CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY
Periprocedural and Late Consequences of Overlapping Cypher Sirolimus-Eluting Stents
Pooled Analysis of Five Clinical Trials
Dean J. Kereiakes, MD, FACC*,*,
Hong Wang, MD, MPH ,a,
Jeffrey J. Popma, MD ,
Richard E. Kuntz, MD,d,
Dennis J. Donohoe, MD,a,
Joachim Schofer, MD ,
Erick Schampaert, MD||,
Bernhard Meier, MD, FESC, FACC¶,b,
Martin B. Leon, MD, FACC#,c and
Jeffrey W. Moses, MD, FACC#
* Heart Center of Greater Cincinnati and the Lindner Center for Research and Education at The Christ Hospital, Ohio Heart and Vascular Center Inc., Cincinnati, Ohio
Cordis Corp., Warren, New Jersey
Brigham and Women’s Hospital, Boston, Massachusetts
Hamburg University Cardiovascular Center, Hamburg, Germany
|| Hospital du Sacre’-Coeur de Montreal, Montreal, Canada
¶ Swiss Cardiovascular Center Bern, Bern, Switzerland
# Columbia University Medical Center, New York, New York
Manuscript received September 16, 2005;
revised manuscript received January 25, 2006,
accepted February 17, 2006.
* Reprint requests and correspondence: Dr. Dean J. Kereiakes, The Heart Center of Greater Cincinnati and The Lindner Center for Research and Education at the Christ Hospital, 2123 Auburn Avenue, Suite 424, Cincinnati, Ohio 45219. (Email: lindner{at}fuse.net).
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Abstract
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OBJECTIVES: The purpose of this research was to determine the relative safety and efficacy of multiple ( 2) overlapping Cypher sirolimus-eluting stents (SES) (Johnson & Johnson, New Brunswick, New Jersey).
BACKGROUND: Overlapping coronary stents are common. The periprocedural and late clinical and angiographic consequences of overlapped coronary stents are not clearly defined, particularly for drug-eluting stents.
METHODS: All patients enrolled into five clinical trials of the SES were analyzed. Three of these trials were prospective randomized comparisons of the SES to the bare-metal stent (BMS), and two were prospective non-randomized trials of SES-treated patients with historical controls. All clinical and angiographic outcomes in overlap-stent–treated patients were compared by stent type and with single-stent–treated patients for the same stent device.
RESULTS: In all, 575 patients with stent overlap (337 SES, 238 BMS) and 1,162 patients with single stents (697 SES, 465 BMS) were analyzed. Stent overlap was associated with a greater late lumen loss in stent and more frequent angiographic restenosis regardless of stent type. Among overlap-stent–treated patients, the SES provided similar magnitude of restenosis benefit as observed for single-stent–treated patients. Overlapped SES was not associated with an increase in myocardial infarction.
CONCLUSIONS: The strategy of SES overlap, when required, is both safe and efficacious in reducing restenosis with no increase in the incidence of myocardial infarction or major adverse cardiovascular events, when compared with a bare metal coronary stent prosthesis.
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Abbreviations and Acronyms
| | BMS = bare-metal stent | | CK = creatine kinase | | MACE = major adverse cardiovascular events | | PES = paclitaxel-eluting stent | | QCA = quantitative coronary angiography | | SES = sirolimus-eluting stent | | SIRIUS = Sirolimus-Eluting Stent in Coronary Lesions trial |
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The implantation of multiple (2) overlapping coronary stents may be prompted by excessive target lesion length, incomplete lesion coverage, and/or endoluminal injury requiring additional stent scaffolding beyond the margins of the initial stent deployed. Furthermore, multiple overlapping stents may be required to repair extensive or spiral coronary dissection. Stent strut overlap has been incriminated both as a stimulus to neointimal hyperplasia and as a correlate to late angiographic restenosis in man (1–4). However, the relative contribution(s) of target lesion length, total stented segment length, and number of stents deployed per target lesion (stent overlap) toward the occurrence of periprocedural major adverse cardiovascular events (MACE) and/or late angiographic restenosis have been the subject of debate (5–10). Specifically, the role of stent overlap as an independent determinant of restenosis is unclear. Recently, concern has been raised by the observation of an increased incidence of periprocedural myocardial infarction after overlap of the paclitaxel-eluting TAXUS stent (Boston Scientific, Marlborough, Massachusetts) (11–13). As the currently available drug-eluting stent platforms differ considerably in metal platform design, polymer and active pharmacologic agent, the extent to which the observations made after TAXUS stent overlap may be extrapolated to the Cypher sirolimus-eluting stent (SES) (Johnson & Johnson, New Brunswick, New Jersey) is unknown. The purpose of the present study was to determine if the deployment of multiple, overlapping SES is associated with an excess of major adverse clinical events (especially myocardial infarction) and/or angiographic restenosis when compared with bare-metal stent (BMS) treatment.
