Perspective
Stent Thrombosis Redux — The FDA Perspective
N Engl J Med 2007; 356:984-987February 12, 2007
- Article
In the light of recent studies suggesting that drug-eluting stents may pose a risk of thrombosis that was not observed during pre-market testing, the Food and Drug Administration (FDA) convened a meeting of its Circulatory System Devices Advisory Panel on December 7 and 8, 2006, to examine the safety of these devices. The FDA will carefully consider the information and views presented at the meeting in deciding on future actions.
An understanding of the mechanisms of neointimal growth within bare-metal stents led to the development of drug-eluting stents designed to reduce restenosis rates. Both drug-eluting stents approved by the FDA (Cordis's Cypher stent, approved in 2003, and Boston Scientific's Taxus stent, approved in 2004) were shown to be effective in reducing repeated-revascularization rates, as compared with bare-metal stents. Moreover, there appeared to be no safety disadvantage: studies showed no increase in the rates of stent thrombosis, death, or myocardial infarction up to 1 year after implantation. Drug-eluting stents were therefore enthusiastically adopted in the United States and were soon used in approximately 80% of percutaneous coronary interventions.
Given this widespread use, it should be noted that the FDA-approved indications were limited to newly diagnosed coronary lesions, less than 28 to 30 mm long, in clinically stable patients without additional serious medical conditions. As a condition of approval, and in anticipation of U.S. usage patterns, the FDA required both manufacturers to follow patients in their original clinical trials for 5 years after implantation and to conduct registry studies of consecutively enrolled new patients to collect data on “real-world” use.
Soon after approval, there were reports of subacute stent thrombosis in patients who received Cypher stents. Stent thrombosis is a serious adverse event commonly associated with sudden death or acute myocardial infarction. There are probably multiple risk factors for such events, including complex lesions and coexisting medical conditions. The risk of stent thrombosis may be increased by delayed arterial healing associated with drug-eluting stents. The FDA responded by alerting physicians to these reports in July and October 2003.1 An update was posted on the FDA Web site in November 2003, indicating that additional data from Cypher clinical trials revealed no increased risk of subacute thrombosis. Although these data were reassuring, detecting thrombosis signals remained a high priority for the FDA.
By early 2006, the agency had formulated several impressions from its review of published reports and the registry studies: the implantation of drug-eluting stents in complex lesions (e.g., bifurcations, lesions requiring overlapping stents, or lesions from acute myocardial infarction) and in patients with conditions such as renal dysfunction or diabetes led to higher rates of stent thrombosis than implantation for the approved indications; the magnitude of the increased risk was small (from <1% to approximately 5%); premature discontinuation of antiplatelet therapy was an independent risk factor for thrombosis; and thrombosis can occur years after implantation.
In September 2006, a meta-analysis of randomized trials suggested that there is a small but significant increase in the risk of death or Q-wave myocardial infarction throughout a period of 3 years after implantation of a Cypher stent, possibly because of late stent thrombosis.2 Another study showed that stent thromboses occurred at a rate of 0.6% per year between 30 days and 3 years after implantation.3 These studies received wide attention, prompting the FDA to convene an advisory panel meeting to review the data.
The panel meeting focused on safety issues and the use of dual antiplatelet therapy. The discussions covered both on-label and off-label use of drug-eluting stents, since it is estimated that more than 60% of use is off-label — for example, the stents are implanted in types of lesions that were excluded from the pivotal trials or in patients such as those with diabetes who were not sufficiently represented in the trial populations for a specific labeled indication.
The panel agreed, and the FDA concurs, that when drug-eluting stents are used for their approved indications, the risk of thrombosis does not outweigh their advantages over bare-metal stents in reducing the rate of repeated revascularization. But the panel also concluded that, as compared with on-label use, off-label use is associated with increased risks of both early and late stent thrombosis, as well as death or myocardial infarction.
With regard to antiplatelet therapy, data from nonrandomized studies suggest that a more prolonged course of clopidogrel than that recommended in the stent labels (currently 3 months for recipients of the Cypher stent and 6 months for recipients of the Taxus stent) is beneficial.4 Nevertheless, stent thrombosis may occur despite continued dual antiplatelet therapy. Recognizing that the optimal duration of such therapy remains unknown, the panel requested that the instructions for use of both stents include a reference to the current guidelines for percutaneous coronary interventions, which state that dual antiplatelet therapy should be continued for 12 months in patients who are not at high risk for bleeding.5
Although the absolute risk appears to be less than 2% throughout the first 3 years after implantation when stents are used for the approved indications, thrombosis with drug-eluting stents is a clinically important problem that may occur long after implantation. It is uncertain whether cases of late stent thrombosis will continue to accrue with longer-term follow-up. Not unexpectedly, the risk of thrombosis increases when drug-eluting stents are used in complex lesions and in patients with coexisting conditions, but the magnitude of this risk as compared with that posed by alternative treatments is unknown. Early discontinuation of antiplatelet therapy is associated with an increased risk of thrombosis, but the optimal duration of clopidogrel treatment remains undefined.
It is also uncertain why the increased rates of stent thrombosis seen more than 1 year after implantation even with on-label use (0.44% with the Taxus stent vs. 0.07% with bare-metal stents, P=0.054; 0.6% with the Cypher stent vs. 0% with bare-metal stents, P=0.03) did not translate into increased rates of death or myocardial infarction in the randomized studies, despite high rates of morbidity and mortality due to stent thrombosis. It is possible that the samples in the pooled studies were simply not large enough to permit the detection of a difference between treatment groups. Alternatively, increases in the rate of death or myocardial infarction among patients who received drug-eluting stents might have been offset by a reduction in adverse events associated with in-stent restenosis and repeated revascularization.
