Letters to the Editor [4] Hermansky SJ, Holcslaw TL. Biochemical and functional effects of 2,3,7,8-tetrachlorodibenzo-p-dioxin on the heart of female rats. Toxicol Appl Pharmacol 1988;95:175–84. [5] Nobuyuki K, Mariko K. Biochemical and molecular biological analysis of different response to 2,3,7,8-teterachlorodibenzo-p-dioxin in chick embryo heart and liver. Arch Biochem Biophys 2004;427:58–67.
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[6] Kim JS, Lim HS. Impact of Agent Orange exposure among Korean Vietnam veterans. Ind Health 2003;41:149–57. [7] Kang HK, Dalager NA. Health status of army chemical corps Vietnam veterans who sprayed defoliant in Vietnam. Am J Ind Med 2006;49:875–84.
http://dx.doi.org/10.1016/j.ijcard.2014.03.182 0167-5273/© 2014 Published by Elsevier Ireland Ltd.
Angioplasty and stenting in middle cerebral artery: Results from multicenter China interventional stroke registry Yunyun Xiong a,1, Wenhua Liu a,1, Zhiming Zhou b, Hang Lin c, Min Lin c, Jianlin Liu d, Guozhong Niu e, Wei Wang f, Yi Jia g, Thomas W. Leung h, Dezhi Liu a, Xiaobing Fan a, Qin Yin a, Wusheng Zhu a, Minmin Ma a, Renliang Zhang a, George Liu i, Shang Wang j, Gelin Xu a, Xinfeng Liu a,⁎ a b c d e f g h i j
Department of Neurology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, Jiangsu Province, China Department of Neurology, Yijishan Hospital of Wannan Medical College, Anhui Province, China Department of Neurology, Fuzhou General Hospital of Nanjing Military Region, Fuzhou, Fujian Province, China Center of Cerebrovascular Diseases, The First Affiliated Hospital, Medical School of Xi'an Jiaotong University, Xi'an 710061, China Department of Neurology, The First People's Hospital of Hangzhou, Hangzhou, Zhejiang Province, China Department of Radiology, Yangzhou No.1 People's Hospital, Yangzhou, Jiangsu Province, China Department of Neurology, Xi'an Gaoxin Hospital, Shanxi Province, China Deparment of Medicine & Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong Institute of Cardiovascular Sciences, Peking University Health Science Center, 38 Xueyuan Road, Hai Dian District, 100083 Beijing, China Deparment of Cardiology, Drum Tower Hospital Affiliated to Nanjing University School of Medicine, Nanjing, China
a r t i c l e
i n f o
Article history: Received 14 February 2014 Accepted 29 March 2014 Available online 6 April 2014 Keywords: Angioplasty Ischemic stroke Middle cerebral artery Stent Registry
Atherosclerotic middle cerebral artery (MCA) stenosis is a devastating cause of cerebral ischemia and stroke, which portends a high recurrence rate despite medical therapy [1]. It is particularly prevalent in Asia with more diffuse lesion and tandem lesion, but relatively rare in North America [2,3]. Although percutaneous coronary intervention with stenting is a recommended treatment for patients with coronary artery stenosis nowadays [4], whether angioplasty and stenting should be performed for atherosclerotic MCA stenosis is still controversial. We set up a multicenter prospective registry in China — the China interventional stroke registry (CISR), aimed to illustrate the technical success rate, periprocedural event rate, and long-term clinical outcomes for angioplasty and stenting of MCA in China. Details of the study design were published previously [5]. In brief, we included patients undergoing angioplasty and/or stenting in extracranial and intracranial arteries. Until Feb 2013, 7 centers across 5 provinces (Jiangsu, Anhui, Zhejiang, Shanxi and Fujian) have entered data into our online database. The primary clinical outcome
⁎ Corresponding author at: Department of Neurology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China. Tel.: +86 25 84801861; fax: + 86 25 84866453. E-mail address: xfl[email protected] (X. Liu). 1 These two authors contributed equally to this work.
