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European Heart Journal Advance Access originally published online on February 13, 2007
European Heart Journal 2007 28(6):719-725; doi:10.1093/eurheartj/ehl490
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© The European Society of Cardiology 2007. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org

Targeted stent use in clinical practice based on evidence from the BAsel Stent Cost Effectiveness Trial (BASKET){dagger}

Hans-Peter Brunner-La Rocca, Christoph Kaiser, Matthias Pfisterer on behalf of the BASKET Investigators*

Division of Cardiology, University Hospital Basel, CH 4031, Switzerland

Received 10 October 2006; revised 27 December 2006; accepted 4 January 2007; online publish-ahead-of-print 13 February 2007.

* Corresponding author. Tel: +41 61 265 25 25/52 14; fax: +41 61 265 45 98. E-mail address: pfisterer{at}email.ch

See page 653 for the editorial comment on this article (doi:10.1093/eurheartj/ehl566)


   Abstract
Top
 Abstract
Introduction
 Methods
 Results
 Discussion
 Acknowledgements
 References
 
Aim It is unknown which patients benefit most from drug-eluting stents (DES) against bare-metal stents (BMS) in a long-term clinical outcome.

Methods and results To address this question, data from 826 consecutive patients with angioplasty, randomized 2:1 to DES vs. BMS, with an 18-month follow-up for cardiac death/myocardial infarction (MI) and non-MI-related target-vessel revascularization (TVR) were analysed for interactions between stent type and patient/vessel characteristics predicting events. Rates of 18-month TVRs were lower with DES vs. BMS use (7.5 vs. 11.6%, P = 0.05), but similar for both stents regarding cardiac death/MI (DES, 8.4%; BMS, 7.5%; P = 0.70). Significant interactions between stent type and two multivariable event predictors were identified: small stents (<3.0 mm) and bypass graft stenting. In these patient groups together (n = 268, 32%), DES reduced non-MI-related TVR (HR = 0.44; P = 0.02) and cardiac death/MI (HR = 0.44; P = 0.04), whereas in the other 558 patients (68%) TVR rate was similar (HR = 0.75; P = 0.38) and cardiac death/MI rate increased after DES (HR = 2.07; P = 0.05).

Conclusion Patients with angioplasty of small vessels or bypass grafts seem to benefit from DES use, in long-term outcome, in contrast to patients with large native vessel stenting where there might even be late harm. Still, this hypothesis needs to be tested prospectively.

Key Words: Angioplasty • Coronary disease • Outcome • Stents • Stent thrombosis


   Introduction
Top
 Abstract
 Introduction
Methods
 Results
 Discussion
 Acknowledgements
 References
 
Drug-eluting-stents (DES) have a proven benefit when compared with bare-metal stents (BMS) in reducing restenosis and thus target vessel revascularization (TVR),1–5 resulting in a wide-spread use of DES in clinical practice6,7 despite higher costs8 and no significant effects on either mortality or rates of non-fatal myocardial infraction (MI).4,5 To assess the benefits of drug-coating, the same bare stainless steal stent platform has been used for comparative trials with vs. without drug. However, new stent platforms based on cobalt–chromium9 or titanium10 have been developed for BMS and new stent designs mainly using thinner struts have been shown to be advantageous.11

In addition, the initial euphoria which led to an unrestricted use of DES was somewhat tempered by recent concerns relating to a possible late harm of DES due to delayed intimal healing and related clinical events.12–15 Therefore, there is a new debate as to which patients should be treated safely and effectively with DES and in which ones BMS may still be preferred in everyday practice today. To address this important question, a retrospective analysis of the large ‘real-world’ BAsel Stent Cost Effectiveness Trial (BASKET)8,15 patient population was performed to identify subgroups of patient or vessel characteristics with most benefit from either stent type by determining significant interactions between stent type and outcome in these subgroups.


   Methods
Top
 Abstract
 Introduction
 Methods
Results
 Discussion
 Acknowledgements
 References
 
Study design and patient population have been described previously.8 In brief, all patients treated with PCI and stenting between May 2003 and May 2004 were enrolled irrespective of indication, except those with ≥ 4 mm vessels, restenotic lesions, or no consent. Thus, 826 of consecutive 988 patients (84%) with 1281 treated lesions were randomized 2:1 to receive DES [Cypher® Cordis, Johnson&Johnson, Miami Lakes, FL, USA (n = 264); TAXUS®, Boston Scientific Corporation, Natick, MA, USA (n = 281)] or a cobalt–chromium BMS [Vision®, Guidant Corporation, Indianapolis, IN, USA (n = 281)]. In patients with ST-elevation MI, primary angioplasty was the treatment of choice, whereas patients with non-ST-elevation acute coronary syndromes had angioplasty usually within 24 h. Angioplasty was performed according to standard techniques. The use of glycoprotein (GP) IIb/IIIa inhibitors was left to the discretion of the physician in charge, mainly given in patients with acute coronary syndromes or suboptimal angioplasty results. All patients received clopidogrel 75 mg orally for 6 months, whereas aspirin 100 mg was maintained. In addition, long-term statin therapy was prescribed in all patients. Other drugs were prescribed as clinically indicated.

