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European Heart Journal Advance Access published online on June 13, 2008
European Heart Journal, doi:10.1093/eurheartj/ehn231
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Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2008. For permissions please email: journals.permissions@oxfordjournals.org

Two-year clinical outcomes after paclitaxel-eluting stent or brachytherapy treatment for bare metal stent restenosis: the TAXUS V ISR trial

Stephen G. Ellis1,*, Charles D. O'Shaughnessy2, Steven L. Martin3, Kenneth Kent4, Thomas McGarry5, Mark A. Turco6, Dean J. Kereiakes7, Jeffrey J. Popma8, Mark Friedman9, Joerg Koglin9, Gregg W. Stone for the TAXUS V ISR Investigators10

1 Department of Cardiovascular Medicine, Cleveland Clinic, 9500 Euclid Avenue, F25, Cleveland, OH 44195, USA
2 Elyria Memorial Hospital, Elyria, OH, USA
3 Nebraska Heart Institute, Lincoln, NE, USA
4 Washington Hospital Center, Washington, DC, USA
5 Oklahoma Heart Institute, Oklahoma City, OK, USA
6 Washington Adventist Hospital, Takoma Park, MD, USA
7 The Christ Hospital Heart and Vascular Center and The Lindner Research Center, Cincinnati, OH, USA
8 Caritas St Elizabeth Medical Center, Boston, MA, USA
9 Boston Scientific Corporation, Natick, MA, USA
10 The Cardiovascular Research Foundation, Columbia University Medical Center, New York, NY, USA

Received 7 November 2007; revised 26 March 2008; accepted 15 May 2008.

* Corresponding author. Tel: +1 216 445 6712, Fax: +1 216 445 6714, Email: elliss{at}ccf.org

See page 1595 for the editorial comment on this article (doi:10.1093/eurheartj/ehn068)


   Abstract
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Aims: This study sought to investigate the 2-year outcomes of patients treated with the paclitaxel-eluting TAXUS® stent (PES) or vascular brachytherapy (VBT), the previous ‘gold standard therapy’, for bare metal stent in-stent restenosis (ISR).

Methods and results: In the TAXUS V-ISR trial, 396 patients with bare metal stent ISR referred for percutaneous coronary intervention were prospectively randomized to either PES or beta source VBT. The present analysis reports 24-month clinical outcomes from that study. Between 9 and 24 months, ischaemia-driven target lesion revascularization tended to be required less frequently with assignment to PES compared to VBT (5.3 vs. 10.3%, P = .07). As a result, ischaemia-driven target lesion revascularization at 24 months was significantly reduced with PES compared with VBT (10.1 vs. 21.6%, P = 0.003), as was ischaemia-driven target vessel revascularization (18.1 vs. 27.5%, P = .03). There were no significant differences between the two groups with regard to death, myocardial infarction, or target vessel thrombosis either between 12 and 24 months, or cumulative to 24 months.

Conclusion: Freedom from clinical restenosis at 2 years is significantly enhanced after PES placement compared with VBT for bare metal stent ISR, with similar rates of death, myocardial infarction, and target vessel thrombosis.

Key Words: Drug-eluting stents • Brachytherapy • Restenosis


   Introduction
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Long-term clinical follow-up to assess late device risk and benefit is available for many subsets of patients receiving drug-eluting stents (DES).1–3 However, no study has reported late follow-up for patients receiving DES for the indication of bare metal in-stent restenosis (ISR). As the proportion of patients receiving bare metal stents (BMS) is rising following reports of late stent thrombosis with DES,4–7 this topic is of increasing importance. Moreover, given the different underlying pathology of de novo atherosclerotic lesions and bare metal ISR,8,9 the long-term vascular responses to DES may also vary. In this regard, vascular brachytherapy (VBT), the previously accepted gold standard therapy for bare metal ISR,10–13 is complicated by restenosis ‘catch-up’ and late stent thrombosis.14–18 These phenomena are not clearly related. Whether the same adverse responses apply to DES for bare metal ISR is unknown.

It is in this context that we examine the 2-year outcomes in patients randomized in the TAXUS V-ISR trial to either the paclitaxel-eluting TAXUS® stent (PES) or VBT to treat bare metal ISR.


