EXPEDITED REVIEW
Stent Thrombosis, Myocardial Infarction, and Death After Drug-Eluting and Bare-Metal Stent Coronary Interventions
Lisette Okkels Jensen, MD, PhD*,*,
Michael Maeng, MD, PhD ,
Anne Kaltoft, MD, PhD,
Per Thayssen, MD, DMSci*,
Hans Henrik Tilsted Hansen, MD ,
Morten Bottcher, MD, PhD,
Jens Flensted Lassen, MD, PhD,
Lars Romer Krussel, MD, DMSci,
Klaus Rasmussen, MD, DMSci, ,
Knud Noerregaard Hansen, MD*,
Lars Pedersen, MSc||,
Soeren Paaske Johnsen, MD, PhD,||,
Henrik Toft Soerensen, MD, DMSci, PhD||,¶ and
Leif Thuesen, MD, DMSci
* Department of Cardiology, Odense University Hospital, Odense, Denmark
Department of Cardiology, Skejby Sygehus University, Aarhus, Denmark
|| Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark
Department of Cardiology, Aalborg Hospital, Aarhus University Hospital, Aalborg, Denmark
Center of Cardiovascular Research, Aalborg Hospital, Aarhus University Hospital, Aalborg, Denmark
¶ Department of Epidemiology, Boston University, Boston, Massachusetts.
Manuscript received April 4, 2007;
revised manuscript received May 21, 2007,
accepted June 3, 2007.
* Reprint requests and correspondence: Dr. Lisette Okkels Jensen, Department of Cardiology, Odense University Hospital, Sdr. Boulevard 29, 5000 Odense C, Denmark. (Email: okkels{at}dadlnet.dk).
Objectives: The aim of the study was to examine outcomes subsequent to implantation of drug-eluting stents (DES) and bare-metal stents (BMS).
Background: Use of DES might be associated with increased risk of stent thrombosis (ST), myocardial infarction (MI), and death.
Methods: From January 2002 through June 2005, data from all percutaneous coronary interventions in western Denmark were prospectively recorded in the Western Denmark Heart Registry; 12,395 consecutive patients (17,152 lesions) treated with stent implantation were followed for 15 months. Data on death and MI were ascertained from the national databases. The Academic Research Consortium definition of ST was used.
Results: The DES were implanted in 3,548 patients (5,422 lesions) and BMS were implanted in 8,847 patients (11,730 lesions). Definite, probable, or possible ST was found in 190 (2.15%) patients in the BMS group and in 64 (1.80%) patients in the DES. The risk of definite ST was similar in the 2 groups (DES: 0.65%; BMS: 0.61%). Very late definite ST (between 12 and 15 months after implantation) occurred more frequently in patients receiving DES (hazard ratio [HR] 10.93, 95% confidence interval [CI] 1.27 to 93.76). Also, the risk of MI between 12 and 15 months after implantation was higher in the DES group (HR 4.00, 95% CI 2.06 to 7.79). Mortality was similar in the 2 groups. Target lesion revascularization was reduced by 43% in patients treated with DES (HR 0.57, 95% CI 0.48 to 0.67).
Conclusions: The minor risk of ST and MI within 15 months after implantation of DES seems unlikely to outweigh the benefit of these stents.
|
Abbreviations and Acronyms
| | BMS = bare-metal stent(s) | | CI = confidence interval | | DES = drug-eluting stent(s) | | FDA = Food and Drug Administration | | HR = hazard ratio | | MI = myocardial infarction | | PCI = percutaneous coronary intervention | | ST = stent thrombosis | | TLR = target lesion revascularization |
|
This article has been cited by other articles:
|
|
|
|
 
S.-Y. Choi, B. Witzenbichler, A. Maehara, A. J. Lansky, G. Guagliumi, B. Brodie, M. A. Kellett Jr, O. Dressler, H. Parise, R. Mehran, et al.
