Two New SES Show Improvement Over First-Generation Stents

SAN FRANCISCO, CALIF.—Compared with a first-generation paclitaxel-eluting stent, two new sirolimus-eluting stents—one polymer free, one with a biodegradable polymer—resulted in less in-stent late lumen loss, according to the results of two late-breaking trial presentations at TCT 2011.

For the prospective, multicenter NEXT trial, Didier Carrié, MD, PhD, of Hôpital de Rangueil (Toulouse, France), and colleagues randomized patients with ischemic myocardial symptoms related to de novo lesions to the new polymer-free Cre8 stent (n = 162; Carbostent & Implantable Devices) or Taxus Liberté (n = 161; Boston Scientific). Cre8 utilizes abluminal reservoir technology, which controls and directs drug elution to the vessel wall, as well as a sirolimus/organic acid formulation that enhances drug bioavailability, permeability, and overall safety and efficacy.

Multivariate analysis showed significantly less in-stent late lumen loss at 6 months (primary endpoint) with Cre8 vs. Taxus (figure 1). For this endpoint, Cre8 proved to be both noninferior and superior to the Taxus Liberté stent (P <  0.0001 for both). Six-month angiographic results also showed Cre8 was associated with significantly less in-segment late lumen loss (P = 0.0041), in-stent minimal lumen diameter (P = 0.0006), in-segment minimal lumen diameter (P = 0.0353), in-stent diameter stenosis (P < 0.0001) and in-segment diameter stenosis (P = 0.0022). Differences in binary restenosis between the two stents were not significant at 1 year. There was a low incidence of cumulative cardiac death, MI and target lesion revascularization at 1 year, resulting in an overall Cre8 MACE rate of 6.5%, consistent with lesion complexity, according to Carrié.

“The NEXT study results support the rationale that high-risk patients should benefit from polymer-free DES implantation,” Carrié said. “Further clinical trials to address clinical safety and efficacy are highly recommended.”

Combo dual therapy stent

For the prospective, multicenter, first-in-man REMEDEE trial, Michael Haude, MD, of Lukaskrankenhaus Neuss, Germany, and colleagues randomized patients with single de novo lesions in native coronary arteries to the new dual therapy Combo stent (n = 124; Orbus-Neich) or Taxus Liberté stent (n = 59). The sirolimus-eluting Combo stent has a backbone of 316L stainless steel, with an abluminal biodegradable polymer matrix and a layer of anti-CD34 antibody treatment.

Multivariate analysis showed less in-stent late lumen loss at 9 months (primary endpoint) with Combo, demonstrating non-inferiority to Taxus Liberté; however, results did not meet superiority criteria (figure 2). There were no significant differences in minimum lumen diameter, restenosis or other clinical endpoints, including death, MI and stent thrombosis, between the two stents.MACE at 9 months were also similar (11% with Taxus Liberté vs. 8.7% with Combo; P = 0.69).

“The results of this study show that the Combo stent proves to be effective and safe,” Haude said. An optimal coherence tomography follow-up study is currently being conducted comparing Combo with a limus-eluting stent.

Study details

For the NEXT study, there was trend for more men randomized to the Cre8 (76.5%) stent compared withTaxus Liberté (67.7%; P = 0.0832). Patients enrolled were aged 65 years on average, and about one-fourth had diabetes.

For REMEDEE, 72% of patients were men, half were smokers and one-third had diabetes.

Disclosures

• Dr. Carrié reports no relevant financial disclosures.
• Dr. Haude received grant/research support from Biotronik and Orbus Neich and consulting fees/honoraria from Abbott Vascular, Medtronic and Volcano.