   Methods
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Study population and protocol
The study design and 9-month results of the TAXUS V-ISR trial have been previously reported.19 Briefly, patients presenting with stable or unstable angina, or inducible ischaemia, undergoing percutaneous coronary intervention of a single bare metal ISR lesion in a native coronary artery were considered for enrolment and randomization between PES and any FDA-approved beta brachytherapy source. Patients were excluded for previous placement of an anti-restenotic DES in the target vessel, myocardial infarction within 72 h, haemorrhagic diatheses or contraindication to aspirin or thienopyridines, serum creatinine >2.0 mg/dL, possible pregnancy, limited life expectancy, vessel diameter <2.5 or >3.75 mm, or lesion length >46 mm. All patients signed informed consent and the protocol was approved by the institutional review board at all sites.

Telephone-transmitted randomization was performed before mandatory predilatation. Predilatation, using standard or cutting balloon angioplasty, brachytherapy, and/or stent placement was performed per clinical practice, with protocolization of some aspects of the procedure as previously described,19 including placement of the radiation train source length to include a margin of at least 5 mm beyond each end of the balloon injury zone and stent coverage of at least 3 mm of the adjacent angiographic normal reference segment.

All patients received 325 mg aspirin within 24 h prior to the procedure, with 81–325 mg of aspirin continued daily indefinitely. A loading dose of at least 300 mg clopidogrel was recommended >6 h before the procedure, to be followed by 75 mg/day for at least 6 months in all patients and a minimum of 12 months in patients receiving new stents prior to or after brachytherapy. Clinical follow-up was scheduled at 9 months, and annually for 5 years. Follow-up angiography was scheduled for all patients at 9 months.

Data management and statistical methods
Independent study monitors verified all case report form data from on site. Major adverse cardiac events and stent thromboses were adjudicated on the basis of original source documentation by an independent committee masked to treatment allocation. All safety and efficacy analyses were performed using intention to treat allocation, while endpoints after 9 months were analysed excluding patients who did not receive a study treatment at index procedure. The primary study endpoint was 9-month incidence of ischaemia-driven target vessel revascularization (TVR), as previously defined.19 Target vessel thrombosis was defined as an acute coronary syndrome with angiographic documentation of either vessel occlusion or thrombus within the target vessel, or in the absence of angiographic confirmation, either acute myocardial infarction in the distribution of the treated vessel or cardiac death within 30 days.2 Time-independent comparisons were made using Student's t-test for means, and the {chi}2 test or Fisher's exact test for categorical variables, as appropriate. For 9–24-month binary event rates, missing outcome data were not imputed for patients who were followed for less than 285 days without any known MACE. To account for censoring, cumulative 24-month event rates were calculated using the Kaplan–Meier method for time to event data and compared using the log-rank test. A significance level of 0.05 was used and tests were two-sided. The principal investigators had unrestricted access to the database. This manuscript was prepared by the co-principal investigator (S.G.E.) and revised after co-author review. All statistical analyses were performed with SAS software version 8.2 (SAS Institute Inc., Cary, NC, USA).


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Baseline characteristics and procedural outcomes
Three hundred and ninety-six patients with bare metal ISR were randomly assigned to treatment with either VBT (n = 201) or PES (n = 195) between 6 June 2003 and 16 July 2004. Baseline characteristics are presented in Table 1 and are notable for a high incidence of diabetes mellitus and relatively long ISR lesions. The two groups were well matched, although there was a higher incidence of insulin-requiring diabetes and diffuse lesions in the PES group. Patient flow is described in Figure 1. Initial procedural outcomes are shown in Table 2. VBT was successfully delivered in 191 patients (95.0%), all of whom received a beta source with median radiation activity of 87.8 mCi [interquartile range (IQR) 52.8–167.0]. Of patients randomized to paclitaxel-eluting stents, 191 (97.9%) had a study stent successfully delivered.


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  		Table 1 Baseline characteristics19

 

Figure 1
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  		Figure 1 Patient recruitment, treatment, and follow-up.

 

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  		Table 2 Procedural results19

 
Summary of clinical outcomes at 9 months
As reported previously,19 ischaemia-driven TVR through 9 months occurred in 17.5% of patients randomized to VBT and 10.5% of patients randomized to the PES (P = .046). Similarly, ischaemia-driven target lesion revascularization (TLR) through 9 months was reduced with PES compared to brachytherapy (6.3 vs. 13.9% respectively, P = .01). There were no between-group differences with regard to death, myocardial infarction, or target vessel thrombosis through 9 months.

