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Ann Thorac Surg 2008;85:501-507. doi:10.1016/j.athoracsur.2007.09.036
© 2008 The Society of Thoracic Surgeons
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Original Articles: Cardiovascular

Does Previous Percutaneous Coronary Stenting Compromise the Long-Term Efficacy of Subsequent Coronary Artery Bypass Surgery? A Microsimulation Study

Christopher Rao, MBBS, BSca, Rex De Lisle Stanbridge, FRCSb, Joanna Chikwe, MBBS, FRCSc, John Pepper, MBBS, MDd, Petros Skapinakis, MSc, PhDe, Omer Aziz, MRCSa, Ara Darzi, MD, FRCSa, Thanos Athanasiou, PhD, FETCSa,b,*

a Department of Biosurgery and Surgical Technology, Imperial College London, United Kingdom
b Department of Cardiothoracic Surgery, St. Mary’s Hospital, London, United Kingdom
c Department of Cardiothoracic Surgery, Mount Sinai Hospital, New York, New York
d Department of Cardiothoracic Surgery, National Heart and Lung Institute, Imperial College London, Royal Brompton Hospital, London, United Kingdom
e Department of Psychiatry, University of Ioannina School of Medicine, Ioannina, Greece

Accepted for publication September 20, 2007.

* Address correspondence to Mr Athanasiou, Department of Biosurgery and Surgical Technology, Imperial College London, 10th Floor, QEQM Building, St. Mary’s Hospital, London W2 1NY, United Kingdom (Email: tathan5253{at}aol.com).


   Abstract
Top
 Abstract
Introduction
 Material and Methods
 Results
 Comment
 References
 
Background: This study aims to compare long-term survival and health-related quality of life in patients undergoing coronary artery bypass surgery with and without previous coronary stenting.

Methods: Markov microsimulation was used to model long-term survival and quality of life after surgical revascularization using data from referenced sources. Probabilistic sensitivity analysis was used to investigate the effect of uncertainty associated with the model parameters on the microsimulation results.

Results: Percutaneous coronary stenting was found to significantly decrease the effectiveness of coronary surgery. The model suggests that after a single stenting procedure ten-year survival was reduced by 3.3% (SD 0.7%), from 79.9% (SD 1.3%) to 76.6% (SD 1.4%). Similarly, after multiple stenting procedures ten-year survival was reduced by 3.5% (SD 0.7%) to 76.4% (SD 1.4%). Over a ten-year period a single stenting procedure reduced the quality adjusted life year (QALY) payoff by 0.25 QALY (SD 0.11 QALY) and multiple stenting procedures reduced the QALY payoff by 0.27 QALY (SD 0.08 QALY).

Conclusions: This study suggests that patients who undergo surgical bypass after stenting have worse long-term outcomes than patients who undergo surgical revascularization without previous percutaneous intervention. The pathophysiological mechanisms for this are not fully understood and must be further investigated. The findings of this study suggest that the timing of surgical bypass in relation to percutaneous intervention is important. This may have significant implications for clinical practice, suggesting that greater emphasis should be placed on selecting the optimum initial revascularization strategy.


   Introduction
Top
 Abstract
 Introduction
Material and Methods
 Results
 Comment
 References
 
Coronary artery bypass grafting (CABG) offers greater freedom from repeat revascularization, angina, and myocardial infarction (MI) than percutaneous coronary stenting (PCS) in the treatment of both single and multiple vessel ischemic heart disease 1, 2]. Both randomized controlled trials [3–6] and real-world registry databases [7–9] suggest that survival is better after CABG. Furthermore, CABG is more cost effective than stenting for treatment of both single-vessel and multiple-vessel coronary artery disease [10–12].

Despite compelling evidence supporting the superior efficacy of CABG, stenting has become first-line treatment in many patients who are amenable to CABG [13]. Several studies have suggested that 8% to 20% of patients undergoing coronary stenting will have bypass surgery within five years [3–5, 8, 14]. In the UK, of the 25,000 patients who underwent coronary surgery in 2003, over 5% had a history of previous percutaneous coronary intervention, compared with 3% in 1998 [15]. In our institution the incidence of bypass surgery after stenting is currently four times higher compared with the national average reported by the UK cardiothoracic database, suggesting significant variation in revascularization strategies across the UK.

