Current treatment of in-stent restenosis.

Management of patients with in-stent restenosis (ISR) remains an important clinical problem. Although drug-eluting stents (DES) have drastically reduced the incidence of ISR, treatment of DES-ISR is particularly challenging. ISR mainly results from aggressive neointimal proliferation, but recent data also suggest that neoatherosclerosis may play an important pathophysiological role. Intracoronary imaging provides unique insights to unravel the underlying substrate of ISR and may be used to guide repeated interventions. In this paper, we systematically reviewed clinical trial data with currently available therapeutic modalities, including DES and drug-coated balloons, in patients presenting with ISR within bare-metal stents or DES.

[1]  Marco Valgimigli,et al.  Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents. , 2007, The New England journal of medicine.

[2]  K. Kent,et al.  Intravascular brachytherapy versus drug-eluting stents for the treatment of patients with drug-eluting stent restenosis. , 2006, The American journal of cardiology.

[3]  P. Teirstein,et al.  Rotational atherectomy (stentablation) in a lesion with stent underexpansion due to heavily calcified plaque , 2001, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[4]  F. Alfonso,et al.  Second-generation drug-eluting stents. Moving the field forward. , 2011, Journal of the American College of Cardiology.

[5]  J. Fajadet,et al.  One-year results of the CRISTAL Trial, a randomized comparison of cypher sirolimus-eluting coronary stents versus balloon angioplasty for restenosis of drug-eluting stents. , 2012, Journal of interventional cardiology.

[6]  P. Serruys,et al.  Late coronary occlusion after intracoronary brachytherapy. , 1999, Circulation.

[7]  D. Trabattoni,et al.  Randomized trial of conventional balloon angioplasty versus cutting balloon for in-stent restenosis. Acute and 24-hour angiographic and intravascular ultrasound changes and long-term follow-up. , 2004, Italian heart journal : official journal of the Italian Federation of Cardiology.

[8]  C. Macaya,et al.  Value of the American College of Cardiology/American Heart Association angiographic classification of coronary lesion morphology in patients with in-stent restenosis. Insights from the Restenosis Intra-stent Balloon angioplasty versus elective Stenting (RIBS) randomized trial. , 2006, American heart journal.

[9]  A. Kastrati,et al.  Sirolimus-Eluting Stent or Paclitaxel-Eluting Stent vs Balloon Angioplasty for Prevention of Recurrences in Patients With Coronary In-Stent Restenosis , 2005 .

[10]  A. Kastrati,et al.  New roads, new ruts: lessons from drug-eluting stent restenosis. , 2011, JACC. Cardiovascular interventions.

[11]  Ralf Degenhardt,et al.  Paclitaxel-Coated Balloon Catheter Versus Paclitaxel-Coated Stent for the Treatment of Coronary In-Stent Restenosis , 2009, Circulation.

[12]  H. Routledge,et al.  A noncompliant, high pressure balloon to manage undilatable coronary lesions , 2010, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[13]  KyoheiYamaji,et al.  Bare Metal Stent Thrombosis and In-Stent Neoatherosclerosis , 2012 .

[14]  I. Palacios,et al.  Directional coronary atherectomy vs. rotational atherectomy for the treatment of in-stent restenosis of native coronary arteries. , 2003, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[15]  Shao-Liang Chen,et al.  A prospective, multicenter, randomized trial of paclitaxel-coated balloon versus paclitaxel-eluting stent for the treatment of drug-eluting stent in-stent restenosis: results from the PEPCAD China ISR trial. , 2014, JACC. Cardiovascular interventions.

[16]  G. Stone,et al.  Paclitaxel-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the TAXUS V ISR randomized trial. , 2006, JAMA.

[17]  A. Íñiguez,et al.  Long-term clinical benefit of sirolimus-eluting stents in patients with in-stent restenosis results of the RIBS-II (Restenosis Intra-stent: Balloon angioplasty vs. elective sirolimus-eluting Stenting) study. , 2008, Journal of the American College of Cardiology.

[18]  C. Macaya,et al.  Implications of the “watermelon seeding” phenomenon during coronary interventions for in‐stent restenosis , 2005, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[19]  F. Alfonso.  Treatment of drug-eluting stent restenosis the new pilgrimage: quo vadis? , 2010, Journal of the American College of Cardiology.

