European Stroke Conference

LONDON – The use of a specialized ambulance enabled more patients with acute ischemic stroke to receive thrombolytic therapy than if standard emergency response vehicles were used in a randomized, controlled trial.

Preliminary results of the PHANTOM-S study also showed that stroke patients were given intravenous tissue plasminogen activator (TPA) 25 minutes sooner in the weeks when the stroke emergency mobile (STEMO) unit was in service, compared with the weeks when it was not.

Sara Freeman/IMNG Medical Media

"We have shown that the STEMO concept can be integrated into a metropolitan emergency medical system," said Dr. Heinrich Audebert, the head of the STEMO project, which is based at Charité-Universitätsmedizin Berlin.

Speaking at the annual European Stroke Conference, Dr. Audebert added that the approach was "safe and superior to regular [emergency] care regarding the quality of care, the proportion of patients receiving TPA, and the time to treatment."

There is further potential to use the mobile stroke unit in the treatment of patients with intracranial hemorrhage and to triage for interventional treatment, he suggested.

Speed is key for stroke thrombolysis

The rationale for the STEMO project, which is based in Berlin, is that thrombolysis is an effective treatment for some patients with acute ischemic stroke. Thrombolytic treatment needs to be administered within a short time frame, Dr. Audebert said, and past a critical time point of 4.5 hours, TPA is no longer given in Germany. The latest guidelines issued jointly by the American Heart Association and the American Stroke Association recommend that TPA be given within 3 hours of stroke onset (Stroke 2013;44:870-947).

However, there are several difficulties in administering TPA in the first few hours after an acute stroke, including determining if the patient is a suitable candidate for thrombolytic therapy, identifying the exact time at which the ischemic injury actually occurred, and transporting the patient quickly enough to a hospital for such treatment.

Sara Freeman/IMNG Medical Media

The STEMO project aims to improve stroke patients’ clinical care by enabling TPA to be administered before the patient arrives at hospital. To achieve this, an ambulance owned by the Berlin Fire Department was adapted to accommodate an onboard computed tomography (CT) scanner, point-of-care laboratory, and teleradiography system. This specialized mobile stroke unit is staffed by a paramedic, a neurologist with emergency medicine training, and a radiographer.

The PHANTOM-S study

The PHANTOM-S (Pre-Hospital Acute Neurological Treatment and Optimization of Medical Care in Stroke) study follows on from a 3-month pilot study that provided proof-of-concept for the use of the STEMO unit in 23 hospitals in the Berlin area (Neurology 2013;80:163-8). The larger, randomized study involved 28 hospitals in the region, which provide emergency services to about 1.3 million people.

During the PHANTOM-S study, the STEMO vehicle was in service alternating weeks. The weeks when the specialized ambulance was not deployed were used as the control period. A stroke identification algorithm previously developed by the team (Stroke 2012;43:776-81) was used to decide whether to deploy the STEMO unit to an emergency call.

Over a 21-month study period, 7,098 suspected stroke patients were enrolled and 6,573 were transported to the nearest adequately equipped hospital. Around half were seen in the weeks that the STEMO vehicle was in service.

During the in-service weeks, the STEMO vehicle was deployed a total of 2,027 times out of 3,668 calls. There were a total of 1,804 patients seen by the unit with enough data for study evaluation. Of these, 201 of 614 (33%) patients with acute ischemic stroke were given TPA before reaching the hospital.

A significantly higher percentage of stroke patients received prehospital thrombolysis when the STEMO unit was in service, at 29%, compared with 21% for the control weeks (P less than .001).

Sara Freeman/IMNG Medical Media

The percentage of patients subsequently transported to a hospital with a dedicated stroke unit was also higher during the weeks when the STEMO unit was in service than during the control weeks (93% vs. 87%; P less than .01).

Quicker time to TPA

The mean time from "deployment to needle," said Dr. Audebert, was 77 minutes for the weeks when the specialized ambulance was not in use, compared with 62 minutes when it was (P less than .01). This was reduced to 52 minutes if the STEMO unit was actually deployed (P less than .01 versus control weeks), and dropped to 48 minutes for patients who were actually given TPA in the mobile unit.

In-hospital death rates in confirmed stroke cases were 4.4% for the STEMO in-service weeks (3.8% if the unit was actually deployed) and 4.5% for control weeks.

In TPA-treated patients, there was a nonsignificant trend toward fewer patients having intracranial hemorrhage if TPA was delivered in the STEMO unit, at 3.5%, compared with the overall rates during STEMO-serviced weeks (4.8%) and control weeks (6.0%).

"The current response time is about 16 minutes," coinvestigator Dr. Martin Ebinger, also of Charité-Universitätsmedizin Berlin, commented at a press briefing.

"Sometimes there were multiple, simultaneous calls," he said, noting that, at the current time, there is only one STEMO vehicle. If there were two mobile stroke units, then of course more people in the catchment area could be reached, and the response time could maybe even be halved to 8 minutes.

"We really need a very good, independent cost-effectiveness analysis," Dr. Ebinger conceded. Discussions with patient insurance groups and politicians have been started to determine how best to conduct such an analysis.

Dr. Michael Hennerici, professor of neurology at the University of Heidelberg in Germany, commented at the press briefing that giving thrombolysis to patients who have had a stroke is perhaps more complex than giving it to those who have had a heart attack. There are many different types of stroke, and only a selected population may require thrombolysis, he observed.

Dr. Martin Brown, professor of stroke medicine at University College London, also gave his thoughts on the data in an interview. "It certainly makes sense to get the treatment to patients as quickly as possible, but we need a CT scan of every patient before we give the treatment," he said.

"The real question is, however, ‘Is it more efficient to work on getting the patient to hospital as quickly as possible, or if we should be working on this model and trying to get money for more expensive ambulances?" Dr. Brown added.

"What we really need to know is what difference an extra 25 minutes means in terms of the number of patients that gain benefit. If it is only a small proportion, it might not be cost-effective," Dr. Brown said.

