Dual antiplatelet therapy, drug-eluting stents and bioresorbable vascular scaffolds: Evolutionary perspectives
Felipe N. Albuquerque MD
Division of Cardiovascular Diseases—Montefiore Medical Center, Albert Einstein College of Medicine, New York, New York
Search for more papers by this authorAnna Bortnick MD, PhD
Division of Cardiovascular Diseases—Montefiore Medical Center, Albert Einstein College of Medicine, New York, New York
Search for more papers by this authorJavaid Iqbal MRCP, PhD
ThoraxCenter, Erasmus University Medical Center, Rotterdam, The Netherlands
Search for more papers by this authorYuki Ishibashi MD, PhD
ThoraxCenter, Erasmus University Medical Center, Rotterdam, The Netherlands
Search for more papers by this authorGregg W. Stone MD
Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York
Search for more papers by this authorCorresponding Author
Patrick W. Serruys MD, PhD
ThoraxCenter, Erasmus University Medical Center, Rotterdam, The Netherlands
Correspondence to: P.W. Serruys, MD, PhD, Erasmus MC, Rotterdam, The Netherlands or International Centre for Circulatory Health, NHLI, Imperial College London, London, UK or Room BD416, Dr. Molewaterplein 40, Rotterdam 3015, Netherlands. E-mail: [email protected]Search for more papers by this authorFelipe N. Albuquerque MD
Division of Cardiovascular Diseases—Montefiore Medical Center, Albert Einstein College of Medicine, New York, New York
Search for more papers by this authorAnna Bortnick MD, PhD
Division of Cardiovascular Diseases—Montefiore Medical Center, Albert Einstein College of Medicine, New York, New York
Search for more papers by this authorJavaid Iqbal MRCP, PhD
ThoraxCenter, Erasmus University Medical Center, Rotterdam, The Netherlands
Search for more papers by this authorYuki Ishibashi MD, PhD
ThoraxCenter, Erasmus University Medical Center, Rotterdam, The Netherlands
Search for more papers by this authorGregg W. Stone MD
Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York
Search for more papers by this authorCorresponding Author
Patrick W. Serruys MD, PhD
ThoraxCenter, Erasmus University Medical Center, Rotterdam, The Netherlands
Correspondence to: P.W. Serruys, MD, PhD, Erasmus MC, Rotterdam, The Netherlands or International Centre for Circulatory Health, NHLI, Imperial College London, London, UK or Room BD416, Dr. Molewaterplein 40, Rotterdam 3015, Netherlands. E-mail: [email protected]Search for more papers by this authorThis article was published online on 10 August 2015. An error was subsequently identified. This notice is included in the online and print versions to indicate that both have been corrected [28 September 2015].
Conflict of interest: Nothing to report.
Abstract
Dual antiplatelet therapy reduces the risk of myocardial infarction, stent thrombosis, and cardiovascular mortality after percutaneous coronary intervention, but the optimal duration of therapy remains unclear. Stent thrombosis, one of the most feared complications of coronary intervention, is associated with high mortality and morbidity and is related in part to technical and patient-specific factors. Advances in device technology and better understanding of the pathophysiology of stent thrombosis have reduced the frequency of this devastating complication. Bioresorbable vascular scaffolds possess a number of advantageous features and are currently undergoing active investigation. Bioresorbable vascular scaffolds have been demonstrated to restore physiologic vasomotion, allow for late lumen enlargement, and upon full resorption remove the nidus for very late polymer reactions and resolve concerns of stent malapposition and side branch jailing. Based on the results from recent large-scale randomized trials, the optimal duration of dual antiplatelet therapy may depend on the choice of device type, as well as the individual patient risk of ischemic versus hemorrhagic complications. © 2015 Wiley Periodicals, Inc.
REFERENCES
- 1 Lopez AD, Murray CC. The global burden of disease, 1990-2020. Nat Med 1998; 4: 1241–1243.
- 2 Davi G, Patrono C. Platelet activation and atherothrombosis. N Engl J Med 2007; 357: 2482–2494.
