Literature Monitor

Stenting Procedures Equivalent in Safety and Efficacy in High-Risk Patients
Carotid artery stenting via an emboli-protection device or carotid endarterectomy provides comparable long-term efficacy and safety in high-risk patients, according to the three-year results of the Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) trial. Hitinder S. Gurm, MD, and colleagues reported in the April 10 New England Journal of Medicine on the occurrence of the prespecified major secondary end point of the study—a composite of death, stroke, or myocardial infarction within 30 days after the procedure or death or ipsilateral stroke between 31 days and three years.

A total of 334 patients with either a symptomatic carotid artery stenosis of at least 50% of the luminal diameter or an asymptomatic stenosis of at least 80%, plus one or more criteria for high surgical risk, were randomly assigned to a study group. “The criteria for high surgical risk were clinically significant cardiac disease …, severe pulmonary disease, contralateral carotid occlusion, contralateral laryngeal-nerve palsy, recurrent stenosis after carotid endarterectomy, previous radical neck surgery or radiation therapy to the neck, and an age of more than 80 years,” said Dr. Gurm, Director of Carotid Interventions in Cardiovascular Medicine at the University of Michigan Health System in Ann Arbor, and coauthors.

Three-year clinical follow-up data were available for 85.6% and 70.1% of the patients in the stenting and endarterectomy groups, respectively. The major secondary end point had occurred in 41 patients in the stenting group (24.6%) and in 45 patients (26.9%) who underwent endarterectomy. Between years 1 and 3, an additional 21 patients in the stenting group and 13 patients in the endarterectomy group had an event. In that time, there were 19 additional deaths in the stenting group and 14 additional deaths in the endarterectomy group. Fifteen strokes occurred in each of the two groups at three years, including 11 ipsilateral strokes in the stenting group and nine in the endarterectomy group, of which four and one, respectively, occurred between one and three years.

The authors noted that the cumulative incidence of death was substantial, as the patients were elderly and often had coexisting conditions that increased risk of death. “In our opinion, an invasive treatment for prevention of stroke is reasonable, even in a high-risk population, if the projected five-year mortality is less than 50% and the intervention is not itself associated with an increased risk of death or other major adverse effects related to safety,” they asserted. However, because a medical-therapy group was not included in the study, Dr. Gurm and colleagues said that a comparison of safety and efficacy with antithrombotic or lipid-lowering therapies could not be completed, and they added that some practitioners may choose to treat this high-risk group in that way.
Gurm HS, Yadav JS, Fayad P, et al. Long-term results of carotid stenting versus endarterectomy in high-risk patients. N Engl J Med. 2008;358(15):1572-1579.

Predicting Unfavorable Outcome in Head Trauma Patients
A combination of six variables can predict unfavorable outcomes in patients with moderate head injury, reported researchers in the May Journal of Neurology, Neurosurgery, and Psychiatry. Andrea Fabbri, MD, of the Emergency Department at Azienda Unità Sanitaria Locale di Forlì in Italy, and colleagues said that these predictors can be assessed early and may be important for rapid sequence decisions made in the emergency department.

The investigative team prospectively reviewed 12,675 subjects attending the emergency department of a single general hospital between 1999 and 2005; 309 (2.4%) were identified as having moderate head injury (Glasgow Coma Scale [GCS] score, 9 to 13). The median patient age was 50, and the most common comorbidities were coronary artery disease (35.3%) and neurologic diseases (22.7%). Two hundred patients had intracranial lesions detected on CT scans (nine cases required a second scan for diagnosis). Eighty-one cases had a single lesion, and 64 had more than one lesion; the authors noted that the prevalence of intracranial lesions increased with decreasing GCS scores, from 44.2% in patients with a GCS score of 13 to 80% and 90% in those with scores of 9 and 10, respectively. Linear skull fracture was also diagnosed in 82 cases and basal skull fracture in 48.

At six-month follow-up, 45 cases had an unfavorable outcome, as determined by a Glasgow outcome scale score; 12 patients died, two were left in a permanent vegetative state, and the remaining 31 patients were severely disabled. Of the 264 cases with favorable outcome, 31 had moderate disability. Unfavorable outcomes were more common in patients classified in the Marshall categories IV, V, and VI (90%, 21.5%, and 93.7%, respectively) compared with those in categories I and II (0.9% and 5.2%, respectively), reported the researchers.

