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Expert panel publishes consensus on robotic TME
in an effort to establish uniform training and education and improve outcomes for the robotic operations.
“The aim of this consensus study was to establish a detailed description of technical steps for robotic anterior resection and TME of the rectum as recommended by a representative group of established European expert surgeons,” wrote Danilo Miskovic, PhD, FRCS, of St. Mark’s Hospital in London, and his coauthors. The study, published in Colorectal Disease, provides a baseline for technical standards and structured training in robotic rectal surgery.
The consensus authors acted at the behest of the European Academy for Robotic Colorectal Surgery (EARCS), a nonprofit organization that provides training for robotic colorectal surgery. They cited evidence suggesting that the robotic approach to TME confers significant benefits in selected patients, compared with laparoscopic surgery (Dis Colon Rectum. 2014;57:570-7), but that the ROLARR trial found no benefit with robotic surgery (Int J Colorectal Dis. 2012;27:233-41).
“Notwithstanding the absence of evidence, robotic surgery continues to increase in popularity in many countries,” Dr. Miskovic and his coauthors wrote.
The consensus statement covers recommendations for the da Vinci Si and Xi robotic platforms in the following areas.
- Surgical setup, including patient positioning and port placement and docking.
- Colonic mobilization, including vascular pedicle dissection and splenic flexure mobilization.
- Pelvic dissection, including establishing operative planes and specimen extraction.
Dr. Miskovic and his coauthors arrived at the consensus statement by asking 24 EARCS faculty members to complete a 72-item questionnaire. The initial responses yielded an 87% agreement among the responses, but after suggested modifications, the average level of agreement for all items was 97%.
One of the limitations of the study that the investigators acknowledged is that it covers only two da Vinci robotic platforms; the recommendations may not apply to new robotic systems. Secondly, a selected group of experts provided input. “There may be other experienced surgeons who might disagree with some aspects of our recommendations,” the authors wrote. “This document should therefore be seen as a foundation for debate and modification in light of future technical developments.”
Future research should evaluate how training of technical standards within a group like EARCS impacts clinical outcomes, Dr. Miskovic and his coauthors noted.
The investigators had no financial relationships to report. Participating surgeons are members of the EARCS faculty and/or its scientific committee
SOURCE: Miskovic D et al. Colorectal Dis. 2018 Nov 29. doi: 10.1111/codi.14502.
in an effort to establish uniform training and education and improve outcomes for the robotic operations.
“The aim of this consensus study was to establish a detailed description of technical steps for robotic anterior resection and TME of the rectum as recommended by a representative group of established European expert surgeons,” wrote Danilo Miskovic, PhD, FRCS, of St. Mark’s Hospital in London, and his coauthors. The study, published in Colorectal Disease, provides a baseline for technical standards and structured training in robotic rectal surgery.
The consensus authors acted at the behest of the European Academy for Robotic Colorectal Surgery (EARCS), a nonprofit organization that provides training for robotic colorectal surgery. They cited evidence suggesting that the robotic approach to TME confers significant benefits in selected patients, compared with laparoscopic surgery (Dis Colon Rectum. 2014;57:570-7), but that the ROLARR trial found no benefit with robotic surgery (Int J Colorectal Dis. 2012;27:233-41).
“Notwithstanding the absence of evidence, robotic surgery continues to increase in popularity in many countries,” Dr. Miskovic and his coauthors wrote.
The consensus statement covers recommendations for the da Vinci Si and Xi robotic platforms in the following areas.
- Surgical setup, including patient positioning and port placement and docking.
- Colonic mobilization, including vascular pedicle dissection and splenic flexure mobilization.
- Pelvic dissection, including establishing operative planes and specimen extraction.
Dr. Miskovic and his coauthors arrived at the consensus statement by asking 24 EARCS faculty members to complete a 72-item questionnaire. The initial responses yielded an 87% agreement among the responses, but after suggested modifications, the average level of agreement for all items was 97%.
One of the limitations of the study that the investigators acknowledged is that it covers only two da Vinci robotic platforms; the recommendations may not apply to new robotic systems. Secondly, a selected group of experts provided input. “There may be other experienced surgeons who might disagree with some aspects of our recommendations,” the authors wrote. “This document should therefore be seen as a foundation for debate and modification in light of future technical developments.”
Future research should evaluate how training of technical standards within a group like EARCS impacts clinical outcomes, Dr. Miskovic and his coauthors noted.
The investigators had no financial relationships to report. Participating surgeons are members of the EARCS faculty and/or its scientific committee
SOURCE: Miskovic D et al. Colorectal Dis. 2018 Nov 29. doi: 10.1111/codi.14502.
in an effort to establish uniform training and education and improve outcomes for the robotic operations.
“The aim of this consensus study was to establish a detailed description of technical steps for robotic anterior resection and TME of the rectum as recommended by a representative group of established European expert surgeons,” wrote Danilo Miskovic, PhD, FRCS, of St. Mark’s Hospital in London, and his coauthors. The study, published in Colorectal Disease, provides a baseline for technical standards and structured training in robotic rectal surgery.
The consensus authors acted at the behest of the European Academy for Robotic Colorectal Surgery (EARCS), a nonprofit organization that provides training for robotic colorectal surgery. They cited evidence suggesting that the robotic approach to TME confers significant benefits in selected patients, compared with laparoscopic surgery (Dis Colon Rectum. 2014;57:570-7), but that the ROLARR trial found no benefit with robotic surgery (Int J Colorectal Dis. 2012;27:233-41).
“Notwithstanding the absence of evidence, robotic surgery continues to increase in popularity in many countries,” Dr. Miskovic and his coauthors wrote.
The consensus statement covers recommendations for the da Vinci Si and Xi robotic platforms in the following areas.
- Surgical setup, including patient positioning and port placement and docking.
- Colonic mobilization, including vascular pedicle dissection and splenic flexure mobilization.
- Pelvic dissection, including establishing operative planes and specimen extraction.
Dr. Miskovic and his coauthors arrived at the consensus statement by asking 24 EARCS faculty members to complete a 72-item questionnaire. The initial responses yielded an 87% agreement among the responses, but after suggested modifications, the average level of agreement for all items was 97%.
One of the limitations of the study that the investigators acknowledged is that it covers only two da Vinci robotic platforms; the recommendations may not apply to new robotic systems. Secondly, a selected group of experts provided input. “There may be other experienced surgeons who might disagree with some aspects of our recommendations,” the authors wrote. “This document should therefore be seen as a foundation for debate and modification in light of future technical developments.”
Future research should evaluate how training of technical standards within a group like EARCS impacts clinical outcomes, Dr. Miskovic and his coauthors noted.
The investigators had no financial relationships to report. Participating surgeons are members of the EARCS faculty and/or its scientific committee
SOURCE: Miskovic D et al. Colorectal Dis. 2018 Nov 29. doi: 10.1111/codi.14502.
FROM COLORECTAL DISEASE
Digital alerts reduced AF-related stroke, MI rates
CHICAGO – and had significantly lower rates of death and other cardiovascular events, compared with patients on a standard admissions protocol, according to results of a randomized, controlled trial presented at the American Heart Association Scientific Sessions.
“Alert-based computerized decision support [CDS] increased the prescription of anticoagulation for stroke prevention in atrial fibrillation during hospitalization, at discharge, and at 90 days after randomization in high-risk patients,” said Gregory Piazza, MD, of Brigham and Women’s Hospital, Boston, in presenting results of the AF-ALERT trial. “The reductions in major cardiovascular events was attributable to reductions in MI and stroke/transient ischemic attack at 90 days in patients whose physicians received the alert.”
The trial evaluated 458 patients hospitalized for AF or flutter and with CHA2DS2-VASc scores of 1-8 randomly assigned to the alert (n = 258) or no-alert (n = 210) groups.
Dr. Piazza explained that for those in the alert group, the CDS system notified physicians when the patient’s CHA2DS2-VASc score increased. From there, the physician could choose to open an order template to prescribe evidence-based medications to prevent stroke, to elect to review evidence-based clinical practice guidelines, or to continue with the admissions order with an acknowledged reason for omitting anticoagulation (such as high bleeding risk, low stroke risk, high risk for falls, or patient refusal of anticoagulation).
“In patients for whom their providers were alerted, 35% elected to open the stroke-prevention order set, a very tiny percentage elected to read the AF guidelines, and about 64% exited but provided a rationale for omitting anticoagulation,” Dr. Piazza noted.
The alert group was far more likely to be prescribed anticoagulation during the hospitalization (25.8% vs. 9.5%; P less than .0001), at discharge (23.8% vs. 12.9%; P = .003), and at 90 days (27.7% vs. 17.1%; P = .007) than the control group. The alert resulted in a 55% relative risk reduction in a composite outcome of death, MI, cerebrovascular event, and systemic embolic event at 90 days (11.3% vs. 21.9%; P = .002). The alert group had an 87% lower incidence of MI at 90 days (1.2% vs. 8.6%, P = .0002) and 88% lower incidence of cerebrovascular events or systemic embolism at 90 days (0% vs. 2.4%; P = .02). Death at 90 days occurred in 10.1% in the alert group and 14.8% in the control group (P = .13).
One of the limitations of the study, Dr. Piazza noted, was that the most dramatic finding – reduction of major cardiovascular events – was a secondary, not a primary, endpoint. “CDS has the potential to be a powerful tool in prevention of cardiovascular events in patients with atrial fibrillation.”
Moderator Mintu Turakhia, MD, of Stanford (Calif.) University, questioned the low rate of anticoagulation in the study’s control arm – 9.5% – much lower than medians reported in many registries. He also asked Dr. Piazza to describe the mechanism of action for prescribing anticoagulation in these patients.
Dr. Piazza noted the study population was hospitalized patients whose providers had decided prior to their admissions not to prescribe anticoagulation; hence, the rate of anticoagulation in these patients was actually higher than expected.
Regarding the mechanism of action, “the electronic alert seems to preferentially increase the prescription of [direct oral anticoagulants] over warfarin, and that may have been one of the mechanisms,” Dr. Piazza said. Another explanation he offered were “off-target” effects whereby, if providers have a better idea of a patient’s risk for a stroke or MI, they’ll be more aggressive about managing other risk factors.
“There are a number of interventions that could be triggered if the alert prompted the provider to have a conversation with patients about their risk of stroke from AF,” he said. “This may have impact beyond what we can tell from this simple [Best Practice Advisory in the Epic EHR system]. I think we don’t have a great understanding of the full mechanisms of CDS.”
Dr. Piazza reported financial relationships with BTG, Janssen, Bristol-Myers Squibb, Daiichi Sankyo, Portola, and Bayer. Daiichi Sankyo funded the trial. Dr. Turakhia reported relationships with Apple, Janssen, AstraZeneca, VA, Boehringer Ingelheim, Cardiva Medical, Medtronic, Abbott, Precision Health Economics, iBeat, iRhythm, MyoKardia, Biotronik, and an ownership Interest in AliveCor.
CHICAGO – and had significantly lower rates of death and other cardiovascular events, compared with patients on a standard admissions protocol, according to results of a randomized, controlled trial presented at the American Heart Association Scientific Sessions.
“Alert-based computerized decision support [CDS] increased the prescription of anticoagulation for stroke prevention in atrial fibrillation during hospitalization, at discharge, and at 90 days after randomization in high-risk patients,” said Gregory Piazza, MD, of Brigham and Women’s Hospital, Boston, in presenting results of the AF-ALERT trial. “The reductions in major cardiovascular events was attributable to reductions in MI and stroke/transient ischemic attack at 90 days in patients whose physicians received the alert.”
The trial evaluated 458 patients hospitalized for AF or flutter and with CHA2DS2-VASc scores of 1-8 randomly assigned to the alert (n = 258) or no-alert (n = 210) groups.
Dr. Piazza explained that for those in the alert group, the CDS system notified physicians when the patient’s CHA2DS2-VASc score increased. From there, the physician could choose to open an order template to prescribe evidence-based medications to prevent stroke, to elect to review evidence-based clinical practice guidelines, or to continue with the admissions order with an acknowledged reason for omitting anticoagulation (such as high bleeding risk, low stroke risk, high risk for falls, or patient refusal of anticoagulation).
“In patients for whom their providers were alerted, 35% elected to open the stroke-prevention order set, a very tiny percentage elected to read the AF guidelines, and about 64% exited but provided a rationale for omitting anticoagulation,” Dr. Piazza noted.
The alert group was far more likely to be prescribed anticoagulation during the hospitalization (25.8% vs. 9.5%; P less than .0001), at discharge (23.8% vs. 12.9%; P = .003), and at 90 days (27.7% vs. 17.1%; P = .007) than the control group. The alert resulted in a 55% relative risk reduction in a composite outcome of death, MI, cerebrovascular event, and systemic embolic event at 90 days (11.3% vs. 21.9%; P = .002). The alert group had an 87% lower incidence of MI at 90 days (1.2% vs. 8.6%, P = .0002) and 88% lower incidence of cerebrovascular events or systemic embolism at 90 days (0% vs. 2.4%; P = .02). Death at 90 days occurred in 10.1% in the alert group and 14.8% in the control group (P = .13).
One of the limitations of the study, Dr. Piazza noted, was that the most dramatic finding – reduction of major cardiovascular events – was a secondary, not a primary, endpoint. “CDS has the potential to be a powerful tool in prevention of cardiovascular events in patients with atrial fibrillation.”
