Objective: To observe the incidence rate of stent thrombosis after implantation of drug-eluting stents (DES) in patients with coronary artery disease (CAD) in the real world.
Methods: A total of 8190 consecutive CAD patients underwent implantation with Cypher or Cypher Select stents (Cordis, USA, n = 2986), TAXUS stents (Boston Scientific Corp., USA, n = 1587) and Chinese Rapamycin eluting stents (Firebird, Microport Medical Company, China, n = 3617) for enrolled in this single center registry study from Dec.2001 to April 2007. One-year follow-up was completed in 5412 patients (2210 Cypher or Cypher select stents, 1238 TAXUS stents and 1964 Firebird stents). Two-year follow-up was finished in 2176 patients (1245 Cypher or Cypher Select stents, 558 TAXUS stents and 373 Firebird stents). 80.1% of all the lesions were the type B2 and type C lesions. All patients were treated with aspirin plus clopidogrel for at least 9 months post DES.
Results: Among 8190 patients, 17 patients had acute stent thrombosis (0.21%): 7 in the Cypher group, 4 in the TAXUS group, 6 in the Firebird group; 23 patients had subacute stent thrombosis (0.28%): 8 in Cypher group, 6 in TAXUS group and 9 in Firebird group. The incidence rate of acute and subacute thrombosis was 0.49% (40/8190) and incidence of thrombosis was similar among the three groups (0.50% in Cypher group, 0.63% in TAXUS group and 0.41% in Firebird group, P > 0.05). One-year follow-up showed that late thrombosis rate was 0.63 % (34/5412) and similar among the groups (0.63% in Cypher group, 0.89% in TAXUS group and 0.46% in Firebird group, P > 0.05). Two-year follow-up showed that late thrombosis rate was 0.74 % (16/2176) and was similar among the 3 groups (0.72% in Cypher group, 0.90% in TAXUS group and 0.54% in Firebird group, P > 0.05).
Conclusion: This study indicates that using the first-generation DES to treat complex coronary lesions is safe and effective and the incidence of late thrombosis remains low (< 1%) under double antiplatelet treatment.