[20]  C. Macaya,et al.  “Candy wrapper” effect after drug‐eluting stent implantation: Déjà vu or stumbling over the same stone again? , 2004, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[21]  G. Knapp,et al.  Drug-eluting balloon angioplasty for in-stent restenosis: a systematic review and meta-analysis of randomised controlled trials , 2013, Heart.

[22]  C. Di Mario,et al.  Cutting balloon angioplasty for the treatment of in-stent restenosis: a matched comparison with rotational atherectomy, additional stent implantation and balloon angioplasty. , 2001, Journal of the American College of Cardiology.

[23]  K. Asai,et al.  Optical coherence tomography after new scoring balloon angioplasty for in-stent restenosis and de novo coronary lesions. , 2010, International journal of cardiology.

[24]  M. Sabaté,et al.  Registro Español de Hemodinámica y Cardiología Intervencionista. XX Informe Oficial de la Sección de Hemodinámica y Cardiología Intervencionista de la Sociedad Española de Cardiología (1990-2010) , 2011 .

[25]  A. Kastrati,et al.  Paclitaxel-eluting balloons, paclitaxel-eluting stents, and balloon angioplasty in patients with restenosis after implantation of a drug-eluting stent (ISAR-DESIRE 3): a randomised, open-label trial , 2013, The Lancet.

[26]  A. Colombo,et al.  Long-term outcomes after the percutaneous treatment of drug-eluting stent restenosis. , 2011, JACC. Cardiovascular interventions.

[27]  S. Sdringola,et al.  Abciximab administration and clinical outcomes after percutaneous intervention for in‐stent restenosis , 2002, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[28]  G. Stone,et al.  Impact of routine angiographic follow-up on the clinical benefits of paclitaxel-eluting stents: results from the TAXUS-IV trial. , 2006, Journal of the American College of Cardiology.

[29]  M. Leon,et al.  Mechanisms and results of balloon angioplasty for the treatment of in-stent restenosis. , 1996, The American journal of cardiology.

[30]  J. Rieber,et al.  Sirolimus-eluting stent implantation versus beta-irradiation for the treatment of in-stent restenotic lesions: clinical and ultrasound results from a randomised trial. , 2011, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[31]  A. Pichard,et al.  Twelve Versus Six Months of Clopidogrel to Reduce Major Cardiac Events in Patients Undergoing &ggr;-Radiation Therapy for In-Stent Restenosis: Washington Radiation for In-Stent restenosis Trial (WRIST) 12 Versus WRIST PLUS , 2002, Circulation.

[32]  P. Jiménez-Quevedo,et al.  Treatment of coronary in-stent restenosis with bioabsorbable vascular scaffolds. , 2014, Journal of the American College of Cardiology.

[33]  H Yokoi,et al.  Three-year follow-up after implantation of metallic coronary-artery stents. , 1996, The New England journal of medicine.

[34]  D. Saura,et al.  Utility of the fractional flow reserve in the evaluation of angiographically moderate in-stent restenosis. , 2004, European heart journal.

[35]  SuhridParikh,et al.  Geographic Miss: A Cause of Treatment Failure in Radio-Oncology Applied to Intracoronary Radiation Therapy , 2001 .

[36]  G. Stone,et al.  Angiographic patterns of in-stent restenosis: classification and implications for long-term outcome. , 1999, Circulation.

[37]  S. Silber,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) , 2002 .

[38]  A. Kastrati,et al.  Effectiveness of drug-eluting stents in patients with bare-metal in-stent restenosis: meta-analysis of randomized trials. , 2007, Journal of the American College of Cardiology.

[39]  C. Macaya,et al.  Long-term outcome and determinants of event-free survival in patients treated with balloon angioplasty for in-stent restenosis. , 1999, The American journal of cardiology.

[40]  T. Kwan,et al.  Successful Expansion of an Underexpanded Stent by Rotational Atherectomy , 2013, International Journal of Angiology.

[41]  Á. Cequier,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. , 2004, European heart journal.

[42]  Gary S Mintz,et al.  In-stent restenosis in the drug-eluting stent era. , 2010, Journal of the American College of Cardiology.

[43]  Á. Cequier,et al.  Stenting the stent: initial results and long-term clinical and angiographic outcome of coronary stenting for patients with in-stent restenosis. , 2000, The American journal of cardiology.