was stroke or death within 30 days after angioplasty and/or stenting for the treated lesion and ischemic stroke in the territory of the stented artery beyond 30 days. The stenting procedures, definition of stroke and technical success as well as the follow-up process were illustrated in Supplementary data. The authors of this manuscript have certified that they comply with the Principles of Ethical Publishing in the International Journal of Cardiology. One hundred and fifty-five patients with MCA angioplasty and/or stenting were included in data analyses. Table S1 shows the baseline characteristics of these patients. Table S2 summarizes the pre- and post-procedure parameters. The technical success rate was 95.5% (148/155). The frequency of stroke or death within 30 days was 8.4% (13/155). Among 13 patients, 4 patients had non-fatal ischemic stroke, 5 patients had intracerebral hemorrhage (4 deaths) and 4 patients had non-fatal subarachnoid hemorrhage. Hemorrhagic stroke accounted for 60% (9/15) in all primary clinical outcome. The follow-up rate was 93.5% (145/155). Two patients had ipsilateral recurrent stroke beyond 30 days. The frequency of stroke or death within 30 days or ipsilateral stroke beyond 30 days was 9.67% with a median follow-up duration of 20 months (range: 1– 87 months). Kaplan–Meier curve was provided in Supplementary data (Fig. S1). Multivariate Cox regression analysis revealed that only serum albumin (HR 1.118, 95% CI: 1.038–1.204, P = 0.003) was an independent predictor for the primary outcome with other significant factors in the univariate analyses as covariates (Table 1). Subgroup analysis found that there was a significantly higher serum albumin in patients with hemorrhagic stroke (median: 48.4 g/L, interquartile range [IQR]: 45.95–50.35 g/L) than those with ischemic stroke (median: 44.7 g/L, IQR: 42.50–46.80 g/L) (P = 0.012), and those without clinical primary outcome (median: 42.6 g/L, IQR: 40.10–45.10 g/L) (P b 0.001), whereas there was no significant difference between patients with ischemic stroke and those without clinical primary outcome (P N 0.05). Comparing our CISR with the stenting versus aggressive medical therapy for intracranial arterial stenosis (SAMMPRIS) trial [6], we used different device and treatment strategies in the real-world, and
190
Letters to the Editor
Table 1 Predictors for any stroke and/or death within 30 days and ipsilateral stroke beyond 30 days. Univariate Cox regression
History of hypertension Albumin at admission History of hypertension ∗ serum albumin Glucose at admission NIHSS at discharge
Multivariate Cox regression
Hazard ratio
95% CI
P
Hazard ratio
95% CI
P
0.282 1.096 0.956 0.572 1.09
0.098–0.811 1.036–1.159 0.925–0.988 0.334–0.979 1.039–1.144
0.019 0.001 0.007 0.042 b 0.001
0.238 1.118 0.984 0.785 0.658
0.001–410.764 1.038–1.204 0.847–1.142 0.458–1.345 0.157–2.757
0.706 0.003 0.829 0.378 0.567
most of our patients' lesion types were Mori type [7] A or B, which may be accounted for the lower periprocedural stroke or death rate in MCA patients in our registry. Interestingly, high serum albumin is the unique predictor for periprocedural stroke and/or death and ipsilateral stroke beyond 30 days in our study. Moreover, our subgroup analyses showed that the effect was mainly driven by hemorrhagic stroke. This is unexpected because low serum albumin was found to be an independent predictor for all cause mortality in the hospitalized very elderly [8]. However, the high-dose serum albumin treatment for acute ischemic stroke (ALIAS) part 2 trial [9] failed to show significant benefit of serum albumin over saline, moreover, serum albumin doubled the risk for symptomatic intracranial hemorrhage within 24 h. In our study, 60% of the events were hemorrhagic stroke within 24 h, which was considered to be induced by cerebral hyperperfusion. Patients with impaired cerebral