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![Goals
• Primary:
• Death or disability [Modified Rankin Scale (mRS) 4-6] at 90 days
• Secondary:
• European Quality of Life–5 Dimensions (EQ-5D) questionnaire at 3
months
• > 33% expansion of hematoma at 24 hours](https://image.slidesharecdn.com/journalclub-161011200445/85/ATACH-II-trial-6-320.jpg)
![PICO
• P:
• Patients > 18 years with intracerebral hemorrhage (< 60 cm3) and a GCS ≥5 who
presented within 4.5 hours of symptom onset and at least one blood pressure reading
with an SBP ≥180 mm Hg
• I:
• Aggressively lowering blood pressure to an SBP = 110-139 mmHg for 24 hours using
nicardipine (1st line) and labetalol, diltiazem or urapidil (2nd line)
• C:
• Standard treatment guided at a SBP = 140 – 179 mm Hg for 24 hours using nicardipine
(1st line) and labetalol, diltiazem or urapidil (2nd line)
• O:
• Primary: Death or disability [Modified Rankin Scale (mRS) 4-6] at 90 days
• Secondary: EQ-5D utility index score at 3 months, > 33% expansion of hematoma at
24 hours](https://image.slidesharecdn.com/journalclub-161011200445/85/ATACH-II-trial-18-320.jpg)
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ATACH II trial
- 2. OUTLINE • Summarizing thestudy • Critical appraisal: • Validity • Results • Applicability of the study • Conclusion
- 4. Trial Overview • ATACHII trial : Antihypertensive Treatment of Acute cerebral Hemorrhage • NINDS funded international phase III clinical trial • From May 2011 and September 2015 • Hypothesis: • hematoma expansion and the rate of subsequent death or disability might be reduced with very early and more aggressive reduction in the systolic blood- pressure level. • Aim: • To determine the efficacy of rapidly lowering the systolic blood-pressure level in patients in an earlier time window after symptom onset than that evaluated in previous trials.
- 5.
- 6. Goals • Primary: • Deathor disability [Modified Rankin Scale (mRS) 4-6] at 90 days • Secondary: • European Quality of Life–5 Dimensions (EQ-5D) questionnaire at 3 months • > 33% expansion of hematoma at 24 hours
- 9. Literature Review • Previousstudies (ATACH I and INTERACT trial) have shown that early reduction of BP is safe for the patient and may reduce hematoma volume expansion. • INTERACT trial: • Reduce SBP (150-220) to <140mmHg in one hour • Time of presentation : first 6 hours • Mortality rate was equal in both groups • Nonfatal ADE was the same.
- 10. Design: • Randomized, multicenter(110 sites), multinational (6 countries), open-label trial. United States, Japan, China, Taiwan, South Korea, and Germany
- 11. Subject selection cretria •Eligible participants • 18 years and above • GCS > 4 • Intra-parenchymal hematoma of less than 60cm3 on initial CT scan • Within 3 hours (extended to 4.5 hours) of symptom onset • At least one reading of systolic blood pressure of 180 mmHg or more between symptom onset and the initiation of intravenous antihypertensive treatment
- 12. Exclusion criteria • Timeof symptom onset could not be reliably assessed • Admission SBP >240mmHg on two repeat measurements at least 5 min apart • Previously known neoplasms, AVM, or aneurysms • Intracerbral hematoma considered to be related to trauma • ICH located in intratentorial regions such as pons or cerebellum • Intraventricular hemorrhage associated with intraparenchymal hemorrhage and blood completely fills on lateral ventricle or more than half of both ventricles • Patient is considered a candidate for immediate surgical intervention by neurosurgery • Pregnancy, lactation, or parturition within previous 30d • Any history of bleeding diathesis or coagulopathy • Use of warfarin within the last 5d • Platelet count < 50,000/mm3 • Known sensitivity to nicardipine • Pre-morbid mRS of 4 or greater • Patient with living will that precludes aggressive ICU management • Signed and dated informed consent by patient, representative or surrogate could not be obtained
- 13. Study intervention • TwoGroups : • standard therapy (SBP 140-180): 500 patient • Intervention therapy: (SBP 110-140): 500 patient • Main Goal of study protocol: • KEEP SBP IN THE TRAGETED RANGE IN HE FIRST 24 HOURS.
- 15. Management common toboth groups • 1st line = IV nicardipine • infusion initiated at 5mg/hr, increased by 2.5mg/hour every 15 minutes as needed, up to a maximum dose of 15mg/hr • 2nd line (if target not achieved after 30 mins) = IV labetalol (IV diltiazem or urapidil if labetolol not available)
- 16. Results >8500 screened 500 Standard 37.7% primary outcome (deathand disability) 500 Intervention 38.7% primary outcome (death and disability) 1000 met inclusion criteria RR= 1.02 (95% CI 0.85- 1.27)
- 17.