Neurosurgical intervention was required in 16.5% of the patients, which the investigators indicated was associated with favorable outcome. “In particular, in Marshall category V, the prevalence of unfavorable outcome dropped to nearly 20% following neurosurgical intervention, confirming the importance of mass lesion evacuation in these cases,” they stated.

Of the 18 variables considered, six were independently associated with unfavorable outcome at six months: basal skull fracture, subarachnoid hemorrhage, coagulopathy, subdural hematoma, modified Marshall category, and GCS. “This ­combination of variables predicts the six-month outcome with high sensitivity (95.6%) and specificity (86%),” said the authors. They noted that although coagulopathy was the third strongest predictor of unfavorable outcome in the model, after GCS and Marshall category, the exclusion of coagulopathy did not significantly impair the sensitivity for outcome prediction.
Fabbri A, Servadei F, Marchesini G, et al. Early predictors of unfavourable outcome in subjects with moderate head injury in the emergency department. J Neurol Neurosurg Psychiatry. 2008;79(5):567-573.

Coffee and Tea Drinkers May Have Increased Protection From Cerebral Infarction
Men who drink eight or more cups of coffee or two or more cups of tea per day may have a significantly decreased stroke risk than men whose daily consumption is less than that, according to a study published in the March 27 online Stroke. The effect was independent of known cardiovascular risk factors, added Susanna C. Larsson, PhD, from the Division of Nutritional Epidemiology at the Karolinska Institute in Stockholm, and colleagues.

Data on the participants—26,556 Finnish men ages 50 to 69—were collected prospectively as part of the Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study. All were smokers (five or more cigarettes per day) with no history of stroke at baseline. About 2.5% of the cohort reported that they never drank coffee, and 64% said that they never drank tea.

During the mean 13.6 years of follow-up, there were 2,702 cerebral infarctions, 383 intracerebral hemorrhages, 196 subarachnoid hemorrhages, and 84 unspecified strokes. “After adjustment for age, supplementation group, and cardiovascular risk factors, both coffee consumption and tea consumption were statistically significantly ­inversely associated with risk of cerebral infarction but not of intracerebral or subarachnoid hemorrhage,” the authors said. The relative risk (RR) of cerebral infarction for the men who drank the most coffee (eight or more cups per day) compared with those who drank the least (less than two cups per day) was 0.77, and the relationship was mediated in a dose-response fashion. High consumption of tea (two or more cups per day) also protected against cerebral infarction (RR compared with nondrinkers, 0.79).

“Caffeine intake also showed an inverse association with cerebral infarction,” stated Dr. Larsson and colleagues (RR for median of 880 vs 189 mg/day, 0.76). However, because a previous study had found that supplementation of the dietary antioxidant α-tocopherol had also decreased a patient’s risk of cerebral infarction, the researchers added that “this association may reflect the correlation between caffeine intake and other potentially protective factors in coffee and tea rather than a direct association between caffeine and cerebral infarction.”
Larsson SC, Männistö S, Virtanen MJ, et al. Coffee and tea consumption and risk of stroke subtypes in male smokers. Stroke. 2008 Mar 27; [Epub ahead of print].

Stenting Procedures Equivalent in Safety and Efficacy in High-Risk Patients
Carotid artery stenting via an emboli-protection device or carotid endarterectomy provides comparable long-term efficacy and safety in high-risk patients, according to the three-year results of the Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) trial. Hitinder S. Gurm, MD, and colleagues reported in the April 10 New England Journal of Medicine on the occurrence of the prespecified major secondary end point of the study—a composite of death, stroke, or myocardial infarction within 30 days after the procedure or death or ipsilateral stroke between 31 days and three years.

A total of 334 patients with either a symptomatic carotid artery stenosis of at least 50% of the luminal diameter or an asymptomatic stenosis of at least 80%, plus one or more criteria for high surgical risk, were randomly assigned to a study group. “The criteria for high surgical risk were clinically significant cardiac disease …, severe pulmonary disease, contralateral carotid occlusion, contralateral laryngeal-nerve palsy, recurrent stenosis after carotid endarterectomy, previous radical neck surgery or radiation therapy to the neck, and an age of more than 80 years,” said Dr. Gurm, Director of Carotid Interventions in Cardiovascular Medicine at the University of Michigan Health System in Ann Arbor, and coauthors.

