Endoprótesis coronarias bioabsorbibles

2009, EuroIntervention, 5, SupplF Monagan, 2007 Wykrzykowska, 2009, Vascular restoration therapy: the fourth revolution in interventional cardiology and the ultimate “Rosy” prophecy, EuroIntervention, 5, F7, 10.4244/EIJV5IFA1 Ormiston, 2009, Bioabsorbable coronary stents, Circ Cardiovasc Interv, 2, 255, 10.1161/CIRCINTERVENTIONS.109.859173 Meier, 1985, Transluminal coronary angioplasty-state of the art 1984, Acta Med Scand Suppl, 701, 142 Mintz, 1996, Arterial remodeling after coronary angioplasty: A serial intravascular ultrasound study, Circulation, 94, 35, 10.1161/01.CIR.94.1.35 Serruys, 2006, Coronary-artery stents, N Engl J Med, 354, 483, 10.1056/NEJMra051091 Serruys, 1994, A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease, N Engl J Med, 331, 489, 10.1056/NEJM199408253310801 Pocock, 2008, 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, 51, 23, 10.1016/j.jacc.2007.07.084 Van Beusekom, 1993, Histology after stenting of human saphenous vein bypass grafts: observations from surgically excised grafts 3 to 320 days after stent implantation, J Am Coll Cardiol, 21, 45, 10.1016/0735-1097(93)90715-D Cook, 2009, Correlation of intravascular ultrasound findings with histopathological analysis of thrombus aspirates in patients with very late drug-eluting stent thrombosis, Circulation, 120, 391, 10.1161/CIRCULATIONAHA.109.854398 Shah, 2002, Background incidence of late malapposition after bare-metal stent implantation, Circulation, 106, 1753, 10.1161/01.CIR.0000035239.90657.B1 Khattab, 2009, Vascular restoration therapy: what should the clinical and angiographic measures for success be?, EuroIntervention, 5, F49, 10.4244/EIJV5IFA8 Vorpahl, 2009, The bioabsorption process: tissue and cellular mechanisms and outcomes, EuroIntervention, 5, F28, 10.4244/EIJV5IFA5 Waksman, 2009, Coating bioabsorption and chronic bare metal scaffolding versus fully bioabsorbable stent, EuroIntervention, 5, F36, 10.4244/EIJV5IFA6 Waksman, 2003, Coronary brachytherapy in the drug-eluting stent era, Circulation, 108, 386, 10.1161/01.CIR.0000082928.33891.B7 Sousa, 2001, Sustained suppression of neointimal proliferation by sirolimus-eluting stents: one-year angiographic and intravascular ultrasound follow-up, Circulation, 104, 2007, 10.1161/hc4201.098056 Morice, 2002, A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization, N Engl J Med, 346, 1773, 10.1056/NEJMoa012843 Moses, 2003, Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery, N Engl J Med, 349, 1315, 10.1056/NEJMoa035071 Stone, 2004, A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease, N Engl J Med, 350, 221, 10.1056/NEJMoa032441 Moses, 2003, Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery, N Engl J Med, 349, 1315, 10.1056/NEJMoa035071 Stone, 2005, Comparison of a polymer based paclitaxel-eluting stent with a bare metal stent in patients with complex coronary artery disease: A randomized controlled trial, JAMA, 294, 1215, 10.1001/jama.294.10.1215 Tamai, 2000, Initial and 6–month results of biodegradable poly(L-lactic acid) coronary stents in humans, Circulation, 102, 399, 10.1161/01.CIR.102.4.399 Onuma, 2009, Ten-year follow-up of the IGAKI-TAMAI stent. A posthumous tribute to the scientific work of Dr, Hideo Tamai. EuroIntervention, 5, F109, 10.4244/EIJV5IFA19 Daemen, 2007, Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study, Lancet, 369, 667, 10.1016/S0140-6736(07)60314-6 Wenaweser, 2008, Incidence and correlates of drug-eluting stent thrombosis in routine clinical practice. 