- 18. PICO • P: • Patients> 18 years with intracerebral hemorrhage (< 60 cm3) and a GCS ≥5 who presented within 4.5 hours of symptom onset and at least one blood pressure reading with an SBP ≥180 mm Hg • I: • Aggressively lowering blood pressure to an SBP = 110-139 mmHg for 24 hours using nicardipine (1st line) and labetalol, diltiazem or urapidil (2nd line) • C: • Standard treatment guided at a SBP = 140 – 179 mm Hg for 24 hours using nicardipine (1st line) and labetalol, diltiazem or urapidil (2nd line) • O: • Primary: Death or disability [Modified Rankin Scale (mRS) 4-6] at 90 days • Secondary: EQ-5D utility index score at 3 months, > 33% expansion of hematoma at 24 hours
- 19.
- 20. • Q1: Wasthe assignment of patients to treatment groups truly randomized? • YES. • Randomization was performed centrally through the trial website with the use of a minimization algorithm combined with the biased-coin method. • Q2: Were patients analyzed in the groups they were allocated to at the start of the study? • YES.
- 21. Continue Validity • Q3:Were patients, physicians, and those doing the assessments "blind" to treatment? • Open labled study : the patient and physician knows • Follow up assessment : blind • Radiographer : blind • Q4: Was similarity between groups documented?
- 22.
- 23. • Q5: Asidefrom the intervention, were the groups treated in the same way? • Both groups were randomized before 4.5 hours • Treated by ED and neurology staff • Same antihypertensive medications • Same follow up
- 24.
- 25. >8500 screened 500 Standard 37.7% primary outcome 500 Intervention 38.7% primary outcome 1000 met inclusion criteria •primary Rx failure: 12.2 % • secondary Rx failure : 15.6% • primary Rx failure: 0.8% • secondary Rx failure : 1.4% Relative Risk: 1.02 (95% CI 0.83 – 1.25)
- 26. Analysis of theprimary outcome according to prespecified subgroups showed no significant differences
- 27.
- 28. Strengths • Large studythat was appropriately randomized and asked a clinically relevant question • Multicenter, multinational nature of study increases generalizability • Outcome assessment performed by investigators blinded to treatment arm • Follow up was near complete for the primary outcome (96.1%) • Application in apple and Android phones that help physician to check eligibility of the patient for the study
- 29. Limitations • Study wasopen-label introducing significant biases for clinicians. • Recruitment criteria changed during the trial • Exclusion criteria not clearly stated in manuscript. • Blood pressure control after discharge not measured. • More than 50% of patients recruited from Asia sites and may not be reflective of European population • Significant difference between groups with regards to treatment failure (primary and secondary)
- 30. Author’s conclusions: “The treatmentof participants with intracerebral hemorrhage to achieve a target systolic blood pressure of 110 to 139 mm Hg did not result in a lower rate of death or disability than standard reduction to a target of 140 to 179 mm Hg.”
- 31. Potential Impact toCurrent Practice: This study confirms the negative findings seen in the INTERACT-2 trial that aggressive control of blood pressure in patients with intracerebral hemorrhage does not improve outcomes. Based on current evidence, intensive blood pressure reduction should not be pursued.
- 32. Home message There doesnot appear to be a benefit to aggressive blood pressure reduction in patients with intracerebral hemorrhage. Standard therapy aimed at SBP < 180 mm Hg should be pursued in most patients.
- 33.
Editor's Notes
- #11 Open label study: both the researchers and participants know which treatment is being administered unavoidable under some circumstances, such as comparing the effectiveness of a medication to intensive physical therapy sessions.
- #19 Management of BP in Intervention and Control Arms: 1st Line Agent = IV nicardipine infusion initiated at 5mg/hr, increased by 2.5mg/hr every 15min as needed up to a maximum dose of 15mg/hr 2nd Line Agent = If target BP not achieved after 30 minutes
- #26 - Primary treatment failure was defined as not reaching the target systolic blood pressure of less than 140 mm Hg in the intensive-treatment group and less than 180 mm Hg in the standardtreatment group within 2 hours after randomization. Secondary treatment failure was defined as the hourly minimum systolic blood pressure remaining higher than the upper limit of the target range for 2 consecutive hours during the period of 2 to 24 hours after randomization
- #31 Our Conclusion: Intensive blood pressure control (SBP 110-139 mm Hg) in patients with intracerebral hemorrhage does not improve 90 day death or disability (mRS 4-6) in comparison to standard management.