The STEMO project is a collaboration between Charité-Universitätsmedizin Berlin, the Berlin Fire Department, Brahms GmbH, and MEYTEC GmbH. It is cofunded by Technology Foundation Berlin and the European Fund for Regional Development. Dr. Hennerici and Dr. Brown were not involved in the study. Dr. Ebinger had no conflicts of interest. Dr. Audebert has received honoraria from Bayer, Bristol-Myers Squibb, and other companies.

LONDON – The use of a specialized ambulance enabled more patients with acute ischemic stroke to receive thrombolytic therapy than if standard emergency response vehicles were used in a randomized, controlled trial.

Preliminary results of the PHANTOM-S study also showed that stroke patients were given intravenous tissue plasminogen activator (TPA) 25 minutes sooner in the weeks when the stroke emergency mobile (STEMO) unit was in service, compared with the weeks when it was not.

Sara Freeman/IMNG Medical Media

"We have shown that the STEMO concept can be integrated into a metropolitan emergency medical system," said Dr. Heinrich Audebert, the head of the STEMO project, which is based at Charité-Universitätsmedizin Berlin.

Speaking at the annual European Stroke Conference, Dr. Audebert added that the approach was "safe and superior to regular [emergency] care regarding the quality of care, the proportion of patients receiving TPA, and the time to treatment."

There is further potential to use the mobile stroke unit in the treatment of patients with intracranial hemorrhage and to triage for interventional treatment, he suggested.

Speed is key for stroke thrombolysis

The rationale for the STEMO project, which is based in Berlin, is that thrombolysis is an effective treatment for some patients with acute ischemic stroke. Thrombolytic treatment needs to be administered within a short time frame, Dr. Audebert said, and past a critical time point of 4.5 hours, TPA is no longer given in Germany. The latest guidelines issued jointly by the American Heart Association and the American Stroke Association recommend that TPA be given within 3 hours of stroke onset (Stroke 2013;44:870-947).

However, there are several difficulties in administering TPA in the first few hours after an acute stroke, including determining if the patient is a suitable candidate for thrombolytic therapy, identifying the exact time at which the ischemic injury actually occurred, and transporting the patient quickly enough to a hospital for such treatment.

Sara Freeman/IMNG Medical Media

The STEMO project aims to improve stroke patients’ clinical care by enabling TPA to be administered before the patient arrives at hospital. To achieve this, an ambulance owned by the Berlin Fire Department was adapted to accommodate an onboard computed tomography (CT) scanner, point-of-care laboratory, and teleradiography system. This specialized mobile stroke unit is staffed by a paramedic, a neurologist with emergency medicine training, and a radiographer.

The PHANTOM-S study

The PHANTOM-S (Pre-Hospital Acute Neurological Treatment and Optimization of Medical Care in Stroke) study follows on from a 3-month pilot study that provided proof-of-concept for the use of the STEMO unit in 23 hospitals in the Berlin area (Neurology 2013;80:163-8). The larger, randomized study involved 28 hospitals in the region, which provide emergency services to about 1.3 million people.

During the PHANTOM-S study, the STEMO vehicle was in service alternating weeks. The weeks when the specialized ambulance was not deployed were used as the control period. A stroke identification algorithm previously developed by the team (Stroke 2012;43:776-81) was used to decide whether to deploy the STEMO unit to an emergency call.

Over a 21-month study period, 7,098 suspected stroke patients were enrolled and 6,573 were transported to the nearest adequately equipped hospital. Around half were seen in the weeks that the STEMO vehicle was in service.

During the in-service weeks, the STEMO vehicle was deployed a total of 2,027 times out of 3,668 calls. There were a total of 1,804 patients seen by the unit with enough data for study evaluation. Of these, 201 of 614 (33%) patients with acute ischemic stroke were given TPA before reaching the hospital.

A significantly higher percentage of stroke patients received prehospital thrombolysis when the STEMO unit was in service, at 29%, compared with 21% for the control weeks (P less than .001).

Sara Freeman/IMNG Medical Media

The percentage of patients subsequently transported to a hospital with a dedicated stroke unit was also higher during the weeks when the STEMO unit was in service than during the control weeks (93% vs. 87%; P less than .01).

Quicker time to TPA

The mean time from "deployment to needle," said Dr. Audebert, was 77 minutes for the weeks when the specialized ambulance was not in use, compared with 62 minutes when it was (P less than .01). This was reduced to 52 minutes if the STEMO unit was actually deployed (P less than .01 versus control weeks), and dropped to 48 minutes for patients who were actually given TPA in the mobile unit.

In-hospital death rates in confirmed stroke cases were 4.4% for the STEMO in-service weeks (3.8% if the unit was actually deployed) and 4.5% for control weeks.

In TPA-treated patients, there was a nonsignificant trend toward fewer patients having intracranial hemorrhage if TPA was delivered in the STEMO unit, at 3.5%, compared with the overall rates during STEMO-serviced weeks (4.8%) and control weeks (6.0%).

"The current response time is about 16 minutes," coinvestigator Dr. Martin Ebinger, also of Charité-Universitätsmedizin Berlin, commented at a press briefing.

"Sometimes there were multiple, simultaneous calls," he said, noting that, at the current time, there is only one STEMO vehicle. If there were two mobile stroke units, then of course more people in the catchment area could be reached, and the response time could maybe even be halved to 8 minutes.

"We really need a very good, independent cost-effectiveness analysis," Dr. Ebinger conceded. Discussions with patient insurance groups and politicians have been started to determine how best to conduct such an analysis.

Dr. Michael Hennerici, professor of neurology at the University of Heidelberg in Germany, commented at the press briefing that giving thrombolysis to patients who have had a stroke is perhaps more complex than giving it to those who have had a heart attack. There are many different types of stroke, and only a selected population may require thrombolysis, he observed.

