March 14, 2006 -- This small study titled BASKET-LATE (Basel Stent Cost-effectiveness Trial—Late Thrombotic Events) was almost overlooked when presented on the final day of the American College of Cardiology annual meeting, but the conclusion of the study mirrors a concern that we here at Angioplasty.Org have been writing about -- the need for continued long term antiplatelet therapy after drug-eluting stents. Now, Dr. Matthias E. Pfisterer of University Hospital in Basel, Switzerland, has concluded that there is concern for patients with drug-eluting stents for a year or more AFTER stopping the recommended clopidogrel (Plavix) and aspirin therapy.

The study tracked over 800 patients. Two-thirds had received drug-eluting stents, the remaining third got a bare metal stent. Clopidogrel (Plavix) was stopped at 6 months, as per current minimum recommendations. What the study revealed was that in the period after clopidogrel was stopped, thrombosis-related events (which are very serious) occurred twice as often in the drug-eluting stent patients, and that these events carried "4 times higher risk of cardiac death/MI vs non-thrombosis-related events". The worrisome statistic was that these increased thrombosis-related events were still occurring a year after stopping antiplatelet therapy. The authors concluded that "real-world DES use in 100 patients avoids 5 target vessel revascularization events at 6 months but leads to 3.3 late deaths or MI."

Dr. William O'Neill of William Beaumont Medical Center in Michigan, commented to the cardiologists in the audience:

"The real question that clinicians are going to have is: are you really trading late restenosis, which is not a health hazard, for death or reinfarction? That's obviously a very important and worrisome trade-off."

On theheart.org, Drs. Eric Topol and Rob Califf discuss the trial as well, and both agree on the concern. Dr. Califf states, "In my practice, if you get a drug-eluting stent, you're going to be on clopidogrel for life until more data come in."

related stories:
BASKET-LATE: Late Clinical Events Related to Late Stent Thrombosis After Stopping Clopidogrel: Drug-Eluting vs Bare-Metal Stenting -- Luis Gruberg, MD, FACC, Medscape

BASKET-LATE: High cardiac death and MI rates in DES-treated patients fuel
late stent thrombosis debate -- theheart.org

Late Clinical Events Related to Late Stent Thrombosis After Stopping Clopidogrel: Prospective Randomized
Comparison Between Drug-Eluting Versus Bare-Metal Stenting -- American College of Cardiology (scroll to link which is a video of the presentation -- ACC subscription required)

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