Taxus Element Versus Xience Prime in a Diabetic Population–India - TUXEDO–India

Description:

This trial sought to compare the efficacy of the Taxus Element paclitaxel-eluting stent (PES) and Xience Prime everolimus-eluting stent (EES) in patients with coronary artery disease (CAD) and type 2 diabetes mellitus (DM2).

Contribution to the Literature: TUXEDO–India showed that EES is superior to PES for clinical endpoints at 1 year in patients with DM2 undergoing drug-eluting stent (DES)-percutaneous coronary intervention (PCI).

Study Design

Patients were randomized to either PES (n = 914) or EES (n = 916).

  • Total number of enrollees: 1,830
  • Duration of follow-up: 12 months
  • Mean patient age: 58.3 years
  • Percentage female: 25%

Other salient features:

  • Insulin-dependent DM: 40%
  • Hemoglobin A1c: 8.2%
  • Duration of DM: 6.4 years
  • Acute coronary syndrome: 53%
  • Reference vessel diameter (mean): 2.9 mm
  • Lesion length (mean): 20.1 mm
  • Multivessel disease: 27%

Inclusion criteria:

  • DM2
  • Symptomatic CAD or silent ischemia
  • Lesion length: ≤34 mm
  • Reference vessel diameter: 2.25-4.0 mm

Principal Findings:

The primary endpoint, target-vessel failure (cardiovascular death, target-vessel myocardial infarction [MI], ischemia-driven target-lesion revascularization) for PES vs. EES, was 5.6% vs. 2.9%, p for noninferiority of PES: 0.38, p for superiority of EES: 0.005.

Secondary outcomes:

  • All-cause mortality: 2.5% vs. 2.3%, p = 0.75
  • Spontaneous MI: 3.2% vs. 1.2%, p = 0.004, target-vessel MI: 2.8% vs. 0.5%, p < 0.001
  • Stent thrombosis: 2.1% vs. 0.4%, p = 0.002
  • Target-lesion revascularization: 3.4% vs. 1.2%, p = 0.002

Interpretation:

The results of this trial indicate that EES is superior to PES for clinical endpoints at 1 year in patients with DM2 undergoing DES-PCI. The trial was designed to show noninferiority of PES to EES. Consistent with other reports, rates of stent thrombosis with PES were also higher. PES are no longer available for clinical use for coronary arteries in the United States, but are still widely used in other parts of the world. The trial also embellishes the excellent safety record of the Xience stent with respect to stent thrombosis (0.4% at 1 year).

As an aside, the trial also raises questions about the contemporary validity of the FREEDOM trial, where coronary artery bypass grafting was superior to PCI performed with PES.

References:

Kaul U, Bangalore S, Seth A, et al., on behalf of the TUXEDO–India Investigators. Paclitaxel-Eluting Versus Everolimus-Eluting Coronary Stents in Diabetes. N Engl J Med 2015;Oct 14:[Epub ahead of print].

Presented by Dr. Upendra Kaul at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2015), San Francisco, CA, October 14, 2015.

Clinical Topics: Acute Coronary Syndromes, Invasive Cardiovascular Angiography and Intervention, Interventions and ACS, Interventions and Coronary Artery Disease

Keywords: Acute Coronary Syndrome, Coronary Artery Disease, Diabetes Mellitus, Type 2, Drug-Eluting Stents, Myocardial Infarction, Paclitaxel, Percutaneous Coronary Intervention, Sirolimus, Taxus, Thrombosis, Transcatheter Cardiovascular Therapeutics


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