[44]  I. Seong,et al.  Randomized trial of optimal treatment strategies for in-stent restenosis after drug-eluting stent implantation. , 2012, Journal of the American College of Cardiology.

[45]  Michael Joner,et al.  Tissue Characterization After Drug-Eluting Stent Implantation Using Optical Coherence Tomography , 2013, Arteriosclerosis, thrombosis, and vascular biology.

[46]  Masataka Nakano,et al.  The pathology of neoatherosclerosis in human coronary implants bare-metal and drug-eluting stents. , 2011, Journal of the American College of Cardiology.

[47]  C. Macaya,et al.  A randomized comparison of repeat stenting with balloon angioplasty in patients with in-stent restenosis. , 2003, Journal of the American College of Cardiology.

[48]  P. Teirstein,et al.  Sirolimus-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the SISR randomized trial. , 2006, JAMA.

[49]  Volkmar Falk,et al.  Guidelines on myocardial revascularization. , 2010, European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery.

[50]  M. Leon,et al.  In-stent restenosis: the Washington Hospital Center experience. , 1998, The American journal of cardiology.

[51]  E. Topol,et al.  Unexpected mortality reduction with abciximab for in-stent restenosis. , 2000, The Journal of invasive cardiology.

[52]  Michael Joner,et al.  Risk of stent thrombosis among bare-metal stents, first-generation drug-eluting stents, and second-generation drug-eluting stents: results from a registry of 18,334 patients. , 2013, JACC. Cardiovascular interventions.

[53]  F. Alfonso,et al.  Stenting for coronary dissection after balloon dilation of in-stent restenosis: stenting a previously stented site. , 1996, American heart journal.

[54]  P. Jiménez-Quevedo,et al.  Neoatherosclerosis after paclitaxel-coated balloon angioplasty for in-stent restenosis. , 2014, Circulation.

[55]  D. Nori,et al.  Geographic miss: a cause of treatment failure in radio-oncology applied to intracoronary radiation therapy. , 2000, Circulation.

[56]  D. Holmes,et al.  Drug-eluting coronary-artery stents. , 2013, The New England journal of medicine.

[57]  H. Samady,et al.  Percutaneous treatment of focal vs. diffuse in‐stent restenosis: A prospective randomized comparison of conventional therapies , 2004, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[58]  Seung‐Jung Park,et al.  Treatment of diffuse in-stent restenosis with drug-eluting stents vs. intracoronary beta-radiation therapy: INDEED Study. , 2008, International journal of cardiology.

[59]  W. Baxley,et al.  Balloon angioplasty for treatment of in-stent restenosis: feasibility, safety, and efficacy. , 1994, Catheterization and cardiovascular diagnosis.

[60]  Seung‐Jung Park,et al.  Optical Coherence Tomographic Analysis of In-Stent Neoatherosclerosis After Drug–Eluting Stent Implantation , 2011, Circulation.

[61]  A. Ionescu,et al.  Bare metal stent restenosis is not a benign clinical entity. , 2006, American heart journal.

[62]  Simon Wandel,et al.  Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis , 2007, The Lancet.

[63]  S. Silber,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) , 2002, Circulation.

[64]  F. Alfonso,et al.  Neoatherosclerosis: the missing link between very late stent thrombosis and very late in-stent restenosis. , 2013, Journal of the American College of Cardiology.

[65]  Y. Hayashi,et al.  A multicenter randomized comparison of paclitaxel-coated balloon catheter with conventional balloon angioplasty in patients with bare-metal stent restenosis and drug-eluting stent restenosis. , 2013, American heart journal.

[66]  G. Stone,et al.  The clinical impact of routine angiographic follow-up in randomized trials of drug-eluting stents: a critical assessment of "oculostenotic" reintervention in patients with intermediate lesions. , 2010, JACC. Cardiovascular interventions.

[67]  J. Maessen,et al.  Letter regarding article by Kühl et al, "High prevalence of viral genomes and multiple viral infections in the myocardium of adults with 'idiopathic' left ventricular dysfunction". , 2005, Circulation.

[68]  T. Maruo,et al.  Effectiveness of paclitaxel-eluting balloon catheter in patients with sirolimus-eluting stent restenosis. , 2011, JACC. Cardiovascular interventions.

[69]  M. Böhm,et al.  Two year follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. , 2006, Clinical research in cardiology : official journal of the German Cardiac Society.

