Surgery and ‘care bundle’ trials raise expectations for ICH care

Unlike recent successes in ischemic stroke, positive results are delayed in bleeding patients.

MUNICH, Germany—Two randomized trials testing different types of interventions for patients with acute intracerebral hemorrhage (ICH), presented at the European Stroke Organization Congress (ESOC), are promising treatments for this fatal and debilitating disease. raising cautious expectations of

Improved functional outcomes and reduced mortality were associated with the ENRICH trial of ICH evacuation using minimally invasive parafascial surgery (MIPS) and a care bundle protocol aimed at rapid correction of hypertension, hyperglycemia and fever. It was seen in both INTERACT3 trials. With the reversal of warfarin anticoagulation, the researchers reported in consecutive presentations.

The excitement of the participants was evident. The results suggested a shift in ICH management in the right direction, where dramatic advances in the treatment of ischemic stroke have so far been lacking.

“Anything that shows some impact on intangible cultural heritage is promising.”,” Charlotte Sandset, M.D., Oslo University Hospital, Norway, co-chair of the session where the results were presented, told TCTMD.

“Care for ischemic stroke patients has improved tremendously. We can see that in our daily practice,” she said. “But for ICH patients, we can’t offer the same care, so I think it’s exciting to see positive things happening for ICH patients. People will want to participate.” In a trial in patients with intracerebral hemorrhage. So I think this will be very positive for her ICH patients in the future. “

Indeed, Craig Anderson, M.D., Ph.D. (George Institute, University of New South Wales, Sydney, Australia), who presented the INTERACT3 results, said: Same as for acute ischemic stroke. “

Minimally Invasive Surgical ICH Evacuation in ENRICH

According to Alex Hall, M.D., RN, who presented ENRICH results with Jonathan Ratcliffe, M.D., both from Emory University in Atlanta, Georgia, there are several obvious reasons to consider surgery for ICH. It is said that there is These include early control of intracranial pressure, prevention of thrombus expansion and secondary inflammation.

Two Preliminary Trials of Early Surgery and Early Conservative Therapy in Patients with Acute ICH—Stitch and Stitch II“While there were signals that helped us design ENRICH, they didn’t show significant benefit,” Hall said. He said a third trial had taken place after their trial began. Misty IIIfailed to show that minimally invasive surgery with thrombolytic therapy for ICH evacuation improves functional outcome.

In ENRICH, which was conducted at 37 centers in the United States, investigators found that the very early We investigated the impact of minimally invasive hemorrhage (within 24 hours). They used an adaptive design to randomize 300 patients to enrich for lobar ICH, which represented 69% of the study population. The rest had hemorrhages in the anterior basal ganglia (ABG).

This is the first clinical trial to demonstrate the functional benefits of surgical thrombectomy. Jonathan Ratcliffe

The primary outcome was a functional outcome based on the mean utility-weighted modified Rankin scale (mRS) score after 180 days, with a positive outcome defined by a Bayesian posterior probability of success greater than 97.5%. This was met in the entire cohort, with a MIPS success rate of 98.1%, met in patients with lobar ICH (99.7%) but not in patients with ABG bleeding (43.0%).

Patients treated with MIPS had an overall lower risk of poor functional outcome (OR 0.636; 95% CI 0.421-0.959) and benefited as early as day 7 or hospital discharge (whichever came first). was seen

Ratcliffe said the researchers hypothesized that the benefits of MIPS were related to hematoma clearance and reported a median postoperative ICH volume of 14.9 mL, down from 50.5 mL preoperatively. rice field. Median ICH reduction was 87.7%. Outcomes worsened with higher doses of ICH and improved with lower doses.

In addition to improving functional outcomes with MIPS, this procedure also reduced 30-day mortality compared with standard medical management (9.3% vs. 18.1%; P. = 0.027) and reduced mean length of stay in the ICU (7.0 days vs 9.6 days; P. < 0.001) and hospital (14.7 days vs 17.1 days. P. = 0.021). Ratcliffe reported that 21 people needed treatment to prevent one death.

“This is the first clinical trial to demonstrate the functional benefits of surgical thrombectomy,” said Dr. Ratcliffe, adding, “The overall benefit of MIPS was importantly observed in participants in the lobar ICH cohort. It seems to be due to a strong positive effect,” he said.

INTERACT3 Care-Bundle Protocol

Mr. Anderson reported the results of INTERACT3 following the ENRICH presentation. The results were published online at the same time. lancet. This phased wedge cluster randomized trial was conducted in 122 hospitals in 9 low-middle-income countries (Brazil, China, India, Mexico, Nigeria, Pakistan, Peru, Sri Lanka, Vietnam) and 1 high-income country. rice field. Country (Chile). Hospitals with local advocates who could lead the implementation of care bundles were selected for participation, even if they did not have ICH protocols or were inconsistent.