For infrequent events such as stent thrombosis, large studies are needed to assess risk accurately. The FDA concurs with the panel's recommendation that larger and longer studies be conducted, focusing on important safety end points (death and myocardial infarction) and on the appropriate duration of dual antiplatelet therapy. The FDA also believes that randomized, controlled trials (see table
Randomized Studies of Currently Approved Drug-Eluting Stents That May Result in Expansion of Indications for Use.) are needed to determine the best treatment strategies for lesions in patients with common, complex conditions such as multivessel coronary disease, diabetes, and acute myocardial infarction.Given the benefits and risks, physicians should consider certain patient characteristics in deciding whether to use a drug-eluting or a bare-metal stent. For example, patients who cannot comply with extended clopidogrel use or have planned procedures requiring early discontinuation of antiplatelet therapy may not be candidates for a drug-eluting stent. Patients should be thoroughly educated about the need for strict adherence to the recommended course of antiplatelet therapy and should discuss any changes with their cardiologist. Health care providers who are considering discontinuation of antiplatelet therapy in order to perform invasive procedures should also consult with the patient's cardiologist.
The safety and effectiveness of drug-eluting stents as compared with those of alternative treatments deserve continued study. The lessons we have learned and the answers to remaining questions will facilitate the development and review of future drug-eluting stents.
A discussion between Dr. Donald Baim, chief medical and scientific officer of Boston Scientific, and Dr. Steven Nissen, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, on the risks and benefits of drug-eluting stents can be heard at www.nejm.org.
This article (10.1056/NEJMp068304) was published at www.nejm.org on February 12, 2007.
Source Information
Dr. Farb is a medical officer, and Ms. Boam the chief of the Interventional Cardiology Devices Branch, of the Office of Device Evaluation, Center for Devices and Radiological Health, FDA, Rockville, MD.
- References
References
1
Muni NI ,Gross TP . Problems with drug-eluting coronary stents -- the FDA perspective. N Engl J Med 2004;351:1593-1595
Full Text | Web of Science | Medline2
Camenzind E, Steg PG, Wijns W. A meta-analysis of first generation drug eluting stent programs. Presented at the World Congress of Cardiology 2006, Barcelona, September 2–5, 2006.
3
Wenaweser P, Tsuchida K, Vaina S, et al. Late stent thrombosis following drug-eluting stent implantation: data from a large, two-institutional cohort study. Presented at the World Congress of Cardiology 2006, Barcelona, September 2–5, 2006.
4
Eisenstein EL ,Anstrom KJ ,Kong DF , et al. Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation. JAMA 2006;297:159-168
CrossRef | Web of Science | Medline5
Smith SC Jr, Feldman TE, Hirshfeld JW Jr, et al. 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 (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention). J Am Coll Cardiol 2006;47:e1-e121. (Also available at http://www.acc.org/qualityandscience/clinical/guidelines/percutaneous/update/index.pdf.)
- Citing Articles (106)
Citing Articles
1
Jerome J. Federspiel, Sally C. Stearns, Kristin L. Reiter, Kimberley H. Geissler, Matthew A. Triplette, Laura P. D'Arcy, Brett C. Sheridan, Joseph S. Rossi. (2012) Disappearing and reappearing differences in drug-eluting stent use by race. Journal of Evaluation in Clinical Practiceno-no
CrossRef2
Andrew J. Epstein, Jonathan D. Ketcham, Saif S. Rathore, Peter W. Groeneveld. (2012) Variations in the Use of an Innovative Technology by Payer. Medical Care 50:1, 1-9
CrossRef3
K. Hamesch, P. Subramanian, X. Li, K. Dembowsky, E. Chevalier, C. Weber, A. Schober. (2012) The CXCR4 antagonist POL5551 is equally effective as sirolimus in reducing neointima formation without impairing re-endothelialisation. Thrombosis and Haemostasis 107:2,
CrossRef4
Sandy M. Green, Faith Selzer, Suresh R. Mulukutla, Edward J. Tadajweski, Jamie A. Green, Robert L. Wilensky, Warren K. Laskey, Howard A. Cohen, Sunil V. Rao, Steven D. Weisbord, Joon S. Lee, Steven E. Reis, Kevin E. Kip, Sheryl F. Kelsey, David O. Williams, Oscar C. Marroquin. (2011) Comparison of Bare-Metal and Drug-Eluting Stents in Patients with Chronic Kidney Disease (from the NHLBI Dynamic Registry). The American Journal of Cardiology 108:11, 1658-1664
CrossRef5
Mitchell W. Krucoff, David R. Rutledge, Luis Gruberg, Lalitha Jonnavithula, John N. Katopodis, William Lombardi, Vivian W. Mao, Samin K. Sharma, Charles A. Simonton, Hoshedar P. Tamboli, Jin Wang, Olivia Wilburn, Weiying Zhao, Krishnankutty Sudhir, James B. Hermiller. (2011) A New Era of Prospective Real-World Safety Evaluation. JACC: Cardiovascular Interventions 4:12, 1298-1309
