CLINICAL STUDIES
In-stent restenosis: long-term outcome and predictors of subsequent target lesion revascularization after repeat balloon angioplasty
Irene Bossi, MD*,
Catherine Klersy, MD ,
Alexander J. Black, MB, BS ,
Rosario Cortina, MD*,
Remi Choussat, MD*,
Bernard Cassagneau, MD*,
Christian Jordan, MD*,
Jean-Claude Laborde, MD*,
Jean-Pierre Laurent, MD*,
Monique Bernies, MD*,
Jean Fajadet, MD* and
Jean Marco, MD*
* Unité de Cardiologie Interventionelle, Clinique Pasteur, Toulouse, France
Biometry-Research Management Department, I.R.C.C.S. Policlinico S. Pavia, Italy
Department of Cardiology, The Geelong Hospital, Victoria, Australia
Manuscript received January 4, 1999;
revised manuscript received December 30, 1999,
accepted January 12, 2000.
Reprint requests and correspondence: Dr. Irene Bossi, Unité de Cardiologie Interventionelle, Clinique Pasteur, 45, Av de Lombez, Toulouse Cedex 31076, France
marco{at}interv-cardio-toul.com
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Abstract
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OBJECTIVES
We sought to evaluate the long-term clinical outcome of patients undergoing successful balloon angioplasty for in-stent restenosis, and to determine correlates of the need for subsequent target lesion revascularization (TLR).
BACKGROUND
In-stent restenosis can be safely treated by repeat percutaneous intervention. Reported subsequent TLR rates have varied from 20% to 80% and seem related to the type of restenotic lesion.
METHODS
The study population comprised 234 patients with follow-up data who were successfully treated with repeat balloon angioplasty for in-stent restenosis in 257 lesions between May 1995 and January 1998 at our institution.
RESULTS
Clinical follow-up was available at 459 (286 to 693) days after the repeat procedure. Event-free survival was 78.5% and 74.6% at 12 and 24 months, respectively. Recurrent events occurred in 58 patients (24.8%), including 6 deaths (2.6%), 4 myocardial infarction (1.7%) and repeat target vessel revascularization in 50 patients (21.4%). Independent predictors of repeat TLR were time to in-stent restenosis <90 days (Hazard ratio 4.67, p < 0.001), minimal luminal diameter after repeat procedure (Hazard ratio 0.38, p = 0.034) and the angiographic pattern of in-stent restenosis (Hazard ratio 1.65, p = 0.036).
CONCLUSIONS
Balloon angioplasty is an effective means of treating in-stent restenosis. The long-term results are acceptable particularly for focal restenotic lesions. Further restenosis is more common in patients with early initial recurrence, more proliferative lesions and a poorer angiographic result from repeat angioplasty.
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Abbreviations and Acronyms
| | CABG | = coronary artery bypass graft | | CI | = confidence interval | | DCA | = directional coronary atherectomy | | ELCA | = excimer laser catheter ablation | | MI | = myocardial infarction | | MLD | = minimal lumen diameter | | PTCA | = percutaneous transluminal coronary angioplasty | | PTRA | = percutaneous transluminal rotational atherectomy | | RD | = reference vessel diameter | | TLR | = target lesion revascularization |
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Coronary stenting reduces periprocedural complications and/or restenosis compared with balloon angioplasty (1,2). The current use of high-pressure balloon inflations and antithrombotic pharmacologic regimens has been associated with a marked reduction in the incidence of acute and subacute stent thrombosis (3–5). Together with improvements in stent and delivery system design, this has led to a rapid increase in the use of coronary stents. The restenosis rate after coronary stenting is not well defined, varying between 10% and 58% depending on lesion characteristics and patient subset (6–9). With the recent explosion in stent use, including its application to more complex lesions and in smaller vessels, in-stent restenosis has become a significant clinical problem (10). Different percutaneous approaches are currently used to treat in-stent restenosis: percutaneous transluminal coronary angioplasty (PTCA) alone (11–13), lesion debulking, using excimer laser catheter ablation (ELCA) (14,15), percutaneous transluminal rotational atherectomy (PTRA) (16–18) or directional coronary atherectomy (DCA) (19,20), with adjunctive balloon dilation and additional stent implantation (21). Although
short-term results are generally favorable, the rate of recurrence after treatment with these different devices varies among the reported series, and there are no randomized trial results. The use of endovascular brachytherapy, of local or systemic pharmacologic therapy, and of stent coating are now being extensively studied with the aim of reducing the inflammatory response and subsequent neointimal proliferation (22–24).
