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Taxus Element Versus Xience Prime in a Diabetic Population–India - TUXEDO–India
Highlighted text has been updated as of Nov. 10, 2025.
Contribution To Literature:
TUXEDO–India showed that everolimus-eluting stent (EES) is superior to paclitaxel-eluting stent (PES) for clinical endpoints at 1 year in patients with type 2 diabetes mellitus (DM) undergoing drug-eluting stent (DES)-PCI.
TUXEDO-2 showed that Supraflex Cruz, a biodegradable polymer sirolimus-eluting stent (BP-SES) with an ultra-thin strut was noninferior to Xience, a durable-polymer everolimus-eluting stent (DP-EES) for target lesion failure at 1 year in this patient population; however, safety and efficacy were comparable. An analysis showed that ticagrelor was not noninferior to prasugrel at 1 year when added to aspirin as part of dual antiplatelet therapy (DAPT).
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:
- Type 2 DM
- Symptomatic coronary artery disease (CAD) or silent ischemia
- Lesion length: ≤34 mm
- Reference vessel diameter: 2.25-4.0 mm
The TUXEDO-2 trial, performed at 66 centers in India, randomized 1,800 patients (mean age, 60 years; 29% women) with type 1 or type 2 DM and multivessel CAD to PCI with either the Supraflex Cruz BP-SES (n=901) or one of the Xience stents (DP-EES; n=899), plus optimal medical therapy.
TUXEDO-2 ticagrelor vs. prasugrel analysis: Patients were also randomized to 1 year of DAPT with either ticagrelor (n=901) or prasugrel (n=899), in combination with aspirin, after the procedure.
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
TUXEDO-2 Results:
Target lesion failure at 1 year was 7.92% with Supraflex Cruz vs. 8.75% with Xience, with a between-group difference of -0.83% (95% CI -3.42% to 1.76%) and a noninferiority margin of 4.5% (p=0.005). The individual components of target lesion failure (ischemia-driven target lesion revascularization, cardiac death, and target-vessel MI) occurred at similar rates in both groups.
No significant differences were found between the Supraflex Cruz and Xience groups in cardiac death (3.56% vs. 3.36%; p=0.80), target-vessel MI (6.61% vs. 7.54%; p=0.40), ischemia-driven target lesion revascularization (0.82% vs. 1.07%; p=0.44), all-cause death (4.00% vs. 4.67%; p=0.82), nonfatal MI (4.72% vs. 6.45%; p=0.10), major adverse cardiovascular events (8.69% vs. 10.35%; p=0.29), or stent thrombosis (0.67% vs. 1.00%; p=0.44).
TUXEDO-2 ticagrelor vs. prasugrel analysis: The primary composite endpoint of death, nonfatal MI, stroke, or major bleeding was 16.57% for ticagrelor vs. 14.23% for prasugrel. The rate of nonfatal MI was 5.96% for ticagrelor vs. 5.21% for prasugrel; the rate of major bleeding was 8.41% for ticagrelor vs. 7.14% for prasugrel; and mortality rate was 5.03% for ticagrelor vs. 3.67% for prasugrel.
Interpretation:
The results of this trial indicate that EES is superior to PES for clinical endpoints at 1 year in patients with type 2 DM 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 U.S., 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 CABG was superior to PCI performed with PES.
TUXEDO-2 demonstrated that Supraflex Cruz (BP-SES) with an ultra-thin strut was noninferior to Xience (DP-EES) for target lesion failure in patients with multivessel CAD and DM undergoing PCI, with comparable safety and efficacy of the two stents.
The TUXEDO-2 analysis revealed that a ticagrelor-based DAPT regimen did not offer the same level of benefit at preventing the primary endpoint as a prasugrel-based DAPT regimen. Thus, the researchers write that ticagrelor and prasugrel do not appear to be interchangeable and that prasugrel may be a better choice in this patient population.
References:
Presented by Sripal Bangalore, MBBS, FACC, at the American Heart Association Scientific Sessions (AHA 2025), New Orleans, LA, Nov. 10, 2025.
Presented by Upendra Kaul, MD, at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2025), San Francisco, CA, Oct. 28, 2025.
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, Atherosclerotic Disease (CAD/PAD), 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, AHA Annual Scientific Sessions, AHA25, TCT25
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