Three-year clinical follow-up data were available for 85.6% and 70.1% of the patients in the stenting and endarterectomy groups, respectively. The major secondary end point had occurred in 41 patients in the stenting group (24.6%) and in 45 patients (26.9%) who underwent endarterectomy. Between years 1 and 3, an additional 21 patients in the stenting group and 13 patients in the endarterectomy group had an event. In that time, there were 19 additional deaths in the stenting group and 14 additional deaths in the endarterectomy group. Fifteen strokes occurred in each of the two groups at three years, including 11 ipsilateral strokes in the stenting group and nine in the endarterectomy group, of which four and one, respectively, occurred between one and three years.

The authors noted that the cumulative incidence of death was substantial, as the patients were elderly and often had coexisting conditions that increased risk of death. “In our opinion, an invasive treatment for prevention of stroke is reasonable, even in a high-risk population, if the projected five-year mortality is less than 50% and the intervention is not itself associated with an increased risk of death or other major adverse effects related to safety,” they asserted. However, because a medical-therapy group was not included in the study, Dr. Gurm and colleagues said that a comparison of safety and efficacy with antithrombotic or lipid-lowering therapies could not be completed, and they added that some practitioners may choose to treat this high-risk group in that way.
Gurm HS, Yadav JS, Fayad P, et al. Long-term results of carotid stenting versus endarterectomy in high-risk patients. N Engl J Med. 2008;358(15):1572-1579.

Predicting Unfavorable Outcome in Head Trauma Patients
A combination of six variables can predict unfavorable outcomes in patients with moderate head injury, reported researchers in the May Journal of Neurology, Neurosurgery, and Psychiatry. Andrea Fabbri, MD, of the Emergency Department at Azienda Unità Sanitaria Locale di Forlì in Italy, and colleagues said that these predictors can be assessed early and may be important for rapid sequence decisions made in the emergency department.

The investigative team prospectively reviewed 12,675 subjects attending the emergency department of a single general hospital between 1999 and 2005; 309 (2.4%) were identified as having moderate head injury (Glasgow Coma Scale [GCS] score, 9 to 13). The median patient age was 50, and the most common comorbidities were coronary artery disease (35.3%) and neurologic diseases (22.7%). Two hundred patients had intracranial lesions detected on CT scans (nine cases required a second scan for diagnosis). Eighty-one cases had a single lesion, and 64 had more than one lesion; the authors noted that the prevalence of intracranial lesions increased with decreasing GCS scores, from 44.2% in patients with a GCS score of 13 to 80% and 90% in those with scores of 9 and 10, respectively. Linear skull fracture was also diagnosed in 82 cases and basal skull fracture in 48.

At six-month follow-up, 45 cases had an unfavorable outcome, as determined by a Glasgow outcome scale score; 12 patients died, two were left in a permanent vegetative state, and the remaining 31 patients were severely disabled. Of the 264 cases with favorable outcome, 31 had moderate disability. Unfavorable outcomes were more common in patients classified in the Marshall categories IV, V, and VI (90%, 21.5%, and 93.7%, respectively) compared with those in categories I and II (0.9% and 5.2%, respectively), reported the researchers.

Neurosurgical intervention was required in 16.5% of the patients, which the investigators indicated was associated with favorable outcome. “In particular, in Marshall category V, the prevalence of unfavorable outcome dropped to nearly 20% following neurosurgical intervention, confirming the importance of mass lesion evacuation in these cases,” they stated.

Of the 18 variables considered, six were independently associated with unfavorable outcome at six months: basal skull fracture, subarachnoid hemorrhage, coagulopathy, subdural hematoma, modified Marshall category, and GCS. “This ­combination of variables predicts the six-month outcome with high sensitivity (95.6%) and specificity (86%),” said the authors. They noted that although coagulopathy was the third strongest predictor of unfavorable outcome in the model, after GCS and Marshall category, the exclusion of coagulopathy did not significantly impair the sensitivity for outcome prediction.
Fabbri A, Servadei F, Marchesini G, et al. Early predictors of unfavourable outcome in subjects with moderate head injury in the emergency department. J Neurol Neurosurg Psychiatry. 2008;79(5):567-573.

Coffee and Tea Drinkers May Have Increased Protection From Cerebral Infarction
Men who drink eight or more cups of coffee or two or more cups of tea per day may have a significantly decreased stroke risk than men whose daily consumption is less than that, according to a study published in the March 27 online Stroke. The effect was independent of known cardiovascular risk factors, added Susanna C. Larsson, PhD, from the Division of Nutritional Epidemiology at the Karolinska Institute in Stockholm, and colleagues.

Data on the participants—26,556 Finnish men ages 50 to 69—were collected prospectively as part of the Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study. All were smokers (five or more cigarettes per day) with no history of stroke at baseline. About 2.5% of the cohort reported that they never drank coffee, and 64% said that they never drank tea.