autoregulation or postoperative hypertension may lead to cerebral hemorrhage once the MCA was stented with good perfusion. And the serum albumin may contribute to the hemorrhagic events through its reported platelet anti-aggregatory effect [10–12]. Our study has several limitations. First, our study was initiated in 2004, and the study protocol was revised in 2011, some information was retrieved from medical records for those cases entered before June 2011, which may not be accurate. Second, the emphasis on degree of stenosis ignores the hemodynamics of fluid flow–fractional flow, which may predict the risk of subsequent ischemia and the risk of reperfusion injury, including hemorrhage [13]. However, the assessment method of fractional flow in cerebral arteries needs further investigation. To conclude, the angioplasty and/or stenting in China had high rate of technical success and acceptable periprocedural rate of stroke or death in patients with symptomatic MCA atherosclerosis. Larger studies are warranted to identify the association between serum albumin and hemorrhagic stroke in MCA angioplasty and/or stenting patients. The project is supported by the National Natural Science Foundation of China — the Major International (Regional) Joint Research Program of China (Grant Number: 81220108008), the National Natural Science http://dx.doi.org/10.1016/j.ijcard.2014.03.181 0167-5273/© 2014 Elsevier Ireland Ltd. All rights reserved.
Foundation of China (Grant Number: 31300900), and the Jiangsu Provincial Special Program of Medical Science (Grant Number: BL2013025). Appendix A. Supplementary data Supplementary data to this article can be found online at http:// dx.doi.org/10.1016/j.ijcard.2014.03.181.
References [1] Chimowitz MI, Lynn MJ, Howlett-Smith H, et al. Comparison of warfarin and aspirin for symptomatic intracranial arterial stenosis. N Engl J Med 2005;352:1305–16. [2] Wong LK. Global burden of intracranial atherosclerosis. Int J Stroke 2006;1:158–9. [3] Gorelick PB, Wong KS, Bae HJ, Pandey DK. Large artery intracranial occlusive disease: a large worldwide burden but a relatively neglected frontier. Stroke 2008;39:2396–9. [4] Wan YD, Sun TW, Kan QC, et al. Long-term outcomes of percutaneous coronary intervention with stenting and coronary artery bypass graft surgery — a metaanalysis. Int J Cardiol 2013;168:e161–4. [5] Liu X, Xiong Y, Zhou Z, et al. China interventional stroke registry: rationale and study design. Cerebrovasc Dis 2013;35:349–54. [6] Chimowitz MI, Lynn MJ, Derdeyn CP, et al. Stenting versus aggressive medical therapy for intracranial arterial stenosis. N Engl J Med 2011;365:993–1003. [7] Mori T, Kazita K, Chokyu K, Mima T, Mori K. Short-term arteriographic and clinical outcome after cerebral angioplasty and stenting for intracranial vertebrobasilar and carotid atherosclerotic occlusive disease. AJNR Am J Neuroradiol 2000;21:249–54. [8] Zhang Y, Protogerou AD, Iaria P, Safar ME, Xu Y, Blacher J. Prognosis in the hospitalized very elderly: the PROTEGER study. Int J Cardiol 2013;168:2714–9. [9] Ginsberg MD, Palesch YY, Hill MD, et al. High-dose albumin treatment for acute ischaemic stroke (ALIAS) part 2: a randomised, double-blind, phase 3, placebocontrolled trial. Lancet Neurol 2013;12:1049–58. [10] Ammit AJ, O'Neill C. Studies of the nature of the binding by albumin of plateletactivating factor released from cells. J Biol Chem 1997;272:18772–8. [11] Gresele P, Deckmyn H, Huybrechts E, Vermylen J. Serum albumin enhances the impairment of platelet aggregation with thromboxane synthase inhibition by increasing the formation of prostaglandin D2. Biochem Pharmacol 1984;33:2083–8. [12] Jorgensen KA, Stoffersen E. On the inhibitory effect of albumin on platelet aggregation. Thromb Res 1980;17:13–8. [13] Liebeskind DS, Feldmann E. Fractional flow in cerebrovascular disorders. Intervent Neurol 2012;1:87–9.
