Safety and effectiveness of drug-eluting stents in Chinese patients with coronary artery disease with off- and on-label indications: results from a single-centre registry.

BACKGROUND

Off-label use of drug-eluting stents (DES) is more common than on-label use and may be associated with a persistently higher rate of adverse angiographic and clinical outcomes.

OBJECTIVE

To evaluate the safety and effectiveness of unrestricted use of DES in everyday practice in a Chinese population.

METHODS

Between January 2004 and May 2009, we retrospectively enrolled 1209 consecutive patients who received DES in our single centre. 84.7% of patients were treated with sirolimus-eluting stents (SES) and 15.3% of patients were treated with paclitaxel-eluting stents (PES).

RESULTS

59.0% of patients (n=713) were treated for off-label indications, with a significantly higher proportion of patients with previous coronary artery bypass grafting (CABG) (6.2% vs 0.6%, p<0.001). There were no differences in coronary risk factors. During 6-66 months' follow-up, the rate of repeat target vessel revascularisation (TVR) was significantly higher in the off-label group (14.6% vs 9.7%, p=0.011). The risk of death and myocardial infarction were not statistically different with off-label from standard use. Multivariate logistic regression showed that the independent predictors of TVR were stent type (SES vs PES, HR=0.567, 95% CI 0.395 to 0.813), previous CABG (HR=2.393, 95% CI 1.440 to 3.977), the treatment of chronic total occlusion (HR=2.786, 95% CI 1.731 to 4.484) and the treatment of left main lesion (HR=1.854, 95% CI 1.022 to 3.363).

CONCLUSIONS

In our local unselected cohort of Chinese people, off-label use of DES was safe in comparison with on-label use and associated with an excellent procedural success rate, but higher TVR.