Risk Factors for Coronary Drug-Eluting Stent Thrombosis: Influence of Procedural, Patient, Lesion, and Stent Related Factors and Dual Antiplatelet Therapy
The complication of stent thrombosis (ST) emerged at a rate of 0.5% annually for first-generation drug-eluting stents (DES), often presenting as death or myocardial infarction. Procedural factors such as stent underexpansion and malapposition are risk factors for ST in patients. The type of lesion being treated and lesion morphology also influence healing after treatment with DES and can contribute to ST. Second-generation DES such as the XIENCE V everolimus-eluting stent differ from the first-generation stents with respect to antiproliferative agents, coating technologies, and stent frame. Improvements in stent structure have resulted in a more complete endothelialization, thereby decreasing the incidence of ST. Bioresorbable scaffolds show promise for restoring vasomotor function and minimizing rates of very late ST. Post-PCI treatment with aspirin and clopidogrel for a year is currently the standard of care for DES, but high-risk patients may benefit from more potent antiplatelet agents. The optimal duration of DAPT for DES is currently unclear and will be addressed in large-scale randomized clinical trials. 1. Introduction Cardiovascular disease accounts for roughly one-third of human mortality throughout the world [1]. Although the last five decades have seen impressive improvements in the diagnosis, evaluation, and therapeutic strategies in patients with symptomatic cardiovascular disease the majority of deaths still occur in patients with occult disease. So-called “sudden cardiac death” (SCD) accounts for over half of all fatalities from cardiovascular disease, and remains a significant challenge to human health and longevity [2, 3]. This review will focus on a specific clinical and anatomic subset of coronary thrombosis that can lead to MI and SCD of thrombotic occlusion of a previously-stented coronary artery (stent thrombosis, ST) [4–6]. Although recognized and appreciated relatively recently [7–9], the study of the causes of ST has yielded invaluable pathophysiological observations and greatly accelerated the understanding of arterial clotting in general and its prevention. While a reliable and permanent solution for ST has remained elusive so far, considerable progress has been made in decreasing its incidence through optimal deployment techniques, improved stent design, and effective antiplatelet therapies. 2. Historical Perspectives PCI dates back to the introduction of balloon angioplasty by Gruentzig [10]. Both early complications such as elastic recoil and acute vessel occlusion, as well as late restenosis from negative remodeling and
References
[1]
D. Lloyd-Jones, R. Adams, M. Carnethon, et al., “Heart disease and stroke statistics 2009 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Committee,” Circulation, vol. 119, pp. e21–e181, 2009.
[2]
G. I. Fishman, S. S. Chugh, J. P. Dimarco et al., “Sudden cardiac death prediction and prevention: report from a national heart, lung, and blood institute and heart rhythm society workshop,” Circulation, vol. 122, no. 22, pp. 2335–2348, 2010.
[3]
R. Virmani, A. P. Burke, and A. Farb, “Sudden cardiac death,” Cardiovascular Pathology, vol. 10, no. 5, pp. 211–218, 2001.
[4]
D. R. Holmes Jr., D. J. Kereiakes, S. Garg et al., “Stent thrombosis,” Journal of the American College of Cardiology, vol. 56, no. 17, pp. 1357–1365, 2010.
[5]
D. R. Holmes Jr., D. J. Kereiakes, W. K. Laskey et al., “Thrombosis and drug-eluting stents. An objective appraisal,” Journal of the American College of Cardiology, vol. 50, no. 2, pp. 109–118, 2007.
[6]
D. E. Cutlip, D. S. Baim, K. K. L. Ho et al., “Stent thrombosis in the modern Era: a pooled analysis of multicenter coronary stent clinical trials,” Circulation, vol. 103, no. 15, pp. 1967–1971, 2001.
[7]
I. Iakovou, T. Schmidt, E. Bonizzoni et al., “Incidence, predictors and outcome of thrombosis after succesful implantation of drug-eluting stents,” Journal of the American Medical Association, vol. 293, no. 17, pp. 2126–2130, 2005.