In clinical practice, balloon angioplasty remains the most frequently utilized method of treatment of in-stent restenosis. Although the immediate results of balloon angioplasty for in-stent restenosis are acceptable, the long-term clinical event rate in terms of recurrent restenosis and target lesion revascularization (TLR) (12,13,25,26) has not been adequately documented.
The aim of this study was to evaluate the long-term results of repeat percutaneous balloon angioplasty for the treatment of in-stent restenosis, and to identify correlates of the need for subsequent TLR.
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Methods
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Patients.
Between May 1995 and January 1998, 270 patients underwent repeat percutaneous intervention for first occurrence of in-stent restenosis at our institution. The procedure was successful in 268 patients (99%) with 294 lesions. Twenty-nine patients, predominantly with diffuse in-stent restenosis, were treated with atherectomy or laser plaque debulking and are not considered in this study. Two hundred thirty-nine patients were planned to be treated with balloon angioplasty alone; of these, long-term follow-up was available in 234 patients (257 lesions) who formed the study population. Adjunctive stenting was performed (for suboptimal angiographic results or adjacent dissection) as a "routine" component of contemporary balloon angioplasty in 29 (11.3%) patients. Long-term follow-up (median 459 days, interquartile range 286 to 693 days) was obtained in all patients.
Initial stenting procedure.
Before initial stent implantation, all patients were treated with aspirin (250 mg), and a bolus of 10,000 IU of heparin was given after sheath insertion, with repeated boluses of 5,000 IU of heparin given as needed to maintain an activated clotting time  250 s.
From 1990 to 1993, all patients were treated with oral anticoagulation with warfarin for one month after stent deployment and aspirin (250 mg daily) indefinitely. Since 1994, all patients undergoing interventional procedures were pretreated with ticlopidine (250 mg bid) for 72 h and aspirin (250 mg daily). Before the intervention, patients received a bolus of heparin (100 IU/kg). After stent deployment, ticlopidine (250 mg bid) was continued for one month, and aspirin (250 mg daily) indefinitely.
Repeat angioplasty procedure for in-stent restenosis.
All patients undergoing repeat angioplasty were treated with ticlopidine (250 mg bid) for 72 h before the procedure and aspirin (250 mg daily). Before intervention, patients received a bolus of heparin (100 IU/kg).
Balloon dilation of in-stent restenotic lesions was performed using semicompliant balloons inflated to high pressure, aiming for a balloon/artery ratio of at least 1:1. The balloon/artery ratios quoted refer to the predicted balloon size (based on manufacturer’s compliance charts) for the recorded maximum inflation pressure. Only in the case of suboptimal results (residual stenosis >30%) or in the presence of adjacent dissections was an additional stent implanted. After additional stent deployment, ticlopidine and aspirin were administered as above. After balloon angioplasty, ticlopidine (250 mg bid) was continued for one week, and aspirin (250 mg daily) indefinitely.
Angiographic analysis.
Coronary angiograms were obtained in a routine manner. All patients received intracoronary isosorbide dinitrate before initial and postprocedural angiograms to achieve maximal vasodilation. The vessels and the lesions were analyzed using a computerized quantitative analysis system (Philips Medical System, The Netherlands) according to previously described and validated edge detection algorithms (27). Lesion length, minimal lumen diameter (MLD), reference vessel diameter (RD) and percent stenosis were measured before and after stent implantation and before and after repeat intervention for in-stent restenosis. Lesion length was measured as the distance from shoulder to shoulder in the projection that demonstrated the in-stent restenosis with the least amount of foreshortening.
Follow-up.
Information was obtained from routine follow-up visits or directly from referring cardiologists or patients by telephone. Follow-up information was collected on standard questionnaires that were included with the patients’ medical records. For patients who had clinical events (see below), follow-up ended at the time of the event.
Definitions.
In-stent restenosis was defined as 50% diameter stenosis at the stented site. The angiographic patterns of in-stent restenosis were defined according to the classification proposed by Mehran et al. (28), as follows: "focal" (length  10 mm), "diffuse" (length >10 mm and within stent margins), "proliferative" (length >10 mm extending beyond stent margins), and "total occlusion" (100% diameter stenosis).
