formulary prices. Costs were trimmed for those patients beyond the 97.5th percentile to minimise the impact of very high resource use patients (outliers). For the construction of simulated PCI costs, we used the median length of stay for elective PCI at our hospital of 1.4 days on the general cardiology ward and an additional 0.1 days on coronary care unit (ranged in proportion to the general surgical ward and intensive care unit stay, respectively, of the surgical patients). We also calculated the costs of a general cardiology ward stay of 2.8 days with an additional 0.2 days coronary care unit stay to allow for the increased complexity of these cases. Separate fees were taken into account for the surgeon, anaesthetist and cardiac interventionist and a cost was also included for cardiac rehabilitation following bypass grafting.
One year outcomes for the CABG group were not available and therefore simulated 1 year costs were assigned based on the rates of repeat revascularisation experienced by the surgical group in ARTS i.e. 3.1% PCI, 0.5% re-do CABG and 0.2% PCI+re-do CABG [3]. Simulated 1 year costs were assigned to the PCI group based on repeat revascularisation rates of 5, 10 and 15% and at equal cost to the initial procedure. Modes of repeat revascularisation for this group were assigned in the same ratio as that experienced in the ARTS PCI group i.e. 68:25:7% for repeat PCI:CABG:repeat PCI+CABG [3]. Cost differences were tested by Student's t-test.
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3. Results
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Baseline characteristics are shown in Table 1 and details of the CABG procedures in Table 2. An off-pump technique was adopted in 14 (7%) cases and total arterial revascularisation was achieved in 35 (17%). The in-hospital mortality of 0.5% was very low by comparison with nationally reported rates. The ITU stay was skewed by 4 patients with a stay of >10 days.
3.1. Percutaneous intervention
Percutaneous coronary intervention was considered unfeasible in 51 (24%) patients for the reasons documented in Fig. 3
. The most common reason for exclusion from percutaneous revascularisation in this cohort was the presence of an unfavourable total occlusion in 47/51 (92%) patients. Three patients were excluded because of excessive tortuosity or calcification and 1 was excluded on the basis of both unfavourable total occlusion and excessive tortuosity/calcification. Only 59 (28%) cases would have been suitable for randomisation in the ARTS trial but 128 (61%) would have fulfilled the more open inclusion criteria for SoS [3,4].
The 158 suitable patients required treatment of 525 lesions or 3.3±1.2 per case. The lesion characteristics, predicted stent use and anticipated completeness of percutaneous revascularisation are shown in Table 3. Treatment of challenging lesion sub-types would frequently have been necessary. Stenting the left main was mandatory in 32 (20%) patients. Only 127 (24%) lesions had characteristics corresponding to those treated in the RAVEL trial and 116 (39%) were SIRIUS like. A drug eluting stent use of 3.6±1.4 per case was predicted. Despite a total stented segment length per case of 73±37 mm a potential CABG distal anastomotic site was covered in only 10 (6%) cases.
3.2. Cost
The results of the cost analysis are illustrated in Table 4. A percutaneous approach to revascularisation with drug eluting stents was cheaper than CABG from a hospital perspective but when repeat revascularisation at a rate of 15% was considered, this cost saving was lost. The results were relatively insensitive to length of stay. National reference costs were not presented according to length of stay as they are defined on the basis of a national average.
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4. Discussion
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4.1. Feasibility
Previous studies of multi-vessel angioplasty have demonstrated equivalent mortality compared with the results of coronary artery bypass grafting but greater rates of repeat revascularisation as a result of re-stenosis [7–11]. The introduction of coronary stents has seen a reduction of the gap between surgery and percutaneous revascularisation at 1 year follow-up. The incidence of adverse events at 2 years, however, has increased and the cost advantage with the use of stents has become negligible. This is particularly evident in patients with high rates of repeated target lesion revascularisation e.g. diabetics [3,4,12]. The recent data on DES has demonstrated much lower re-stenosis and event rates at 1–2 years [2,13]. It is unknown whether this will translate into equivalent long-term results between percutaneous revascularisation with DES and CABG in patients with multi-vessel disease. Previous comparisons of the two strategies have adopted strict inclusion criteria and have not reported registry data of patients screened for randomisation. As a result, the proportion of the population with multi-vessel disease suitable technically for percutaneous revascularisation has been unknown. Although 128 (61%) patients would have fulfilled the entry criteria for SoS, the lesions actually treated in that trial were not comparable with those present in our cohort [4]. Our analysis confirms that multi-vessel disease is not simply a series of lesions involving multiple vessels but indicates a diffuse involvement of the arterial tree, commonly including stenoses of the left main coronary artery, of major bifurcations or in ostial locations and is frequently associated with long standing occlusions of coronary segments. The 76% of patients judged suitable for PCI may overestimate the proportion of patients eventually undergoing a successful procedure because of failure in the presence of total occlusion and diffuse disease. Despite favourable angiographic characteristics, the probability of opening an occlusion present for more than 3 months or of indeterminate duration (‘chronic’) is unlikely to be greater than 80% even by skilled operators with state of the art angioplasty equipment [5]. Estimation of the duration of occlusion was not possible based on the data available but the relatively low prevalence of urgent cases and the angiographic characteristics suggested strongly that most of these occlusions were chronic.