Patients were then followed over 18 months for cardiac death, non-fatal MI, or symptom-driven TVR. Follow-up angiography was only allowed if clinically indicated to rule out angiography-driven TVR. These major cardiac events (MACE) were adjudicated by an independent Critical Events Committee blinded to the stent type used. Since TVR events related to MI may be clinically more significant and may have a different underlying mechanism than other TVRs, death and MI as ‘hard’ endpoints and TVR not related to these hard endpoints (i.e. non-MI-related TVR) were considered separately. Although MACE is the combination of these two endpoints, we included it in the present analysis as most reported endpoint in previous trials, reflecting in some way a ‘net clinical benefit’, as death/MI and TVR tend to develop in different directions long-term. Ten patients were alive and well but did not consent to follow-up questioning, whereas three had left the country and could not be located. Follow-up was censored in these patients at the time of last contact. Thus, follow-up was complete in 813 of 826 patients (98.4%).

All patients gave written informed consent. The study was approved by the Ethical Committee of the University of Basel, Switzerland.

Statistics
Data are presented as mean ± SD, median (interquartile range), or percentage as appropriate. Kaplan–Meier curves were used for the calculation of time-dependent occurrence of events. Both forward and backward stepwise conditional Cox-regression was used for multivariable analysis and for calculation of interaction of stent-type with patient- and lesion-specific factors. For inclusion of factors in the model, a probability of 0.05, and for exclusion a probability of 0.10 were used. In case of non-significant interactions, results of interaction terms in backward model prior to exclusion from the model are reported. Significant factors included in multivariable models did not differ between forward and backward model. In the case of time-dependence of proportional hazards, Cox-regression with time-dependent covariables was used. Statistical significance remained unchanged; nevertheless, time-dependence of covariables is reported if statistically significant. Results are expressed as hazard ratios (HR) with 95% confidence intervals (95% CI). A P-value < 0.05 was considered to be statistically significant.

First, DES vs. BMS were compared in relation to cardiac death/MI as well as non-MI-related TVR and MACE, followed by an exploratory subgroup analysis of the two DES used. Then, univariable predictors of these events were identified and predictors related to events (P < 0.1) were incorporated in multivariable Cox-regression. Interactions between stent type and patient and vessel characteristics were analysed using bivariable Cox-regression including interactions between the two co-variables. Finally, significant interactions derived from this analysis were tested in multivariable Cox-regression including significant predictors of events as well as interactions between stent type and patient and vessel characteristics. Based on significant interactions in multivariable analyses, subgroups of patient or vessel characteristics with most benefit from either stent type were identified. Factors tested for interactions with stent-type were selected based on previous reports suggesting particular benefit,16–24 the 6-month results of this study,8 and possible risk factors for events (as listed in Figure 2). In addition, patients were classified based on whether they received ‘on-’ or ‘off-label’ use of DES as recently defined by the FDA.25 All analyses were done with the use of the statistical package SPSS 14.0 for Windows.


   Results
Top
 Abstract
 Introduction
 Methods
 Results
Discussion
 Acknowledgements
 References
 
Patients enrolled in BASKET were at relatively high risk with ST-elevation MI and acute coronary syndrome in almost two-thirds, prior coronary disease manifestations in nearly 40%, multivessel disease in nearly 70%, and complex coronary lesions including chronic total occlusions, bifurcation, and bypass lesions. Baseline characteristics were well-balanced between the different stent groups apart from the off-label use,25 which was more common in the Cypher stent group (Table 1).


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  		Table 1 Baseline characteristics

 
Events in relation to stent type
Overall, event rates were low in all groups. 18-month rate of cardiac death/MI was 8.4% for DES and 7.5% for BMS (HR = 1.11; 95% CI 0.66–1.86; P = 0.70). There was, however, a reduced rate of non-MI-related TVR with DES of 7.5% compared with 11.6% with BMS (HR = 0.62; 95% CI 0.39–0.99; P = 0.05). This resulted in not significantly different MACE rates after 18 months: 15.8 vs. 18.9%, DES vs. BMS, respectively (HR = 0.81; 95% CI 0.57–1.14; P = 0.22). There were no significant differences in any of these events between the two DES used. The corresponding Kaplan–Meier survival curves are shown in Figure 1.