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Methods
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All patients enrolled into five clinical trials of the SES who received multiple overlapped stents or single stent were analyzed (14–19). The individual trials as well as the numbers of patients treated with single versus multiple overlapped SES or bare metal (control) stents are shown in Table 1. All trials specified single target vessel treatment and allowed for the use of more than one stent per target lesion. Stents of 2.5 mm, 3.0 mm, and 3.5 mm diameter as well as 8.0 and 18.0 mm length were available for each trial. All trials had pre-specified clinical and angiographic follow-up as well as similar pre-specified analyses of serial cardiac enzymes and electrocardiograms. Cardiac enzymes (creatine kinase [CK] and CK-MB) were obtained 6 to 8 h, 12 to 16 h, and 18 to 24 h after the procedure or before hospital discharge. The 12-lead electrocardiogram (ECG) was obtained before and within 24 h after the procedure or at the time of hospital discharge (whichever came first). The diagnosis of Q-wave myocardial infarction was defined as the development of new, pathological Q waves in two or more continuous leads (as assessed by the ECG core laboratory) with post-procedure CK or CK-MB levels elevated above normal. The diagnosis of non–Q-wave myocardial infarction required elevation of post-procedure CK levels to greater than two times normal with elevated CK-MB in the absence of new pathological Q waves. All MACE were adjudicated by independent clinical events committees. Three of the trials (SIRIUS [Sirolimus-Eluting Stent in Coronary Lesions], E-SIRIUS [Sirolimus-Eluting Stents for Treatment of Patients With Long Atherosclerotic Lesions in Small Coronary Arteries], C-SIRIUS [Canadian Study of the Sirolimus-Eluting Stent in the Treatment of Patients with Long De Novo Lesions in Small Native Coronary Arteries]) were prospective, randomized controlled comparisons of the SES to the bare metal Bx Velocity stent (BMS) (Cordis/J&J, Miami Lakes, Florida), and two (DIRECT [Direct Stenting Using the Sirolimus-Eluting Stent], SVELTE [A multicenter, non-randomized, historical controlled study in patients with de novo native coronary artery lesions in Small VessELs treated with the Cypher sTEnt]) were prospective non-randomized trials of SES-treated patients with historical controls. These non-randomized trials were performed with rigorous protocol adherence, clinical event committee adjudication of all MACE as well as data and safety monitoring boards. The non-randomized historical control groups from these trials were not included in this analysis. To avoid bias caused by using non-randomized trial data, additional analyses were performed including examination of patient baseline clinical and angiographic characteristics as well as study impact on all major end points for patients enrolled in all five trials with a similar analysis of those patients enrolled into the three randomized trials. The results of these additional analyses (data not shown) demonstrate that patient baseline characteristics were similar for all five trials and that study was not a significant confounder for any major end point. A separate analysis confined to the three randomized trials provides results that are similar to the pooled five trial analysis with no change in any conclusion drawn (). In all trials, the overlapping stent subgroup was determined by both clinical site as well as independent quantitative coronary angiographic (QCA) core lab analysis. Standard QCA definitions for "in-stent" (within the stented segment only) and "in-lesion" (stented segment plus 5 mm proximal and distal margins) were employed for measurements of late lumen loss and binary angiographic restenosis. Patients who were treated with multiple, non-overlapping stents in the same target vessel were not included in the present analysis.
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Table 1. Individual Trials As Well As the Numbers of Patients Treated With Single Versus Multiple Overlapped SES or BMS (Control)
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Statistical methods.