During the mean 13.6 years of follow-up, there were 2,702 cerebral infarctions, 383 intracerebral hemorrhages, 196 subarachnoid hemorrhages, and 84 unspecified strokes. “After adjustment for age, supplementation group, and cardiovascular risk factors, both coffee consumption and tea consumption were statistically significantly ­inversely associated with risk of cerebral infarction but not of intracerebral or subarachnoid hemorrhage,” the authors said. The relative risk (RR) of cerebral infarction for the men who drank the most coffee (eight or more cups per day) compared with those who drank the least (less than two cups per day) was 0.77, and the relationship was mediated in a dose-response fashion. High consumption of tea (two or more cups per day) also protected against cerebral infarction (RR compared with nondrinkers, 0.79).

“Caffeine intake also showed an inverse association with cerebral infarction,” stated Dr. Larsson and colleagues (RR for median of 880 vs 189 mg/day, 0.76). However, because a previous study had found that supplementation of the dietary antioxidant α-tocopherol had also decreased a patient’s risk of cerebral infarction, the researchers added that “this association may reflect the correlation between caffeine intake and other potentially protective factors in coffee and tea rather than a direct association between caffeine and cerebral infarction.”
Larsson SC, Männistö S, Virtanen MJ, et al. Coffee and tea consumption and risk of stroke subtypes in male smokers. Stroke. 2008 Mar 27; [Epub ahead of print].

Stenting Procedures Equivalent in Safety and Efficacy in High-Risk Patients
Carotid artery stenting via an emboli-protection device or carotid endarterectomy provides comparable long-term efficacy and safety in high-risk patients, according to the three-year results of the Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) trial. Hitinder S. Gurm, MD, and colleagues reported in the April 10 New England Journal of Medicine on the occurrence of the prespecified major secondary end point of the study—a composite of death, stroke, or myocardial infarction within 30 days after the procedure or death or ipsilateral stroke between 31 days and three years.

A total of 334 patients with either a symptomatic carotid artery stenosis of at least 50% of the luminal diameter or an asymptomatic stenosis of at least 80%, plus one or more criteria for high surgical risk, were randomly assigned to a study group. “The criteria for high surgical risk were clinically significant cardiac disease …, severe pulmonary disease, contralateral carotid occlusion, contralateral laryngeal-nerve palsy, recurrent stenosis after carotid endarterectomy, previous radical neck surgery or radiation therapy to the neck, and an age of more than 80 years,” said Dr. Gurm, Director of Carotid Interventions in Cardiovascular Medicine at the University of Michigan Health System in Ann Arbor, and coauthors.

Three-year clinical follow-up data were available for 85.6% and 70.1% of the patients in the stenting and endarterectomy groups, respectively. The major secondary end point had occurred in 41 patients in the stenting group (24.6%) and in 45 patients (26.9%) who underwent endarterectomy. Between years 1 and 3, an additional 21 patients in the stenting group and 13 patients in the endarterectomy group had an event. In that time, there were 19 additional deaths in the stenting group and 14 additional deaths in the endarterectomy group. Fifteen strokes occurred in each of the two groups at three years, including 11 ipsilateral strokes in the stenting group and nine in the endarterectomy group, of which four and one, respectively, occurred between one and three years.

The authors noted that the cumulative incidence of death was substantial, as the patients were elderly and often had coexisting conditions that increased risk of death. “In our opinion, an invasive treatment for prevention of stroke is reasonable, even in a high-risk population, if the projected five-year mortality is less than 50% and the intervention is not itself associated with an increased risk of death or other major adverse effects related to safety,” they asserted. However, because a medical-therapy group was not included in the study, Dr. Gurm and colleagues said that a comparison of safety and efficacy with antithrombotic or lipid-lowering therapies could not be completed, and they added that some practitioners may choose to treat this high-risk group in that way.
Gurm HS, Yadav JS, Fayad P, et al. Long-term results of carotid stenting versus endarterectomy in high-risk patients. N Engl J Med. 2008;358(15):1572-1579.

Predicting Unfavorable Outcome in Head Trauma Patients
A combination of six variables can predict unfavorable outcomes in patients with moderate head injury, reported researchers in the May Journal of Neurology, Neurosurgery, and Psychiatry. Andrea Fabbri, MD, of the Emergency Department at Azienda Unità Sanitaria Locale di Forlì in Italy, and colleagues said that these predictors can be assessed early and may be important for rapid sequence decisions made in the emergency department.