CrossRef6
Manrico Balbi, Massimiliano Fedele, Gian P. Bezante, Claudio Brunelli, Antonio Barsotti. (2011) Acute myocardial infarction related to very late sirolimus-eluting stent thrombosis 6 months after discontinuation of dual antiplatelet therapy. Journal of Cardiovascular Medicine 12:11, 839-842
CrossRef7
David Planer, Pieter C. Smits, Dean J. Kereiakes, Elvin Kedhi, Martin Fahy, Ke Xu, Patrick W. Serruys, Gregg W. Stone. (2011) Comparison of Everolimus- and Paclitaxel-Eluting Stents in Patients With Acute and Stable Coronary Syndromes. JACC: Cardiovascular Interventions 4:10, 1104-1115
CrossRef8
David E. Kandzari, Colin S. Barker, Martin B. Leon, Laura Mauri, William Wijns, Jean Fajadet, Roxana Mehran. (2011) Dual Antiplatelet Therapy Duration and Clinical Outcomes Following Treatment With Zotarolimus-Eluting Stents. JACC: Cardiovascular Interventions 4:10, 1119-1128
CrossRef9
SUSAN BEZENEK, JAMES HERMILLER, ALEXANDRA LANSKY, MANEJEH YAQUB, KYOKO HATTORI, SHERRY CAO, POORNIMA SOOD, KRISHNAKUTTY SUDHIR. (2011) Low Stent Thrombosis Risk with the XIENCE V® Everolimus-Eluting Coronary Stent: Evidence from Randomized and Single-Arm Clinical Trials. Journal of Interventional Cardiology 24:4, 326-341
CrossRef10
Aida Ribera, Ignacio Ferreira-González, Bruno García del Blanco, Josep R. Marsal, Purificación Cascant, Gerard Martí, Ángel R. Cequier, Joan Antoni Gómez-Hospital, Eduard Fernandez-Nofrerías, Xavier Carrillo, M. Carmen López-Pérez, Josep Navarro, Rafael Raso, David García-Dorado, Gaietà Permanyer-Miralda. (2011) Drug-eluting stents for off-label indications in real clinical world: Evidence based or ‘intuition’ based clinical practice?. International Journal of Cardiology
CrossRef11
Renato Valenti, Ruben Vergara, Angela Migliorini, Guido Parodi, Piergiovanni Buonamici, Giampaolo Cerisano, Nazario Carrabba, David Antoniucci. (2011) Comparison of Everolimus-Eluting Stent With Paclitaxel-Eluting Stent in Long Chronic Total Occlusions. The American Journal of Cardiology 107:12, 1768-1771
CrossRef12
R. Scott Wright, Jeffrey L. Anderson, Cynthia D. Adams, Charles R. Bridges, Donald E. Casey, Steven M. Ettinger, Francis M. Fesmire, Theodore G. Ganiats, Hani Jneid, A. Michael Lincoff, Eric D. Peterson, George J. Philippides, Pierre Theroux, Nanette K. Wenger, James Patrick Zidar. (2011) 2011 ACCF/AHA Focused Update Incorporated Into the ACC/AHA 2007 Guidelines for the Management of Patients With Unstable Angina/Non–ST-Elevation Myocardial Infarction. Journal of the American College of Cardiology 57:19, e215-e367
CrossRef13
Asmir Syed, Itsik Ben-Dor, Yanlin Li, Sara Collins, Rebecca Torguson, Kohei Wakabayashi, Manuel Gonzalez, Gabriel Maluenda, Cedric Delhaye, Loic Belle, Michael Gaglia, Zhenyi Xue, Kimberly Kaneshige, Nelson Bernardo, Kenneth Kent, William Suddath, Lowell Satler, Augusto Pichard, Joseph Lindsay, Ron Waksman. (2011) Hybrid strategy of a bare metal stent combined with a drug-eluting stent versus exclusive drug-eluting stent implantation for multivessel percutaneous coronary intervention. EuroIntervention 6:9, 1085-1090
CrossRef14
Sigmund Silber, Stephan Windecker, Pascal Vranckx, Patrick W Serruys. (2011) 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 377:9773, 1241-1247
CrossRef15
David E. Kandzari, Ahmad A. Zankar, Paul S. Teirstein, Emmanouil S. Brilakis, Subhash Banerjee, Matthew J. Price, Curtiss T. Stinis, Paul A. Hudson, Thom G.A. Dahle, Marvin Eng, Ryan Brown, Andrew Ferguson, Tayo A. Addo, Jeffrey J. Popma. (2011) Clinical outcomes following predilation with a novel 1.25-mm diameter angioplasty catheter. Catheterization and Cardiovascular Interventions 77:4, 510-514
CrossRef16
Payman Zamani, Scott Kinlay. (2011) Long-term risk of clinical events from stenting side branches of coronary bifurcation lesions with drug-eluting and bare-metal stents: An observational meta-analysis. Catheterization and Cardiovascular Interventions 77:2, 202-212
CrossRef17
Jin Sook Kwon, Rho Kwan Park, Tae Jin Shim, Myung Ho Jeong, Myeong Chan Cho, Youngkeun Ahn, Dong-Woon Kim. (2011) Comparison of bare metal stent and paclitaxel-eluting stent using a novel rat aorta stent model. Journal of Veterinary Science 12:2, 143
CrossRef18
Hiroyuki Hao, Hatsue Ishibashi-Ueda, Masahiko Tsujimoto, Yasunori Ueda, Junya Shite, Giulio Gabbiani, Kenichi Fujii, Seiichi Hirota. (2011) Drug-Eluting Stent. Circulation Journal 75:7, 1548-1558
CrossRef19
Kaiser, Christoph, Galatius, Soeren, Erne, Paul, Eberli, Franz, Alber, Hannes, Rickli, Hans, Pedrazzini, Giovanni, Hornig, Burkhard, Bertel, Osmund, Bonetti, Piero, De Servi, Stefano, Brunner-La Rocca, Hans-Peter, Ricard, Ingrid, Pfisterer, Matthias, . (2010) Drug-Eluting versus Bare-Metal Stents in Large Coronary Arteries. New England Journal of Medicine 363:24, 2310-2319