Success of repeat procedure for in-stent restenosis was defined as 30% residual stenosis at the restenotic lesion without the occurrence of major clinical complications. Clinical events were defined as death from any cause, myocardial infarction (MI) (defined by the development of new Q waves or increase in the serum cardiac enzymes to more than twice the upper limit of normal) and repeat TLR by PTCA or by coronary artery bypass graft (CABG). The decision to perform repeat revascularization was clinically driven by symptoms or objective markers of myocardial ischemia. Recurrence of anginal symptoms and subsequent new hospitalization were noted, but not considered in the statistical analysis.
Statistical analysis.
In the tables and in the body of the text, continuous variables are expressed as mean ± standard deviation except for time to and from revascularization, lesion length and stented segment length, which had a skewed distribution and is expressed as median and interquartile range. Categorical variables are expressed as absolute or relative frequencies.
Cumulative TLR-free survival and event free survival has been computed by means of Kaplan Meier estimation; survival probabilities together with their estimated 95% confidence interval (95% CI) are reported. Potential risk factors for the need for TLR were examined using univariate and multivariate Cox proportional hazard models, combining the small number of "total occlusion" patients with the "proliferative" group. Hazard ratios together with their 95% CI and p value (log likelihood ratio test) are reported. Variables entered into the multivariate model are listed in Table 1. Six- and 12-month TLR was compared between focal and nonfocal groups and for the ordinal grouping "focal < diffuse < proliferative < total" using a chi-square analysis for trend. A p value < 0.05 has been considered statistically significant. Statistical analysis was performed using Stata 5.0 for Windows (StataCorp, College Station, TX).
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Results
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Initial stenting procedure: clinical and procedural data.
Initial clinical and angiographic characteristics are shown in Table 2. A total of 324 stents were implanted, with a stent/lesion ratio of 1.26. A coil stent or a slotted tube stent were used in 42.4% and in 50.2% of the cases, respectively, while a mixture of both types was used in 7.4% of the lesions. Stents used included Gianturco-Roubin Flexstent (Cook Inc., Bloomington, Indiana) 38.1%, Palmaz-Schatz (Johnson and Johnson Interventional Systems Inc, Warren, Michigan) 19.1%, NIR (Boston Scientific, Maple Grove, Minnesota) 9.7%, Microstent/GFX-I (Arterial Vascular Engineering, Santa Rosa, California) 6.2%, Crossflex (Cordis, Miami, Florida) 3.1% and Wallstent (Schneider AG, Bülach, Switzerland) 9.3%. In 14.5% of the cases, other stent types were used. In 20.6% of the vessels, multiple stents were implanted. All stents were deployed using high-pressure balloon inflations (mean pressure = 15.8 ± 2.9 ATM). No intravascular ultrasound guidance was used.
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Table 2 Patient Clinical and Angiographic Characteristics, Lesion Morphology and Stenting Procedure in the Original Lesion
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Repeat intervention for in-stent restenosis: clinical, angiographic and procedural data.
Clinical and angiographic restenotic lesion characteristics at the time of repeat intervention are summarized in Table 3. Repeat treatment for stent restenosis was performed at 156 (101 to 209) days after initial stent implantation.
Balloon angioplasty for in-stent restenosis was performed using high-pressure balloon inflations (mean pressure = 14.4 ± 4.1 ATM). The mean balloon/artery ratio was 1.19 ± 0.16. In 29 lesions (11.3%), a nonelective additional stent was implanted to optimize a suboptimal result or to cover adjacent dissections. Quantitative angiographic results of the initial and repeat procedures are summarized in Table 4. The pattern of in-stent restenosis was "focal" in 38%, "diffuse" in 29%, "proliferative" in 29% and "total occlusion" in 4%. The distribution of angiographic characteristics according to in-stent restenosis pattern is shown in Table 5.
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Table 5 Distribution of Clinical Variables and Angiographic Characteristics According to In-Stent Restenosis Pattern
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Long-term outcome and correlates of TLR.
Long-term follow-up (median 459 days, interquartile range 286 to 693) was available in all patients, and the results are shown in Table 6. During the follow-up period, 58 patients had one or more events (death, MI and repeat TLR). Six patients died: one due to gastric cancer and one due to colon cancer 10 and eight months after the repeat procedure, respectively, one of renal insufficiency nine months after repeat procedure, one suddenly 11 months after repeat intervention and two of unknown causes two and three months after repeat angioplasty, respectively. Target lesion revascularization was repeated in 50 patients (53 lesions); in 40 of these, an additional percutaneous treatment was performed to a new site (1 PTRA, 5 ELCA and 34 PTCA), while 10 patients underwent CABG. Among the 29 lesions in which adjunctive stenting was performed at long-term follow up (median days 431; interquartile range 294 to 821), a TLR of 17.2% was observed.
