Published online before print April 12, 2004, doi: 10.1161/01.CIR.0000127129.94129.6F
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
(Circulation. 2004;109:1948-1954.)
© 2004 American Heart Association, Inc.
Clinical Investigation and Reports |
Non–Polymer-Based Paclitaxel-Coated Coronary Stents for the Treatment of Patients With De Novo Coronary Lesions
Angiographic Follow-Up of the DELIVER Clinical Trial
From the Cardiovascular Research Foundation and Lenox Hill Heart and Vascular Institute, New York, NY (A.J.L., R.A.C., G.S.M., Y.T., E.C., G.W.S., M.B.L.); St Joseph Medical Center, Towson, Md (M.M.); Presbyterian Hospital, Charlotte, NC (D.A.C.); EMF Regional Medical Center, Elyria, Ohio (C.O.S.); Wake Forest University Baptist Medical Center, Winston-Salem, NC (R.A.A.); Michigan Cardiovascular Institute, Saginaw, Mich (L.A.C.); Minneapolis Heart Institute, Minneapolis, Minn (M.M.); Allegheny General Hospital, Pittsburgh, Pa (A.F.); Iowa Heart Center, Des Moines, Iowa (M.A.T.); Riverside Methodist Hospital, Columbus, Ohio (S.Y.); Ohio Heart Health Center, Cincinnati, Ohio (D.J.K.); New York Presbyterian Hospital, New York, NY (S.C.W.); North Shore University Hospital, Manhasset, NY (B.K.); St Joseph’s Hospital, Atlanta, Ga (W.D.K.); and William Beaumont Hospital, Royal Oak, Mich (W.W.O.).
Correspondence to Alexandra J. Lansky, MD, Director of the Angiographic Core Laboratory, The Cardiovascular Research Foundation, 55 E 59th St, 6th Floor, New York, NY 10022-1112. E-mail alansky{at}crf.org
Received December 3, 2003; revision received February 17, 2004; accepted February 20, 2004.
 |
Abstract |
|---|
 Top Abstract IntroductionMethodsResultsDiscussionConclusionsReferences |
|---|
Background— Paclitaxel, a microtubule-stabilizing compound with potent antitumor activity, has been shown to inhibit smooth muscle cell proliferation and migration. The DELIVER trial was a prospective, randomized, blinded, multicenter clinical evaluation of the non–polymer-based paclitaxel-coated ACHIEVE stent compared with the stainless steel Multi-Link (ML) PENTA stent.
Methods and Results— A total of 1043 patients with focal de novo coronary lesions, <25 mm in length, in 2.5- to 4.0-mm vessels were randomized (ACHIEVE n=524; ML PENTA n=519). Angiographic follow-up was performed in a subset of 442 patients (ACHIEVE n=228; ML PENTA n=214). Prespecified end points were a 40% reduction in target-vessel failure at 9 months (primary clinical end point) and a 50% reduction in binary restenosis at 8 months (major secondary end point). Baseline clinical characteristics were comparable between the groups. Patients in ACHIEVE had more type C lesions and a larger reference diameter. At follow-up, stent late loss was 0.81 versus 0.98 mm (P=0.003), stent binary restenosis was 14.9% versus 20.6% (P=0.076), and target-vessel failure was 11.9% versus 14.5% (P=0.12) for ACHIEVE and ML PENTA, respectively.
Conclusions— The ACHIEVE paclitaxel-coated stent decreased neointimal proliferation compared with the bare-metal PENTA stent; however, this reduction was insufficient to meet the prespecified primary end point of target-vessel failure and the secondary end point of binary restenosis.
Key Words: stents • restenosis • angioplasty • coronary artery disease • trials
|
Introduction |
|---|
|
TopAbstractIntroductionMethodsResultsDiscussionConclusionsReferences |
|---|
Stents reduce the rate of restenosis compared with balloon angioplasty and other devices1–3; however, a considerable number of patients still develop restenosis and require repeat revascularization within 6 to 12 months.4–6 Many therapies to prevent or treat restenosis after stent implantation have been evaluated,7–12 including systemic pharmacological approaches that have failed, possibly because of insufficient local drug concentration.13–16
See p 1906
The most recent approach has been the development of drug-eluting stents that by design deliver medication directly to the site of vascular injury.17–18 Recent clinical trials of polymer- and non–polymer-based paclitaxel- and sirolimus-eluting stents have demonstrated promising results in the treatment of de novo coronary lesions.19–24 Because early studies investigating the biocompatibility of synthetic polymers showed significant inflammatory and proliferative responses,25–26 the use of non–polymer-based local drug delivery became an attractive approach. We report the angiographic outcomes of the non–polymer-based, paclitaxel-coated ACHIEVE stent evaluated in the DELIVER clinical trial.
