A novel drug-eluting stent using bioabsorbable polymer technology: two-year follow-up of the CURAMI registry.
BACKGROUND
There are safety concerns on drug-eluting stents (DESs) using durable polymer. The long-term outcome of next generation DESs using bioabsorbable polymer technology remains unknown.


METHODS
From March to June, 2005, a novel sirolimus-eluting (170 microg/cm2), bioabsorbable polymer (PLA and PLGA, eroded over 45 days) coated stent was implanted for treatment of acute myocardial infarction (AMI) in 49 patients (male 86%, age 55+10 years, diabetes 31%). All culprits were de novo lesions in the native coronary artery. On discharge, aspirin and clopidogrel for 3 months followed by life-long aspirin were prescribed. Angiographic follow-up was performed at 8 months. Clinical follow-up was performed at 4, 9 and 24 months.


RESULTS
Angiographic success rate was 100%. In-hospital adverse events consisted of 1 death (2%). All except one patient (due to aspirin allergy) were compliant to the 3 months dual antiplatelet therapy, and there was no adverse event during this period. One patient developed re-infarction in another coronary territory at 6 months. Twenty-seven patients (56%) underwent 8-month angiographic follow-up (Table 3). At 24 months, 6 patients had 7 major adverse cardiac events (12.2%, 1 death, 2 re-infarctions and 4 target lesion revascularizations). There were no incidences of subacute or late stent thrombosis.


CONCLUSIONS
The Cura stent, using bioabsorbable polymer technology, appears to be safe at 2 years follow-up. Although the angiographic follow-up parameters were unfavorable, this report paves the way for further studies on DES using bioabsorbable polymer technology.
Tin Hay
Eduardo
E
Hou
Xu-Min
XM
Lim
Jimmy
J
Low
Adrian
A
Teo
Swee-Guan
SG
Tan
Huay-Cheem
HC
Lee
Chi-Hang
CH
D020341:Absorbable Implants / Q000639:trends*; D000368:Aged; D023903:Coronary Restenosis / Q000517:prevention & control / Q000628:therapy; D054855:Drug-Eluting Stents / Q000639:trends*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011108:Polymers / Q000008:administration & dosage*; D012042:Registries
D011108:Polymers