- 3 Yusuf S, Zhao F, Mehta SR, Chrolavicius S, Tognoni G, Fox KK. Clopidogrel in Unstable Angina to Prevent Recurrent Events Trial I. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. N Engl J Med 2001; 345: 494–502.
- 4 Hollopeter G, Jantzen HM, Vincent D, Li G, England L, Ramakrishnan V, Yang RB, Nurden P, Nurden A, Julius D, Conley PB. Identification of the platelet ADP receptor targeted by antithrombotic drugs. Nature 2001; 409: 202–207.
- 5 Steinhubl SR, Berger PB, Mann JT III, Fry ET, DeLago A, Wilmer C, Topol EJ. Early and sustained dual oral antiplatelet therapy following percutaneous coronary intervention: A randomized controlled trial. J Am Med Assoc 2002; 288: 2411–2420.
- 6 Albiero R, Hall P, Itoh A, Blengino S, Nakamura S, Martini G, Ferraro M, Colombo A. Results of a consecutive series of patients receiving only antiplatelet therapy after optimized stent implantation. Comparison of aspirin alone versus combined ticlopidine and aspirin therapy. Circulation 1997; 95: 1145–1156.
- 7 Quinn MJ, Fitzgerald DJ. Ticlopidine and clopidogrel. Circulation 1999; 100: 1667–1672.
- 8 Matetzky S, Shenkman B, Guetta V, Shechter M, Beinart R, Goldenberg I, Novikov I, Pres H, Savion N, Varon D, Hod H. Clopidogrel resistance is associated with increased risk of recurrent atherothrombotic events in patients with acute myocardial infarction. Circulation 2004; 109: 3171–3175.
- 9 Wiviott SD, Braunwald E, McCabe CH, Montalescot G, Ruzyllo W, Gottlieb S, Neumann FJ, Ardissino D, De Servi S, Murphy SA, Riesmeyer J, Weerakkody G, Gibson CM, Antman EM; Investigators T-T. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med 2007; 357: 2001–2015.
- 10 Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA, Freij A, Thorsen M; Investigators P. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med 2009; 361: 1045–1057.
- 11 Angiolillo DJ, Firstenberg MS, Price MJ, Tummala PE, Hutyra M, Welsby IJ, Voeltz MD, Chandna H, Ramaiah C, Brtko M, Cannon L, Dyke C, Liu T, Montalescot G, Manoukian SV, Prats J, Topol EJ; Investigators B. Bridging antiplatelet therapy with cangrelor in patients undergoing cardiac surgery: A randomized controlled trial. J Am Med Assoc 2012; 307: 265–274.
- 12 Bhatt DL, Lincoff AM, Gibson CM, Stone GW, McNulty S, Montalescot G, Kleiman NS, Goodman SG, White HD, Mahaffey KW, Pollack CV, Jr, Manoukian SV, Widimsky P, Chew DP, Cura F, Manukov I, Tousek F, Jafar MZ, Arneja J, Skerjanec S, Harrington RA; Investigators CP. Intravenous platelet blockade with cangrelor during PCI. N Engl J Med 2009; 361: 2330–2341.
- 13 White HD, Chew DP, Dauerman HL, Mahaffey KW, Gibson CM, Stone GW, Gruberg L, Harrington RA, Bhatt DL. Reduced immediate ischemic events with cangrelor in PCI: A pooled analysis of the CHAMPION trials using the universal definition of myocardial infarction. Am Heart J 2012; 163: 182–190, e184.
- 14 Bhatt DL, Stone GW, Mahaffey KW, Gibson CM, Steg PG, Hamm CW, Price MJ, Leonardi S, Gallup D, Bramucci E, Radke PW, Widimsky P, Tousek F, Tauth J, Spriggs D, McLaurin BT, Angiolillo DJ, Genereux P, Liu T, Prats J, Todd M, Skerjanec S, White HD, Harrington RA; Investigators CP. Effect of platelet inhibition with cangrelor during PCI on ischemic events. N Engl J Med 2013; 368: 1303–1313.