Figure 1
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  		Figure 1 Survival free of cardiac death or non-fatal MI (top), cumulative rate of non-MI-related TVR (middle), and survival free of MACE (bottom) in patients receiving BMS [Vision® (finely dashed grey line)] compared with those receiving DES [either Cypher® (continuous black line) or Taxus® (dashed black line) stents]. P < 0.05 only for TVR rate. BMS vs. DES, no significant difference between the two DES.

 
Uni- and multivariable predictors of events
Univariable predictors of events are depicted in Table 2, separated for cardiac death/MI, non-MI-related TVR, and MACE. Only three-vessel disease and to a lesser extent diabetes were predictors for all events. Cardiac death and MI were more predicted by age, severity, and complexity of coronary artery disease (CAD), and suboptimal angioplasty result, whereas non-MI-related TVR were more vessel/intervention-related. The only factor showing significant time-dependence of proportional hazards was bypass PCI for both non-infarction-related TVR and MACE. In multivariable analysis, three-vessel disease (HR = 3.02; P < 0.0001), type C lesion (HR = 1.81; P = 0.03), and right coronary artery (RCA) intervention (HR = 0.53; P = 0.03) were predictive for cardiac death/MI, but stent type was without influence. Independent predictors of non-MI-related TVR were bypass stenting (HR = 2.8; P = 0.001; proportional hazard significantly time-dependent), more than one segment treated (HR = 1.61; P = 0.04), and DES use (HR = 0.58; P = 0.02), whereas predictors of MACE were three-vessel disease (HR = 2.03; P < 0.0001) and diabetes (HR = 1.54; P < 0.03), but not stent type used.


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  		Table 2 Univariable predictors of events

 
Interactions between stent type and predictors of events
There were significant interactions between stent type and some of the patient or lesion characteristics, respectively (Figure 2). Thus, effects of DES on cardiac death/MI were favourable in patients > 65 years of age and stent size < 3.0 mm. Effects of DES on non-MI-related TVR were particularly evident in lesions exceeding 24 mm of length, in bypass graft angioplasty, in men, and in patients with previous angioplasty. Favourable effects of DES on MACE were primarily seen in patients without history of MI, with history of CABG, no need for GP IIb/IIIa inhibitors, receiving stents < 3.0 mm diameter, in lesions exceeding 24 mm of length, and in bypass graft PCI.


Figure 2
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  		Figure 2 Interactions of patient and lesion characteristics with stent-type used in bivariable Cox-regression model depicted as HR (95% CI) of interaction terms. Values to the right of the line of identity indicate a larger difference between DES and BMS if the factor was present; values to the left a larger difference if the factor was absent. For example, response to DES when compared with BMS was significantly larger if small vessels (i.e. < 3.0 mm) were treated with respect to death/MI as well as MACE. Black symbols indicate significant factors in multivariable analysis, diamonds indicate proportional, and quads indicate non-proportional hazards (for details see Methods section).

 
Overall, only the use of at least one small stent (<3.0 mm diameter) and bypass graft interventions showed significant interactions between stent type and two of the three event groups in multivariable analyses (i.e. death/MI, non-MI-related TVR, and MACE, respectively; Figure 2). Therefore, we analysed outcomes in patients with vs. without these two characteristics. There were 268 patients (32%), in whom small stents < 3.0 mm diameter were used or bypass grafts were treated, and 558 patients (68%) treated for large native vessels. Kaplan–Meier survival curves show the significant benefit of patients with small vessel or bypass graft angioplasty from DES use not only with regard to the rate of non-MI-related TVR, but also of cardiac death/MI and MACE (Figure 3). This contrasts with the lack of a difference in MACE rate and even in non-MI-related TVRs between the two stent types in large native vessel angioplasty; there was a small increased risk of cardiac death/MI late after the intervention by DES use in these latter patients.


Figure 3
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  		Figure 3 Comparison of BMS (dashed grey line) and DES (continuous black line) regarding cardiac survival free of non-fatal MI (top), cumulative rate of non-MI-related TVR (middle), and survival free of MACE (bottom) in patients with small stents < 3.0 mm or bypass grafts treated (left side) and in the other patients (right side; only stents ≥ 3.0 mm and no bypass PCI). Whereas all event rates were significantly lower with DES in the first group, this was not the case in the other group where even a late excess rate of cardiac death or non-fatal MI was noted. Proportional hazards were time-dependent for survival free of non-fatal MI, but effects remained statistically significant even after adjustment for this.

 

   Discussion
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
Acknowledgements
 References
 
This retrospective analysis of prospectively collected ‘real-world’ data indicates that high-risk patients, particularly those in need of stents < 3.0 mm or bypass graft stenting, seem to benefit from DES. However, this benefit applied only to one-third of this unselected patient population, whereas in the other two-thirds, no such clinical benefit was found. In fact, there was even the possibility of some late harm in these patients if treated with DES. These findings parallel those of a separate analysis of cost-effectiveness over the initial 6 months, where DES turned out to be most cost-effective in high-risk patient subgroups.8 Thus, it may be appropriate that only high-risk patients receive DES in current practice. This is the first prospective study of an unselected patient population allowing such an analysis, but proper prospective testing is necessary before these results may be used in clinical practice.