A recent study suggested that patients who underwent bypass surgery after stenting had a higher in-hospital incidence of death and major adverse coronary events [16]. However, none of the sophisticated risk stratification systems, which help to facilitate informed patient consent, as well as reliable comparison of individual surgeon outcomes, include prior coronary stenting as a variable [17, 18].

It is important to investigate what impact coronary stenting may have on long-term outcomes in patients who require surgical revascularization after coronary stenting in view of the increasingly widespread use of coronary stents, the frequent need for surgical reintervention in these patients, and the clinical impression that surgical outcomes may also be compromised in this patient group. Specifically, we will attempt to answer the following questions: (1) Does previous stenting affect long-term survival after CABG? (2) How does previous stenting effect long-term health-related quality of life (HRQoL) after CABG? In order to investigate the long-term impact of stenting on outcomes after bypass surgery we constructed a Markov microsimulation model to combine published data on outcomes after bypass surgery after stenting [16] with data on the incidence and HRQoL associated with stroke, MI, repeat revascularization, and death at different time horizons after revascularization [4, 19].


   Material and Methods
Top
 Abstract
 Introduction
 Material and Methods
Results
 Comment
 References
 
Markov microsimulation is a powerful tool that can be used to model morbidity and mortality after surgical interventions in the absence of empirical follow-up data. It has previously been used in the cardiovascular literature to model outcomes after aortic valve replacement [20–23]. In Markov modeling it is assumed that a patient’s HRQoL can be described by a finite number of states, and by modeling the transition between these states at the end of discrete time periods, called cycles, long-term predictions can be made about HRQoL and survival.

Model Structure and Variables
Figure 1 shows the structure of the model used. We carried out analysis over a ten-year time horizon, with one year cycles. Each patient cohort starts the simulation in one of states indicated by the shaded boxes and may move between states as indicated by the solid arrows. The probability of transition between different states each cycle, as well as the HRQoL associated with each state, depends on the most recent method of revascularization. If revascularization occurs using a different method, indicated by the dashed arrows, the transition probabilities, and HRQoL associated with each state change. Analysis was based on a cohort of 61-year-old males, as this was the average age of the predominantly male cohort on which the transition probabilities are based [4]. Survival and quality adjusted life years (QALY), a function of survival and HRQoL were used as measures of effectiveness. The model structure was validated by comparing estimates of survival for patients undergoing CABG generated by our model with real-world registry data [8]. Analysis was performed using decision analytic software (TreeAge-ProTM; TreeAge, Williamstown, MA).


Figure 1
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  		Fig 1. Markov microsimulation comparing long-term survival and health-related quality of life (HRQoL) after coronary artery bypass grafting (CABG) and CABG after percutaneous coronary stenting (PCS). Each patient cohort starts the simulation in one of states indicated by the shaded boxes and may remain in the same state, or move between states as indicated by the solid arrows. The probability of transition between states each cycle as well as the HRQoL associated with each state depends on the most recent method of revascularization. If revascularization occurs using a different method, indicated by the dashed arrows, the transition probabilities, and HRQoL associated with each state change. (CVA = cardiovascular accident; MI = myocardial infarction.)

 
Clinical Variables
We converted published incidence of clinical outcomes, obtained from the Arterial Revascularization Therapies Study (ARTS) [4], into transition probabilities [24]. Transition probabilities for baseline mortality were obtained from the mortality tables of the actuary department of the UK government [25]. Data on the likelihood of death after myocardial infarction and stroke were obtained from the National Institute for Health and Clinical Excellence (NICE) report on coronary revascularization [19]; confidence intervals of ±50% were arbitrarily used. The perioperative mortality rate and the incidence of MI after bypass we adjusted using published data [16], according to whether the patient had previous stenting on one or more occasions. Variables used in the analysis are presented in Table 1.