|
Methods |
|---|
|
TopAbstractIntroductionMethodsResultsDiscussionConclusionsReferences |
|---|
The DELIVER clinical trial was a prospective, randomized, blinded, multicenter, placebo-controlled trial comparing the paclitaxel-coated RX ACHIEVE Coronary Stent System (CSS) versus the RX ML PENTA stainless steel stent in the treatment of focal de novo coronary lesions. The RX ACHIEVE drug-coated stent incorporated Guidant’s ML RX PENTA CSS and Cook’s proprietary paclitaxel nonpolymeric coating process. This coating was applied directly to the stent at a dosing density of 3.0 µg/mm2 stent surface area. After the release of paclitaxel, only a bare-metal stent remains.
Study Population
Patients were enrolled from November 2001 to March 2002 at 61 US clinical sites. Inclusion criteria included age >18 years, history of angina or a positive functional study, candidate for coronary bypass surgery (CABG), and agreement to undergo all protocol-required long-term follow-up examinations. Angiographic eligibility criteria were the presence of focal de novo lesions located in a major native coronary vessel or branch with a visual reference diameter of 2.5 to 4.0 mm and <25 mm in length (visually estimated), stenosis of 
50% and <100%, and TIMI (Thrombolysis In Myocardial Infarction) flow grade 1. Two-vessel treatment was allowed, with only 1 lesion per vessel. If 2 lesions were treated, the first lesion treated was designated the nontarget lesion and the second the target lesion. Exclusion criteria included acute myocardial infarction within 3 days preceding the index procedure, renal insufficiency (serum creatinine >2.5 mg/dL or dialysis), multiple lesions requiring staged procedures within 180 days of the index procedure, left ventricular ejection fraction <30%, presence of untreated lesion of 40% diameter stenosis proximal or distal to the target lesion, locations <2 mm from the origin of the left anterior descending coronary artery or left circumflex coronary artery, aorto-ostial and unprotected left main, bifurcations, within or beyond an arterial graft or saphenous vein graft, total occlusions, heavy calcification, excessive tortuosity of the proximal vessel, presence of intraluminal thrombus, and restenotic lesions. All treated lesions had to meet these inclusion and exclusion criteria.
End Points
The primary study clinical end point was target-vessel failure at 270 days: the composite of death, Q-wave myocardial infarction, non–Q-wave myocardial infarction, and target-lesion revascularization by CABG or percutaneous coronary intervention. The major secondary end point was binary restenosis by independent quantitative angiography at 240 days.
Procedure
Patients received a loading dose of antiplatelet medications, clopidogrel 300 mg and aspirin 325 mg, within 24 hours before or immediately after the implant procedure. Subsequent pharmacology included clopidogrel (75 mg daily for 90 days) and aspirin (325 mg daily for 1 year). When 2 lesions were present, the nontarget lesion was treated first with any Food and Drug Administration–approved bare-metal stent. If the patient continued to meet all inclusion and exclusion criteria after the first lesion was treated, the eligible target lesion was randomized to implantation of either the ACHIEVE or ML PENTA stent. Predilatation was required. Stents were available in 2.5-, 3.0-, 3.5-, and 4.0-mm diameters and in lengths of 15, 18, 23, and 28 mm. In the event of bailout or if an additional stent was required to cover the lesion, additional stents had to be identical to the randomized treatment group; stents were available in diameters of 2.5 to 4.0 mm and lengths of 8 and 13 mm for use in these circumstances. An optimal result was considered when all of the following criteria were met: (1) postprocedural residual stenosis <10% and free of filling defects or edge dissections, (2) any or all side branches patent, (3) TIMI 3 flow, and (4) freedom from chest pain and ischemic ECG changes. Angiographic follow-up was mandated in the first 500 consecutive patients at 240 days (8 months), which constituted the angiographic subset. If clinically warranted, angiography and revascularization were performed at the physician’s discretion.
