CORRESPONDENCE: LETTER TO THE EDITOR
Reply
Leif Thuesen, MD, DMSc, FESC,
Lisette Okkels Jensen, MD, PhD*,
Anne Kaltoft, MD, PhD and
Michael Maeng, MD, PhD
* Odense University Hospital, Department of Cardiology, Sdr. Boulevard 29, Odense C, Denmark 5000, Denmark (Email: okkels{at}dadlnet.dk).
We appreciate the interest of Dr. Pfisterer and colleagues in our registry study on stent thrombosis, myocardial infarction (MI), and death after drug-eluting stent (DES) and bare-metal stent (BMS) coronary interventions (1).
Dr. Pfisterer and colleagues have the following comments to our study:
- 1 Early and late thrombotic events should be separated
It is our opinion that the overall conclusions should include the entire study period and not only a post-hoc selected period. Moreover, as we are dealing with registry data, we find it important to focus on total mortality as the most reliable parameter. Therefore, we concluded that DES, as compared with BMS, was a safe intervention in a population with 15 months follow-up (1). We are aware that the event curves for stent thrombosis and myocardial infarction diverge in favor of the BMS group and, as Dr. Pfisterer and colleagues, we acknowledge that late stent thrombosis is a problem, albeit numerically small, after DES implantation. Interestingly, the event curves of stent thrombosis and MI seem to cross at a later time point in the Western Denmark Heart registry than in the Swedish Coronary Angiography and Angioplasty registry (2), possibly due to a longer clopidogrel treatment time in Denmark.
- 2 No data on clinical events related to restenosis/target lesion revascularization
We agree that these data are of great interest. It is, however, a time-consuming task to get a detailed clinical assessment of reinterventions in our >12,000 patient cohort. Hopefully, we will be able to describe the delicate safety balance between stent thrombosis and target lesion revascularization in a future publication.
- 3 Too short follow-up
Our data were collected over a 3-year period during which the proportion of DES increased from 0% to 75%. In order to reduce bias during this transition period, we decided to follow all patients for 15 months. As mentioned in the manuscript (1), the follow-up period of 15 months may be inadequate for a comprehensive assessment of possible risks with use of DES. Consequently, we intend to follow the Western Denmark Heart registry cohort as long as data are clinically relevant. The preliminary 2-year results were recently presented at TCT, basically confirming the 15-month results (3).
Unfortunately, the implementation of DES treatment was not based on large randomized studies with hard clinical end points and long-term follow-up. Therefore, to evaluate potential problems associated with the use of DES, we have to obtain information from various scientifically less reliable sources, such as registry studies, meta-analyses and nonprimary end point results from randomized trials. The results from the Western Denmark Heart Registry is one piece of the puzzle and must be interpreted in combination with results from other registries and outcome from studies like the BASKET-LATE (Basel Stent Kosten Effektivitäts Trial–Late Thrombotic Events) (4). Based on such combined sources of data, we may obtain the best available information to guide our choice of treatment.
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References
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- Jensen LO, Maeng M, Kaltoft A, et al. Stent thrombosis, myocardial infarction, and death after drug-eluting and bare-metal stent coronary interventions J Am Coll Cardiol 2007;50:463-470.[Abstract/Free Full Text]
- Lagerqvist B, James SK, Stenestrand U, Lindback J, Nilsson T, Wallentin L. Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden N Engl J Med 2007;356:1009-1019.[Abstract/Free Full Text]
- Jensen LO, Kaltoft A, Maeng M, et al. Two-year clinical outcome after implantation of drug eluting or bare metal coronary stents in Western Denmark. Paper presented at: Transcatheter Cardiovascular Therapeutics, October 20–25, 2007; Washington, DC.
- Pfisterer M, Brunner-La Rocca HP, Buser PT, et al. Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents: an observational study of drug-eluting versus bare-metal stents J Am Coll Cardiol 2006;48:2584-2591.[Abstract/Free Full Text]
Related Article
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The Balance of Risks and Benefits of Drug-Eluting Versus Bare-Metal Stents
- Matthias Pfisterer, Hans Peter Brunner-La Rocca, and Christoph Kaiser
J. Am. Coll. Cardiol. 2008 51: 972.
[Full Text]
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