[8]
T. F. Lüscher, J. Steffel, F. R. Eberli et al., “Drug-eluting stent and coronary thrombosis: biological mechanisms and clinical implications,” Circulation, vol. 115, no. 8, pp. 1051–1058, 2007.
[9]
Y. Honda and P. J. Fitzgerald, “Stent thrombosis: an issue revisited in a changing world,” Circulation, vol. 108, no. 1, pp. 2–5, 2003.
[10]
A. R. Gruentzig, “Percutaneous transluminal coronary angioplasty,” Seminars in Roentgenology, vol. 16, no. 2, pp. 152–153, 1981.
[11]
S. Nakamura, A. Colombo, A. Gaglione et al., “Intracoronary ultrasound observations during stent implantation,” Circulation, vol. 89, no. 5, pp. 2026–2034, 1994.
[12]
A. Sch？mig, F. Neumann, A. Kastrati et al., “A randomized comparison of antiplatelet and anticoagulant therapy after the placement of coronary-artery stents,” The New England Journal of Medicine, vol. 334, no. 17, pp. 1084–1089, 1996.
[13]
P. W. Serruys, M. J. B. Kutryk, and A. T. L. Ong, “Coronary-artery stents,” The New England Journal of Medicine, vol. 354, no. 5, pp. 483–495, 2006.
[14]
J. Daemen, P. Wenaweser, K. Tsuchida et al., “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,” The Lancet, vol. 369, no. 9562, pp. 667–678, 2007.
[15]
D. E. Cutlip, S. Windecker, R. Mehran et al., “Clinical end points in coronary stent trials: a case for standardized definitions,” Circulation, vol. 115, no. 17, pp. 2344–2351, 2007.
[16]
M. Joner, A. V. Finn, A. Farb et al., “Pathology of drug-eluting stents in humans. Delayed healing and late thrombotic risk,” Journal of the American College of Cardiology, vol. 48, no. 1, pp. 193–202, 2006.
[17]
A. V. Finn, G. Nakazawa, M. Joner et al., “Vascular responses to drug eluting stents: importance of delayed healing,” Arteriosclerosis, Thrombosis, and Vascular Biology, vol. 27, no. 7, pp. 1500–1510, 2007.
[18]
G. J. Wilson, G. Nakazawa, R. S. Schwartz et al., “Comparison of inflammatory response after implantation of sirolimus- and paclitaxel-eluting stents in porcine coronary arteries,” Circulation, vol. 120, no. 2, pp. 141–149, 2009.
[19]
A. V. Finn, F. D. Kolodgie, J. Harnek et al., “Differential response of delayed healing and persistent inflammation at sites of overlapping sirolimus- or paclitaxel-eluting stents,” Circulation, vol. 112, no. 2, pp. 270–278, 2005.
[20]
M. Joner, G. Nakazawa, A. V. Finn et al., “Endothelial cell recovery between comparator polymer-based drug-eluting stents,” Journal of the American College of Cardiology, vol. 52, no. 5, pp. 333–342, 2008.
[21]
A. V. Finn, M. Joner, G. Nakazawa et al., “Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization,” Circulation, vol. 115, no. 18, pp. 2435–2441, 2007.
[22]
P. Roy, D. H. Steinberg, S. J. Sushinsky et al., “The potential clinical utility of intravascular ultrasound guidance in patients undergoing percutaneous coronary intervention with drug-eluting stents,” European Heart Journal, vol. 29, no. 15, pp. 1851–1857, 2008.
[23]
D. J. Kereiakes, J. K. Choo, J. J. Young, and T. M. Broderick, “Thrombosis and drug-eluting stents: a critical appraisal,” Reviews in Cardiovascular Medicine, vol. 5, no. 1, pp. 9–15, 2004.