Full Text20
Saami Yazdani, Masataka Nakano, Fumiyuki Otsuka, Frank Kolodgie, Renu Virmani. (2010) Atheroma and coronary bifurcations: before and after stenting. EuroIntervention 6:J, J24-J30
CrossRef21
P. Barash, S. Akhtar. (2010) Coronary stents: factors contributing to perioperative major adverse cardiovascular events. British Journal of Anaesthesia 105:Supplement 1, i3-i15
CrossRef22
Nathan D Lambert, Robert J Applegate. (2010) The comparative safety of bare-metal and drug-eluting intracoronary stents. Expert Review of Medical Devices 7:5, 611-624
CrossRef23
Scot Garg, Patrick W. Serruys. (2010) Coronary Stents. Journal of the American College of Cardiology 56:10, S1-S42
CrossRef24
ZHAN GAO, BO XU, YUEJIN YANG, JILIN CHEN, SHUBIN QIAO, JIAN-JUN LI, XUEWEN QIN, YONGJIAN WU, MIN YAO, JINQING YUAN, JUE CHEN, HAIBO LIU, JUN DAI, RUN-LIN GAO. (2010) Stent Thrombosis Following 2 Drug-Eluting Stent Implantations for Coronary Bifurcation Lesion: A Single-Center Analysis. Journal of Interventional Cardiology 23:4, 346-351
CrossRef25
Boris Radeleff, Ruben Lopez-Benitez, Ulrike Stampfl, Sibylle Stampfl, Christof Sommer, Heidi Thierjung, Irina Berger, Guenter Kauffmann, Goetz M. Richter. (2010) Paclitaxel-induced Arterial Wall Toxicity and Inflammation: Tissue Uptake in Various Dose Densities in a Minipig Model. Journal of Vascular and Interventional Radiology 21:8, 1262-1270
CrossRef26
Serruys, Patrick W., Silber, Sigmund, Garg, Scot, van Geuns, Robert Jan, Richardt, Gert, Buszman, Pawel E., Kelbæk, Henning, van Boven, Adrianus Johannes, Hofma, Sjoerd H., Linke, Axel, Klauss, Volker, Wijns, William, Macaya, Carlos, Garot, Philippe, DiMario, Carlo, Manoharan, Ganesh, Kornowski, Ran, Ischinger, Thomas, Bartorelli, Antonio, Ronden, Jacintha, Bressers, Marco, Gobbens, Pierre, Negoita, Manuela, van Leeuwen, Frank, Windecker, Stephan, . (2010) Comparison of Zotarolimus-Eluting and Everolimus-Eluting Coronary Stents. New England Journal of Medicine 363:2, 136-146
Full Text27
Young-Hak Kim, Duk-Woo Park, Won-Jang Kim, Jong-Young Lee, Sung-Cheol Yun, Soo-Jin Kang, Seung-Whan Lee, Cheol Whan Lee, Myeong-Ki Hong, Seong-Wook Park, Seung-Jung Park. (2010) Impact of the Extent of Coronary Artery Disease on Outcomes After Revascularization for Unprotected Left Main Coronary Artery Stenosis. Journal of the American College of Cardiology 55:23, 2544-2552
CrossRef28
Art Sedrakyan, Danica Marinac-Dabic, Sharon-Lise T. Normand, Alvin Mushlin, Tom Gross. (2010) A Framework for Evidence Evaluation and Methodological Issues in Implantable Device Studies. Medical Care 48, S121-S128
CrossRef29
Helmar Bornemann, Florian Prüller, Helfried Metzler. (2010) The patient with coronary stents and antiplatelet agents: what to do and how to deal?. European Journal of Anaesthesiology 27:5, 406-410
CrossRef30
Gaku Nakazawa, Saami K. Yazdani, Aloke V. Finn, Marc Vorpahl, Frank D. Kolodgie, Renu Virmani. (2010) Pathological Findings at Bifurcation Lesions. Journal of the American College of Cardiology 55:16, 1679-1687
CrossRef31
Scot Garg, Patrick Serruys. (2010) Benefits of and safety concerns associated with drug-eluting coronary stents. Expert Review of Cardiovascular Therapy 8:3, 449-470
CrossRef32
Patrick W. Serruys, Yoshinobu Onuma, Scot Garg, Pascal Vranckx, Bernard De Bruyne, Marie-Claude Morice, Antonio Colombo, Carlos Macaya, Gert Richardt, Jean Fajadet, Christian Hamm, Monique Schuijer, Tessa Rademaker, Kristel Wittebols, Hans Peter Stoll. (2010) 5-Year Clinical Outcomes of the ARTS II (Arterial Revascularization Therapies Study II) of the Sirolimus-Eluting Stent in the Treatment of Patients With Multivessel De Novo Coronary Artery Lesions. Journal of the American College of Cardiology 55:11, 1093-1101
CrossRef33
Dominique Joyal, Kristian B. Filion, Mark J. Eisenberg. (2010) Effectiveness and safety of drug-eluting stents in vein grafts: A meta-analysis. American Heart Journal 159:2, 159-169.e4
CrossRef34
Sarah K. Gualano, Hitinder S. Gurm, David Share, Dean Smith, Herbert D. Aronow, Thomas LaLonde, Eric R Bates, Hameem Changezi, Richard McNamara, Mauro Moscucci. (2010) Temporal Trends in the Use of Drug-eluting Stents for Approved and Off-label Indications: A Longitudinal Analysis of a Large Multicenter Percutaneous Coronary Intervention Registry. Clinical Cardiology 33:2, 111-116
CrossRef35
U. Stenestrand, S. K. James, J. Lindback, O. Frobert, J. Carlsson, F. Schersten, T. Nilsson, B. Lagerqvist, . (2010) Safety and efficacy of drug-eluting vs. bare metal stents in patients with diabetes mellitus: long-term follow-up in the Swedish Coronary Angiography and Angioplasty Registry (SCAAR). European Heart Journal 31:2, 177-186
CrossRef36
S. WILLIS, V. O'BYRNE. 2010. Safety and efficacy issues in designing drug–device combination products: the case of drug eluting stents. , 341-368.