Dr. Martin Brown, professor of stroke medicine at University College London, also gave his thoughts on the data in an interview. "It certainly makes sense to get the treatment to patients as quickly as possible, but we need a CT scan of every patient before we give the treatment," he said.

"The real question is, however, ‘Is it more efficient to work on getting the patient to hospital as quickly as possible, or if we should be working on this model and trying to get money for more expensive ambulances?" Dr. Brown added.

"What we really need to know is what difference an extra 25 minutes means in terms of the number of patients that gain benefit. If it is only a small proportion, it might not be cost-effective," Dr. Brown said.

The STEMO project is a collaboration between Charité-Universitätsmedizin Berlin, the Berlin Fire Department, Brahms GmbH, and MEYTEC GmbH. It is cofunded by Technology Foundation Berlin and the European Fund for Regional Development. Dr. Hennerici and Dr. Brown were not involved in the study. Dr. Ebinger had no conflicts of interest. Dr. Audebert has received honoraria from Bayer, Bristol-Myers Squibb, and other companies.

LONDON – The use of a specialized ambulance enabled more patients with acute ischemic stroke to receive thrombolytic therapy than if standard emergency response vehicles were used in a randomized, controlled trial.

Preliminary results of the PHANTOM-S study also showed that stroke patients were given intravenous tissue plasminogen activator (TPA) 25 minutes sooner in the weeks when the stroke emergency mobile (STEMO) unit was in service, compared with the weeks when it was not.

Sara Freeman/IMNG Medical Media

"We have shown that the STEMO concept can be integrated into a metropolitan emergency medical system," said Dr. Heinrich Audebert, the head of the STEMO project, which is based at Charité-Universitätsmedizin Berlin.

Speaking at the annual European Stroke Conference, Dr. Audebert added that the approach was "safe and superior to regular [emergency] care regarding the quality of care, the proportion of patients receiving TPA, and the time to treatment."

There is further potential to use the mobile stroke unit in the treatment of patients with intracranial hemorrhage and to triage for interventional treatment, he suggested.

Speed is key for stroke thrombolysis

The rationale for the STEMO project, which is based in Berlin, is that thrombolysis is an effective treatment for some patients with acute ischemic stroke. Thrombolytic treatment needs to be administered within a short time frame, Dr. Audebert said, and past a critical time point of 4.5 hours, TPA is no longer given in Germany. The latest guidelines issued jointly by the American Heart Association and the American Stroke Association recommend that TPA be given within 3 hours of stroke onset (Stroke 2013;44:870-947).

However, there are several difficulties in administering TPA in the first few hours after an acute stroke, including determining if the patient is a suitable candidate for thrombolytic therapy, identifying the exact time at which the ischemic injury actually occurred, and transporting the patient quickly enough to a hospital for such treatment.

Sara Freeman/IMNG Medical Media

The STEMO project aims to improve stroke patients’ clinical care by enabling TPA to be administered before the patient arrives at hospital. To achieve this, an ambulance owned by the Berlin Fire Department was adapted to accommodate an onboard computed tomography (CT) scanner, point-of-care laboratory, and teleradiography system. This specialized mobile stroke unit is staffed by a paramedic, a neurologist with emergency medicine training, and a radiographer.

The PHANTOM-S study

The PHANTOM-S (Pre-Hospital Acute Neurological Treatment and Optimization of Medical Care in Stroke) study follows on from a 3-month pilot study that provided proof-of-concept for the use of the STEMO unit in 23 hospitals in the Berlin area (Neurology 2013;80:163-8). The larger, randomized study involved 28 hospitals in the region, which provide emergency services to about 1.3 million people.

During the PHANTOM-S study, the STEMO vehicle was in service alternating weeks. The weeks when the specialized ambulance was not deployed were used as the control period. A stroke identification algorithm previously developed by the team (Stroke 2012;43:776-81) was used to decide whether to deploy the STEMO unit to an emergency call.

Over a 21-month study period, 7,098 suspected stroke patients were enrolled and 6,573 were transported to the nearest adequately equipped hospital. Around half were seen in the weeks that the STEMO vehicle was in service.

During the in-service weeks, the STEMO vehicle was deployed a total of 2,027 times out of 3,668 calls. There were a total of 1,804 patients seen by the unit with enough data for study evaluation. Of these, 201 of 614 (33%) patients with acute ischemic stroke were given TPA before reaching the hospital.

A significantly higher percentage of stroke patients received prehospital thrombolysis when the STEMO unit was in service, at 29%, compared with 21% for the control weeks (P less than .001).

Sara Freeman/IMNG Medical Media

The percentage of patients subsequently transported to a hospital with a dedicated stroke unit was also higher during the weeks when the STEMO unit was in service than during the control weeks (93% vs. 87%; P less than .01).

Quicker time to TPA

The mean time from "deployment to needle," said Dr. Audebert, was 77 minutes for the weeks when the specialized ambulance was not in use, compared with 62 minutes when it was (P less than .01). This was reduced to 52 minutes if the STEMO unit was actually deployed (P less than .01 versus control weeks), and dropped to 48 minutes for patients who were actually given TPA in the mobile unit.

In-hospital death rates in confirmed stroke cases were 4.4% for the STEMO in-service weeks (3.8% if the unit was actually deployed) and 4.5% for control weeks.

In TPA-treated patients, there was a nonsignificant trend toward fewer patients having intracranial hemorrhage if TPA was delivered in the STEMO unit, at 3.5%, compared with the overall rates during STEMO-serviced weeks (4.8%) and control weeks (6.0%).

"The current response time is about 16 minutes," coinvestigator Dr. Martin Ebinger, also of Charité-Universitätsmedizin Berlin, commented at a press briefing.

"Sometimes there were multiple, simultaneous calls," he said, noting that, at the current time, there is only one STEMO vehicle. If there were two mobile stroke units, then of course more people in the catchment area could be reached, and the response time could maybe even be halved to 8 minutes.