Quantitative Angiographic Measurements
Cineangiograms were analyzed independently by Cardiovascular Research Foundation’s Angiographic Core Laboratory. Quantitative coronary angiography was performed with the CMS-GFT algorithm (MEDIS). The accuracy of this method has been reported in detail.27 The minimum lumen diameter (MLD) and mean reference diameter (RD), obtained by averaging 5-mm segments proximal and distal to the target-lesion location, were used to calculate the diameter stenosis [diameter stenosis=(1–MLD/RD)x100] at baseline, after final intervention, and at follow-up in the prespecified angiographic subset. Acute gain was the change in MLD from baseline to final intervention; late loss was the change in MLD from final intervention to follow-up. Restenosis was defined as a 50% diameter stenosis at follow-up within the stent and the treated segment. The stent analysis was confined to the stent itself, and the segment analysis included the stent plus a 5-mm segment proximal and a 5-mm segment distal to the stent. The proximal and distal persistent margins were analyzed and reported individually.
Statistical Analysis
Patients were randomly assigned in a 1:1 ratio to 1 of the 2 treatment groups. The primary end point was analyzed on an intent-to-treat basis, and the secondary end point analysis was limited to the first 500 consecutive patients, which constituted the prespecified angiographic patient subset. A sample size of 238 patients in each treatment group provided 92% power to demonstrate a 50% reduction in binary restenosis at 240 days, which was based on the assumption of a 25% restenosis in the control group and 12.5% in the test group. The sample size was increased to allow for an 
5% dropout rate, for a total of 250 patients per treatment group. Statistical testing of the primary and major secondary end points was 1-tailed and was performed at the 0.025 significance level. Fisher’s exact test was used for categorical variables and Student’s t tests for continuous variables. A value of P<0.05 was considered significant.
|
Results |
|---|
|
TopAbstractIntroductionMethodsResultsDiscussionConclusionsReferences |
|---|
A total of 1043 patients were randomly assigned (ACHIEVE n=524; ML PENTA n=519). Baseline clinical characteristics were comparable in both groups (Table 1). Patients in the ACHIEVE group had more type C lesions. The procedural success rate was 99.0% versus 99.8% for ACHIEVE and ML PENTA, respectively (P=NS). Glycoprotein IIb/IIIa inhibitors were used in 64% of patients in both groups.
|
Two patients in the ACHIEVE group had non-study stents and were excluded from the analysis. Angiographic measurements are shown in Table 2. At baseline, ACHIEVE patients had a larger reference diameter and longer lesions; the MLD was similar in both groups. Postprocedural reference diameter, final in-stent MLD, and segment MLD were also similar in the 2 groups. Stent length in the ACHIEVE group was 19.8 mm versus 19.7 mm in the ML PENTA group (P=1.0).
|
Figure 1 shows a flow diagram for the angiographic follow-up subset. Of the 501 patients selected for angiographic follow-up, 59 were excluded, which left 442 patients (88.2% of the initial subset) with evaluable angiograms at follow-up. Baseline clinical demographics were similar in the 2 angiographic substudy groups, including diabetes that required treatment (23.3% versus 24.8%, P=NS, for ACHIEVE and ML PENTA, respectively).
|
At follow-up, patients in the ACHIEVE group showed a larger in-stent and segment MLD. The larger MLD in the proximal and distal persistent margins in the ACHIEVE group were not significant. Figure 2 illustrates the in-stent cumulative frequency distribution curves for MLD. Significantly lower in-stent and segment late lumen losses were observed with ACHIEVE, which corresponded to a nonsignificant trend for a reduction in stent and segment binary restenosis with ACHIEVE (Table 3).
|
|
On the basis of the intent-to-treat analysis, ACHIEVE patients had a nonsignificant trend toward a lower incidence of target-lesion revascularization (8.1% versus 11.3%, P=0.09) and target-vessel failure (11.9% versus 14.5%, P=0.12).
In the multivariate model, independent predictors of binary restenosis (Table 4) included use of a 2.5-mm stent, diabetes that required treatment, glycoprotein IIb/IIIa inhibitor use, and prior myocardial infarction. For patients who received IIb/IIIa inhibitors, restenosis was 17.5% for ACHIEVE versus 23.9% for ML PENTA (P=0.2), and among patients who did not receive IIb/IIIa inhibitors, restenosis was 8.8% for ACHIEVE versus 14.5% for ML PENTA (P=0.4).
|
|
Discussion |
|---|
|
TopAbstractIntroductionMethodsResultsDiscussionConclusionsReferences |
|---|
Paclitaxel, a microtubule-stabilizing compound with potent antitumor activity, has been shown to inhibit smooth muscle cell proliferation and migration.28,29 Results from the ELUTES (European evaLUation of pacliTaxel-Eluting Stent) and ASPECT (A paclitaxel-eluting Stent for the PrEvention of Coronary restenosis Trial) dose-finding studies showed a significant dose-dependent decrease in late loss and restenosis rate with nonpolymeric paclitaxel-coated stents in patients with single de novo coronary lesions.19,20 The pivotal DELIVER trial demonstrated that the reduction in late loss seen with the paclitaxel-eluting ACHIEVE stent compared with the bare ML PENTA stent did not translate into a meaningful reduction in clinical revascularization or restenosis. Differences in the outcomes of these trials may be related in part to the characteristics and performance of the different stent platforms used, which could have affected the results of the control arm and the drug dose and elution properties of the active arm.