CrossRef37
Andrew J. Carter. (2009) Drug-Eluting Stent Fracture. Journal of the American College of Cardiology 54:21, 1932-1934
CrossRef38
Seung-Jung Park, Young-Hak Kim. (2009) Percutaneous coronary intervention for unprotected left main coronary artery stenosis. Interventional Cardiology 1:1, 93-106
CrossRef39
John A. Ormiston, Mark W.I. Webster, Robert S. Schwartz, Patrick Gladding, James T. Stewart, I. Patrick Kay, Peter N. Ruygrok, Robert Hatrick. (2009) Feasibility, Safety, and Efficacy of a Novel Polymeric Pimecrolimus-Eluting Stent. JACC: Cardiovascular Interventions 2:10, 1017-1024
CrossRef40
Demosthenes G. Katritsis, Socrates Korovesis, Efthalia Tzanalaridou, Eleftherios Giazitzoglou, Eutychios Voridis, Bernhard Meier. (2009) Comparison of Long Versus Short (“Spot”) Drug-Eluting Stenting for Long Coronary Stenoses. The American Journal of Cardiology 104:6, 786-790
CrossRef41
Rainer Hoffmann, Helene Klinker, Umar Adamu, Malte Kelm, Rüdiger Blindt. (2009) The risk of definitive stent thrombosis is increased after “off-label” stent implantation irrespective of drug-eluting stent or bare-metal stent use. Clinical Research in Cardiology 98:9, 549-554
CrossRef42
C. Jones, B. Liban. (2009) Anaesthesia and coronary artery stents. Current Anaesthesia & Critical Care 20:4, 150-154
CrossRef43
Michelle J. Butler, David Eccleston, David J. Clark, Andrew E. Ajani, Nick Andrianopoulos, Angela Brennan, Gishel New, Alexander Black, Gregory Szto, Chris M. Reid, Bryan P. Yan, James A. Shaw, Anthony M. Dart, Stephen J. Duffy. (2009) The effect of intended duration of clopidogrel use on early and late mortality and major adverse cardiac events in patients with drug-eluting stents. American Heart Journal 157:5, 899-907
CrossRef44
Jörg Carlsson, Stefan K. James, Johan Lindbäck, Fredrik Scherstén, Tage Nilsson, Ulf Stenestrand, Bo Lagerqvist. (2009) Outcome of Drug-Eluting Versus Bare-Metal Stenting Used According to On- and Off-Label Criteria. Journal of the American College of Cardiology 53:16, 1389-1398
CrossRef45
Robert J. Applegate, Matthew T. Sacrinty, Michael A. Kutcher, Renato M. Santos, Sanjay K. Gandhi, William C. Little. (2009) 3-Year Comparison of Drug-Eluting Versus Bare-Metal Stents. JACC: Cardiovascular Interventions 2:3, 231-239
CrossRef46
Young-Hoon Jeong, Seung-Whan Lee, Bong-Ryong Choi, In-Suk Kim, Myung-Ki Seo, Choong Hwan Kwak, Jin-Yong Hwang, Seong-Wook Park. (2009) Randomized Comparison of Adjunctive Cilostazol Versus High Maintenance Dose Clopidogrel in Patients With High Post-Treatment Platelet Reactivity. Journal of the American College of Cardiology 53:13, 1101-1109
CrossRef47
Alberto Berenguer, Pascual Bordes, Vicente Mainar, Jose Valencia, Silvia Gómez, Teresa Lozano. (2009) Predictors of death after coronary stenting with sirolimus-eluting stent in high-risk patients. International Journal of Cardiology 132:3, 342-347
CrossRef48
Gaku Nakazawa, Aloke V Finn, Frank D Kolodgie, Renu Virmani. (2009) A review of current devices and a look at new technology: drug-eluting stents. Expert Review of Medical Devices 6:1, 33-42
CrossRef49
Kyounghoon Lee, Seung-Whan Lee, Jun-Won Lee, Seong-Yoon Kim, Young-Jin Youn, Min-Soo Ahn, Jang-Young Kim, Byung-Su Yoo, Junghan Yoon, Kyung-Hoon Choe. (2009) The Significance of Clopidogrel Low-Responsiveness on Stent Thrombosis and Cardiac Death Assessed by the Verifynow P2Y12 Assay in Patients With Acute Coronary Syndrome Within 6 Months After Drug-Eluting Stent Implantation. Korean Circulation Journal 39:12, 512
CrossRef50
Jack L. Martin, Stephen G. Ellis, Antonio Colombo, Eberhard Grube, Tom Maloney, Mark I. Friedman, Donald S. Baim, Keith Dawkins, Ron Caputo, Gregg W. Stone. (2009) Frequency of Coronary Artery Bypass Grafting Following Implantation of a Paclitaxel-Eluting or a Bare-Metal Stent Into a Single Coronary Artery. The American Journal of Cardiology 103:1, 11-16
CrossRef51
Ferdinando Varbella, Andrea Gagnor, Francesco Tomassini, Vincenzo Infantino, Maria Rosa Conte. (2008) Immediate and long-term results of treatment of complex lesions of the left anterior descending coronary artery involving a large diagonal branch with drug-eluting stents. Journal of Cardiovascular Medicine 9:11, 1088-1094
CrossRef52
Gaku Nakazawa, Aloke V Finn, Elena Ladich, Flavio Ribichini, Leslie Coleman, Frank D Kolodgie, Renu Virmani. (2008) Drug-eluting stent safety: findings from preclinical studies. Expert Review of Cardiovascular Therapy 6:10, 1379-1391
CrossRef53