4-year results from a large 2-institutional cohort study, J Am Coll Cardiol, 52, 1134, 10.1016/j.jacc.2008.07.006 Finn, 2007, Pathological correlates of late drug-eluting stent thrombosis: Strut coverage as a marker of endothelialization, Circulation, 115, 2435, 10.1161/CIRCULATIONAHA.107.693739 Kotani, 2006, Incomplete neointimal coverage of sirolimus-eluting stents. Angioscopic findings, J Am Coll Cardiol, 47, 2108, 10.1016/j.jacc.2005.11.092 Daemen, 2007, Comparison of three-year clinical outcome of sirolimus- and paclitaxel-eluting stents versus bare metal stents in patients with ST-segment elevation myocardial infarction (from the RESEARCH and T-SEARCH Registries), Am J Cardiol, 99, 1027, 10.1016/j.amjcard.2006.11.070 Mauri, 2008, Studies of drug-eluting stents: to each his own?, Circulation, 117, 2047, 10.1161/CIRCULATIONAHA.108.770164 Lüscher, 2007, Drug-eluting stent and coronary thrombosis, biological mechanisms and clinical implications, Circulation, 115, 1051, 10.1161/CIRCULATIONAHA.106.675934 Finn, 2007, Vascular responses to drug eluting stents, importance of delayed healing, Arterioscler Thromb Vasc Biol, 27, 1500, 10.1161/ATVBAHA.107.144220 Togni, 2005, Sirolimus-eluting stents associated with paradoxic coronary vasoconstriction, J Am Coll Cardiol, 46, 231, 10.1016/j.jacc.2005.01.062 Virmani, 2002, Mechanism of late in-stent restenosis after implantation of a paclitaxel derivate-eluting polymer stent system in humans, Circulation, 106, 2649, 10.1161/01.CIR.0000041632.02514.14 Virmani, 2004, Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious?, Circulation, 109, 701, 10.1161/01.CIR.0000116202.41966.D4 Nebeker, 2006, Hypersensitivity cases associated with drug-eluting coronary stents: a review of available cases from the Research on Adverse Drug Events and Reports (RADAR) project, J Am Coll Cardiol, 47, 175, 10.1016/j.jacc.2005.07.071 Joner, 2008, Endothelial cell recovery between comparator polymer-based drug-eluting stents, J Am Coll Cardiol, 52, 333, 10.1016/j.jacc.2008.04.030 Joner, 2006, Pathology of drug-eluting stents in humans: Delayed healing and late thrombotic risk, J Am Coll Cardiol, 48, 193, 10.1016/j.jacc.2006.03.042 Guagliumi, 2003, Images in cardiovascular medicine. Sirolimus-eluting stent implanted in human coronary artery for 16 months: Pathological findings, Circulation, 107, 1340, 10.1161/01.CIR.0000062700.42060.6F Hassan, 2010, Late stent malapposition risk is higher after drug-eluting stent compared with bare-metal stent implantation and associates with late stent thrombosis, Eur Heart J, 31, 1172, 10.1093/eurheartj/ehn553 King, 2008, 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, Circulation, 117, 261, 10.1161/CIRCULATIONAHA.107.188208 Hofma, 2006, Indication of long-term endothelial dysfunction after sirolimus-eluting stent implantation, Eur Heart J, 27, 166, 10.1093/eurheartj/ehi571 Vert, 2009, Bioabsorbable polymers in medicine: an overview, EuroIntervention, 5, F9, 10.4244/EIJV5IFA2 Forrester, 1991, A paradigm for restenosis based on cell biology: Clues for the development of new preventive therapies, J Am Coll Cardiol, 17, 758, 10.1016/S0735-1097(10)80196-2 Serruys, 1988, Incidence of restenosis after successful coronary angioplasty: A time-related phenomenon. A quantitative angiographic study in 342 consecutive patients at 1, 2, 3, and 4 months, Circulation, 77, 361, 10.1161/01.CIR.77.2.361 Asakura, 1998, Remodeling