This article is more than 5 years old. Information may no longer be current.
TALENT: Biodegradable polymer SES noninferior to durable polymer EES
SAN DIEGO — A biodegradable polymer sirolimus-eluting stent was noninferior to a durable polymer everolimus-eluting stent at 12 months in patients who underwent PCI, according to data presented at TCT 2018.
The biodegradable polymer SES (Supraflex, Sahajanand Medical Technologies) had a lower rate of clinically indicated target lesion revascularization in a per-protocol analysis compared with the durable polymer EES (Xience, Abbott).
Patrick W. Serruys, MD, PhD, professor of cardiology (honorary) at Imperial College London and professor of medicine (emeritus) at Erasmus University in Rotterdam, the Netherlands, and colleagues analyzed data from 1,435 patients from 23 sites with any ischemic coronary syndrome, any type of lesion and unrestricted use of DES. Patients were assigned an SES (n = 720; mean age, 65 years; 76% men) or an EES (n = 715; mean age, 65 years; 77% men).
According to the researchers, the SES used in the present study is made out of cobalt chromium that is 60 µm across all diameters, and includes a protective layer and a base layer with sirolimus and mixtures of poly(l-lactic acid) and poly(lactic-co-glycolic acid). The SES is circumferential with an average thickness between 4 µm and 5 µm. The initial burst of sirolimus is 70% released within 7 days and is sustained up to 48 days.
The primary endpoint was a noninferiority comparison of device-oriented composite endpoints at 12 months, defined as a composite of target vessel MI, cardiac death and clinically indicated target lesion failure.
The primary endpoint occurred in 5.3% assigned the EES vs. 4.9% assigned the SES (difference = –0.3 percentage points; 95% CI, –2.6 to 2; P for noninferiority < .001).
“This is the lowest that I have seen so far [for Xience],” Serruys said during the press conference.
In a per-protocol analysis, device-oriented composite endpoints occurred in 3.5% in the SES group and 4.4% in the EES group (difference = –0.9 percentage points; 95% CI, –3 to 1.2; P = .411). Clinically indicated TLR was performed in 1.2% of patients assigned SES compared with 3.1% of those assigned EES (difference = –1.9 percentage points; 95% CI, –3.5 to –0.3; log-rank P = .021), which contributed to a 61% RR reduction.
“The study results have important economic implications in countries with capped stent prices such as India and in some European countries with competitive pricing and different models of health care cost savings,” Serruys said during the press conference. “Market competitiveness may influence future decisions on which stent to use.” – by Darlene Dobkowski
Reference:
Serruys PW, et al. Late-Breaking Trials 2. Presented at: TCT Scientific Symposium; Sept. 21-25, 2018; San Diego.
Disclosures: The study was funded by the European Cardiovascular Research Institute with grant support from SMT. Serruys reports he received grant/research support and consultant fees/honoraria from Abbott, Biosensors, HeartFlow, Medtronic, Micell, Philips/Volcano, Sinomedical Sciences Technology and Xeltis.
Perspective
Back to Top
These are very strong results. We’ve learned over the last 20 years — largely through the work of Prof. Serruys and others — how to do a good trial to test stents, and this is such a trial.
Based on the results, this looks like a very competitive stent compared with current generation drug-eluting stents. If it’s much less expensive than other stents, interventional cardiologists and hospitals will want to use it. However, I’m not certain whether this study — which was designed to gain regulatory approval in India — is sufficient to allow this stent to gain FDA approval.
The one thing that many interventional cardiologists worry about is that the companies that make these kinds of “me too” stents don’t often support the kind of innovation that we’ve come to expect from the larger U.S.-based device companies. If the market shifts entirely to these less expensive devices, one side effect may be a significant reduction in research and development across the field, which could have deleterious consequences in the future.
University of Missouri-Kansas City School of Medicine
Saint Luke's Mid America Heart Institute