Jae-Youn Moon, Jong Won Chung, Ju Han Kim, Young Keun Ahn, Myung Ho Jeong. (2008) Simultaneous subacute stent thrombosis of two sirolimus-eluting stents in a patient treated by ReoPro, thrombus aspiration and triple anti-platelet agents. International Journal of Cardiology 130:1, e25-e29
CrossRef54
Gregory A. Nuttall, Michael J. Brown, John W. Stombaugh, Peter B. Michon, Matthew F. Hathaway, Kevin C. Lindeen, Andrew C. Hanson, Darrell R. Schroeder, William C. Oliver, David R. Holmes, Charanjit S. Rihal. (2008) Time and Cardiac Risk of Surgery after Bare-metal Stent Percutaneous Coronary Intervention. Anesthesiology 109:4, 588-595
CrossRef55
Ph. G. Steg, K. A.A. Fox, K. A. Eagle, M. Furman, F. Van de Werf, G. Montalescot, S. G. Goodman, A. Avezum, W. Huang, J. M. Gore, . (2008) Mortality following placement of drug-eluting and bare-metal stents for ST-segment elevation acute myocardial infarction in the Global Registry of Acute Coronary Events. European Heart Journal 30:3, 321-329
CrossRef56
Seung-Jung Park, Young-Hak Kim. (2008) Percutaneous coronary intervention as an alternative to bypass surgery for unprotected LMCA stenosis. Expert Review of Cardiovascular Therapy 6:8, 1107-1114
CrossRef57
Boris Radeleff, Heidi Thierjung, Ulrike Stampfl, Sibylle Stampfl, Ruben Lopez-Benitez, Christof Sommer, Irina Berger, Goetz M. Richter. (2008) Restenosis of the CYPHER-Select, TAXUS-Express, and Polyzene-F Nanocoated Cobalt-Chromium Stents in the Minipig Coronary Artery Model. CardioVascular and Interventional Radiology 31:5, 971-980
CrossRef58
John P Girod, Suresh R Mulukutla, Oscar C Marroquin. (2008) Off-label use of stents: bare-metal versus drug-eluting stents. Expert Review of Cardiovascular Therapy 6:8, 1095-1106
CrossRef59
Lisa T. Newsome, Michael A. Kutcher, Roger L. Royster. (2008) Coronary Artery Stents: Part I. Evolution of Percutaneous Coronary Intervention. Anesthesia & Analgesia 107:2, 552-569
CrossRef60
A. Chieffo, S.-J. Park, E. Meliga, I. Sheiban, M. S. Lee, A. Latib, Y.-H. Kim, M. Valgimigli, D. Sillano, V. Magni, G. Biondi-Zoccai, M. Montorfano, F. Airoldi, R. Rogacka, M. Carlino, I. Michev, C.-W. Lee, M.-K. Hong, S.-W. Park, C. Moretti, E. Bonizzoni, G. M. Sangiorgi, J. Tobis, P. W. Serruys, A. Colombo. (2008) Late and very late stent thrombosis following drug-eluting stent implantation in unprotected left main coronary artery: a multicentre registry. European Heart Journal 29:17, 2108-2115
CrossRef61
Michael Joner, Gaku Nakazawa, Aloke V. Finn, Shawn Chin Quee, Leslie Coleman, Eduardo Acampado, Patricia S. Wilson, Kristi Skorija, Qi Cheng, Xin Xu, Herman K. Gold, Frank D. Kolodgie, Renu Virmani. (2008) Endothelial Cell Recovery Between Comparator Polymer-Based Drug-Eluting Stents. Journal of the American College of Cardiology 52:5, 333-342
CrossRef62
Ehtisham Mahmud, Guilherme Bromberg-Marin, Vachaspathi Palakodeti, Lawrence Ang, Dana Creanga, Anthony N. DeMaria. (2008) Clinical Efficacy of Drug-Eluting Stents in Diabetic Patients. Journal of the American College of Cardiology 51:25, 2385-2395
CrossRef63
Simon R. Dixon, Cindy L. Grines, William W. O'Neill. (2008) The Year in Interventional Cardiology. Journal of the American College of Cardiology 51:24, 2355-2369
CrossRef64
Mehdi H. Shishehbor, Reza Amini, Russell E. Raymond, Anthony A. Bavry, Sorin J. Brener, Samir R. Kapadia, Patrick L. Whitlow, Stephen G. Ellis, Deepak L. Bhatt. (2008) Safety and efficacy of overlapping sirolimus-eluting versus paclitaxel-eluting stents. American Heart Journal 155:6, 1075-1080
CrossRef65
Jinsheng Li, Refat Jabara, Lakshmana Pendyala, Yoritaka Otsuka, Toshiro Shinke, Dongming Hou, Keith Robinson, Nicolas Chronos. (2008) Abnormal Vasomotor Function of Porcine Coronary Arteries Distal to Sirolimus-Eluting Stents. JACC: Cardiovascular Interventions 1:3, 279-285
CrossRef66
Peter W. Groeneveld, Mary Anne Matta, Alexis P. Greenhut, Feifei Yang. (2008) Drug-Eluting Compared With Bare-Metal Coronary Stents Among Elderly Patients. Journal of the American College of Cardiology 51:21, 2017-2024
CrossRef67
Daniel B. Mark. (2008) Interpreting the Music of Drug-Eluting Stents. Journal of the American College of Cardiology 51:19, 1854-1856
CrossRef68
Stephen D Wiviott, Eugene Braunwald, Carolyn H McCabe, Ivan Horvath, Matyas Keltai, Jean-Paul R Herrman, Frans Van de Werf, William E Downey, Benjamin M Scirica, Sabina A Murphy, Elliott M Antman. (2008) Intensive oral antiplatelet therapy for reduction of ischaemic events including stent thrombosis in patients with acute coronary syndromes treated with percutaneous coronary intervention and stenting in the TRITON-TIMI 38 trial: a subanalysis of a randomised trial. The Lancet 371:9621, 1353-1363
CrossRef69