Moderator Mintu Turakhia, MD, of Stanford (Calif.) University, questioned the low rate of anticoagulation in the study’s control arm – 9.5% – much lower than medians reported in many registries. He also asked Dr. Piazza to describe the mechanism of action for prescribing anticoagulation in these patients.
Dr. Piazza noted the study population was hospitalized patients whose providers had decided prior to their admissions not to prescribe anticoagulation; hence, the rate of anticoagulation in these patients was actually higher than expected.
Regarding the mechanism of action, “the electronic alert seems to preferentially increase the prescription of [direct oral anticoagulants] over warfarin, and that may have been one of the mechanisms,” Dr. Piazza said. Another explanation he offered were “off-target” effects whereby, if providers have a better idea of a patient’s risk for a stroke or MI, they’ll be more aggressive about managing other risk factors.
“There are a number of interventions that could be triggered if the alert prompted the provider to have a conversation with patients about their risk of stroke from AF,” he said. “This may have impact beyond what we can tell from this simple [Best Practice Advisory in the Epic EHR system]. I think we don’t have a great understanding of the full mechanisms of CDS.”
Dr. Piazza reported financial relationships with BTG, Janssen, Bristol-Myers Squibb, Daiichi Sankyo, Portola, and Bayer. Daiichi Sankyo funded the trial. Dr. Turakhia reported relationships with Apple, Janssen, AstraZeneca, VA, Boehringer Ingelheim, Cardiva Medical, Medtronic, Abbott, Precision Health Economics, iBeat, iRhythm, MyoKardia, Biotronik, and an ownership Interest in AliveCor.
CHICAGO – and had significantly lower rates of death and other cardiovascular events, compared with patients on a standard admissions protocol, according to results of a randomized, controlled trial presented at the American Heart Association Scientific Sessions.
“Alert-based computerized decision support [CDS] increased the prescription of anticoagulation for stroke prevention in atrial fibrillation during hospitalization, at discharge, and at 90 days after randomization in high-risk patients,” said Gregory Piazza, MD, of Brigham and Women’s Hospital, Boston, in presenting results of the AF-ALERT trial. “The reductions in major cardiovascular events was attributable to reductions in MI and stroke/transient ischemic attack at 90 days in patients whose physicians received the alert.”
The trial evaluated 458 patients hospitalized for AF or flutter and with CHA2DS2-VASc scores of 1-8 randomly assigned to the alert (n = 258) or no-alert (n = 210) groups.
Dr. Piazza explained that for those in the alert group, the CDS system notified physicians when the patient’s CHA2DS2-VASc score increased. From there, the physician could choose to open an order template to prescribe evidence-based medications to prevent stroke, to elect to review evidence-based clinical practice guidelines, or to continue with the admissions order with an acknowledged reason for omitting anticoagulation (such as high bleeding risk, low stroke risk, high risk for falls, or patient refusal of anticoagulation).
“In patients for whom their providers were alerted, 35% elected to open the stroke-prevention order set, a very tiny percentage elected to read the AF guidelines, and about 64% exited but provided a rationale for omitting anticoagulation,” Dr. Piazza noted.
The alert group was far more likely to be prescribed anticoagulation during the hospitalization (25.8% vs. 9.5%; P less than .0001), at discharge (23.8% vs. 12.9%; P = .003), and at 90 days (27.7% vs. 17.1%; P = .007) than the control group. The alert resulted in a 55% relative risk reduction in a composite outcome of death, MI, cerebrovascular event, and systemic embolic event at 90 days (11.3% vs. 21.9%; P = .002). The alert group had an 87% lower incidence of MI at 90 days (1.2% vs. 8.6%, P = .0002) and 88% lower incidence of cerebrovascular events or systemic embolism at 90 days (0% vs. 2.4%; P = .02). Death at 90 days occurred in 10.1% in the alert group and 14.8% in the control group (P = .13).
One of the limitations of the study, Dr. Piazza noted, was that the most dramatic finding – reduction of major cardiovascular events – was a secondary, not a primary, endpoint. “CDS has the potential to be a powerful tool in prevention of cardiovascular events in patients with atrial fibrillation.”
Moderator Mintu Turakhia, MD, of Stanford (Calif.) University, questioned the low rate of anticoagulation in the study’s control arm – 9.5% – much lower than medians reported in many registries. He also asked Dr. Piazza to describe the mechanism of action for prescribing anticoagulation in these patients.
Dr. Piazza noted the study population was hospitalized patients whose providers had decided prior to their admissions not to prescribe anticoagulation; hence, the rate of anticoagulation in these patients was actually higher than expected.
Regarding the mechanism of action, “the electronic alert seems to preferentially increase the prescription of [direct oral anticoagulants] over warfarin, and that may have been one of the mechanisms,” Dr. Piazza said. Another explanation he offered were “off-target” effects whereby, if providers have a better idea of a patient’s risk for a stroke or MI, they’ll be more aggressive about managing other risk factors.
“There are a number of interventions that could be triggered if the alert prompted the provider to have a conversation with patients about their risk of stroke from AF,” he said. “This may have impact beyond what we can tell from this simple [Best Practice Advisory in the Epic EHR system]. I think we don’t have a great understanding of the full mechanisms of CDS.”
Dr. Piazza reported financial relationships with BTG, Janssen, Bristol-Myers Squibb, Daiichi Sankyo, Portola, and Bayer. Daiichi Sankyo funded the trial. Dr. Turakhia reported relationships with Apple, Janssen, AstraZeneca, VA, Boehringer Ingelheim, Cardiva Medical, Medtronic, Abbott, Precision Health Economics, iBeat, iRhythm, MyoKardia, Biotronik, and an ownership Interest in AliveCor.
REPORTING FROM AHA SCIENTIFIC SESSIONS
Key clinical point: A digital alert system led to improved outcomes in atrial fibrillation patients.
Major finding: Anticoagulation rates were 25.8% in the alert group versus 9.5% for controls.
Study details: AF-ALERT was a randomized, controlled trial of 458 high-risk patients with atrial fibrillation or flutter.
Disclosures: Dr. Piazza reported financial relationships with BTG, Janssen, Bristol-Myers Squibb, Daiichi Sankyo, Portola, and Bayer. Daiichi Sankyo provided funding for the study.
All-or-none approach boosts adherence to stroke treatments
CHICAGO – Stroke patients in low to middle income care settings may frequently fail to get timely evidence-based treatments when they’re admitted to the hospital and even when they’re discharged, but a large South American study found that an “all-or-none” approach to a multistep quality-improvement program led to a significant increase in therapy adherence and smoking cessation. The results were reported at the American Heart Association scientific sessions.
“A multifaceted quality-improvement intervention did not result in a significant increase in the composite adherence score for evidence-based therapies in patients with acute ischemic stroke [AIS] or transient ischemic attack [TIA],” said M. Julia Machline-Carrion, MD, PhD, principal investigator of the BRIDGE-Stroke study and a cardiologist at the Hospital for Heart in São Paulo. “However, when using a more conservative ‘all-or-none’ approach of complete adherence, the intervention resulted in improved adherence to evidence-based therapies.”
The quality-improvement program also resulted in a significant increase in the use of thrombolysis and uptake in smoking cessation education by study participants, Dr. Machline-Carrion added.
The study randomized 1,624 patients with AIS or TIA to the multifaceted quality-improvement intervention or routine practice. The intervention consisted of a patient identification system (wristband and printed reminders), a therapeutic plan road map and checklist, case management, educational materials, interactive workshops, and periodic audit and feedback reports to each participating cluster. Colored wristbands were to help promptly identify AIS or TIA patients in the emergency department and other departments they may have been sent to later on, such as the ICU, to avoid delays in initiating recommended therapies.
On average, the composite adherence score was 85.3% for those in the intervention group vs. 77.8% for controls, Dr. Machline-Carrion said. The composite adherence score consisted of 10 quality measures, ranging from early antithrombotics and prophylaxis for deep vein thrombosis to anticoagulation for atrial fibrillation or flutter, and smoking cessation education. “There was no statistically significant difference in the composite adherence score between the intervention group and the usual-care group,” she said.
However, when the researchers applied the all-or-none model – that is, complete adherence to all 10 in-hospital quality measures – the results were strikingly different, Dr. Machline-Carrion said. “Patients in the intervention group were more likely to receive all eligible therapies,” she said: 49.2% vs. 25.3%.
“Despite the established efficacy of several interventions for the management of patients with acute ischemic stroke and transient ischemic attack, the uptake of evidence-based measures remains suboptimal, especially in low- and middle-income countries,” Dr. Machline-Carrion said.
The BRIDGE-Stroke study involved 36 hospitals in Brazil, Argentina, and Peru with full emergency department coverage, central nervous system imaging, and access to recombinant tissue plasminogen activator therapies.
Dr. Machline-Carrion disclosed financial relationships with Amgen and Boehringer Ingelheim. The Brazil Ministry of Health was the lead sponsor of the study.
SOURCE: Machline-Carrion MJ et al. AHA scientific sessions, Abstract 19361.
CHICAGO – Stroke patients in low to middle income care settings may frequently fail to get timely evidence-based treatments when they’re admitted to the hospital and even when they’re discharged, but a large South American study found that an “all-or-none” approach to a multistep quality-improvement program led to a significant increase in therapy adherence and smoking cessation. The results were reported at the American Heart Association scientific sessions.
“A multifaceted quality-improvement intervention did not result in a significant increase in the composite adherence score for evidence-based therapies in patients with acute ischemic stroke [AIS] or transient ischemic attack [TIA],” said M. Julia Machline-Carrion, MD, PhD, principal investigator of the BRIDGE-Stroke study and a cardiologist at the Hospital for Heart in São Paulo. “However, when using a more conservative ‘all-or-none’ approach of complete adherence, the intervention resulted in improved adherence to evidence-based therapies.”
The quality-improvement program also resulted in a significant increase in the use of thrombolysis and uptake in smoking cessation education by study participants, Dr. Machline-Carrion added.
The study randomized 1,624 patients with AIS or TIA to the multifaceted quality-improvement intervention or routine practice. The intervention consisted of a patient identification system (wristband and printed reminders), a therapeutic plan road map and checklist, case management, educational materials, interactive workshops, and periodic audit and feedback reports to each participating cluster. Colored wristbands were to help promptly identify AIS or TIA patients in the emergency department and other departments they may have been sent to later on, such as the ICU, to avoid delays in initiating recommended therapies.
On average, the composite adherence score was 85.3% for those in the intervention group vs. 77.8% for controls, Dr. Machline-Carrion said. The composite adherence score consisted of 10 quality measures, ranging from early antithrombotics and prophylaxis for deep vein thrombosis to anticoagulation for atrial fibrillation or flutter, and smoking cessation education. “There was no statistically significant difference in the composite adherence score between the intervention group and the usual-care group,” she said.
However, when the researchers applied the all-or-none model – that is, complete adherence to all 10 in-hospital quality measures – the results were strikingly different, Dr. Machline-Carrion said. “Patients in the intervention group were more likely to receive all eligible therapies,” she said: 49.2% vs. 25.3%.
“Despite the established efficacy of several interventions for the management of patients with acute ischemic stroke and transient ischemic attack, the uptake of evidence-based measures remains suboptimal, especially in low- and middle-income countries,” Dr. Machline-Carrion said.
The BRIDGE-Stroke study involved 36 hospitals in Brazil, Argentina, and Peru with full emergency department coverage, central nervous system imaging, and access to recombinant tissue plasminogen activator therapies.
Dr. Machline-Carrion disclosed financial relationships with Amgen and Boehringer Ingelheim. The Brazil Ministry of Health was the lead sponsor of the study.
SOURCE: Machline-Carrion MJ et al. AHA scientific sessions, Abstract 19361.
CHICAGO – Stroke patients in low to middle income care settings may frequently fail to get timely evidence-based treatments when they’re admitted to the hospital and even when they’re discharged, but a large South American study found that an “all-or-none” approach to a multistep quality-improvement program led to a significant increase in therapy adherence and smoking cessation. The results were reported at the American Heart Association scientific sessions.
“A multifaceted quality-improvement intervention did not result in a significant increase in the composite adherence score for evidence-based therapies in patients with acute ischemic stroke [AIS] or transient ischemic attack [TIA],” said M. Julia Machline-Carrion, MD, PhD, principal investigator of the BRIDGE-Stroke study and a cardiologist at the Hospital for Heart in São Paulo. “However, when using a more conservative ‘all-or-none’ approach of complete adherence, the intervention resulted in improved adherence to evidence-based therapies.”
The quality-improvement program also resulted in a significant increase in the use of thrombolysis and uptake in smoking cessation education by study participants, Dr. Machline-Carrion added.
The study randomized 1,624 patients with AIS or TIA to the multifaceted quality-improvement intervention or routine practice. The intervention consisted of a patient identification system (wristband and printed reminders), a therapeutic plan road map and checklist, case management, educational materials, interactive workshops, and periodic audit and feedback reports to each participating cluster. Colored wristbands were to help promptly identify AIS or TIA patients in the emergency department and other departments they may have been sent to later on, such as the ICU, to avoid delays in initiating recommended therapies.
