TAXUS VI final 5-year results: a multicentre, randomised trial comparing polymer-based moderate-release paclitaxel-eluting stent with a bare metal stent for treatment of long, complex coronary artery lesions

Abstract

To assess the long-term safety and efficacy of the paclitaxel-eluting TAXUS moderate-release (MR) investigation-only stent for the treatment of long, complex coronary artery lesions. TAXUS VI was a prospective, double-blind, multicentre trial wherein 446 patients were randomised between a TAXUS Express MR stent and an uncoated Express Control stent. At 5-years, the overall rate of major adverse cardiac events (MACE) was similar in the two groups at 27.8% in control and 31.3% in TAXUS (P = 0.61), including similar rates for stent thrombosis. The target vessel revascularisation (TVR) rate was 23.7% in control and 22.2% in TAXUS (P = 0.45) with a non-target lesion revascularisation (non-TLR) rate of 5.1% in control and 10.9% in TAXUS (P = 0.0274) and a TLR rate of 21.4% in control and 14.6% in TAXUS (relative reduction, 32%; P = 0.0325). Furthermore, subgroup analysis revealed that the TLR benefit of TAXUS was preserved among study groups including small vessels, long lesions and patients receiving multiple overlapping stents. Treatment of complex coronary lesions with the TAXUS MR stent demonstrated similar MACE, similar TVR, and reduced TLR rates compared with control through five years. Based on these positive results, the aetiology of increased non-TLR TVR rate in TAXUS remains unclear.