TAXUS VI 2-year follow-up: randomized comparison of polymer-based paclitaxel-eluting with bare metal stents for treatment of long, complex lesions
Identifieur interne : 001297 ( Main/Exploration ); précédent : 001296; suivant : 001298TAXUS VI 2-year follow-up: randomized comparison of polymer-based paclitaxel-eluting with bare metal stents for treatment of long, complex lesions
Auteurs : Eberhard Grube [Allemagne] ; Keith D. Dawkins [Royaume-Uni] ; Giulio Guagliumi [Italie] ; Adrian P. Banning [Royaume-Uni] ; Krzysztof Zmudka [Pologne] ; Antonio Colombo [Italie] ; Leif Thuesen [Danemark] ; Karl Hauptman [Allemagne] ; Jean Marco [France] ; William Wijns [Belgique] ; Jeffrey J. Popma [États-Unis] ; Lutz Buellesfeld [Allemagne] ; Joerg Koglin [États-Unis] ; Mary E. Russell [États-Unis]Source :
- European Heart Journal [ 0195-668X ] ; 2007-11.
Abstract
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 TAXUS 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.
Url:
DOI: 10.1093/eurheartj/ehm424
Affiliations:
- Allemagne, Belgique, Danemark, France, Italie, Pologne, Royaume-Uni, États-Unis
- Angleterre, Massachusetts, Midi-Pyrénées, Occitanie (région administrative), Oxfordshire
- Boston, Oxford, Toulouse
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<front><div type="abstract">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 TAXUS 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.</div>
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