Summaries of mean and SD for each treatment group are reported. For analysis of continuous variables, a two sample t test was conducted for comparison of treatment difference, and both t test p value as well as 95% confidence intervals of the mean difference are reported. The homogeneity of the variance was tested. For categorical variables, Cochran-Mantel-Haenszel statistics were employed, and the mean difference as well as 95% confidence intervals and Fisher exact test p values are reported. A univariate and multivariable predictor analysis using logistic regression in-stent binary restenosis was performed. The predictors were chosen by stepwise procedure criteria using an entry criterion of 0.20 with a stay criterion of 0.10 in the multiple logistic regression model.
All statistical analyses were performed using SAS Version 8.2 (SAS Institute, Cary, North Carolina). In the multiple comparisons of QCA and clinical end points among the subgroups by treatment and overlap stent or single stent use, Bonferroni adjusted significance level of 0.0125 (0.05/4) were applied. For any other comparisons, a statistical significance level of 0.05 was used.
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Results
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Baseline clinical and angiographic demographic variables for patients treated with either single or overlapped SES as well as BMS controls are shown in Table 2. The only significant clinical difference observed between stent overlap patient cohorts was a higher incidence of systemic hypertension in SES treated patients. The only significant clinical difference observed between single-stent–treated patient cohorts was a more frequent history of smoking in SES-treated patients. All other clinical variables were similar between single versus overlap or SES versus BMS-treated patient groups. Baseline quantitative coronary angiographic and procedural variables are shown in Table 3. Baseline angiography was similar in overlap-stent–treated patient cohorts except for more frequent moderate or severe vessel tortuosity in BMS-treated patients. Procedural variables were similar for overlap stent-treated patients except for a greater total stent-length-to-lesion-length ratio determined by QCA in SES-treated patients. The length of overlapped stent segment (mean ± SD) by QCA was assessed only in the SIRIUS trial and was 4.6 ± 9.1 mm for SES, 4.0 ± 4.9 mm for BMS. Quantitative coronary angiographic variables post-procedure and at 8-month follow-up are shown in Table 4. Stent overlap (vs. single-stent deployment) was associated with a significant increase in both in-stent and in-lesion binary angiographic restenosis for patients treated with BMS (p < 0.001). Conversely, SES overlap (vs. single SES) was not associated with a significant difference in in-lesion restenosis (8.9 vs. 5.8%, respectively; p = 0.1314), although in-stent restenosis was increased (6.2 vs. 1.7%, respectively; p = 0.0016). Similarly, although late lumen loss in-stent was increased by stent overlap regardless of stent type (SES or BMS), in-lesion late lumen loss did not differ significantly between overlap and single SES-treated patients. Late lumen loss in-stent, as well as in the proximal and distal stent margin segments, is illustrated by stent type and overlap status in Figure 1. After multivariable analysis with adjustments for lesion length and implanted total stent length, no differences in late lumen loss in-stent were observed for either SES- or BMS-treated patients stratified by overlap status.
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Table 3. Baseline Pre-Procedural Quantitative Coronary Angiographic and Procedural Variables by Stent Type and Stent Overlap Status
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Table 4. Post-Procedure and Late (8-Month) Quantitative Coronary Angiography by Stent Type and Stent Overlap Status
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Figure 1 Late lumen loss by quantitative coronary angiography stratified by stent type, overlapped stent status, and region of interest. BMS = bare-metal stent; SES = sirolimus-eluting stent.
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Major adverse cardiovascular events to 30 days and 1 year after stent deployment by stent type and overlap status are shown in Table 5. At 1 year, a significant increase in MACE and target lesion revascularization (p < 0.001) was observed for overlapped BMS but not SES stents. Furthermore, among overlap stent-treated patients, no difference in total myocardial infarctions (both Q-wave and non–Q-wave) to either 30 days or 1 year (Figs. 2A to 2C) was observed by stent type or total implanted stent length. Although both late target vessel revascularization and target vessel failure were increased in stent-overlap–treated patients regardless of stent type, SES overlap was less frequently associated with these adverse events than was BMS overlap (Fig. 3). Further analysis of late binary angiographic and clinical restenosis (Fig. 4) by stent type and overlap (vs. single stent) status demonstrates a significant benefit for restenosis reduction in favor of the SES.
