Basel Stent Cost-Effectiveness (BASKET) Trial

1. BASKET Trial Basel Stent Cost-Effectiveness (BASKET) Trial Presented at The European Society of Cardiology Hotline Session 2005 Presented by Dr. Matthias E. Pfisterer

2. BASKET Trial 826 undergoing primary PCI irrespective of indication for PCI mean follow-up 18 months; 6 months reported to date, mean age 64 years, 21% female Concomitant medications: clopidogrel for 6 months (irrespective of stent type), aspirin and statin therapy 19% Diabetic, 27% prior MI, 69% with triple vessel disease, 52% LAD lesions, 26% txd with glycoprotein IIb/IIa inhibitors Bare Metal Stent: Vision Stent n = 281 Drug Eluting Stent Taxus Stent n = 281 Cypher Stent n = 264 Primary Endpoint: Cost-effectiveness after 6 months, with effectiveness defined as reduction of major adverse cardiac events for the comparison of drug-eluting stent vs bare metal stent. Presented at ESC 2005

3. BASKET Trial: MACE at 6 Months p = 0.02 p = 0.08 p = 0.12 p = 0.62 Presented at ESC 2005

4. BASKET Trial: 6 Month MACE • MACE at 6 months was lower in the Drug-Eluting Stent (DES) group compared with the bare metal stent (BMS) group. This was primarily due to a reduction in target vessel revascularization (TVR) and less so by a reduction in myocardial infarction, with no difference in cardiac death. • For the comparison of Cypher and Taxus stents, there were no significant differences in MACE or components of MACE including TVR, MI or cardiac death (it should be noted that the trial may not have been adequately powered for this comparison) Presented at ESC 2005

5. BASKET Trial: Cost-effectiveness p < 0.001 p < 0.001 Euros Presented at ESC 2005

6. BASKET Trial: Cost-effectiveness • Initial procedural costs were higher with DES than BMS, resulting in higher overall cost during the index hospitalization. • Costs during follow-up were slightly lower in the DES group, although this difference did not offset the initial higher index hospitalization costs for DES, resulting in higher costs through 6 months in the DES group. • This resulted in a cost-effectiveness ratio of €18,031 for one MACE avoided, or the more commonly used cost-effectiveness ratio, €54,546 to €73,283 per one quality life year (QALY) gained. • Several high-risk subgroups were identified that potentially had a better cost-effectiveness ratio, including those aged >65 years, triple vessel disease, lesion length >20 mm and those with 2.5 mm vessel or smaller. Presented at ESC 2005

7. BASKET Trial: Summary • Among patients undergoing PCI with coronary stenting, irrespective of indication, use of drug-eluting stents were associated with higher costs through 6 months and a very high cost-effectiveness ratio, despite a lower MACE rate compared with bare metal stents. • Despite being more effective at reducing MACE and TVR, the higher initial cost with the drug-eluting stents were not offset by lower follow-up costs through 6 months; however, longer follow-up data will be collected. • Since it may not be feasible for all sites to use these high-cost devices in all patients, an alternative may be to focus on high-risk subsets that had a more favorable cost-effectivenss ratio such as those with small vessels or those older than age 65 years. • Higher costs with drug-eluting stents occurred despite the trial using one of the most expensive bare metal stents, the Vision stent, which should have narrowed the cost gap between the two stent types. • These data contrast with those of the cot-effectiveness study of the SIRIUS trial, which showed higher initial costs with the drug-eluting stent Cypher but no difference in total costs through one year follow-up. (It should be noted that the BASKET trial was conducted without any industry funding or sponsorship.)