- 15 Mega JL, Simon T, Collet JP, Anderson JL, Antman EM, Bliden K, Cannon CP, Danchin N, Giusti B, Gurbel P, Horne BD, Hulot JS, Kastrati A, Montalescot G, Neumann FJ, Shen L, Sibbing D, Steg PG, Trenk D, Wiviott SD, Sabatine MS. Reduced-function CYP2C19 genotype and risk of adverse clinical outcomes among patients treated with clopidogrel predominantly for PCI: A meta-analysis. J Am Med Assoc 2010; 304: 1821–1830.
- 16 Mega JL, Hochholzer W, Frelinger AL III, Kluk MJ, Angiolillo DJ, Kereiakes DJ, Isserman S, Rogers WJ, Ruff CT, Contant C, Pencina MJ, Scirica BM, Longtine JA, Michelson AD, Sabatine MS. Dosing clopidogrel based on CYP2C19 genotype and the effect on platelet reactivity in patients with stable cardiovascular disease. J Am Med Assoc 2011; 306: 2221–2228.
- 17 Price MJ, Angiolillo DJ, Teirstein PS, Lillie E, Manoukian SV, Berger PB, Tanguay JF, Cannon CP, Topol EJ. Platelet reactivity and cardiovascular outcomes after percutaneous coronary intervention: A time-dependent analysis of the Gauging Responsiveness with a VerifyNow P2Y12 assay: Impact on Thrombosis and Safety (GRAVITAS) trial. Circulation 2011; 124: 1132–1137.
- 18 Scott SA, Sangkuhl K, Stein CM, Hulot JS, Mega JL, Roden DM, Klein TE, Sabatine MS, Johnson JA, Shuldiner AR. Clinical Pharmacogenetics Implementation C. Clinical Pharmacogenetics Implementation Consortium guidelines for CYP2C19 genotype and clopidogrel therapy: 2013 update. Clin Pharmacol Therap 2013; 94: 317–323.
- 19 Silvain J, Cayla G, Hulot JS, Finzi J, Kerneis M, O'Connor SA, Bellemain-Appaix A, Barthelemy O, Beygui F, Collet JP, Montalescot G. High on-thienopyridine platelet reactivity in elderly coronary patients: the SENIOR-PLATELET study. Eur Heart J 2012; 33: 1241–1249.
- 20 Murphy SA, Antman EM, Wiviott SD, Weerakkody G, Morocutti G, Huber K, Lopez-Sendon J, McCabe CH, Braunwald E; Investigators T-T. Reduction in recurrent cardiovascular events with prasugrel compared with clopidogrel in patients with acute coronary syndromes from the TRITON-TIMI 38 trial. Eur Heart J 2008; 29: 2473–2479.
- 21 Dewilde WJ, Oirbans T, Verheugt FW, Kelder JC, De Smet BJ, Herrman JP, Adriaenssens T, Vrolix M, Heestermans AA, Vis MM, Tijsen JG, van't Hof AW, ten Berg JM; Investigators WS. Use of clopidogrel with or without aspirin in patients taking oral anticoagulant therapy and undergoing percutaneous coronary intervention: An open-label, randomised, controlled trial. Lancet 2013; 381: 1107–1115.
- 22 Latib A, Ielasi A, Ferri L, Chieffo A, Godino C, Carlino M, Montorfano M, Colombo A. Aspirin intolerance and the need for dual antiplatelet therapy after stent implantation: A proposed alternative regimen. Int J Cardiol 2013; 165: 444–447.
- 23 Varenhorst C, Jensevik K, Jernberg T, Sundstrom A, Hasvold P, Held C, Lagerqvist B, James S. Duration of dual antiplatelet treatment with clopidogrel and aspirin in patients with acute coronary syndrome. Eur Heart J 2014; 35: 969–978.
- 24 Karanasos A, van Geuns RJ, Zijlstra F, Regar E. Very late bioresorbable scaffold thrombosis after discontinuation of dual antiplatelet therapy. Eur Heart J 2014; 35:1781.