"We really need a very good, independent cost-effectiveness analysis," Dr. Ebinger conceded. Discussions with patient insurance groups and politicians have been started to determine how best to conduct such an analysis.

Dr. Michael Hennerici, professor of neurology at the University of Heidelberg in Germany, commented at the press briefing that giving thrombolysis to patients who have had a stroke is perhaps more complex than giving it to those who have had a heart attack. There are many different types of stroke, and only a selected population may require thrombolysis, he observed.

Dr. Martin Brown, professor of stroke medicine at University College London, also gave his thoughts on the data in an interview. "It certainly makes sense to get the treatment to patients as quickly as possible, but we need a CT scan of every patient before we give the treatment," he said.

"The real question is, however, ‘Is it more efficient to work on getting the patient to hospital as quickly as possible, or if we should be working on this model and trying to get money for more expensive ambulances?" Dr. Brown added.

"What we really need to know is what difference an extra 25 minutes means in terms of the number of patients that gain benefit. If it is only a small proportion, it might not be cost-effective," Dr. Brown said.

The STEMO project is a collaboration between Charité-Universitätsmedizin Berlin, the Berlin Fire Department, Brahms GmbH, and MEYTEC GmbH. It is cofunded by Technology Foundation Berlin and the European Fund for Regional Development. Dr. Hennerici and Dr. Brown were not involved in the study. Dr. Ebinger had no conflicts of interest. Dr. Audebert has received honoraria from Bayer, Bristol-Myers Squibb, and other companies.

LONDON – Approximately 2%-3% of patients with spontaneous intracerebral hemorrhage may benefit from early surgical removal of hematoma, according to the results of the second Surgical Trial in Lobar Intracerebral Hemorrhage.

As reported at the annual European Stroke Conference and published simultaneously in the Lancet, patients with superficial lesions and an unfavorable prognostic score appeared to benefit from early surgical intervention, compared with those given conservative medical treatment (odds ratio [OR] = 0.49, P =.02). Conversely, those with a good prognostic score did not seem to benefit (OR = 1.12, P = .57).

The primary analysis showed no significant benefit of early surgery overall, with 41.4% of 297 patients in the early surgery group and 37.7% of 286 patients in the conservative treatment group having a favorable outcome at 6 months, as determined by the 8-point extended Glasgow Outcome Scale (GOS-E) (P = .367).

"That’s a 3.7% absolute benefit, which is not enough to change surgical practice on its own," said Dr. A. David Mendelow, professor of neurosurgery at Newcastle University in Newcastle upon Tyne, England. "We were looking for a 12% benefit when we set out to do this trial," he added during a press conference.

A 6% decrease in mortality at 6 months was seen favoring surgery (18% vs. 24% for conservative therapy), but this was not statistically significant (P = .095).

"Intracerebral hemorrhage is not a homogenous condition," Dr. Mendelow said, adding that it can be a difficult decision to operate. Clinical manifestations can range from no apparent effects to severe disability and rapid death. "STICH [Surgical Trial in Lobar Intracerebral Hemorrhage] focused on patients that we are not quite sure about whether to operate or not," he said.

The hypothesis for the trial was based on the findings of the first STICH trial (Acta Neurochir. Suppl. 2006;96:65-8). The results of the trial were again neutral overall, but subgroup analyses showed that some groups of patients did worse with surgery, such as those with deep-seated bleeds, and some may fare better, such as those with superficial lobar hematomas.

STICH II therefore specifically recruited this latter group of patients to see if the effect was real or an artifact of the scientific analysis. In total, 601 conscious ICH patients with a median age of 65 years were recruited at 78 centers in 27 countries. Patients had to have a superficial lesion (1 cm or less from the cortical surface of the brain) that was between 10 mL and 100 mL in volume, and with no sign of intraventricular hemorrhage on CT scanning. Patients had to be recruited within 48 hours of the stroke and surgical intervention had to be performed within 12 hours (Lancet 2013 May 29 [doi:10.1016/S0140-6736(13)60986-1]). (A total of 6 patients were excluded or withdrew from the study before intervention, and after intervention another 12 withdrew, were lost to follow-up, or were alive but had an unknown status.)

The GOS-E was calculated from the answers to a questionnaire sent out to patients and their relatives 6 months following their stroke. A cutoff score of approximately 27 was used to categorize patients as having a good or bad prognosis. At baseline, about two-thirds of patients had a good prognosis, and the remainder had a poor prognosis.

"The notion that early surgery might be beneficial in this subgroup of patients is supported by the results of the investigator’s updated meta-analysis of 15 trials,"

"One of the reasons, perhaps, for a lack of significance was the [number of] crossovers from initial conservative therapy to surgery," Dr. Mendelow said. Indeed, 21% of patients who were originally randomized to conservative treatment crossed over to the surgical arm. These patients had "clearly deteriorated" prior to having surgery, he said when presenting the findings. Furthermore, only 37% of these crossovers received surgery within the specified 12-hour time limit.

STICH provides the best, albeit insufficient, evidence to date on the role of surgery in ICH, Dr. Oliver Gautschi and Dr. Karl Schaller, both of the University of Geneva, commented in an editorial about the trial (Lancet 2013 May 29 [doi:10.1016/S0140-6736(13)61087-9]) .

"The notion that early surgery might be beneficial in this subgroup of patients is supported by the results of the investigator’s updated meta-analysis of 15 trials," they wrote. "The overall result of this meta-analysis of patients with different types of intracerebral hemorrhage favors surgery."

The results of two other surgical studies, CLEAR III and MISTIE III, "are eagerly awaited," Dr. Gautschi and Dr. Schaller said, noting that, "decompressive hemicraniectomy might be a[nother] promising surgical procedure."

The U.K. Medical Research Council funded STICH II. Dr. Mendelow reported having no relevant financial disclosures.

LONDON – Approximately 2%-3% of patients with spontaneous intracerebral hemorrhage may benefit from early surgical removal of hematoma, according to the results of the second Surgical Trial in Lobar Intracerebral Hemorrhage.

