TAXUS VI 2-year follow-up: randomized comparison of polymer-based paclitaxel-eluting with bare metal stents for treatment of long, complex lesions.

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) p...

Full description

Bibliographic Details
Main Authors: Grube, E, Dawkins, K, Guagliumi, G, Banning, A, Zmudka, K, Colombo, A, Thuesen, L, Hauptman, K, Marco, J, Wijns, W, Popma, J, Buellesfeld, L, Koglin, J, Russell, M
Format: Journal article
Language:English
Published: 2007
_version_ 1797072264479375360
author Grube, E
Dawkins, K
Guagliumi, G
Banning, A
Zmudka, K
Colombo, A
Thuesen, L
Hauptman, K
Marco, J
Wijns, W
Popma, J
Buellesfeld, L
Koglin, J
Russell, M
author_facet Grube, E
Dawkins, K
Guagliumi, G
Banning, A
Zmudka, K
Colombo, A
Thuesen, L
Hauptman, K
Marco, J
Wijns, W
Popma, J
Buellesfeld, L
Koglin, J
Russell, M
author_sort Grube, E
collection OXFORD
description 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.
first_indexed 2024-03-06T23:05:15Z
format Journal article
id oxford-uuid:638da94b-b95f-4827-8fca-c4df841496fd
institution University of Oxford
language English
last_indexed 2024-03-06T23:05:15Z
publishDate 2007
record_format dspace
spelling oxford-uuid:638da94b-b95f-4827-8fca-c4df841496fd2022-03-26T18:13:44ZTAXUS VI 2-year follow-up: randomized comparison of polymer-based paclitaxel-eluting with bare metal stents for treatment of long, complex lesions.Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:638da94b-b95f-4827-8fca-c4df841496fdEnglishSymplectic Elements at Oxford2007Grube, EDawkins, KGuagliumi, GBanning, AZmudka, KColombo, AThuesen, LHauptman, KMarco, JWijns, WPopma, JBuellesfeld, LKoglin, JRussell, M 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.
spellingShingle Grube, E
Dawkins, K
Guagliumi, G
Banning, A
Zmudka, K
Colombo, A
Thuesen, L
Hauptman, K
Marco, J
Wijns, W
Popma, J
Buellesfeld, L
Koglin, J
Russell, M
TAXUS VI 2-year follow-up: randomized comparison of polymer-based paclitaxel-eluting with bare metal stents for treatment of long, complex lesions.
title TAXUS VI 2-year follow-up: randomized comparison of polymer-based paclitaxel-eluting with bare metal stents for treatment of long, complex lesions.
title_full TAXUS VI 2-year follow-up: randomized comparison of polymer-based paclitaxel-eluting with bare metal stents for treatment of long, complex lesions.
title_fullStr TAXUS VI 2-year follow-up: randomized comparison of polymer-based paclitaxel-eluting with bare metal stents for treatment of long, complex lesions.
title_full_unstemmed TAXUS VI 2-year follow-up: randomized comparison of polymer-based paclitaxel-eluting with bare metal stents for treatment of long, complex lesions.
title_short TAXUS VI 2-year follow-up: randomized comparison of polymer-based paclitaxel-eluting with bare metal stents for treatment of long, complex lesions.
title_sort taxus vi 2 year follow up randomized comparison of polymer based paclitaxel eluting with bare metal stents for treatment of long complex lesions
work_keys_str_mv AT grubee taxusvi2yearfollowuprandomizedcomparisonofpolymerbasedpaclitaxelelutingwithbaremetalstentsfortreatmentoflongcomplexlesions
AT dawkinsk taxusvi2yearfollowuprandomizedcomparisonofpolymerbasedpaclitaxelelutingwithbaremetalstentsfortreatmentoflongcomplexlesions
AT guagliumig taxusvi2yearfollowuprandomizedcomparisonofpolymerbasedpaclitaxelelutingwithbaremetalstentsfortreatmentoflongcomplexlesions
AT banninga taxusvi2yearfollowuprandomizedcomparisonofpolymerbasedpaclitaxelelutingwithbaremetalstentsfortreatmentoflongcomplexlesions
AT zmudkak taxusvi2yearfollowuprandomizedcomparisonofpolymerbasedpaclitaxelelutingwithbaremetalstentsfortreatmentoflongcomplexlesions
AT colomboa taxusvi2yearfollowuprandomizedcomparisonofpolymerbasedpaclitaxelelutingwithbaremetalstentsfortreatmentoflongcomplexlesions
AT thuesenl taxusvi2yearfollowuprandomizedcomparisonofpolymerbasedpaclitaxelelutingwithbaremetalstentsfortreatmentoflongcomplexlesions
AT hauptmank taxusvi2yearfollowuprandomizedcomparisonofpolymerbasedpaclitaxelelutingwithbaremetalstentsfortreatmentoflongcomplexlesions
AT marcoj taxusvi2yearfollowuprandomizedcomparisonofpolymerbasedpaclitaxelelutingwithbaremetalstentsfortreatmentoflongcomplexlesions
AT wijnsw taxusvi2yearfollowuprandomizedcomparisonofpolymerbasedpaclitaxelelutingwithbaremetalstentsfortreatmentoflongcomplexlesions
AT popmaj taxusvi2yearfollowuprandomizedcomparisonofpolymerbasedpaclitaxelelutingwithbaremetalstentsfortreatmentoflongcomplexlesions
AT buellesfeldl taxusvi2yearfollowuprandomizedcomparisonofpolymerbasedpaclitaxelelutingwithbaremetalstentsfortreatmentoflongcomplexlesions
AT koglinj taxusvi2yearfollowuprandomizedcomparisonofpolymerbasedpaclitaxelelutingwithbaremetalstentsfortreatmentoflongcomplexlesions
AT russellm taxusvi2yearfollowuprandomizedcomparisonofpolymerbasedpaclitaxelelutingwithbaremetalstentsfortreatmentoflongcomplexlesions