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Health economic evaluation of the use of drug-eluting stents

First results from the Drug-Eluting Stent Registry (DES.de)

Gesundheitsökonomische Evalution von medikamentenfreisetzenden Stents

Baseline-Ergebnisse des deutschen Drug-Eluting-Stent-Registers (DES.de)

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Abstract

Objective

The purpose of the economic evaluation of the German Drug-Eluting Stent (DES) registry includes the investigation of the economic impact and cost-effectiveness of DES compared to bare-metal stents (BMS) and between paclitaxel-eluting (PES) and sirolimus-eluting stents (SES). Here, methodology and initial results are presented.

Methods

Patients were recruited in 2005 and 2006 in 87 centres across Germany. Selection of PES, SES, or BMS was made at the discretion of the cardiologists in charge. Clinical, economic, and quality of life (QoL) data were collected at baseline and up to 12 months. Group comparisons were conducted using Fisher’s exact and t test.

Results

Overall, 3,930 patients were enrolled: 3,471 (75% male, 65 ± 11 years) received DES and 458 (74% male, 67 ± 11 years) BMS. Among the DES patients, 1,821 received PES (75% male, 65 ± 10 years) and 1,600 SES (76% male, 65 ± 11 years). There were baseline differences in clinical and procedural characteristics but not in QoL. During the hospital stay, major adverse cardiac and cerebrovascular events occurred in 1.6% of DES (PES 1.9%, SES 1.1%) and 2.2% of BMS patients (BMS vs. DES, PES, and SES p = 0.327, 0.706, and 0.098, respectively). Hospital treatment costs were 4,989 ± 1,284 € and 3,609 ± 924 €, respectively, in DES and BMS patients (p < 0.001) with no significant difference between PES and SES.

Conclusion

The economic evaluation of the large DES registry demonstrates increased initial hospitalisation costs associated with DES compared to BMS. Further analysis of the economic impact and cost-effectiveness of DES will provide estimates on large “real world” patient populations for decision makers and aid in reimbursement decisions of DES within the German and other health care systems.

Zusammenfassung

Zielsetzung

Die gesundheitsökonomische Evaluation des deutschen Drug-Eluting-Stent (DES)-Registers untersucht die wirtschaftlichen Auswirkungen und die Kosteneffektivität von DES im Vergleich zu Bare-Metal-Stents (BMS) sowie von Paclitaxelfreisetzenden (PES) im Vergleich zu Sirolimus-freisetzenden Stents (SES). Ziel der vorliegenden Analyse ist die detaillierte Darstellung von Methoden und Baseline-Ergebnissen des gesundheitsökonomischen Teilprojekts von DES.de.

Methoden

Patienten wurden in den Jahren 2005 und 2006 in 87 Zentren in Deutschland rekrutiert. Die Wahl der Implantation von PES, SES oder BMS lag im Ermessen des verantwortlichen Kardiologen. Klinische, gesundheitsökonomische und Lebensqualitätsdaten wurden zu Studienbeginn sowie 3, 6, 9 und 12 Monate nach Stent-Implantation erhoben. Der Vergleich der Behandlungsgruppen bezüglich untersuchter Outcomes erfolgte unter Verwendung des Fisher-Exact- und des t-Tests.

Ergebnisse

Insgesamt wurden 3930 Patienten in die gesundheitsökonomische Evaluation von DES.de eingeschlossen. Bei 3471 Patienten (75% männlich, 65±11 Jahre) wurde ein DES und bei 458 Patienten (74% männlich, 67±11 Jahre) ein BMS implantiert. Bezogen auf DES-Patienten wurden 1821 mit PES (75% männlich, 65±10 Jahre) und 1600 mit SES (76% männlich, 65±11 Jahre) behandelt. Zu Studienbeginn wurden Unterschiede zwischen den Gruppen hinsichtlich klinischer und prozeduraler Eigenschaften, nicht aber hinsichtlich der Lebensqualität beobachtet. MACCE („major adverse cardiac and cerebrovascular events“) traten im Verlauf des initialen Krankenhausaufenthalts bei 1,6% der DES- (PES: 1,9%, SES: 1,1%) bzw. 2,2% der BMS-Patienten auf. Die Unterschiede zwischen BMS und DES, PES und SES waren statistisch nicht signifikant (p=0,327/0,706/0,098). Die initialen Behandlungskosten betrugen 4989±1284 Euro und 3609±924 Euro für DES- bzw. BMS-Patienten (p<0,001), wobei kein signifikanter Unterschied zwischen PES- und SES-Patienten bestand.

Schlussfolgerungen

Die gesundheitsökonomische Evaluation von DES.de stellt eine der größten Untersuchungen der wirtschaftlichen Auswirkungen und der Kosteneffektivität von DES dar. Die bisherigen Ergebnisse machen die stark erhöhten anfänglichen Behandlungskosten durch DES deutlich. Follow-up-Ergebnisse werden für Entscheidungsträger wichtige Hinweise hinsichtlich der ökonomischen Auswirkungen und der Kosteneffektivität von DES im deutschen und in anderen Gesundheitssystemen liefern.

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Conflict of interest

The corresponding author states the following: this study was funded by Boston Scientific and Cordis GmbH.

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Authors and Affiliations

  1. Institute for Social Medicine, Epidemiology and Health Economics, Charité University Medical Center, Luisenstr. 57, 10117, Berlin, Germany

    S.N. Willich MPH, MBA, F. Müller-Riemenschneider, D. McBride & B. Brüggenjürgen

  2. Department of Cardiology, Asklepios Hospital Hamburg, Hamburg, Germany

    S. Silber

  3. Department of Cardiology, Asklepios Hospital Hamburg, Hamburg, Germany

    K.-H. Kuck

  4. Heart Center Rostock, University of Rostock, Rostock, Germany

    C.A. Nienaber

  5. Department of Cardiology, Heart Center Ludwigshafen, Ludwigshafen, Germany

    S. Schneider & J. Senges

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  1. S.N. Willich MPH, MBA
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Correspondence to S.N. Willich MPH, MBA.

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Willich, S., Müller-Riemenschneider, F., McBride, D. et al. Health economic evaluation of the use of drug-eluting stents. Herz 38, 57–64 (2013). https://doi.org/10.1007/s00059-012-3581-5

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  • DOI: https://doi.org/10.1007/s00059-012-3581-5

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