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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Cost Effectiveness of Paclitaxel-Eluting Stents for Patients Undergoing Percutaneous Coronary Revascularization

Results From the TAXUS-IV Trial

Ameet Bakhai, MD, MRCP^_*,,1, Gregg W. Stone, MD^,3, Elizabeth Mahoney, ScD^_*, Tara A. Lavelle, BA^_*, Chunxue Shi, MS^_*, Ronna H. Berezin, MPH^_*, Betsy J. Lahue, MPH^,2, Mary Ann Clark, MHA^,2, Michael J. Lacey, MS^,2, Mary E. Russell, MD^,2, Stephen G. Ellis, MD^||,3, James B. Hermiller, MD^¶,3, David A. Cox, MD^#, David J. Cohen, MD, MSc^_*,_**,_* on behalf of the TAXUS-IV Investigators

^_* Harvard Clinical Research Institute, Boston, Massachusetts
Barnet and Chase Farm NHS Trust, Barnet, England
Columbia Presbyterian Hospital, New York, New York
Health Economics and Outcomes Research, Boston Scientific, Natick, Massachusetts
^|| Cleveland Clinic Foundation, Cleveland, Ohio
^¶ St. Vincent’s Hospital, Indianapolis, Indiana
^# Mid Carolina Cardiology, Charlotte, North Carolina
^_** Division of Cardiology, Beth Israel–Deaconess Medical Center, Boston, Massachusetts.

Manuscript received July 30, 2005; revised manuscript received February 27, 2006, accepted February 28, 2006.

^_* Reprint requests and correspondence: Dr. David J. Cohen, Cardiovascular Division, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, Massachusetts 02215. (Email: dcohen{at}caregroup.harvard.edu).

OBJECTIVES: This study sought to compare aggregate medical care costs for patients undergoing percutaneous coronary intervention with paclitaxel-eluting stents (PES) and bare-metal stents (BMS) and to formally evaluate the incremental cost effectiveness of PES for patients undergoing single-vessel percutaneous coronary intervention.

BACKGROUND: Although the cost effectiveness of SES has been studied in both clinical trials and decision-analytic models, few data exist on the cost effectiveness of alternative drug-eluting stent (DES) designs. In addition, no clinical trials have specifically examined the cost effectiveness of DES among patients managed without mandatory angiographic follow-up.

METHODS: We performed a prospective economic evaluation among 1,314 patients undergoing percutaneous coronary revascularization randomized to either PES (N = 662) or BMS (N = 652) in the TAXUS-IV trial. Clinical outcomes, resource use, and costs (from a societal perspective) were assessed prospectively for all patients over a 1-year follow-up period. Cost effectiveness was defined as the incremental cost per target vessel revascularization (TVR) event avoided and was analyzed separately among cohorts assigned to mandatory angiographic follow-up (n = 732) or clinical follow-up alone (n = 582).

RESULTS: The PES reduced TVR by 12.2 events per 100 patients treated, resulting in a 1-year cost difference of $572 per patient with incremental cost-effectiveness ratios of $4,678 per TVR avoided and $47,798/quality-adjusted life year (QALY) gained. Among patients assigned to clinical follow-up alone, the net 1-year cost difference was $97 per patient with cost-effectiveness ratios of $760 per TVR event avoided and $5,105/QALY gained.

CONCLUSIONS: In the TAXUS-IV trial, treatment with PES led to substantial reductions in the need for repeat revascularization while increasing 1-year costs only modestly. The cost-effectiveness ratio for PES in the study population compares reasonably with that for other treatments that reduce coronary restenosis, including alternative drug-eluting stent platforms.

Abbreviations and Acronyms   BMS = bare-metal stent   CI = confidence interval   DES = drug-eluting stent   DRG = diagnosis-related group   ICU = intensive care unit   PCI = percutaneous coronary intervention   PES = paclitaxel-eluting stent   QALY = quality-adjusted life year   SES = sirolimus-eluting stent   TVR = target vessel revascularization

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