CORRESPONDENCE: LETTER TO THE EDITOR
The Balance of Risks and Benefits of Drug-Eluting Versus Bare-Metal Stents
Matthias Pfisterer, MD, FACC*,
Hans Peter Brunner-La Rocca, MD and
Christoph Kaiser, MD
* Department of Cardiology, University Hospital, CH-4031 Basel, Switzerland (Email: pfisterer{at}email.ch).
In a recent article entitled "Stent Thrombosis, Myocardial Infarction, and Death After Drug-Eluting and Bare-Metal Stent Coronary Interventions," Jensen et al. (1) added another piece of evidence to the "late stent thrombosis story" based on registry data of >12,000 patients. Similar to the findings of BASKET-LATE (Basel Stent Kosten Effektivitäts Trial–Late Thrombotic Events) (2) and the Swedish registry (3) as well as several meta-analyses recently published, they found no excess mortality overall but an excess in very late (>12 months) stent thrombosis and myocardial infarction (MI). In fact, according to their Figures 1A and 1D (1), the event curves for MI and stent thromboses seem to diverge already after 6 to 9 months as in BASKET-LATE and the Swedish registry, which were performed before the publication of the Academic Research Consortium (4) definition of very late as being after 1 year. This stresses the need to separate findings of thrombotic events in the first (6 or) 12 months from later events and suggests not to lump them together in overall conclusions as in the report by Jensen et al. (1). Thus, it seems not quite correct, for the authors to write in their discussion that their findings differed from those of BASKET-LATE, particularly since that study only reported "late" stent thrombosis and related clinical events after 6 months.
The most important point in their study is, however, the balance of risks and benefits of drug-eluting versus bare-metal stents. Unfortunately, they do not present data on clinical events related to restenosis/target lesion revascularization that would have to be weighed against late clinical events related to very late stent thrombosis as has recently been described by Stone et al. (5): the first year excess in death/MI due to restenosis after bare-metal stent implantation was exactly balanced by a second and third year excess in the same hard events due to stent thrombosis of drug-eluting stent–treated patients. Again, a similar balance was calculated from the BASKET/BASKET-LATE experience (2). Since the rate of death/MI due to restenosis is much lower than that due to late stent thrombosis, it would be most helpful to the reader of the article by Jensen et al. (1) if such a balance could be specified in "hard" clinical events based on this Danish registry. A major limitation, however, will be the short period of very late follow-up of only 3 months. Still, the patient and his treating physician will have to decide upon such outcome data: long-term clinical—death or MI—risks and benefits.
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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]
- Pfisterer M, Brunner-La Rocca HP, Buser PT, et al. Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents J Am Coll Cardiol 2006;48:2584-2591.[Abstract/Free Full Text]
- Lagerqvist B, James SK, Stenestrand U, et al. Long-term with drug-eluting stents versus bare-metal stents in Sweden N Engl J Med 2007;356:1009-1019.[Abstract/Free Full Text]
- Cutlip DE, Windecker S, Mehran R, et al. Clinical end points in coronary stent trials: a case for standardized definitions Circulation 2007;115:2344-2351.[Abstract/Free Full Text]
- Stone GW, Stephen GE, Colombo A, 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 2007;115:2842-2847.[Abstract/Free Full Text]
Related articles in JACC:
- Reply
- Leif Thuesen, Lisette Okkels Jensen, Anne Kaltoft, and Michael Maeng
JACC 2008 51: 972-973.
[Full Text]