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Figure 2 (A) Total myocardial infarction (MI) (both Q- and non–Q-wave) by stent type (bare-metal stents [BMS], n = 238; sirolimus-eluting stent [SES], n = 337) in patients treated with overlapping stents. (B) Incidence of total MI at 30 days by stent type stratified by total implanted stent length. (C) Total MI at 360 days by stent type stratified by total implanted stent length. Solid bars = BMS; open bars = SES.
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Figure 3 Target lesion revascularization (TLR) and target vessel revascularization (TVR) through 360 days as well as target vessel failure (TVF) (composite occurrence of death, myocardial infarction, and TLR) stratified by stent type in patients treated with overlapping stents. BMS = bare metal stent; SES = sirolimus-eluting stent.
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Figure 4 In-stent binary (>50%) angiographic restenosis (A) and target lesion revascularization (B) stratified by stent type and overlap (vs. single) stent status. *p < 0.0001 for comparisons sirolimus-eluting stent (SES) versus bare-metal stent (BMS) and BMS overlap versus single stent; p = 0.0016 for SES overlap versus single stent. p < 0.0001 for comparisons SES versus BMS; p = 0.0006 BMS overlap versus single stent; p = NS SES overlap versus single stent. Solid bars = BMS; open bars = SES.
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Both univariate and multivariate predictors of in-stent binary angiographic restenosis were analyzed. After adjustment for covariates of total stent length implanted and target lesion length, stent overlap (vs. single stent) was a significant predictor of in-stent restenosis only for BMS (but not SES) treated patients (Table 6).
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Discussion
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The scenario of stent overlap necessitated by excessive target lesion length, incomplete target lesion coverage, or stent marginal dissection may complicate up to one-third or more of coronary stent procedures (15–19). The relative importance of stent metal overlap as a stimulus for neointimal proliferation versus the efficacy of stent-based drug elution to suppress neointimal growth has not been adequately defined (20). Furthermore, as the potential for both early periprocedural and late toxicity related to overlapped drug-eluting stents may be derived from the specific metal platform, polymer, or pharmacologic agent utilized, it is important to carefully analyze all clinical and angiographic outcomes in these patients for each available device. This study provides novel insights into coronary stent overlap for both BMS and SES. The major observations derived from this study include: 1) BMS overlap is associated with an increased incidence of myocardial infarction and total MACE that was not apparent for SES overlap; 2) both BMS and SES overlap are associated with a greater degree of late lumen loss, as well as more frequent angiographic in-stent binary restenosis; 3) clinical restenosis (target lesion revascularization) was increased by stent overlap for BMS but not SES-overlap–treated patients; and 4) among stent-overlap–treated patients, SES was associated with a marked reduction in the frequency of both angiographic and clinical restenosis with no difference in the occurrence of periprocedural or late myocardial infarction when compared with BMS-treated patients. Thus, stent overlap is associated with neointimal proliferation and subsequent late lumen loss regardless of stent type. Although both angiographic and clinical restenosis are increased after stent overlap regardless of stent type, polymer-based stent elution of sirolimus is effective in reducing the frequency of restenosis and provides the same magnitude of restenosis benefit in overlap as observed for single-stent–treated patients.
Safety of overlapping stents.
