Reporting the results, Stephan Windecker, Professor and Chief of Cardiology, Swiss Cardiovascular Center and Clinical Trials Unit Bern, Bern University Hospital, Switzerland, said, “The Orsiro sirolimus-eluting stent with a biodegradable polymer was non-inferior to the Xience Prime everolimus-eluting stent with a durable polymer for the primary angiographic endpoint of in-state late loss at nine months in this prospective, randomised trial.”
Looking to the future, he concluded, “These results will need to be extended to larger randomised trials including more complex patients and powered for clinical endpoints.”
The DESolve Nx trial treated target lesions in 126 patients with single de novo coronary artery lesions with the DESolve device. Results showed the primary endpoint of in-stent late lumen loss was 0.21mm (+0.34) at six months. Major adverse cardiac events occurred in 3.25% of patients, including one cardiac death. Acute recoil occurred in 6.6% of patients at six months.
But he cautioned, “The promising results shown with bioresorbable drug-eluting scaffolds so far need corroboration in larger patient cohorts followed for a longer period. Last, but not at least, available devices still need design improvement before offering their advantages to the majority of complex lesions we are currently treating.”
European and US NSTE-ACS guidelines currently recommend bivalirudin alone as an alternative to unfractionated heparin plus GP IIb/IIIa receptor inhibitors in patients undergoing an intended urgent or early invasive strategy.
“One should be very careful when interpreting the results, however none of our models show that treatment with bivalirudin improves outcome. The results therefore question the superiority of bivalirudin to heparin in the absence of GP IIb/IIIa blockade in patients with NSTE-ACS undergoing PCI,” concluded Angerås. “The clinical implication is that if we use heparin alone, we can be assured that it’s enough. For those using bivalirudin, switching to heparin achieves similar outcomes and will reduce the cost of procedures.”
Commenting on the data, William Wijns, Chairman of PCR and Course Director of EuroPCR, said, “This new data comparing heparin with bivalirudin in NSTE-ACS patients undergoing PCI is very interesting and we await results from new trials looking at this further.”
“Results for one-year outcomes showed a large treatment effect in terms of symptom relief and improved quality of life,” reported Stephan Windecker, Professor and Chief of Cardiology, Swiss Cardiovascular Center and Clinical Trials Unit Bern, Bern University Hospital, Switzerland. Patients showed sustained improvement in effective orifice area, with low rates of moderate or severe aortic regurgitation.
Windecker concluded, “SOURCE XT showed high rates of device success for all access approaches, valve sizes and delivery systems.”
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