Clinical outcomes through 24 months
Aspirin use at 12 months in the PES group was 185/188 (98.4%) and 189/191 (99.0%) in the brachytherapy group (P = 0.68) and at 24 months in the PES group was 172/180 (95.6%) and 176/182 (96.7%) in the brachytherapy group (P = 0.57). Similarly, clopidogrel use at 12 months in the PES group was 147/188 (78.2%) and 151/191 (79.1%) in the brachytherapy group (P = 0.84) and at 24 months in the PES group was 114/180 (63.3%) and 124/181 (68.5%) in the brachytherapy group (P = 0.30).

Clinical endpoints through 24 months are presented in Tables 3 and 4 and Figures 2 and 3. As shown in Figure 1, 95.3% of patients in each group were available for late follow-up. By 24 months, the primary study endpoint of ischaemia-driven TVR had occurred in 27.5% of patients randomized to brachytherapy and 18.1% of patients randomized to PES (P = .031). Similarly, ischaemia-driven TLR was significantly reduced at 24 months in patients assigned to PES rather than VBT (10.1 vs. 21.6% respectively, P = 0.003). This reflects a continued separation in the TLR curves between 9 and 24 months (10.3% events with brachytherapy vs. 5.3% with PES, P = 0.07). Between 12 and 24 months, there was a significant reduction in the rate of TLR (8.1 vs. 2.2%, P = 0.009) and a numerical reduction in TVR (9.2 vs. 4.8%, P = 0.10) with PES compared to brachytherapy (Figure 3).


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  		Table 3 Time-to-event analyses of clinical outcomes through 24 months

 

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  		Table 4 Binary event rates of clinical outcomes between 9 and 24 months

 

Figure 2
Figure 2
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  		Figure 2 Comparative safety of paclitaxel-eluting stents and vascular brachytherapy after treatment of bare metal in-stent restenosis. (A) Upper panel: freedom from cardiac death. (B) Lower panel: freedom from myocardial infarction. (C) Upper panel, following page: freedom from death or myocardial infarction. (D) Lower panel, following page: freedom from target vessel thrombosis.

 

Figure 3
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  		Figure 3 Comparative efficacy of paclitaxel-eluting stents and vascular brachytherapy after treatment of bare metal in-stent restenosis. (A) Upper panel: freedom from target vessel revascularization. (B) Lower panel: freedom from target lesion revascularization.

 
As seen in Figure 2, there were no significant differences in the rates of death or myocardial infarction between the two groups (Figures 2–4). By 24-month follow-up, protocol-defined target vessel thrombosis had occurred in seven brachytherapy patients (3.8%) and five PES patients (2.7%), P = 0.56. Very late thrombotic events (between 9 months and 2 years) occurred in two patients assigned to PES and in two patients assigned to brachytherapy. All four of these patients were on aspirin at the time of the event. One patient from the TAXUS arm and one from the Brachytherapy arm were also on Clopidogrel at the time of the event. The remaining Brachytherapy patient was not on Clopidogrel and the other TAXUS patient's Clopidogrel status is unclear. Rates of major adverse cardiac events (19.7 vs. 29.5%, P = 0.03) and target vessel failure (19.7 vs. 29.0%, P = .04) were significantly reduced with PES compared to brachytherapy at 2 years.

Of the 18 patients with TLR after PES, five then underwent bypass surgery and 13 underwent a variety of other percutaneous treatments. Of the latter, five received another revascularization treatment at the same site later within the follow-up period.


   Discussion
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Prior to the advent of DES, VBT was demonstrated to provide superior clinical outcomes compared to other percutaneous treatment modalities for the treatment of bare metal ISR, particularly in terms of prevention of repeat restenosis.10–13 More recent randomized trials have shown that the use of either PES or sirolimus-eluting stents is superior to VBT as measured by 9-month clinical outcomes.19,20 Concern, however, has arisen about late adverse outcomes both after VBT and DES placement. This study is the first to report comparative 2-year outcomes between these therapies when they are utilized to treat bare metal ISR. This analysis is particularly important given the recent increase in the utilization of BMS due to concerns about the late thrombotic risk of DES.

