Background and purpose: Recanalization of cerebral aneurysm is a limitation of bare platinum coils (BPCs). In a swine aneurysm model, polyglycolide/polylactide (a polymer)-coated platinum coils (Matrix) accelerated clot fibrosis and reduced recanalization rate and aneurysmal volume. We aimed to evaluate the safety of Matrix coils in patients with intracranial aneurysm.
Methods: This is a single-center, prospective study of patients with intracranial aneurysms treated with Matrix alone or in combination with BPCs. Follow-up evaluation included a 1-month clinical evaluation and a 6- and 12-month clinical and angiographic examination. Primary adverse events included death, stroke, and permanent neurological deficits.
Results: Between May 2002 and January 2004, 52 patients (range 34 to 79 years of age; 38 females) were treated for 54 aneurysms (size 7.9+/-4.6 mm; neck 3.9+/-1.5 mm; 26 ruptured). Matrix alone was used in 13 aneurysms. In 39, we used a combination of Matrix and BPCs. Twenty-one aneurysms had a 6-month follow-up examination (11 Matrix; 10 Matrix combined with bare platinum), and 11 completed the 12-month follow-up evaluation (Matrix only). Adverse events not related to the procedure were 2 deaths (ruptured basilar aneurysms) and 1 stroke at day 10 postcoiling secondary to vasospasm. Procedure-related adverse events were 2 strokes. At 6-month follow-up (n=21) evaluation, 2 of 3 recanalizations needed retreatment. At 12-month follow-up (n=11), there was no recanalization in patients treated with Matrix alone and no significant reduction in aneurysmal size.
Conclusions: Polyglycolide/polylactide-coated coils had a satisfactory safety profile. Significant aneurysmal size reduction after coiling was not observed.