[70]  P. Teirstein,et al.  Acute and long-term outcomes of cutting balloon angioplasty followed by gamma brachytherapy for in-stent restenosis. , 2003, The American journal of cardiology.

[71]  F. Burzotta,et al.  Arterial Versus Venous Bypass Grafts in Patients With In-Stent Restenosis , 2005, Circulation.

[72]  C. Macaya,et al.  Fate of stent-related side branches after coronary intervention in patients with in-stent restenosis. , 2000, Journal of the American College of Cardiology.

[73]  M. Joner,et al.  Restenosis in bare metal and drug-eluting stents: distinct mechanistic insights from histopathology and optical intravascular imaging. , 2012, Minerva cardioangiologica.

[74]  E. Faglia,et al.  Risk reduction of cardiac events by screening of unknown asymptomatic coronary artery disease in subjects with type 2 diabetes mellitus at high cardiovascular risk: an open-label randomized pilot study. , 2005, American heart journal.

[75]  M. Böhm,et al.  Long-term follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. , 2012, JACC. Cardiovascular interventions.

[76]  A. Kastrati,et al.  Durability of antirestenotic efficacy in drug-eluting stents with and without permanent polymer. , 2009, JACC. Cardiovascular interventions.

[77]  M. Joner,et al.  Incidence and predictors of restenosis after coronary stenting in 10 004 patients with surveillance angiography , 2013, Heart.

[78]  B. Koo,et al.  Usefulness of coronary pressure measurement for functional evaluation of drug-eluting stent restenosis. , 2011, American Journal of Cardiology.

[79]  C. Macaya,et al.  A randomized comparison of sirolimus-eluting stent with balloon angioplasty in patients with in-stent restenosis: results of the Restenosis Intrastent: Balloon Angioplasty Versus Elective Sirolimus-Eluting Stenting (RIBS-II) trial. , 2006, Journal of the American College of Cardiology.

[80]  S. Silber,et al.  Cutting balloon versus conventional balloon angioplasty for the treatment of in-stent restenosis: results of the restenosis cutting balloon evaluation trial (RESCUT). , 2004, Journal of the American College of Cardiology.

[81]  Á. Cequier,et al.  Implantation of a drug-eluting stent with a different drug (switch strategy) in patients with drug-eluting stent restenosis. Results from a prospective multicenter study (RIBS III [Restenosis Intra-Stent: Balloon Angioplasty Versus Drug-Eluting Stent]). , 2012, JACC. Cardiovascular interventions.

[82]  M. Böhm,et al.  Two year follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter , 2008, Clinical Research in Cardiology.

[83]  G. Stone,et al.  Treatment of in-stent restenosis with excimer laser coronary angioplasty versus rotational atherectomy: comparative mechanisms and results. , 2000, Circulation.

[84]  P. Fitzgerald,et al.  Intracoronary gamma-radiation therapy after angioplasty inhibits recurrence in patients with in-stent restenosis. , 2000, Circulation.

[85]  A. Íñiguez,et al.  A randomized comparison of drug-eluting balloon versus everolimus-eluting stent in patients with bare-metal stent-in-stent restenosis: the RIBS V Clinical Trial (Restenosis Intra-stent of Bare Metal Stents: paclitaxel-eluting balloon vs. everolimus-eluting stent). , 2014, Journal of the American College of Cardiology.

[86]  M. Joner,et al.  Differential relative efficacy between drug-eluting stents in patients with bare metal and drug-eluting stent restenosis; evidence in support of drug resistance: insights from the ISAR-DESIRE and ISAR-DESIRE 2 trials. , 2013, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[87]  R. H. Hernández Antolín,et al.  [Spanish Registry of Cardiac Catheterization and Coronary Interventions. Thirteenth Official Report of the Working Group on Cardiac Catheterization and Interventional Cardiology of the Spanish Society of Cardiology (1990-2003)]. , 2004, Revista espanola de cardiologia.

[88]  Samin K. Sharma,et al.  Randomized trial of Rotational Atherectomy Versus Balloon Angioplasty for Diffuse In-stent Restenosis (ROSTER). , 2004, American heart journal.

[89]  P. Teirstein,et al.  Localized intracoronary gamma-radiation therapy to inhibit the recurrence of restenosis after stenting , 2001 .