4.2. Complexity
We have proposed the treatment of complex lesion sub-types that are not attempted frequently during everyday interventional practice. Prognostic benefit following PCI in multi-vessel and left main coronary disease has not been shown but studies describing outcome data for such lesions are now being increasingly reported. Stenting of the left main in ‘good surgical candidates’ can be achieved with a procedural mortality of <2% [14–17]. Nevertheless, the balance of evidence for revascularisation in these patterns of coronary anatomy remains with CABG and the mortality of 0.5% in our cohort undergoing their first procedure was very low.
We assumed the use of a kissing stent technique for the majority of bifurcation lesions but the present experience with CypherTM stents indicates a greater risk of ostial side branch re-stenosis following conventional T-stenting compared with the use of a single stent and balloon dilatation of the side branch. It remains to be seen whether the current development of different techniques of stent deployment (Culotte, ‘crush’, V-stenting) and the use of drug eluting bifurcation stents will deliver improved results [18,19].
4.3. Cost
Economic analyses alongside both RAVEL (retrospective, DES cost 2000) and SIRIUS (prospective, DES cost $3000) have demonstrated that drug eluting stents are cost effective when compared to bare metal stenting in their respective European and US settings. These trials included treatment of single coronary lesions only [6,20]. Economic data from ARTS, demonstrated an initial superior cost effectiveness for bare metal stenting over coronary artery bypass grafting in patients with multi-vessel coronary disease [21]. Our data suggests that PCI with drug eluting stents may be cheaper from a hospital perspective than CABG despite the high cost of the device. Our estimated stent use of 3.6 (1.4) per patient must of course be regarded as a minimum figure and in practice costs might be higher. In addition, the effect of procedural failure with crossover to CABG, arising predominantly from failure to re-cannalise a proportion of favourable chronic occlusions would result in increased costs for PCI.
The early cost effectiveness of bare metal stenting in ARTS was not maintained at 3 year follow-up as a result of a higher rate of re-intervention in the PCI arm [21]. The target lesion revascularisation rate (TLR) following treatment with drug eluting stents of complex diffuse multi-vessel disease including left main and total occlusion remains undefined. It will be expected to contribute to a 1 year TLR greater than the 4.9% reported in SIRIUS but perhaps not as high as the 21% undergoing repeat procedures in ARTS [3,21]. Sub-group analysis of SIRIUS has demonstrated angiographic re-stenosis rates up to 20% for long lesions, small vessels and in diabetics [22]. The RESEARCH registry reported a 3.7% clinically driven TLR rate at 1 year following treatment with drug eluting stents of 508 consecutive patients. This ‘real world’ population included 54% with multi-vessel disease and 3% with left main disease, a level of complexity below that described in our report [23]. The effect of complex disease could not be quantified for the purposes of our cost analysis and we therefore considered three hypotheses of repeat revascularisation at 1 year, ranging from 5 to 15%. It should be noted that in the absence of definitive data, we assumed a cost for repeat PCI equal to the index procedure. In practice, fewer DES would be used during targeted repeat procedures resulting in an overall lower cost for target lesion revascularisation. We did not factor in, however, the increased cost incurred by a staged approach to percutaneous revascularisation in these complex patients. Neither did we include the impact of increased vascular and renal complications or the need for emergency coronary bypass surgery which might be more prevalent in such patients.
Our model predicts that treatment with DES will be roughly cost equivalent to CABG if the rate of repeat revascularisation is around 15%. If the true rate is higher, the cost effectiveness of PCI will depend largely upon the cost of DES. The paclitaxel coated TaxusTM stent has now been introduced to the European market and the cost of the CypherTM stent is reducing. ARTS II with drug eluting stents will provide clinical and economic data on patients with multi-vessel disease and will place this issue on an objective footing. Until these results are available, there is no clinical or economic mandate for the routine use of PCI in patients with complex multi-vessel disease.
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Footnotes
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Presented at American College of Cardiology Annual Scientific Session, New Orleans, USA, March 10, 2004.
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Abstract
1. Introduction
