November 2, 2016 — Investigators recently unveiled clinical data from the independent BIO-RESORT study, representing the first all-comers analysis to compare the safety and efficacy of biodegradable polymer drug-eluting stents (BP-DES), using the Boston Scientific Synergy and Biotronik Orsiro, to a durable polymer Resolute Integrity drug-eluting stent (DP-DES) from Medtronic. At one year, patients with coronary artery disease who were treated with a biodegradable polymer stent showed no clinical benefits over patients treated with Resolute Integrity.
The results were presented during a Late-Breaking Clinical Trial session at the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting, Oct. 29-Nov. 3 in Washington, D.C., and simultaneously published in The Lancet.
“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,” M.D., Ph.D., co-director of the Department of Cardiology at Thoraxcentrum Twente, professor of cardiology at University of Twente in the Netherlands, principal investigator of the trial and presenter of the data at TCT. “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.”
As the authors write in The Lancet manuscript, "Neither of these [biodegradable] stents have [previously] been compared with the new-generation thin-strut durable polymer zotarolimus-eluting stent (Resolute Integrity) — an established device with excellent clinical outcomes."
In the BIO-RESORT study, the primary composite endpoint of target vessel failure at one-year showed no statistically significant difference in outcomes for the Resolute Integrity DP-DES treated group (N=1173) at 5.4 percent compared to 4.7 percent with the Synergy BP-DES (N=1172) arm and 4.7 percent with the Orsiro (N=1169) BP-DES am (difference of 0.7 percent; p=0.45 for Boston Scientific Synergy and p=0.46 for Biotronik Orsiro). The one-year outcomes also found no statistically significant difference in stent thrombosis between Resolute Integrity and the BP-DES groups (difference of 0.1 percent; p=0.77).
"The BIO-RESORT trial demonstrates the continued value of high-quality randomized DES trials in true all-comers, reflecting real-world clinical practice. BIO-RESORT included the greatest proportion of patients with STEMI [ST elevated myocardial infarction] — more than 30 percent — of all previous randomized stent trial in all-comers and one of the greatest proportions of patients with acute coronary syndromes at almost 70 percent," von Birgelen said. "As in our previous randomized study, the DUTCH PEERS trial, patients treated with the Resolute Integrity stent showed low and favorable one-year clinical event rates. The stent was an excellent challenge for the two novel very-thin strut biodegradable polymer drug-eluting stents to compare with, and the results showed no significant difference in the 12-month incidence of the composite primary endpoint. The long-term results of the BIO-RESORT trial will be of great interest, too."
The Resolute Integrity DES features Continuous Sinusoid Technology, which provides excellent deliverability and conformability to the vessel wall, according to Medtronic. The durable polymer used with the Resolute Integrity DES, called BioLinx, was specifically designed for DES use. BioLinx is non-inflammatory and non-thrombogenic, which allows for rapid and complete endothelial healing, while minimizing the risk of stent thrombosis. Long-term performance of BioLinx in over 16,000 patients studied in the RESOLUTE clinical program, demonstrated low stent thrombosis in real-world patients through five years, as well as a low risk for stent thrombosis with interruption or discontinuation of dual antiplatelet therapy (DAPT) after one month. The Resolute Integrity stent offers a treatment option with a proven long-term safety and efficacy profile that is yet to be established for new DES designs with biodegradable polymers, according to the company.
Three TCT 2016 Trials Failed To Show Differences in Patient Outcomes With Bioreorbable Polymers
There were three trials presented at TCT 2016 that compared metallic stents with bioresorbable polymers (including the Biosensor's Osiro and the Boston Scientific Synergy) to durable polymer stents (including the Medtronic Endeavor and Abbott Xience V). The data from thee trials all showed there was no statistical difference between bioresorbable and non-bioresorbable polymer metallic stents. There were high hopes that bioresorbable polymer metallic DES would be a big step forward to further reduce rates of late stent thrombosis and in-stent restenosis.
Read the related articles:
The BIO-RESORT study was supported by Boston Scientific, Biotronik and Medtronic.
For more information: www.medtronic.com