Stent strut thickness has been shown to have an effect on restenosis of bare-metal stents.30 The ACHIEVE CSS incorporates the ML PENTA platform with 0.09- to 0.12-mm-thick struts, 12% to 16% metal/artery coverage,31 and a similar metal surface area coverage (25 mm2 for a 15-mm stent) compared with the V-Flex stent used in ELUTES (strut thickness 0.08 mm, 
15% metal/artery coverage, and metal surface area of 22 mm2)32 but less than the Supra-G stent used in ASPECT (0.11-mm-thick struts and a metal surface area of 42 to 47 mm2 for the 15-mm stent).19 All 3 stent platforms were coated with paclitaxel by Cook’s proprietary process.
At follow-up, the control group in DELIVER had a restenosis rate of 20.6%. This was similar to the control group in ELUTES (20.6%), but considerably lower than control groups in the ASPECT (27%), TAXUS-IV (A Polymer-Based Paclitaxel-Eluting Stent in Patients With Coronary Artery Disease) (24.4%), RAVEL (Randomized Comparison of a Sirolimus-Eluting Stent for Coronary Revascularization) (26.6%), and SIRIUS (Sirolimus-Eluting Stent Versus Standard Stents in Patients With Stenosis in Native Coronary Artery) (35.4%) trials.19,20,22–24 Although multiple factors contribute to restenosis, the overall performance of the ML PENTA stent in DELIVER was excellent, demonstrating larger acute gains than with other bare-metal stents for similar vessel sizes (Table 5). The performance of the ML PENTA resulted in lower than expected restenosis rates in the control arm (20.5% instead of the estimated 25% used for sample-size calculation), which somewhat blunted the beneficial results of the ACHIEVE stent.
|
The angiographic restenosis rates in patients treated with a high-dose density of paclitaxel-coated stents in ASPECT (3.1 µg/mm2) and ELUTES (2.7 µg/mm2) were 4% and 3.2%, respectively. A comparison of ASPECT and ELUTES suggests that it is the dose density, not the total dose, that is important. In ASPECT, the total dose delivered was 130 to 146 µg at the 3.1-µg/mm2 dose density. Conversely, in ELUTES, the total dose was 60 µg at the highest (2.7 µg/mm2) dose density.19,20 Thus, there were identical biological responses despite different overall amounts of drug but similar dose densities. The dose density of paclitaxel used in the ACHIEVE stent in DELIVER (3.0 µg/mm2) was similar to both ASPECT and ELUTES; however, the restenosis rate was higher (14.9% at 8 months of follow-up). It is not clear why the treatment arm of DELIVER was so dissimilar from ASPECT and ELUTES. One possibility is that the ELUTES and ASPECT trials enrolled patients with less complex lesions (Table 5).
Drug release kinetics are different for polymer- versus non–polymer-based systems, which may further explain differences in outcomes seen in DELIVER, TAXUS-IV, and SIRIUS. In DELIVER, ASPECTS, and ELUTES, paclitaxel was adhered to the abluminal surface of the stent by a similar proprietary coating technique without polymer. Pre-clinical studies have estimated that up to 40% of drug is lost during stent delivery of non–polymer-based systems and that paclitaxel release is relatively rapid and complete within days to weeks, leaving the underlying bare metal stent exposed. This is considerably different from the polymerized paclitaxel-coated stent used in the recently reported TAXUS-IV trial.24 Even though paclitaxel had a lower dosing density in the TAXUS program, the release kinetics were slower (<10% elution in 30 days), which may explain the differential effectiveness of the 2 systems, with the greater late loss in DELIVER compared with TAXUS-IV (Table 5).