On average, the composite adherence score was 85.3% for those in the intervention group vs. 77.8% for controls, Dr. Machline-Carrion said. The composite adherence score consisted of 10 quality measures, ranging from early antithrombotics and prophylaxis for deep vein thrombosis to anticoagulation for atrial fibrillation or flutter, and smoking cessation education. “There was no statistically significant difference in the composite adherence score between the intervention group and the usual-care group,” she said.
However, when the researchers applied the all-or-none model – that is, complete adherence to all 10 in-hospital quality measures – the results were strikingly different, Dr. Machline-Carrion said. “Patients in the intervention group were more likely to receive all eligible therapies,” she said: 49.2% vs. 25.3%.
“Despite the established efficacy of several interventions for the management of patients with acute ischemic stroke and transient ischemic attack, the uptake of evidence-based measures remains suboptimal, especially in low- and middle-income countries,” Dr. Machline-Carrion said.
The BRIDGE-Stroke study involved 36 hospitals in Brazil, Argentina, and Peru with full emergency department coverage, central nervous system imaging, and access to recombinant tissue plasminogen activator therapies.
Dr. Machline-Carrion disclosed financial relationships with Amgen and Boehringer Ingelheim. The Brazil Ministry of Health was the lead sponsor of the study.
SOURCE: Machline-Carrion MJ et al. AHA scientific sessions, Abstract 19361.
REPORTING FROM THE AHA SCIENTIFIC SESSIONS
Key clinical point:
Major finding: Intervention group received evidence-based treatments at a rate of 49.2% vs. 25.3% for controls.
Data source: BRIDGE-Stroke, a cluster-randomized trial among 36 hospitals in Brazil, Argentina, and Peru with 1,624 patients enrolled.
Disclosures: Dr. Machline-Carrion disclosed financial relationships with Amgen and Boehringer Ingelheim. The Brazil Ministry of Health was the lead sponsor of the study.
Source: Machline-Carrion MJ et al. AHA scientific sessions, Abstract 19361.
Combined novel risk factors raise coronary event rates
CHICAGO – Individuals with both elevated lipoprotein(a) levels and a family history of coronary heart disease are at a considerably higher long-term risk of atherosclerotic cardiovascular disease and coronary heart disease events than those with one risk factor alone, according to results from a large clinical study presented at the American Heart Association scientific sessions.
“Elevated lipoprotein(a) levels or a positive family history of coronary heart disease each is independently associated with cardiovascular disease risk,” said Anurag Mehta, MD, of Emory University School of Medicine, Atlanta. “This study showed that the presence of both an elevated Lp(a) level and a positive family history has an additive joint association with long-term cardiovascular risk.”
Dr. Mehta reported on an analysis of 12,149 individuals participating in the Atherosclerosis Risk in Communities (ARIC) study. All study participants were free of cardiovascular disease at the time of enrollment. The researchers measured Lp(a) levels and ascertained family history by self-report. Forty-four percent of the study participants had a family history of coronary heart disease (CHD), and 23% were black.
Median follow-up of study participants was 21 years, over which time 3,114 atherosclerotic cardiovascular disease (ASCVD) and 2,283 CHD events occurred.
Black participants had a significantly higher average plasma Lp(a) concentration than white persons, at 16.7 mg/dL vs. 5.7 mg/dL. However, plasma Lp(a) levels between participants with either a positive or a negative family history of CHD were similar on average, 7.6 mg/dL and 7.8 mg/dL, respectively.
The study pooled black and white ARIC participants by race-specific Lp(a) levels (quintiles) and stratified them into four different groups: 1. positive family history and an elevated race-specific Lp(a) level (quintile 5); 2. positive family history and nonelevated race-specific Lp(a) level (quintiles 1-4); 3. negative family history and elevated race-specific Lp(a) level; and 4. negative family history and nonelevated race-specific Lp(a) level. “There was an increase in the proportion of participants with a family history of CHD across race-specific Lp(a) quintiles, highlighting the fact that family history is associated with race-specific Lp(a) levels,” Dr. Mehta said.
“We observed that the ASCVD incidence was higher among participants with an elevated Lp(a) level or a family history of CHD as compared with participants with nonelevated Lp(a) levels and no family history,” Dr. Mehta said. “The highest ASCVD incidence was noted among participants with an elevated Lp(a) level as well as a positive family history.” Among those patients, the cumulative incidence of ASCVD events was nearly 25%, compared with 22% for those with a positive family history and nonelevated Lp(a) levels (group 2) or those with a negative family history but elevated Lp(a) levels (group 3), and 18% for those with negative family history and nonelevated Lp(a) levels.
Results for the cumulative incidence of coronary events trended similarly, Dr. Mehta noted: around 22% for group 1, 19% for group 2, 17% for group 3, and 14% for group 4.
“Having an elevated Lp(a) level as well as a family history of CHD was associated with a higher adjusted hazard for ASCVD and coronary events,” he said. Group 1 patients had a 43% greater risk for ASCVD and 68% greater risk for CHD, respectively, compared with a 16% and 30% greater risk for group 2, and 20% and 27% greater risk for group 3.
“Our findings indicate that these easily measurable nontraditional risk markers can help identify those at an elevated long-term CVD risk and may be useful for informing CVD prevention strategies among asymptomatic individuals,” Dr. Mehta said.
Dr. Mehta had no financial relationships to disclose.
SOURCE: Mehta A et al. AHA scientific sessions, Abstract AT.AOS.03 119.
CHICAGO – Individuals with both elevated lipoprotein(a) levels and a family history of coronary heart disease are at a considerably higher long-term risk of atherosclerotic cardiovascular disease and coronary heart disease events than those with one risk factor alone, according to results from a large clinical study presented at the American Heart Association scientific sessions.
“Elevated lipoprotein(a) levels or a positive family history of coronary heart disease each is independently associated with cardiovascular disease risk,” said Anurag Mehta, MD, of Emory University School of Medicine, Atlanta. “This study showed that the presence of both an elevated Lp(a) level and a positive family history has an additive joint association with long-term cardiovascular risk.”
Dr. Mehta reported on an analysis of 12,149 individuals participating in the Atherosclerosis Risk in Communities (ARIC) study. All study participants were free of cardiovascular disease at the time of enrollment. The researchers measured Lp(a) levels and ascertained family history by self-report. Forty-four percent of the study participants had a family history of coronary heart disease (CHD), and 23% were black.
Median follow-up of study participants was 21 years, over which time 3,114 atherosclerotic cardiovascular disease (ASCVD) and 2,283 CHD events occurred.
Black participants had a significantly higher average plasma Lp(a) concentration than white persons, at 16.7 mg/dL vs. 5.7 mg/dL. However, plasma Lp(a) levels between participants with either a positive or a negative family history of CHD were similar on average, 7.6 mg/dL and 7.8 mg/dL, respectively.
The study pooled black and white ARIC participants by race-specific Lp(a) levels (quintiles) and stratified them into four different groups: 1. positive family history and an elevated race-specific Lp(a) level (quintile 5); 2. positive family history and nonelevated race-specific Lp(a) level (quintiles 1-4); 3. negative family history and elevated race-specific Lp(a) level; and 4. negative family history and nonelevated race-specific Lp(a) level. “There was an increase in the proportion of participants with a family history of CHD across race-specific Lp(a) quintiles, highlighting the fact that family history is associated with race-specific Lp(a) levels,” Dr. Mehta said.
“We observed that the ASCVD incidence was higher among participants with an elevated Lp(a) level or a family history of CHD as compared with participants with nonelevated Lp(a) levels and no family history,” Dr. Mehta said. “The highest ASCVD incidence was noted among participants with an elevated Lp(a) level as well as a positive family history.” Among those patients, the cumulative incidence of ASCVD events was nearly 25%, compared with 22% for those with a positive family history and nonelevated Lp(a) levels (group 2) or those with a negative family history but elevated Lp(a) levels (group 3), and 18% for those with negative family history and nonelevated Lp(a) levels.
Results for the cumulative incidence of coronary events trended similarly, Dr. Mehta noted: around 22% for group 1, 19% for group 2, 17% for group 3, and 14% for group 4.
“Having an elevated Lp(a) level as well as a family history of CHD was associated with a higher adjusted hazard for ASCVD and coronary events,” he said. Group 1 patients had a 43% greater risk for ASCVD and 68% greater risk for CHD, respectively, compared with a 16% and 30% greater risk for group 2, and 20% and 27% greater risk for group 3.
“Our findings indicate that these easily measurable nontraditional risk markers can help identify those at an elevated long-term CVD risk and may be useful for informing CVD prevention strategies among asymptomatic individuals,” Dr. Mehta said.
Dr. Mehta had no financial relationships to disclose.
SOURCE: Mehta A et al. AHA scientific sessions, Abstract AT.AOS.03 119.
CHICAGO – Individuals with both elevated lipoprotein(a) levels and a family history of coronary heart disease are at a considerably higher long-term risk of atherosclerotic cardiovascular disease and coronary heart disease events than those with one risk factor alone, according to results from a large clinical study presented at the American Heart Association scientific sessions.
“Elevated lipoprotein(a) levels or a positive family history of coronary heart disease each is independently associated with cardiovascular disease risk,” said Anurag Mehta, MD, of Emory University School of Medicine, Atlanta. “This study showed that the presence of both an elevated Lp(a) level and a positive family history has an additive joint association with long-term cardiovascular risk.”
Dr. Mehta reported on an analysis of 12,149 individuals participating in the Atherosclerosis Risk in Communities (ARIC) study. All study participants were free of cardiovascular disease at the time of enrollment. The researchers measured Lp(a) levels and ascertained family history by self-report. Forty-four percent of the study participants had a family history of coronary heart disease (CHD), and 23% were black.
Median follow-up of study participants was 21 years, over which time 3,114 atherosclerotic cardiovascular disease (ASCVD) and 2,283 CHD events occurred.
Black participants had a significantly higher average plasma Lp(a) concentration than white persons, at 16.7 mg/dL vs. 5.7 mg/dL. However, plasma Lp(a) levels between participants with either a positive or a negative family history of CHD were similar on average, 7.6 mg/dL and 7.8 mg/dL, respectively.
The study pooled black and white ARIC participants by race-specific Lp(a) levels (quintiles) and stratified them into four different groups: 1. positive family history and an elevated race-specific Lp(a) level (quintile 5); 2. positive family history and nonelevated race-specific Lp(a) level (quintiles 1-4); 3. negative family history and elevated race-specific Lp(a) level; and 4. negative family history and nonelevated race-specific Lp(a) level. “There was an increase in the proportion of participants with a family history of CHD across race-specific Lp(a) quintiles, highlighting the fact that family history is associated with race-specific Lp(a) levels,” Dr. Mehta said.
“We observed that the ASCVD incidence was higher among participants with an elevated Lp(a) level or a family history of CHD as compared with participants with nonelevated Lp(a) levels and no family history,” Dr. Mehta said. “The highest ASCVD incidence was noted among participants with an elevated Lp(a) level as well as a positive family history.” Among those patients, the cumulative incidence of ASCVD events was nearly 25%, compared with 22% for those with a positive family history and nonelevated Lp(a) levels (group 2) or those with a negative family history but elevated Lp(a) levels (group 3), and 18% for those with negative family history and nonelevated Lp(a) levels.
Results for the cumulative incidence of coronary events trended similarly, Dr. Mehta noted: around 22% for group 1, 19% for group 2, 17% for group 3, and 14% for group 4.
“Having an elevated Lp(a) level as well as a family history of CHD was associated with a higher adjusted hazard for ASCVD and coronary events,” he said. Group 1 patients had a 43% greater risk for ASCVD and 68% greater risk for CHD, respectively, compared with a 16% and 30% greater risk for group 2, and 20% and 27% greater risk for group 3.
“Our findings indicate that these easily measurable nontraditional risk markers can help identify those at an elevated long-term CVD risk and may be useful for informing CVD prevention strategies among asymptomatic individuals,” Dr. Mehta said.
Dr. Mehta had no financial relationships to disclose.
SOURCE: Mehta A et al. AHA scientific sessions, Abstract AT.AOS.03 119.
REPORTING FROM THE AHA SCIENTIFIC SESSIONS
Key clinical point: .
Major finding: Patients with both risk factors had a 68% greater risk for coronary events.
Study details: Analysis of 12,149 asymptomatic participants enrolled in the ARIC study.
Disclosures: Dr. Mehta has no financial relationships to report.
Source: Mehta A et al. AHA scientific sessions, Abstract AT.AOS.03 119.
EARLY: Angiography within 2 hours of acute non-ST event cut recurrent ischemic events
CHICAGO – Coronary angiography within 2 hours of a diagnosis of non–ST-segment elevation acute coronary syndrome (NSTE-ACS) significantly reduced the risk of recurrent ischemic events as compared to angiography delayed for 12 hours or more, based on the results of the EARLY trial presented at the American Heart Association scientific sessions.
EARLY examined the impacts of not pretreating with a P2Y12-ADP antagonist and of delay before coronary angiography; all study participants received the loading dose of a P2Y12-ADP antagonist at the time of intervention. The early group received angiography within 2 hours, and a delayed group received angiography 12 or more hours after NSTE-ACS.
“Regarding the primary endpoint at 30 days, which is a composite of cardiovascular death and recurrent ischemic event, there is a fivefold lower rate of MACE [major adverse cardiovascular events] in the very-early [group as] compared to the control group,” said Laurent Bonello, MD, PhD, of University Hospital North in Marseilles, France.
