Published online before print January 13, 2003, doi: 10.1161/01.CIR.0000048184.96491.8A
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(Circulation. 2003;107:559.)
© 2003 American Heart Association, Inc.
Clinical Investigation and Reports |
TAXUS III Trial
In-Stent Restenosis Treated With Stent-Based Delivery of Paclitaxel Incorporated in a Slow-Release Polymer Formulation
From the Division of Cardiology (K.T., P.W.S., P.C.S., W.J.G., P.F., E.R., M.D., J.M.R.L.), Thoraxcenter, Erasmus MC, Rotterdam, the Netherlands; Department of Cardiology/Angiology (E.G., G.S., M.S., R.M.), Heart Center Siegburg, Siegburg, Germany; Cardialysis BV (C.D., B.B.), Rotterdam, the Netherlands; and Boston Scientific Corporation (M.E.R.), Natick, Mass.
Correspondence to P.W. Serruys, MD, PhD; Thoraxcenter, Bd 408, Erasmus MC, Dr Molewaterplein 40, 3015GD, Rotterdam, the Netherlands. E-mail serruys{at}card.azr.nl
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Abstract |
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Background— The first clinical study of paclitaxel-eluting stent for de novo lesions showed promising results. We performed the TAXUS III trial to evaluate the feasibility and safety of paclitaxel-eluting stent for the treatment of in-stent restenosis (ISR).
Methods and Results— The TAXUS III trial was a single-arm, 2-center study that enrolled 28 patients with ISR meeting the criteria of lesion length 
30 mm, 50% to 99% diameter stenosis, and vessel diameter 3.0 to 3.5 mm. They were treated with one or more TAXUS NIRx paclitaxel-eluting stents. Twenty-five patients completed the angiographic follow-up at 6 months, and 17 of these underwent intravascular ultrasound (IVUS) examination. No subacute stent thrombosis occurred up to 12 months, but there was one late chronic total occlusion, and additional 3 patients showed angiographic restenosis. The mean late loss was 0.54 mm, with neointimal hyperplasia volume of 20.3 mm3. The major adverse cardiac event rate was 29% (8 patients; 1 non-Q-wave myocardial infarction, 1 coronary artery bypass grafting, and 6 target lesion revascularization [TLR]). Of the patients with TLR, 1 had restenosis in a bare stent implanted for edge dissection and 2 had restenosis in a gap between 2 paclitaxel-eluting stents. Two patients without angiographic restenosis underwent TLR as a result of the IVUS assessment at follow-up (1 incomplete apposition and 1 insufficient expansion of the stent).
Conclusions— Paclitaxel-eluting stent implantation is considered safe and potentially efficacious in the treatment of ISR. IVUS guidance to ensure good stent deployment with complete coverage of target lesion may reduce reintervention.
Key Words: stents • restenosis • drugs
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Introduction |
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The development of coronary stents has revolutionized the field of interventional cardiology by reducing the incidence of restenosis after balloon angioplasty.1,2 With the widespread clinical use of coronary stents, in-stent restenosis (ISR) has become the most challenging problem.3 Previous pharmacological and mechanical approaches have shown disappointing results in eliminating this iatrogenic disease. Presently, intravascular brachytherapy is the only treatment for ISR proven to be effective in clinical randomized trials.4–6 Brachytherapy requires special handling and is hampered by potential issues such as edge restenosis,7,8 late thrombosis,9 geographical miss,10 late stent malapposition,11 persisting dissection,12,13 and positive vascular remodeling after treatment.14,15
Stent-based local drug delivery is expected to cause a revolutionary change in the field of percutaneous intervention, with recent clinical trials of paclitaxel or sirolimus-eluting stents demonstrating promising results in the treatment of de novo lesions.16–19 Paclitaxel is a microtubule inhibitor presently used to treat several kinds of cancer, most commonly breast and ovarian. Microtubular dynamics regulate many of the inflammatory and profibrotic steps implicated in the restenotic cascade. This agent has been reported to reduce vascular cell proliferation and migration in vitro and in vivo.20–23 In accordance with these experimental results, paclitaxel-eluting stents for de novo lesions showed no restenosis in the TAXUS I feasibility trial.16 However, it has not been established whether this is applicable to a more complex patient group, such as patients with ISR. The TAXUS III trial is a single-arm, 2-center study aiming to evaluate the feasibility and safety of this eluting stent for the treatment of ISR.
