Comment
medical therapy (particularly statins, blood pressure management, and antithrombotic therapy) in lowering the risk of recurrent stroke was probably a contributing factor.7 Moreover, medical therapy was not optimised in VAST (the median systolic blood pressure was 150 mm Hg at 12 months and there was no requirement for early short-term dual-antiplatelet therapy in the medical group), which suggests that the use of intensive medical therapy as implemented in SAMMPRIS5 may have further reduced the stroke risk in the medical group of VAST. Since the results of studies have shown that medical therapy obviates the need for endovascular revascularisation in stable coronary artery stenosis (COURAGE8), renal artery stenosis (CORAL9), symptomatic intracranial arterial stenosis (SAMMPRIS5 and VISSIT6), and vertebral artery stenosis (VAST4), continuation of the search for evidence of low levels of efficacy from costly endovascular procedures for patients with these diseases does not seem warranted when effective medical therapies are available. Perhaps a focus on methods to improve implementation of intensive medical therapy is in the better interests of our patients, because intensive medical therapy has earned the right to be the standard of care.
Disorders and Stroke (NINDS; grant number U01 NS058728). Both authors received salary support from the SAMMPRIS grant. TNT is a past recipient of funding from the American Academy of Neurology Foundation Clinical Research Training Fellowship and is the current recipient of a K23 grant from the National Institutes of Health and NINDS (1 K23 NS069668-01A1). She also reports other compensation for participating on stroke adjudication committees for clinical trials funded by Gore Associates and Boehringer Ingelheim. MIC was the grant recipient (U01 NS058728) for the NINDS-funded SAMMPRIS trial discussed in the paper. MIC has also received research grants from NINDS to fund the WASID trial (1 R01 NS36643) and to fund other research on intracranial stenosis (1 K24 NS050307 and 1 R01 NS051688). He has also received other compensation for participating on stroke adjudication committees and a data safety monitoring committee for clinical trials funded by Merck/Parexel, Medtronic, and Gore Associates. The completed NINDS-funded SAMMPRIS trial that MIC led was also supported by the Investigator-Sponsored Study Program of AstraZeneca, which donated rosuvastatin to the patients in the study, and Stryker Neurovascular (formerly Boston Scientific Neurovascular), which provided study devices and supplemental funding for third party device distribution, site monitoring, and study auditing in SAMMPRIS. 1 2
3
4
5
6
Tanya N Turan, *Marc I Chimowitz Department of Neurology, Medical University of South Carolina Stroke Program, 19 Hagood Ave, Suite 501, Charleston, SC 29425, USA (TNT, MIC) [email protected] Both authors served on the executive committee of the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) trial, which was funded by the National Institute of Neurological
7
8 9
Caplan LR, Wityk RJ, Glass TA, et al. New England Medical Center Posterior Circulation Registry. Ann Neurol 2004; 56: 389–98. Wityk RJ, Chang HM, Rosengart A, et al. Proximal extracranial vertebral artery disease in the New England Medical Center Posterior Circulation Registry. Arch Neurol 1998; 55: 470–78. Gulli G1, Marquardt L, Rothwell PM, Markus HS. Stroke risk after posterior circulation stroke/transient ischemic attack and its relationship to site of vertebrobasilar stenosis: pooled data analysis from prospective studies. Stroke 2013; 44: 598–604. Compter AE, van der Worp HB, Schonewille WJ, et al, on behalf of the VAST investigators. Stenting versus medical treatment in patients with symptomatic vertebral artery stenosis: a randomised open-label phase 2 trial. Lancet Neurol 2015; published online April 21. http://dx.doi. org/10.1016/S1474-4422(15)00017-4. Derdeyn CP, Chimowitz MI, Lynn MJ, et al , for the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis Trial Investigators. 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: 333–41. Zaidat OO, Fitzsimmons BF, 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: 1240–48. Hong KS, Yegiaian S, Lee M, Lee J, Saver JL. Declining stroke and vascular event recurrence rates in secondary prevention trials over the past 50 years and consequences for current trial design. Circulation 2011; 123: 2111–19. Boden WE, O’Rourke RA, Teo KK, et al. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med 2007; 356: 1503–16. Cooper CJ, Murphy TP, Cutlip DE, et al. Stenting and medical therapy for atherosclerotic renal-artery stenosis. N Engl J Med 2014; 370: 13–22.
Corrections Published Online April 14, 2015 http://dx.doi.org/10.1016/ S1474-4422(15)00045-9
Menon P, Geevasinga N, Yiannikas C, Howells J, Kiernan MC, Vucic S. Sensitivity and specificity of threshold tracking transcranial magnetic stimulation for diagnosis of amyotrophic lateral sclerosis: a prospective study. Lancet Neurol 2015; 14: 478–84—“James Howells” was listed incorrectly as “James Howell.” This correction has been made as of April 14, 2015. The CADISS trial investigators. Antiplatelet treatment compared with anticoagulation treatment for cervical artery dissection (CADISS): a randomised trial. Lancet Neurol 2015; 14: 361–67—In the list of participating centres and investigators in this Article, Southern General Hospital, Glasgow, (Keith Muir should not have been listed). Instead, Western General Hospital, Edinburgh (Malcolm Macleod, Bridget Colam, Rustam Al-Shahi Salman) should have been included. These corrections have been made to the online version as of May 11, 2015.