189
[6] Kim JS, Lim HS. Impact of Agent Orange exposure among Korean Vietnam veterans. Ind Health 2003;41:149–57. [7] Kang HK, Dalager NA. Health status of army chemical corps Vietnam veterans who sprayed defoliant in Vietnam. Am J Ind Med 2006;49:875–84.
http://dx.doi.org/10.1016/j.ijcard.2014.03.182 0167-5273/© 2014 Published by Elsevier Ireland Ltd.
Angioplasty and stenting in middle cerebral artery: Results from multicenter China interventional stroke registry Yunyun Xiong a,1, Wenhua Liu a,1, Zhiming Zhou b, Hang Lin c, Min Lin c, Jianlin Liu d, Guozhong Niu e, Wei Wang f, Yi Jia g, Thomas W. Leung h, Dezhi Liu a, Xiaobing Fan a, Qin Yin a, Wusheng Zhu a, Minmin Ma a, Renliang Zhang a, George Liu i, Shang Wang j, Gelin Xu a, Xinfeng Liu a,⁎ a b c d e f g h i j
Department of Neurology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, Jiangsu Province, China Department of Neurology, Yijishan Hospital of Wannan Medical College, Anhui Province, China Department of Neurology, Fuzhou General Hospital of Nanjing Military Region, Fuzhou, Fujian Province, China Center of Cerebrovascular Diseases, The First Affiliated Hospital, Medical School of Xi'an Jiaotong University, Xi'an 710061, China Department of Neurology, The First People's Hospital of Hangzhou, Hangzhou, Zhejiang Province, China Department of Radiology, Yangzhou No.1 People's Hospital, Yangzhou, Jiangsu Province, China Department of Neurology, Xi'an Gaoxin Hospital, Shanxi Province, China Deparment of Medicine & Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong Institute of Cardiovascular Sciences, Peking University Health Science Center, 38 Xueyuan Road, Hai Dian District, 100083 Beijing, China Deparment of Cardiology, Drum Tower Hospital Affiliated to Nanjing University School of Medicine, Nanjing, China
a r t i c l e
i n f o
Article history: Received 14 February 2014 Accepted 29 March 2014 Available online 6 April 2014 Keywords: Angioplasty Ischemic stroke Middle cerebral artery Stent Registry
Atherosclerotic middle cerebral artery (MCA) stenosis is a devastating cause of cerebral ischemia and stroke, which portends a high recurrence rate despite medical therapy [1]. It is particularly prevalent in Asia with more diffuse lesion and tandem lesion, but relatively rare in North America [2,3]. Although percutaneous coronary intervention with stenting is a recommended treatment for patients with coronary artery stenosis nowadays [4], whether angioplasty and stenting should be performed for atherosclerotic MCA stenosis is still controversial. We set up a multicenter prospective registry in China — the China interventional stroke registry (CISR), aimed to illustrate the technical success rate, periprocedural event rate, and long-term clinical outcomes for angioplasty and stenting of MCA in China. Details of the study design were published previously [5]. In brief, we included patients undergoing angioplasty and/or stenting in extracranial and intracranial arteries. Until Feb 2013, 7 centers across 5 provinces (Jiangsu, Anhui, Zhejiang, Shanxi and Fujian) have entered data into our online database. The primary clinical outcome
⁎ Corresponding author at: Department of Neurology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China. Tel.: +86 25 84801861; fax: + 86 25 84866453. E-mail address: xfl[email protected] (X. Liu). 1 These two authors contributed equally to this work.
