Late Restenosis in Patients Receiving a Polymer-Coated Sirolimus-Eluting Stent

Letters6 September 2005Late Restenosis in Patients Receiving a Polymer-Coated Sirolimus-Eluting StentFREERainer Wessely, MD, Adnan Kastrati, MD, and Albert Schömig, MDRainer Wessely, MDFrom Technische Universität, 80636 Munich, Germany., Adnan Kastrati, MDFrom Technische Universität, 80636 Munich, Germany., and Albert Schömig, MDFrom Technische Universität, 80636 Munich, Germany.Author, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-143-5-200509060-00119 SectionsAboutVisual AbstractPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail TO THE EDITOR:Background: Drug-eluting stents have been broadly available for more than 2 years. Several studies have shown the efficacy of both sirolimus- and paclitaxel-eluting stents for prevention of coronary in-stent restenosis (1, 2). In-stent restenosis is usually detectable in bare-metal stents within the first 6 to 9 months after stent placement; therefore, this time frame is commonly used as follow-up in trials of drug-eluting stents (3). Angiographic results in bare-metal stents approximately 6 months after placement constitute the peak of neointimal obstruction in most patients (3), and angiographic follow-up at later time points often demonstrates decreased neointimal burden, most likely because of apoptotic or remodeling processes (4). Current commercially available drug-eluting stents use a nonbiodegradable polymeric surface, and there is ongoing discussion about increased late stent thrombosis in patients who receive them (5, 6). Besides late thrombotic events, especially after discontinuation of antiplatelet therapy with clopidogrel, the development of late in-stent restenosis is an important unresolved issue.Objective: We describe 2 patients who presented with late in-stent restenosis and recurrent angina pectoris, but no evidence of acute coronary syndrome, 20.4 and 18.9 months, respectively, after placement of a sirolimus-eluting stent. Of importance, both of our patients had an excellent angiographic result immediately after stent placement and at the scheduled 7-month follow-up visit, with no or minimal in-stent restenosis (Figures 1 and 2).Figure 1. Coronary angiograms of 2 patients who received sirolimus-eluting stents and presented with late in-stent restenosis.The first patient received a sirolimus-eluting stent to treat proximal left anterior descending stenosis (part A, white arrow) with an appropriate angiographic follow-up result at 7 months (part B). Later, after 20.4 months, the patient presented with late restenosis in the sirolimus-eluting stent (parts C and D). Of note, a bare-metal stent implanted around the same time did not reveal progressive restenosis (parts A through C, black arrows). The second patient received a sirolimus-eluting stent for treatment of de novo right coronary artery stenosis (part E, arrow) with adequate result at angiographic follow-up at 7 months (part F). Later, after 18.9 months, the patient presented with late restenosis in the sirolimus-eluting stent (parts G and H). Of note, a bare-metal stent implanted around the same time showed regression of in-stent neointima (see Figure 2). Download figure Download PowerPoint Figure 2. Development of in-stent minimal lumen diameter as a measure of neointimal growth in patients receiving a sirolimus-eluting stent and a bare-metal stent at approximately the same time.Minimal lumen diameter in bare-metal stents reached the minimum at 7-month follow-up in both patients and increased thereafter. In contrast, minimal lumen diameter steadily decreased in both polymer-coated sirolimus-eluting stents, demonstrating delayed neointimal growth. Download figure Download PowerPoint Case Report: A 52-year-old man with arterial hypertension and hypercholesterolemia presented with stable angina pectoris that had lasted for more than 12 weeks. Three years earlier, he had received a bare-metal stent, 3.0 mm in diameter and 18 mm long, to treat a left circumflex lesion. Twenty months before the admission discussed here, he presented with stable angina. The left circumflex bare-metal stent showed no clinically significant in-stent restenosis; however, he received a sirolimus-eluting stent (Cypher, Cordis Corp., Miami Lakes, Florida) of the same dimensions to treat a proximal left anterior descending de novo