Nevertheless, the findings in the DELIVER trial confirmed that nonpolymeric paclitaxel-coated stents decrease neointimal proliferation compared with the bare-metal stent control group given the lower in-stent and segment late loss observed with the ACHIEVE stent. However, the benefit of this nonpolymeric paclitaxel-coated stent was significantly less than that observed in other polymer-based drug-eluting stent programs with paclitaxel or sirolimus and did not translate into meaningful reductions in angiographic or clinical restenosis (Table 5). Late loss has proven to be one of the most sensitive and operator-independent angiographic measures of the effect of drug-eluting stents and may be used to predict restenosis rates in different vessel diameters. Therefore, as an end point in clinical trials, late loss offers the advantage of reducing sample size; however, caution is necessary in using late loss as the sole end point, because significant differences in late loss may be clinically meaningless. A late loss threshold should be predefined for the study device in the range of vessel sizes studied that correlates with a meaningful reduction in target-lesion revascularization.
|
Conclusions |
|---|
|
TopAbstractIntroductionMethodsResultsDiscussionConclusionsReferences |
|---|
The ACHIEVE paclitaxel-coated stent system decreased neointimal proliferation compared with the bare-metal stent; however, this reduction was insufficient to meet the prespecified primary end point of target-vessel failure and the secondary end point of binary restenosis.
|
Acknowledgments |
|---|
This study was supported in part by an unrestricted educational grant from Guidant Corporation.
|
References |
|---|
|
TopAbstractIntroductionMethodsResultsDiscussionConclusionsReferences |
|---|
1. Serruys PW, de Jaegere P, Kiemeneij F, et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease: Benestent Study Group. N Engl J Med. 1994; 331: 489–495.
2. Fischman DL, Leon MB, Baim DS, et al. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease: Stent Restenosis Study Investigators. N Engl J Med. 1994; 331: 496–501.
3. Umans VA, Melkert R, Foley DP, et al. Clinical and angiographic comparison of matched patients with successful directional coronary atherectomy or stent implantation for primary coronary artery lesions. J Am Coll Cardiol. 1996; 28: 637–644.[Abstract]
4. Costa MA, Foley DP, Serruys PW. Restenosis: the problem and how to deal with it. In: Grech ED, Ramsdale DR, eds. Practical Interventional Cardiology. 2nd ed. London, UK: Martin Dunitz; 2002: 279–294.
5. Serruys PW, Unger F, Sousa JE, et al. Comparison of coronary-artery bypass surgery and stenting for the treatment of multivessel disease. N Engl J Med. 2001; 344: 1117–1124.
6. Martinez-Elbal L, Ruiz-Nodar JM, Zueco J, et al. Direct coronary stenting versus stenting with balloon pre-dilatation: immediate and follow-up results of a multicentre, prospective, randomized study: the DISCO trial: DIrect Stenting of COronary Arteries. Eur Heart J. 2002; 23: 633–640.
7. Eltchaninoff H, Koning R, Tron C, et al. Balloon angioplasty for the treatment of coronary in-stent restenosis: immediate results and 6-month angiographic recurrent restenosis rate. J Am Coll Cardiol. 1998; 32: 980–984.
8. Dauerman HL, Baim DS, Cutlip DE, et al. Mechanical debulking versus balloon angioplasty for the treatment of diffuse in-stent restenosis. Am J Cardiol. 1998; 82: 277–284.[CrossRef][Medline] [Order article via Infotrieve]
9. vow Dahl J, Radke PW, Haager PK, et al. Clinical and angiographic predictors of recurrent restenosis after percutaneous transluminal rotational atherectomy for treatment of diffuse in-stent restenosis. Am J Cardiol. 1999; 83: 862–867.[CrossRef][Medline] [Order article via Infotrieve]
10. Teirstein PS, Massullo V, Jani S, et al. Catheter-based radiotherapy to inhibit restenosis after coronary stenting. N Engl J Med. 1997; 336: 1697–1703.
11. Leon MB, Teirstein PS, Moses JW, et al. Localized intracoronary gamma-radiation therapy to inhibit the recurrence of restenosis after stenting. N Engl J Med. 2001; 344: 250–256.
12. Kuntz RE, Baim DS. Prevention of coronary restenosis. Circulation. 2000; 101: 2130–2133.
13. Ellis SG, Effron MB, Gold HK, et al. Acute platelet inhibition with abciximab does not reduce in-stent restenosis (ERASER study). Circulation. 1999; 100: 799–806.
14. Lee CW, Chae JK, Lim HY, et al. Prospective randomized trial of corticosteroids for the prevention of restenosis after intracoronary stent implantation. Am Heart J. 1999; 138: 60–63.[CrossRef][Medline] [Order article via Infotrieve]
15. Serruys PW, Foley DP, Pieper M, et al. The TRAPIST study: a multicentre randomized placebo controlled clinical trial of Trapicil for prevention of restenosis after coronary stenting, measured by 3-D intravascular ultrasound. Eur Heart J. 2001; 22: 1938–1947.