Dietmar Trenk, Franz-Josef Neumann. (2008) Drug-eluting coronary stents: as safe as bare-metal stents, but optimized antiplatelet therapy may further improve clinical outcome. European Journal of Clinical Pharmacology 64:3, 227-232
CrossRef70
Miodrag Ostojic, Dragan Sagic, Branko Beleslin, Robert Jung, Zoran Perisic, Nikola Jagic, Milan Nedeljkovic, Ljupco Mangovski, Bratislav Milosavljevic, Sinisa Stojkovic, Dejan Orlic, Zelimir Antonic, Vladimir Miloradovic, Dragan Topic, Dragica Paunovic. (2008) First clinical comparison of Nobori –Biolimus A9 eluting stents with Cypher– Sirolimus eluting stents: Nobori Core nine months angiographic and one year clinical outcomes. EuroIntervention 3:5, 574-579
CrossRef71
Christina Henn, Stefanie Satzl, Patricia Christoph, Patrick Kurz, Boris Radeleff, Ulrike Stampfl, Sibylle Stampfl, Irina Berger, Goetz Martin Richter. (2008) Efficacy of a Polyphosphazene Nanocoat in Reducing Thrombogenicity, In-stent Stenosis, and Inflammatory Response in Porcine Renal and Iliac Artery Stents. Journal of Vascular and Interventional Radiology 19:3, 427-437
CrossRef72
Peter Lanzer, Lutz Prechelt. (2008) Spelling out risk reduction strategies for intracoronary stenting. EuroIntervention 3:5, 622-626
CrossRef73
David P. Taggart, Sanjay Kaul, William E. Boden, T. Bruce Ferguson, Robert A. Guyton, Michael J. Mack, Paul T. Sergeant, Richard J. Shemin, Peter K. Smith, Salim Yusuf. (2008) Revascularization for Unprotected Left Main Stem Coronary Artery Stenosis. Journal of the American College of Cardiology 51:9, 885-892
CrossRef74
Helfried Metzler, Sibylle Kozek-Langenecker, Kurt Huber. (2008) Antiplatelet therapy and coronary stents in perioperative medicine – the two sides of the coin. Best Practice & Research Clinical Anaesthesiology 22:1, 81-94
CrossRef75
Johannes Ruef, Hans Störger, Franz Schwarz, Jürgen Haase. (2008) Comparison of a polymer-free rapamycin-eluting stent (YUKON) with a polymer-based paclitaxel-eluting stent (TAXUS) in real-world coronary artery lesions. Catheterization and Cardiovascular Interventions 71:3, 333-339
CrossRef76
Helfried Metzler, Kurt Huber, Sibylle Kozek-Langenecker. (2008) Anaesthesia in patients with drug-eluting stents. Current Opinion in Anaesthesiology 21:1, 55-59
CrossRef77
Henry H. Ting, Matthew T. Roe, Bernard J. Gersh, John A. Spertus, John S. Rumsfeld, Fang-Shu Ou, John Kao, Kirsten Hall Long, David R. Holmes, Eric D. Peterson. (2008) Factors Associated With Off-Label Use of Drug-Eluting Stents in Patients With ST-Elevation Myocardial Infarction. The American Journal of Cardiology 101:3, 286-292
CrossRef78
Robert J. Applegate, Matthew T. Sacrinty, Michael A. Kutcher, Renato M. Santos, Sanjay K. Gandhi, Talal T. Baki, William C. Little. (2008) “Off-Label” Stent Therapy. Journal of the American College of Cardiology 51:6, 607-614
CrossRef79
Tracy Y. Wang, Lee A. Robinson, Fang-Shu Ou, Matthew T. Roe, E. Magnus Ohman, W. Brian Gibler, Sidney C. Smith, Eric D. Peterson, Richard C. Becker. (2008) Discharge antithrombotic strategies among patients with acute coronary syndrome previously on warfarin anticoagulation: Physician practice in the CRUSADE registry. American Heart Journal 155:2, 361-368
CrossRef80
Marroquin, Oscar C., Selzer, Faith, Mulukutla, Suresh R., Williams, David O., Vlachos, Helen A., Wilensky, Robert L., Tanguay, Jean-François, Holper, Elizabeth M., Abbott, J. Dawn, Lee, Joon S., Smith, Conrad, Anderson, William D., Kelsey, Sheryl F., Kip, Kevin E., . (2008) A Comparison of Bare-Metal and Drug-Eluting Stents for Off-Label Indications. New England Journal of Medicine 358:4, 342-352
Full Text81
Carrozza, Joseph P. Jr., . (2008) Drug-Eluting Stents — Pushing the Envelope beyond the Labels?. New England Journal of Medicine 358:4, 405-407
Full Text82
Mitchell D. Feldman, Amy J. Petersen, Leah S. Karliner, Jeffrey A. Tice. (2008) Who is Responsible for Evaluating the Safety and Effectiveness of Medical Devices? The Role of Independent Technology Assessment. Journal of General Internal Medicine 23:S1, 57-63
CrossRef83
M. Cohen, G. Roubin, F. Kuepper. (2007) The challenge of ST-segment elevation myocardial infarction. International Journal of Clinical Practice 61:12, 2079-2092
CrossRef84
David P Taggart. (2007) Coronary artery bypass graft vs. percutaneous coronary angioplasty: CABG on the rebound?. Current Opinion in Cardiology 22:6, 517-523
CrossRef85
Jennifer M. Sims. (2007) Update on Drug-Eluting Stents. Dimensions of Critical Care Nursing 26:6, 237-240
CrossRef86
Roberto Scatena. (2007) New nitric oxide-releasing polymers for implantable devices. Expert Opinion on Therapeutic Patents 17:11, 1397-1400
