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May 13, 2015

BMI Shown to Have No Impact on Long-Term Outcomes of Resolute ZES Implantation

May 14, 2015—Individual patient data from the RESOLUTE clinical program were pooled to investigate the impact of body mass index (BMI) on long-term clinical outcomes after implantation of Resolute zotarolimus-eluting stents (ZES; Medtronic plc) and were published by Roberto Diletti, MD, et al in Catheterization and Cardiovascular Interventions (2015;85:952–958). The RESOLUTE program included five trials worldwide. 

As the investigators noted in the background of the study, increased BMI is associated with a high risk of cardiovascular disease and reduction in life expectancy, but several studies reported improved clinical outcomes in obese patients treated for cardiovascular diseases.

In the present study, the investigators concluded that patients’ BMI had no impact on long-term clinical outcomes after coronary artery interventions.

As summarized in Catheterization and Cardiovascular Interventions, the study population was sorted according to BMI tertiles, and clinical outcomes were evaluated at 2-year follow-up. Data from a total of 5,127 patients receiving the Resolute ZES were included in the present study. BMI tertiles were as follows: I tertile (≤ 25.95 kg/m2 = low or normal weight) had 1,727 patients; II tertile (> 25.95 and ≤ 29.74 kg/m2 = overweight) had 1,695 patients, and III tertile (> 29.74 kg/m2 = obese) had 1,705 patients.

At 2-year follow-up, the investigators found no difference for patients with high BMIs (III tertile) compared with patients with normal or low BMIs (I tertile) in regard to the following:

  • Target lesion failure (I–III tertile: hazard ratio [HR],0.89; 95% confidence interval [CI], 0.69–1.14; P = .341)
  • Major adverse cardiac events (I–III tertile: HR, 0.9; 95% CI, 0.72–1.14; P = .389)
  • Cardiac death (I–III tertile: HR, 1.2; 95% CI, 0.73–1.99; P = .476)
  • Myocardial infarction (I–III tertile: HR, 0.86; 95% CI, 0.55–1.35; P = .509)
  • Clinically driven target lesion revascularization (I–III tertile: HR, 0.75; 95% CI, 0.53, 1.08; P = .123)
  • Definite or probable stent thrombosis (I–III tertile: HR, 0.98; 95% CI, 0.49–1.99; P = .964)

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May 14, 2015

Reva Medical Expands FANTOM II Clinical Trial to Australia

May 14, 2015

Reva Medical Expands FANTOM II Clinical Trial to Australia


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