Patrick W. Serruys
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
Serruys PW, et al. Late-Breaking Trials 2. Presented at: TCT Scientific Symposium; Sept. 21-25, 2018; San Diego.
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.