Long-term clinical, angiographic, and intravascular ultrasound outcomes of biodegradable polymer-coated sirolimus-eluting stents.
BACKGROUND
The residual drug carriers on drug-eluting stents (DES) surfaces are considered to be one of the most significant reasons causing late thrombosis. There is no documented data currently available on the safety/benefit profile beyond 6 months of EXCEL stent, a novel sirolimus-eluting stent with biodegradable polymer coating, in treating patients with coronary artery disease (CHD).


OBJECTIVE
To evaluate the long-term efficacy and safety of EXCEL stent on treating CHD patients.


METHODS
Between February and March 2006, a consecutive cohort of complex patients treated with the EXCEL stent was prospectively enrolled in this single-center registry. Antiplatelet protocol was 6-month dual antiplatelet therapy with clopidogrel and aspirin followed by aspirin alone indefinitely. The primary outcome was major adverse cardiac events (MACE) at 12 months. Secondary outcomes included in-segment and in-stent late lumen loss and binary restenosis rate measured by quantitative coronary angiography (QCA) analysis at 8 months postindex PCI procedure.


RESULTS
A total of 100 patients with 153 lesions were included in this analysis. Most lesions (83.0%) were classified as complex (B2/C). At 12 months, four patients (4.0%) experienced MACE, which were four target-lesion revascularizations due to in-stent restenosis (ISR). All patients received follow-up up to 24 +/- 0.4 months and no cardiac death, MI, and in-stent thrombosis occurred during the 6 months of dual antiplatelet therapy or the subsequent 15 months of aspirin treatment alone. QCA analysis of 112 lesions from 75 patients showed 3.6% (4/112) in-stent lesion restenosis, 5.4% (6/112) in-segment lesion restenosis, 0.12 +/- 0.34 mm in-stent late lumen loss, and 0.08 +/- 0.35 mm in-segment late lumen loss.


CONCLUSIONS
In this single-center experience with complex patients and lesions, the EXCEL stent implantation with 6-month dual antiplatelet treatment proved to markedly reduce the incidence of 24-month ISR and MACE. These preliminary findings require further validation by large scale, randomized trials.
Han
Yaling
Y
Department of Cardiology, Shenyang Northern Hospital, Shenyang, Liaoning, China. hanyaling@263.net
Jing
Quanmin
Q
Chen
Xuezhi
X
Wang
Shouli
S
Ma
Yingyan
Y
Liu
Haiwei
H
Luan
Bo
B
Wang
Geng
G
Li
Yi
Y
Wang
Zulu
Z
Wang
Dongmei
D
Xu
Bo
B
Gao
Runlin
R
D000042:Absorption; D054058:Acute Coronary Syndrome / Q000000981:diagnostic imaging / Q000628:therapy*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001241:Aspirin / Q000627:therapeutic use; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000628:therapy; D003331:Coronary Vessels / Q000000981:diagnostic imaging*; D054855:Drug-Eluting Stents / Q000009:adverse effects; D005260:Female; D006801:Humans; D019344:Lactic Acid; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011091:Polyesters; D011108:Polymers; D020123:Sirolimus; D018084:Ultrasonography, Interventional
D020099:Coated Materials, Biocompatible; D010975:Platelet Aggregation Inhibitors; D011091:Polyesters; D011108:Polymers; D019344:Lactic Acid; C033616:poly(lactide); D001241:Aspirin; D020123:Sirolimus