- 25 Park SJ, Park DW, Kim YH, Kang SJ, Lee SW, Lee CW, Han KH, Park SW, Yun SC, Lee SG, Rha SW, Seong IW, Jeong MH, Hur SH, Lee NH, Yoon J, Yang JY, Lee BK, Choi YJ, Chung WS, Lim DS, Cheong SS, Kim KS, Chae JK, Nah DY, Jeon DS, Seung KB, Jang JS, Park HS, Lee K. Duration of dual antiplatelet therapy after implantation of drug-eluting stents. N Engl J Med 2010; 362: 1374–1382.
- 26 Valgimigli M, Campo G, Monti M, Vranckx P, Percoco G, Tumscitz C, Castriota F, Colombo F, Tebaldi M, Fuca G, Kubbajeh M, Cangiano E, Minarelli M, Scalone A, Cavazza C, Frangione A, Borghesi M, Marchesini J, Parrinello G, Ferrari R. Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia Study I. Short- versus long-term duration of dual-antiplatelet therapy after coronary stenting: A randomized multicenter trial. Circulation 2012; 125: 2015–2026.
- 27 Task Force M, Montalescot G, Sechtem U, Achenbach S, Andreotti F Arden C., Budaj A, Bugiardini R, Crea F, Cuisset T, Di Mario C, Ferreira JR, Gersh BJ, Gitt AK, Hulot JS, Marx N, Opie LH Pfisterer M, Prescott E, Ruschitzka F, Sabate M, Senior R, Taggart DP, van der Wall EE, Vrints CJ, Guidelines ESCCfP, Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S, Document R, Knuuti J, Valgimigli M, Bueno H, Claeys MJ, Donner-Banzhoff N, Erol C, Frank H, Funck-Brentano C, Gaemperli O, Gonzalez-Juanatey JR, Hamilos M, Hasdai D, Husted S, James SK, Kervinen K, Kolh P, Kristensen SD, Lancellotti P, Maggioni AP, Piepoli MF, Pries AR, Romeo F, Ryden L, Simoons ML, Sirnes PA, Steg PG, Timmis A, Wijns W, Windecker S, Yildirir A, Zamorano JL. 2013 ESC guidelines on the management of stable coronary artery disease: The Task Force on the management of stable coronary artery disease of the European Society of Cardiology. Eur Heart J 2013; 34: 2949–3003.
- 28 Schulz-Schüpke S, Byrne RA, Ten Berg JM, Neumann FJ, Han Y, Adriaenssens T, Tölg R, Seyfarth M, Maeng M, Zrenner B, Jacobshagen C, Mudra H, von Hodenberg E, Wöhrle J, Angiolillo DJ, von Merzljak B, Rifatov N, Kufner S, Morath T, Feuchtenberger A, Ibrahim T, Janssen PW, Valina C, Li Y, Desmet W, Abdel-Wahab M, Tiroch K, Hengstenberg C, Bernlochner I, Fischer M, Schunkert H, Laugwitz KL, Schömig A, Mehilli J, Kastrati A; Intracoronary Stenting and Antithrombotic Regimen: Safety And EFficacy of 6 Months Dual Antiplatelet Therapy After Drug-Eluting Stenting (ISAR-SAFE) Trial Investigators. ISAR-SAFE: a randomized, double-blind, placebo-controlled trial of 6 vs. 12 months of clopidogrel therapy after drug-eluting stenting. Eur Heart J 2015; 36: 1252-1263.
- 29 Gwon HC, Hahn JY, Park KW, Song YB, Chae IH, Lim DS, Han KR, Choi JH, Choi SH, Kang HJ, Koo BK, Ahn T, Yoon JH, Jeong MH, Hong TJ, Chung WY, Choi YJ, Hur SH, Kwon HM, Jeon DW, Kim BO, Park SH, Lee NH, Jeon HK, Jang Y, Kim HS. Six-month versus 12-month dual antiplatelet therapy after implantation of drug-eluting stents: The Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting (EXCELLENT) randomized, multicenter study. Circulation 2012; 125: 505–513.