[24]
J. L. Orford, R. Lennon, S. Melby et al., “Frequency and correlates of coronary stent thrombosis in the modern era: analysis of a single center registry,” Journal of the American College of Cardiology, vol. 40, no. 9, pp. 1567–1572, 2002.
[25]
H. Schühlen, A. Kastrati, J. Dirschinger et al., “Intracoronary stenting and risk for major adverse cardiac events during the first month,” Circulation, vol. 98, no. 2, pp. 104–111, 1998.
[26]
E. Cheneau, L. Leborgne, G. S. Mintz et al., “Predictors of subacute stent thrombosis: results of a systematic intravascular ultrasound study,” Circulation, vol. 108, no. 1, pp. 43–47, 2003.
[27]
A. Chieffo, E. Bonizzoni, D. Orlic et al., “Intraprocedural stent thrombosis during implantation of sirolimus-eluting stents,” Circulation, vol. 109, no. 22, pp. 2732–2736, 2004.
[28]
S. Hur, J. Ako, Y. Honda, K. Sudhir, and P. J. Fitzgerald, “Late-acquired incomplete stent apposition: morphologic characterization,” Cardiovascular Revascularization Medicine, vol. 10, no. 4, pp. 236–246, 2009.
[29]
A. Farb, A. P. Burke, F. D. Kolodgie, and R. Virmani, “Pathological mechanisms of fatal late coronary stent thrombosis in humans,” Circulation, vol. 108, no. 14, pp. 1701–1706, 2003.
[30]
A. T. L. Ong, A. Hoye, J. Aoki et al., “Thirty-day incidence and six-month clinical outcome of thrombotic stent occlusion after bare-metal, sirolimus, or paclitaxel stent implantation,” Journal of the American College of Cardiology, vol. 45, no. 6, pp. 947–953, 2005.
[31]
P. K. Kuchulakanti, W. W. Chu, R. Torguson et al., “Correlates and long-term outcomes of angiographically proven stent thrombosis with sirolimus- and paclitaxel-eluting stents,” Circulation, vol. 113, no. 8, pp. 1108–1113, 2006.
[32]
D. Park, S. Park, K. Park et al., “Frequency of and risk factors for stent thrombosis after drug-eluting stent implantation during long-term follow-up,” American Journal of Cardiology, vol. 98, no. 3, pp. 352–356, 2006.
[33]
I. Moussa, C. Di Mario, B. Reimers, T. Akiyama, J. Tobis, and A. Colombo, “Subacute stent thrombosis in the era of intravascular ultrasound-guided coronary stenting without anticoagulant: frequency, predictors and clinical outcome,” Journal of the American College of Cardiology, vol. 29, no. 1, pp. 6–12, 1997.
[34]
J. A. Silva, S. R. Ramee, C. J. White et al., “Primary stenting in acute myocardial infarction: Influence of diabetes mellitus in angiographic results and clinical outcome,” American Heart Journal, vol. 138, no. 3 I, pp. 446–455, 1999.
[35]
E. Kedhi, G. W. Stone, D. J. Kereiakes et al., “Stent thrombosis: insights on outcomes, predictors and impact of dual antiplatelet therapy interruption from the SPIRIT II, SPIRIT III, SPIRIT IV and COMPARE Trials,” Eurointervention, vol. 8, pp. 599–606, 2012.
[36]
J. B. Hermiller, K. Sudhir, R. J. Applegate et al., “Impact of age on clinical outcomes after everolimus-eluting and paclitaxel-eluting stent implantation: pooled analysis from the SPIRIT III and SPIRIT IV Clinical Trials,” EuroIntervention, vol. 8, pp. 87–93, 2012.
[37]
H. K. Win, A. E. Caldera, K. Maresh et al., “Clinical outcomes and stent thrombosis following off-label use of drug-eluting stents,” Journal of the American Medical Association, vol. 297, no. 18, pp. 2001–2009, 2007.