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Methods |
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Patient Selection
Patients were eligible if they had ISR of a native coronary artery with objective evidence of ischemia. Angiographic inclusion criteria were lesion length
30 mm, 50% to 99% diameter stenosis, and vessel diameter between 3.0 and 3.5 mm. Patients were excluded if they had an acute myocardial infarction, left ventricular ejection fraction <30%, stroke within the last 6 months, a renal dysfunction (serum creatinine >1.7 µg/100 mL), or a contraindication to aspirin, clopidogrel, or ticlopidine. Between May 2001 and August 2001, patients were enrolled in two centers (Thoraxcenter, Rotterdam, the Netherlands, and Heart Center Siegburg, Siegburg, Germany). All patients gave written informed consent. The study was reviewed and approved by both institutions’ ethics review committees.
Procedure
The stent used in the study was the TAXUS NIRx paclitaxel-eluting stent (Boston Scientific Corporation), with a total load of 1.0 µg/mm2 of paclitaxel incorporated into a slow-release copolymer carrier system that gives biphasic release. The initial release is over the first 48 hours followed by slow release over the next 10 days. All stents were 15 mm long and 3.0 or 3.5 mm in diameter. Balloon predilatation was performed followed by NIRx paclitaxel-eluting stent implantation using conventional techniques. Postdilatation was performed if necessary. Periprocedural intravenous heparin was given to maintain an activated clotting time 
250 seconds, and all patients received aspirin (at least 75 mg) and clopidogrel (300 mg loading dose followed by 75 mg once daily for 6 months).
Follow-Up
Clinical information was collected 6 and 12 months after procedure. Angiographic and intravascular ultrasound (IVUS) follow-ups were performed at the 6-month visit. Major adverse cardiac events (MACEs) were defined as death, myocardial infarction (MI), target-vessel repeat percutaneous coronary intervention, or coronary artery bypass grafting (CABG). MI was defined as Q-wave MI (development of new pathological Q waves in 2 or more leads with CK-MB levels elevated above normal) or non-Q-wave MI (elevation of CK levels to >2 times upper normal limit with CK-MB levels elevated above normal).
Angiographic Analysis
Coronary angiograms were obtained in multiple views after intracoronary nitrate. ISR was classified according to a modified Mehran classification.3 Three coronary segments underwent quantitative angiography: in-stent, proximal edge, and distal edge segment. The in-stent analysis encompassed the entire length of all stents used during the procedure. The proximal and distal edge segments included up to 5 mm on either side of the in-stent segment. Quantitative coronary angiographic analysis was performed by an independent core laboratory (Cardialysis, Rotterdam, the Netherlands).24 The reference vessel diameter, minimal lumen diameter (MLD), and percent diameter stenosis were measured before procedure, after procedure, and at follow-up. Late loss was calculated as the difference between the MLD after procedure and that at follow-up. The target lesion was defined as the in-stent segment plus the proximal and distal edge segments. Angiographic restenosis was defined as >50% diameter stenosis within the target lesion.
IVUS Analysis
IVUS images were acquired after procedure and at 6-month follow-up using automated pull-back at 0.5 mm/s following intracoronary nitrate.25 The total coronary analysis segment beginning 5 mm distal to and extending 5 mm proximal to the study stent was examined. A computer-based contour detection program was used for automated 3D reconstruction of the segments from up to 200 cross-sectional images. Lumen, stent boundaries, and external elastic membrane were detected using a minimum cost algorithm, and volumetric quantification was performed.26,27 Percent volume obstruction was calculated as neointimal volume/stent volumex100. The quantitative ultrasound analysis was performed by the same independent core laboratory.
Statistical Analysis
Continuous variables are expressed as mean±SD. Comparisons between postprocedure and 6-month follow-up measurements were performed with a 2-tailed paired t test. P<0.05 was considered statistically significant.
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Results |
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Baseline Clinical and Lesion Characteristics
Twenty-eight patients with 28 target lesions were included. The patients’ baseline clinical and lesion characteristics are summarized in Tables 1 and 2, respectively. The incidence of diabetes, previous MI, and previous CABG are in keeping with the higher risk population of ISR.3 Diffuse ISR pattern was present in 64% of target lesions. Thirteen lesions (46%) were treated with 2 paclitaxel-eluting stents.