16. Meurice T, Bauters C, Hermant X, et al. Effect of ACE inhibitors on angiographic restenosis after coronary stenting (PARIS): a randomized, double-blind, placebo-controlled trial. Lancet. 2001; 357: 1321–1324.[CrossRef][Medline] [Order article via Infotrieve]
17. Lincoff AM, Topol EJ, Ellis SG. Local drug delivery for the prevention of restenosis: fact, fancy, and future. Circulation. 1994; 90: 2070–2084.
18. Topol EJ, Serruys PW. Frontiers in interventional cardiology. Circulation. 1998; 98: 1802–1820.
19. Park SJ, Shim WH, Ho DS, et al. A paclitaxel-eluting stent for the prevention of coronary restenosis. N Engl J Med. 2003; 348: 1537–1545.
20. Gershlick A, DeScheerder I, Chevalier B, et al. Inhibition of restenosis with a paclitaxel-eluting, polymer-free coronary stent: the European evaLUation of pacliTaxel Eluting Stent (ELUTES) Trial. Circulation. 2004; 109: 487–493.
21. Colombo A, Drzewiecki J, Banning A, et al. Randomized study to assess the effectiveness of slow- and moderate release polymer-based paclitaxel-eluting stents for coronary artery lesions. Circulation. 2003; 108: r36–r42.[CrossRef]
22. Morice MC, Serruys PW, Sousa JE, et al. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002; 346: 1773–1780.
23. Moses JW, Leon MB, Popma JJ, et al. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003; 349: 1315–1323.
24. Stone GW, Ellis SG, Cox DA. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med. 2004; 350: 221–231.
25. van der Giessen WJ, Lincoff AM, Schwartz RS, et al. Marked inflammatory sequelae to implantation of biodegradable and nonbiodegradable polymers in porcine coronary arteries. Circulation. 1996; 94: 1690–1697.
26. Suzuki T, Kopia G, Hayashi S, et al. Stent-based delivery of sirolimus reduces neointimal formation in a porcine coronary model. Circulation. 2001; 104: 1188–1193.
27. Lansky AJ, Popma JJ. Qualitative and quantitative angiography. In: Topol EJ, ed. Textbook of Interventional Cardiology. 3rd ed. Philadelphia, Pa: WB Saunders; 1999: 725–747.
28. Axel DI, Kunert W, Goggelmann C, et al. Paclitaxel inhibits arterial smooth muscle cell proliferation and migration in vitro and in vivo using local drug delivery. Circulation. 1997; 96: 636–645.
29. Herdeg C, Oberhoff M, Baumbach A, et al. Local paclitaxel delivery for the prevention of restenosis: biological effects and efficacy in vivo. J Am Coll Cardiol. 2000; 35: 1969–1976.
30. Kastrati A, Mehilli J, Dirschinger J, et al. Intracoronary Stenting And Angiographic Results: Strut Thickness Effect on Restenosis Outcome (ISAR-STEREO) trial. Circulation. 2001; 103: 2816–2821.
31. Colombo A, Stankovic G, Moses JW. Selection of coronary stents. J Am Coll Cardiol. 2002; 40: 1021–1033.
32. Chevalier B, Glatt B, Guyon P, et al. The V-FLEX Plus TM coronary stent. In: Serruys PW, Kutryk MJB, eds. Handbook of Coronary Stents. London, UK: Martin Dunitz; 2000: 211–216.
Related Article:
Circulation 2004 109: 1906-1910.