of in-stent neointima, which became thinner and transparent over 3 years: serial angiographic and angioscopic follow-up, Circulation, 97, 2003, 10.1161/01.CIR.97.20.2003 Nobuyoshi, 1988, Restenosis after successful percutaneous transluminal coronary angioplasty: serial angiographic follow-up of 229 patients, J Am Coll Cardiol, 12, 616, 10.1016/S0735-1097(88)80046-9 Oberhauser, 2009, Design principles and performance of bioresorbable polymeric vascular scaffolds, EuroIntervention, 5, F15, 10.4244/EIJV5IFA3 Van Alst, 2009, ABC's of bioabsorption: application of lactide based polymers in fully resorbable cardiovascular stents, EuroIntervention, 5, F23, 10.4244/EIJV5IFA4 Van der Giessen, 1996, Marked inflammatory sequelae to implantation of biodegradable and nonbiodegradable polymers in porcine coronary arteries, Circulation, 94, 1690, 10.1161/01.CIR.94.7.1690 ISO 11607-1:2006, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging. Geneva: International Standards Organization; 2006. 2006 AAMI TIR17:2008, Compatibility of Materials Subject to Sterilisation. Arlington: Association for the Advancement of Medical Instrumentation; 2008. Lambert, 2010, Sterilisation: material compatibility challenges and guidance for combination products, Eur Medic Dev Technol, 21 Lambert, 2011, Radiation and ethylene oxide terminal sterilization experiences with drug eluting stent products, AAPS PharmSciTech, 12, 1116, 10.1208/s12249-011-9644-8 Lambert, 2013, Sterilization of implants and devices, 1339 Schwartz, 2008, Drug-eluting stents in preclinical studies: updated consensus recommendations for preclinical evaluation, Circ Cardiovasc Interv, 1, 143, 10.1161/CIRCINTERVENTIONS.108.789974 Perkins, 2010, Preclinical models of restenosis and their application in the evaluation of drug-eluting stent systems, Vet Pathol, 47, 58, 10.1177/0300985809352978 USDHHS. Guidance for industry and FDA staff: general considerations for animal studies for cardiovascular devices. Rockville: CDRH FDA; 2010. Schwartz, 2002, Drug-eluting stents in preclinical studies: recommended evaluation from a consensus group, Circulation, 106, 1867, 10.1161/01.CIR.0000033485.20594.6F Onuma, 2009, Everolimus-eluting bioabsorbable stent – Abbott Vascular programme, EuroIntervention, 5, F98, 10.4244/EIJV5IFA17 Brugaletta, 2012, Eur Heart J, 33, 1325, 10.1093/eurheartj/ehr466 Bangalore, 2009, Late loss in a disappearing frame of reference: is it still applicable to fully absorbable scaffolds?, EuroIntervention, 5, F43, 10.4244/EIJV5IFA7 Serruys, 2007, Assessment of bioabsorbable stent Onuma, 2012, Freeing the vessel from metallic cage: what can we achieve with bioresorbable vascular scaffolds?, Cardiovasc Interv Ther, 27, 141, 10.1007/s12928-012-0101-8 Ormiston, 1997, Late regression of the dilated site after coronary angioplasty: a 5-year quantitative angiographic study, Circulation, 96, 468, 10.1161/01.CIR.96.2.468 Mintz, 2000, Remodeling and restenosis: observations from serial intravascular ultrasound studies, Curr Interv Cardiol Rep, 2, 316 Nobuyoshi, 1988, Restenosis after successful percutaneous transluminal coronary angioplasty: serial angiographic follow-up of 229 patients, J Am Coll Cardiol, 12, 616, 10.1016/S0735-1097(88)80046-9 Waksman, 2008, Bioabsorbable stents update from the clinical trials Pollman, 2009, Engineering a bioabsorbable stent: REVA programme update, EuroIntervention, 5, F54, 10.4244/EIJV5IFA9 Bourantas, 2012, Bioresorbable scaffolds: current evidence