[38]
O. C. Marroquin, F. Selzer, S. R. Mulukutla et al., “A comparison of bare-metal and drug-eluting stents for off-label indications,” The New England Journal of Medicine, vol. 358, no. 4, pp. 342–352, 2008.
[39]
R. J. Applegate, M. T. Sacrinty, M. A. Kutcher et al., “‘Off-label’ stent therapy. 2-year comparison of drug-eluting versus bare-metal stents,” Journal of the American College of Cardiology, vol. 51, no. 6, pp. 607–614, 2008.
[40]
L. Mauri, W. Hsieh, J. M. Massaro, K. K. L. Ho, R. D'Agostino, and D. E. Cutlip, “Stent thrombosis in randomized clinical trials of drug-eluting stents,” The New England Journal of Medicine, vol. 356, no. 10, pp. 1020–1029, 2007.
[41]
A. J. Kirtane, A. Gupta, S. Iyengar et al., “Safety and efficacy of drug-eluting and bare metal stents: comprehensive meta-analysis of randomized trials and observational studies,” Circulation, vol. 119, no. 25, pp. 3198–3206, 2009.
[42]
G. W. Stone, S. G. Ellis, A. Colombo et al., “Offsetting impact of thrombosis and restenosis on the occurrence of death and myocardial infarction after paclitaxel-eluting and bare metal stent implantation,” Circulation, vol. 115, no. 22, pp. 2842–2847, 2007.
[43]
J. Kotani, M. Awata, S. Nanto et al., “Incomplete neointimal coverage of sirolimus-eluting stents. Angioscopic findings,” Journal of the American College of Cardiology, vol. 47, no. 10, pp. 2108–2111, 2006.
[44]
US Food and Drug Administration, “Update to FDA statement on coronary drug-eluting stents. MedSun: Newsletter #11,” http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=11, 2007.
[45]
G. Weisz, M. B. Leon, D. R. Holmes Jr. et al., “Five-year follow-up after sirolimus-eluting stent implantation. Results of the SIRIUS (sirolimus-eluting stent in de-novo native coronary lesions) trial,” Journal of the American College of Cardiology, vol. 53, no. 17, pp. 1488–1497, 2009.
[46]
P. Wenaweser, J. Daemen, M. Zwahlen et al., “Incidence and correlates of drug-eluting stent thrombosis in routine clinical practice. 4-year results from a large 2-institutional cohort study,” Journal of the American College of Cardiology, vol. 52, no. 14, pp. 1134–1140, 2008.
[47]
G. W. Stone, A. Rizvi, W. Newman et al., “Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease,” The New England Journal of Medicine, vol. 362, no. 18, pp. 1663–1674, 2010.
[48]
P. C. Smits, E. Kedhi, K. Royaards et al., “2-year follow-up of a randomized controlled trial of everolimus- and paclitaxel-eluting stents for coronary revascularization in daily practice: COMPARE (Comparison of the everolimus eluting XIENCE-V stent with the paclitaxel eluting TAXUS LIBERT stent in all-comers: a randomized open label trial),” Journal of the American College of Cardiology, vol. 58, no. 1, pp. 11–18, 2011.
[49]
D. Planer, P. C. Smits, D. J. Kereiakes et al., “Comparison of everolimus- and paclitaxel-eluting stents in patients with acute and stable coronary syndromes: pooled results from the SPIRIT (A Clinical Evaluation of the XIENCE v Everolimus Eluting Coronary Stent System) and COMPARE (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) trials,” JACCC, vol. 4, no. 10, pp. 1104–1115, 2011.
[50]
J. Doostzadeh, L. N. Clark, S. Bezenek, W. Pierson, P. R. Sood, and K. Sudhir, “Recent progress in percutaneous coronary intervention: evolution of the drug-eluting stents, focus on the XIENCE v drug-eluting stent,” Coronary Artery Disease, vol. 21, no. 1, pp. 46–56, 2010.
