Thin-strut stents from Boston Scientific, Biotronik, Medinol as good as Medtronic’s Resolute
Thin-strut drug-eluting stents made by Boston Scientific (NYSE:BSX), Biotronik and Medinol proved as good as the Resolute DES made by Medtronic (NYSE:MDT) at 1 year in a pair of studies presented yesterday at the conference and published in The Lancet.
In the 3,500-patient Bio-Resort trial, patients were randomized 1:1:1 to treatment with Medtronic’s zotarolimus-eluting Resolute Integrity stent or Boston’s everolimus-eluting Synergy and Biotronik’s sirolimus-eluting Orsiro stents, both of which use bioresorbable coatings. The primary safety endpoint was a composite of cardiac death and target-vessel-related myocardial infarction; the primary efficacy endpoint was target-vessel revascularization.
After 12 months, the primary endpoint was met by 4.7% of the Synergy arm, 4.7% of the Orsiro arm and 5.4% of the Resolute Integrity arm, with definite stent thrombosis in 0.3% of all 3 arms.
“In patients with coronary artery disease treated with durable polymer-coated drug-eluting stents, the life-long presence of the polymer may delay arterial healing and even cause adverse clinical events,” lead author Dr. Clemens von Birgelen of Thoraxcentrum Twente in Enschede, Holland, said in prepared remarks. “Biodegradable polymer stents might improve long-term outcomes, but studies with early biodegradable polymer stents that had thick stainless steel struts (120 μm) showed equivocal results. However, very thin-strut (60-81μm) biodegradable polymer stents that have flexible designs and thin, refined coatings are now available.
“The 1-year results of Bio-Resort show that treatment with 2 very-thin-strut biodegradable polymer stents and the thin-strut durable polymer zotarolimus-eluting stent was similarly efficacious and safe with excellent one-year clinical outcomes in a complex population of all-comers,” von Birgelen said. “The absence of a loss of 1-year safety and efficacy with the use of these biodegradable polymer-coated stents is a prerequisite before assessing their potential longer-term benefits.”
“The findings of the Bio-Resort trial reinforce the optimal design and proven, long-term performance of Resolute Integrity, which continues to meet both the current and future needs of our customers even when compared to the benefits of biodegradable technologies,” added Medtronic’s Dr. Martin Rothman.
“The results of Bio-Resort are in line with long-term data from the large SCAAR registry (Orsiro: n=6969)4, which confirms Orsiro’s outstanding performance for restenosis,” Biotronic vascular intervention marketing vice president Alexander Uhl said in a statement. “Orsiro has now proven non-inferior to all major competitors across a variety of indications, giving physicians confidence to use our highly deliverable DES for the treatment of coronary artery disease in diverse clinical settings. Orsiro has already benefited over half a million patients, and clinical evidence for its safety and efficacy continues to grow.”
The 2nd trial, the 1,900-patient Bionics study, compared Medinol’s thin-strut Bionir ridaforolimus-eluting stent with Medtronic’s zotarolimus-eluting Resolute stent at 1 year. The primary endpoint was target lesion failure, the composite rate of cardiac death, target vessel myocardial infarction and ischemia-driven target lesion revascularization; secondary endpoints were 1-year major adverse cardiovascular events, target vessel failure and individual component endpoints, definite/probable stent thrombosis and procedural success.
The study showed identical TLF rates for both arms at 5.3% and similar rates of cardiac death (0.5% vs. 0.2%), TV-MI (3.1% vs. 3.3%) and ID-TLR (3.0% vs. 2.4%). Definite/probable stent thrombosis was 0.4% for the Bionir device and 0.6% for Resolute. Device success was 98.3% for the ridaforolimus-eluting compared to 99.5% for the zotarolimus-eluting stent.
“One-year clinical outcomes from the Bionics study clearly show that the ridaforolimus-eluting stent was non-inferior to the zotarolimus-eluting stent with identical target lesion failure rates,” principal investigator Dr. David Kandzari, of the Piedmont Heart Institute in Atlanta, said in prepared remarks. “In addition, it had a low stent thrombosis rate with no events beyond 30 days.”
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