Basel Stent Cost-Effectiveness Trial - BASKET

Description:

The goal of the trial was to evaluate the cost-effectiveness of drug-eluting stents compared with bare metal stents among all patients undergoing percutaneous coronary intervention (PCI) with coronary stenting.

Study Design

Study Design:

Patients Enrolled: 826
Mean Follow Up: 18 months; six months reported to date
Mean Patient Age: Mean age 64 years
Female: 21

Patient Populations:

All patients undergoing PCI irrespective of indication for PCI

Exclusions:

Target vessel diameter ≥4 mm, restenotic lesions, or no informed consent given

Primary Endpoints:

Cost-effectiveness after six months, with effectiveness defined as reduction of MACE for the comparison of drug-eluting stent versus bare metal stent

Drug/Procedures Used:

All consecutive patients at a single center scheduled for PCI who gave informed consent were randomized to coronary stenting with either a drug-eluting stent (Cypher, n=264 or Taxus, n=281) or bare metal stent using the Vision stent (n=281) in a 2:1 manner. Patient costs were collected for the index procedure, during hospitalization, and through six-month follow-up. The trial was conducted without any industry funding or sponsorship.

Concomitant Medications:

Clopidogrel for six months (irrespective of stent type), aspirin, and statin therapy

Principal Findings:

Baseline characteristics were similar between randomized groups, with 19% diabetics, and 27% having had a prior myocardial infarction (MI). Indication for PCI was stable angina in 42% of patients, unstable angina in 36%, and ST elevation MI in 21%. The majority of patients had triple-vessel disease (69%) and left anterior descending artery lesion location (52%). Glycoprotein IIb/IIIa inhibitors were used in 26% of cases. The average number of stents used per patient was 1.9.

Major adverse cardiac events (MACE) at six months was lower in the drug-eluting stent group compared with the bare metal stent group (7.2% vs. 12.1%, p=0.02), driven by a reduction in target vessel revascularization (4.6% vs. 7.8%, p=0.08) and less so MI (2.2% vs. 4.3%, p=0.12), with no difference in cardiac death (1.7% vs. 2.1%, p=0.62). For the comparison of Cypher and Taxus stents, there were no significant differences in MACE (5.7% for Cypher vs. 8.5% for Taxus) or components of MACE including target vessel revascularization (3.0% vs. 6.0%), MI (2.3% vs. 2.1%), or cardiac death (1.1% vs 2.1%). Initial procedural costs were higher with drug-eluting stents compared with bare metal stents (€3,961 vs. €2,259, p<0.001), driving a higher overall cost during the index hospitalization (€5,710 vs. €6,194).

Costs during follow-up were slightly lower in the drug-eluting stent group (€873 vs. €1,185), although this difference did not offset the initial higher index hospitalization costs for drug-eluting stents, resulting in a higher total cost through six months in the drug-eluting stent group (€10,544 vs. €9,639, p<0.001). 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 with age >65 years, triple-vessel disease, lesion length >20 mm, and a 2.5 mm vessel or smaller.

Interpretation:

Among patients undergoing PCI with coronary stenting, irrespective of indication, use of drug-eluting stents were associated with higher total costs through six 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 target vessel revascularization, the higher initial costs with the drug-eluting stents were not offset by lower follow-up costs through six months; however, longer follow-up data will be collected. The authors noted that it may not be feasible for all sites to use these high-cost devices in all patients, but an alternative may be to focus on high-risk subsets that had a more favorable cost-effectiveness ratio such as those with small vessels or those older than age 65 years.

The 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 cost-effectiveness study in the SIRIUS trial, which showed higher initial costs with the drug-eluting stent Cyper, but no difference in total costs through one-year follow-up. It should be noted that the trial was conducted without any industry funding or sponsorship.

References:

Presented by Dr. Matthias E. Pfisterer at the European Society of Cardiology Hot Line Session, September 2005.

Kaiser C, Brunner-La Rocca HP, Buser PT, et al. Incremental cost-effectiveness of drug-eluting stents compared with a third-generation bare-metal stent in a real-world setting: randomised Basel Stent Kosten Effektivitäts Trial (BASKET). Lancet 2005;366:921-9.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Chronic Angina

Keywords: Myocardial Infarction, Follow-Up Studies, Coronary Restenosis, Metals, Drug-Eluting Stents, Angioplasty, Balloon, Coronary, Diabetes Mellitus, Quality-Adjusted Life Years, Stents


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