The principal finding of this follow-up analysis through 2 years after randomization is that placement of PES for the treatment of restenosis after BMS implantation yields freedom from subsequent ischaemic TLR and TVR that is superior to brachytherapy. Notably, TLR was required infrequently between 1 and 2 years after PES (2.2%), whereas such events continued to accumulate in patients assigned to VBT (8.1%, P = 0.009). Thus, the efficacy of PES in preventing restenosis relative to brachytherapy is enhanced with continuing long-term follow-up, due largely to mitigation of the restenosis ‘catch-up phenomenon’ described after radiation therapy. Teirstein et al., 15 describing their use with the gamma emitter 192-Ir, reported a continued late loss of 0.37 mm between 6 months and 3 years in a small cohort of patients, and in the same group a 3.9% need for TLR between years 1 and 2 after treatment, as well as a further 7.7% incidence of TLR between years 2 and 5.15,16 Similar results have been reported by Waksman et al.17 and Leon et al.18 Comparability of gamma and beta radiation in this context has also been suggested,21 although not proven through randomized clinical trials.

The long-term freedom from revascularization after 1 year with PES in the present study also demonstrates that despite the fact that restenotic lesions are typically far more cellular than de novo lesions and hence might be expected to behave in a different fashion after PES placement, the 12–24-month clinical outcomes after stenting for restenotic and de novo lesions appear similar (2.2% ischaemic TLR in this study compared with 1.4 and 2.6%, in the TAXUS IV and TAXUS V studies, respectively).6

Longer-term follow-up (planned for 5 years) is required to determine whether this difference is sustained, continues to grow, or narrows.

The second major observation is the relative safety of the two treatment modalities, while acknowledging limited power to detect low frequency events. There was no difference in the long-term rates of death, myocardial infarction, or target vessel thrombosis with the two therapies. Notably, two patients in each group (~1%) developed late target vessel thrombosis between 9 and 24 months despite continuation of thienopyridines to 2 years in approximately two thirds of patients. Thus, late thrombosis after treatment of bare metal ISR, a problem initially described with VBT,22 also occurs with PES. The relatively modest number of patients in this study precludes answering the question as to whether or not the risk in this setting is increased compared to treating the de novo lesions.23

There are several limitations which should be borne in mind when interpreting these data. First, since follow-up angiography was required by the protocol, TLR rates are likely higher than they would have been in routine clinical practice,24 hence the difference in that endpoint between DES and brachytherapy may be somewhat exaggerated. This is a common problem for current FDA pivotal approval trials.1–3 Second, while the study is adequately powered to detect differences in the primary study endpoint, it lacks sufficient patient numbers to study infrequently occurring events, such as target vessel thrombosis, myocardial infarction, and death. Third, it is somewhat limited due to patient entry criteria, specifically excluding patients with multiple ISR, very long lesions, or restenosis after DES. Fourth, there are some data suggesting that modestly better long-term clinical outcomes after brachytherapy might have been achieved using higher doses,25 although brachytherapy is no longer widely clinically available, making it highly unlikely that this strategy will ever be tested against DES. Finally, the stent and vessel thrombosis data reported utilize protocol-based definitions, and have not been re-adjudicated by other definitions.26

In conclusion, the present study supports the use of PESs to treat bare metal stent ISR based upon clinical data with 2-year safety and efficacy outcomes, extending upon previous 9-month data. Indeed, the freedom from clinical restenosis, and consequently MACE and TVF appear to be increasingly in favour of PES. Given the logistical complexities of VBT and late adverse effects, DES are now considered front-line therapy for most patients with bare metal ISR, especially when diffuse (although other treatment modalities such as paclitaxel-coated balloon treatment27 warrant further study). However, late thrombotic events with DES have not been eliminated, and further study is required to determine the optimal duration of dual antiplatelet therapy administration after DES treatment for bare metal ISR, and alternative approaches to limit this serious complication.

Conflict of Interest: The authors wish to declare the following conflicts of interest: Boston Scientific Research Grant (J.J.P.); Boston Scientific Consultant/Advisory Board (S.G.E. and G.W.S.); Boston Scientific Employment (M.F. and J.K.); Boston Scientific Speakers Bureau (M.A.T).


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Boston Scientific Corporation, Natick, MA, USA.


   References
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