The Kaplan-Meier event-free survival curve is shown in Figure 1. Event-free survival estimates (with 95% CI) were 0.84 (0.78 to 0.87) at six months, 0.78 (0.73 to 0.83) at 12 months, 0.76 (0.69 to 0.8) at 18 months and 0.75 (0.68 to 0.80) at 24 months. The Kaplan-Meier survival curves for different patterns of in-stent restenosis are depicted in Figure 2.
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Figure 2 Death, MI and TLR-free survival.
Overall p value = 0.02; P values: focal versus diffuse = 0.07; focal versus proliferative-total occlusion = 0.01; diffuse versus proliferative-total occlusion = 0.47.
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The results of univariate Cox regression analysis are shown in Table 7. The time to first in-stent restenosis, the presence of unstable angina, the MLD after the repeat intervention, the RD and the restenosis pattern are significant univariate correlates. Multivariate analysis (Table 8 ) showed that the independent predictors of TLR were time from initial stent implantation to restenosis <90 days, MLD after repeat intervention and the angiographic pattern of restenosis. The likelihood of repeat intervention for diffuse versus focal and proliferative versus focal patterns of in-stent restenosis was 1.99 (95% CI = 0.95 to 4.18; p = 0.067) and 2.51 (95% CI = 1.26 to 5.03; p = 0.009), respectively. Analysis at six and 12 months showed a significant difference between the focal and nonfocal groups, as well as a significant linear trend for increasing TLR with increasing grades of angiographic classification of in-stent restenosis (28) at 12 months (p = 0.023), and to a lesser extent at six months (p = 0.057; Table 9).
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Discussion
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This study represents the largest series yet reported of long-term follow-up after repeat angioplasty for in-stent restenosis. The low long-term clinical event rate we observed is comparable with that reported by Reimers et al. (13) and by Bauters et al. (25) in patients with restenosis that was predominantly focal and within stent borders. Recently, Eltchaninoff et al. (26) reported a 54% angiographic restenosis rate and a 35% TLR at six months in patients with more diffuse restenosis. These studies seem to indicate a trend toward a higher recurrence rate in more proliferative lesions than in focal lesions, as does the series of Mehran et al. (28), in which the pattern of in-stent restenosis was predictive of subsequent TLR. In our population, the presence of diffuse or proliferative restenosis was found to be an independent correlate of one-year TLR in multivariate analysis (p = 0.036), and there was a significant trend for increasing TLR with increasing proliferation at 12-month point analysis (Table 9).
A time interval between initial stent implantation and subsequent in-stent restenosis <3 months was a highly significant independent predictor of repeat TLR (Hazard ratio = 4.67; p < 0.001). This phenomenon previously described by Reimers et al. (13) and Perez-Vizcayno et al. (29) after PTCA, and by Sharma et al. (34) after rotational atherectomy for in-stent restenosis and by Black et al. (30) after repeat coronary angioplasty for restenosis without prior stenting, suggests that an early restenotic process may be more aggressive than a late one. The similarity in behavior between stented and nonstented vessels raises the question of whether there is any basic biologic difference in restenosis occurring in stented compared with unstented vessels. Moreover, this aggressive intimal hyperplastic vascular response to injury caused by initial stent implantation does not appear to be altered by successful rotational atherectomy. Evidence from histopathological findings in stented coronary arteries (31,32) has documented a high proliferation index in smooth muscle cells at the site of stent restenosis. Intracoronary ultrasound studies (33) have shown progressively more neointimal hyperplasia and progressively less negative remodelling at axial distances closer to the edge of the stent. These findings suggest that there may be at least a quantitative difference in stented vessels.
Unlike the previously reported studies of Mehran et al. (28) and Dauerman et al. (20), in our study, diabetes was not strongly associated with more frequent recurrent TLR (Hazard ratio 1.22; 95% CI 0.48 to 3.08; p = 0.67). However, our study was not powered to detect an effect given the small number of diabetic patients, and in any case, the trend noted for increased TLR in patients with insulin-dependent diabetes (Hazard ratio 3.10, 95% CI 0.97 to 9.95; p = 0.057) is consistent with previous reports.
Adequacy of result of repeat procedure.
