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PICASSO: Cilostazol similar to aspirin for reduction of CV events in patients with ischemic stroke, TIA
According to a presentation at the International Stroke Conference, cilostazol showed non-inferiority to aspirin for decreasing CV events in patients with ischemic stroke prone to cerebral hemorrhage.
Compared with aspirin, cilostazol was associated with decreased risk for stroke but increased risk for MI in this population, according to the researchers.
While antiplatelet treatment is effective in preventing recurrent ischemic events among patients with non-cardioembolic stroke, the therapy increases risk for cerebral hemorrhaging, according to the study background. The phosphodiesterase 3 inhibitor cilostazol not only decreased risk for recurrent stroke, but also decreased risk for hemorrhagic events among patients with non-cardioembolic stroke or transient ischemic attack, Sun U. Kwon, MD, PhD, from the Asan Medical Center in Seoul, Korea, said at a press conference.
“Cilostazol may be alternatively used to aspirin for secondary prevention for vascular events in non-cardioembolic stroke or TIA patients with extensive small vessel occlusive disease,” Kwon said.
To test the safety and efficacy of cilostazol, the researchers enrolled patients with ischemic stroke at high risk for cerebral hemorrhage in PICASSO, an international, multicenter controlled trial at 67 institutions in three countries between 2009 and 2014.
A total of 1,512 patients (mean age, 65 years; 62% men) were randomly assigned to either 200 mg per day of cilostazol (n = 755) or 100 mg per day of aspirin (n = 757).
Patients were included in the study had non-cardioembolic ischemic stroke or TIA within 180 days of the trial, were over the age of 20 years and had previous intracerebral hemorrhage based on clinical radiologic findings or multiple comorbidities.
The primary efficacy endpoint was time to first occurrence of a composite of major vascular events: stroke, MI and vascular death. The primary safety endpoint was time to first occurrence of cerebral hemorrhage.
The researchers performed a noninferiority test for efficacy and a superiority test for safety.
At a mean follow-up of 2 years, there were 63 (4.27 per 100 person-years) composite vascular events in the cilostazol group and 80 (5.33 per 100 person-years) events in the aspirin group (P for noninferiority = .0038), Kwon reported.
For the safety outcome, total of eight events (1.1%; 0.61 per 100 person-years) occurred in the cilostazol group vs. 16 events (2.1%; 1.2 per 100 person-years) in the aspirin group (P = .0916), according to the researchers.
In the cilostazol group, there were fewer occurrences of stroke (48 events; 3.25 per 100 person-years) than in the aspirin group (73 events; 4.86 per 100 person-year; P = .0273). There were more occurrences in MI in the cilostazol group (nine events; 0.61 per 100 person-years) than in the aspirin group (two events; 0.13 per 100 person-years; P = .0319), however.
“Cilostazol significantly decreased any stroke in comparison to aspirin in this cohort, but increased MI and therefore, failed to demonstrate superiority in reducing composites of CV events,” Kwon said. “Future study verifying patients who may benefit from cilostazol may be needed.” – by Dave Quaile
Reference:
Kwon SU, et al. LB5. Presented at: International Stroke Conference; Feb. 22-24, 2017; Houston, TX.
Disclosure: Kwon reports no relevant financial disclosures.