Transcript Journal Club

Jim Hoehns, Pharm.D.
Lancet 2013;382:507-15
Other
5%
Cryptogenic
30%
Cardiogenic
embolism
20%
Hemorrhagic stroke
15%
Atherosclerotic
cerebrovascular
disease
20%
Small vessel
disease
“lacunes”
25%
Ischemic stroke
85%
Albers G et al. Chest. 2001; 119 (suppl): 300S.

Randomized, open-label, multi-center trial
 3,020 patients; mean follow-up: 3.4 years
 North America, Latin America, Spain; 81 centers
 Funding: NINDS

Treatment
 High SBP: 130-149 mm Hg
 Low SBP: <130 mm Hg
 Randomization
Starting at least 2 weeks
after stroke
▪ Stratified by baseline hypertensive status

Inclusion criteria:
 Age ≥30 yrs
 Symptomatic lacunar stroke within past 180 days
▪ MRI criteria: lesion ≤ 2.0 cm; corresponded to clinical syndrome
▪ TIAs allowed only if MRI evidence present
 No surgically correctable carotid artery disease
 No major risk factors for cardioembolic stroke
N Engl J Med 2012;367:817-25.

Exclusion criteria:
 History of intracerebral bleeding
 Disabling stroke (modified Rankin score ≥4)

Primary outcome:
 Stroke recurrence (any ischemic stroke or ICH,
including subdural hematomas)

Power analysis:
 Estimated 3 yr rate of recurrent stroke: 21%
▪ 90% power to detect 25% RRR with combination

Blood pressure
 Managed by site PI
Median time from qualifying stroke
until randomization: 62 days
138
127
At 1 year: 75% of high BP group at goal, 65% of low BP group at goal

Rate of recurrent stroke much lower than
anticipated
 Frequent use of statins, high adherence to
antiplatelets, good BP control in both groups


Unblinded; however endpoints were
adjudicated in blind fashion
Approximately 5% in either group did not
attain BP goal

Authors
 Findings consistent with those of previous
studies…support a treatment target of <130 for
most patients with recent lacunar stroke

Intervention well tolerated
 BP meds permanently discontinued in 17% in both
groups

Patient disposition
 3% lost to follow-up
 15% prematurely discontinued study