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TUXEDO-India: EES better than paclitaxel-eluting stent in patients with diabetes undergoing PCI
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SAN FRANCISCO — In patients with diabetes and CAD undergoing PCI, a paclitaxel-eluting stent failed to reach noninferiority vs. an everolimus-eluting stent, according to 1-year data from the TUXEDO-India study.
Patients who received a paclitaxel-eluting stent (Taxus Element, Boston Scientific) had higher rates of target vessel failure, MI, stent thrombosis and target vessel revascularization compared with those who received an everolimus-eluting stent (EES; Xience Prime, Abbott Vascular) in the multicenter trial.
“This study supports the current worldwide practice of using limus stents even in patients with insulin-requiring diabetes,” Upendra Kaul, MD, of the Fortis Escorts Heart Institute, New Delhi, said during a presentation. “This may have important implications for Taxus.”
Upendra Kaul
Kaul and colleagues randomly assigned 1,830 patients with diabetes and CAD undergoing PCI, in a 1:1 ratio, to a paclitaxel-eluting stent or an EES.
The trial was designed for noninferiority, with a margin of 4 percentage points for the upper boundary of the 95% CI of the risk difference and a 1-year follow-up. The investigators sought target vessel failure as primary endpoint; this was defined as a composite of CV death, target vessel MI or ischemia-driven TVR.
At 1-year, the paclitaxel-eluting stent failed to reach noninferiority endpoints vs. the EES for all three primary endpoint criteria, with target vessel failure rates of 5.6% vs. 2.9% (risk difference, 2.7 percentage points; 95% CI, 0.8-4.5 and RR = 1.89; 95% CI, 1.2-2.99).
Compared with EES, patients with paclitaxel-eluting stents demonstrated higher incidence of target vessel failure (P = .005), spontaneous MI (3.2% vs. 1.2%; P = .004), stent thrombosis (2.1% vs. 0.4%, P =.002), TVR (3.4% vs. 1.2%; P = .002) and target lesion revascularization (3.4% vs. 1.2%; P = .002).
“The present results question the outcomes of FREEDOM and BARI-2D studies showing superiority of bypass grafting over [EES],” Kaul said. – by Allegra Tiver
References:
Kaul U, et al. TUXEDO: A prospective randomized trial of paclitaxel-eluting vs. everolimus-eluting stents in diabetic patients with coronary artery disease. Presented at: TCT Scientific Symposium; Oct. 11-15, 2015; San Francisco.
Kaul U, et al. N Engl J Med. 2015;doi:10.1056/NEJMoa1510188.
Disclosure: The trial was supported by Boston Scientific. Kaul reports receiving research grants and lecture fees from Boston Scientific and lectures fees from Abbott Vascular. Please see the full study for a list of all other authors’ relevant financial disclosures.
Perspective
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Aloke V. Finn, MD
Patients with diabetes are an important subset because they have a lot of vascular disease. They represent 25% to 40% of patients presenting to the catheterization lab every day. Yet, we have a paucity of data from trials involving patients with diabetes only for drug-eluting stents, for which these patients are a major target population.
This was an important trial to examine whether or not the mechanism-of-action of different stents — one employing paclitaxel and one employing everolimus — made a difference in outcomes in patients with diabetes. The answer was, it did not. In fact, the everolimus-eluting stent was superior to the paclitaxel-eluting stent, similar to results we have seen in patients without diabetes.
This really confirms a lot of already-existing data. In the United States, we don’t have the paclitaxel-eluting stent anymore. So it’s consistent with the company decision to not do this system anymore.
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