As reported at the annual European Stroke Conference and published simultaneously in the Lancet, patients with superficial lesions and an unfavorable prognostic score appeared to benefit from early surgical intervention, compared with those given conservative medical treatment (odds ratio [OR] = 0.49, P =.02). Conversely, those with a good prognostic score did not seem to benefit (OR = 1.12, P = .57).

The primary analysis showed no significant benefit of early surgery overall, with 41.4% of 297 patients in the early surgery group and 37.7% of 286 patients in the conservative treatment group having a favorable outcome at 6 months, as determined by the 8-point extended Glasgow Outcome Scale (GOS-E) (P = .367).

"That’s a 3.7% absolute benefit, which is not enough to change surgical practice on its own," said Dr. A. David Mendelow, professor of neurosurgery at Newcastle University in Newcastle upon Tyne, England. "We were looking for a 12% benefit when we set out to do this trial," he added during a press conference.

A 6% decrease in mortality at 6 months was seen favoring surgery (18% vs. 24% for conservative therapy), but this was not statistically significant (P = .095).

"Intracerebral hemorrhage is not a homogenous condition," Dr. Mendelow said, adding that it can be a difficult decision to operate. Clinical manifestations can range from no apparent effects to severe disability and rapid death. "STICH [Surgical Trial in Lobar Intracerebral Hemorrhage] focused on patients that we are not quite sure about whether to operate or not," he said.

The hypothesis for the trial was based on the findings of the first STICH trial (Acta Neurochir. Suppl. 2006;96:65-8). The results of the trial were again neutral overall, but subgroup analyses showed that some groups of patients did worse with surgery, such as those with deep-seated bleeds, and some may fare better, such as those with superficial lobar hematomas.

STICH II therefore specifically recruited this latter group of patients to see if the effect was real or an artifact of the scientific analysis. In total, 601 conscious ICH patients with a median age of 65 years were recruited at 78 centers in 27 countries. Patients had to have a superficial lesion (1 cm or less from the cortical surface of the brain) that was between 10 mL and 100 mL in volume, and with no sign of intraventricular hemorrhage on CT scanning. Patients had to be recruited within 48 hours of the stroke and surgical intervention had to be performed within 12 hours (Lancet 2013 May 29 [doi:10.1016/S0140-6736(13)60986-1]). (A total of 6 patients were excluded or withdrew from the study before intervention, and after intervention another 12 withdrew, were lost to follow-up, or were alive but had an unknown status.)

The GOS-E was calculated from the answers to a questionnaire sent out to patients and their relatives 6 months following their stroke. A cutoff score of approximately 27 was used to categorize patients as having a good or bad prognosis. At baseline, about two-thirds of patients had a good prognosis, and the remainder had a poor prognosis.

"The notion that early surgery might be beneficial in this subgroup of patients is supported by the results of the investigator’s updated meta-analysis of 15 trials,"

"One of the reasons, perhaps, for a lack of significance was the [number of] crossovers from initial conservative therapy to surgery," Dr. Mendelow said. Indeed, 21% of patients who were originally randomized to conservative treatment crossed over to the surgical arm. These patients had "clearly deteriorated" prior to having surgery, he said when presenting the findings. Furthermore, only 37% of these crossovers received surgery within the specified 12-hour time limit.

STICH provides the best, albeit insufficient, evidence to date on the role of surgery in ICH, Dr. Oliver Gautschi and Dr. Karl Schaller, both of the University of Geneva, commented in an editorial about the trial (Lancet 2013 May 29 [doi:10.1016/S0140-6736(13)61087-9]) .

"The notion that early surgery might be beneficial in this subgroup of patients is supported by the results of the investigator’s updated meta-analysis of 15 trials," they wrote. "The overall result of this meta-analysis of patients with different types of intracerebral hemorrhage favors surgery."

The results of two other surgical studies, CLEAR III and MISTIE III, "are eagerly awaited," Dr. Gautschi and Dr. Schaller said, noting that, "decompressive hemicraniectomy might be a[nother] promising surgical procedure."

The U.K. Medical Research Council funded STICH II. Dr. Mendelow reported having no relevant financial disclosures.

LONDON – Approximately 2%-3% of patients with spontaneous intracerebral hemorrhage may benefit from early surgical removal of hematoma, according to the results of the second Surgical Trial in Lobar Intracerebral Hemorrhage.

As reported at the annual European Stroke Conference and published simultaneously in the Lancet, patients with superficial lesions and an unfavorable prognostic score appeared to benefit from early surgical intervention, compared with those given conservative medical treatment (odds ratio [OR] = 0.49, P =.02). Conversely, those with a good prognostic score did not seem to benefit (OR = 1.12, P = .57).

The primary analysis showed no significant benefit of early surgery overall, with 41.4% of 297 patients in the early surgery group and 37.7% of 286 patients in the conservative treatment group having a favorable outcome at 6 months, as determined by the 8-point extended Glasgow Outcome Scale (GOS-E) (P = .367).

"That’s a 3.7% absolute benefit, which is not enough to change surgical practice on its own," said Dr. A. David Mendelow, professor of neurosurgery at Newcastle University in Newcastle upon Tyne, England. "We were looking for a 12% benefit when we set out to do this trial," he added during a press conference.

A 6% decrease in mortality at 6 months was seen favoring surgery (18% vs. 24% for conservative therapy), but this was not statistically significant (P = .095).

"Intracerebral hemorrhage is not a homogenous condition," Dr. Mendelow said, adding that it can be a difficult decision to operate. Clinical manifestations can range from no apparent effects to severe disability and rapid death. "STICH [Surgical Trial in Lobar Intracerebral Hemorrhage] focused on patients that we are not quite sure about whether to operate or not," he said.