[51]
R. A. Lange and L. D. Hillis, “Second-generation drug-eluting coronary stents,” The New England Journal of Medicine, vol. 362, no. 18, pp. 1728–1730, 2010.
[52]
C. Simon, J. C. Palmaz, and E. A. Sprague, “Influence of topography on endothelialization of stents: clues for new designs,” Journal of Long-Term Effects of Medical Implants, vol. 10, no. 1-2, pp. 143–151, 2000.
[53]
P. W. Serruys, P. Ruygrok, J. Neuzner et al., “randomised comparison of an everolimus-eluting coronary stent with a paclitaxel-eluting coronary stent: the SPIRIT II trial,” EuroIntervention, vol. 2, pp. 286–294, 2006.
[54]
R. J. Petersen and L. T. Rozelle, “Ethylcellulose perfluorobutyrate: a highly non-thrombogenic fluoropolymer for gas exchange membranes,” Transactionsof the American Society for Artificial Internal Organs, vol. 21, pp. 242–248, 1975.
[55]
D. Kiaei, A. S. Hoffman, and T. A. Horbett, “Tight binding of albumin to glow discharge treated polymers,” Journal of Biomaterials Science, vol. 4, no. 1, pp. 35–44, 1992.
[56]
P. W. Serruys, S. Silber, S. Garg et al., “Comparison of zotarolimus-eluting and everolimus-eluting coronary stents,” The New England Journal of Medicine, vol. 363, no. 2, pp. 136–146, 2010.
[57]
S. Silber, S. Windecker, P. Vranckx, and P. W. Serruys, “Unrestricted randomised use of two new generation drug-eluting coronary stents: 2-year patient-related versus stent-related outcomes from the RESOLUTE All Comers trial,” The Lancet, vol. 377, no. 9773, pp. 1241–1247, 2011.
[58]
E. Kedhi, K. S. Joesoef, E. McFadden et al., “Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial,” The Lancet, vol. 375, no. 9710, pp. 201–209, 2010.
[59]
T. Palmerini, G. Biondi-Zoccai, D. D. Riva et al., “Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis,” The Lancet, vol. 379, no. 9824, pp. 1393–1402, 2012.
[60]
T. Palmerini, A. J. Kirtane, P. W. Serruys et al., “Stent thrombosis with everolimus-eluting stents: meta-analysis of comparative randomized controlled trials,” Circulation, vol. 5, pp. 357–364, 2012.
[61]
S. Bangalore, S. Kumar, M. Fusaro et al., “Short- and long-term outcomes with drug-eluting and bare-metal coronary stents: a mixed-treatment comparison analysis of 117 762 patient-years of follow-up from randomized trials,” Circulation, vol. 125, pp. 2873–2891, 2012.
[62]
S. Bangalore, S. Kumar, M. Fusaro et al., “Outcomes with various drug eluting or bare metal stents in patients with diabetes mellitus: mixed treatment comparison analysis of 22, 844 patient years of follow-up from randomised trials,” British Medical Journal, vol. 345, Article ID e5170, 2012.
[63]
K. Sudhir, J. B. Hermiller, S. S. Naidu et al., “on behalf of the XIENCE V USA Investigators. Clinical outcomes in real-world patients with acute myocardial infarction receiving XIENCE V everolimus-eluting stents: one-year results from the XIENCE V USA study,” Catheterization and Cardiovascular Interventions, 2012.
[64]
T. Palmerini, G. Biondi-Zoccai, D. Della Riva et al., “Clinical outcomes with drug-wluting and bare metal stents in patients with ST-segment elevation myocardial infarction: evidence from a comprehensive network meta-analysis,” Journal of the American College of Cardiology, 2013.
[65]
S. Windecker, P. W. Serruys, S. Wandel et al., “Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial,” The Lancet, vol. 372, no. 9644, pp. 1163–1173, 2008.
[66]
J. Wykrzykowska, P. Serruys, P. Buszman et al., “The three year follow-up of the randomised “all-comers” trial of a biodegradable polymer biolimus-eluting stent versus permanent polymer sirolimus-eluting stent (LEADERS),” EuroIntervention, vol. 7, no. 7, pp. 789–795, 2011.
