Hostname: page-component-cd9895bd7-gvvz8 Total loading time: 0 Render date: 2024-12-22T18:03:44.746Z Has data issue: false hasContentIssue false
  • English
  • Français

DO STUDY RESULTS TRANSLATE INTO PRACTICE? INTRACRANIAL STENTING IN GERMANY

Published online by Cambridge University Press:  29 August 2017

Gerhard Schillinger ,
Ernst-Günther Hagenmeyer ,
Andreas Pritzkau  and
Jörg Friedrich
Gerhard Schillinger
Affiliation:
Medical Department, Federal Association of the Local Health Care [email protected]
Ernst-Günther Hagenmeyer
Affiliation:
Medical Department, National Association of the Statutory Health Insurance Funds
Andreas Pritzkau
Affiliation:
Research Department Hospitals, Institute of the Local Health Care Funds
Jörg Friedrich
Affiliation:
Research Department Hospitals, Research Institute of the Local Health Care Funds
Get access Rights & Permissions [Opens in a new window]

Abstract

Objectives: Enrolment into the SAMMPRIS trial published in September 2011 had to be stopped due to a 2.5 higher 30-day stroke and death rate in patients with percutaneous transluminal angioplasty and stenting (PTAS) compared with the control group with only medical therapy. After these results were published, one would have expected a change toward a clearer definition of indications for intracranial stent implantation in patients with intracranial artery stenosis, using this treatment only in patients suffering from recurrent strokes despite aggressive medical management.

Methods: The frequency of intracranial stenting and indication parameters in patients with intracranial artery stenosis were assessed from 2010 to 2013 using claims data for all inpatient episodes from Germany's largest provider of statutory health insurance.

Results: The number of intracranial stenting procedures decreased slowly from 580 in 2010 to 375 in 2013. With a rate of 29 percent there was no change between 2010 and 2013 of patients who were admitted to hospital for stent implantation, without documentation of an acute stroke or transient ischemic attack (TIA). Before PTAS, one-third of patients were admitted twice because of a stroke or TIA over a period of 5 years, 17 percent of patients had been prescribed platelet aggregation inhibitors and at least two admissions to hospital were for an ischemic cerebrovascular event before PTAS.

Conclusions: Our analysis of German claims data provides little evidence of changed indications for stenting in cases of intracranial atherosclerotic disease which one might expect to be caused by the emergence of high-level evidence.

Keywords

Intracranial stentingPercutaneous transluminal angioplasty and stentingMedical devices
Type
Assessments
Information
International Journal of Technology Assessment in Health Care , Volume 33 , Issue 2 , 2017 , pp. 222 - 226
Copyright
Copyright © Cambridge University Press 2017 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