was stroke or death within 30 days after angioplasty and/or stenting for the treated lesion and ischemic stroke in the territory of the stented artery beyond 30 days. The stenting procedures, definition of stroke and technical success as well as the follow-up process were illustrated in Supplementary data. The authors of this manuscript have certified that they comply with the Principles of Ethical Publishing in the International Journal of Cardiology. One hundred and fifty-five patients with MCA angioplasty and/or stenting were included in data analyses. Table S1 shows the baseline characteristics of these patients. Table S2 summarizes the pre- and post-procedure parameters. The technical success rate was 95.5% (148/155). The frequency of stroke or death within 30 days was 8.4% (13/155). Among 13 patients, 4 patients had non-fatal ischemic stroke, 5 patients had intracerebral hemorrhage (4 deaths) and 4 patients had non-fatal subarachnoid hemorrhage. Hemorrhagic stroke accounted for 60% (9/15) in all primary clinical outcome. The follow-up rate was 93.5% (145/155). Two patients had ipsilateral recurrent stroke beyond 30 days. The frequency of stroke or death within 30 days or ipsilateral stroke beyond 30 days was 9.67% with a median follow-up duration of 20 months (range: 1– 87 months). Kaplan–Meier curve was provided in Supplementary data (Fig. S1). Multivariate Cox regression analysis revealed that only serum albumin (HR 1.118, 95% CI: 1.038–1.204, P = 0.003) was an independent predictor for the primary outcome with other significant factors in the univariate analyses as covariates (Table 1). Subgroup analysis found that there was a significantly higher serum albumin in patients with hemorrhagic stroke (median: 48.4 g/L, interquartile range [IQR]: 45.95–50.35 g/L) than those with ischemic stroke (median: 44.7 g/L, IQR: 42.50–46.80 g/L) (P = 0.012), and those without clinical primary outcome (median: 42.6 g/L, IQR: 40.10–45.10 g/L) (P b 0.001), whereas there was no significant difference between patients with ischemic stroke and those without clinical primary outcome (P N 0.05). Comparing our CISR with the stenting versus aggressive medical therapy for intracranial arterial stenosis (SAMMPRIS) trial [6], we used different device and treatment strategies in the real-world, and
190
Letters to the Editor
Table 1 Predictors for any stroke and/or death within 30 days and ipsilateral stroke beyond 30 days. Univariate Cox regression
History of hypertension Albumin at admission History of hypertension ∗ serum albumin Glucose at admission NIHSS at discharge
Multivariate Cox regression
Hazard ratio
95% CI
P
Hazard ratio
95% CI
P
0.282 1.096 0.956 0.572 1.09
0.098–0.811 1.036–1.159 0.925–0.988 0.334–0.979 1.039–1.144
0.019 0.001 0.007 0.042 b 0.001
0.238 1.118 0.984 0.785 0.658
0.001–410.764 1.038–1.204 0.847–1.142 0.458–1.345 0.157–2.757
0.706 0.003 0.829 0.378 0.567
most of our patients' lesion types were Mori type [7] A or B, which may be accounted for the lower periprocedural stroke or death rate in MCA patients in our registry. Interestingly, high serum albumin is the unique predictor for periprocedural stroke and/or death and ipsilateral stroke beyond 30 days in our study. Moreover, our subgroup analyses showed that the effect was mainly driven by hemorrhagic stroke. This is unexpected because low serum albumin was found to be an independent predictor for all cause mortality in the hospitalized very elderly [8]. However, the high-dose serum albumin treatment for acute ischemic stroke (ALIAS) part 2 trial [9] failed to show significant benefit of serum albumin over saline, moreover, serum albumin doubled the risk for symptomatic intracranial hemorrhage within 24 h. In our study, 60% of the events were hemorrhagic stroke within 24 h, which was considered to be induced by cerebral hyperperfusion. Patients with impaired cerebral autoregulation or postoperative hypertension may lead to cerebral hemorrhage once the MCA was stented with good perfusion. And the serum albumin may contribute to the hemorrhagic events through its reported platelet anti-aggregatory effect [10–12]. Our study has several limitations. First, our study was initiated in 2004, and the study protocol was revised in 2011, some information was retrieved from medical records for those cases entered before June 2011, which may not be accurate. Second, the emphasis on degree of stenosis ignores the hemodynamics of fluid flow–fractional flow, which may predict the risk of subsequent ischemia and the risk of reperfusion injury, including hemorrhage [13]. However, the assessment method of fractional flow in cerebral arteries needs further investigation. To conclude, the angioplasty and/or stenting in China had high rate of technical success and acceptable periprocedural rate of stroke or death in patients with symptomatic MCA atherosclerosis. Larger studies are warranted to identify the association between serum albumin and hemorrhagic stroke in MCA angioplasty and/or stenting patients. The project is supported by the National Natural Science Foundation of China — the Major International (Regional) Joint Research Program of China (Grant Number: 81220108008), the National Natural Science http://dx.doi.org/10.1016/j.ijcard.2014.03.181 0167-5273/© 2014 Elsevier Ireland Ltd. All rights reserved.