Recent reports have raised concerns regarding safety after the practice of stent overlap with currently available drug-eluting stents. Indeed, the cumulative effect of "double-dose" metal, polymer, and drug was specifically discouraged by protocol in the pivotal TAXUS-IV trial of the TAXUS paclitaxel-eluting stent (PES) (Boston Scientific). In the TAXUS-V (12,13) and -VI (14) trials, which compared the PES in a randomized fashion with the bare metal EXPRESS stent (Boston Scientific) platform for the treatment of patients with longer target lesion lengths, stent overlap was required in an appreciable portion of subjects. Recent analyses from these trials have reported an increased incidence of periprocedural myocardial enzyme elevation in patients treated with PES overlap when compared with those who received overlapping EXPRESS stents. A post-hoc exploratory angiographic analysis has suggested that a reduction in side branch flow in PES overlap stent-treated patients may explain these observed differences in periprocedural infarction (21). As the metal platforms are similar between the PES and EXPRESS stent prostheses, any observed difference in the occurrence of myocardial infarction not attributable to chance variability alone must relate to the specific polymer and/or pharmacologic agent disposed on the PES. Furthermore, the issue of whether or not an increased incidence of periprocedural infarction also complicates overlap of non-PES polymer-based drug-eluting stents has not been defined. In this regard, the fact that no increase in the incidence of myocardial infarction at either 30 days or 1 year was observed in the present study of patients treated with overlapped SES is in contrast with the results of the TAXUS-V and -VI trials. If periprocedural infarction related to stent overlap is associated only with PES (but not SES) when directly compared with their respective BMS counterparts, differences in polymer thickness or viscoelastic properties, as well as pharmacologic agent must be explored. Both coating weight and thickness differ between the PES Translute (Boston Scientific) (1,227 and 18 µm, respectively) and the SES EVA-BMA (SurModics, Minneapolis, Minnesota) (600 and 10 µm, respectively) polymers (22,23). For example, Translute demonstrates polymer "webbing" on in-vitro PES deployment (24), a phenomenon not observed with the EVA-BMA polymer-coated SES. Although differences in endoluminal histology have been reported between overlapped PES and SES in a porcine model (24,25), what specific effects are attributable to polymer versus pharmacologic agent (paclitaxel vs. sirolimus) (26) and the proposed mechanisms by which these histologic differences may be temporally related to infarction remain unclear. Finally, although data are limited, neither PES nor SES overlap appear to be associated with late angiographic stent malapposition or aneurysm formation by either QCA or intravascular ultrasound (12,13,27,28).
Stent overlap and neointimal proliferation.
An important observation of this study is the association between stent overlap and neointimal proliferation for both SES and BMS. For both stent platforms, late quantitative coronary angiographic measurements in-stent demonstrate that minimum lumen diameter was significantly less, while percent diameter stenosis, late lumen loss, and binary angiographic restenosis were significantly greater in overlapped versus single stents. Nevertheless, the relative magnitude of restenosis reduction observed in patients treated with single SES versus BMS was maintained in the comparison of overlap stent-treated patients. Thus, polymer-based elution of sirolimus appears to be effective in reducing the enhanced degree of neointimal proliferation and late lumen loss observed in overlapped stents. Of note, after multivariable regression analysis with adjustments for total stent length deployed and target lesion length, stent overlap remained a predictor of in-stent restenosis for BMS but not SES.
Stent thrombosis.
Although both stent length (29) and stent overlap (30) have been incriminated as being associated with an increased incidence of drug-eluting stent thrombosis, no such relationship was identified in the current study despite complete follow-up to one year in all subjects. Combination oral antiplatelet therapy with aspirin and clopidogrel was mandated by study protocol for only three months for the trials included in this analysis. Although concerns that stent overlap might increase the likelihood of subsequent stent strut malapposition, and thus the propensity for thrombosis, late follow-up (to 1,080 days) from the cumulative experience in four randomized comparative trials of SES versus BMS demonstrates no evidence for an increase in stent thrombosis (M. Leon, personal communication, May 2005). Similarly, no evidence for an increase in localized aneurysm formation at the overlap segment was observed by quantitative angiography in the current study or by intravascular ultrasound in previous reports (31,32).
MACE related to stent overlap.
Although stent overlap was associated with an increase in total MACE to both 30 days and 1 year for BMS-treated patients, no increase in MACE was observed in patients who received overlapping SES. The major differences between patients treated with overlapping stents by stent type were in the frequency occurrence of target lesion and target vessel revascularization, as well as target vessel failure (increased in BMS- vs. SES-treated cohorts).
Study limitations.
The major limitation of the present analysis, which compares patients treated with overlapping stents, is that the decision to deploy stents in an overlapping fashion was not randomly assigned. However, the factors prompting overlapping stent deployment were not predictable in the majority of cases, and the portion of patients who required stent overlap was similar between SES- and BMS-treated patients among those enrolled into randomized comparative trials. Furthermore, the present study represents the largest experience to date for patients with overlapping coronary stents that includes complete angiographic and late clinical follow-up. In addition, although data from both randomized and non-randomized trials were pooled for this report, separate detailed analyses demonstrated all clinical and angiographic end points to be similar between the three randomized trials and all five trials (). Of note, patients enrolled into all five trials had similar baseline clinical and angiographic characteristics.
Conclusions.
