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Surgery to Prevent Stroke: High Hopes and Deep Disappointment

Published online by Cambridge University Press:  10 March 2009

Bryan Jennett
Affiliation:
Institute of Neurological Sciences, Glasgow

Extract

Carotid endarterectomy and EC/IC bypass grafting have been widely adopted for patients considered at risk from stroke, without good evidence of efficacy. Unjustified claims for surgery usually derive from overestimating the dangers of the disease without surgery, while perioperative risks are underestimated. Inadequate follow-up and choosing irrelevant outcome measures often add to the confusion. All these factors apply to surgery for stroke. A trial of EC/lC bypass in 1,377 patients from three continents took 8 years to complete and showed no benefit in patients randomized to surgery. Reluctance to accept this result led to detailed critiques of this trial in several journals, largely based on the discovery that many patients had been operated on in some centers without having been randomized. In reply, the investigators showed that these cases did not affect the “resounding negativity of the results.” Lack of good data about the prognosis of patients with TlAs or minor strokes was the fundamental reason for so much misplaced surgical effort. This applies equally to carotid endarterectomy, for which large trials are currently being completed. Had there been a reliable data base of patients at risk of stroke, prospectively collected and followed, the efficacy of these two operations could have been determined much sooner, and inappropriate diffusion might have been prevented.

Type
Special Section: Technology Assessment and Surgical Policy
Copyright
Copyright © Cambridge University Press 1989