lesion (Figure 1, part A). Scheduled follow-up coronary angioplasty 7 months later showed no restenosis in the sirolimus-eluting stent (Figure 1, part B). At that time, clopidogrel therapy was discontinued. Thirteen months later, the patient was admitted with stable recurrent angina. His medication consisted of a statin, an angiotensin-converting enzyme inhibitor, a β-blocker, and low-dose aspirin. His total cholesterol level was 4.24 mmol/L (164 mg/dL), and his low-density lipoprotein cholesterol level was 1.97 mmol/L (76.3 mg/dL). Results of electrocardiography performed at rest were normal, but exercise electrocardiography revealed significant ST-segment depression at 100 W. Levels of creatine kinase, creatine kinase-MB, troponin T, and C-reactive protein were within normal ranges. Coronary angiography revealed marked late in-stent restenosis within the sirolimus-eluting stent (Figure 1, parts C and D) 20 months after implantation. In-stent restenosis was treated by percutaneous coronary intervention with no concomitant increase in myocardial markers. Of note, the bare-metal stent located in the left circumflex coronary artery showed no clinically significant restenosis, consistent with the preceding angiographic evaluation 13 months before. The patient's recovery was uneventful.In March 2003, an 82-year-old man with 3-vessel coronary artery disease received a sirolimus-eluting stent (Cypher), 2.5 mm in diameter and 23 mm long, to treat severe stenosis of the distal right coronary artery (Figure 1, part E) with an adequate postinterventional result. His risk factors were arterial hypertension and hypercholesterolemia. Medical treatment included low-dose aspirin, a statin, an angiotensin-converting enzyme inhibitor, a β-blocker, and clopidogrel. His total cholesterol level was 4.53 mmol/L (175 mg/dL), and his low-density lipoprotein cholesterol level was 3.18 mmol/L (123 mg/dL). In September 2003, he presented for scheduled angiographic follow-up, which revealed an excellent angiographic result in the sirolimus-eluting stent (Figure 1, part F). However, because the patient's coronary artery disease had progressed, a bare-metal stent was placed into the left circumflex artery and clopidogrel therapy was continued. In January 2004, the patient presented with atypical angina and no signs of acute coronary syndrome. Coronary angiography showed adequate results within both the sirolimus-eluting stent and the bare-metal stent (images not shown). In September 2004, while still receiving combined antiplatelet therapy, including both aspirin and clopidogrel, the patient presented with recurrent angina at exertion, which lasted for approximately 6 weeks. Electrocardiography results and laboratory values ruled out acute cardiac syndrome, and the C-reactive protein level was normal. Coronary angiography revealed marked restenosis (Figure 1, parts G and H) within the sirolimus-eluting stent, whereas the bare-metal stent maintained its initial, adequate angiographic result. Percutaneous intervention and in-hospital stay were uncomplicated.Discussion: To our knowledge, this is the first published report of recurrent angina and severe in-stent stenosis in patients presenting more than 18 months after receiving a sirolimus-eluting stent. Scheduled follow-up coronary angiography at 7 months revealed no evidence of sirolimus-eluting stent restenosis in either patient. Of note, bare-metal stents implanted at about the same time did not show clinically significant restenosis at any point in time or any significant decrease of minimal lumen diameter more than 7 months after stent placement (Figure 2).Preclinical porcine studies have consistently demonstrated effective limitation of coronary neointima formation with several drug-eluting stents, in particular polymer-coated stents eluting paclitaxel (7) or sirolimus (8) 30 days after stenting. However, a recent study reports ongoing neointimal growth in sirolimus-eluting stents in this model and "catch-up" of neointimal formation after 90 days in pigs receiving sirolimus-eluting stents compared with bare-metal stents (9), thus indicating delayed neointimal growth. In a human trial, patients who received 7-hexanoyltaxol-eluting polymer stents (QuaDDS-QP2, Quanam, Santa Clara, California) to treat de novo coronary lesions had appropriate 6-month angiographic results but developed