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  		Table 1 Model Parameters
 
Quality of Life Parameters
All utility variables were obtained from the NICE assessment report on coronary revascularization [19] and were based on data collected empirically using the EQ-5D instrument [26], a well-validated tool commonly used to evaluate the utility of different health states. One year of good cardiac health was valued at 0.86 QALYs, consistent with other published estimates of age-adjusted normal population values [27]. Patients undergoing either stenting or surgical bypass were assumed to have had angina for six weeks before the procedure, hence incurring a disutility of 0.02 QALYs for six weeks. Although we accept that variations in service provision may mean that patients have symptoms for longer, we thought that it is important to compare the efficacy and not the availability of the interventions. Patients incurred a disutility of 0.012 QALYs for 13 weeks when surviving bypass surgery, 0.0035 QALYs for six weeks when surviving stenting, and 0.1 QALYs for 13 weeks when surviving MI. Patients surviving a stroke incurred a permanent disutility of 0.3 QALYs, which was higher after a second stroke (0.33 QALYs). Modeling limitations meant that the disutility of subsequent stokes could not be accounted for. Although this has the potential to bias results in favor of stenting, the number of patients with serial strokes is small.

The QALY were discounted at 3.5% per year, and probabilistic sensitivity analysis was performed to investigate the uncertainty associated with our results, according to the NICE guidelines on health technology assessment [28]. In the sensitivity analysis we sampled utility values from beta distributions described in Table 1.

Sensitivity Analysis and Uncertainty
An element of uncertainty is always associated with attempts to consider the long-term implications of health care interventions [29]. We carried out a probabilistic analysis to examine the combined effect of parameter uncertainty in the model using a two-layered Monte Carlo simulation [29], with 1,000 iterations in each loop. We sampled variables from the distributions described in Table 1.


   Results
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 Abstract
 Introduction
 Material and Methods
 Results
Comment
 References
 
Effect on Survival
The results of our analysis suggest that prior stenting significantly affects survival after CABG, especially in the first two years after the surgical intervention. Over the first two years after surgery, survival was reduced after one previous stenting procedure by 3.9% (SD 0.7%), from 94.1% (SD 0.8%) to 90.2% (SD 1.0%). After multiple stenting procedures, survival was reduced by 4.1% (SD 0.7%) to 90.0% (SD 1.0%). Over 10 years, survival after surgery was reduced after one previous stenting procedure by 3.3% (SD 0.7%), from 79.9% (SD 1.3%) to 76.6% (SD 1.4%). After multiple stenting procedures, survival was reduced by 3.5% (SD 0.7%) to 76.4% (SD 1.4%) (Fig 2). Estimates of long-term survival generated by our model correlated closely with registry data, supporting the validity of our model structure (Fig 3).


Figure 2
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  		Fig 2. Survival curves for coronary artery bypass grafting (CABG) and CABG after percutaneous coronary stenting (PCS). — = CABG; – – – = CABG after PCS; - - - = CABG after multiple PCS.

 

Figure 3
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  		Fig 3. Survival after coronary artery bypass grafting estimated using Markov microsimulation compared with empirical registry data [6]. — = model data; – – – = registry data.

 
Effect on Quality of Life
The results of our analysis suggest that HRQoL is also compromised by prior stenting. Over a ten-year period the QALY payoff is reduced by 0.25 QALY (SD 0.11 QALY) after a single stenting procedure, and by 0.27 QALY (SD 0.08 QALY) after multiple stenting procedures (Fig 4).


Figure 4
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  		Fig 4. The effect of percutaneous coronary stenting (PCS) on quality adjusted life year (QALY) payoff after coronary artery bypass grafting (CABG). — = CABG after PCS; – – – = CABG after multiple PCS.

 

   Comment
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
References
 
The results of this microsimulation Markov model suggest that stenting has a negative impact on outcomes after coronary surgery. Survival was reduced by 3.3% over a ten-year period after a single stenting procedure and 3.5% after multiple stenting procedures. The QALY payoff after CABG was also reduced after percutaneous stenting. After a single stenting procedure the QALY payoff was reduced by 0.25 QALY, and by 0.27 QALY after multiple stenting procedures.

Although worse outcomes after coronary stenting have previously been reported [16], our results represent long-term estimates of the impact of stenting on surgical outcomes. Several hypotheses may play a role for this effect on outcomes after CABG after stenting. First, in-stent restenosis is associated with a higher risk of early venous graft failure [30]. Second, the presence of stents could result in grafts being performed more distally. Third, antiplatelet medication may cause excess postoperative bleeding, while stopping this medication has been associated with in-stent thrombosis especially in patients undergoing beating heart surgery without cardiopulmonary bypass [31, 32]. Finally, the pathophysiological response to the presence of an intravascular foreign body may also adversely affect surgical outcomes; stenting can cause prolonged endothelial dysfunction, a local inflammatory response because of persistent radial mechanical strain, and vessel wall rupture [33–35].