- 30 Kim BK, Hong MK, Shin DH, Nam CM, Kim JS, Ko YG, Choi D, Kang TS, Park BE, Kang WC, Lee SH, Yoon JH, Hong BK, Kwon HM Jang Y; Investigators R. A new strategy for discontinuation of dual antiplatelet therapy: The RESET Trial (REal Safety and Efficacy of 3-month dual antiplatelet Therapy following Endeavor zotarolimus-eluting stent implantation). J Am Coll Cardiol 2012; 60: 1340–1348.
- 31 Feres F, Costa RA, Abizaid A, Leon MB, Marin-Neto JA, Botelho RV, King SB III, Negoita M, Liu M, de Paula JE, Mangione JA, Meireles GX, Castello HJ, Jr, Nicolela EL, Jr, Perin MA, Devito FS, Labrunie A, Salvadori D, Jr, Gusmao M, Staico R, Costa JR, Jr, de Castro JP, Abizaid AS, Bhatt DL; Investigators OT. Three vs. twelve months of dual antiplatelet therapy after zotarolimus-eluting stents: the OPTIMIZE randomized trial. J Am Med Assoc 2013; 310: 2510–2522.
- 32 van Werkum JW, Heestermans AA, Zomer AC, Kelder JC, Suttorp MJ, Rensing BJ, Koolen JJ, Brueren BR, Dambrink JH, Hautvast RW, Verheugt FW, ten Berg JM. Predictors of coronary stent thrombosis: the Dutch Stent Thrombosis Registry. J Am Coll Cardiol 2009; 53: 1399–1409.
- 33 Airoldi F, Colombo A, Morici N, Latib A, Cosgrave J, Buellesfeld L, Bonizzoni E, Carlino M, Gerckens U, Godino C, Melzi G, Michev I, Montorfano M, Sangiorgi GM, Qasim A, Chieffo A, Briguori C, Grube E. Incidence and predictors of drug-eluting stent thrombosis during and after discontinuation of thienopyridine treatment. Circulation 2007; 116: 745–754.
- 34 Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Nallamothu BK, Ting HH. ACCF, AHA, SCAI. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention: executive summary: A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. Catheter Cardiovasc Interv 2012; 79: 453–495.
- 35 Task Force on Myocardial Revascularization of the European Society of C, the European Association for Cardio-Thoracic S, European Association for Percutaneous Cardiovascular I, Wijns W, Kolh P, Danchin N, Mario Di, Falk C, Folliguet V, Garg T, Huber S, James K, Knuuti S, Lopez-Sendon J, Marco J, Menicanti J, Ostojic L, Piepoli M, Pirlet MF, Pomar C, Reifart JL, Ribichini N, Schalij FL, Sergeant MJ, Serruys P, Silber PW, Sousa Uva S, Taggart MD. Guidelines on myocardial revascularization. Eur Heart J 2010; 31: 2501–2555.
- 36 Colombo A, Chieffo A, Frasheri A, Garbo R, Masotti M, Salvatella N, Oteo Dominguez JF, Steffanon L, Tarantini G, Presbitero P, Menozzi A, Pucci E, Mauri J, Cesana BM, Giustino G, Sardella G. Second generation drug-eluting stents implantation followed by six versus twelve-month - Dual antiplatelet therapy- The SECURITY Randomized Clinical Trial. J Am Coll Cardiol 2014; 64: 2086–2097.
- 37 Lee CW, Ahn JM, Park DW, Kang SJ, Lee SW, Kim YH, Park SW, Han S, Lee SG, Seong IW, Rha SW, Jeong MH, Lim DS, Yoon JH, Hur SH, Choi YS, Yang JY, Lee NH, Kim HS, Lee BK, Kim KS, Lee SU, Chae JK, Cheong SS, Suh IW, Park HS, Nah DY, Jeon DS, Seung KB, Lee K, Jang JS, Park SJ. Optimal duration of dual antiplatelet therapy after drug-eluting stent implantation: A randomized, controlled trial. Circulation 2014; 129: 304–312.
