OBJECTIVES: This study examined the economics, pharmacodynamics, and clinical outcomes among patients randomly assigned to receive either abciximab (ReoPro, Centocor, Inc, Malvern, Pa, and Eli Lilly &; Company, Indianapolis, Ind) or eptifibatide (Integrilin, COR Therapeutics, Inc, South San Francisco, Calif, and Key Pharmaceuticals, Inc, Kenilworth, NJ) therapy during elective percutaneous coronary intervention (PCI). BACKGROUND: Clinical and safety outcomes after elective PCI with a high-dose eptifibatide treatment strategy have not previously been systematically evaluated. In addition, comparative economic and pharmacodynamic studies of platelet glycoprotein (GP) IIb/IIIa receptor antagonists during PCI are sparse. METHODS: This randomized, double-blind study assessed the 30-day economic and clinical outcomes of 320 consecutive patients undergoing elective coronary balloon angioplasty or stent implantation who were randomly assigned to receive adjunct abciximab (n = 163) or eptifibatide (n = 157) therapy. The primary study end point was total in-hospital costs based on an intention-to-treat analysis. A secondary end point included 30-day total hospital costs. A platelet aggregometry substudy was performed on 155 patients (abciximab: n = 74 and eptifibatide: n = 81) with use of the Ultegra Rapid Platelet Function Assay. RESULTS: Baseline demographic, angiographic, and procedural variables were similar between the two treatment groups. The median and interquartile ranges of total in-hospital costs were $8268 ($6505, $9958) and $7207 ($5659, $9307), respectively, between the abciximab- and eptifibatide-treated patients (P =.009). Median total costs at 30 days were $8336 ($6505, $10,126) and $7207 ($5659, $9431), respectively, between the abciximab- and eptifibatide-treated groups (P =.009). The composite secondary clinical end points (death/nonfatal myocardial infarction/urgent revascularization) occurred in 4.9% versus 5.1% of patients, respectively, by hospital discharge (P =.84) and in 5.6% versus 6.3% of patients, respectively, at 30 days (P =.95) in the abciximab and eptifibatide groups. With the eptifibatide dose used, early and more durable platelet inhibition was achieved compared with abciximab (P <.00001). CONCLUSION: In drug dosages and patients similar to those enrolled in the current study, eptifibatide achieved durable platelet inhibition throughout drug infusion and was associated with lower in-hospital and 30-day costs compared with abciximab in patients undergoing elective PCI.
RCT Entities:
OBJECTIVES: This study examined the economics, pharmacodynamics, and clinical outcomes among patients randomly assigned to receive either abciximab (ReoPro, Centocor, Inc, Malvern, Pa, and Eli Lilly & Company, Indianapolis, Ind) or eptifibatide (Integrilin, COR Therapeutics, Inc, South San Francisco, Calif, and Key Pharmaceuticals, Inc, Kenilworth, NJ) therapy during elective percutaneous coronary intervention (PCI). BACKGROUND: Clinical and safety outcomes after elective PCI with a high-dose eptifibatide treatment strategy have not previously been systematically evaluated. In addition, comparative economic and pharmacodynamic studies of platelet glycoprotein (GP) IIb/IIIa receptor antagonists during PCI are sparse. METHODS: This randomized, double-blind study assessed the 30-day economic and clinical outcomes of 320 consecutive patients undergoing elective coronary balloon angioplasty or stent implantation who were randomly assigned to receive adjunct abciximab (n = 163) or eptifibatide (n = 157) therapy. The primary study end point was total in-hospital costs based on an intention-to-treat analysis. A secondary end point included 30-day total hospital costs. A platelet aggregometry substudy was performed on 155 patients (abciximab: n = 74 and eptifibatide: n = 81) with use of the Ultegra Rapid Platelet Function Assay. RESULTS: Baseline demographic, angiographic, and procedural variables were similar between the two treatment groups. The median and interquartile ranges of total in-hospital costs were $8268 ($6505, $9958) and $7207 ($5659, $9307), respectively, between the abciximab- and eptifibatide-treated patients (P =.009). Median total costs at 30 days were $8336 ($6505, $10,126) and $7207 ($5659, $9431), respectively, between the abciximab- and eptifibatide-treated groups (P =.009). The composite secondary clinical end points (death/nonfatal myocardial infarction/urgent revascularization) occurred in 4.9% versus 5.1% of patients, respectively, by hospital discharge (P =.84) and in 5.6% versus 6.3% of patients, respectively, at 30 days (P =.95) in the abciximab and eptifibatide groups. With the eptifibatide dose used, early and more durable platelet inhibition was achieved compared with abciximab (P <.00001). CONCLUSION: In drug dosages and patients similar to those enrolled in the current study, eptifibatide achieved durable platelet inhibition throughout drug infusion and was associated with lower in-hospital and 30-day costs compared with abciximab in patients undergoing elective PCI.
Authors: Michael Koutouzis; Bo Lagerqvist; Jonas Oldgren; Axel Akerblom; Magnus Wahlin; Thomas Karlsson; Per Albertsson; Göran Matejka; Lars Grip Journal: Clin Cardiol Date: 2010-11 Impact factor: 2.882
Authors: Sarah Dewilde; Bernd Brüggenjürgen; Christoph Nienaber; Jochen Senges; Robert Welte; Stefan N Willich Journal: Eur J Health Econ Date: 2011-04-12