and ongoing clinical trials, Curr Cardiol Rep, 14, 626, 10.1007/s11886-012-0295-5 Tamai, 1999, A biodegradable poly-L-lactic acid coronary stent in the porcine coronary artery, J Am Coll Cardiol, 443 Tsuji, 2004, Four year follow-up of the bioabsorbable stent (IGAKI-TAMAI Stent), Circulation, 68, 135 Ormiston, 2008, A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial, Lancet, 371, 899, 10.1016/S0140-6736(08)60415-8 Serruys, 2009, A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods, Lancet, 373, 897, 10.1016/S0140-6736(09)60325-1 Onuma, 2010, Circulation, 122, 2288, 10.1161/CIRCULATIONAHA.109.921528 Perkins, 2010, Preclinical illustrative of a bioresorbable vascular scaffold (Abst), Cardiovasc Res Tech, 51, 812 Erbel, 2007, Absorbable coronary stents. New promising technology, Herz, 32, 308, 10.1007/s00059-007-2995-y Erbel, 2007, Temporary scaffolding of coronary arteries with bioabsorbable magnesium stents: a prospective, non-randomised multicentre trial, Lancet, 369, 1869, 10.1016/S0140-6736(07)60853-8 Pinto Slottow, 2008, Serial imaging and histology illustrating the degradation of a bioabsorbable magnesium stent in a porcine coronary artery, Eur Heart J, 29, 314, 10.1093/eurheartj/ehm365 Slottow, 2008, Optical coherence tomography and intravascular ultrasound imaging of bioabsorbable magnesium stent degradation in porcine coronary arteries, Cardiovasc Revasc Med, 9, 248, 10.1016/j.carrev.2008.04.001 Waksman, 2006, Safety and efficacy of bioabsorbable magnesium-alloy stent in porcine coronary arteries: morphometric analysis of a long-term study, Cardiovasc Revasc Med, 7, 92, 10.1016/j.carrev.2006.03.026 Waksman, 2006, Safety and efficacy of bioabsorbable magnesium alloy stents in porcine coronary arteries, Catheter Cardiovasc Interv, 68, 607, 10.1002/ccd.20727 Waksman, 2009, Current state of the absorbable metallic (magnesium) stent, EuroIntervention, 5, F94, 10.4244/EIJV5IFA16 Pollman, 2009, Engineering a bioabsorbable stent: REVA programme update, EuroIntervention, 5, F54, 10.4244/EIJV5IFA9 Asikainen, 2007, Bioabsorbable tyrosine-derived polycarbonate in guided bone regeneration Ramcharitar, 2008, Fully biodegradable coronary stents: progress to date, Am J Cardiovasc Drugs, 8, 305, 10.2165/00129784-200808050-00003 REVA Medical, Inc: REVA Medical I - FORM S-1 - August 13, 2010. Disponible en: http://www.faqs.org/sec-filings/100813/REVA-Medical-Inc_S-1. Abizaid, 2008, Stent pipeline: An update on absorbable polymer stents, J Cardiac Interventions Today, 2, 56 Elixir Medical. Disponible en: http://elixirmedical.com/index.php?page=ous-desolve Nishio, 2012, Long-term (>10 years) clinical outcomes of first-in-human biodegradable poly-l-lactic acid coronary stents: Igaki-Tamai stents, Circulation, 125, 2343, 10.1161/CIRCULATIONAHA.110.000901 Ormiston, 2008, A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial, Lancet, 371, 899, 10.1016/S0140-6736(08)60415-8 Serruys, 2009, A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods, Lancet, 373, 897, 10.1016/S0140-6736(09)60325-1 Onuma, 2010, Three-year results of clinical follow-up after a bioresorbable everolimus-eluting scaffold in patients with de novo coronary artery disease: the ABSORB trial, EuroIntervention, 6, 447, 10.4244/EIJ30V6I4A76 Ormiston, 2010, 9 months clinical results of the evaluation of the bioresorbable everolimus-eluting vascular scaffold (BVS) in the treatment of patients with de novo native coronary artery lesions, J Am Coll Cardiol, 56, B9