Previous subgroup analyses of DES vs. BMS in selected patient groups also suggested that high-risk patients may benefit most from DES. The presence of diabetes mellitus,16–18 small vessel size, or long lesions19–22,26 were identified as patient or lesion characteristics, where DES had most benefit. In the present study, diabetes mellitus and long lesions were risk factors for clinical events, too, but the beneficial effect of DES was not as prominent in these two subgroups of patients when compared with other characteristics as in other trials. For diabetics, this may have been due to their generally smaller vessels, which was a strong independent predictor of outcome, and due to silent restenosis that did not lead to symptom-driven TVR in this study. In addition, some smaller studies specifically addressing bypass graft PCI indicated a particular benefit of DES in these subsets.23,24 or restenotic lesions.27,28 However, these studies were performed in very selected patient groups with limited follow-up of up to 12 months with only few studies covering a follow-up exceeding 12 months.29–31 An analysis of a large registry using propensity scores for stent type used comparing DES with BMS concluded that only high-risk patients had a marked benefit from DES use,30 similar to the findings of the present analysis. However, this was not a randomized trial with a limited follow-up.

As recently reported, a large proportion of late cardiac death and non-fatal MI may be attributed to stent thrombosis,13 which seems to be accompanied by a high rate of death and MI.15,32 Meta-analyses after sirolimus-eluting or paclitaxel-eluting stent implantation showed no increase in stent thrombosis within the first year,33,34 but new long-term data from TAXUS35- and SIRIUS-trials36 point into the same direction as follow-up findings of BASKET15 indicating that longer clinical follow-up is necessary to fully assess the safety of DES. The present analysis suggests that there might be a particular risk for such late events in patients who received DES for large native vessel angioplasty.

There are important limitations to the findings of the present study, particularly since they are based on a retrospective analysis, although subgroup analyses of this prospectively collected data were planned a priori. In particular, such analyses tend to overestimate the true difference between risk groups. Therefore, this data puts up a hypothesis which will have to be studied in a prospective trial. Then, in a ‘real-world’ patient sample with a high rate of multi-vessel disease and a prolonged follow-up, not all events may be due to failures of the baseline treatment, but there may also be progression of other disease, which was deemed irrelevant at baseline. This aspect, which should be equally important in all patient groups in a randomized trial, cannot be ruled out without control angiography, which, on the other hand, would have interfered with the clinical ‘nature’ of the present study. Also, patient numbers for multiple subgroup analyses were relatively small, particularly in certain patient subsets such as those with bifurcation lesions or chronic total occlusions, leaving some room for chance findings. Infrequent subsets such as those mentioned above could still be identified as significant predictors of DES effect in larger studies. Finally, the third generation BMS used in BASKET were different from standard BMS used in other trials evaluating drug-coating effects, making direct comparisons difficult. However, for fair comparisons between DES and BMS, best available stent types should be used. Unfortunately, there is a lack of direct prospective comparisons of third generation cobalt–chromium with standard stainless steal BMS. Finally, the study was not powered to detect differences between sirolimus when compared with paclitaxel eluting stents, but there was not even a trend towards any relevant differences between these two DES in clinical events in this first comparative follow-up of 18 months published.

Despite these limitations, the findings of the present retrospective analysis may have important implications, because it challenges the notion that every patient should receive DES irrespective of today's baseline characteristics and labelling by authorities.25 In patients at low risk of clinically relevant restenosis and related events, the benefit of DES seems neglectable and there might be even a certain increased risk of late death/MI due to delayed healing. On the other hand, high-risk patients may benefit not only with reduced TVR rates but possibly also with a better survival without MI. Because of the retrospective nature of this analysis with the possibility of significant statistical bias, this may be seen as hypothesis only. To validate these findings, a prospective clinical trial is necessary and about to start with according risk stratification at baseline and longer clinical follow-up. The BASKET experience also highlights the fact that there is a great need for true prospective ‘real-world’ trials, comparing the best available DES with the best available BMS, because results may differ significantly from studies in selected patients.


   Acknowledgements
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Acknowledgements
References
 
This study was supported by the Basel Cardiovascular Research Foundation, Basel, and the University Hospital, Basel, Switzerland.

Conflict of interest: none declared.


   Footnotes
 
{dagger} BASKET/BASKET-LATE Hospitals and Investigators: Kaiser et al. (2005)8 Back


   References
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 Abstract
 Introduction
 Methods
 Results
 Discussion
 Acknowledgements
 References
 

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