- 38 Collet JP, Cayla G, Cuisset T, Elhadad S, Range G, Vicaut E, Montalescot G. Randomized comparison of platelet function monitoring to adjust antiplatelet therapy versus standard of care: rationale and design of the assessment with a double randomization of (1) a fixed dose versus a monitoring-guided dose of aspirin and clopidogrel after DES implantation, and (2) treatment interruption versus continuation, 1 year after stenting (ARCTIC) study. Am Heart J 2011; 161: 5–12.
- 39 Helft G, Le Feuvre C, Georges JL, Carrie D, Leclercq F, Eltchaninoff H, Furber A, Prunier F, Sebagh L, Cattan S, Cayla G, Vicaut E, Metzger JP. Efficacy and safety of 12 versus 48 months of dual antiplatelet therapy after implantation of a drug-eluting stent: The OPTImal DUAL antiplatelet therapy (OPTIDUAL) trial: Study protocol for a randomized controlled trial. Trials 2013; 14: 56.
- 40 Mehran R, Baber U, Steg PG, Ariti C, Weisz G, Witzenbichler B, Henry TD, Kini AS, Stuckey T, Cohen DJ, Berger PB, Iakovou I, Dangas G, Waksman R, Antoniucci D, Sartori S, Krucoff MW, Hermiller JB, Shawl F, Gibson CM, Chieffo A, Alu M, Moliterno DJ, Colombo A, Pocock S. Cessation of dual antiplatelet treatment and cardiac events after percutaneous coronary intervention (PARIS): 2 Year results from a prospective observational study. Lancet 2013; 382: 1714–1722.
- 41 Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, 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.
- 42 Kolandaivelu K, Swaminathan R, Gibson WJ, Kolachalama VB, Nguyen-Ehrenreich KL, Giddings VL, Coleman L, Wong GK, Edelman ER. Stent thrombogenicity early in high-risk interventional settings is driven by stent design and deployment and protected by polymer-drug coatings. Circulation 2011; 123: 1400–1409.
- 43 Iakovou I, Schmidt T, Bonizzoni E, Ge L, Sangiorgi GM, Stankovic G, Airoldi F, Chieffo A, Montorfano M, Carlino M, Michev I, Corvaja N, Briguori C, Gerckens U, Grube E, Colombo A. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. J Am Med Assoc 2005; 293: 2126–2130.
- 44 Camenzind E, Steg PG, Wijns W. Stent thrombosis late after implantation of first-generation drug-eluting stents: A cause for concern. Circulation 2007; 115: 1440–1455.
- 45 Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW. Clinical end points in coronary stent trials: A case for standardized definitions. Circulation 2007; 115: 2344–2351.
- 46 Windecker S, Meier B. Late coronary stent thrombosis. Circulation 2007; 116: 1952–1965.
- 47 Holmes DR, Jr, Kereiakes DJ, Garg S, Serruys PW, Dehmer GJ, Ellis SG, Williams DO, Kimura T, Moliterno DJ. Stent thrombosis. J Am Coll Cardiol 2010; 56: 1357–1365.
- 48 Nakazawa G. Stent thrombosis of drug eluting stent: pathological perspective. J Cardiol 2011; 58: 84–91.
- 49 Ong AT, McFadden EP, Regar E, de Jaegere PP, van Domburg RT, Serruys PW. Late angiographic stent thrombosis (LAST) events with drug-eluting stents. J Am Coll Cardiol 2005; 45: 2088–2092.
- 50 Pfisterer ME. Late stent thrombosis after drug-eluting stent implantation for acute myocardial infarction: A new red flag is raised. Circulation 2008; 118: 1117–1119.
- 51 Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, Kutys R, Skorija K, Gold HK, Virmani R. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol 2006; 48: 193–202.