The hypothesis for the trial was based on the findings of the first STICH trial (Acta Neurochir. Suppl. 2006;96:65-8). The results of the trial were again neutral overall, but subgroup analyses showed that some groups of patients did worse with surgery, such as those with deep-seated bleeds, and some may fare better, such as those with superficial lobar hematomas.

STICH II therefore specifically recruited this latter group of patients to see if the effect was real or an artifact of the scientific analysis. In total, 601 conscious ICH patients with a median age of 65 years were recruited at 78 centers in 27 countries. Patients had to have a superficial lesion (1 cm or less from the cortical surface of the brain) that was between 10 mL and 100 mL in volume, and with no sign of intraventricular hemorrhage on CT scanning. Patients had to be recruited within 48 hours of the stroke and surgical intervention had to be performed within 12 hours (Lancet 2013 May 29 [doi:10.1016/S0140-6736(13)60986-1]). (A total of 6 patients were excluded or withdrew from the study before intervention, and after intervention another 12 withdrew, were lost to follow-up, or were alive but had an unknown status.)

The GOS-E was calculated from the answers to a questionnaire sent out to patients and their relatives 6 months following their stroke. A cutoff score of approximately 27 was used to categorize patients as having a good or bad prognosis. At baseline, about two-thirds of patients had a good prognosis, and the remainder had a poor prognosis.

"The notion that early surgery might be beneficial in this subgroup of patients is supported by the results of the investigator’s updated meta-analysis of 15 trials,"

"One of the reasons, perhaps, for a lack of significance was the [number of] crossovers from initial conservative therapy to surgery," Dr. Mendelow said. Indeed, 21% of patients who were originally randomized to conservative treatment crossed over to the surgical arm. These patients had "clearly deteriorated" prior to having surgery, he said when presenting the findings. Furthermore, only 37% of these crossovers received surgery within the specified 12-hour time limit.

STICH provides the best, albeit insufficient, evidence to date on the role of surgery in ICH, Dr. Oliver Gautschi and Dr. Karl Schaller, both of the University of Geneva, commented in an editorial about the trial (Lancet 2013 May 29 [doi:10.1016/S0140-6736(13)61087-9]) .

"The notion that early surgery might be beneficial in this subgroup of patients is supported by the results of the investigator’s updated meta-analysis of 15 trials," they wrote. "The overall result of this meta-analysis of patients with different types of intracerebral hemorrhage favors surgery."

The results of two other surgical studies, CLEAR III and MISTIE III, "are eagerly awaited," Dr. Gautschi and Dr. Schaller said, noting that, "decompressive hemicraniectomy might be a[nother] promising surgical procedure."

The U.K. Medical Research Council funded STICH II. Dr. Mendelow reported having no relevant financial disclosures.

LONDON – Decompressive surgery dramatically increased the survival chances of older adult patients who had massive brain swelling after a middle cerebral artery stroke, according to the results of a randomized clinical trial.

After 1 year of follow-up, 57% of patients aged 61 years or older were still alive if they had undergone hemicraniectomy, compared with 24% (P less than .001) of those who received standard intensive care alone in the DESTINY II trial. The increase in survival did not lead to an increase in severe disability, study investigator Dr. Werner Hacke of the University of Heidelberg, Germany, reported at the annual European Stroke Conference.

Sara Freeman/IMNG Medical Media

"Malignant infarction of the middle cerebral artery [MCA] is the deadliest type of ischemic brain infarction," Dr. Hacke noted. It is associated with rapid neurological deterioration caused by cerebral edema (Postgrad. Med. J. 2010;86:235-42) and is responsible for 70%-80% of in-hospital mortality if treated conservatively using mechanical ventilation and intracranial pressure reduction.

Evidence supporting decompressive surgery

Previous pooled research, including the DESTINY I study (Decompressive Surgery for the Treatment of Malignant Infarction of the Middle Cerebral Artery), showed that relieving the pressure on the brain by temporarily removing part of the skull within the first 48 hours of ischemic injury reduces the risk of death and poor clinical outcome by almost 50% in patients under the age of 60 years (Lancet Neurol. 2007;6:215-22). The DESTINY II data now show that older patients also can benefit from decompressive surgery, perhaps as much as their younger counterparts.

A total of 112 patients with malignant MCA infarction aged 61 years and older were recruited into the study and randomized to receive maximum conservative treatment alone or in addition to hemicraniectomy within 48 hours after symptom onset (Int. J. Stroke 2011;6:79-86). The mean age was 70 years, and 60%-67% had infarctions affecting the nondominant cerebral hemisphere. The mean National Institutes of Health Stroke Scale (NIHSS) score was 20-22 at admission.

The primary endpoint was the proportion of patients achieving a modified Rankin Scale (mRS) score of 0-4 versus 5-6 at 6 months. A score of 6 on this scale signifies death and a score of 5 represents severe disability, such as being bedridden and incontinent and requiring constant nursing care and attention.

Dr. Hacke noted that the trial’s data and safety monitoring board halted the trial at the 6-month assessment after reviewing data on 82 patients. The exact reasons were undisclosed, but part of the study’s protocol was to stop the trial once statistical significance was reached. At the time the trial has halted, a further 30 patients had already been randomized and were included in the intention-to-treat analysis (ITT).

DESTINY II results

Significantly more patients who underwent surgery had a mRS of 0-4 than did those who had standard intensive care treatment (40.5% vs. 18.6%, P = .039) using the DSMB data set. The percentages of surgically and conservatively treated patients with an mRS of 5 or 6 were 59.5% and 81.4%, respectively. Performing an ITT analysis did not change the findings.

The number needed to treat was just 4, Dr. Hacke reported.

At 12 months in the ITT population, he noted that 38% of surgically and 16% of conservatively managed patients with an mRS of 0-4 were alive, as were 62% versus 84% of those, respectively, who had a mRS of 5-6 (P =.009).