late, accelerated in-stent restenosis after 12 months (10). Examinations of tissue atherectomies from these patients suggested that ongoing inflammation might have caused the negative outcome (11).In our patients, the exact mechanism for the development of late in-stent restenosis in sirolimus-eluting stents despite excellent immediate and 7-month angiographic results remains elusive. The regression of neointimal hyperplasia in the bare-metal stents of both patients (Figure 2) suggests that the delay of neointimal growth and consequently the development of late restenosis are due to the stent coating. Whether the polymeric coating, for which hypersensitivity reactions and delayed vascular healing are described (5), or the pharmacologic compound sirolimus or both are primarily responsible remains elusive.Since long-term studies in "real-world" patients with drug-eluting stents are lacking, it is uncertain whether the phenomenon we observed is rare. Considering the clinical course and the angiographic appearance in our patients, late stent thrombosis is unlikely to have caused stent obstruction, although it cannot be ruled out entirely. Further studies should investigate the clinical relevance of this phenomenon and the appropriate length of follow-up in patients who receive drug-eluting stents.Rainer Wessely, MDAdnan Kastrati, MDAlbert Schömig, MDTechnische Universität; 80636 Munich, GermanyReferences1. Stone GW, Ellis SG, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT, et al. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med. 2004;350:221-31. [PMID: 14724301] CrossrefMedlineGoogle Scholar2. Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, et al. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003;349:1315-23. [PMID: 14523139] CrossrefMedlineGoogle Scholar3. Kastrati A, Schömig A, Dietz R, Neumann FJ, Richardt G. Time course of restenosis during the first year after emergency coronary stenting. Circulation. 1993;87:1498-505. [PMID: 8491004] CrossrefMedlineGoogle Scholar4. Kimura T, Yokoi H, Nakagawa Y, Tamura T, Kaburagi S, Sawada Y, et al. Three-year follow-up after implantation of metallic coronary-artery stents. N Engl J Med. 1996;334:561-6. [PMID: 8569823] CrossrefMedlineGoogle Scholar5. Virmani R, Guagliumi G, Farb A, Musumeci G, Grieco N, Motta T, et al. Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious? Circulation. 2004;109:701-5. [PMID: 14744976] CrossrefMedlineGoogle Scholar6. McFadden EP, Stabile E, Regar E, Cheneau E, Ong AT, Kinnaird T, et al. Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet. 2004;364:1519-21. [PMID: 15500897] CrossrefMedlineGoogle Scholar7. Heldman AW, Cheng L, Jenkins GM, Heller PF, Kim DW, Ware M, et al. Paclitaxel stent coating inhibits neointimal hyperplasia at 4 weeks in a porcine model of coronary restenosis. Circulation. 2001;103:2289-95. [PMID: 11342479] CrossrefMedlineGoogle Scholar8. Suzuki T, Kopia G, Hayashi S, Bailey LR, Llanos G, Wilensky R, et al. Stent-based delivery of sirolimus reduces neointimal formation in a porcine coronary model. Circulation. 2001;104:1188-93. [PMID: 11535578] CrossrefMedlineGoogle Scholar9. Carter AJ, Aggarwal M, Kopia GA, Tio F, Tsao PS, Kolata R, et al. Long-term effects of polymer-based, slow-release, sirolimus-eluting stents in a porcine coronary model. Cardiovasc Res. 2004;63:617-24. [PMID: 15306217] CrossrefMedlineGoogle Scholar10. Liistro F, Stankovic G, Di Mario C, Takagi T, Chieffo A, Moshiri S, et al. First clinical experience with a paclitaxel derivate-eluting polymer stent system implantation for in-stent restenosis: immediate and long-term clinical and angiographic outcome. Circulation. 2002;105:1883-6. [PMID: 11997271] CrossrefMedlineGoogle Scholar11. Virmani R, Liistro F, Stankovic G, Di Mario C, Montorfano M, Farb A, et al. Mechanism of late in-stent restenosis after implantation of a paclitaxel derivate-eluting polymer stent system in humans. Circulation. 