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medical therapy (particularly statins, blood pressure management, and antithrombotic therapy) in lowering the risk of recurrent stroke was probably a contributing factor.7 Moreover, medical therapy was not optimised in VAST (the median systolic blood pressure was 150 mm Hg at 12 months and there was no requirement for early short-term dual-antiplatelet therapy in the medical group), which suggests that the use of intensive medical therapy as implemented in SAMMPRIS5 may have further reduced the stroke risk in the medical group of VAST. Since the results of studies have shown that medical therapy obviates the need for endovascular revascularisation in stable coronary artery stenosis (COURAGE8), renal artery stenosis (CORAL9), symptomatic intracranial arterial stenosis (SAMMPRIS5 and VISSIT6), and vertebral artery stenosis (VAST4), continuation of the search for evidence of low levels of efficacy from costly endovascular procedures for patients with these diseases does not seem warranted when effective medical therapies are available. Perhaps a focus on methods to improve implementation of intensive medical therapy is in the better interests of our patients, because intensive medical therapy has earned the right to be the standard of care.
Disorders and Stroke (NINDS; grant number U01 NS058728). Both authors received salary support from the SAMMPRIS grant. TNT is a past recipient of funding from the American Academy of Neurology Foundation Clinical Research Training Fellowship and is the current recipient of a K23 grant from the National Institutes of Health and NINDS (1 K23 NS069668-01A1). She also reports other compensation for participating on stroke adjudication committees for clinical trials funded by Gore Associates and Boehringer Ingelheim. MIC was the grant recipient (U01 NS058728) for the NINDS-funded SAMMPRIS trial discussed in the paper. MIC has also received research grants from NINDS to fund the WASID trial (1 R01 NS36643) and to fund other research on intracranial stenosis (1 K24 NS050307 and 1 R01 NS051688). He has also received other compensation for participating on stroke adjudication committees and a data safety monitoring committee for clinical trials funded by Merck/Parexel, Medtronic, and Gore Associates. The completed NINDS-funded SAMMPRIS trial that MIC led was also supported by the Investigator-Sponsored Study Program of AstraZeneca, which donated rosuvastatin to the patients in the study, and Stryker Neurovascular (formerly Boston Scientific Neurovascular), which provided study devices and supplemental funding for third party device distribution, site monitoring, and study auditing in SAMMPRIS. 1 2
3
4
5
6
Tanya N Turan, *Marc I Chimowitz Department of Neurology, Medical University of South Carolina Stroke Program, 19 Hagood Ave, Suite 501, Charleston, SC 29425, USA (TNT, MIC) [email protected] Both authors served on the executive committee of the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) trial, which was funded by the National Institute of Neurological
7
8 9
Caplan LR, Wityk RJ, Glass TA, et al. New England Medical Center Posterior Circulation Registry. Ann Neurol 2004; 56: 389–98. Wityk RJ, Chang HM, Rosengart A, et al. Proximal extracranial vertebral artery disease in the New England Medical Center Posterior Circulation Registry. Arch Neurol 1998; 55: 470–78. Gulli G1, Marquardt L, Rothwell PM, Markus HS. Stroke risk after posterior circulation stroke/transient ischemic attack and its relationship to site of vertebrobasilar stenosis: pooled data analysis from prospective studies. Stroke 2013; 44: 598–604. Compter AE, van der Worp HB, Schonewille WJ, et al, on behalf of the VAST investigators. Stenting versus medical treatment in patients with symptomatic vertebral artery stenosis: a randomised open-label phase 2 trial. Lancet Neurol 2015; published online April 21. http://dx.doi. org/10.1016/S1474-4422(15)00017-4. Derdeyn CP, Chimowitz MI, Lynn MJ, et al , for the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis Trial Investigators. 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: 333–41. Zaidat OO, Fitzsimmons BF, 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: 1240–48. Hong KS, Yegiaian S, Lee M, Lee J, Saver JL. Declining stroke and vascular event recurrence rates in secondary prevention trials over the past 50 years and consequences for current trial design. Circulation 2011; 123: 2111–19. Boden WE, O’Rourke RA, Teo KK, et al. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med 2007; 356: 1503–16. Cooper CJ, Murphy TP, Cutlip DE, et al. Stenting and medical therapy for atherosclerotic renal-artery stenosis. N Engl J Med 2014; 370: 13–22.
Corrections Published Online April 14, 2015 http://dx.doi.org/10.1016/ S1474-4422(15)00045-9
Menon P, Geevasinga N, Yiannikas C, Howells J, Kiernan MC, Vucic S. Sensitivity and specificity of threshold tracking transcranial magnetic stimulation for diagnosis of amyotrophic lateral sclerosis: a prospective study. Lancet Neurol 2015; 14: 478–84—“James Howells” was listed incorrectly as “James Howell.” This correction has been made as of April 14, 2015. The CADISS trial investigators. Antiplatelet treatment compared with anticoagulation treatment for cervical artery dissection (CADISS): a randomised trial. Lancet Neurol 2015; 14: 361–67—In the list of participating centres and investigators in this Article, Southern General Hospital, Glasgow, (Keith Muir should not have been listed). Instead, Western General Hospital, Edinburgh (Malcolm Macleod, Bridget Colam, Rustam Al-Shahi Salman) should have been included. These corrections have been made to the online version as of May 11, 2015.
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