1. Hemicraniectomy in Older Patients with Extensive Middle-Cerebral-Artery Stroke DESTINY II TRIAL
Katherine Steele
7 April 2014

2. Why choose this trial? DECIMAL, DESTINY and HAMLET trials
Improved morbidity and mortality in younger patient groups:
Increased 1 year survival from 29% to 78%
Increased rate of mild-mod disability 43% vs. 21% conservative management
Rate of survival with severe disability low in both groups

3. DESTINY II TRIAL
Prospective, randomised controlled multi center trial - 13 sites throughout Germany: August May 2013
112 patients > 61 years (61-82 with median 70 years)
Comparison of outcomes of malignant MCA ischaemic stroke:
Control group - conservative management
Treatment group - early hemicraniectomy
Limited to patients admitted to the ICU
Primary endpoint: Modified Rankin score at 6 months
Secondary endpoints: 12 months survival, disability, depression and satisfaction

4. Inclusion Criteria 61 years of age or older
Acute unilateral MCA stroke symptoms
Onset of symptoms <48hrs before treatment initiation
National Institutes of Health Stroke Scale (NIHSS) scores:
>14 (non-dominant hemisphere) with reduced level of consciousness
>19 (dominant hemisphere) with reduced level of consciousness
Ischaemic infarction of at least 2/3 of the MCA territory, including basal ganglia, on imaging

5. Exclusion Criteria
Pre-existing score of >1 on the modified Rankin scale OR
Pre-existing score of <95 on the Barthel Index
Absence of pupillary reflexes
GCS < 6
Haemorrhages or other associated brain lesions
Contraindications to surgery
Estimated life expectancy of < 3 years

6. Treatments
Initiated within 48 hours of onset of symptoms, no later than 6 hours after randomisation
Therapies for the control group included the following:
Basic therapy in the ICU for stroke
Osmotherapy - mannitol, glycerol or hypertonic hydroxyethyl starch
Sedation, intubation and mechanical ventilation
Hyperventilation
Buffer solutions
Surgical treatment: large hemicraniectomy (diameter at least 12cm) and duroplasty

7. Results - primary endpoint at 6 months
Patient recruitment was stopped after 82 patients assessed for the primary endpoint (6 months)
Hemicraniectomy group - 40 patients (9 additional)
Control group - 42 patients (21 additional)
Modified Rankin score of 4 or less:
Hemicraniectomy group: 20 out of 49 patients
Control group: 10 out of 63 patients
Mortality at 6 months: 33% surgery vs. 70% control

8. Results - primary endpoint at 6 months

9. Secondary Endpoint: 12 months

10. Secondary Endpoint: 12 months

11. Secondary Endpoint: 12 months

12. Secondary Endpoint: 12 months

13. Secondary Endpoint: 12 months

14. Points for Discussion
Trial design - initial design: sample size determined for 90% power
Sample size
Heterogeneity of groups
Statistical significance of endpoints
Morbidity after intervention - is intervention worth it?