Intracoronary ultrasound data (34,35) suggests that lumen enlargement during PTCA of in-stent restenosis is due to a combination of plaque compression/extrusion and further stent expansion. In our population, a larger MLD after repeat intervention was strongly associated with less repeat TLR (Hazard ratio = 0.38; p = 0.036). There has been considerable interest in the concept of lesion debulking (14–20,34) as a means of achieving a higher MLD. Whether this approach will reduce restenosis and the need for repeat TLR is not yet clear.
Study limitations.
The present study is a retrospective analysis, without systematic angiographic follow-up and without the use of intravascular ultrasound. Different stent designs and materials were used. Patients who received plaque debulking by atherectomy or laser may have had more proliferative restenotic lesions; however, the number excluded is relatively small and unlikely to affect the overall result.
Clinical implications.
Despite the above limitations, our study represents the current experience in treating in-stent restenosis in a high-volume interventional catheterization laboratory, and suggests that for most patients, in-stent restenosis treated with balloon angioplasty does not necessarily carry a poor long-term prognosis. It is therefore reasonable to recommend balloon angioplasty for focal in-stent restenosis, especially in larger vessels. Nevertheless, some patients appear to be at increased risk. Predictors of high risk include smaller final MLD, earlier neointimal response and the extent of neointimal proliferation.
Optimal strategies to deal with high-risk patients remain to be defined. A common method of classification of in-stent restenotic lesions, and prospective randomized trials to define the best treatment in different subsets of lesions comparing new techniques with balloon angioplasty, are warranted.
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September 6, 2005;
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[Abstract]
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F. Alfonso, R. Melgares, V. Mainar, R. Lezaun, N. Vazquez, J. Tascon, F. Pomar, A. Cequier, J. Angel, M.-J. Perez-Vizcayno, et al.
Therapeutic implications of in-stent Restenosis located at the stent edge.: Insights from the Restenosis Intra-stent Balloon angioplasty versus elective Stenting (RIBS) randomized trial
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[Abstract]
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Cutting balloon versus conventional balloon angioplasty for the treatment of in-stent restenosis: Results of the restenosis cutting balloon evaluation trial (RESCUT)
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[Abstract]
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F. Alfonso, J. Zueco, A. Cequier, R. Mantilla, A. Bethencourt, J. R. Lopez-Minguez, J. Angel, J. M. Auge, M. Gomez-Recio, C. Moris, et al.
A randomized comparison ofrepeat stenting with balloon angioplasty in patients with in-stent restenosis
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[Abstract]
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R. Waksman, E. Cheneau, A. E. Ajani, R. L. White, E. Pinnow, R. Torguson, R. Deible, L. F. Satler, A. D. Pichard, K. M. Kent, et al.
Intracoronary Radiation Therapy Improves the Clinical and Angiographic Outcomes of Diffuse In-Stent Restenotic Lesions: Results of the Washington Radiation for In-Stent Restenosis Trial for Long Lesions (Long WRIST) Studies
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[Abstract]
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P.W Radke, A Kaiser, C Frost, and U Sigwart
Outcome after treatment of coronary in-stent restenosis: Results from a systematic review using meta-analysis techniques
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[Abstract]
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J. vom Dahl, U. Dietz, P. K. Haager, S. Silber, L. Niccoli, H. J. Buettner, F. Schiele, M. Thomas, P. Commeau, D. R. Ramsdale, et al.
Rotational Atherectomy Does Not Reduce Recurrent In-Stent Restenosis: Results of the Angioplasty Versus Rotational Atherectomy for Treatment of Diffuse In-Stent Restenosis Trial (ARTIST)
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[Abstract]
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J. M. Ahmed, G. S. Mintz, R. Waksman, R. Mehran, B. Leiboff, A. D. Pichard, L. F. Satler, K. M. Kent, and N. J. Weissman
Serial Intravascular Ultrasound Assessment of the Efficacy of Intracoronary {gamma}-Radiation Therapy for Preventing Recurrence in Very Long, Diffuse, In-Stent Restenosis Lesions
Circulation,
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F. SCHIELE
The "angioplastically correct" follow up strategy after stent implantation
Heart,
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J. M. Ahmed, G. S. Mintz, R. Waksman, N. J. Weissman, B. Leiboff, A. D. Pichard, L. F. Satler, K. M. Kent, and M. B. Leon
Serial Intravascular Ultrasound Analysis of the Impact of Lesion Length on the Efficacy of Intracoronary {{gamma}}-Irradiation for Preventing Recurrent In-Stent Restenosis
Circulation,
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J. P. Carrozza Jr.
In-stent restenosis: should an old device treat a new problem?
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Abstract
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