2002;106:2649-51. [PMID: 12438288] CrossrefMedlineGoogle Scholar Comments0 CommentsSign In to Submit A Comment Author, Article, and Disclosure InformationAuthors: Rainer Wessely, MD; Adnan Kastrati, MD; Albert Schömig, MDAffiliations: From Technische Universität, 80636 Munich, Germany.Disclosures: Honoraria: R. Wessely (Lilly), A. Kastrati (Guidant); Grant support: R. Wessely (Cordis [Johnson & Johnson]), A. Kastrati (Deutsches Herzzentrum, Medtronic), A. Schömig (Bristol-Myers Squibb, Guidant, Lilly). PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoVery Late Restenosis after Paclitaxel-Eluting Stent Implantation John Cosgrave , Asif Qasim , Azeem Latib , Tiziana Claudia Aranzulla , and Antonio Colombo Metrics Cited byThe Predictors of Target Lesion Revascularization and Rate of In-Stent Restenosis in the Second-Generation Drug-Eluting Stent EraNovel Biomarkers for Coronary Restenosis Occurrence After Drug-Eluting Stent Implantation in Patients With Diabetes Having Stable Coronary Artery DiseaseVascular brachytherapy versus drug-eluting stents in the treatment of in-stent restenosis: A meta-analysis of long-term outcomesExtremely Late Catch-Up Phenomenon After First-Generation Sirolimus-Eluting Stent in the Left Main StemEfficacy and safety of limus-eluting versus paclitaxel-eluting coronary artery stents in patients with diabetes mellitus: A meta-analysisCharacterization of in-stent neointimal tissue components following drug-eluting stent implantation according to the phase of restenosis using a 40-MHz intravascular ultrasound imaging systemGenetic risk of restenosis after percutaneous coronary interventions in the era of drug-eluting stentsCABG Versus PCI in the Treatment of Diabetic Patients Affected by Coronary Artery DiseaseIncidence and predictors of the late catch-up phenomenon after drug-eluting stent implantationPorous TiO 2 surface formed on nickel-titanium alloy by plasma electrolytic oxidation: A prospective polymer-free reservoir for drug eluting stent applicationsIncidence, time course and predictors of early vs. late target lesion revascularisation after everolimus-eluting stent implantation: a SPIRIT V substudyLate catch-up in lumen diameter at five-year angiography in MACE-free patients treated with sirolimus-eluting stents in the Primary Stenting of Totally Occluded Native Coronary Arteries: a randomised comparison of bare metal stent implantation with sirolimus-eluting stent implantation for the treatment of total coronary occlusions (PRISON II)Addition of Cilostazol to Conventional Dual Antiplatelet Therapy Reduces the Risk of Cardiac Events and Restenosis After Drug-Eluting Stent Implantation: A Meta-AnalysisPredictors of Early and Late Target Lesion Revascularization after Drug-Eluting Stent ImplantationFive-year clinical outcomes of a polymer-free sirolimus-eluting stent versus a permanent polymer paclitaxel-eluting stent: Final results of the intracoronary stenting and angiographic restenosis - test equivalence between two drug-eluting stents (ISAR-TESLong-term serial angiographic outcomes after sirolimus-eluting stent implantationThe Important Role of Inflammatory Biomarkers Pre and Post Bare–Metal and Drug–Eluting Stent ImplantationIn vivo comparison of a polymer-free Biolimus A9-eluting stent with a biodegradable polymer-based Biolimus A9 eluting stent and a bare metal stent in balloon denuded and radiated hypercholesterolemic rabbit iliac arteries"Angiographic late catch-up" phenomenon after sirolimus-eluting stent implantationNanosecond Laser Induced Periodic Surface Structures on Drug Elution Profiles in StentsCharacterization of Porous TiO2 Surfaces Formed on 316L Stainless Steel by Plasma Electrolytic Oxidation for Stent ApplicationsComparison of drug-eluting stents with bare metal stents in patients with ST-segment elevation myocardial infarctionFive-year clinical outcome after primary stenting of totally occluded native coronary arteries: a randomised comparison of bare metal stent implantation with sirolimus-eluting stent implantation for the treatment of total coronary occlusions (PRISON II study)Angiographic evidence of progressive lumen narrowing over 2years following drug-eluting stent implantationSerial angiographic and intravascular ultrasound evaluation to interrogate the presence of late "catch-up" phenomenon after cypher® sirolimus-eluting stent implantationThe emerging role of allergic inflammation in adverse reactions after coronary stent implantationUse of remote film loading methodology to entrap sirolimus into liposomes: Preparation, characterization and in vivo efficacy for treatment of restenosisRecent developments in drug-eluting stentsIn-Stent Restenosis in the DES EraA Randomized Comparison of Sirolimus- Versus Paclitaxel-Eluting Stent Implantation in Patients With Diabetes MellitusTwo-year