Two-year follow-up of the NEVO ResElution-I(NEVO RES-I)trial: a randomised, multicentre comparison of the NEVOsirolimus-eluting coronary stent with the TAXUS Libertépaclitaxel-eluting stent in de novo native coronary arterylesions

Aims: To assess the two-year clinical follow-up of the NEVO RES-1 study, a randomised comparisonbetween 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 maximumlength of 28 mm and diameter of 2.5-3.5 mm to NEVO SES (n=202) versus TAXUS PES (n=192). Six-monthangiographic results demonstrated the superiority of the NEVO SES over the TAXUS PES for the primaryendpoint, in-stent late loss. At one year, MACE (death, emergent CABG, TLR, and MI) in the NEVO SESgroup was 6.1% versus 10.6% in the TAXUS PES group (p=0.139). After two years, MACE was 7.2% in theNEVO 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 withNEVO SES while two occurred with TAXUS PES.Conclusions: While not designed or powered for clinical endpoints, individual and composite clinical endpointsnumerically favoured the NEVO SES over the TAXUS PES, with continued separation over time upto two years. No ARC-defined definite or probable ST was reported in the NEVO SES group at two years.

Procedural and early clinical outcomes of patients withde novo coronary bifurcation lesions treated with the novelNile PAX dedicated bifurcation polymer-free paclitaxelcoated stents: results from the prospective, multicentre,non-randomised BIPAX clinical trial

Aims: To demonstrate the acute and early outcomes of the novel Nile PAX dedicated polymer-free paclitaxelcoatedstents (Minvasys SAS, Gennevilliers, France) in the treatment of de novo coronary bifurcation lesions.Methods and results: The Nile PAX device incorporates a cobalt-chromium alloy with a side aperture inthe mid-stent designed to optimise scaffold at the bifurcation carina and side branch (SB) ostium, while maintainingSB access during procedure. From December 2008 to February 2010, 101 patients were prospectivelyenrolled in a non-randomised, multicentre study. Lesion criteria were: vessel size 2.5-3.5 mm in the parentvessel (PV) and 2.0-3.0 mm in the SB, and lesion length <14 mm in the PV, and <5 mm in the SB. Mean agewas 63 years, 29% had diabetes, LAD/Dg was involved in 80.4%, and 61.7% had significant involvement ofboth branches. The study stent was successfully attempted and implanted in 98%. SB received additionalstent in 26%; final kissing-balloon inflation was performed in 93%; and lesion (angiographic) success wasachieved in 98%. There was only one non-Q myocardial infarction during hospitalisation, and no additionalevents up to 30 days.Conclusions: Preliminary results of the prospective, non-randomised, multicentre BIPAX clinical trial demonstratedencouraging results with the novel Nile PAX bifurcation DES in the treatment of coronary bifurcationlesions, including high device and procedural success. Overall, there was only one major adverse cardiac eventduring hospitalisation, with no additional events up to 30 days follow-up. Long-term follow-up is warranted.

Six-month results of the NEVO RES-ELUTION I (NEVO RES-I) trial: randomized, multicenter comparison of the NEVO Sirolimus-Eluting coronary stent vith the TAXUS libert paclitaxel-eluting stent in de novo native coronary artery lesions

Background—Drug-eluting stents reduce restenosis and reintervention rates but are complicated by stent thrombosis,which may be related to polymer coating. The NEVO sirolimus-eluting coronary stent (NEVO SES) is designed to improve long-term percutaneous coronary intervention safety by combining sirolimus release from reservoirs withbioabsorbable polymer to reduce spatial and temporal polymer exposure.Methods and Results—NEVO ResElution-I was a prospective randomized study in 394 patients with coronary arterydisease comparing the NEVO SES with the TAXUS Liberte´ paclitaxel-eluting coronary stent (TAXUS Liberte´ PES)stent. The primary end point was in-stent angiographic late loss at 6 months. Six months after percutaneous coronaryintervention (PCI), the primary end point favored NEVO SES (0.13 0.31 mm versus 0.36 0.48 mm, P 0.001 fornoninferiority and superiority). The study was not powered for clinical end points and showed no significant differencefor NEVO SES versus TAXUS Liberte´ PES: death: 0.5 versus 1.6%, P 0.36; myocardial infarction: 2.0 versus 2.6%,P 0.75; target lesion revascularization: 1.5 versus 3.2%, P 0.33; major adverse cardiac events: 4.0 versus 7.4%, P 0.19.No stent thrombosis was observed with NEVO SES, whereas 2 cases occurred in TAXUS Liberte´ PES. Intravascularultrasound showed lower percent volume obstruction for NEVO SES (5.5 11% versus 11.5 9.7%, P 0.016).Conclusions—This trial proved the superiority of NEVO SES over TAXUS Liberte´ PES for the primary angiographic endpoint of in-stent late loss. No stent thrombosis occurred in the NEVO SES group.

A Randomized comparison of a sirulimus-eluting stent with a standard stent for coronary revascularization

The need for repeated treatment of restenosis treated vessels remains the main limitation of percutaneous coronary revascularization. Because sirolimus (rapamycin) inhibits the proliferation of lymphocytes and smooth-muscle cells, we compared a sirolimus-eluting stent with a standard uncoated stents in patients with angina pectoris..