Intravascular Ultrasound Findings of Early Stent Thrombosis After Primary Percutaneous Intervention in Acute Myocardial Infarction: A Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) Substudy
Circ Cardiovasc Interv,
June 1, 2011;
4(3):
239 - 247.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
T. Nakamura, B. C. Brott, I. Brants, D. Panchal, J. Li, J. P. Chen, S. B. King III, N. Chronos, and D. Hou
Vasomotor Function After Paclitaxel-Coated Balloon Post-Dilation in Porcine Coronary Stent Model
J. Am. Coll. Cardiol. Intv.,
February 1, 2011;
4(2):
247 - 255.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
T.-H. Chen and R. Matyal
The Management of Antiplatelet Therapy in Patients With Coronary Stents Undergoing Noncardiac Surgery
Seminars in Cardiothoracic and Vascular Anesthesia,
December 1, 2010;
14(4):
256 - 273.
[Abstract]
[PDF]
|
|
|
|
|
|
|
J.-M. Daniel, W. Bielenberg, P. Stieger, S. Weinert, H. Tillmanns, and D. G. Sedding
Time-Course Analysis on the Differentiation of Bone Marrow-Derived Progenitor Cells Into Smooth Muscle Cells During Neointima Formation
Arterioscler Thromb Vasc Biol,
October 1, 2010;
30(10):
1890 - 1896.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
R. J. Krone, S. V. Rao, D. Dai, H. V. Anderson, E. D. Peterson, M. A. Brown, R. G. Brindis, L. W. Klein, R. E. Shaw, W. S. Weintraub, et al.
Acceptance, Panic, and Partial Recovery: The Pattern of Usage of Drug-Eluting Stents After Introduction in the U.S. (A Report From the American College of Cardiology/National Cardiovascular Data Registry)
J. Am. Coll. Cardiol. Intv.,
September 1, 2010;
3(9):
902 - 910.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. Kaltoft, H. Kelbaek, L. Thuesen, J. F. Lassen, P. Clemmensen, L. Klovgaard, T. Engstrom, H. E. Botker, K. Saunamaki, L. R. Krusell, et al.
Long-Term Outcome After Drug-Eluting Versus Bare-Metal Stent Implantation in Patients With ST-Segment Elevation Myocardial Infarction: 3-Year Follow-Up of the Randomized DEDICATION (Drug Elution and Distal Protection in Acute Myocardial Infarction) Trial
J. Am. Coll. Cardiol.,
August 17, 2010;
56(8):
641 - 645.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
R. J. Krone
Selection of Patients for Drug-Eluting Stents Based on Insurance Coverage: Pay or Don't Play
J. Am. Coll. Cardiol. Intv.,
July 1, 2010;
3(7):
780 - 782.
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. Vasa-Nicotera and T. Gershlick
Chapter 29 Stent thrombosis
Oxford Textbook of Interventional Cardiology,
January 1, 2010;
1(1):
med-9780199569083-chapter - med-9780199569083-chapter.
[Abstract]
[Full Text]
|
|
|
|
|
|
|
L. K. Pendyala, X. Yin, J. Li, J. P. Chen, N. Chronos, and D. Hou
The First-Generation Drug-Eluting Stents and Coronary Endothelial Dysfunction
J. Am. Coll. Cardiol. Intv.,
December 1, 2009;
2(12):
1169 - 1177.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
K. M. Kenney, M. C. Marzo, N. R. Ondrasik, and T. Wisenbaugh
Percutaneous Coronary Intervention Outcomes in a Low-Volume Center: Survival, Stent Thrombosis, and Repeat Revascularization
Circ Cardiovasc Qual Outcomes,
November 1, 2009;
2(6):
671 - 677.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
B. Lagerqvist, J. Carlsson, O. Frobert, J. Lindback, F. Schersten, U. Stenestrand, S. K. James, and for the Swedish Coronary Angiography and Angioplas
Stent Thrombosis in Sweden: A Report From the Swedish Coronary Angiography and Angioplasty Registry
Circ Cardiovasc Interv,
October 1, 2009;
2(5):
401 - 408.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. P. Chen, D. Hou, L. Pendyala, J. A. Goudevenos, and N. G. Kounis
Drug-Eluting Stent Thrombosis: The Kounis Hypersensitivity-Associated Acute Coronary Syndrome Revisited
J. Am. Coll. Cardiol. Intv.,
July 1, 2009;
2(7):
583 - 593.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
N. Kukreja, Y. Onuma, H. M. Garcia-Garcia, J. Daemen, R. van Domburg, P. W. Serruys, and on behalf of the Interventional cardiologists of t
The Risk of Stent Thrombosis in Patients With Acute Coronary Syndromes Treated With Bare-Metal and Drug-Eluting Stents
J. Am. Coll. Cardiol. Intv.,
June 1, 2009;
2(6):
534 - 541.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
P. S. Douglas, J. M. Brennan, K. J. Anstrom, A. Sedrakyan, E. L. Eisenstein, G. Haque, D. Dai, D. F. Kong, B. Hammill, L. Curtis, et al.
