Safety and efficacy of the CYPHER Select Sirolimus-eluting stent in the "Real World"--clinical and angiographic results from the China CYPHER Select registry.

OBJECTIVE: This post-marketing surveillance registry is aimed at determining the safety and reliability of the CYPHER Select Sirolimus-eluting stent (SES) in routine clinical practice.
BACKGROUND: Little information and angiographic follow-up data in large-scale "real world" registry is available for the CYPHER Select SES, an advanced-generation SES.
METHODS: This was a prospective multicenter (20 centers) registry. 1189 consecutive patients who received at least 1 CYPHER Select SES during daily clinical practice were enrolled. Patients who underwent emergency stenting for acute myocardial infarction were excluded.
RESULTS: The procedure's success rate was 98.3% for CYPHER Select SES implantation, and follow-up rates were 98% with 100% data auditing. Target lesion revascularization (TLR) at 12 months occurred in 60 (5.14%) cases, cardiac death in 13 cases (1.11%), Q wave myocardial infarction (MI) in 5 cases (0.43%), non-Q-MI in 9 cases (0.77%), target vessel revascularization (TVR) in 67 cases (5.74%), and MACE defined as cardiac death, nonfatal MI and TLR in 76 cases (6.51%). MACE-free survival rate at 12 months was 93.7%. Angiographic follow-up at 9 months was performed in 418 (68.3%) lesions treated by CYPHER Select SES. The binary restenosis rate was 4.8% in-stent and 9.6% in-segment. Subgroup analysis showed diabetes, bifurcation lesion and combined use of different stents were independent risk factors of cumulative MACE. In-segment MLD </=2.25 mm at post-procedure and ostial lesion was independent predictors of in-segment restenosis.
CONCLUSIONS: In this registry, the MACE, TLR, angiographic late loss and binary restenosis rates of CYPHER Select SES were similar to those reported in SES randomized trials and "real world" registries. The safety and efficacy of CYPHER Select SES shown in this registry are consistent with those seen in SES studies.