This analysis of patients with overlapping SES or BMS platforms demonstrates that stent overlap is a stimulus for neointimal proliferation and late lumen loss with subsequent restenosis regardless of stent type. Stent-based polymer elution of sirolimus is effective in suppressing neointimal hyperplasia and provides a similar degree of restenosis benefit when compared with BMS in both overlapped and single-stent–treated patient cohorts. Sirolimus-eluting stent overlap is not associated with an increased incidence of myocardial infarction or MACE in late follow-up when compared with either single SES-treated patients or with patients treated with single or overlapped BMS. Thus, the strategy of SES overlap, when required, is both safe and efficacious in reducing restenosis in comparison with a BMS prosthesis. Careful attention should be paid to achieve optimal stent deployment in those cases where stent overlap is required.
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Appendix
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For the analysis of key independent and response variables in SIRIUS, C- SIRIUS, and E- SIRIUS trials, please see the online version of this article.
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Footnotes
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a Drs. Wang and Donohoe are Cordis employees. Cordis research grants were used to pay for the angiographic analysis for the study. 
b Dr. Meier’s institution, the Swiss Cardiovascular Center Bern, receives unconditional grants from Cordis, J&J, and Boston Scientific.
c Dr. Leon has common stock in Cordis, is a consultant, and receives research grants.
d Since the writing of this manuscript, Dr. Kuntz has now become an employee of Medtronic Inc.
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References
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J. Am. Coll. Cardiol.,
March 23, 2010;
55(12):
1178 - 1188.
[Abstract]
[Full Text]
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F. Mangiacapra, B. De Bruyne, O. Muller, C. Trana, A. Ntalianis, J. Bartunek, G. Heyndrickx, G. Di Sciascio, W. Wijns, and E. Barbato
High Residual Platelet Reactivity After Clopidogrel: Extent of Coronary Atherosclerosis and Periprocedural Myocardial Infarction in Patients With Stable Angina Undergoing Percutaneous Coronary Intervention
J. Am. Coll. Cardiol. Intv.,
January 1, 2010;
3(1):
35 - 40.
[Abstract]
[Full Text]
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A. Caixeta, P. Genereux, G. Dangas, and R. Mehran
Chapter 28 In-stent restenosis in the drug-eluting stent era
Oxford Textbook of Interventional Cardiology,
January 1, 2010;
1(1):
med-9780199569083-chapter - med-9780199569083-chapter.
[Abstract]
[Full Text]
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D. E. Drachman
Drug-Eluting Stents in Animals and Patients: Where Do We Stand Today?
Circulation,
July 14, 2009;
120(2):
101 - 103.
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Effect of length and diameter of drug-eluting stents versus bare-metal stents on late outcomes.
Circ Cardiovasc Interv,
February 1, 2009;
2(1):
35 - 42.
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J. E. Tcheng, I. H. Lim, S. Srinivasan, J. Jozic, C. M. Gibson, J. C. O'Shea, J. A. Puma, and D. I. Simon
Stent Parameters Predict Major Adverse Clinical Events and the Response to Platelet Glycoprotein IIb/IIIa Blockade: Findings of the ESPRIT Trial
Circ Cardiovasc Interv,
February 1, 2009;
2(1):
43 - 51.
[Abstract]
[Full Text]
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K. E. Kip, K. Hollabaugh, O. C. Marroquin, and D. O. Williams
The Problem With Composite End Points in Cardiovascular Studies: The Story of Major Adverse Cardiac Events and Percutaneous Coronary Intervention
J. Am. Coll. Cardiol.,
February 19, 2008;
51(7):
701 - 707.
[Abstract]
[Full Text]
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C. L. Grines
Off-Label Use of Drug-Eluting Stents: Putting it in Perspective
J. Am. Coll. Cardiol.,
February 12, 2008;
51(6):
615 - 617.
[Full Text]
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S. R. Dixon, C. L. Grines, and W. W. O'Neill
The Year in Interventional Cardiology
J. Am. Coll. Cardiol.,
July 17, 2007;
50(3):
270 - 285.
[Full Text]
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R. Jaffe and B. H. Strauss
Late and Very Late Thrombosis of Drug-Eluting Stents: Evolving Concepts and Perspectives
J. Am. Coll. Cardiol.,
July 10, 2007;
50(2):
119 - 127.
[Abstract]
[Full Text]
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Abstract
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