Clinical Effectiveness of Coronary Stents in Elderly Persons: Results From 262,700 Medicare Patients in the American College of Cardiology-National Cardiovascular Data Registry
J. Am. Coll. Cardiol.,
May 5, 2009;
53(18):
1629 - 1641.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
T. Higo, Y. Ueda, J. Oyabu, K. Okada, M. Nishio, A. Hirata, K. Kashiwase, N. Ogasawara, S. Hirotani, and K. Kodama
Atherosclerotic and thrombogenic neointima formed over sirolimus drug-eluting stent an angioscopic study.
J. Am. Coll. Cardiol. Img.,
May 1, 2009;
2(5):
616 - 624.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. Carlsson, S. K. James, J. Lindback, F. Schersten, T. Nilsson, U. Stenestrand, B. Lagerqvist, and for the SCAAR (Swedish Coronary Angiography and An
Outcome of Drug-Eluting Versus Bare-Metal Stenting Used According to On- and Off-Label Criteria
J. Am. Coll. Cardiol.,
April 21, 2009;
53(16):
1389 - 1398.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
H E Thomas, P J Avery, J M Ahmed, R Edwards, I Purcell, A G Zaman, H M Arthur, and B D Keavney
Local vessel injury following percutaneous coronary intervention does not promote early mobilisation of endothelial progenitor cells in the absence of myocardial necrosis
Heart,
April 1, 2009;
95(7):
555 - 558.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. Kaltoft, L. O. Jensen, M. Maeng, H. H. Tilsted, P. Thayssen, M. Bottcher, J. F. Lassen, L. R. Krusell, K. Rasmussen, K. N. Hansen, et al.
2-Year Clinical Outcomes After Implantation of Sirolimus-Eluting, Paclitaxel-Eluting, and Bare-Metal Coronary Stents: Results From the WDHR (Western Denmark Heart Registry)
J. Am. Coll. Cardiol.,
February 24, 2009;
53(8):
658 - 664.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. Ryan, W. Linde-Zwirble, L. Engelhart, L. Cooper, and D. J. Cohen
Temporal Changes in Coronary Revascularization Procedures, Outcomes, and Costs in the Bare-Metal Stent and Drug-Eluting Stent Eras: Results From the US Medicare Program
Circulation,
February 24, 2009;
119(7):
952 - 961.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M Maeng, L O Jensen, E Falk, H R Andersen, and L Thuesen
Negative vascular remodelling after implantation of bioabsorbable magnesium alloy stents in porcine coronary arteries: a randomised comparison with bare-metal and sirolimus-eluting stents
Heart,
February 1, 2009;
95(3):
241 - 246.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. C. Philpott MD, D. A. Southern MSc, F. M. Clement PhD, P. D. Galbraith BN MSc, M. Traboulsi MD, M. L. Knudtson MD, W. A. Ghali MD, and for the APPROACH Investigators
Long-term outcomes of patients receiving drug-eluting stents
Can. Med. Assoc. J.,
January 20, 2009;
180(2):
167 - 174.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
Authors/writing members:, J. Daemen, M. L. Simoons, W. Wijns, A. Bagust, G. Bos, J. M. Bowen, E. Braunwald, E. Camenzind, B. Chevalier, et al.
Meeting Report: ESC Forum on Drug Eluting Stents European Heart House, Nice, 27-28 September 2007
Eur. Heart J.,
January 2, 2009;
30(2):
152 - 161.
