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Biodegradable polymer SES noninferior to BES for target lesion failure at 1 year
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A biodegradable polymer sirolimus-eluting stent was noninferior to a biodegradable polymer biolimus-eluting stent in unselected patients for target lesion failure at 1 year and was also linked to a lower risk for definite stent thrombosis, according to results from the SORT OUT VII trial.
In the large-scale, registry-based, randomized, multicenter, single blind, two-arm noninferiority trial, researchers evaluated 2,525 adult patients with chronic stable CAD or ACS, with a minimum of one coronary lesion with more than 50% diameter stenosis requiring drug-eluting stents.
From November 2012 to February 2014, participants were randomly assigned to treatment with the biodegradable polymer sirolimus-eluting stent (SES; Orsiro, Biotronik; n = 1,261; 1,590 lesions) or a biodegradable polymer biolimus-eluting stent (BES; Nobori, Terumo; n = 1,264; 1,588 lesions). The primary endpoint was TLF, which was a composite of cardiac death, MI (not related to non-index lesions) or clinically indicated target lesion revascularization with PCI or CABG within 1 year. This endpoint was analyzed by the intention-to-treat principle (noninferiority margin of 3%).
At 1 year, 48 patients (3.8%) in the SES group experienced the composite endpoint TLF vs. 58 patients (4.6%) in the BES group. The noninferiority of the SES was recorded with an absolute risk difference of –0.78% and the upper limit of 1-sided 95% CI at 0.61% (P < .0001 in 1-sided noninferiority test). There was no significant disparity between the two stent groups in the 1-year rates of death, cardiac death, MI or clinically driven TLR.
The SES-treated patients had a lower 1-year rate of definite stent thrombosis vs. BES-treated patients (0.4% vs. 1.2%; RR = 0.33; 95% CI, 0.12-0.92). This decreased rate of definite stent thrombosis was due to a lower risk for early (≤ 30 days) stent thrombosis (SES, 0.2% vs. BES, 0.8%; RR = 0.2; 95% CI, 0.04-0.91). All patients who had definite stent thrombosis within the first year (n = 20) were on dual antiplatelet therapy with aspirin and clopidogrel, ticagrelor (Brilinta, AstraZeneca) or prasugrel (Effient, Daiichi Sankyo/Eli Lilly). Overall, there was not a significant difference in definite/probable stent thrombosis rates between the two groups (SES, 0.9% vs. BES, 1.6%; RR = 0.55; 95% CI 0.26-1.15).
“The SORT OUT VII demonstrated excellent results with low [TLF] rates and low stent failure rates during implantation in both the stent groups in an all-comer population,” the researchers wrote. “This study compared two different third-generation DES, both using biodegradable polymers. Our data indicate that results obtained with DES with biodegradable polymers may not be a class effect.” – by Jennifer Byrne
Disclosure: The study was supported with grants from Biotronik and Terumo. Please see the full study for a list of the researchers’ relevant financial disclosures.
Perspective
Back to TopDominick J. Angiolillo, MD, PhD
The SORT OUT VII study provides new insights on coronary DES with biodegradable polymers. In this study, the Orsiro stent and the Nobori stent were compared in an all-comer patient population. The primary endpoint of noninferiority in TLF at 1 year was met, with lower rates of definite stent thrombosis, mainly subacute, in the sirolimus-eluting stent group compared with the biolimus-eluting stent group. Key differences between these stent types include their coating, strut thickness, drug release kinetics and polymer degradation. While results of long-term outcomes are warranted for this new stent technology, these advancements in the field are encouraging step forwards in defining options for percutaneous treatment of CAD.
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