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SORT OUT IX: Biolimus-eluting stent no longer noninferior to SES
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SAN DIEGO — In an update to a presentation at TCT 2018, a polymer-free biolimus-eluting stent did not meet noninferiority criteria compared with a biodegradable polymer sirolimus-eluting stent in patients who underwent PCI, according to a press release from Biotronik.
The polymer-free biolimus-eluting stent (BioFreedom, Biosensors) was inferior to the biodegradable polymer sirolimus-eluting stent (Orsiro, Biotronik) regarding the primary endpoint of target lesion failure at 1 year (5.2% vs. 4%; P for noninferiority = .123). Regarding target lesion revascularization, the polymer-free biolimus-eluting stent had a significantly lower efficacy vs. the biodegradable polymer sirolimus-eluting stent (3.5% vs. 1.3%; P < .0001).
“We had initially said the BioFreedom stent was not worse than the Orsiro,” Lisette Okkels Jensen, MD, DMSci, PhD, of Odense University Hospital in Odense, Denmark, said in the press release. “Now, when we found a nonsignificant P-value, the overall message is that it didn’t meet the criteria for noninferiority.”
Before the statistical errors were known, data were presented at TCT showing the polymer-free biolimus-eluting stent was noninferior to the biodegradable polymer sirolimus-eluting stent (Orsiro, Biotronik) in these patients.
Researchers analyzed data from 3,151 patients treated with PCI who were enrolled between December 2015 to April 2017.
Patients were assigned a polymer-free biolimus-eluting stent (BioFreedom, Biosensors; n = 1,572) or a biodegradable polymer sirolimus-eluting stent (Orsiro, Biotronik; n = 1,579).
“The two stents are different in almost all possible ways,” Jensen said during the presentation. “The stent material, the strut thickness — the Orsiro stent has a thin strut of 80 µm and the BioFreedom stent has 120 µm. The BioFreedom stent is polymer-free and the Orsiro stent has a polymer under passive coating. The drug ... and the time of the drug to be released is also different.”
Dual antiplatelet therapy was given to patients per the guidelines: aspirin and clopidogrel for 6 months in patients with stable angina or aspirin and either ticagrelor (Brilinta, AstraZeneca) or prasugrel (Effient, Daiichi Sankyo/Eli Lilly) for 12 months in patients with ACS.
The primary endpoint of target lesion failure, defined as cardiac death, index lesion-related MI and target revascularization, was monitored at 12 months and annually through 5 years.
“We don’t schedule the patient for a 12-month follow-up and see the patients,” Jensen said during the press conference. “We use the Danish registries where all events or hospitalizations will be covered in these registries. ... The symptoms of the patients have to be severe enough by themselves to have contact with the health care system.”
According to the presentation before the statistical errors were known, at 12 months, the primary endpoint occurred in 5.3% of patients assigned the biolimus-eluting stent and 4% assigned the SES (P for noninferiority = .01).
The rate of definite stent thrombosis was 0.7% in both groups (rate ratio [RR]= 1; 95% CI, 0.43-2.3), although the rate of target lesion revascularization was significantly higher in the biolimus-eluting stent group compared with the SES group (3.5% vs. 1.3%; RR = 2.77; 95% CI, 1.66-4.62). – by Darlene Dobkowski
Editor’s Note: This article underwent a major update on Nov. 20, 2018 because of statistical errors reported by the investigators.
Reference:
Jensen LO, et al. Late-Breaking Trials 2. Presented at: TCT Scientific Symposium; Sept. 21-25, 2018; San Diego.
Disclosure: Jensen reports she received grant/research support from Biosensors, Biotronik and St. Jude Medical.
Perspective
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David J. Cohen, MD, MSc
The major takeaways are that the BioFreedom stent is not a drug-eluting stent. It is a drug-coated stent, and there is a reason why it is different. Although the performance differences are small, in interventional cardiology, we sometimes care about small differences. This is because our PCI devices are all generally so good.
To me, the take-home message is if you have a patient who can tolerate 6 to 12 months of DAPT, you should continue to choose a conventional drug-eluting stent. As such, the SORT-OUT IX trial helps to define what is the "sweet spot" for a drug-coated stent. The answer right now, based on the two trials that have been done with that device, is that it is for patients in whom you are truly uncomfortable giving more than a month of DAPT.
The next logical step would be a head-to-head trial of the drug-coated stent vs. a current-generation DES in patients at high bleeding risk with 1 month of DAPT. All the device companies now are starting to ask whether you can get away with 1 month of DAPT in a patient using a conventional DES? Of course, if the answer to that is yes, then we have much less need for any other alternatives. Some people suspect that may be the case; that the polymers have gotten so good that the whole fear of polymers is overblown. We will find out in the next several years.
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