The MACE rate was 4.4% in the early group and 21.3% in the delayed group. However, the reduction in MACE was largely because of a reduction in recurrent ischemic events; death rates were similar in the two groups.
The EARLY trial randomized 740 patients at 16 hospitals in France with NSTE-ACS to one of two timing strategies for intervention: within 2 hours of diagnosis, the early-intervention group, and between 12 and 72 hours after diagnosis, the delayed group. Intermediate- and high-risk patients did not receive pretreatment with a P2Y12-ADP antagonist such as clopidogrel before angiography; they received the loading dose at the time of the intervention.
On average, angiography was done within 1 hour in the early group and at 18 hours in the delayed group. Percutaneous coronary intervention (PCI) was performed on 75% of the study population; 3% underwent coronary artery bypass grafting; and 20% received medical therapy.
Dr. Bonello said the purpose of the trial was to settle some uncertainties over the management of NSTE-ACS patients regarding the benefit of pretreatment with P2Y12-ADP antagonists – namely, to evaluate the impact of the lack of pretreatment on the optimal timing of the intervention. “There are no randomized clinical trials available on this specific group of non-ST elevation acute coronary syndrome patients not pretreated for the timing of the invasive strategy,” he said.
Both groups had similar baseline characteristics, such as history of MI, PCI, and aspirin and P2Y12-ADP use, although the delayed group had a higher rate of diabetes (35% vs. 28.3%).
Regarding secondary endpoints, rates of recurrent ischemic events were 2.9% for the early group and 19.8% for the delayed group during hospitalization, and 4.1% vs. 20.7% at 30 days.
Dr. Bonello noted that rates of cardiovascular death were similar for both groups: 0.3% and 0.8% in-hospital deaths, and 0.6% and 1.1% deaths at 30 days.
The disparity in MACE between all subgroups paralleled that of the overall results with two exceptions, Dr. Bonello said: The positive effect of early intervention was less pronounced in women, and there were no differences in MACE rates among those who had interventions other than PCI.
In his discussion of the trial, Gilles Montalescot, MD, PhD, of the Institute of Cardiology at Pitié-Salpêtrière Hospital in Paris, said the EARLY trial with no P2Y12-ADP pretreatment confirms findings of studies before the ACCOAST trial (N Engl J Med. 2013;369:999-1010), that early angiography has no benefit on survival, recurrent MI, revascularization, or bleeding. While the ACCOAST trial, of which Dr. Montalescot was a principal investigator, found no benefit of pretreatment with prasugrel in patients with NTSE-ASC, the EARLY trial extends those findings to other P2Y12-ADP antagonists. “With the immediate angiography strategy, there is a trivial benefit on recurrent ischemia and length of stay, like in the previous studies, thus not related to pretreatment,” he said.
Dr. Montalescot cautioned against embracing this early-intervention strategy with no P2Y12-ADP pretreatment in all situations.
“If you have a conservative strategy for managing the NTSE-ASC patient or if you are in a center far away from a cath lab and your patients have to wait days for a test, yes, you should consider administration of the P2Y12-ADP antagonist,” Dr. Montalescot said.
Dr. Montalescot disclosed receiving grants or honoraria from ADIR, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Beth Israel Deaconess Medical, and Action Coeur Academic Research Organization.
Dr. Bonello reported financial relationships with AstraZeneca, Boston Scientific, Abbott, and Biotronik. The EARLY trial received funding from the French Ministry of Health.
SOURCE: Bonello B et al. AHA scientific sessions, Session LBS.04 19343.
CHICAGO – Coronary angiography within 2 hours of a diagnosis of non–ST-segment elevation acute coronary syndrome (NSTE-ACS) significantly reduced the risk of recurrent ischemic events as compared to angiography delayed for 12 hours or more, based on the results of the EARLY trial presented at the American Heart Association scientific sessions.
EARLY examined the impacts of not pretreating with a P2Y12-ADP antagonist and of delay before coronary angiography; all study participants received the loading dose of a P2Y12-ADP antagonist at the time of intervention. The early group received angiography within 2 hours, and a delayed group received angiography 12 or more hours after NSTE-ACS.
“Regarding the primary endpoint at 30 days, which is a composite of cardiovascular death and recurrent ischemic event, there is a fivefold lower rate of MACE [major adverse cardiovascular events] in the very-early [group as] compared to the control group,” said Laurent Bonello, MD, PhD, of University Hospital North in Marseilles, France.
The MACE rate was 4.4% in the early group and 21.3% in the delayed group. However, the reduction in MACE was largely because of a reduction in recurrent ischemic events; death rates were similar in the two groups.
The EARLY trial randomized 740 patients at 16 hospitals in France with NSTE-ACS to one of two timing strategies for intervention: within 2 hours of diagnosis, the early-intervention group, and between 12 and 72 hours after diagnosis, the delayed group. Intermediate- and high-risk patients did not receive pretreatment with a P2Y12-ADP antagonist such as clopidogrel before angiography; they received the loading dose at the time of the intervention.
On average, angiography was done within 1 hour in the early group and at 18 hours in the delayed group. Percutaneous coronary intervention (PCI) was performed on 75% of the study population; 3% underwent coronary artery bypass grafting; and 20% received medical therapy.
Dr. Bonello said the purpose of the trial was to settle some uncertainties over the management of NSTE-ACS patients regarding the benefit of pretreatment with P2Y12-ADP antagonists – namely, to evaluate the impact of the lack of pretreatment on the optimal timing of the intervention. “There are no randomized clinical trials available on this specific group of non-ST elevation acute coronary syndrome patients not pretreated for the timing of the invasive strategy,” he said.
Both groups had similar baseline characteristics, such as history of MI, PCI, and aspirin and P2Y12-ADP use, although the delayed group had a higher rate of diabetes (35% vs. 28.3%).
Regarding secondary endpoints, rates of recurrent ischemic events were 2.9% for the early group and 19.8% for the delayed group during hospitalization, and 4.1% vs. 20.7% at 30 days.
Dr. Bonello noted that rates of cardiovascular death were similar for both groups: 0.3% and 0.8% in-hospital deaths, and 0.6% and 1.1% deaths at 30 days.
The disparity in MACE between all subgroups paralleled that of the overall results with two exceptions, Dr. Bonello said: The positive effect of early intervention was less pronounced in women, and there were no differences in MACE rates among those who had interventions other than PCI.
In his discussion of the trial, Gilles Montalescot, MD, PhD, of the Institute of Cardiology at Pitié-Salpêtrière Hospital in Paris, said the EARLY trial with no P2Y12-ADP pretreatment confirms findings of studies before the ACCOAST trial (N Engl J Med. 2013;369:999-1010), that early angiography has no benefit on survival, recurrent MI, revascularization, or bleeding. While the ACCOAST trial, of which Dr. Montalescot was a principal investigator, found no benefit of pretreatment with prasugrel in patients with NTSE-ASC, the EARLY trial extends those findings to other P2Y12-ADP antagonists. “With the immediate angiography strategy, there is a trivial benefit on recurrent ischemia and length of stay, like in the previous studies, thus not related to pretreatment,” he said.
Dr. Montalescot cautioned against embracing this early-intervention strategy with no P2Y12-ADP pretreatment in all situations.
“If you have a conservative strategy for managing the NTSE-ASC patient or if you are in a center far away from a cath lab and your patients have to wait days for a test, yes, you should consider administration of the P2Y12-ADP antagonist,” Dr. Montalescot said.
Dr. Montalescot disclosed receiving grants or honoraria from ADIR, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Beth Israel Deaconess Medical, and Action Coeur Academic Research Organization.
Dr. Bonello reported financial relationships with AstraZeneca, Boston Scientific, Abbott, and Biotronik. The EARLY trial received funding from the French Ministry of Health.
SOURCE: Bonello B et al. AHA scientific sessions, Session LBS.04 19343.
CHICAGO – Coronary angiography within 2 hours of a diagnosis of non–ST-segment elevation acute coronary syndrome (NSTE-ACS) significantly reduced the risk of recurrent ischemic events as compared to angiography delayed for 12 hours or more, based on the results of the EARLY trial presented at the American Heart Association scientific sessions.
EARLY examined the impacts of not pretreating with a P2Y12-ADP antagonist and of delay before coronary angiography; all study participants received the loading dose of a P2Y12-ADP antagonist at the time of intervention. The early group received angiography within 2 hours, and a delayed group received angiography 12 or more hours after NSTE-ACS.
“Regarding the primary endpoint at 30 days, which is a composite of cardiovascular death and recurrent ischemic event, there is a fivefold lower rate of MACE [major adverse cardiovascular events] in the very-early [group as] compared to the control group,” said Laurent Bonello, MD, PhD, of University Hospital North in Marseilles, France.
The MACE rate was 4.4% in the early group and 21.3% in the delayed group. However, the reduction in MACE was largely because of a reduction in recurrent ischemic events; death rates were similar in the two groups.
The EARLY trial randomized 740 patients at 16 hospitals in France with NSTE-ACS to one of two timing strategies for intervention: within 2 hours of diagnosis, the early-intervention group, and between 12 and 72 hours after diagnosis, the delayed group. Intermediate- and high-risk patients did not receive pretreatment with a P2Y12-ADP antagonist such as clopidogrel before angiography; they received the loading dose at the time of the intervention.
On average, angiography was done within 1 hour in the early group and at 18 hours in the delayed group. Percutaneous coronary intervention (PCI) was performed on 75% of the study population; 3% underwent coronary artery bypass grafting; and 20% received medical therapy.
Dr. Bonello said the purpose of the trial was to settle some uncertainties over the management of NSTE-ACS patients regarding the benefit of pretreatment with P2Y12-ADP antagonists – namely, to evaluate the impact of the lack of pretreatment on the optimal timing of the intervention. “There are no randomized clinical trials available on this specific group of non-ST elevation acute coronary syndrome patients not pretreated for the timing of the invasive strategy,” he said.
Both groups had similar baseline characteristics, such as history of MI, PCI, and aspirin and P2Y12-ADP use, although the delayed group had a higher rate of diabetes (35% vs. 28.3%).
Regarding secondary endpoints, rates of recurrent ischemic events were 2.9% for the early group and 19.8% for the delayed group during hospitalization, and 4.1% vs. 20.7% at 30 days.
Dr. Bonello noted that rates of cardiovascular death were similar for both groups: 0.3% and 0.8% in-hospital deaths, and 0.6% and 1.1% deaths at 30 days.
The disparity in MACE between all subgroups paralleled that of the overall results with two exceptions, Dr. Bonello said: The positive effect of early intervention was less pronounced in women, and there were no differences in MACE rates among those who had interventions other than PCI.
In his discussion of the trial, Gilles Montalescot, MD, PhD, of the Institute of Cardiology at Pitié-Salpêtrière Hospital in Paris, said the EARLY trial with no P2Y12-ADP pretreatment confirms findings of studies before the ACCOAST trial (N Engl J Med. 2013;369:999-1010), that early angiography has no benefit on survival, recurrent MI, revascularization, or bleeding. While the ACCOAST trial, of which Dr. Montalescot was a principal investigator, found no benefit of pretreatment with prasugrel in patients with NTSE-ASC, the EARLY trial extends those findings to other P2Y12-ADP antagonists. “With the immediate angiography strategy, there is a trivial benefit on recurrent ischemia and length of stay, like in the previous studies, thus not related to pretreatment,” he said.
Dr. Montalescot cautioned against embracing this early-intervention strategy with no P2Y12-ADP pretreatment in all situations.
“If you have a conservative strategy for managing the NTSE-ASC patient or if you are in a center far away from a cath lab and your patients have to wait days for a test, yes, you should consider administration of the P2Y12-ADP antagonist,” Dr. Montalescot said.
Dr. Montalescot disclosed receiving grants or honoraria from ADIR, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Beth Israel Deaconess Medical, and Action Coeur Academic Research Organization.
Dr. Bonello reported financial relationships with AstraZeneca, Boston Scientific, Abbott, and Biotronik. The EARLY trial received funding from the French Ministry of Health.
SOURCE: Bonello B et al. AHA scientific sessions, Session LBS.04 19343.
REPORTING FROM THE AHA SCIENTIFIC SESSIONS
Key clinical point: Coronary angiography within 2 hours of non–ST-segment elevation acute coronary syndrome yielded improved outcomes.
Major finding: Rates of major cardiovascular events were 4.4% with early intervention and 21.3% with delayed intervention.
Study details: Prospective, multicenter, randomized clinical trial of 709 patients.
Disclosures: Dr. Bonello reported financial relationships with AstraZeneca, Boston Scientific, Abbott, and Biotronik. The trial received funding from the French Ministry of Health.
Source: Bonello B et al. AHA scientific sessions, Session LBS.04 19343.
Impella heart pump may enable 30-minute reperfusion delay
CHICAGO – An investigative heart pump for unloading the left ventricle in patients who had an ST-elevation myocardial infarction (STEMI) yielded similar safety and efficacy outcomes with a 30-minute delay in reperfusion or the standard approach of immediate reperfusion.
That’s according to results of a pilot feasibility trial presented at the American Heart Association scientific sessions.
The trial, titled the DTU (Door to Unload)–STEMI trial, evaluated the Impella CP (Abiomed) device used for unloading the left ventricle (LV). “No prohibitive safety signals that would preclude proceeding to a larger pivotal study of left ventricle unloading and delaying reperfusion for 30 minutes were identified,” said principal investigator Navin Kapur, MD, of Tufts Medical Center.