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Clinical Outcome
Table 3 summarizes MACE up to 12 months after procedure. No subacute stent thrombosis occurred, and no deaths were reported. There was 100% technical success in deploying the study stents; however, 1 patient had postprocedural non-Q-wave MI, yielding a 30-day MACE rate of 4%.
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During the 6-month follow-up, an additional 7 patients had a MACE, for a 6-month rate of 29%. One patient underwent CABG attributable to progression of left main and ostial left circumflex lesions, which were at a distance from the target lesion. The remaining 6 patients underwent percutaneous target lesion revascularization (TLR). For 3 of these patients, the indication for TLR was angiographic restenosis. In the remaining 3 patients, 1 without angiographic restenosis had TLR because of anginal symptoms in the presence of a small MLD (1.33 mm). IVUS findings at follow-up triggered 2 additional interventions in the absence of angiographic restenosis. One showed incomplete stent apposition, the other showed insufficient stent expansion, and neither showed neointimal hyperplasia (percent volume obstruction, 0%). It was unknown whether the incomplete apposition was already present at baseline, because no IVUS assessment was performed after procedure. Between 6 and 12 months, no additional MACE was reported.
Angiographic and IVUS Outcome
Of 28 patients, 25 (89%) underwent 6-month follow-up angiography. Binary angiographic restenosis was documented in 4 patients (16%). One of these patients had target vessel total occlusion. Two paclitaxel-eluting stents had been implanted to treat ISR of a covered stent, which had been used to treat ISR of a gold-coated stent. Additional intervention was not undertaken, because the patient had no anginal symptoms.
Of the remaining 3 patients, 1 had restenosis in a bare metal stent implanted because of a dissection at the distal edge of the paclitaxel-eluting stent. Two patients had restenosis in a gap between 2 paclitaxel-eluting stents, as evident on IVUS (Figure 1). Minimal neointimal hyperplasia is seen in the segments with double contours of stent struts; however, where there is a single layer of stent struts, ie, a gap between the paclitaxel-eluting stents, occlusive neointimal tissue is evident. Hence, of the 4 with binary restenosis, 3 occurred within a region with no local delivery of paclitaxel.
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The quantitative coronary angiographic data are summarized in Table 4. The mean reference vessel diameter was 2.75 mm. Figure 2 shows the cumulative distribution curve of MLD in the in-stent segment. The MLD at follow-up (1.84 mm) was significantly lower than that after procedure (2.40 mm). Diameter stenosis at follow-up was 30.8%, with an average in-stent late loss of 0.54 mm. Late loss of the proximal and distal edges were 0.20 and 0.11 mm, respectively, without angiographic restenosis.
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Seventeen patients underwent IVUS examination at follow-up. The neointimal hyperplasia volume amounted to 20.3±23.1 mm3 with the stent volume of 172.1±85.4 mm3. In addition, serial analysis (n=14 pairs) of the total vessel volume after procedure (411.2±332.9 mm3) versus follow-up (435.8±217.5 mm3) showed no statistically significant change, suggesting that paclitaxel-eluting stent does not cause positive or negative vessel remodeling. No late acquired incomplete stent apposition was detected by serial IVUS investigation.
Subgroup Analysis
We performed subgroup analysis to estimate the treatment effect within stented segments directly exposed to local paclitaxel delivery by excluding the 3 patients who showed restenosis in a bare stent or a gap between 2 paclitaxel-eluting stents, as tabulated in Table 4. In this subgroup, the late loss and restenosis rate was 0.47 mm and 4.5%, respectively. Figure 3 shows the results of subgroup analysis between patients with single stent (n=13) and those with 2 stents (n=12). Post-hoc statistical analysis showed a significantly smaller MLD and larger diameter stenosis at follow-up for the 2-stent group (P<0.01). Post-hoc statistical analysis of IVUS data at follow-up reveal that percent volume obstruction in the single-stent group (n=10; length, 15.4±2.8 mm) was 12.4±15.7% for a stent volume of 111.9±27.9 mm3, whereas percent volume obstruction in the 2-stent group (n=7, length 29.4±3.0 mm) was 10.1±8.2% for a stent volume of 258.1±60.3 mm3. In this latter group, the analysis included only 1 of the 4 patients who had angiographic restenosis.