The investigative team prospectively reviewed 12,675 subjects attending the emergency department of a single general hospital between 1999 and 2005; 309 (2.4%) were identified as having moderate head injury (Glasgow Coma Scale [GCS] score, 9 to 13). The median patient age was 50, and the most common comorbidities were coronary artery disease (35.3%) and neurologic diseases (22.7%). Two hundred patients had intracranial lesions detected on CT scans (nine cases required a second scan for diagnosis). Eighty-one cases had a single lesion, and 64 had more than one lesion; the authors noted that the prevalence of intracranial lesions increased with decreasing GCS scores, from 44.2% in patients with a GCS score of 13 to 80% and 90% in those with scores of 9 and 10, respectively. Linear skull fracture was also diagnosed in 82 cases and basal skull fracture in 48.

At six-month follow-up, 45 cases had an unfavorable outcome, as determined by a Glasgow outcome scale score; 12 patients died, two were left in a permanent vegetative state, and the remaining 31 patients were severely disabled. Of the 264 cases with favorable outcome, 31 had moderate disability. Unfavorable outcomes were more common in patients classified in the Marshall categories IV, V, and VI (90%, 21.5%, and 93.7%, respectively) compared with those in categories I and II (0.9% and 5.2%, respectively), reported the researchers.

Neurosurgical intervention was required in 16.5% of the patients, which the investigators indicated was associated with favorable outcome. “In particular, in Marshall category V, the prevalence of unfavorable outcome dropped to nearly 20% following neurosurgical intervention, confirming the importance of mass lesion evacuation in these cases,” they stated.

Of the 18 variables considered, six were independently associated with unfavorable outcome at six months: basal skull fracture, subarachnoid hemorrhage, coagulopathy, subdural hematoma, modified Marshall category, and GCS. “This ­combination of variables predicts the six-month outcome with high sensitivity (95.6%) and specificity (86%),” said the authors. They noted that although coagulopathy was the third strongest predictor of unfavorable outcome in the model, after GCS and Marshall category, the exclusion of coagulopathy did not significantly impair the sensitivity for outcome prediction.
Fabbri A, Servadei F, Marchesini G, et al. Early predictors of unfavourable outcome in subjects with moderate head injury in the emergency department. J Neurol Neurosurg Psychiatry. 2008;79(5):567-573.

Coffee and Tea Drinkers May Have Increased Protection From Cerebral Infarction
Men who drink eight or more cups of coffee or two or more cups of tea per day may have a significantly decreased stroke risk than men whose daily consumption is less than that, according to a study published in the March 27 online Stroke. The effect was independent of known cardiovascular risk factors, added Susanna C. Larsson, PhD, from the Division of Nutritional Epidemiology at the Karolinska Institute in Stockholm, and colleagues.

Data on the participants—26,556 Finnish men ages 50 to 69—were collected prospectively as part of the Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study. All were smokers (five or more cigarettes per day) with no history of stroke at baseline. About 2.5% of the cohort reported that they never drank coffee, and 64% said that they never drank tea.

During the mean 13.6 years of follow-up, there were 2,702 cerebral infarctions, 383 intracerebral hemorrhages, 196 subarachnoid hemorrhages, and 84 unspecified strokes. “After adjustment for age, supplementation group, and cardiovascular risk factors, both coffee consumption and tea consumption were statistically significantly ­inversely associated with risk of cerebral infarction but not of intracerebral or subarachnoid hemorrhage,” the authors said. The relative risk (RR) of cerebral infarction for the men who drank the most coffee (eight or more cups per day) compared with those who drank the least (less than two cups per day) was 0.77, and the relationship was mediated in a dose-response fashion. High consumption of tea (two or more cups per day) also protected against cerebral infarction (RR compared with nondrinkers, 0.79).

“Caffeine intake also showed an inverse association with cerebral infarction,” stated Dr. Larsson and colleagues (RR for median of 880 vs 189 mg/day, 0.76). However, because a previous study had found that supplementation of the dietary antioxidant α-tocopherol had also decreased a patient’s risk of cerebral infarction, the researchers added that “this association may reflect the correlation between caffeine intake and other potentially protective factors in coffee and tea rather than a direct association between caffeine and cerebral infarction.”
Larsson SC, Männistö S, Virtanen MJ, et al. Coffee and tea consumption and risk of stroke subtypes in male smokers. Stroke. 2008 Mar 27; [Epub ahead of print].