REFERENCES

1. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. OJ L 169 July 12, 1993. Directive 2001/104/EC of the European Parliament and of the Council of 7 December 2001. Amending Council Directive 93/42/EEC concerning medical devices. OJ L6/50 2002 January 10, 2002.Google Scholar
2. U.S. Food and Drug Administration. Humanitarian Device Exemption (HDE) 2005. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=h050001 (accessed September 20, 2016).Google Scholar
3. Chimowitz, MI, Lynn, MJ, Derdeyn, CP, et al. 2011. Stenting versus aggressive medical therapy for intracranial arterial stenosis. N Engl J Med. 2011;365:993–1003.CrossRefGoogle ScholarPubMed
4. Derdeyn, CP, Chimowitz, MI, Lynn, MJ, et al. Aggressive medical treatment with or without stenting in high-risk patients with intracranial artery stenosis (SAMMPRIS): The final results of a randomised trial. Lancet. 2014;383:333–341.CrossRefGoogle ScholarPubMed
5. Zaidat, OO, Castonguay, AC, Fitzsimmons, BF, et al. Design of the Vitesse Intracranial Stent Study for Ischemic Therapy (VISSIT) trial in symptomatic intracranial stenosis. J Stroke Cerebrovasc Dis. 2013;22:1131–1139.CrossRefGoogle ScholarPubMed
6. Zaidat, OO, Fitzsimmons, B-F, Woodward, BK, et al. Effect of a balloon-expandable intracranial stent vs medical therapy on risk of stroke in patients with symptomatic intracranial stenosis: The VISSIT randomized clinical trial. JAMA. 2015;313:1240–1248.CrossRefGoogle Scholar
7. IQWiG (Institute for Quality and Efficiency in Health Care). Stents for the treatment of intracranial artery stenosis - Rapid report, September 10, 2014 [cited 2016 Sep 20]. https://www.iqwig.de/de/projekte-ergebnisse/projekte/nichtmedikamentoese-verfahren/n14-01-stents-zur-behandlung-intrakranieller-arterieller-stenosenrapid-report.5989.html#overview (accessed September 20, 20160). German.Google Scholar
8. U.S. Food and Drug Administration. Narrowed indications for use for the Stryker Wingspan stent system: FDA safety communication, August 8, 2012, last updated January 12, 2015. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm314600.htm (accessed September 20, 20160).Google Scholar
9. Aerzteblatt.de. September 8, 2011. [Wingspan-stent increases stroke risk] http://m.aerzteblatt.de/news/47274.htm (accessed September 20, 20160). German.Google Scholar
10. Farooq, MU, Al-Ali, F, Min, J, Gorelick, PB. Reviving intracranial angioplasty and stenting “SAMMPRIS and beyond” Front Neurol. 2014;5:101.CrossRefGoogle ScholarPubMed
11. DGN (German Society of Neurology). Press release: [Medical Societies make clear: stoke patients are to be treated primarily with medication] January 19, 2012. http://www.dgn.org/pressemitteilungen/schlaganfalltherapie.html (accessed December 18, 2014).Google Scholar
12. Kurre, W, Berkefeld, J, Brassel, F, et al. In-hospital complication rates after stent treatment of 388 symptomatic intracranial stenoses: Results from the INTRASTENT multicentric registry. Stroke. 2010;41:494–498.CrossRefGoogle ScholarPubMed
13. Neumann-Haefelin: Intrakranielle Stenose: Stent oder konservativ? Die Sicht des Neurologen. J Neurol Neurochir Psychiatr. 2014;15:20–22. German.Google Scholar
14. DIMDI (German Institute of Medical Documentation and Information). OPS - German procedure classification. https://www.dimdi.de/static/en/klassi/ops/kodesuche/index.htm (accessed December 18, 2014).Google Scholar
15. Vajda, Z, Miloslavski, E, Guthe, T, et al. Treatment of intracranial atherosclerotic arterial stenoses with a balloon-expandable cobalt chromium stent (Coroflex Blue): Procedural safety, efficacy, and midterm patency. Neuroradiology. 2010;52:645–651.CrossRefGoogle ScholarPubMed
16. Tanweer, O, Wilson, TA, El Helou, A, Becske, T, Riina, HA. National trends in utilization and outcomes of angioplasty and stenting for revascularization in intracranial stenosis. Clin Neurol Neurosurg. 2014;116:54–60.CrossRefGoogle ScholarPubMed
17. Turan, TN, Cotsonis, G, Lynn, MJ, et al. Intracranial stenosis: Impact of randomized trials on treatment preferences of US neurologists and neurointerventionists. Cerebrovasc Dis. 2014;37: 203–211.CrossRefGoogle ScholarPubMed
18. Morris, ZS, Wooding, S, Grant, J. The answer is 17 years, what is the question: Understanding time lags in translational research. J R Soc Med. 2011;104:510–520.CrossRefGoogle ScholarPubMed
19. Hölzel, D, Altwein, JE. Hodentumoren. Ist der Rückgang der Mortalität in der Bundesrepublik Deutschland zu langsam erfolgt? Dt Ärztebl. 1991;88:4123–4130. German.Google Scholar
20. Federal Ministry of Health (Bundesministerium für Gesundheit). Statutory Health Insurance Statistics. Annual average 2012. (Gesetzliche Krankenversicherung: Mitglieder, mitversicherte Angehörige und Krankenstand. Jahresdurchschnitt 2012). http://www.bmg.bund.de/fileadmin/dateien/Downloads/Statistiken/GKV/Mitglieder_Versicherte/KM1_JD_2012.pdf (accessed June 2016). German.Google Scholar
21. InEK (Institut für das Entgeltsystem im Krankenhaus). German coding rules (Deutsche Kodierrichtlinien). 2015. http://www.g-drg.de/cms/content/view/full/5064 (accessed June 20, 2016).Google Scholar