Conversely, it has been argued that worse surgical outcomes after stenting are artefacts of the more aggressive atherosclerotic disease processes in patients who require reintervention, and not a consequence of previous coronary stenting [30]. Neither retrospective data from cardiothoracic surgery databases nor the study by Thielmann and colleagues [16], from which we extracted some of our model parameters, demonstrate a causal relationship between stenting and worse outcomes after bypass surgery. In the study by Thielmann and colleagues [16], while patients were well-matched for their demographics, risk factors, comorbidities, and angiographic characteristics, a significantly higher number of patients with the highest stent burden had hypertension and hyperlipidemia, received aspirin and statins, suffered more often from MI, and had more often been treated with thrombolysis. This suggested that these patients were more risky surgical candidates, perhaps because they suffered from more aggressive coronary disease, independent of the effects of stenting. While it could be argued that this weakens the findings of our study, it is important to note that the group of patients with only a single previous stenting procedure, which was well-matched to the control group, also experienced worse outcomes after surgery [16]. Ultimately, however, the question of whether a causal relationship can explain worse surgical outcomes after stenting will only be addressed by the prospective studies [36], which are currently underway.

Implications for Practice
When patients amenable to surgical revascularization are initially revascularized with coronary stenting rather than CABG they are being denied optimum long-term management. In addition to exposing these patients to the increased mortality and morbidity associated with stenting [1–9], this study suggests that the significant proportion of these patients who subsequently undergo surgical bypass after stenting will have worse long-term outcomes than those patients initially revascularized with CABG.

It has previously been suggested that patients may prefer to opt for stenting knowing that the option of coronary bypass is available later; especially when angina symptoms return [37]. This study suggests that the timing of surgical bypass in relation to percutaneous intervention is important, making a rational choice of initial revascularization strategy imperative. Stenting of patients who ultimately may need CABG, such as younger patients or diabetic patients, not only denies them definitive management but will also result in worse long-term outcomes. Consequently we should examine patient consent and referral mechanisms. There is evidence that adequate information is routinely not given to patients undergoing revascularization in the UK [38]. It has been suggested that current referral pathways may account for why some patients receive suboptimal treatment, and that revascularization after multidisciplinary discussion may be more likely to be evidence-based [39].

Study Limitations
Decision analytic modeling is always limited by the accuracy of the model structure and estimates of the model variables. We have explicitly quantified the uncertainty associated with model parameters, and while our results may assist in selection of optimum revascularization strategy the results must be interpreted in the context of the uncertainty associated with them.

A significant limitation of study is that we used data from the ARTS study [4] as the source of many of our model parameters. The ARTS study has been criticized as it compares only patients for whom "equivalent revascularization" with stenting and CABG could be achieved, and there was a significant delay in treating the CABG group compared with the stenting group, resulting in increased morbidity and mortality [1]. We used ARTS data for several reasons. First, no other source reported the long-term incidences for all of the outcomes needed to populate our model. Furthermore, we felt that the impact of using ARTS data on the strength of our findings would be minimal, as we were not comparing stenting and bypass surgery directly. Finally, the survival curves generated by our model for patients after CABG correlated closely to real-world registry data [6], suggesting that our use of ARTS data did not affect the validity of our model [Fig 3].

This study suggests that patients who undergo CABG after stenting will have worse long-term survival and HRQoL than those patients initially revascularized with CABG.

The pathophysiological mechanism underlying these findings is, however, unclear and requires further research. Furthermore, neither our study nor the study by Thielmann and colleagues [16] were designed to investigate the relationship between adverse surgical outcomes and percutaneous stenting and further research is required to investigate if there is a "dose relationship" between stenting and worse surgical outcomes, or if there are particular circumstances in which worse surgical outcomes are more likely to occur.

The findings of this study emphasize that the choice of initial revascularization strategy is imperative and that we should urgently examine patient referral pathways and strategy for selecting the initial revascularization approach, especially for patients who may ultimately need coronary bypass surgery.


   References
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 References
 

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