Latest news with #thrombolysis
Medscape
26-05-2025
- Health
- Medscape
Tenecteplase Before Thrombectomy Boosts LVO Stroke Outcomes
HELSINKI — In patients with large vessel occlusion stroke treated within 4.5 hours of symptom onset, outcomes were better in those who received the thrombolytic tenecteplase prior to endovascular therapy than in those who underwent endovascular treatment alone. Results from the BRIDGE-TNK trial showed that patients who received tenecteplase had a significantly higher likelihood of achieving functional independence at day 90. Several earlier trials of thrombolysis before endovascular therapy — most using alteplase as the thrombolytic — failed to show significant benefit. Commentators now suggest that the latest findings from the BRIDGE-TNK trial suggested tenecteplase may potentially be a more suitable agent in this clinical scenario. 'Essentially, what our trial showed was that patients who received tenecteplase before endovascular therapy did better than those who did not receive tenecteplase. And it was a highly significant result, supporting the idea that we should give tenecteplase to these patients who are presenting directly to endovascular centers. All patients in this trial were directly presenting to the endovascular center,' said study investigator Thanh Nguyen, MD, director of Interventional Neurology/Neuroradiology at Boston Medical Center, Boston. The BRIDGE-TNK trial results were presented on May 21 at the European Stroke Organization Conference (ESOC) 2025 and simultaneously published online in The New England Journal of Medicine. Better Functional Independence The open-label BRIDGE-TNK trial included 550 patients with acute ischemic stroke due to large-vessel occlusion who presented within 4.5 hours of symptom onset and were eligible for thrombolysis. Patients were randomly assigned to receive either intravenous tenecteplase followed by endovascular thrombectomy or endovascular thrombectomy alone. The primary outcome was functional independence at 90 days, measured on a scale from 0 to 6, with higher scores indicating greater disability. Secondary outcomes included successful reperfusion before and after thrombectomy. Safety outcomes assessed symptomatic intracranial hemorrhage within 48 hours and death within 90 days. At 90 days, functional independence — defined as a score of 0-2 on the modified Rankin Scale — was achieved in 52.9% of patients in the tenecteplase-thrombectomy group compared with 44.1% in the thrombectomy-alone group (unadjusted risk ratio, 1.20; 95% CI, 1.01-1.43; P = .04). The time between tenecteplase administration and the start of endovascular therapy was very short — a median of 16 minutes — yet there was still a significant increase in successful reperfusion before thrombectomy in the tenecteplase group (6.1%) vs thrombectomy-alone group (1.1%). Successful reperfusion after thrombectomy occurred in 91.4% of patients in the tenecteplase group and 94.1% in the thrombectomy-alone group. Symptomatic intracranial hemorrhage within 48 hours occurred in 8.5% of patients in the tenecteplase-thrombectomy group and 6.7% in the thrombectomy-alone group — a nonsignificant difference. Ninety-day mortality was 22.3% in the tenecteplase group vs 19.9% in the thrombectomy-alone group. Peter Kelly, MD, professor of neurology at University College Dublin in Dublin, Ireland, who was not involved in the trial, asked Nguyen how the BRIDGE-TNK results should be interpreted in light of previous, 'perhaps inconclusive,' alteplase trials — and why the signals appear to differ between the two agents. Nguyen said that an individual patient meta-analysis of the alteplase trials suggested a potential benefit of administering the drug before thrombectomy in patients treated very early — within 2.5 hours of symptom onset. However, beyond that time window, the benefit appeared to plateau, with no clear advantage observed. 'I think it depends on what you have available at your hospital. So, if you have alteplase, then you use alteplase. If you have tenecteplase, you use tenecteplase. But if you have the choice between the two, then it would seem reasonable to go with tenecteplase because it's showing superiority over the whole 4.5-hour time window,' Nguyen added. Discussing why tenecteplase may be more effective than alteplase in this setting, Nguyen explained that tenecteplase is more fibrin-specific and has been associated with better recanalization outcomes. She added that its bolus administration makes it faster and more convenient than alteplase, which requires an infusion — an important advantage when time is critical for getting patients to the cath lab. Kelly responded: 'So it might be as simple as that; perhaps it's all down to speed again.' He concluded: 'I think the main take home message is not to withhold thrombolytics in patients with large vessel occlusion stroke on the way to endovascular therapy.' In response, Kelly suggested the difference in outcomes might simply come down to timing. 