The trial evaluated 50 patients who received the Impella device in two different groups: one that underwent immediate reperfusion after LV unloading, the other that had a 30-minute delay before reperfusion. The study found no significant difference in major adverse cardiovascular or cerebral events between the two groups (there were two in the delayed group vs. none in the immediate group), and no difference in infarct size increase as a percentage of LV mass at 30 days between the groups, Dr. Kapur said.
Door-to-balloon times averaged 73 minutes in the immediate reperfusion group and 97 minutes in the delayed reperfusion group, with door-to-unload times averaging around 60 minutes in both groups. “We were able to see successful enrollment and distribution across multiple sites and multiple operators, suggesting the feasibility of this approach,” Dr. Kapur said.
He noted “one of the most important messages” of the study was that no patients in either arm required percutaneous coronary intervention. “What this suggests is that, when we look at operator behavior, operators were comfortable with initiating LV unloading and waiting 30 minutes,” Dr. Kapur said.
The primary endpoint of the trial was to determine if delayed reperfusion led to an increase in infarct size. “We did not see that,” he noted. “And among patients with an anterior ST-segment elevation sum in leads V1-V4 of more than 6 mm Hg, infarct size normalized to the area at risk was significantly lower with 30 minutes of LV unloading before reperfusion, compared to LV unloading with immediate reperfusion.”
The next step is to initiate a pivotal trial of the device, Dr. Kapur said. “The findings from the DTU-STEMI pilot trial will inform the pivotal trial based on preclinical data showing that LV unloading attenuates myocardial ischemia and also preconditions the myocardium to allow it to be more receptive to reperfusion with a reduction in reperfusion injury,” he said. The pivotal trial will have two similar arms: one using the standard of care of immediate reperfusion and the other utilizing the 30-minute delay.
In his discussion of the DTU-STEMI trial, Holger Thiele, MD, of the Leipzig (Germany) Heart Institute and the University of Leipzig, expressed concern with the lack of a standard-of-care group in the trial. “Thus, the primary efficacy endpoint on infarct size cannot be reliably compared,” he said. “Based on the small sample size, there’s no reliable information on safety.”
Dr. Kapur reported financial relationships with Abiomed, Boston Scientific, Abbott, Medtronic, and MD Start. Dr. Thiele had no financial disclosures.
SOURCE: Kapur NK et al. AHA scientific sessions, LBCT-19578
CHICAGO – An investigative heart pump for unloading the left ventricle in patients who had an ST-elevation myocardial infarction (STEMI) yielded similar safety and efficacy outcomes with a 30-minute delay in reperfusion or the standard approach of immediate reperfusion.
That’s according to results of a pilot feasibility trial presented at the American Heart Association scientific sessions.
The trial, titled the DTU (Door to Unload)–STEMI trial, evaluated the Impella CP (Abiomed) device used for unloading the left ventricle (LV). “No prohibitive safety signals that would preclude proceeding to a larger pivotal study of left ventricle unloading and delaying reperfusion for 30 minutes were identified,” said principal investigator Navin Kapur, MD, of Tufts Medical Center.
The trial evaluated 50 patients who received the Impella device in two different groups: one that underwent immediate reperfusion after LV unloading, the other that had a 30-minute delay before reperfusion. The study found no significant difference in major adverse cardiovascular or cerebral events between the two groups (there were two in the delayed group vs. none in the immediate group), and no difference in infarct size increase as a percentage of LV mass at 30 days between the groups, Dr. Kapur said.
Door-to-balloon times averaged 73 minutes in the immediate reperfusion group and 97 minutes in the delayed reperfusion group, with door-to-unload times averaging around 60 minutes in both groups. “We were able to see successful enrollment and distribution across multiple sites and multiple operators, suggesting the feasibility of this approach,” Dr. Kapur said.
He noted “one of the most important messages” of the study was that no patients in either arm required percutaneous coronary intervention. “What this suggests is that, when we look at operator behavior, operators were comfortable with initiating LV unloading and waiting 30 minutes,” Dr. Kapur said.
The primary endpoint of the trial was to determine if delayed reperfusion led to an increase in infarct size. “We did not see that,” he noted. “And among patients with an anterior ST-segment elevation sum in leads V1-V4 of more than 6 mm Hg, infarct size normalized to the area at risk was significantly lower with 30 minutes of LV unloading before reperfusion, compared to LV unloading with immediate reperfusion.”
The next step is to initiate a pivotal trial of the device, Dr. Kapur said. “The findings from the DTU-STEMI pilot trial will inform the pivotal trial based on preclinical data showing that LV unloading attenuates myocardial ischemia and also preconditions the myocardium to allow it to be more receptive to reperfusion with a reduction in reperfusion injury,” he said. The pivotal trial will have two similar arms: one using the standard of care of immediate reperfusion and the other utilizing the 30-minute delay.
In his discussion of the DTU-STEMI trial, Holger Thiele, MD, of the Leipzig (Germany) Heart Institute and the University of Leipzig, expressed concern with the lack of a standard-of-care group in the trial. “Thus, the primary efficacy endpoint on infarct size cannot be reliably compared,” he said. “Based on the small sample size, there’s no reliable information on safety.”
Dr. Kapur reported financial relationships with Abiomed, Boston Scientific, Abbott, Medtronic, and MD Start. Dr. Thiele had no financial disclosures.
SOURCE: Kapur NK et al. AHA scientific sessions, LBCT-19578
CHICAGO – An investigative heart pump for unloading the left ventricle in patients who had an ST-elevation myocardial infarction (STEMI) yielded similar safety and efficacy outcomes with a 30-minute delay in reperfusion or the standard approach of immediate reperfusion.
That’s according to results of a pilot feasibility trial presented at the American Heart Association scientific sessions.
The trial, titled the DTU (Door to Unload)–STEMI trial, evaluated the Impella CP (Abiomed) device used for unloading the left ventricle (LV). “No prohibitive safety signals that would preclude proceeding to a larger pivotal study of left ventricle unloading and delaying reperfusion for 30 minutes were identified,” said principal investigator Navin Kapur, MD, of Tufts Medical Center.
The trial evaluated 50 patients who received the Impella device in two different groups: one that underwent immediate reperfusion after LV unloading, the other that had a 30-minute delay before reperfusion. The study found no significant difference in major adverse cardiovascular or cerebral events between the two groups (there were two in the delayed group vs. none in the immediate group), and no difference in infarct size increase as a percentage of LV mass at 30 days between the groups, Dr. Kapur said.
Door-to-balloon times averaged 73 minutes in the immediate reperfusion group and 97 minutes in the delayed reperfusion group, with door-to-unload times averaging around 60 minutes in both groups. “We were able to see successful enrollment and distribution across multiple sites and multiple operators, suggesting the feasibility of this approach,” Dr. Kapur said.
He noted “one of the most important messages” of the study was that no patients in either arm required percutaneous coronary intervention. “What this suggests is that, when we look at operator behavior, operators were comfortable with initiating LV unloading and waiting 30 minutes,” Dr. Kapur said.
The primary endpoint of the trial was to determine if delayed reperfusion led to an increase in infarct size. “We did not see that,” he noted. “And among patients with an anterior ST-segment elevation sum in leads V1-V4 of more than 6 mm Hg, infarct size normalized to the area at risk was significantly lower with 30 minutes of LV unloading before reperfusion, compared to LV unloading with immediate reperfusion.”
The next step is to initiate a pivotal trial of the device, Dr. Kapur said. “The findings from the DTU-STEMI pilot trial will inform the pivotal trial based on preclinical data showing that LV unloading attenuates myocardial ischemia and also preconditions the myocardium to allow it to be more receptive to reperfusion with a reduction in reperfusion injury,” he said. The pivotal trial will have two similar arms: one using the standard of care of immediate reperfusion and the other utilizing the 30-minute delay.
In his discussion of the DTU-STEMI trial, Holger Thiele, MD, of the Leipzig (Germany) Heart Institute and the University of Leipzig, expressed concern with the lack of a standard-of-care group in the trial. “Thus, the primary efficacy endpoint on infarct size cannot be reliably compared,” he said. “Based on the small sample size, there’s no reliable information on safety.”
Dr. Kapur reported financial relationships with Abiomed, Boston Scientific, Abbott, Medtronic, and MD Start. Dr. Thiele had no financial disclosures.
SOURCE: Kapur NK et al. AHA scientific sessions, LBCT-19578
REPORTING FROM AHA SCIENTIFIC SESSIONS
Key clinical point:
Major finding: Door-to-balloon times averaged 73 minutes in the immediate reperfusion group and 97 minutes in the delayed reperfusion group.
Study details: A phase 1, randomized, exploratory safety and feasibility trial in 50 patients with anterior STEMI to left ventricle unloading using the Impella CP followed by immediate reperfusion versus delayed reperfusion after 30 minutes of unloading.
Disclosures: Dr. Kapur reported financial relationships with Abiomed, Boston Scientific, Abbott, Medtronic and MD Start/Precardia.
Source: Kapur NK et al. AHA scientific sessions, LBCT-19578.
Is prehospital cooling in cardiac arrest ready for prime time?
CHICAGO – Starting transnasal evaporative cooling before patients in cardiac arrest arrive at the hospital has been found to be safe, according to study results presented at the American Heart Association scientific sessions.
The European trial didn’t determine any benefit in the out-of-hospital approach, compared with in-hospital cooling across all study patients. But it did suggest that patients with ventricular fibrillation may achieve higher rates of complete neurologic recovery with the prehospital cooling approach.
“Transnasal evaporative cooling in out-of-hospital cardiac arrest is hemodynamically safe,” said Per Nordberg, MD, PhD, of Karolinska Institute in Stockholm, reporting for the Prehospital Resuscitation Intra-arrest Cooling Effectiveness Survival Study (PRINCESS). “I think this an important message, because guidelines state at the moment that you shouldn’t cool patients outside the hospital. We have shown that this is possible with this new method.”
Transnasal evaporative cooling (RhinoChill) is a noninvasive method that involves cooling of the brain and provides continuous cooling without volume loading.
Centers in seven European countries participated in the trial, randomizing 677 patients to the transnasal, early cooling protocol or standard in-hospital hypothermia. The final analysis evaluated 671 patients: 337 in the intervention group and 334 in the control group. In the intervention group, the transnasal cooling technique was started on patients during CPR in their homes or in the ambulance.
The study found that the rate of 90-day survival with good neurological outcome was 16.6% in the intervention group, compared with 13.5% in the control group, a nonsignificant difference (P = .26).
“However, we could see a signal or a clinical trend toward an improved neurologic outcome in patients with ventricular fibrillation,” Dr. Nordberg said: 34.8% vs. 25.9% for the intervention vs. control populations, a relative, nonsignificant difference of 25% (P = .11).
In terms of complete neurologic recovery, the differences between the treatment groups among those with ventricular fibrillation were even more profound, and significant: 32.6% vs. 20% (P = .002).
Rates of cardiovascular complications – ventricular fibrillation, cardiogenic shock, pulmonary edema, and need for vasopressor – were similar between both groups, although the intervention group had low rates of nasal-related problems such as nose bleed and white nose tip that the control group didn’t have.
Transnasal evaporative cooling “could significantly shorten the time to the target temperature; we have shown that in previous safety feasibility trials,” Dr. Nordberg said. “Now, we can confirm that this method is effective to cool patients with cardiac arrest outside the hospital.”
In his discussion of the trial, Christopher B. Granger, MD, of Duke University, Durham, N.C., noted that the trial was well conducted and that it confirmed that patients can be rapidly cooled during or immediately after cardiac arrest. “But we still do not know if this has meaningful improvement in clinical outcomes,” he cautioned. A strength of the trial is its size, particularly “in a very challenging setting,” Dr. Granger added.
But he questioned the potential for neurological benefit in patients with ventricular fibrillation, particularly because the finding conflicts with a previously published trial (Crit Care Med. 2009 Dec;37[12]:3062-9). “With the primary outcome not significantly reduced, the subgroup analysis may not be reliable,” he said.
What’s needed next? “This trial provides some suggestion of the benefit of early rapid cooling in the ventricular fibrillation population,” Dr. Granger said, “but another trial is needed to justify a widespread change in practice.”
He reported receiving funding from the Swedish Heart-Lung Foundation. The makers of RhinoChill provided the cooling device used in the study at no cost to the participating sites.
Dr. Granger reported financial relationships with AbbVie, Armetheon, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Daiichi Sankyo, Duke Clinical Research Institute, Gilead Sciences, GlaxoSmithKline, Janssen Pharmaceuticals, Medtronic and the Medtronic Foundation, Merck, National Institutes of Health, Novartis, Pfizer, Rho Pharmaceuticals, Sirtex, and Verseon.
SOURCE: Nordberg P et al. Abstract 2018-LBCT-18598-AHA.
CHICAGO – Starting transnasal evaporative cooling before patients in cardiac arrest arrive at the hospital has been found to be safe, according to study results presented at the American Heart Association scientific sessions.
The European trial didn’t determine any benefit in the out-of-hospital approach, compared with in-hospital cooling across all study patients. But it did suggest that patients with ventricular fibrillation may achieve higher rates of complete neurologic recovery with the prehospital cooling approach.