Foundation of China (Grant Number: 31300900), and the Jiangsu Provincial Special Program of Medical Science (Grant Number: BL2013025). Appendix A. Supplementary data Supplementary data to this article can be found online at http:// dx.doi.org/10.1016/j.ijcard.2014.03.181.
References [1] Chimowitz MI, Lynn MJ, Howlett-Smith H, et al. Comparison of warfarin and aspirin for symptomatic intracranial arterial stenosis. N Engl J Med 2005;352:1305–16. [2] Wong LK. Global burden of intracranial atherosclerosis. Int J Stroke 2006;1:158–9. [3] Gorelick PB, Wong KS, Bae HJ, Pandey DK. Large artery intracranial occlusive disease: a large worldwide burden but a relatively neglected frontier. Stroke 2008;39:2396–9. [4] Wan YD, Sun TW, Kan QC, et al. Long-term outcomes of percutaneous coronary intervention with stenting and coronary artery bypass graft surgery — a metaanalysis. Int J Cardiol 2013;168:e161–4. [5] Liu X, Xiong Y, Zhou Z, et al. China interventional stroke registry: rationale and study design. Cerebrovasc Dis 2013;35:349–54. [6] Chimowitz MI, Lynn MJ, Derdeyn CP, et al. Stenting versus aggressive medical therapy for intracranial arterial stenosis. N Engl J Med 2011;365:993–1003. [7] Mori T, Kazita K, Chokyu K, Mima T, Mori K. Short-term arteriographic and clinical outcome after cerebral angioplasty and stenting for intracranial vertebrobasilar and carotid atherosclerotic occlusive disease. AJNR Am J Neuroradiol 2000;21:249–54. [8] Zhang Y, Protogerou AD, Iaria P, Safar ME, Xu Y, Blacher J. Prognosis in the hospitalized very elderly: the PROTEGER study. Int J Cardiol 2013;168:2714–9. [9] Ginsberg MD, Palesch YY, Hill MD, et al. High-dose albumin treatment for acute ischaemic stroke (ALIAS) part 2: a randomised, double-blind, phase 3, placebocontrolled trial. Lancet Neurol 2013;12:1049–58. [10] Ammit AJ, O'Neill C. Studies of the nature of the binding by albumin of plateletactivating factor released from cells. J Biol Chem 1997;272:18772–8. [11] Gresele P, Deckmyn H, Huybrechts E, Vermylen J. Serum albumin enhances the impairment of platelet aggregation with thromboxane synthase inhibition by increasing the formation of prostaglandin D2. Biochem Pharmacol 1984;33:2083–8. [12] Jorgensen KA, Stoffersen E. On the inhibitory effect of albumin on platelet aggregation. Thromb Res 1980;17:13–8. [13] Liebeskind DS, Feldmann E. Fractional flow in cerebrovascular disorders. Intervent Neurol 2012;1:87–9.