[67]
B. Chevalier, S. Silber, S. Park et al., “Randomized comparison of the nobori biolimus A9- eluting coronary stent with the taxus liberté paclitaxel-eluting coronary stent in patients with stenosis in native coronary arteries: The NOBORI 1 trial—phase 2,” Circulation, vol. 2, no. 3, pp. 188–195, 2009.
[68]
P. C. Smits, S. Hofma, M. Togni et al., “Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent (COMPARE II): a randomised, controlled, noninferiority trial,” The Lancet, vol. 381, pp. 651–660, 2013.
[69]
Y. Yang, M. Kim, C. Kim et al., “Late stent thrombosis after drug-eluting stent implantation: a rare case of accelerated neo-atherosclerosis and early manifestation of neointimal rupture,” Korean Circulation Journal, vol. 41, no. 7, pp. 409–412, 2011.
[70]
Y. Onuma, K. Nieman, M. Webster et al., “Five-year clinical and functional multi-slice CT angiographic results after coronary implantation of the fully resorbable polymeric everolimus-eluting scaffold in patients with de novo coronary artery disease: the ABSORB trial,” Journal of the American College of Cardiology. In press.
[71]
R. Diletti, V. Farooq, C. Girasis et al., “Clinical and intravascular imaging outcomes at 1 and 2 years after implantation of absorb everolimus eluting bioresorbable vascular scaffolds in small vessels. Late lumen enlargement: does bioresorption matter with small vessel size? Insight from the ABSORB cohort B trial,” Heart, vol. 99, pp. 98–105, 2013.
[72]
B. Chevalier, “On behalf of the ABSORB Extend investigators. ABSORB EXTEND 12-month outcomes in the first 450 patient enrolled. Abstract presented at the Rotterdam EuroPCR Focus on Bioresorbable Vascular Scaffolds,” 2013.
[73]
A. Sch？mig, F. Neumann, A. Kastrati et al., “A randomized comparison of antiplatelet and anticoagulant therapy after the placement of coronary artery stents,” The New England Journal of Medicine, vol. 334, no. 17, pp. 1084–1089, 1996.
[74]
M. E. Bertrand, H. Rupprecht, P. Urban, and A. H. Gershlick, “Double-blind study of the safety of clopidogrel with and without a loading dose in combination with aspirin compared with ticlopidine in combination with aspirin after coronary stenting: the clopidogrel aspirin stent international cooperative study (CLASSICS),” Circulation, vol. 102, no. 6, pp. 624–629, 2000.
[75]
S. R. Mehta, S. Yusuf, R. J. G. Peters et al., “Effects of pretreatment with clopidogrel and aspirin followed by long-term therapy in patients undergoing percutaneous coronary intervention: the PCI-CURE study,” The Lancet, vol. 358, no. 9281, pp. 527–533, 2001.
[76]
C. P. Cannon, R. A. Harrington, S. James et al., “Comparison of ticagrelor with clopidogrel in patients with a planned invasive strategy for acute coronary syndromes (PLATO): a randomised double-blind study,” The Lancet, vol. 375, no. 9711, pp. 283–293, 2010.
[77]
G. Montalescot, S. D. Wiviott, E. Braunwald et al., “Prasugrel compared with clopidogrel in patients undergoing percutaneous coronary intervention for ST-elevation myocardial infarction (TRITON-TIMI 38): double-blind, randomised controlled trial,” The Lancet, vol. 373, no. 9665, pp. 723–731, 2009.
[78]
D. R. Holmes Jr., G. J. Dehmer, S. Kaul, D. Leifer, P. T. O'Gara, and C. M. Stein, “ACCF/AHA clinical alert: ACCF/AHA clopidogrel clinical alert: approaches to the FDA “boxed warning” a report of the American college of cardiology foundation task force on clinical expert consensus documents and the American heart association,” Circulation, vol. 122, no. 5, pp. 537–557, 2010.