[90]  P. Teirstein,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 , 2003, Circulation.

[91]  F. Alfonso,et al.  Calcified in-stent restenosis: a rare cause of dilation failure requiring rotational atherectomy. , 2012, Circulation. Cardiovascular interventions.

[92]  J. Brachmann,et al.  A randomized, multicenter, single-blinded trial comparing paclitaxel-coated balloon angioplasty with plain balloon angioplasty in drug-eluting stent restenosis: the PEPCAD-DES study. , 2012, Journal of the American College of Cardiology.

[93]  D. Baim,et al.  Defining coronary restenosis. Newer clinical and angiographic paradigms. , 1993, Circulation.

[94]  R. Virmani,et al.  Temporal course of neointimal formation after drug-eluting stent placement: is our understanding of restenosis changing? , 2009, JACC. Cardiovascular interventions.

[95]  J. Escaned,et al.  Treatment of patients with in-stent restenosis. , 2009, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[96]  A. Denktas,et al.  Cutting balloon angioplasty vs. conventional balloon angioplasty in patients receiving intracoronary brachytherapy for the treatment of in‐stent restenosis , 2004, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[97]  C. Macaya,et al.  Repeat stenting for the prevention of the early lumen loss phenomenon in patients with in-stent restenosis. Angiographic and intravascular ultrasound findings of a randomized study. , 2005, American heart journal.

[98]  G. Stone,et al.  Angiographic patterns of drug-eluting stent restenosis and one-year outcomes after treatment with repeated percutaneous coronary intervention. , 2008, The American journal of cardiology.

[99]  A. Kastrati,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 , 2004, Circulation.

[100]  A. Kastrati,et al.  Long-term risk of adverse outcomes and new malignancies in patients treated with oral sirolimus for prevention of restenosis. , 2009, JACC. Cardiovascular interventions.

[101]  R A Schatz,et al.  Catheter-based radiotherapy to inhibit restenosis after coronary stenting. , 1997, The New England journal of medicine.

[102]  P. Serruys,et al.  Post–Sirolimus-Eluting Stent Restenosis Treated With Repeat Percutaneous Intervention: Late Angiographic and Clinical Outcomes , 2004, Circulation.

[103]  A. Kastrati,et al.  Randomized trial of paclitaxel- versus sirolimus-eluting stents for treatment of coronary restenosis in sirolimus-eluting stents: the ISAR-DESIRE 2 (Intracoronary Stenting and Angiographic Results: Drug Eluting Stents for In-Stent Restenosis 2) study. , 2010, Journal of the American College of Cardiology.

[104]  P. Teirstein,et al.  Contribution of Stent Underexpansion to Recurrence After Sirolimus-Eluting Stent Implantation for In-Stent Restenosis , 2004, Circulation.

[105]  M. Sabaté,et al.  Spanish Cardiac Catheterization and Coronary Intervention Registry. 19th Official Report of the Spanish Society of Cardiology Working Group on Cardiac Catheterization and Interventional Cardiology (1990-2009). , 2011, Revista espanola de cardiologia.

[106]  F. Alfonso,et al.  Optical coherence tomography: from research to clinical application. , 2012, Minerva medica.

[107]  B. Cremers,et al.  Inhibition of neo‐intimal hyperplasia in porcine coronary arteries utilizing a novel paclitaxel‐coated scoring balloon catheter , 2014, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[108]  D. Desilvey.  Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. , 2007, The American journal of geriatric cardiology.

[109]  Sirolimus-eluting stent or paclitaxel-eluting stent vs balloon angioplasty for prevention of recurrences in patients with coronary in-stent restenosis: a randomized controlled trial. , 2005 .

[110]  A. Íñiguez,et al.  Midterm outcome of patients with asymptomatic restenosis after coronary balloon angioplasty. , 1992, Journal of the American College of Cardiology.

[111]  M. Joner,et al.  Drug-coated balloon therapy in coronary and peripheral artery disease , 2014, Nature Reviews Cardiology.

[112]  A. Kastrati,et al.  Drug-Eluting Stents in Percutaneous Coronary Intervention , 2009, Drug safety.

[113]  C. Macaya,et al.  New stent implantation for recurrences after stenting for in-stent restenosis: implications of a third metal layer in human coronary arteries. , 2009, Journal of the American College of Cardiology.