ABSTRACT
AIMS: We performed a propensity score matched analysis to explore whether TiNOX stents are superior to paclitaxel- (PES) and sirolimus-eluting stents (SES) in routine clinical practice. METHODS AND RESULTS: A total of 1,607 patients undergoing implantation of SES, PES or TiNOX stents were prospectively entered into a stent registry and followed up for three years. Using propensity score matching, we compared clinical outcome among 319 pairs of patients treated with TiNOX stents or SES and 337 pairs of patients treated with TiNOX stents or PES. The primary outcome MACE, a composite of death, myocardial infarction, and target vessel revascularisation occurred in 20% of patients with TiNOX stents, 19% of patients with SES and 23% of patients with PES at 3-years. The hazard ratio was 1.00 comparing TiNOX stents with SES (95% CI 0.69-1.45, p=1.00), and 0.95 comparing TiNOX stents with PES (95% CI 0.66-1.36, p=0.78). CONCLUSION: We did not find evidence to suggest superiority of TiNOX stents over SES or PES. In view of similar clinical outcomes, but with the reduced duration of dual antiplatelet therapy used with the TiNOX stent, we suggest that TiNOX stents may be an alternative to drug-eluting stents in patients unsuitable for long-term dual antiplatelet therapy.
Subject(s)
Angioplasty, Balloon, Coronary/methods , Coronary Artery Disease/therapy , Drug-Eluting Stents , Paclitaxel , Propensity Score , Sirolimus , Stents , Titanium , Aged , Contraindications , Female , Follow-Up Studies , Humans , Kaplan-Meier Estimate , Longitudinal Studies , Male , Middle Aged , Platelet Aggregation Inhibitors , Proportional Hazards Models , Prospective Studies , Registries , Thrombosis/prevention & control , Treatment OutcomeABSTRACT
PURPOSE: Uncoated self-expanding nitinol stents (NS) are commonly oversized in peripheral arteries. In current practice, 1-mm oversizing is recommended. Yet, oversizing of NS may be associated with increased restenosis. To provide further evidence, NS were implanted in porcine iliofemoral arteries with a stent-to-artery-ratio between 1.0 and 2.3. Besides conventional uncoated NS, a novel self-expanding NS with an antiproliferative titanium-nitride-oxide (TiNOX) coating was tested for safety and efficacy. METHODS: Ten uncoated NS and six TiNOX-coated NS (5-6 mm) were implanted randomly in the iliofemoral artery of six mini-pigs. After implantation, quantitative angiography (QA) was performed for calculation of artery and minimal luminal diameter. Follow-up was performed by QA and histomorphometry after 5 months. RESULTS: Stent migration, stent fracture, or thrombus formation were not observed. All stents were patent at follow-up. Based on the location of the stent (iliac/femoral) and the stent-to-artery-ratio, stent segments were divided into "normal-sized" (stent-to-artery-ratio < 1.4, n = 12) and "oversized" (stent-to-artery-ratio ≥ 1.4, n = 9). All stent segments expanded to their near nominal diameter during follow-up. Normal-sized stent segments increased their diameter by 6% and oversized segments by 29%. A significant correlation between oversizing and restenosis by both angiography and histomorphometry was observed. Restenosis rates were similar for uncoated NS and TiNOX-coated NS. CONCLUSIONS: TiNOX-coated NS are as safe and effective as uncoated NS in the porcine iliofemoral artery. All stents further expand to near their nominal diameter during follow-up. Oversizing is linearly and positively correlated with neointimal proliferation and restenosis, which may not be reduced by TiNOX-coating.