“Transnasal evaporative cooling in out-of-hospital cardiac arrest is hemodynamically safe,” said Per Nordberg, MD, PhD, of Karolinska Institute in Stockholm, reporting for the Prehospital Resuscitation Intra-arrest Cooling Effectiveness Survival Study (PRINCESS). “I think this an important message, because guidelines state at the moment that you shouldn’t cool patients outside the hospital. We have shown that this is possible with this new method.”
Transnasal evaporative cooling (RhinoChill) is a noninvasive method that involves cooling of the brain and provides continuous cooling without volume loading.
Centers in seven European countries participated in the trial, randomizing 677 patients to the transnasal, early cooling protocol or standard in-hospital hypothermia. The final analysis evaluated 671 patients: 337 in the intervention group and 334 in the control group. In the intervention group, the transnasal cooling technique was started on patients during CPR in their homes or in the ambulance.
The study found that the rate of 90-day survival with good neurological outcome was 16.6% in the intervention group, compared with 13.5% in the control group, a nonsignificant difference (P = .26).
“However, we could see a signal or a clinical trend toward an improved neurologic outcome in patients with ventricular fibrillation,” Dr. Nordberg said: 34.8% vs. 25.9% for the intervention vs. control populations, a relative, nonsignificant difference of 25% (P = .11).
In terms of complete neurologic recovery, the differences between the treatment groups among those with ventricular fibrillation were even more profound, and significant: 32.6% vs. 20% (P = .002).
Rates of cardiovascular complications – ventricular fibrillation, cardiogenic shock, pulmonary edema, and need for vasopressor – were similar between both groups, although the intervention group had low rates of nasal-related problems such as nose bleed and white nose tip that the control group didn’t have.
Transnasal evaporative cooling “could significantly shorten the time to the target temperature; we have shown that in previous safety feasibility trials,” Dr. Nordberg said. “Now, we can confirm that this method is effective to cool patients with cardiac arrest outside the hospital.”
In his discussion of the trial, Christopher B. Granger, MD, of Duke University, Durham, N.C., noted that the trial was well conducted and that it confirmed that patients can be rapidly cooled during or immediately after cardiac arrest. “But we still do not know if this has meaningful improvement in clinical outcomes,” he cautioned. A strength of the trial is its size, particularly “in a very challenging setting,” Dr. Granger added.
But he questioned the potential for neurological benefit in patients with ventricular fibrillation, particularly because the finding conflicts with a previously published trial (Crit Care Med. 2009 Dec;37[12]:3062-9). “With the primary outcome not significantly reduced, the subgroup analysis may not be reliable,” he said.
What’s needed next? “This trial provides some suggestion of the benefit of early rapid cooling in the ventricular fibrillation population,” Dr. Granger said, “but another trial is needed to justify a widespread change in practice.”
He reported receiving funding from the Swedish Heart-Lung Foundation. The makers of RhinoChill provided the cooling device used in the study at no cost to the participating sites.
Dr. Granger reported financial relationships with AbbVie, Armetheon, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Daiichi Sankyo, Duke Clinical Research Institute, Gilead Sciences, GlaxoSmithKline, Janssen Pharmaceuticals, Medtronic and the Medtronic Foundation, Merck, National Institutes of Health, Novartis, Pfizer, Rho Pharmaceuticals, Sirtex, and Verseon.
SOURCE: Nordberg P et al. Abstract 2018-LBCT-18598-AHA.
CHICAGO – Starting transnasal evaporative cooling before patients in cardiac arrest arrive at the hospital has been found to be safe, according to study results presented at the American Heart Association scientific sessions.
The European trial didn’t determine any benefit in the out-of-hospital approach, compared with in-hospital cooling across all study patients. But it did suggest that patients with ventricular fibrillation may achieve higher rates of complete neurologic recovery with the prehospital cooling approach.
“Transnasal evaporative cooling in out-of-hospital cardiac arrest is hemodynamically safe,” said Per Nordberg, MD, PhD, of Karolinska Institute in Stockholm, reporting for the Prehospital Resuscitation Intra-arrest Cooling Effectiveness Survival Study (PRINCESS). “I think this an important message, because guidelines state at the moment that you shouldn’t cool patients outside the hospital. We have shown that this is possible with this new method.”
Transnasal evaporative cooling (RhinoChill) is a noninvasive method that involves cooling of the brain and provides continuous cooling without volume loading.
Centers in seven European countries participated in the trial, randomizing 677 patients to the transnasal, early cooling protocol or standard in-hospital hypothermia. The final analysis evaluated 671 patients: 337 in the intervention group and 334 in the control group. In the intervention group, the transnasal cooling technique was started on patients during CPR in their homes or in the ambulance.
The study found that the rate of 90-day survival with good neurological outcome was 16.6% in the intervention group, compared with 13.5% in the control group, a nonsignificant difference (P = .26).
“However, we could see a signal or a clinical trend toward an improved neurologic outcome in patients with ventricular fibrillation,” Dr. Nordberg said: 34.8% vs. 25.9% for the intervention vs. control populations, a relative, nonsignificant difference of 25% (P = .11).
In terms of complete neurologic recovery, the differences between the treatment groups among those with ventricular fibrillation were even more profound, and significant: 32.6% vs. 20% (P = .002).
Rates of cardiovascular complications – ventricular fibrillation, cardiogenic shock, pulmonary edema, and need for vasopressor – were similar between both groups, although the intervention group had low rates of nasal-related problems such as nose bleed and white nose tip that the control group didn’t have.
Transnasal evaporative cooling “could significantly shorten the time to the target temperature; we have shown that in previous safety feasibility trials,” Dr. Nordberg said. “Now, we can confirm that this method is effective to cool patients with cardiac arrest outside the hospital.”
In his discussion of the trial, Christopher B. Granger, MD, of Duke University, Durham, N.C., noted that the trial was well conducted and that it confirmed that patients can be rapidly cooled during or immediately after cardiac arrest. “But we still do not know if this has meaningful improvement in clinical outcomes,” he cautioned. A strength of the trial is its size, particularly “in a very challenging setting,” Dr. Granger added.
But he questioned the potential for neurological benefit in patients with ventricular fibrillation, particularly because the finding conflicts with a previously published trial (Crit Care Med. 2009 Dec;37[12]:3062-9). “With the primary outcome not significantly reduced, the subgroup analysis may not be reliable,” he said.
What’s needed next? “This trial provides some suggestion of the benefit of early rapid cooling in the ventricular fibrillation population,” Dr. Granger said, “but another trial is needed to justify a widespread change in practice.”
He reported receiving funding from the Swedish Heart-Lung Foundation. The makers of RhinoChill provided the cooling device used in the study at no cost to the participating sites.
Dr. Granger reported financial relationships with AbbVie, Armetheon, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Daiichi Sankyo, Duke Clinical Research Institute, Gilead Sciences, GlaxoSmithKline, Janssen Pharmaceuticals, Medtronic and the Medtronic Foundation, Merck, National Institutes of Health, Novartis, Pfizer, Rho Pharmaceuticals, Sirtex, and Verseon.
SOURCE: Nordberg P et al. Abstract 2018-LBCT-18598-AHA.
REPORTING FROM THE AHA SCIENTIFIC SESSIONS
Key clinical point: Prehospital hypothermia therapy for cardiac arrest patients is safe.
Major finding: Ninety-day survival was 16.6% in the intervention group vs. 13.5% in controls (P = .26).
Study details: A randomized clinical trial of 677 patients who had cardiac arrest outside the hospital.
Disclosures: Dr. Nordberg receives funding from the Swedish Heart-Lung Foundation. The makers of RhinoChill provided the cooling device used in the study at no cost to the participating sites.
Source: Nordberg P et al. Abstract 2018-LBCT-18598-AHA.
REDUCE-IT: Fish-derived agent cut CV events 25%
CHICAGO – Detailed results of the REDUCE-IT trial have confirmed earlier-reported top line results that showed a 25% reduction in the risk of cardiovascular death or nonfatal cardiovascular event with the fish-derived, triglyceride-reducing agent icosapent acid in combination with statin.
But they should not be interpreted as validation of the cardiovascular benefits of fish-oil supplements, according to Deepak L. Bhatt, MD, principal investigator and steering committee chair for REDUCE-IT, who presented the results at the American Heart Association scientific sessions.
He reported the results from 8,179 patients followed for a median of 4.9 years. The treatment group received 4 g/day of icosapent ethyl (Vascepa, Amarin), a single-molecule agent consisting of the omega-3 acid known as eicosapentaeonoic acid (EPA) in ethyl-ester form, which Dr. Bhatt called “a highly purified” formulation. Vascepa is derived from fish but it is not fish oil, a company press release states. Amarin, sponsor of the study, released top line results in September.
To qualify for the trial, patients had to have a diagnosis of cardiovascular disease or diabetes and other risk factors, had been on statin therapy and had above normal triglyceride (135-499 mg/dL) and optimal LDL (41-100 mg/dL) levels. Patients were randomly assigned to receive 4 g/day of icosapent ethyl or placebo.
Dr. Bhatt stressed that the REDUCE-IT results do not necessarily validate the use of fish oil to lower cardiovascular risk. “It would be mistake if patients and physicians” to interpret the results that way, and that classifying the purified formulation of icosapent ethyl used in REDUCE-IT as fish oil is a “misnomer.” He added, “Really, what we’re talking about is prescription therapy icosapent ethyl vs. over-the-counter supplements.” Icosapent ethyl is approved in the United States for patients with triglyceride levels of more than 500 mg/dL.
Dr. Bhatt and the study coauthors acknowledged that the results of REDUCE-IT deviate from other trials of triglyceride-lowering agents, including other n-3 fatty acids. They noted two potential explanations: a high dose; or higher ratios of EPA to docosahexaenoic acid in the REDUCE-IT formulation vs. agents used in the other studies. For example, the ASCEND study, presented at the European Society of Cardiology in September, reported no cardiovascular benefit from a 1-g/day dose of omega-3 fatty acids and low-dose aspirin in patients with diabetes.
The primary endpoint of REDUCE-IT was a composite of cardiovascular death, nonfatal MI or stroke, coronary revascularization or unstable angina, which occurred in 17.2% of the patients taking icosapent ethyl, compared with 22% of the controls, for a risk reduction of 25% (P less than .001). The key secondary endpoint was composite of cardiovascular death and nonfatal MI or stroke, which occurred in 11.2% and 14.8% of the treated and placebo groups, respectively, for a risk reduction of 26% (P less than .001).
The study investigators also zeroed in on specific ischemic endpoints. Cardiovascular death rates were 20% lower in the treated patients (4.2% vs. 5.2%, P less than .03).
The study also evaluated lipid levels. The median change in triglyceride levels after a year of treatment was a decrease of 18.3%, or 39 mg/dL, in the treatment group while triglyceride levels rose 2.2% in the placebo patients (P less than .001). LDL levels increased in the treated patients by 3.1%, or 2 mg/dL (median) vs. 10.2%, or 7 mg/dL, in controls (P less than .001).
The trial also reported a 33% greater risk of hospitalization for atrial fibrillation or flutter and about a 30% heightened risk of serious bleeding among patients taking icosapent ethyl. Dr. Bhatt pointed out that, while the high rate of atrial fibrillation among treated patients was statistically significant, “the most feared complication of atrial fibrillation is stroke, but in this study we saw a 28% reduction in stroke.”
Likewise the nonsignificantly higher rate of bleeding in the treatment group was inconsequential. “When we looked at specific types of serious bleeding – GI or stomach bleeding, CNS or bleeding into the brain or fatal bleeding – there were no significant differences,” he said.
Discussant Carl Orringer, MD, of the University of Miami, said, “My perspective of this is that the likelihood of atrial fibrillation, although statistically higher, is something that should not prevent physicians from prescribing the drug because of the tremendous benefit that we’ve seen in those appropriate patients on high intensity statin.” However, he said, it does merit further investigation. He also pointed out that one limitation of the study was that the population was 90% white. “Thus the potential benefits of icosapent ethyl in patients of other ethnicities remains unclear,” he said.
The results were published simultaneously online in the New England Journal of Medicine.
Dr. Bhatt receives funding from Amarin, which sponsored the REDUCE-IT trial.
SOURCE: Bhatt DL, et al. N Engl J Med. 2018 Nov 10; doi: 10.1056/NEJMoa181279.
CHICAGO – Detailed results of the REDUCE-IT trial have confirmed earlier-reported top line results that showed a 25% reduction in the risk of cardiovascular death or nonfatal cardiovascular event with the fish-derived, triglyceride-reducing agent icosapent acid in combination with statin.
But they should not be interpreted as validation of the cardiovascular benefits of fish-oil supplements, according to Deepak L. Bhatt, MD, principal investigator and steering committee chair for REDUCE-IT, who presented the results at the American Heart Association scientific sessions.
He reported the results from 8,179 patients followed for a median of 4.9 years. The treatment group received 4 g/day of icosapent ethyl (Vascepa, Amarin), a single-molecule agent consisting of the omega-3 acid known as eicosapentaeonoic acid (EPA) in ethyl-ester form, which Dr. Bhatt called “a highly purified” formulation. Vascepa is derived from fish but it is not fish oil, a company press release states. Amarin, sponsor of the study, released top line results in September.
To qualify for the trial, patients had to have a diagnosis of cardiovascular disease or diabetes and other risk factors, had been on statin therapy and had above normal triglyceride (135-499 mg/dL) and optimal LDL (41-100 mg/dL) levels. Patients were randomly assigned to receive 4 g/day of icosapent ethyl or placebo.