- 52 Popma JJ, Weiner B, Cowley MJ, Simonton C, McCormick D, Feldman T. FDA advisory panel on the safety and efficacy of drug-eluting stents: Summary of findings and recommendations. J Interv Cardiol 2007; 20: 425–446.
- 53 Raber L, Magro M, Stefanini GG, Kalesan B, van Domburg RT, Onuma Y, Wenaweser P, Daemen J, Meier B, Juni P, Serruys PW, Windecker S. Very late coronary stent thrombosis of a newer-generation everolimus-eluting stent compared with early-generation drug-eluting stents: A prospective cohort study. Circulation 2012; 125: 1110–1121.
- 54 Dangas GD, Serruys PW, Kereiakes DJ, Hermiller J, Rizvi A, Newman W, Sudhir K, Smith RS, Jr, Cao S, Theodoropoulos K, Cutlip DE, Lansky AJ, Stone GW. Meta-analysis of everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease: final 3-year results of the SPIRIT clinical trials program (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions). JACC Cardiovasc Interv 2013; 6: 914–922.
- 55 Serruys PW, Farooq V, Kalesan B, de Vries T, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Wijns W, Morice MC, Di Mario C, Corti R, Antoni D, Sohn HY, Eerdmans P, Rademaker-Havinga T, van Es GA, Meier B, Juni P, Windecker S. Improved safety and reduction in stent thrombosis associated with biodegradable polymer-based biolimus-eluting stents versus durable polymer-based sirolimus-eluting stents in patients with coronary artery disease: final 5-year report of the LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) randomized, noninferiority trial. JACC Cardiovasc Interv 2013; 6: 777–789.
- 56 Kedhi E, Joesoef KS, McFadden E, Wassing J, van Mieghem C, Goedhart D, Smits PC. Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): A randomised trial. Lancet 2010; 375: 201–209.
- 57 Camenzind E, Boersma E, Wijns W, Mauri L, Rademaker-Havinga T, Ordoubadi FF, Suttorp MJ, Kurdi MA, Steg PG; PROTECT Steering Committee and Investigators. Modifying effect of dual antiplatelet therapy on incidence of stent thrombosis according to implanted drug-eluting stent type. Eur Heart J 2014; 35: 1932–1948.
- 58 Wykrzykowska JJ, Onuma Y, Serruys PW. Vascular restoration therapy: the fourth revolution in interventional cardiology and the ultimate ‘rosy’ prophecy. EuroIntervention 2009; 5(Suppl F): F7–F8.
- 59 Waksman R. Biodegradable stents: they do their job and disappear. J Invasive Cardiol 2006; 18: 70–74.
- 60 Onuma Y, Ormiston J, Serruys PW. Bioresorbable scaffold technologies. Circ J 2011; 75: 509–520.
- 61 van Geuns RJ, Gogas BD, Farooq V, Regar E, Serruys PW. 3Dimensional reconstruction of a bifurcation lesion with double wire after implantation of a second generation everolimus-eluting bioresorbable vascular scaffold. Int J Cardiol 2011; 153: e43–e45.
- 62 Serruys PW, Onuma Y, Dudek D, Smits PC, Koolen J, Chevalier B, de Bruyne B, Thuesen L, McClean D, van Geuns RJ, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Hebert KM, Sudhir K, Garcia-Garcia HM, Ormiston JA. Evaluation of the second generation of a bioresorbable everolimus-eluting vascular scaffold for the treatment of de novo coronary artery stenosis: 12-month clinical and imaging outcomes. J Am Coll Cardiol 2011; 58: 1578–1588.
- 63 Gomez-Lara J, Garcia-Garcia HM, Onuma Y, Garg S, Regar E, De Bruyne B, Windecker S, McClean D, Thuesen L, Dudek D, Koolen J, Whitbourn R, Smits PC, Chevalier B, Dorange C, Veldhof S, Morel MA, de Vries T, Ormiston JA, Serruys PW. A comparison of the conformability of everolimus-eluting bioresorbable vascular scaffolds to metal platform coronary stents. JACC Cardiovasc Interv 2010; 3: 1190–1198.
