European Heart Journal Advance Access published online on October 14, 2007
European Heart Journal, doi:10.1093/eurheartj/ehm424
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TAXUS VI 2-year follow-up: randomized comparison of polymer-based paclitaxel-eluting with bare metal stents for treatment of long, complex lesions
1 HELIOS Heart Center Siegburg, Siegburg, Germany
2 Wessex Cardiothoracic Centre, Southampton University Hospital, Southampton, UK
3 Ospedali Riuniti di Bergamo, Bergamo, Italy
4 John Radcliffe Hospital, Oxford, UK
5 Jan Pawel II Hospital, International Cardiology Clinic, Krakow, Poland
6 Ospedale San Raffaele, Milano, Italy
7 Skejby Sygehus Hospital, Aarhus, Denmark
8 Krankenhaus der Barmherzigen Brüder, Trier, Germany
9 Clinique Pasteur, Toulouse, France
10 O.L.V. Hospital, Aalst, Belgium
11 Brigham and Women's Hospital, Boston, USA
12 Boston Scientific Corporation, Natick, USA
Received 21 February 2006; revised 9 August 2007; accepted 23 August 2007.
* Corresponding author: Department of Cardiology/Angiology, HELIOS Heart Center Siegburg, Ringstrasse 49, 53721 Siegburg, Germany. Tel: +49 2241 18 2322; fax: +49 2241 18 2451. E-mail address: grubee{at}aol.com
Aims: Drug-eluting stents (DESs) have shown to be effective in reducing in-stent restenosis, although data relating to long-term experience in treating more complex lesion subsets are limited. In order to assess the long-term safety and clinical efficacy of the polymer-based moderate release (MR) paclitaxel-eluting TAXUSTM MR stent in treatment of complex lesion subsets, we evaluated the 2-year follow-up of TAXUS VI.
Method and results: TAXUS VI was a randomized multi-centre study enrolling 446 patients with complex lesions, including small vessels in 28% of patients and a mean lesion length of 20.6 mm. At 9-month follow-up, the use of the TAXUS MR stent was highly effective, resulting in a significant 53% reduction of the target vessel revascularization (TVR) rate (primary endpoint) from 19.4% in the control group to 9.1% in the TAXUS group (P = 0.0027). Clinical follow-up at 2 years post-stenting was available in 98.6% of the TAXUS group and 95.6% of the control group. The incidence of major adverse cardiac event at 1- and 2-year follow-up was 16.4% and 21.3% in the TAXUS group when compared with 22.5 and 25.1% in the control group, respectively. A significant difference in TVR was maintained at 2-year follow-up (TAXUS 13.9%; control 21.9%; P = 0.0335). The cumulative 1- and 2-year survival rates free from TVR were, respectively, 91.7 and 90.3% in the TAXUS group vs. 80.0 and 79.0% in the control group (log-rank P < 0.001). The number of patients required to be treated with a TAXUS stent to prevent one re-percutaneous coronary intervention at 2 years was 12.5.
Conclusion: Treatment of complex coronary lesions with the polymer-based MR paclitaxel-eluting TAXUS MR stent is associated with a sustained clinical benefit and low rates of TVR up to 2 years after device implantation.
Key Words: Paclitaxel • Stent • Follow-up • Coronary artery disease
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