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. Pfisterer, H. P. Brunner-La Rocca, P. Rickenbacher, P. Hunziker, C. Mueller, F. Nietlispach, G. Leibundgut, F. Bader, C. Kaiser, and for the BASKET Investigators
Long-term benefit-risk balance of drug-eluting vs. bare-metal stents in daily practice: does stent diameter matter? Three-year follow-up of BASKET
Eur. Heart J.,
January 1, 2009;
30(1):
16 - 24.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. P. Chen, L. V. Crisco, R. Jabara, and S. B. King III
Late Angiographic Stent Thrombosis: The LAST Straw for Drug-Eluting Stents?
Angiology,
January 1, 2009;
59(6):
667 - 675.
[Abstract]
[PDF]
|
|
|
|
|
|
|
J. Daemen, K. H. Kuck, C. Macaya, V. LeGrand, M. Vrolix, D. Carrie, I. Sheiban, M. J. Suttorp, P. Vranckx, T. Rademaker, et al.
Multivessel Coronary Revascularization in Patients With and Without Diabetes Mellitus: 3-Year Follow-Up of the ARTS-II (Arterial Revascularization Therapies Study-Part II) Trial
J. Am. Coll. Cardiol.,
December 9, 2008;
52(24):
1957 - 1967.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
L. O. Jensen, M. Maeng, P. Thayssen, A. Kaltoft, H. H. Tilsted, M. Bottcher, J. F. Lassen, K. N. Hansen, L. R. Krusell, K. Rasmussen, et al.
Clinical Outcome After Primary Percutaneous Coronary Intervention With Drug-Eluting and Bare Metal Stents in Patients With ST-Segment Elevation Myocardial Infarction
Circ Cardiovasc Interv,
December 1, 2008;
1(3):
176 - 184.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. Colombo and R. T. Gerber
Should dual antiplatelet therapy after drug-eluting stents be continued for more than 1 year?: Dual Antiplatelet Therapy After Drug-Eluting Stents Should Not Be Continued for More Than 1 Year and Preferably Indefinitely
Circ Cardiovasc Interv,
December 1, 2008;
1(3):
226 - 232.
[Full Text]
[PDF]
|
|
|
|
|
|
|
L. O. Jensen, M. Maeng, P. Thayssen, E. H. Christiansen, K. N. Hansen, A. Galloe, H. Kelbaek, J. F. Lassen, and L. Thuesen
Neointimal hyperplasia after sirolimus-eluting and paclitaxel-eluting stent implantation in diabetic patients: The Randomized Diabetes and Drug-Eluting Stent (DiabeDES) Intravascular Ultrasound Trial
Eur. Heart J.,
November 2, 2008;
29(22):
2733 - 2741.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. H. Shishehbor, S. S. Goel, S. R. Kapadia, D. L. Bhatt, P. Kelly, R. E. Raymond, J. M. Galla, S. J. Brener, P. L. Whitlow, and S. G. Ellis
Long-Term Impact of Drug-Eluting Stents Versus Bare-Metal Stents on All-Cause Mortality
J. Am. Coll. Cardiol.,
September 23, 2008;
52(13):
1041 - 1048.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
K. J. Anstrom, D. F. Kong, L. K. Shaw, R. M. Califf, J. M. Kramer, E. D. Peterson, S. V. Rao, D. B. Matchar, D. B. Mark, R. A. Harrington, et al.
Long-term Clinical Outcomes Following Coronary Stenting
Arch Intern Med,
August 11, 2008;
168(15):
1647 - 1655.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
D. Austin, K. G. Oldroyd, A. McConnachie, R. Slack, H. Eteiba, A. D. Flapan, K. P. Jennings, R. J. Northcote, A. C.H. Pell, I. R. Starkey, et al.
