EXPEDITED REVIEW
Late Clinical Events After Clopidogrel Discontinuation May Limit the Benefit of Drug-Eluting Stents
An Observational Study of Drug-Eluting Versus Bare-Metal Stents
Matthias Pfisterer, MD, FACC*,*,
Hans Peter Brunner-La Rocca, MD*,
Peter T. Buser, MD, FACC*,
Peter Rickenbacher, MD ,
Patrick Hunziker, MD ,
Christian Mueller, MD ,
Raban Jeger, MD*,
Franziska Bader, RN*,
Stefan Osswald, MD, FACC*,
Christoph Kaiser, MD* for the BASKET-LATE Investigators
* Department of Cardiology, University Hospital, Basel, Switzerland
Department of Intensive Care Medicine, University Hospital, Basel, Switzerland
Department of Internal Medicine, University Hospital, Basel, Switzerland
Bruderholzspital, Basel, Switzerland
Manuscript received June 6, 2006;
revised manuscript received August 24, 2006,
accepted August 28, 2006.
* Reprint requests and correspondence: Dr. Matthias Pfisterer, Professor of Cardiology, Head Department of Cardiology, University Hospital, CH-4031 Basel, Switzerland. (Email: pfisterer{at}email.ch).
OBJECTIVES: We sought to define the incidence of late clinical events and late stent thrombosis in patients treated with drug-eluting (DES) versus bare-metal stents (BMS) after the discontinuation of clopidogrel as well as their timing and outcome.
BACKGROUND: There is growing concern that delayed endothelialization after DES implantation may lead to late stent thrombosis and related myocardial infarction (MI) or death. However, event rates and outcomes after clopidogrel discontinuation versus BMS are unknown.
METHODS: A consecutive series of 746 nonselected patients with 1,133 stented lesions surviving 6 months without major events were followed for 1 year after the discontinuation of clopidogrel. Patients were assigned randomly 2:1 to DES versus BMS in BASKET (Basel Stent Kosten Effektivitäts Trial). The primary focus of this observation was cardiac death/MI.
RESULTS: Rates of 18-month cardiac death/MI were not different between DES and BMS patients. However, after the discontinuation of clopidogrel (between months 7 and 18), these events occurred in 4.9% after DES versus 1.3% after BMS implantation. Target vessel revascularization remained lower after DES, resulting in similar rates of all clinical events for this time period (DES 9.3%, BMS 7.9%). Documented late stent thrombosis and related death/target vessel MI were twice as frequent after DES versus BMS (2.6% vs. 1.3%). Thrombosis-related events occurred between 15 and 362 days after the discontinuation of clopidogrel, presenting as MI or death in 88%.
CONCLUSIONS: After the discontinuation of clopidogrel, the benefit of DES in reducing target vessel revascularization is maintained but has to be balanced against an increase in late cardiac death or nonfatal MI, possibly related to late stent thrombosis.
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Abbreviations and Acronyms
| | BASKET = Basel Stent Kosten Effektivitäts Trial | | BASKET-LATE = BASKET LAte Thrombotic Events Trial | | BMS = bare-metal stent | | CI = confidence interval | | DES = drug-eluting stent | | HR = hazard ratio | | MI = myocardial infarction | | OR = odds ratio | | TVR = target vessel revascularization |
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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
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[Abstract]
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J. P. Chen, L. V. Crisco, R. Jabara, and S. B. King III
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[Abstract]
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F. Burzotta, A. Parma, C. Pristipino, A. Manzoli, F. Belloni, G. Sardella, S. Rigattieri, A. Danesi, P. Mazzarotto, F. Summaria, et al.
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[Abstract]
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R. J. Shemin
Coronary Artery Bypass Grafting Versus Stenting for Unprotected Left Main Coronary Artery Disease: Where Lies the Body of Proof?
Circulation,
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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.
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[Abstract]
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A. K. Chhatriwalla and D. L. Bhatt
Should dual antiplatelet therapy after drug-eluting stents be continued for more than 1 year?: Dual Antiplatelet Therapy After Drug-Eluting Stents Should Be Continued for More Than One Year and Preferably Indefinitely
Circ Cardiovasc Interv,
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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
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M. S. Lee, J. Kobashigawa, and J. Tobis
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M. E Pfisterer
Commentary on drug-eluting stents: to use or not to use--that is the question!