Dr. Bhatt stressed that the REDUCE-IT results do not necessarily validate the use of fish oil to lower cardiovascular risk. “It would be mistake if patients and physicians” to interpret the results that way, and that classifying the purified formulation of icosapent ethyl used in REDUCE-IT as fish oil is a “misnomer.” He added, “Really, what we’re talking about is prescription therapy icosapent ethyl vs. over-the-counter supplements.” Icosapent ethyl is approved in the United States for patients with triglyceride levels of more than 500 mg/dL.
Dr. Bhatt and the study coauthors acknowledged that the results of REDUCE-IT deviate from other trials of triglyceride-lowering agents, including other n-3 fatty acids. They noted two potential explanations: a high dose; or higher ratios of EPA to docosahexaenoic acid in the REDUCE-IT formulation vs. agents used in the other studies. For example, the ASCEND study, presented at the European Society of Cardiology in September, reported no cardiovascular benefit from a 1-g/day dose of omega-3 fatty acids and low-dose aspirin in patients with diabetes.
The primary endpoint of REDUCE-IT was a composite of cardiovascular death, nonfatal MI or stroke, coronary revascularization or unstable angina, which occurred in 17.2% of the patients taking icosapent ethyl, compared with 22% of the controls, for a risk reduction of 25% (P less than .001). The key secondary endpoint was composite of cardiovascular death and nonfatal MI or stroke, which occurred in 11.2% and 14.8% of the treated and placebo groups, respectively, for a risk reduction of 26% (P less than .001).
The study investigators also zeroed in on specific ischemic endpoints. Cardiovascular death rates were 20% lower in the treated patients (4.2% vs. 5.2%, P less than .03).
The study also evaluated lipid levels. The median change in triglyceride levels after a year of treatment was a decrease of 18.3%, or 39 mg/dL, in the treatment group while triglyceride levels rose 2.2% in the placebo patients (P less than .001). LDL levels increased in the treated patients by 3.1%, or 2 mg/dL (median) vs. 10.2%, or 7 mg/dL, in controls (P less than .001).
The trial also reported a 33% greater risk of hospitalization for atrial fibrillation or flutter and about a 30% heightened risk of serious bleeding among patients taking icosapent ethyl. Dr. Bhatt pointed out that, while the high rate of atrial fibrillation among treated patients was statistically significant, “the most feared complication of atrial fibrillation is stroke, but in this study we saw a 28% reduction in stroke.”
Likewise the nonsignificantly higher rate of bleeding in the treatment group was inconsequential. “When we looked at specific types of serious bleeding – GI or stomach bleeding, CNS or bleeding into the brain or fatal bleeding – there were no significant differences,” he said.
Discussant Carl Orringer, MD, of the University of Miami, said, “My perspective of this is that the likelihood of atrial fibrillation, although statistically higher, is something that should not prevent physicians from prescribing the drug because of the tremendous benefit that we’ve seen in those appropriate patients on high intensity statin.” However, he said, it does merit further investigation. He also pointed out that one limitation of the study was that the population was 90% white. “Thus the potential benefits of icosapent ethyl in patients of other ethnicities remains unclear,” he said.
The results were published simultaneously online in the New England Journal of Medicine.
Dr. Bhatt receives funding from Amarin, which sponsored the REDUCE-IT trial.
SOURCE: Bhatt DL, et al. N Engl J Med. 2018 Nov 10; doi: 10.1056/NEJMoa181279.
CHICAGO – Detailed results of the REDUCE-IT trial have confirmed earlier-reported top line results that showed a 25% reduction in the risk of cardiovascular death or nonfatal cardiovascular event with the fish-derived, triglyceride-reducing agent icosapent acid in combination with statin.
But they should not be interpreted as validation of the cardiovascular benefits of fish-oil supplements, according to Deepak L. Bhatt, MD, principal investigator and steering committee chair for REDUCE-IT, who presented the results at the American Heart Association scientific sessions.
He reported the results from 8,179 patients followed for a median of 4.9 years. The treatment group received 4 g/day of icosapent ethyl (Vascepa, Amarin), a single-molecule agent consisting of the omega-3 acid known as eicosapentaeonoic acid (EPA) in ethyl-ester form, which Dr. Bhatt called “a highly purified” formulation. Vascepa is derived from fish but it is not fish oil, a company press release states. Amarin, sponsor of the study, released top line results in September.
To qualify for the trial, patients had to have a diagnosis of cardiovascular disease or diabetes and other risk factors, had been on statin therapy and had above normal triglyceride (135-499 mg/dL) and optimal LDL (41-100 mg/dL) levels. Patients were randomly assigned to receive 4 g/day of icosapent ethyl or placebo.
Dr. Bhatt stressed that the REDUCE-IT results do not necessarily validate the use of fish oil to lower cardiovascular risk. “It would be mistake if patients and physicians” to interpret the results that way, and that classifying the purified formulation of icosapent ethyl used in REDUCE-IT as fish oil is a “misnomer.” He added, “Really, what we’re talking about is prescription therapy icosapent ethyl vs. over-the-counter supplements.” Icosapent ethyl is approved in the United States for patients with triglyceride levels of more than 500 mg/dL.
Dr. Bhatt and the study coauthors acknowledged that the results of REDUCE-IT deviate from other trials of triglyceride-lowering agents, including other n-3 fatty acids. They noted two potential explanations: a high dose; or higher ratios of EPA to docosahexaenoic acid in the REDUCE-IT formulation vs. agents used in the other studies. For example, the ASCEND study, presented at the European Society of Cardiology in September, reported no cardiovascular benefit from a 1-g/day dose of omega-3 fatty acids and low-dose aspirin in patients with diabetes.
The primary endpoint of REDUCE-IT was a composite of cardiovascular death, nonfatal MI or stroke, coronary revascularization or unstable angina, which occurred in 17.2% of the patients taking icosapent ethyl, compared with 22% of the controls, for a risk reduction of 25% (P less than .001). The key secondary endpoint was composite of cardiovascular death and nonfatal MI or stroke, which occurred in 11.2% and 14.8% of the treated and placebo groups, respectively, for a risk reduction of 26% (P less than .001).
The study investigators also zeroed in on specific ischemic endpoints. Cardiovascular death rates were 20% lower in the treated patients (4.2% vs. 5.2%, P less than .03).
The study also evaluated lipid levels. The median change in triglyceride levels after a year of treatment was a decrease of 18.3%, or 39 mg/dL, in the treatment group while triglyceride levels rose 2.2% in the placebo patients (P less than .001). LDL levels increased in the treated patients by 3.1%, or 2 mg/dL (median) vs. 10.2%, or 7 mg/dL, in controls (P less than .001).
The trial also reported a 33% greater risk of hospitalization for atrial fibrillation or flutter and about a 30% heightened risk of serious bleeding among patients taking icosapent ethyl. Dr. Bhatt pointed out that, while the high rate of atrial fibrillation among treated patients was statistically significant, “the most feared complication of atrial fibrillation is stroke, but in this study we saw a 28% reduction in stroke.”
Likewise the nonsignificantly higher rate of bleeding in the treatment group was inconsequential. “When we looked at specific types of serious bleeding – GI or stomach bleeding, CNS or bleeding into the brain or fatal bleeding – there were no significant differences,” he said.
Discussant Carl Orringer, MD, of the University of Miami, said, “My perspective of this is that the likelihood of atrial fibrillation, although statistically higher, is something that should not prevent physicians from prescribing the drug because of the tremendous benefit that we’ve seen in those appropriate patients on high intensity statin.” However, he said, it does merit further investigation. He also pointed out that one limitation of the study was that the population was 90% white. “Thus the potential benefits of icosapent ethyl in patients of other ethnicities remains unclear,” he said.
The results were published simultaneously online in the New England Journal of Medicine.
Dr. Bhatt receives funding from Amarin, which sponsored the REDUCE-IT trial.
SOURCE: Bhatt DL, et al. N Engl J Med. 2018 Nov 10; doi: 10.1056/NEJMoa181279.
REPORTING FROM AMERICAN HEART ASSOCIATION SCIENTIFIC SESSIONS 2018
Key Clinical point: .
Major finding: Cardiovascular death or nonfatal cardiovascular event occurred in 17.7% of treated patients vs. 22% of controls.
Study details: Multicenter, randomized, double-blind, placebo-controlled clinical trial of 8,179 patients with established cardiovascular disease or diabetes and other risk factors.
Disclosures: Dr. Bhatt disclosed having a significant research relationship with Amarin Corp., which funded the trial.
Source: N Engl J Med. 2018; doi: 10.1056/NEJMoa181279.
Quality tool tied to improved adherence
CHICAGO – A multifaceted quality initiative that consists of staff education, patient reminders and a feedback loop may help to improve therapy adherence and encourage lifestyle changes of at-risk cardiovascular patients in settings with limited resources, according to results of a clinical trial from Brazil presented at the American Heart Association scientific sessions 2018.
“In patients at high cardiovascular risk – in this case patients with established cardiovascular disease – a multifaceted quality-improvement intervention resulted in significant improvement in the use of evidence-based therapies,” said Otavio Berwanger, MD, PhD, of the Heart Hospital in Sao Paolo. He reported results of the BRIDGE Cardiovascular Prevention Cluster Randomized Trial. “The tools used in our trial can become the basis for developing quality-improvement programs to maximize the use of evidence-based therapies for the management of these high-risk patients with, especially in limited-resource settings.”
BRIDGE-CV included 1,619 patients from 40 care settings. Institutions that adopted the multifaceted intervention adhered to 73.5% of the evidence-based therapies (antiplatelet agents, statins and ACE inhibitors) while those in the control group adhered to 58.7% of the performance measures, Dr. Berwanger said. That represents a gain of 25%. The study employed an “all-or-none” model. That is, participating sites were required to adopt all components of the quality-improvement initiative or none.
He noted that although the evidence supporting the use of platelet therapies, statins, and ACE inhibitors is strong, “translation of these findings in practice is clearly suboptimal.” He added, “It seems to be an even larger problem in settings like mine in Brazil, so quality-improvement interventions, especially in lower-resource settings such as low- and middle-income countries, are definitely needed.”
The quality-improvement model the trial evaluated involved two levels of intervention. The first level comprised three steps: a case manager evaluating the patient’s treatment needs with the aid of a checklist; then an evaluation by the physician; and then providing physicians with what Dr. Berwanger described as “a physician support tool” – a one-page summary of major guideline recommendations. The second level comprised monthly audit and feedback reports to the providers and patient education about lifestyle modification. Staff education and training was also provided to sites that adopted the model. “Our intervention was sort of based on behavioral marketing,” Dr. Berwanger said.
The trial also identified a number of trends among secondary endpoints, although the populations were too small to reach statistical significance. For example, Dr. Berwanger noted that intervention sites had higher use of high-dose statins and more than double the rate of smoking cessation. He also noted a 24% relative risk reduction in major cardiovascular events in the intervention group vs. controls. Among the intervention sites, teaching institutions seems to have a notable improvement in adherence outcomes than other settings, Dr. Berwanger said, but the study did not fully analyze that trend.
“We see this study not as the final word but as the first step,” he said. “More studies are needed.”
Dr. Berwanger reported receiving research support and/or honoraria from Astra Zeneca, Amgen, Bayer, Eurofarma, Servier, Novartis and NovoNordisk. Amgen sponsored the investigator-initiated trial.
SOURCE: Berwanger O, et al. AHA 2018 Abstr.19360.
CHICAGO – A multifaceted quality initiative that consists of staff education, patient reminders and a feedback loop may help to improve therapy adherence and encourage lifestyle changes of at-risk cardiovascular patients in settings with limited resources, according to results of a clinical trial from Brazil presented at the American Heart Association scientific sessions 2018.
“In patients at high cardiovascular risk – in this case patients with established cardiovascular disease – a multifaceted quality-improvement intervention resulted in significant improvement in the use of evidence-based therapies,” said Otavio Berwanger, MD, PhD, of the Heart Hospital in Sao Paolo. He reported results of the BRIDGE Cardiovascular Prevention Cluster Randomized Trial. “The tools used in our trial can become the basis for developing quality-improvement programs to maximize the use of evidence-based therapies for the management of these high-risk patients with, especially in limited-resource settings.”
BRIDGE-CV included 1,619 patients from 40 care settings. Institutions that adopted the multifaceted intervention adhered to 73.5% of the evidence-based therapies (antiplatelet agents, statins and ACE inhibitors) while those in the control group adhered to 58.7% of the performance measures, Dr. Berwanger said. That represents a gain of 25%. The study employed an “all-or-none” model. That is, participating sites were required to adopt all components of the quality-improvement initiative or none.
He noted that although the evidence supporting the use of platelet therapies, statins, and ACE inhibitors is strong, “translation of these findings in practice is clearly suboptimal.” He added, “It seems to be an even larger problem in settings like mine in Brazil, so quality-improvement interventions, especially in lower-resource settings such as low- and middle-income countries, are definitely needed.”