This article has been cited by other articles:
 |
|
 |
|
  H. S. Hecht, S. Polena, V. Jelnin, M. Jimenez, T. Bhatti, M. Parikh, G. Panagopoulos, and G. Roubin Stent gap by 64-detector computed tomographic angiography relationship to in-stent restenosis, fracture, and overlap failure. J. Am. Coll. Cardiol., November 17, 2009; 54(21): 1949 - 1959. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 T. Higo, Y. Ueda, J. Oyabu, K. Okada, M. Nishio, A. Hirata, K. Kashiwase, N. Ogasawara, S. Hirotani, and K. Kodama Atherosclerotic and thrombogenic neointima formed over sirolimus drug-eluting stent an angioscopic study. J. Am. Coll. Cardiol. Img., May 1, 2009; 2(5): 616 - 624. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 M. A Ostovan, R. Mollazadeh, J. Kojuri, and M. Mirabadi Experience with Paclitaxel-Eluting Infinnium Coronary Stents Asian Cardiovasc Thorac Ann, December 1, 2008; 16(6): 454 - 458. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 B. Chevalier, C. Di Mario, F.-J. Neumann, F. Ribichini, P. Urban, J. J. Popma, P. J. Fitzgerald, D. E. Cutlip, D. O. Williams, J. Ormiston, et al. A Randomized, Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Zotarolimus- Versus Paclitaxel-Eluting Stents in De Novo Occlusive Lesions in Coronary Arteries: The ZoMaxx I Trial J. Am. Coll. Cardiol. Intv., October 1, 2008; 1(5): 524 - 532. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
S. G Raja and G. D Dreyfus Current Status of Off-pump Coronary Artery Bypass Surgery Asian Cardiovasc Thorac Ann, April 1, 2008; 16(2): 164 - 178. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
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] [PDF]
|
|
|
|
|
|
American College of Cardiology/American Heart Asso, 2007 Writing Group to Review New Evidence and Upda, S. B. King III, S. C. Smith Jr, J. W. Hirshfeld Jr, A. K. Jacobs, D. A. Morrison, and D. O. Williams 2007 Focused Update of the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention J. Am. Coll. Cardiol., January 15, 2008; 51(2): 172 - 209. [Full Text] [PDF]
|
|
|
|
 |
|
 S. B. King III, S. C. Smith Jr, J. W. Hirshfeld Jr, A. K. Jacobs, D. A. Morrison, D. O. Williams, 2005 WRITING COMMITTEE MEMBERS, S. C. Smith Jr, T. E. Feldman, J. W. Hirshfeld Jr, et al. 2007 Focused Update of the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines: 2007 Writing Group to Review New Evidence and Update the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention, Writing on Behalf of the 2005 Writing Committee Circulation, January 15, 2008; 117(2): 261 - 295. [Full Text] [PDF]
|
|
|
|
|
|
S. J. Pocock, A. J. Lansky, R. Mehran, J. J. Popma, M. P. Fahy, Y. Na, G. Dangas, J. W. Moses, T. Pucelikova, D. E. Kandzari, et al. Angiographic surrogate end points in drug-eluting stent trials: a systematic evaluation based on individual patient data from 11 randomized, controlled trials. J. Am. Coll. Cardiol., January 1, 2008; 51(1): 23 - 32. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 R. Wessely, A. Kastrati, J. Mehilli, A. Dibra, J. Pache, and A. Schomig Randomized trial of rapamycin- and paclitaxel-eluting stents with identical biodegradable polymeric coating and design Eur. Heart J., November 2, 2007; 28(22): 2720 - 2725. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. Daemen and P. W. Serruys Drug-Eluting Stent Update 2007: Part I: A Survey of Current and Future Generation Drug-Eluting Stents: Meaningful Advances or More of the Same? Circulation, July 17, 2007; 116(3): 316 - 328. [Full Text] [PDF]
|
|
|
|
 |
|
 D. P. Taggart Coronary Artery Bypass Grafting is Still the Best Treatment for Multivessel and Left Main Disease, But Patients Need to Know Ann. Thorac. Surg., December 1, 2006; 82(6): 1966 - 1975. [Full Text] [PDF]
|
|
|
|
 |
|
 B. Scheller, C. Hehrlein, W. Bocksch, W. Rutsch, D. Haghi, U. Dietz, M. Bohm, and U. Speck Treatment of Coronary In-Stent Restenosis with a Paclitaxel-Coated Balloon Catheter N. Engl. J. Med., November 16, 2006; 355(20): 2113 - 2124. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 H. B. Barner Status of percutaneous coronary intervention and coronary artery bypass. Eur. J. Cardiothorac. Surg., September 1, 2006; 30(3): 419 - 424. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 U. Speck, B. Scheller, C. Abramjuk, C. Breitwieser, J. Dobberstein, M. Boehm, and B. Hamm Neointima Inhibition: Comparison of Effectiveness of Non-Stent-based Local Drug Delivery and a Drug-eluting Stent in Porcine Coronary Arteries. Radiology, August 1, 2006; 240(2): 411 - 418. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 R. Tung, S. Kaul, G. A. Diamond, and P. K. Shah Narrative review: drug-eluting stents for the management of restenosis: a critical appraisal of the evidence. Ann Intern Med, June 20, 2006; 144(12): 913 - 919. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 C Roiron, P Sanchez, A Bouzamondo, P Lechat, and G Montalescot Drug eluting stents: an updated meta-analysis of randomised controlled trials Heart, May 1, 2006; 92(5): 641 - 649. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
