Polyglycolide/Polylactide-Coated Platinum Coils for Patients With Ruptured and Unruptured Cerebral Aneurysms

Abstract

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.