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P=0.054 versus 2 stents. |
Discussion |
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In the present study, we report the first clinical experience with the TAXUS NIRx paclitaxel-eluting stent for the treatment of ISR. The major findings of the TAXUS III trial are as follows. First, this polymer-based paclitaxel-eluting stent is feasible and safe for the treatment of ISR with no subacute stent thrombosis. Second, late loss (0.54 mm) is seemingly diminished compared with historical controls. Third, angiographic restenosis rate is 16%; however, when present, it tends to occur in a gap between 2 paclitaxel-eluting stents. Fourth, the TLR rate of 21.4% (6 of 28 patients) is promising given that 3 were not performed according to predefined angiographic criteria.
Safety Consideration
At up to 12 months of clinical follow-up, there has been no late subacute stent thrombosis in our patient population, although clopidogrel was discontinued at 6 months. There was 1 patient with silent total occlusion who had preexisting in-stent restenosis in gold-coated and covered stent sandwich subsequently treated with the study stents. However, the mechanism of this occlusion is difficult to decipher, because the effect of paclitaxel on the adjacent covered stent sandwich is unknown and the covered stent precluded the IVUS assessment with respect to the detection of either a gap or an overlap. The promising safety data in our study contrasts with the high incidence of late subacute stent thrombosis in the randomized Score trial, evaluating de novo lesions with the QuaDS stent that used 4 or 5 polymer sleeves to deliver high concentrations (800 µg/sleeve) of paclitaxel derivative.28 The enrollment of the Score trial was prematurely stopped because of a major imbalance in MACE between the study and control groups associated with stent thrombosis. Previous animal studies showed that paclitaxel may delay the healing process in a dose-dependent manner,29 and stent thrombosis is likely the result of incomplete healing and reendothelialization. Additional preclinical and clinical data will give insight as to whether the dose of paclitaxel (1.0 µg/mm2 [loaded drug/stent surface area]) used in this trial will maintain the promising safety margin.
Efficacy of the TAXUS NIRx Paclitaxel-Eluting Stent for Treatment of In-Stent Restenosis
Previous reports using bare metal stent for treatment of ISR showed a late loss of 0.9 to 1.4 mm.30–32 The overall late loss (0.54 mm) in our study was more favorable, even though it underestimates the treatment effect. If the 2 patients with restenosis attributable to a gap between 2 paclitaxel-eluting stents and the patient with restenosis in a bare stent are excluded, the adjusted late loss is 0.47 mm. In addition, the late loss in the single-stent group was 0.36 mm (Figure 3). These values are close to the loss of 0.35 mm (placebo group, 0.70 mm) observed in the TAXUS I trial on de novo coronary lesions treated with the same slow-release formulation. Furthermore, the neointimal volume from the TAXUS III patients with 1 NIRx stent was 15.6 mm3, comparable to 14.8 mm3 in the TAXUS I patients treated with one NIRx stent. These two values are both lower than the value of 21.6 mm3 seen in the TAXUS I uncoated bare stent group. Taken together, these data suggest that paclitaxel on the NIRx seems to attenuate neointimal formation for ISR as well as de novo lesions.
Restenosis at the Gap
In 2 patients, IVUS identified a gap between 2 eluting stents that led to restenosis. Our hypothesis is that barotrauma from balloon inflation in an area of preexisting in-stent neointima may have triggered the local exuberant hyperplasia in the gap where the concentration of paclitaxel is insufficient to prevent neointimal hyperplasia. Accordingly, we speculate that paclitaxel does not diffuse substantially from the edge of the stent to have biological effect in the gap. Therefore, when treating ISR with the paclitaxel-eluting stents, covering the entire length of the previously implanted stents and providing a margin at either side may reduce TLR associated with restenosis near the drug-treated segments. With this in mind, IVUS guidance may be useful, and the advent of longer-eluting stents will be advantageous.
TLR Without Angiographic Restenosis
The TLR rate of this trial has been artificially inflated by reinterventions because of ultrasound or angiographic findings not always clinically driven or justified by predefined angiographic criteria. In this trial, 3 of 6 TLRs had diameter stenosis <50%. Two of these patients underwent TLR as a result of IVUS findings at follow-up. In one, there was an incomplete apposition at follow-up without postprocedural assessment. In the other patient, the stent was considered at follow-up to be insufficiently expanded, although the mean lumen area of the stent was 4.41 mm2 without neointimal hyperplasia. The third patient had anginal symptoms despite a diameter stenosis of 32.5% and underwent TLR in an attempt to increase the MLD (1.33 mm) and reference diameter (1.96 mm). In this trial, the incidence of TLR may underestimate the clinical benefit related to the inhibition of neointimal hyperplasia resulting from the drug elution.