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References

REFERENCES

Anonymous. Dropouts from clinical trials. Lancet, 1987, 2, 892–93.CrossRefGoogle Scholar
Anonymous. Extracranial–intracranial anastomosis. Lancet, 1979, 1, 1384–85.Google Scholar
Anonymous. Extracranial to intracranial bypass and the prevention of stroke. Lancet, 1985, 2, 1401–02.Google Scholar
Anonymous. The epistemology of surgery. Lancet, 1986, 1, 656–57.Google Scholar
Adams, H.P., Kessell, N. F.. Is this the time for a new therapeutic approach. Stroke, 1984, 15, 371–75.CrossRefGoogle ScholarPubMed
Andrews, B. T., & Weinstein, P. R.Extracranial–intracranial arterial bypass [letter]. New England Journal of Medicine, 1986, 314, 1192–93.Google Scholar
Ausman, J. U., & Diaz, F. G.Critique of the extracranial–intracranial bypass study. Surgical Neurology, 1986, 26, 218–21.CrossRefGoogle ScholarPubMed
Awad, I. A., & Spetzler, R. F.Extracranial–intracranial bypass surgery: A critical analysis in light of the international cooperative study. Neurosurgery, 1986, 19, 655–64.CrossRefGoogle ScholarPubMed
Bannister, C. M.The EC/IC bypass study [letter]. New England Journal of Medicine, 1986, 314, 1193.Google Scholar
Barnett, H. J. M., Fox, A., Hachinski, V. et al. Further conclusions from the extracranial–intracranial bypass trial [letter]. Surgical Neurology, 1986, 26, 227–35.CrossRefGoogle ScholarPubMed
Barnett, H. J. M., Sackett, D., Taylor, D. W. et al. Are the results of the extracranial–intracranial bypass trial generalizable? New England Journal of Medicine, 1987, 316, 820–24.CrossRefGoogle ScholarPubMed
Barnett, H. J. M., Peerless, S. J., Fox, A. et al. The EC/IC bypass study [letter]. New England Journal of Medicine, 1987, 317, 1031.Google Scholar
Bonchek, H. I.Are randomized trials appropriate for evaluating new operations? New England Journal of Medicine, 1979, 301, 4445.CrossRefGoogle ScholarPubMed
Brott, T. G., Labutta, R. J., & Norris, J. W.Outcome in patients with asymptomatic neck bruits. New England Journal of Medicine, 1986, 315, 860–65.Google Scholar
Charlson, M. E., & Horowitz, R. I.Applying results of randomized trials to clinical practice: Impact of losses before randomisation. British Medical Journal, 1984, 289, 28184.CrossRefGoogle ScholarPubMed
Day, A. L., Rhoton, A. L., & Little, J. R.The extracranial–intracranial bypass study. Surgical Neurology, 1986, 26, 222–26.CrossRefGoogle ScholarPubMed
Donaghy, R. M., & Yasargil, M. G.Microangeional surgery and its techniques. Progress in Brain Research, 1968, 30, 263.CrossRefGoogle ScholarPubMed
Dyken, M. L., & Pakras, R.The performance of endarterectomy for disease of the extracranial arteries of the head. Stroke, 1984, 15, 948–50.CrossRefGoogle ScholarPubMed
Earnest, IV F., Forbes, G., Sandok, B. A. et al. Complications of cerebral angiography in prospective assessment of risk. American Journal of Neuroradiology, 1983, 4, 1191–97.Google Scholar
Eastcott, H. H. G., Pickering, G. W., & Robb, C.MReconstruction of internal carotid artery in a patient with intermittent attacks of hemiplegia. Lancet, 1954, 2, 994–96.CrossRefGoogle Scholar
EC/IC Bypass Study Group. Failure of extracranial–intracranial arterial bypass to reduce the risk of ischemic stroke. New England Journal of Medicine, 1985, 313, 11911200.CrossRefGoogle Scholar
EC/IC Bypass Study Group. The international cooperative study of extracranial/intracranial arterial anastomosis (EC/IC Bypass Study): Methodology and entry characteristics. Stroke, 1985, 16, 397406.CrossRefGoogle Scholar
Fields, W. S., Maslenikov, V., Meyer, J. S. et al. Joint study of extracranial arterial occlusion, V. Progress report of prognosis following surgery or non-surgical treatment for transient ischaemic attacks and cervical carotid artery lesions. Journal of the American Medical Association, 1970, 211, 19932003.CrossRefGoogle ScholarPubMed
Goldring, S., Zervas, N., & Langfitt, T.The extracranial–intracranial bypass study. A Report of the Committee Appointed by the American Association of Neurological Surgeons to Examine the Study. New England Journal of Medicine, 1987, 316, 817–20.CrossRefGoogle Scholar
Gur, D., & Yonas, H.Extracranial-intracranial arterial bypass [letter]. New England Journal of Medicine, 1986, 314, 1192.Google Scholar
Haynes, R. B., Sackett, D., Taylor, D. W. et al. Extracranial–intracranial arterial bypass [letter]. New England Journal of Medicine, 1986, 314, 1193.Google Scholar
Haynes, R. B., Mukherjee, J., Sackett, D. L. et al. Functional status changes following medical or surgical treatment for cerebral ischemia. Results of the extracranial–intracranial bypass study. Journal of the American Medical Association, 1987, 257, 2043–46.CrossRefGoogle ScholarPubMed
Jennett, B., Teasdale, G., Braakman, R. et al. Prognosis of patients with severe head injury. Neurosurgery, 1979, 4, 283–88.CrossRefGoogle ScholarPubMed
Jennett, B.Assessment of a technological package using a predictive tool. International Journal of Technology Assessment in Health Care, 1987, 3, 335–38.CrossRefGoogle ScholarPubMed
Johnson, G. T.The EC/C bypass study [letter]. New England Journal of Medicine, 1987, 317, 1031.Google Scholar
Knaus, W. A., Draper, E. A., Wagner, D. P. et al. Evaluation outcome from intensive care: A preliminary multihospital comparison. Critical Care Medicine, 1982, 10, 491–96.CrossRefGoogle ScholarPubMed
Knaus, W. A., Wagner, D. P., Loirat, P. et al. A comparison of intensive care in the USA and France. Lancet, 1982, 2, 642–46.CrossRefGoogle ScholarPubMed
Kunitz, S. C., Gross, C. R., Heyman, A. et al. The pilot stroke data bank: Definition, design, and data. Stroke, 1984, 15, 740–41.CrossRefGoogle Scholar
McDowell, F., IC bypass study. Stroke, 1986, 17, 12.CrossRefGoogle ScholarPubMed
Meissner, I., Wiebers, D. O., Whisnant, J. P. et al. The natural history of asymptomatic carotid artery occlusive lesions. Journal of the American Medical Association, 1987, 258, 2704–07.CrossRefGoogle ScholarPubMed
Merrick, N. J., Brook, R. H., Fink, A. et al. Use of carotid endarterectomy in five California Veterans Administration medical centers. Journal of the American Medical Association, 1986, 256, 2531–35.CrossRefGoogle ScholarPubMed
Murie, J. A.Carotid endarterectomy: An effective therapy? Scottish Medical Journal, 1987, 32, 163–65.CrossRefGoogle ScholarPubMed
Plum, F.Extracranial-intracranial arterial bypass and cerebral vascular disease. New England Journal of Medicine, 1985, 313, 1221–23.CrossRefGoogle ScholarPubMed
Relman, A. S.The extracranial–intracranial arterial bypass study. What have we learned? New England Journal of Medicine, 1987, 316, 809–10.CrossRefGoogle ScholarPubMed
Spetzler, R. F.Extracranial–intracranial bypass trial [letter]. Surgical Neurology, 1987, 27, 503-04.CrossRefGoogle Scholar
Sundt, T. M.Was the international randomized trial of extracranial–intracranial arterial bypass representative of the population at risk? New England Journal of Medicine, 1987, 316, 814–16.CrossRefGoogle ScholarPubMed
Toronto Cerebrovascular Study Group. Risks of carotid endarterectomy. Stroke, 1986, 17, 848–52.CrossRefGoogle Scholar
UK-TIA Study Group. Variation in the use of angiography and carotid endarterectomy by neurologists in the UK-TIA aspirin trial. British Medical Journal, 1983, 286, 514–17.CrossRefGoogle Scholar
Warlow, C.Carotid endarterectomy: Does it work? Stroke, 1984, 15, 1068–76.CrossRefGoogle ScholarPubMed
Wennberg, J. E.Setting outcome-based standards for carotid endarterectomy. Journal of the American Medical Association, 1986, 256, 2566–67.CrossRefGoogle ScholarPubMed
Whisnant, J. P., Matsumoato, N., Transient cerebral ischaemic attacks in a community, Rochester, Minnestoa – 1955 through 1969. Mayo Clinic Proceedings, 1973, 48, 194–98.Google Scholar