An ITT analysis of multiple secondary endpoints at 1 year – which included the NIHSS score, Barthel Activities of Daily Living Index, Short Form-36 physical and mental domains, Hamilton Rating Scale for Depression, and the EuroQoL-5D – was also significantly in favor of early hemicraniectomy. This was perhaps a statistical artifact, Dr. Hacke observed, as the significance disappeared when data were examined in only the patients who had survived to 1 year.

Retrospective consent to surgery

When survivors and their caregivers were asked if they would undergo the same procedure again, given the knowledge of the final outcome, the majority of both surgically treated (77%, n = 27) and conservatively managed survivors (73%, n = 15) said that they would.

This finding shows that most patients, including those with moderately severe disability (mRS of 4) would rather have the procedures than be dead.

Dr. Christine Roffe, professor of medicine at Keele University in Stoke-on-Trent, England, commented that a person’s point of view of disability often changes after having a stroke.

"We’ve always assumed that if you asked someone before they had a stroke, ‘Would you rather have a stroke or be dead?’ that people would say, ‘I’d rather be dead,’ " she said in an interview. It’s not unreasonable that most people would probably say they would rather be dead than be severely incapacitated for the rest of their lives, she added.

However, after having a stroke, people often report that they are able to continue to live their lives reasonably happily despite often being quite disabled and having lost their independence.

The DESTINY II data show that people who had surgery were quite happy despite any disability, and this was at a similar level to those who were treated conservatively but with higher survival rates, Dr. Roffe noted.

The ethical implications of this could be considerable, she suggested. It shows that people who have living wills or who decide that they do not want treatment in the event of a stroke could live just as happy a life after the event as before. It therefore begs the question of whether patients should be allowed to decide on this aspect of their care, she added.

The German Research Foundation and the German Ministry of Science and Education financially supported the study. Dr. Hacke had no disclosures. Dr. Roffe was not involved in the study and had no relevant conflicts of interest.

LONDON – Decompressive surgery dramatically increased the survival chances of older adult patients who had massive brain swelling after a middle cerebral artery stroke, according to the results of a randomized clinical trial.

After 1 year of follow-up, 57% of patients aged 61 years or older were still alive if they had undergone hemicraniectomy, compared with 24% (P less than .001) of those who received standard intensive care alone in the DESTINY II trial. The increase in survival did not lead to an increase in severe disability, study investigator Dr. Werner Hacke of the University of Heidelberg, Germany, reported at the annual European Stroke Conference.

Sara Freeman/IMNG Medical Media

"Malignant infarction of the middle cerebral artery [MCA] is the deadliest type of ischemic brain infarction," Dr. Hacke noted. It is associated with rapid neurological deterioration caused by cerebral edema (Postgrad. Med. J. 2010;86:235-42) and is responsible for 70%-80% of in-hospital mortality if treated conservatively using mechanical ventilation and intracranial pressure reduction.

Evidence supporting decompressive surgery

Previous pooled research, including the DESTINY I study (Decompressive Surgery for the Treatment of Malignant Infarction of the Middle Cerebral Artery), showed that relieving the pressure on the brain by temporarily removing part of the skull within the first 48 hours of ischemic injury reduces the risk of death and poor clinical outcome by almost 50% in patients under the age of 60 years (Lancet Neurol. 2007;6:215-22). The DESTINY II data now show that older patients also can benefit from decompressive surgery, perhaps as much as their younger counterparts.

A total of 112 patients with malignant MCA infarction aged 61 years and older were recruited into the study and randomized to receive maximum conservative treatment alone or in addition to hemicraniectomy within 48 hours after symptom onset (Int. J. Stroke 2011;6:79-86). The mean age was 70 years, and 60%-67% had infarctions affecting the nondominant cerebral hemisphere. The mean National Institutes of Health Stroke Scale (NIHSS) score was 20-22 at admission.

The primary endpoint was the proportion of patients achieving a modified Rankin Scale (mRS) score of 0-4 versus 5-6 at 6 months. A score of 6 on this scale signifies death and a score of 5 represents severe disability, such as being bedridden and incontinent and requiring constant nursing care and attention.

Dr. Hacke noted that the trial’s data and safety monitoring board halted the trial at the 6-month assessment after reviewing data on 82 patients. The exact reasons were undisclosed, but part of the study’s protocol was to stop the trial once statistical significance was reached. At the time the trial has halted, a further 30 patients had already been randomized and were included in the intention-to-treat analysis (ITT).

DESTINY II results

Significantly more patients who underwent surgery had a mRS of 0-4 than did those who had standard intensive care treatment (40.5% vs. 18.6%, P = .039) using the DSMB data set. The percentages of surgically and conservatively treated patients with an mRS of 5 or 6 were 59.5% and 81.4%, respectively. Performing an ITT analysis did not change the findings.

The number needed to treat was just 4, Dr. Hacke reported.

At 12 months in the ITT population, he noted that 38% of surgically and 16% of conservatively managed patients with an mRS of 0-4 were alive, as were 62% versus 84% of those, respectively, who had a mRS of 5-6 (P =.009).

An ITT analysis of multiple secondary endpoints at 1 year – which included the NIHSS score, Barthel Activities of Daily Living Index, Short Form-36 physical and mental domains, Hamilton Rating Scale for Depression, and the EuroQoL-5D – was also significantly in favor of early hemicraniectomy. This was perhaps a statistical artifact, Dr. Hacke observed, as the significance disappeared when data were examined in only the patients who had survived to 1 year.

Retrospective consent to surgery

When survivors and their caregivers were asked if they would undergo the same procedure again, given the knowledge of the final outcome, the majority of both surgically treated (77%, n = 27) and conservatively managed survivors (73%, n = 15) said that they would.

This finding shows that most patients, including those with moderately severe disability (mRS of 4) would rather have the procedures than be dead.

Dr. Christine Roffe, professor of medicine at Keele University in Stoke-on-Trent, England, commented that a person’s point of view of disability often changes after having a stroke.