Study Limitations
The limitations of this study are its small sample size and single-arm open-label design without randomization. The angiographic follow-up rate was acceptable, although a higher IVUS follow-up rate may have provided more information on neointimal hyperplasia. Ongoing clinical follow-up will provide insight on long-term outcomes in this challenging population.
Conclusion
Paclitaxel-eluting stent implantation is considered safe and potentially efficacious in the treatment of ISR. The IVUS guidance to ensure good stent deployment with complete coverage of target lesion may reduce reintervention.
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Acknowledgments |
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The authors appreciate the efforts of the catheterization laboratory staff and would like to thank Dr A. Hoye, E. van Remortel, P. Cummins, and J. Hansen for their continuous support.
Received July 29, 2002; revision received October 22, 2002; accepted October 22, 2002.
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D. R. Holmes Jr, P. Teirstein, L. Satler, M. Sketch, J. O'Malley, J. J. Popma, R. E. Kuntz, P. J. Fitzgerald, H. Wang, E. Caramanica, et al. Sirolimus-Eluting Stents vs Vascular Brachytherapy for In-Stent Restenosis Within Bare-Metal Stents: The SISR Randomized Trial JAMA, March 15, 2006; 295(11): 1264 - 1273. [Abstract] [Full Text] [PDF]
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P. W. Serruys, M. J.B. Kutryk, and A. T.L. Ong Coronary-Artery Stents N. Engl. J. Med., February 2, 2006; 354(5): 483 - 495. [Full Text] [PDF]
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S. C. Smith Jr, T. E. Feldman, J. W. Hirshfeld Jr, A. K. Jacobs, M. J. Kern, S. B. King III, D. A. Morrison, W. W. O'Neill, H. V. Schaff, P. L. Whitlow, et al. ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention--Summary Article: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention) J. Am. Coll. Cardiol., January 3, 2006; 47(1): 216 - 235. [Full Text] [PDF]
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S. C. Smith Jr, T. E. Feldman, J. W. Hirshfeld Jr, A. K. Jacobs, M. J. Kern, S. B. King III, D. A. Morrison, W. W. O'Neill, H. V. Schaff, P. L. Whitlow, et al. ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention--Summary Article: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention) Circulation, January 3, 2006; 113(1): 156 - 175. [Full Text] [PDF]
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F. Alfonso, J. M. Auge, J. Zueco, A. Bethencourt, J. R. Lopez-Minguez, J. M. Hernandez, J. A. Bullones, I. Calvo, E. Esplugas, M. J. Perez-Vizcayno, et al. Long-Term Results (Three to Five Years) of the Restenosis Intrastent: Balloon Angioplasty Versus Elective Stenting (RIBS) Randomized Study J. Am. Coll. Cardiol., September 6, 2005; 46(5): 756 - 760. [Abstract] [Full Text] [PDF]
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M R Thomas Brachytherapy: here today, gone tomorrow? Heart, June 1, 2005; 91(suppl_3): iii32 - iii34. [Full Text] [PDF]
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E. L. Hannan, M. J. Racz, G. Walford, R. H. Jones, T. J. Ryan, E. Bennett, A. T. Culliford, O. W. Isom, J. P. Gold, and E. A. Rose Long-Term Outcomes of Coronary-Artery Bypass Grafting versus Stent Implantation N. Engl. J. Med., May 26, 2005; 352(21): 2174 - 2183. [Abstract] [Full Text] [PDF]
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L. Mauri, E. J. Orav, A. J. O'Malley, J. W. Moses, M. B. Leon, D. R. Holmes Jr, P. S. Teirstein, J. Schofer, G. Breithardt, D. E. Cutlip, et al. Relationship of Late Loss in Lumen Diameter to Coronary Restenosis in Sirolimus-Eluting Stents Circulation, January 25, 2005; 111(3): 321 - 327. [Abstract] [Full Text] [PDF]
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E. Grube, A. Lansky, K. E. Hauptmann, C. Di Mario, G. Di Sciascio, A. Colombo, S. Silber, J. Stumpf, N. Reifart, J. Fajadet, et al. High-dose 7-hexanoyltaxol-eluting stent with polymer sleeves for coronary revascularization: One-year results from the SCORE randomized trial J. Am. Coll. Cardiol., October 6, 2004; 44(7): 1368 - 1372. [Abstract] [Full Text] [PDF]