'I think the main take-home message is not to withhold thrombolytics in patients with large vessel occlusion stroke on the way to endovascular therapy. So, it might be as simple as that; perhaps it's all down to speed again,' he said. A Convincing, Positive Result Commenting on the study for Medscape Medical News , Michael Hill, MD, director of the Stroke Unit for the Calgary Stroke Program, Alberta, Canada, said the results supported the use of thrombolysis before endovascular therapy. 'A meta-analysis of alteplase trials in this situation has suggested a benefit, but this trial with tenecteplase shows a more convincing positive result. This is consistent with previous literature suggesting that tenecteplase may be a more effective thrombolytic agent than alteplase and associated with earlier recanalization.' He suggested that the benefit of thrombolysis before thrombectomy may not just be due to the earlier opening of the vessel. 'The endovascular procedure can cause some distal embolization into the far parts of the circulation, so having a drug on board, which is going to help manage those microcirculatory occlusions should be beneficial. But that's still theoretical at present,' Hill said. 'I think the totality of the alteplase data also suggest that it is beneficial, but tenecteplase could be better, so we should be giving tenecteplase to these patients heading for endovascular therapy,' he added. Hill noted that many regions around the world have already adopted tenecteplase as the thrombolytic of choice for stroke treatment.
Medscape
23-05-2025
- Health
- Medscape
Less Intensive Monitoring After Thrombolysis Is Safe
HELSINKI, Finland — Less intensive monitoring of patients with acute ischemic stroke who have undergone thrombolysis appeared to be safe in new findings that challenge current guidelines. The large international OPTIMISTmain trial showed that less frequent monitoring of vital signs and neurologic function during the first 24 hours did not compromise recovery or increase the risk for serious adverse events compared with standard protocols. 'The key message from our study is that it is safe to relax the monitoring of these patients, and this will allow nurses to be freed up from taking constant measurements so they can spend more time on delivering direct interventions and generally providing better care of the patients,' study investigator Craig Anderson, MD, George Institute for Global Health, Sydney, Australia, told Medscape Medical News . 'Another benefit will be less disruption to patients, which is especially important if they are trying to sleep.' The trial also showed that less intensive monitoring was feasible outside of an intensive care unit (ICU), which the researchers said would have benefits such as flexibility in nursing workflow and the release of intensive care resources. 'This trial result has wide applicability and is relevant all around the world, and we believe that hospitals could consider incorporating this approach to improve systems of care for acute stroke,' Anderson said. Anderson presented the results of the OPTIMISTmain trial on May 21 at the European Stroke Organization Conference (ESOC) 2025. The trial was also simultaneously published online in The Lancet . Nurse-Driven Research Anderson noted that this was a nurse-driven study and was the idea of co-lead author Debbie Summers, MSN, a senior nurse practitioner at Saint Luke's Hospital of Kansas City, Missouri, who questioned whether the high-intensity monitoring of patients with stroke after thrombolysis administration was necessary, given its high burden on nurses and level of disruption to patients. Current guidelines recommended 37 assessments within the first 24 hours after thrombolysis, including vital signs — such as heart rate and blood pressure — and neurologic checks using the Glasgow Coma Scale or the National Institutes of Health Stroke Scale (NIHSS). These are conducted every 15 minutes for 2 hours, every 30 minutes for the next 6 hours, and then hourly. The low-intensity monitoring protocol tested in the study involved 17 assessments over the same 24-hour period, with vital signs and neurologic checks conducted every 15 minutes for 2 hours, every 2 hours for the next 8 hours, and then every 4 hours. Investigators were also encouraged to implement the protocol in a stroke unit rather than an ICU, where hospital infrastructure allowed. Anderson explained that high-intensity monitoring was put in place when thrombolysis was first used in routine clinical practice, as this was the protocol used in the initial randomized clinical trial of alteplase for acute ischemic stroke in the mid-1990s. 'There was concern that use of thrombolysis in this setting could cause intracerebral hemorrhage (ICH), and the trial, therefore, included a careful monitoring strategy to detect any deterioration in the patient as quickly as possible. 