Scientific Publications by FDA Staff

J Interv Cardiol 2002 Jun;15(3):181-6

Ambulatory use of ticlopidine and clopidogrel in association with percutaneous coronary revascularization procedures in a national managed care organization.

Shatin D, Schech SD, Brinker A

The aim of this study was to quantify ambulatory use of ticlopidine and clopidogrel in association with percutaneous coronary revascularization procedures (PTCA, atherectomy, stent) in a national managed care organization. Retrospective administrative claims data over a 3-year period (1996-1998) from 12 UnitedHealth Group-affiliated health plans in four geographic regions were collected. Pharmacy and medical claims data were used to determine the patients exposed to ticlopidine and clopidogrel between January 1, 1996 and December 31, 1998, the duration of use, prescriptions within 2 weeks of a coronary procedure, and stent patients prescribed either drug within 2 weeks of stent placement in 1998. Substantial short-term use of ticlopidine and clopidogrel was found. The percentage of members with duration of use < or = 30 days ranged from 50.4% in 1996 to 56.9% in 1998 for ticlopidine and was 52.7% for clopidogrel. In 1998, 46% and 33% of ticlopidine and clopidogrel users, respectively, had a medical claim for a coronary procedure that fell within 2 weeks of a prescription. The rate was lower for Medicare beneficiaries. In 1998, 78% of stent patients filled a prescription for either drug within 2 weeks of stent implantation. Although little difference was found overall in the use of these agents across geographic regions, a higher proportion of stent patients in the Southeast were prescribed ticlopidine within this time frame. The findings suggest that during the study time period ticlopidine and clopidogrel are frequently used off-label in association with percutaneous coronary revascularization procedures. These results were important in considering the overall benefit-risk profile.