Incidence of thrombosis after implantation of drug-eluting stents in patients with coronary artery disease.

BACKGROUND

Randomized clinical trials have demonstrated equivalent safety to bare-metal stents after drug-eluting stents (DES) implantation. However, the DES thrombosis in randomized trials could not be comparable to those observed in clinical practice, frequently including off-label indications. This study sought to assess the incidence of DES thrombosis after implantation of DES in patients with real world coronary artery disease (CAD) in China.

METHODS

From December 2001 to April 2007, 8190 consecutive patients received the treatment with DES, 5412 patients completed one year follow-up: 2210 with sirolimus-eluting stent Cypher, 1238 with paclitaxel-eluting stent Taxus and 1964 with Chinese sirolimus-eluting stent Firebird. After two years of follow-up, there were 2176 patients (1245 Cypher, 558 Taxus and 373 Firebird). All patients were treated with aspirin and clopidogrel over at least 9 months.

RESULTS

Among 8190 patients, 17 patients had acute stent thrombosis (0.24%): 7 in the Cypher group, 4 Taxus and 6 Firebird; 23 patients had subacute stent thrombosis: 8 Cypher, 6 Taxus and 9 Firebird. The incidence of acute and subacute thrombosis was 0.49%: 0.50% Cypher, 0.63% Taxus and 0.41% Firebird. The incidence of late thrombosis at one year followup was 0.63%: 0.63% Cypher, 0.88% Taxus and 0.46% Firebird; at two year follow-up the incidence was 0.74%: 0.72% Cypher, 0.90% Taxus and 0.54% Firebird. There was no significant difference among three groups at 1 year and 2 years follow-up.

CONCLUSION

The first generation DES in the treatment of complex lesions are safe and effective if patients are aggressively treated with dual antiplatelet agents.