CrossRef87
Heinz Joachim Büttner, Franz-Josef Neumann. (2007) Peeling-Off Labels. Journal of the American College of Cardiology 50:21, 2037-2038
CrossRef88
Tu, Jack V., Bowen, James, Chiu, Maria, Ko, Dennis T., Austin, Peter C., He, Yaohua, Hopkins, Robert, Tarride, Jean-Eric, Blackhouse, Gord, Lazzam, Charles, Cohen, Eric A., Goeree, Ron, . (2007) Effectiveness and Safety of Drug-Eluting Stents in Ontario. New England Journal of Medicine 357:14, 1393-1402
Full Text89
Maggie A.Z. Hupcey, Sean Ekins. (2007) Improving the drug selection and development process for combination devices. Drug Discovery Today 12:19-20, 844-852
CrossRef90
Robert P. Giugliano, Eugene Braunwald. (2007) The Year in Non–ST-Segment Elevation Acute Coronary Syndrome. Journal of the American College of Cardiology 50:14, 1386-1395
CrossRef91
(2007) Guía de Práctica Clínica para el diagnóstico y tratamiento del síndrome coronario agudo sin elevación del segmento ST. Revista Española de Cardiología 60:10, 1070.e1-1070.e80
CrossRef92
Alaide Chieffo, Azeem Latib, Antonio Colombo. (2007) Drug-eluting stents: What is the balance of risks and benefits?. Current Cardiovascular Risk Reports 1:4, 279-283
CrossRef93
Gregory Ducrocq, Victor Serebruany, Jean-Francois Tanguay. (2007) Antiplatelet therapy in the era of drug-eluting stents: current and future perspectives. Expert Review of Cardiovascular Therapy 5:5, 939-953
CrossRef94
Samuel M. Butman. (2007) What kind of stent for you today and how would you like it prepared?. Catheterization and Cardiovascular Interventions 70:2, 173-174
CrossRef95
Douglas C Shook, Wendy Gross. (2007) Offsite anesthesiology in the cardiac catheterization lab. Current Opinion in Anaesthesiology 20:4, 352-358
CrossRef96
S. Silber, M. Borggrefe, M. Böhm, H.M. Hoffmeister, R. Dietz, G. Ertl, G. Heusch. (2007) Positionspapier der DGK zur Wirksamkeit und Sicherheit von Medikamente freisetzenden Koronarstents (DES). Der Kardiologe 1:2, 84-111
CrossRef97
Jeffrey L. Anderson, Cynthia D. Adams, Elliott M. Antman, Charles R. Bridges, Robert M. Califf, Donald E. Casey, William E. Chavey, Francis M. Fesmire, Judith S. Hochman, Thomas N. Levin, A. Michael Lincoff, Eric D. Peterson, Pierre Theroux, Nanette Kass Wenger, R. Scott Wright, Sidney C. Smith, Alice K. Jacobs, Cynthia D. Adams, Jeffrey L. Anderson, Elliott M. Antman, Jonathan L. Halperin, Sharon A. Hunt, Harlan M. Krumholz, Frederick G. Kushner, Bruce W. Lytle, Rick Nishimura, Joseph P. Ornato, Richard L. Page, Barbara Riegel. (2007) ACC/AHA 2007 Guidelines for the Management of Patients With Unstable Angina/Non–ST-Elevation Myocardial Infarction. Journal of the American College of Cardiology 50:7, e1-e157
CrossRef98
Enrico Mangieri, Gaetano Tanzilli, Cesare Greco, Francesco Pelliccia, Paolo Puddu, Maria Acconcia, Vincenzo Paravati, Carlo Gaudio. (2007) Clinical results of two year dual antiplatelet therapy after primary percutaneous coronary intervention with paclitaxel-eluting stents: a single centre study. EuroIntervention 3:2, 222-227
CrossRef99
Sahil A. Parikh, Joshua A. Beckman. (2007) Contemporary use of clopidogrel in patients with coronary artery disease. Current Cardiology Reports 9:4, 257-263
CrossRef100
Mark G. Rabbat, Anthony A. Bavry, Deepak L. Bhatt. (2007) Drug-Eluting Stents: Can We Move Beyond Stent Thrombosis?. The American Heart Hospital Journal 5:3, 155-158
CrossRef101
Stephen B Hanauer. (2007) Uncertainty. Nature Clinical Practice Gastroenterology & Hepatology 4:5, 235-235
CrossRef102
H. Metzler, K. Huber, S. Kozek-Langenecker, M.N. Vicenzi, A. Münch. (2007) Koronare Stents, duale Antiplättchentherapie und die perioperative Problematik. Der Anaesthesist 56:4, 401-412
CrossRef103
Curfman, Gregory D., Morrissey, Stephen, Jarcho, John A., Drazen, Jeffrey M., . (2007) Drug-Eluting Coronary Stents — Promise and Uncertainty. New England Journal of Medicine 356:10, 1059-1060
Full Text104
Hans Mickley. (2007) What should the cardiologist tell the patient facing revascularization for three-vessel disease?. Scandinavian Cardiovascular Journal 41:4, 212-213
CrossRef105
Lars Werkö. (2007) The turmoil around the drug-eluting stents. Scandinavian Cardiovascular Journal 41:3, 131-132
CrossRef106
Jae-Youn Moon, Myung Ho Jeong, In Soo Kim, Chung Hwan Jun, Jung Sun Cho, Jong Won Chung, Doosun Sim, Young Joon Hong, Ju Han Kim, Youngkeun Ahn, Jeong Gwan Cho, Jong Chun Park, Jung Chaee Kang. (2007) The Frequency, Treatment and Clinical Outcomes of Stent Thrombosis after Use of TAXUS??Stent. Korean Circulation Journal 37:12, 641
CrossRef
