Herz, 28:65-71, 2003

Off-label use of clopidogrel after coronary stent implantation in Germany: optional or mandatory?

Silber S

Richtlinienkomitee fur Koronarinterventionen der Europaischen Gesellschaft fur Kardiologie (ESC), Herzkatheterlabor der kardiologischen Gemeinschaftpraxis in der Klinik Dr. Muller, Munich. ssilber@med.de


Although the combined use of acetylsalicylic acid (ASA) and clopidogrel represents the standard in the 4-week treatment after coronary stent implantation, a discussion persists in Germany regarding clopidogrel use and the actual measures for cost containment in the healthcare system. Indeed, clopidogrel has not been approved in Germany for use after stent im-plantation. The prescription of clopidogrel in this context is thus considered off-label use. Consequently, patients with social healthcare insurance should pay for clopidogrel out of their own pockets. This regimen, however, bears the inherent risk that patients will not purchase the drug and thus not take it. This overview article describes the risk to patients when social healthcare insurance companies would not pay for clopidogrel after coronary stent implantation. Five international, prospective, randomized and control-led studies in 3,230 patients have shown that "double" antiaggregation, i.e. a combination of ASA and the thienopyridin derivative ticlopidin, compared with ASA alone clearly reduced death, myocardial infarction and the need for another PCI or CABG to a manifold extent. Due to its lower rate of side effects, clopidogrel has replaced ticlopidin since mid-1998. The clinical results of three prospective, randomized studies and seven single-center registries in approximately 14,000 patients have shown that the combination of ASA and clopidogrel results not only in a lower rate of side effects, but also in a significant rate reduction of cardiovascular events of ca. 50% (from 4.0% to 2.1%). Therefore, the combined use of ASA and clopidogrel should be prescribed to avoid (sub)acute stent thrombosis --even if this is not according to the rules of the German healthcare system. The threat of fines to physicians prescribing clopdiogrel at the expense of the social health care insurance is counterproductive and jeopardizes the life of the patients.

PMID: 12650165 [PubMed]