The trial enrolled 7,036 patients (mean age, 62 years; 36% female) who presented with acute ICH within 6 hours and were treated with a care bundle protocol (n = 3,221) or usual care (n = 3,815). Randomly assigned to management. All hospitals initially began offering routine care and gradually switched to a suite of care as part of a quality assurance program. Most of the participants (about 90%) were Chinese. At baseline, his median NIHSS score was 12 and median hematoma volume was 15 mL.

The aim of the intervention was to rapidly (within 1 hour) treat hypertension, hyperglycemia, fever and reverse warfarin anticoagulation. At baseline, most patients had elevated blood pressure (approximately 90%), but a low proportion (approximately 36%) had hyperglycemia. He had less than 2% of patients with fever or warfarin-related anticoagulant changes.

Perhaps it’s time to raise intracerebral hemorrhage to the same level of urgency as acute ischemic stroke. Craig Anderson

Once the care bundle was introduced, the main intervention delivered was early blood pressure lowering, with 79% of the intervention group and 71% of the control group receiving IV medication. Glycemic control and antipyretic therapy were provided in approximately 10%, and correction of abnormal coagulation was provided in less than 2%.

Importantly, both groups had similar use of other management strategies, including decompressive surgery, ventilators, ICU admission, feeding assistance, and discontinuation of active treatment, Anderson said.

Compared with usual treatment, this intervention significantly reduced systolic blood pressure at both 1 hour (7 mmHg) and 24 hours (4 mmHg) and changed other parameters such as diastolic blood pressure and blood glucose levels. changed little or not at all. , body temperature.

And it was associated with a significant benefit of the care bundle on the primary outcome, change in mRS score after 6 months. After adjustment, the intervention reduced the likelihood of dysfunction (OR 0.84; 95% CI 0.73-0.97).

The effect varied by mRS category, tending to be stronger at the more severe ends of the scale, and the audience applauded the finding when Anderson showed the numbers.

Other efficacy and safety outcomes showed a significant reduction in mortality (14.1% vs. 17.0%), providing a point estimate of benefit for the care bundle. P. = 0.02) and serious adverse events (16% vs 20%; P. = 0.01), and at 6 months, improved quality of life by EQ-5D assessment (P. = 0.001).

According to Anderson, 35 people were needed for treatment to achieve both improved functional outcomes and reduced mortality.

“We are not the first RCT to provide Level 1 evidence. ENRICH did it, but we can claim to be the first to be published,” he joked.

“Aggressive management improves outcomes in intracerebral hemorrhage and care bundle protocols, and aggressive management should be applied to all patients with ICH,” he concluded.

Anderson noted that there are ongoing efforts to improve ICH care, such as ABC-ICH in the UK and CODE ICH in the US. “Maybe now is the time to launch a collaborative campaign across all disciplines to take a more proactive approach to intangible cultural heritage management,” he said. Stated.

“I’m very excited”

Commenting on the TCTMD trial, Pooja Khatri, M.D., Ph.D., University of Cincinnati, Ohio, said demonstrating that strategies for acute ICH can improve outcomes is “really big.”

“We think there is some evidence that seeing patients with bleeding can lower blood pressure and may help limit the spread of bleeding, but it actually has a greater impact on outcomes.” No,” said Katori, adding that the symptoms seen with ENRICH and INTERACT3 are of a similar magnitude to those associated with some treatments for ischemic stroke.

“So we were finally able to do something for our patients,” she said.

Regarding the MIPS for Intangible Cultural Heritage Evacuation, Khatri said we need to see the full manuscript before deciding what impact it will ultimately have. “We’ll have to dig into the details before we’re sure it will make a difference in practice, but I think we like what we’re hearing and we’re very excited.”

I was finally able to do something for my patients. Puja Katri

And of the INTERACT3-rated care bundle, she said, “I’m not surprised it worked.” “My overall impression at this point is that it certainly makes sense and supports education and training based on the current standard of care.”

And the trial’s results could have implications for centers that have established ICH protocols, Khatri suggested. “It’s probably going to change more than we’d like, so it might raise our bar in that sense.”

Sandset pointed out that the benefits seen with INTERACT3 could be explained by changes in care team mindsets and the combined effects of all interventions rather than specific interventions.

“Perhaps synergistic effects of these interventions lead to better outcomes for patients,” she says. “Also, we are taking a proactive approach to patient care with a very structured approach, such as the protocol used in INTERACT3, while also providing better holistic care for our patients. I think we can move a little away from the nihilistic approach that many have gone through.” [towards] ICH patient care. “

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