S. G. Raja Drug-Eluting Stents and the Future of Coronary Artery Bypass Surgery: Facts and Fiction Ann. Thorac. Surg., March 1, 2006; 81(3): 1162 - 1171. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 W. Alvarez Jr and N. K. Kapur Drug Eluting Stent Technology: A Paradigm Shift in the Treatment and Prevention of Restenosis Journal of Pharmacy Practice, December 1, 2005; 18(6): 461 - 478. [Abstract] [PDF]
|
|
|
|
 |
|
 J. J. Nawarskas and L. A. Osborn Paclitaxel-eluting stents in coronary artery disease Am. J. Health Syst. Pharm., November 1, 2005; 62(21): 2241 - 2251. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
L. Mauri, E. J. Orav, S. C. Candia, D. E. Cutlip, and R. E. Kuntz Robustness of Late Lumen Loss in Discriminating Drug-Eluting Stents Across Variable Observational and Randomized Trials Circulation, November 1, 2005; 112(18): 2833 - 2839. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. Hausleiter, A. Kastrati, R. Wessely, A. Dibra, J. Mehilli, T. Schratzenstaller, I. Graf, M. Renke-Gluszko, B. Behnisch, J. Dirschinger, et al. Prevention of restenosis by a novel drug-eluting stent system with a dose-adjustable, polymer-free, on-site stent coating Eur. Heart J., August 1, 2005; 26(15): 1475 - 1481. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
P. W. Serruys, G. Sianos, A. Abizaid, J. Aoki, P. den Heijer, H. Bonnier, P. Smits, D. McClean, S. Verheye, J. Belardi, et al. The Effect of Variable Dose and Release Kinetics on Neointimal Hyperplasia Using a Novel Paclitaxel-Eluting Stent Platform: The Paclitaxel In-Stent Controlled Elution Study (PISCES) J. Am. Coll. Cardiol., July 19, 2005; 46(2): 253 - 260. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
L. Mauri, E. J. Orav, and R. E. Kuntz Late Loss in Lumen Diameter and Binary Restenosis for Drug-Eluting Stent Comparison Circulation, June 28, 2005; 111(25): 3435 - 3442. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
B. Balakrishnan, A. R. Tzafriri, P. Seifert, A. Groothuis, C. Rogers, and E. R. Edelman Strut Position, Blood Flow, and Drug Deposition: Implications for Single and Overlapping Drug-Eluting Stents Circulation, June 7, 2005; 111(22): 2958 - 2965. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. B. Hermiller, A. Raizner, L. Cannon, P. A. Gurbel, M. A. Kutcher, S. C. Wong, M. E. Russell, S. G. Ellis, R. Mehran, G. W. Stone, et al. Outcomes with the polymer-based paclitaxel-eluting TAXUS stent in patients with diabetes mellitus: The TAXUS-IV trial J. Am. Coll. Cardiol., April 19, 2005; 45(8): 1172 - 1179. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
D. J. Kereiakes, R. E. Kuntz, L. Mauri, and M. W. Krucoff Surrogates, substudies, and real clinical end points in trials of drug-eluting stents J. Am. Coll. Cardiol., April 19, 2005; 45(8): 1206 - 1212. [Full Text] [PDF]
|
|
|
|
|
|
W. W. O'Neill, S. R. Dixon, and C. L. Grines The year in interventional cardiology J. Am. Coll. Cardiol., April 5, 2005; 45(7): 1117 - 1134. [Full Text] [PDF]
|
|
|
|
|
|
C.-W. Hwang, A. D. Levin, M. Jonas, P. H. Li, and E. R. Edelman Thrombosis Modulates Arterial Drug Distribution for Drug-Eluting Stents Circulation, April 5, 2005; 111(13): 1619 - 1626. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
Authors/Task Force Members, S. Silber, P. Albertsson, F. F. Aviles, P. G. Camici, A. Colombo, C. Hamm, E. Jorgensen, J. Marco, J.-E. Nordrehaug, et al. Guidelines for Percutaneous Coronary Interventions: The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology Eur. Heart J., April 2, 2005; 26(8): 804 - 847. [Full Text] [PDF]
|
|
|
|
 |
|
 D. P Taggart Surgery is the best intervention for severe coronary artery disease BMJ, April 2, 2005; 330(7494): 785 - 786. [Full Text] [PDF]
|
|
|
|
|
|
A. A. Bavry, D. J. Kumbhani, T. J. Helton, and D. L. Bhatt What is the risk of stent thrombosis associated with the use of paclitaxel-eluting stents for percutaneous coronary intervention?: A meta-analysis J. Am. Coll. Cardiol., March 15, 2005; 45(6): 941 - 946. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
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]
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||