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L. Mauri, T. S. Silbaugh, R. E. Wolf, K. Zelevinsky, A. Lovett, Z. Zhou, F. S. Resnic, and S.-L. T. Normand
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[Abstract]
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S. B. King III and E. L. Hannan
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G. A. Lin, R. A. Dudley, F. L. Lucas, D. J. Malenka, E. Vittinghoff, and R. F. Redberg
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[Abstract]
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M. E. Pfisterer
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Current Guidelines for Preoperative Management Leave Me Wanting More
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T. Shinke, J. Li, J. P. Chen, L. Pendyala, T. Goodchild, R. Jabara, S. Geva, T. Ueno, N. Chronos, K. Robinson, et al.
High Incidence of Intramural Thrombus After Overlapping Paclitaxel-Eluting Stent Implantation: Angioscopic and Histopathologic Analysis in Porcine Coronary Arteries
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[Abstract]
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Drug-Eluting Stents Versus Bare-Metal Stents for Off-Label Indications: A Propensity Score-Matched Outcome Study
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[Abstract]
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P. Roy, D. H. Steinberg, S. J. Sushinsky, T. Okabe, T. L. Pinto Slottow, K. Kaneshige, Z. Xue, L. F. Satler, K. M. Kent, W. O. Suddath, et al.
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L. T. Newsome, M. A. Kutcher, and R. L. Royster
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[Abstract]
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L. T. Newsome, R. S. Weller, J. C. Gerancher, M. A. Kutcher, and R. L. Royster
Coronary Artery Stents: II. Perioperative Considerations and Management
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[Abstract]
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M. Joner, G. Nakazawa, A. V. Finn, S. C. Quee, L. Coleman, E. Acampado, P. S. Wilson, K. Skorija, Q. Cheng, X. Xu, et al.
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S. G. Ellis, C. D. O'Shaughnessy, S. L. Martin, K. Kent, T. McGarry, M. A. Turco, D. J. Kereiakes, J. J. Popma, M. Friedman, J. Koglin, et al.
Two-year clinical outcomes after paclitaxel-eluting stent or brachytherapy treatment for bare metal stent restenosis: the TAXUS V ISR trial
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J. C Coons and S. Battistone
2007 Guideline Update for Unstable Angina/Non-ST-Segment Elevation Myocardial Infarction: Focus on Antiplatelet and Anticoagulant Therapies
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D. J. Malenka, A. V. Kaplan, F. L. Lucas, S. M. Sharp, and J. S. Skinner
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F. Alfonso
The "vulnerable" stent why so dreadful?
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A. S. Brett
Coronary Assessment Before Noncardiac Surgery: Current Strategies Are Flawed
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E. Meliga, H. M. Garcia-Garcia, M. Valgimigli, A. Chieffo, G. Biondi-Zoccai, A. O. Maree, S. Cook, L. Reardon, C. Moretti, S. De Servi, et al.
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S. S. Brar, J. Kim, S. K. Brar, R. Zadegan, M. Ree, I.-L. A. Liu, P. Mansukhani, V. Aharonian, R. Hyett, and A. Y.-J. Shen
Long-term outcomes by clopidogrel duration and stent type in a diabetic population with de novo coronary artery lesions.
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S.-H. Choi, A. Prasad, and S. Tsimikas
The evolution of thienopyridine therapy clopidogrel duration, diabetes, and drug-eluting stents.
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R. C. Becker, T. W. Meade, P. B. Berger, M. Ezekowitz, C. M. O'Connor, D. A. Vorchheimer, G. H. Guyatt, D. B. Mark, and R. A. Harrington
The Primary and Secondary Prevention of Coronary Artery Disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition)
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H. Kelbaek, L. Klovgaard, S. Helqvist, J. F. Lassen, L. R. Krusell, T. Engstrom, H. E. Botker, E. Jorgensen, K. Saunamaki, S. Aljabbari, et al.
Long-Term Outcome in Patients Treated With Sirolimus-Eluting Stents in Complex Coronary Artery Lesions: 3-Year Results of the SCANDSTENT (Stenting Coronary Arteries in Non-Stress/Benestent Disease) Trial
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P. Garg, D. J. Cohen, T. Gaziano, and L. Mauri
Balancing the Risks of Restenosis and Stent Thrombosis in Bare-Metal Versus Drug-Eluting Stents: Results of a Decision Analytic Model
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D. B. Mark
Interpreting the Music of Drug-Eluting Stents: Halcyon Song or Albatross Dirge?
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S. H Bhatt and T. H Hauser
Very Late Stent Thrombosis After Dual Antiplatelet Therapy Discontinuation in a Patient with a History of Acute Stent Thrombosis
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Stent Malapposition After Sirolimus-Eluting and Bare-Metal Stent Implantation in Patients with ST-Segment Elevation Myocardial Infarction: Acute and 9-Month Intravascular Ultrasound Results of the MISSION! Intervention Study
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