Two-year follow-up of the NEVO ResElution-I(NEVO RES-I) trial: a randomised, multicentre comparison of the NEVO sirolimus-eluting coronary stent with the TAXUS Liberté paclitaxel-eluting stent in de novo native coronary artery lesions
Alexandre Abizaid, John A Ormiston, Jean Fajadet, Laura Mauri, Joachim Schofer, Stefan Verheye, Joseph Dens, Leif Thuesen, Nathalie Macours, Ayesha C Qureshi, Christian Spaulding, NEVO ResElution-I Investigators, Alexandre Abizaid, John A Ormiston, Jean Fajadet, Laura Mauri, Joachim Schofer, Stefan Verheye, Michael Farkouh, David Faxon, Bernard Gersh, Christian Hamm, Gary Mintz, E John Orav, Cliff Berger, Scott Bortman, Frank Bowen, John Dashe, Laurence Epstein, Eli Gelfand, Satyendra Giri, David Gossman, Allen Hamdan, Thomas Hauser, Joseph Kannam, Kamal Khabbaz, Megan Leary, David Litvak, Warren Manning, Peter Oettgen, Duane Pinto, David Thaler, Sergio Waxman, Meredith, Whitbourn, Worthley, Verheye, Dens, Dubois, Legrand, Wijns, Debruyne, Abizaid, Ribeiro, Thuesen, Kelbaek, Weber, Fajadet, Morice, Teiger, Carrie, Schofer, Hoffmann, Jung, Kuck, Neumann, Richardt, Stangl, Kahlert, Den Heijer, Koolen, Stella, Suttorp, Ormiston, McClean, Webster, Curzen, Banning, Blackman, De Belder, Oldroyd, Alexandre Abizaid, John A Ormiston, Jean Fajadet, Laura Mauri, Joachim Schofer, Stefan Verheye, Joseph Dens, Leif Thuesen, Nathalie Macours, Ayesha C Qureshi, Christian Spaulding, NEVO ResElution-I Investigators, Alexandre Abizaid, John A Ormiston, Jean Fajadet, Laura Mauri, Joachim Schofer, Stefan Verheye, Michael Farkouh, David Faxon, Bernard Gersh, Christian Hamm, Gary Mintz, E John Orav, Cliff Berger, Scott Bortman, Frank Bowen, John Dashe, Laurence Epstein, Eli Gelfand, Satyendra Giri, David Gossman, Allen Hamdan, Thomas Hauser, Joseph Kannam, Kamal Khabbaz, Megan Leary, David Litvak, Warren Manning, Peter Oettgen, Duane Pinto, David Thaler, Sergio Waxman, Meredith, Whitbourn, Worthley, Verheye, Dens, Dubois, Legrand, Wijns, Debruyne, Abizaid, Ribeiro, Thuesen, Kelbaek, Weber, Fajadet, Morice, Teiger, Carrie, Schofer, Hoffmann, Jung, Kuck, Neumann, Richardt, Stangl, Kahlert, Den Heijer, Koolen, Stella, Suttorp, Ormiston, McClean, Webster, Curzen, Banning, Blackman, De Belder, Oldroyd
Abstract
Aims: To assess the two-year clinical follow-up of the NEVO RES-1 study, a randomised comparison between the NEVO™ sirolimus-eluting coronary stent system (NEVO SES) and the TAXUS Liberté™ paclitaxel-eluting stent (TAXUS PES).
Methods and results: NEVO RES-I randomised 394 patients with single de novo lesions with a maximum length of 28 mm and diameter of 2.5-3.5 mm to NEVO SES (n=202) versus TAXUS PES (n=192). Six-month angiographic results demonstrated the superiority of the NEVO SES over the TAXUS PES for the primary endpoint, in-stent late loss. At one year, MACE (death, emergent CABG, TLR, and MI) in the NEVO SES group was 6.1% versus 10.6% in the TAXUS PES group (p=0.139). After two years, MACE was 7.2% in the NEVO SES group versus 13.0% in TAXUS PES group (p=0.086). Corresponding rates of TLR were 3.6% versus 7.6% (p=0.116). No ARC-defined definite or probable stent thromboses (ST) were reported with NEVO SES while two occurred with TAXUS PES.
Conclusions: While not designed or powered for clinical endpoints, individual and composite clinical endpoints numerically favoured the NEVO SES over the TAXUS PES, with continued separation over time up to two years. No ARC-defined definite or probable ST was reported in the NEVO SES group at two years. Clinical trial identifier: NCT00606333 http://www.clinicaltrials.gov.
Source: PubMed