2nd Generation Drug-Eluting Stents Demonstrate Lesser Rate of Restenosis in CTO

SAN FRANCISCO, CA—Drug-eluting stents used in patients with chronic total occlusion (CTO) is safe with low acute complications, as presented by Sunao Nakamura, MD, PhD from the New Tokyo Hospital, Chiba, Japan at ACC.13, the American College of Cardiology's 62nd Annual Scientific Session. Patients treated with 2nd generation drug-eluting stents such as zotarolimus, biolimusA9, and everolimus-eluting stents demonstrated a lower rate of restenosis compared to 1st generation drug-eluting stents.

Dr. Nakamura and colleagues compared the safety, efficacy, and durability of sirolimus (SES), paclitaxel (PES), zotarolimus (ZES-R/endeavor resolute), biolimusA9 (BES), EPC capture (ECS) and everolimus-eluting stent (EES) on the outcome of patients with left main coronary arteries (LMT) disease with bifurcated stenosis. The antiplatelet therapy consisted of aspirin 100mg/day and clopidogrel 75mg/day  (with 300mg loading dose) for 12 months; patients with EPC only had a 1 month duration.

Investigators performed a prospective analysis on 1,576 patients with 1,738 CTOs (n=396 SES; n=526 PES; n=219 ZES-R; n=209 BES; n=148 ECS; and n=240 EES) from six high volume Asian centers after successful recanalization of CTO was performed.  The primary endpoints for this study were major cardiac events (MACE) at 30 days, 12 months, 24 months, and 48 months including death, MI, CAGB, and repeat PCI. Secondary endpoints included 12 months angiographic restenosis rate and 12 months target lesion revascularization.

The percentage of patients experiencing MACE at 30 days was 0.5 (SES and ZES-R), 0.6 (PES), 0.8 (ECS), and 0 (BES and EES). At 12 and 36 months, MACE occurred in 7.1% and 15.6% (SES), 8.7% and 19.5% (PES), 7.5% and 17.1% (ZES-R), 5.9% and 16.0% (BES), 19.5% and 30.9% (ECS), 4.5% and 13.7% (EES) patients, respectively. Target lesion revascularization was performed in 5.5% and 9.9% (SES), 8.3% and 13.7% (PES), 7.0% and 11.1% (ZES-R), 5.9% and 10.1% (BES), 17.9% and 24.4% (ECS), 4.5% and 8.7% (EES) patients at 12 months and 36 months, respectively.

These results demonstrate that the treatment of unprotected left main coronary artery disease with the SES, PES, ZES-R, ECS, BES, and EES are safe and feasible. Dr. Nakamura stated, “Patients treated with 2nd generation drug-eluting stents showed a lesser rate of restenosis because of the lesser rate loss compared with others.”