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R. S. Schwartz, N. A. Chronos, and R. Virmani Preclinical restenosis models and drug-eluting stents: Still important, still much to learn J. Am. Coll. Cardiol., October 6, 2004; 44(7): 1373 - 1385. [Abstract] [Full Text] [PDF]
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F Saia, P A Lemos, C A Arampatzis, A Hoye, M Degertekin, K Tanabe, G Sianos, P C Smits, W J van der Giessen, P J de Feyter, et al. Routine sirolimus eluting stent implantation for unselected in-stent restenosis: insights from the rapamycin eluting stent evaluated at Rotterdam cardiology hospital (RESEARCH) registry Heart, October 1, 2004; 90(10): 1183 - 1188. [Abstract] [Full Text] [PDF]
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F. Alfonso Optimal Implantation Strategies Using Drug-Eluting Stents for In-Stent Restenosis: Do We Know the Answer? Circulation, September 14, 2004; 110(11): e302 - e302. [Full Text] [PDF]
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J. Hausleiter, A. Kastrati, J. Mehilli, M. Vogeser, D. Zohlnhofer, H. Schuhlen, C. Goos, J. Pache, F. Dotzer, G. Pogatsa-Murray, et al. Randomized, Double-Blind, Placebo-Controlled Trial of Oral Sirolimus for Restenosis Prevention in Patients With In-Stent Restenosis: The Oral Sirolimus to Inhibit Recurrent In-stent Stenosis (OSIRIS) Trial Circulation, August 17, 2004; 110(7): 790 - 795. [Abstract] [Full Text] [PDF]
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P. R Stella, P. Elsman, and P. A Doevendans Remise in the treatment of in-stent restenosis Eur. Heart J., June 1, 2004; 25(11): 898 - 899. [Full Text] [PDF]
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P. W Radke, S. Kobella, A. Kaiser, A. Franke, D. Schubert, E. Grube, P. Hanrath, and R. Hoffmann Treatment of in-stent restenosis using a paclitaxel-eluting stent: acute results and long-term follow-up of a matched-pair comparison with intracoronary {beta}-radiation therapy Eur. Heart J., June 1, 2004; 25(11): 920 - 925. [Abstract] [Full Text] [PDF]
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P. S. Teirstein A Chicken in Every Pot and a Drug-Eluting Stent in Every Lesion Circulation, April 27, 2004; 109(16): 1906 - 1910. [Full Text] [PDF]
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W. W. O'Neill and S. R. Dixon The year in interventional cardiology J. Am. Coll. Cardiol., March 3, 2004; 43(5): 875 - 890. [Full Text] [PDF]
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K. N. Giedd and S. R. Bergmann Myocardial perfusion imaging following percutaneous coronary intervention: the importance of restenosis, disease progression, and directed reintervention J. Am. Coll. Cardiol., February 4, 2004; 43(3): 328 - 336. [Abstract] [Full Text] [PDF]
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J. R. Sindermann, G. Plenz, and G. Breithardt Drug-Eluting Stents: Do We Know Enough About Safety? Circulation, January 27, 2004; 109 (3): e22 - e22. [Full Text] [PDF]
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K. Tanabe, P. W. Serruys, M. Degertekin, G. Guagliumi, E. Grube, C. Chan, T. Munzel, J. Belardi, W. Ruzyllo, L. Bilodeau, et al. Chronic Arterial Responses to Polymer-Controlled Paclitaxel-Eluting Stents: Comparison With Bare Metal Stents by Serial Intravascular Ultrasound Analyses: Data From the Randomized TAXUS-II Trial Circulation, January 20, 2004; 109(2): 196 - 200. [Abstract] [Full Text] [PDF]
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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 J. Am. Coll. Cardiol., September 3, 2003; 42(5): 796 - 805. [Abstract] [Full Text] [PDF]
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A. Colombo, J. Drzewiecki, A. Banning, E. Grube, K. Hauptmann, S. Silber, D. Dudek, S. Fort, F. Schiele, K. Zmudka, et al. Randomized Study to Assess the Effectiveness of Slow- and Moderate-Release Polymer-Based Paclitaxel-Eluting Stents for Coronary Artery Lesions Circulation, August 19, 2003; 108(7): 788 - 794. [Abstract] [Full Text] [PDF]
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