'In addition, thorough monitoring and reporting was necessary in the evaluation of a new drug. Then, because this high-intensity monitoring program had been used in the trial, it was adopted after alteplase was approved for use in acute ischemic stroke and rolled out into clinical practice,' Anderson said. However, this high-intensity monitoring protocol has never been tested in a major study to determine if this intensive monitoring is actually necessary, he added. Lower Rates of ICU Admission Guidelines often recommend ICU monitoring for these patients due to the high level of nursing care required. While some countries have relaxed this requirement, others — such as the United States, where medicolegal concerns are more prominent — continue to manage these patients in the ICU. OPTIMISTmain was an international, cluster-randomized trial conducted at 114 hospitals across eight countries: Australia, Chile, the United Kingdom, the United States, China, Malaysia, Mexico, and Vietnam. It was designed to test the noninferiority of a new low-intensity monitoring protocol to the standard high-intensity monitoring protocol in patients with acute ischemic stroke who were clinically stable with mild to moderate neurologic impairment (NIHSS score < 10) within 2 hours of initiation of thrombolysis. The trial enrolled 4922 patients, with 2789 participants assigned to the low-intensity monitoring group and 2133 to the standard monitoring group. The primary outcome was the proportion of participants with an unfavorable functional outcome defined by a Modified Rankin Scale score from 2 (indicating some disability) to 6 (death) at 90 days. This occurred in 31.7% of patients in the low-intensity monitoring group and 30.9% of those in the standard monitoring group, giving a relative risk of 1.03 (95% CI, 0.92-1.15), satisfying the noninferiority criteria ( P noninferiority = .057). Symptomatic intracerebral hemorrhage occurred in five (0.2%) patients in the low-intensity group and eight (0.4%) patients in the standard monitoring group, a nonsignificant difference. The number of participants with a serious adverse event was similar between the low-intensity monitoring group (11.1%) and the standard monitoring group (11.3%). The low-intensity monitoring protocol was associated with lower rates of ICU admission, with 12.8% in the low-intensity group admitted directly to an ICU compared with 16.8% of patients in the standard monitoring group. Universally Applicable Results These figures and the differences between the protocols were much greater in the United States, where immediate ICU admission occurred in 47.1% of patients in the low-intensity monitoring group vs 77.1% of those in the standard monitoring group. 'This was a large trial with hard, accepted, patient-centered outcomes, and the results should be applicable across the world,' Anderson said. He pointed out that the trial also included process evaluations from the nurses and physicians involved, which he said were 'pretty much uniformly comfortable with the less intensive monitoring protocol.' 'It is not for us to recommend what guidelines do,' he added. 'But we have suggested that hospitals should consider implementing this intervention according to local circumstances to improve the efficiency of their care.' While a cost analysis has not yet been published, Anderson said the less intensive monitoring protocol is expected to save costs. 'Just the observation that there was a significant reduction in the use of ICU beds, especially in the United States, will result in significant cost savings,' he noted. 'This trial shows that we can use our nurses in a more efficient manner, and we don't need to send all our patients to the ICU; we can use our regular beds or stroke unit beds better and be a bit smarter,' he added. Anderson added that over the many years of using thrombolysis for acute ischemic stroke in clinical practice, it has become apparent that the incidence of ICH is low and that such strict monitoring might not be required. 'We have become more confident about how to use thrombolysis and which patients are at higher risk.' However, he cautioned that the low-intensity protocol would not be appropriate for all patients. 'This study only included patients who had a moderate level of disability when they presented. Patients also had to be alert, with good blood pressure control, heart rate, and respiration, and without other complicating health problems. We estimate that this would account for at least a third, maybe half, of all the stroke patients that come through hospitals around the world,' said Anderson. 'Less Is More' Commenting on the OPTIMISTmain trial, Valeria Caso, MD, PhD, professor of neurology and consultant neurologist at Santa Maria della Misericordia Hospital, University of Perugia, Perugia, Italy, and a past president of the European Stroke Organisation, said she was 'very impressed' with the study. She pointed out that nurse-led trials are important as so much of stroke care is carried out by nurses. 'This trial is another example of 'less is more' that we are seeing in several aspects of stroke medicine,' said Caso. 'I think we will implement this lower-intensity monitoring protocol for less severe stroke patients in Italy. Nurses are in high demand, and we need to prioritize the resources we have. These results will allow us to prioritize the nursing resources regarding intensive monitoring in the first 24 hours for patients with severe strokes.'