The quality-improvement model the trial evaluated involved two levels of intervention. The first level comprised three steps: a case manager evaluating the patient’s treatment needs with the aid of a checklist; then an evaluation by the physician; and then providing physicians with what Dr. Berwanger described as “a physician support tool” – a one-page summary of major guideline recommendations. The second level comprised monthly audit and feedback reports to the providers and patient education about lifestyle modification. Staff education and training was also provided to sites that adopted the model. “Our intervention was sort of based on behavioral marketing,” Dr. Berwanger said.
The trial also identified a number of trends among secondary endpoints, although the populations were too small to reach statistical significance. For example, Dr. Berwanger noted that intervention sites had higher use of high-dose statins and more than double the rate of smoking cessation. He also noted a 24% relative risk reduction in major cardiovascular events in the intervention group vs. controls. Among the intervention sites, teaching institutions seems to have a notable improvement in adherence outcomes than other settings, Dr. Berwanger said, but the study did not fully analyze that trend.
“We see this study not as the final word but as the first step,” he said. “More studies are needed.”
Dr. Berwanger reported receiving research support and/or honoraria from Astra Zeneca, Amgen, Bayer, Eurofarma, Servier, Novartis and NovoNordisk. Amgen sponsored the investigator-initiated trial.
SOURCE: Berwanger O, et al. AHA 2018 Abstr.19360.
CHICAGO – A multifaceted quality initiative that consists of staff education, patient reminders and a feedback loop may help to improve therapy adherence and encourage lifestyle changes of at-risk cardiovascular patients in settings with limited resources, according to results of a clinical trial from Brazil presented at the American Heart Association scientific sessions 2018.
“In patients at high cardiovascular risk – in this case patients with established cardiovascular disease – a multifaceted quality-improvement intervention resulted in significant improvement in the use of evidence-based therapies,” said Otavio Berwanger, MD, PhD, of the Heart Hospital in Sao Paolo. He reported results of the BRIDGE Cardiovascular Prevention Cluster Randomized Trial. “The tools used in our trial can become the basis for developing quality-improvement programs to maximize the use of evidence-based therapies for the management of these high-risk patients with, especially in limited-resource settings.”
BRIDGE-CV included 1,619 patients from 40 care settings. Institutions that adopted the multifaceted intervention adhered to 73.5% of the evidence-based therapies (antiplatelet agents, statins and ACE inhibitors) while those in the control group adhered to 58.7% of the performance measures, Dr. Berwanger said. That represents a gain of 25%. The study employed an “all-or-none” model. That is, participating sites were required to adopt all components of the quality-improvement initiative or none.
He noted that although the evidence supporting the use of platelet therapies, statins, and ACE inhibitors is strong, “translation of these findings in practice is clearly suboptimal.” He added, “It seems to be an even larger problem in settings like mine in Brazil, so quality-improvement interventions, especially in lower-resource settings such as low- and middle-income countries, are definitely needed.”
The quality-improvement model the trial evaluated involved two levels of intervention. The first level comprised three steps: a case manager evaluating the patient’s treatment needs with the aid of a checklist; then an evaluation by the physician; and then providing physicians with what Dr. Berwanger described as “a physician support tool” – a one-page summary of major guideline recommendations. The second level comprised monthly audit and feedback reports to the providers and patient education about lifestyle modification. Staff education and training was also provided to sites that adopted the model. “Our intervention was sort of based on behavioral marketing,” Dr. Berwanger said.
The trial also identified a number of trends among secondary endpoints, although the populations were too small to reach statistical significance. For example, Dr. Berwanger noted that intervention sites had higher use of high-dose statins and more than double the rate of smoking cessation. He also noted a 24% relative risk reduction in major cardiovascular events in the intervention group vs. controls. Among the intervention sites, teaching institutions seems to have a notable improvement in adherence outcomes than other settings, Dr. Berwanger said, but the study did not fully analyze that trend.
“We see this study not as the final word but as the first step,” he said. “More studies are needed.”
Dr. Berwanger reported receiving research support and/or honoraria from Astra Zeneca, Amgen, Bayer, Eurofarma, Servier, Novartis and NovoNordisk. Amgen sponsored the investigator-initiated trial.
SOURCE: Berwanger O, et al. AHA 2018 Abstr.19360.
REPORTING FROM AMERICAN HEART ASSOCIATION SCIENTIFIC SESSIONS 2018
Key clinical point: A multifaceted quality-improvement initiative led to improved adherence to evidence-based therapies.
Major finding: Sites that adopted the intervention had adherence rates 25% higher than control sites.
Study details: Two-arm, cluster-randomized, controlled trial of 1,619 high-risk, stable patients with established CVD from 40 sites.
Disclosures: Dr. Berwanger disclosed receiving research support and/or honoraria from AstraZeneca, Amgen, Bayer, Eurofarma, Servier, Novartis and NovoNordisk. Amgen sponsored the investigator-initiated trial.
Source: Berwanger O, et al. 2018-LBCT-19360-AHA.
Combination supplements show neuroprotective potential in Parkinson’s
NEW YORK – Preclinical studies have shown the natural supplements vinpocetine and pomegranate, along with vitamin B complex and vitamin E, may have some effect individually in providing neuroprotection in Parkinson’s disease, but may have a more profound effect when used in combination, a researcher from Egypt reported at the International Conference on Parkinson’s Disease and Movement Disorders.
“We need to carry out a clinical trial to ensure that this multiple direct strategy can provide protection in different stages of neurodegenerative disease – during induction and even during the progression of the disease,” said Azza Ali, PhD, of Al-Azhar University, Cairo. She presented a poster of her research in an unspecified number of rats with manganese-induced Parkinsonian symptoms. The goal of the study was to compare the oral supplements to each other and to evaluate their impact in combinations. Excessive levels of manganese have been associated with movement disorders similar to Parkinson’s disease.
The research involved histologic studies to evaluate the impact of the supplements in the brains, and evaluated biochemical, neuroinflammatory, apoptotic, and oxidative markers. Behavioral tests evaluated cognition, memory, and motor skills.
Histological studies of manganese-induced brains exhibited nuclear pyknosis – clumping of chromosomes, excessive chromatic aberrations, and shrinkage of the nucleus – in the neurons of the cerebral cortex as well as in some areas of the hippocampus, although no alteration was seen in the subiculum, Dr. Ali reported. The stria showed multiple plaque formations with nuclear pyknosis and degeneration in some neurons.
All the studied treatments improved motor, memory, and cognitive decline induced by manganese, with pomegranate and vinpocetine yielding the best results, Dr. Ali said. However, a combination of treatments showed more pronounced improvements in some biochemical markers, as well as the neuroinflammatory, apoptotic, and oxidative markers. “They have a high antioxidant and antiapoptotic effect,” Dr. Ali said. Histopathologic studies confirmed those results, she noted.
Pomegranate (150 mg/kg) had a somewhat positive effect in the subiculum and fascia dentate areas of the hippocampus, although the stria appeared similar to manganese-induced brains. With vinpocetine (20 mg/kg), neurons in the cerebral cortex showed intact histological structure with some degeneration and nuclear pyknosis in the subiculum. There was no alteration in the neurons of the fascia dentate, hilus, and stria of the hippocampus.
Histologic studies of induced brains after treatment with vitamin-B complex (8.5 mg/kg) showed nuclear pyknosis and degeneration in the neurons of the cerebral cortex and hippocampus, including the subiculum. The stria also showed multiple focal eosinophilic plaques with nuclear pyknosis and degeneration in some neurons. Vitamin E (100 mg/kg) resulted in intact neurons in the cerebral cortex but not in the hippocampus.
Histopathologic studies of brains that received combination treatment showed no alteration in the neurons of the cerebral cortex or in the subiculum and fascia dentate of the hippocampus, although a few neurons in the stria showed nuclear pyknosis and degeneration, Dr. Ali said.
She had no financial relationships to disclose.
NEW YORK – Preclinical studies have shown the natural supplements vinpocetine and pomegranate, along with vitamin B complex and vitamin E, may have some effect individually in providing neuroprotection in Parkinson’s disease, but may have a more profound effect when used in combination, a researcher from Egypt reported at the International Conference on Parkinson’s Disease and Movement Disorders.
“We need to carry out a clinical trial to ensure that this multiple direct strategy can provide protection in different stages of neurodegenerative disease – during induction and even during the progression of the disease,” said Azza Ali, PhD, of Al-Azhar University, Cairo. She presented a poster of her research in an unspecified number of rats with manganese-induced Parkinsonian symptoms. The goal of the study was to compare the oral supplements to each other and to evaluate their impact in combinations. Excessive levels of manganese have been associated with movement disorders similar to Parkinson’s disease.
The research involved histologic studies to evaluate the impact of the supplements in the brains, and evaluated biochemical, neuroinflammatory, apoptotic, and oxidative markers. Behavioral tests evaluated cognition, memory, and motor skills.
Histological studies of manganese-induced brains exhibited nuclear pyknosis – clumping of chromosomes, excessive chromatic aberrations, and shrinkage of the nucleus – in the neurons of the cerebral cortex as well as in some areas of the hippocampus, although no alteration was seen in the subiculum, Dr. Ali reported. The stria showed multiple plaque formations with nuclear pyknosis and degeneration in some neurons.
All the studied treatments improved motor, memory, and cognitive decline induced by manganese, with pomegranate and vinpocetine yielding the best results, Dr. Ali said. However, a combination of treatments showed more pronounced improvements in some biochemical markers, as well as the neuroinflammatory, apoptotic, and oxidative markers. “They have a high antioxidant and antiapoptotic effect,” Dr. Ali said. Histopathologic studies confirmed those results, she noted.
Pomegranate (150 mg/kg) had a somewhat positive effect in the subiculum and fascia dentate areas of the hippocampus, although the stria appeared similar to manganese-induced brains. With vinpocetine (20 mg/kg), neurons in the cerebral cortex showed intact histological structure with some degeneration and nuclear pyknosis in the subiculum. There was no alteration in the neurons of the fascia dentate, hilus, and stria of the hippocampus.
Histologic studies of induced brains after treatment with vitamin-B complex (8.5 mg/kg) showed nuclear pyknosis and degeneration in the neurons of the cerebral cortex and hippocampus, including the subiculum. The stria also showed multiple focal eosinophilic plaques with nuclear pyknosis and degeneration in some neurons. Vitamin E (100 mg/kg) resulted in intact neurons in the cerebral cortex but not in the hippocampus.
Histopathologic studies of brains that received combination treatment showed no alteration in the neurons of the cerebral cortex or in the subiculum and fascia dentate of the hippocampus, although a few neurons in the stria showed nuclear pyknosis and degeneration, Dr. Ali said.
She had no financial relationships to disclose.
NEW YORK – Preclinical studies have shown the natural supplements vinpocetine and pomegranate, along with vitamin B complex and vitamin E, may have some effect individually in providing neuroprotection in Parkinson’s disease, but may have a more profound effect when used in combination, a researcher from Egypt reported at the International Conference on Parkinson’s Disease and Movement Disorders.
“We need to carry out a clinical trial to ensure that this multiple direct strategy can provide protection in different stages of neurodegenerative disease – during induction and even during the progression of the disease,” said Azza Ali, PhD, of Al-Azhar University, Cairo. She presented a poster of her research in an unspecified number of rats with manganese-induced Parkinsonian symptoms. The goal of the study was to compare the oral supplements to each other and to evaluate their impact in combinations. Excessive levels of manganese have been associated with movement disorders similar to Parkinson’s disease.
The research involved histologic studies to evaluate the impact of the supplements in the brains, and evaluated biochemical, neuroinflammatory, apoptotic, and oxidative markers. Behavioral tests evaluated cognition, memory, and motor skills.
Histological studies of manganese-induced brains exhibited nuclear pyknosis – clumping of chromosomes, excessive chromatic aberrations, and shrinkage of the nucleus – in the neurons of the cerebral cortex as well as in some areas of the hippocampus, although no alteration was seen in the subiculum, Dr. Ali reported. The stria showed multiple plaque formations with nuclear pyknosis and degeneration in some neurons.
All the studied treatments improved motor, memory, and cognitive decline induced by manganese, with pomegranate and vinpocetine yielding the best results, Dr. Ali said. However, a combination of treatments showed more pronounced improvements in some biochemical markers, as well as the neuroinflammatory, apoptotic, and oxidative markers. “They have a high antioxidant and antiapoptotic effect,” Dr. Ali said. Histopathologic studies confirmed those results, she noted.
Pomegranate (150 mg/kg) had a somewhat positive effect in the subiculum and fascia dentate areas of the hippocampus, although the stria appeared similar to manganese-induced brains. With vinpocetine (20 mg/kg), neurons in the cerebral cortex showed intact histological structure with some degeneration and nuclear pyknosis in the subiculum. There was no alteration in the neurons of the fascia dentate, hilus, and stria of the hippocampus.
Histologic studies of induced brains after treatment with vitamin-B complex (8.5 mg/kg) showed nuclear pyknosis and degeneration in the neurons of the cerebral cortex and hippocampus, including the subiculum. The stria also showed multiple focal eosinophilic plaques with nuclear pyknosis and degeneration in some neurons. Vitamin E (100 mg/kg) resulted in intact neurons in the cerebral cortex but not in the hippocampus.
Histopathologic studies of brains that received combination treatment showed no alteration in the neurons of the cerebral cortex or in the subiculum and fascia dentate of the hippocampus, although a few neurons in the stria showed nuclear pyknosis and degeneration, Dr. Ali said.
She had no financial relationships to disclose.
REPORTING FROM ICPDMD 2018