Clinical Outcomes of Patients with Long Segments Drug-Eluting Stents: Comparison of Sirolimus-Eluting Stent with Paclitaxel-Eluting StentThe Evolving Role of Inflammatory Biomarkers in Risk Assessment After Stent ImplantationVery Late Thrombosis of a Pipeline Embolization Device ConstructIncidence and Risk Factors of Late Target Lesion Revascularization After Sirolimus-Eluting Stent Implantation (3-Year Follow-Up of the j-Cypher Registry)A link between stent radial forces and vascular wall remodeling: The discovery of an optimal stent radial force for minimal vessel restenosisComparison by Meta-Analysis of Drug-Eluting Stents and Bare Metal Stents for Saphenous Vein Graft InterventionNew drug-eluting stent conceptsPolymer-Free Biolimus A9-Coated Stent Demonstrates More Sustained Intimal Inhibition, Improved Healing, and Reduced Inflammation Compared With a Polymer-Coated Sirolimus-Eluting Cypher Stent in a Porcine ModelIncreased Restenosis Rates 12 Months After Coronary Implantation of the Sirolimus-Eluting YUKON-Choice Stent Compared to the Paclitaxel-Eluting TAXUS StentComparison of Triple Antiplatelet Therapy and Dual Antiplatelet Therapy in Patients at High Risk of Restenosis After Drug–Eluting Stent Implantation (from the DECLARE-DIABETES and -LONG Trials)Durability of Antirestenotic Efficacy in Drug-Eluting Stents With and Without Permanent PolymerStenting und technische StentumgebungTreatment of diffuse IN-stent restenosis with Drug-Eluting stents vs. intracoronary bEta-raDiation therapy: INDEED StudyIntroducing the first polymer-free leflunomide eluting stentSirolimus-eluting stent implantation for bare-metal in-stent restenosis: is there any evidence for a late catch-up phenomenon?Randomized trial of three rapamycin-eluting stents with different coating strategies for the reduction of coronary restenosisComparison of a polymer-free rapamycin-eluting stent (YUKON) with a polymer-based paclitaxel-eluting stent (TAXUS) in real-world coronary artery lesionsLate target lesion revascularization after implantation of sirolimus-eluting stentReview: The safety of drug-eluting stentsVery Late Restenosis after Paclitaxel-Eluting Stent ImplantationJohn Cosgrave, MD, Asif Qasim, PhD, Azeem Latib, MD, Tiziana Claudia Aranzulla, MD, and Antonio Colombo, MDComparison of Six-Month Angiographic and Three-Year Outcomes After Sirolimus-Eluting Stent Implantation Versus Brachytherapy for Bare Metal In-Stent RestenosisLate Restenosis Following Sirolimus-Eluting Stent ImplantationTwo-Year Clinical Follow-Up After Sirolimus-Eluting Versus Bare-Metal Stent Implantation Assisted by Systematic Glycoprotein IIb/IIIa Inhibitor Infusion in Patients With Myocardial InfarctionRelease profiles in drug-eluting stents: Issues and uncertaintiesLong-Term Safety and Efficacy of Drug-Eluting StentsIs there delayed restenosis in patients with coronary artery disease treated with sirolimus-eluting stent?Does Addition of Estradiol Improve the Efficacy of a Rapamycin-Eluting Stent?Two-Year Follow-Up of the Quantitative Angiographic and Volumetric Intravascular Ultrasound Analysis After Nonpolymeric Paclitaxel-Eluting Stent ImplantationRandomized Double-Blind Comparison of Sirolimus-Eluting Stent Versus Bare-Metal Stent Implantation in Diseased Saphenous Vein GraftsPolymers for tissue engineering, medical devices, and regenerative medicine. Concise general review of recent studiesPersistence of Neointimal Growth 12 Months After Intervention and Occurrence of Delayed Restenosis in Patients With Left Main Coronary Artery Disease Treated With Drug-Eluting StentsSirolimus and Paclitaxel on Polymer-Based Drug-Eluting StentsRandomized Trial of a Nonpolymer-Based Rapamycin-Eluting Stent Versus a Polymer-Based Paclitaxel-Eluting Stent for the Reduction of Late Lumen LossPrevention of Restenosis by Systemic Drug TherapyPrevention of restenosis by a novel drug-eluting stent system with a dose-adjustable, polymer-free, on-site stent coatingStenting und technische Stentumgebung 6 September 2005Volume 143, Issue 5Page: 392-394KeywordsAnginaAngiographyCholesterolDrugsElectrocardiographyLesionsStable coronary artery diseaseStent implantationThrombosis ePublished: 6 September 2005 Issue Published: 6 September 2005 Copyright & PermissionsCopyright © 2005 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...

Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.