[79]
L. Bonello, U. S. Tantry, R. Marcucci et al., “Consensus and future directions on the definition of high on-treatment platelet reactivity to adenosine diphosphate,” Journal of the American College of Cardiology, vol. 56, no. 12, pp. 919–933, 2010.
[80]
“FDA Drug Safety Communication: reduced effectiveness of Plavix (clopidogrel) in patients who are poor metabolizers of the drug,” http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203888.htm.
[81]
M. J. Price, P. B. Berger, P. S. Teirstein et al., “Standard- vs high-dose clopidogrel based on platelet function testing after percutaneous coronary intervention: the GRAVITAS randomized trial,” Journal of the American Medical Association, vol. 305, no. 11, pp. 1097–1105, 2011.
[82]
J. W. van Werkum, A. A. Heestermans, A. C. Zomer et al., “Predictors of coronary stent thrombosis: the Dutch Stent Thrombosis Registry,” Journal of the American College of Cardiology, vol. 53, no. 16, pp. 1399–1409, 2009.
[83]
M. W. Krucoff, D. R. Rutledge, L. Gruberg et al., “A new era of prospective real-world safety evaluation: primary report of XIENCE v USA (XIENCE v Everolimus Eluting Coronary Stent System Condition-of-Approval Post-Market Study),” Journal of the American College of Cardiology, vol. 4, no. 12, pp. 1298–1309, 2011.
[84]
G. W. Stone, D. R. Rutledge, K. Sudhir et al., “Stent thrombosis and dual antiplatelet interruption. Insights from the XIENCE V everolimus-eluting coronary stent system trials,” Abstract presented at Transcatheter Therapeutics, San Francisco, Calif, USA, 2011.
[85]
F. G. Kushner, M. Hand, S. C. Smith et al., “2009 focused updates: ACC/AHA guidelines for the management of patients with st-elevation myocardial infarction (updating the 2004 guideline and 2007 focused update) and ACC/AHA/SCAI guidelines on percutaneous coronary intervention (updating the 2005 guideline and 2007 focused update),” Circulation, vol. 120, no. 22, pp. 2271–2306, 2009.
[86]
S. Park, D. Park, Y. Kim et al., “Duration of dual antiplatelet therapy after implantation of drug-eluting stents,” The New England Journal of Medicine, vol. 362, no. 15, pp. 1374–1382, 2010.
[87]
M. Valgimigli, G. Campo, M. Monti et al., “Short-versus long-term duration of dual-antiplatelet therapy after coronary stenting: a randomized multicenter trial,” Circulation, vol. 125, no. 16, pp. 2015–2026, 2012.
[88]
L. Mauri, D. J. Kereiakes, S. T. Normand et al., “Rationale and design of the dual antiplatelet therapy study, a prospective, multicenter, randomized, double-blind trial to assess the effectiveness and safety of 12 versus 30 months of dual antiplatelet therapy in subjects undergoing percutaneous coronary intervention with either drug-eluting stent or bare metal stent placement for the treatment of coronary artery lesions,” American Heart Journal, vol. 160, no. 6, pp. 1035–1041, 2010.
[89]
S. S. Naidu, M. W. Krucoff, D. R. Rutledge et al., “Contemporary incidence and predictors of stent thrombosis and other major adverse cardiac events in the year after XIENCE V implantation: results from the 8, 061-patient XIENCE V United States study,” Journal of the American College of Cardiology, vol. 5, pp. 626–635, 2012.
[90]
R. Mehran, J. B. Hermiller, D. R. Rutledge, W. L. Lombardi, and M. W. Krucoff, “Prevalence and predictors of dual antiplatelet therapy non-compliance after drug-eluting stent placement: one year-results from XIENCE V studies,” Abstract presented at EuroPCR, Paris, France, 2013.