- 64 Ormiston JA, Serruys PW. Bioabsorbable coronary stents. Circ Cardiovasc Interv 2009; 2: 255–260.
- 65 Gogas BD, Farooq V, Onuma Y, Serruys PW. The ABSORB bioresorbable vascular scaffold: An evolution or revolution in interventional cardiology? Hellenic J Cardiol 2012; 53: 301–309.
- 66 Nishio S, Kosuga K, Igaki K, Okada M, Kyo E, Tsuji T, Takeuchi E, Inuzuka Y, Takeda S, Hata T, Takeuchi Y, Kawada Y, Harita T, Seki J, Akamatsu S, Hasegawa S, Bruining N, Brugaletta S, de Winter S, Muramatsu T, Onuma Y, Serruys PW, Ikeguchi S. Long-Term (>10 Years) clinical outcomes of first-in-human biodegradable poly-l-lactic acid coronary stents: Igaki-Tamai stents. Circulation 2012; 125: 2343–2353.
- 67 Post MJ, de Graaf-Bos AN, van Zanten HG, de Groot PG, Sixma JJ, Borst C. Thrombogenicity of the human arterial wall after interventional thermal injury. J Vasc Res 1996; 33: 156–163.
- 68 Serruys PW, Ormiston JA, Onuma Y, Regar E, Gonzalo N, Garcia-Garcia HM, Nieman K, Bruining N, Dorange C, Miquel-Hebert K, Veldhof S, Webster M, Thuesen L, Dudek D. A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet 2009; 373: 897–910.
- 69 Shin ES, Garcia-Garcia HM, Serruys PW. A new method to measure necrotic core and calcium content in coronary plaques using intravascular ultrasound radiofrequency-based analysis. Int J Cardiovasc Imaging 2010; 26: 387–396.
- 70 Abizaid A, Costa JR, Jr, Bartorelli AL, Whitbourn R, van Geuns RJ, Chevalier B, Patel T, Seth A, Stuteville M, Dorange C, Cheong WF, Sudhir K, Serruys PW; ABSORB EXTEND investigators. The ABSORB EXTEND study: Preliminary report of the twelve-month clinical outcomes in the first 512 patients enrolled. EuroIntervention 2015; 10: 1396–1401.
- 71 Capodanno D, Gori T, Nef H, Latib A, Mehilli J, Lesiak M, Caramanno G, Naber C, Di Mario C, Colombo A, Capranzano P, Wiebe J, Araszkiewicz A, Geraci S, Pyxaras S, Mattesini A, Naganuma T, Münzel T, Tamburino C. Percutaneous coronary intervention with everolimus-eluting bioresorbable vascular scaffolds in routine clinical practice: Early and midterm outcomes from the European multicentre GHOST-EU registry. EuroIntervention 2015; 10: 1144–1153.
- 72 Ishibashi Y, Nakatani S, Onuma Y. Definite and probable bioresorbable scaffold thrombosis in stable and ACS patients. EuroIntervention 2014.
- 73 Serruys PW, Chevalier B, Dudek D, Cequier A, Carrié D, Iniguez A, Dominici M, van der Schaaf RJ, Haude M, Wasungu L, Veldhof S, Peng L, Staehr P, Grundeken MJ, Ishibashi Y, Garcia-Garcia HM, Onuma Y. A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): An interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial. Lancet 2015; 385: 43–54.
- 74 Diletti R, Serruys PW, Farooq V, Sudhir K, Dorange C, Miquel-Hebert K, Veldhof S, Rapoza R, Onuma Y, Garcia-Garcia HM, Chevalier B. ABSORB II randomized controlled trial: A clinical evaluation to compare the safety, efficacy, and performance of the Absorb everolimus-eluting bioresorbable vascular scaffold system against the XIENCE everolimus-eluting coronary stent system in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions: rationale and study design. Am Heart J 2012; 164: 654–663.