Drug-Eluting Stents Versus Bare-Metal Stents for Off-Label Indications: A Propensity Score-Matched Outcome Study
Circ Cardiovasc Interv,
August 1, 2008;
1(1):
45 - 52.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. J. Rastan, E. Boudriot, V. Falk, A. P. Kappetein, M. A. Borger, P. W. Serruys, G. Schuler, and F. W. Mohr
Frequency and pattern of de-novo three-vessel and left main coronary artery disease; insights from single center enrolment in the SYNTAX study
Eur J Cardiothorac Surg,
August 1, 2008;
34(2):
376 - 383.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
S. R. Dixon, C. L. Grines, and W. W. O'Neill
The Year in Interventional Cardiology
J. Am. Coll. Cardiol.,
June 17, 2008;
51(24):
2355 - 2369.
[Full Text]
[PDF]
|
|
|
|
|
|
|
S.-H. Choi, A. Prasad, and S. Tsimikas
The Evolution of Thienopyridine Therapy: Clopidogrel Duration, Diabetes, and Drug-Eluting Stents
J. Am. Coll. Cardiol.,
June 10, 2008;
51(23):
2228 - 2229.
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. Jabs, S. Gobel, P. Wenzel, A. L. Kleschyov, M. Hortmann, M. Oelze, A. Daiber, and T. Munzel
Sirolimus-Induced Vascular Dysfunction: Increased Mitochondrial and Nicotinamide Adenosine Dinucleotide Phosphate Oxidase-Dependent Superoxide Production and Decreased Vascular Nitric Oxide Formation
J. Am. Coll. Cardiol.,
June 3, 2008;
51(22):
2130 - 2138.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
P. W. Groeneveld, M. A. Matta, A. P. Greenhut, and F. Yang
Drug-Eluting Compared With Bare-Metal Coronary Stents Among Elderly Patients
J. Am. Coll. Cardiol.,
May 27, 2008;
51(21):
2017 - 2024.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
L. Mauri and S.-L. T. Normand
Studies of Drug-Eluting Stents: To Each His Own?
Circulation,
April 22, 2008;
117(16):
2047 - 2050.
[Full Text]
[PDF]
|
|
|
|
|
|
|
C. L. Grines, J. A. Goldstein, and R. D. Safian
Should We Routinely Use Drug-Eluting Stents for Acute Myocardial Infarction?: Let's Wait and See
J. Am. Coll. Cardiol. Intv.,
April 1, 2008;
1(2):
136 - 138.
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. Pfisterer, H. P. Brunner-La Rocca, and C. Kaiser
The Balance of Risks and Benefits of Drug-Eluting Versus Bare-Metal Stents
J. Am. Coll. Cardiol.,
March 4, 2008;
51(9):
972 - 972.
[Full Text]
[PDF]
|
|
|
|
|
|
|
L. Thuesen, L. O. Jensen, A. Kaltoft, and M. Maeng
Reply
J. Am. Coll. Cardiol.,
March 4, 2008;
51(9):
972 - 973.
[Full Text]
[PDF]
|
|
|
|
|
|
|
C. L. Grines
Off-Label Use of Drug-Eluting Stents: Putting it in Perspective
J. Am. Coll. Cardiol.,
February 12, 2008;
51(6):
615 - 617.
[Full Text]
[PDF]
|
|
|
|
|
|
|
F. Saia, A. Marzocchi, and A. Branzi
Review: The safety of drug-eluting stents
Therapeutic Advances in Cardiovascular Disease,
February 1, 2008;
2(1):
43 - 52.
[Abstract]
[PDF]
|
|
|
|
|
|
|
D. Austin, J. P Pell, and K. G Oldroyd
Drug-eluting stents: do the risks really outweigh the benefits?
Heart,
February 1, 2008;
94(2):
127 - 128.
[Full Text]
[PDF]
|
|
|
|
|
|
|
H. J. Buttner and F.-J. Neumann
Peeling-Off Labels: Mounting Evidence for Benefit of Drug-Eluting Stents With Off-Label Use
J. Am. Coll. Cardiol.,
November 20, 2007;
50(21):
2037 - 2038.
[Full Text]
[PDF]
|
|
|
|
|
|
|
Bare-Metal or Drug-Eluting Stents for Coronary Artery Disease?
Journal Watch Cardiology,
August 29, 2007;
2007(829):
2 - 2.
[Full Text]
|
|
|
|
