TUXEDO-2: an Indian trial tests the stent choice in diabetic multivessel disease

Design

investigator-initiated, prospective, open-label, multicentre, 2 × 2 factorial randomised noninferiority trial

Population

1,800 patients with diabetes and multivessel coronary disease undergoing PCI in India; mean age 60.3 years, 28% women

Primary outcome

target lesion failure at 1 year — cardiac death, target-vessel MI or ischaemia-driven target lesion revascularisation

Effect

7.92% vs 8.75%; risk difference −0.83 percentage points, one-sided upper 97.5% bound 3.42% against a 4.5% margin (p=0.005 for noninferiority)

Stent-to-stent comparisons have routinely excluded, or barely enrolled, the patients in whom the choice matters most. TUXEDO-2 is an investigator-initiated, open-label, multicentre randomised trial in exactly that population: 1,800 patients with diabetes and multivessel coronary disease undergoing PCI, randomised in a 2 × 2 factorial design to an ultra-thin biodegradable-polymer sirolimus-eluting stent or a durable-polymer everolimus-eluting stent, and separately to ticagrelor or prasugrel.

Target lesion failure at one year — cardiac death, target-vessel myocardial infarction or ischaemia-driven target lesion revascularisation — occurred in 7.92% with the sirolimus stent and 8.75% with the everolimus stent. The risk difference of −0.83 percentage points, with a one-sided upper 97.5% bound of 3.42%, met the prespecified 4.5% noninferiority margin (p=0.005). Cardiac death (3.6% vs 3.4%), target-vessel MI (6.61% vs 7.54%), ischaemia-driven revascularisation (0.8% vs 1.0%) and stent thrombosis (1.0% vs 0.7%) were all similar.

This matters for Indian practice specifically. The sirolimus stent tested is manufactured in India and costs materially less than the comparator, and the trial was conducted in Indian centres in a population with the disease pattern Indian operators actually see — young onset, diffuse, diabetic multivessel disease. A noninferiority result on a cheaper device in the population it will be used in is a more useful answer than a superiority result in a cohort that excluded these patients.

• Mean age was 60.3 years and 28% were women — check that against your own case mix before generalising.
• The noninferiority margin was 4.5 percentage points, which is wide; the observed difference was well inside it, but the design could not have detected a small disadvantage.
• Event rates were high in both arms — around 8% target lesion failure at one year — which is what diabetic multivessel disease looks like, and a reminder that stent choice is not the main determinant of outcome.
• The antiplatelet randomisation (ticagrelor versus prasugrel) is a separate question reported separately; do not infer anything about it from these results.
• Optimal medical therapy was part of both arms — this compares stents, not strategies.

Why it matters

It gives Indian operators randomised evidence in their own patients for a device decision that is usually made on price and habit.

Don't overread it

Noninferiority at a 4.5-point margin is not equivalence, and one year is short for a stent comparison — late events are where durable and biodegradable polymers have historically diverged.

The statistics, in plain English

Noninferiority asks a narrower question than superiority: not whether the new device is better, but whether it is worse by more than an agreed amount. Here that amount was 4.5 percentage points, and the upper confidence bound landed at 3.42%, so the trial rules out a disadvantage larger than about 3.4 points — not a disadvantage of 2. The p value of 0.005 refers to the noninferiority test, not to a difference between arms; the arms did not differ significantly on anything.

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