"We’ve always assumed that if you asked someone before they had a stroke, ‘Would you rather have a stroke or be dead?’ that people would say, ‘I’d rather be dead,’ " she said in an interview. It’s not unreasonable that most people would probably say they would rather be dead than be severely incapacitated for the rest of their lives, she added.

However, after having a stroke, people often report that they are able to continue to live their lives reasonably happily despite often being quite disabled and having lost their independence.

The DESTINY II data show that people who had surgery were quite happy despite any disability, and this was at a similar level to those who were treated conservatively but with higher survival rates, Dr. Roffe noted.

The ethical implications of this could be considerable, she suggested. It shows that people who have living wills or who decide that they do not want treatment in the event of a stroke could live just as happy a life after the event as before. It therefore begs the question of whether patients should be allowed to decide on this aspect of their care, she added.

The German Research Foundation and the German Ministry of Science and Education financially supported the study. Dr. Hacke had no disclosures. Dr. Roffe was not involved in the study and had no relevant conflicts of interest.

LONDON – Decompressive surgery dramatically increased the survival chances of older adult patients who had massive brain swelling after a middle cerebral artery stroke, according to the results of a randomized clinical trial.

After 1 year of follow-up, 57% of patients aged 61 years or older were still alive if they had undergone hemicraniectomy, compared with 24% (P less than .001) of those who received standard intensive care alone in the DESTINY II trial. The increase in survival did not lead to an increase in severe disability, study investigator Dr. Werner Hacke of the University of Heidelberg, Germany, reported at the annual European Stroke Conference.

Sara Freeman/IMNG Medical Media

"Malignant infarction of the middle cerebral artery [MCA] is the deadliest type of ischemic brain infarction," Dr. Hacke noted. It is associated with rapid neurological deterioration caused by cerebral edema (Postgrad. Med. J. 2010;86:235-42) and is responsible for 70%-80% of in-hospital mortality if treated conservatively using mechanical ventilation and intracranial pressure reduction.

Evidence supporting decompressive surgery

Previous pooled research, including the DESTINY I study (Decompressive Surgery for the Treatment of Malignant Infarction of the Middle Cerebral Artery), showed that relieving the pressure on the brain by temporarily removing part of the skull within the first 48 hours of ischemic injury reduces the risk of death and poor clinical outcome by almost 50% in patients under the age of 60 years (Lancet Neurol. 2007;6:215-22). The DESTINY II data now show that older patients also can benefit from decompressive surgery, perhaps as much as their younger counterparts.

A total of 112 patients with malignant MCA infarction aged 61 years and older were recruited into the study and randomized to receive maximum conservative treatment alone or in addition to hemicraniectomy within 48 hours after symptom onset (Int. J. Stroke 2011;6:79-86). The mean age was 70 years, and 60%-67% had infarctions affecting the nondominant cerebral hemisphere. The mean National Institutes of Health Stroke Scale (NIHSS) score was 20-22 at admission.

The primary endpoint was the proportion of patients achieving a modified Rankin Scale (mRS) score of 0-4 versus 5-6 at 6 months. A score of 6 on this scale signifies death and a score of 5 represents severe disability, such as being bedridden and incontinent and requiring constant nursing care and attention.

Dr. Hacke noted that the trial’s data and safety monitoring board halted the trial at the 6-month assessment after reviewing data on 82 patients. The exact reasons were undisclosed, but part of the study’s protocol was to stop the trial once statistical significance was reached. At the time the trial has halted, a further 30 patients had already been randomized and were included in the intention-to-treat analysis (ITT).

DESTINY II results

Significantly more patients who underwent surgery had a mRS of 0-4 than did those who had standard intensive care treatment (40.5% vs. 18.6%, P = .039) using the DSMB data set. The percentages of surgically and conservatively treated patients with an mRS of 5 or 6 were 59.5% and 81.4%, respectively. Performing an ITT analysis did not change the findings.

The number needed to treat was just 4, Dr. Hacke reported.

At 12 months in the ITT population, he noted that 38% of surgically and 16% of conservatively managed patients with an mRS of 0-4 were alive, as were 62% versus 84% of those, respectively, who had a mRS of 5-6 (P =.009).

An ITT analysis of multiple secondary endpoints at 1 year – which included the NIHSS score, Barthel Activities of Daily Living Index, Short Form-36 physical and mental domains, Hamilton Rating Scale for Depression, and the EuroQoL-5D – was also significantly in favor of early hemicraniectomy. This was perhaps a statistical artifact, Dr. Hacke observed, as the significance disappeared when data were examined in only the patients who had survived to 1 year.

Retrospective consent to surgery

When survivors and their caregivers were asked if they would undergo the same procedure again, given the knowledge of the final outcome, the majority of both surgically treated (77%, n = 27) and conservatively managed survivors (73%, n = 15) said that they would.

This finding shows that most patients, including those with moderately severe disability (mRS of 4) would rather have the procedures than be dead.

Dr. Christine Roffe, professor of medicine at Keele University in Stoke-on-Trent, England, commented that a person’s point of view of disability often changes after having a stroke.

"We’ve always assumed that if you asked someone before they had a stroke, ‘Would you rather have a stroke or be dead?’ that people would say, ‘I’d rather be dead,’ " she said in an interview. It’s not unreasonable that most people would probably say they would rather be dead than be severely incapacitated for the rest of their lives, she added.

However, after having a stroke, people often report that they are able to continue to live their lives reasonably happily despite often being quite disabled and having lost their independence.

The DESTINY II data show that people who had surgery were quite happy despite any disability, and this was at a similar level to those who were treated conservatively but with higher survival rates, Dr. Roffe noted.

The ethical implications of this could be considerable, she suggested. It shows that people who have living wills or who decide that they do not want treatment in the event of a stroke could live just as happy a life after the event as before. It therefore begs the question of whether patients should be allowed to decide on this aspect of their care, she added.

The German Research Foundation and the German Ministry of Science and Education financially supported the study. Dr. Hacke had no disclosures. Dr. Roffe was not involved in the study and had no relevant conflicts of interest.