Novel healing-targeted DES shows promise in 1-year data
A novel healing-targeted drug-eluting stent was as safe and effective as a standard durable polymer DES among adults with acute and chronic coronary disease undergoing PCI, early data from the PIONEER III trial show.
Polymer-based DES are associated with chronic inflammation and delayed vessel healing, which contribute to an annual 2% to 3% rate of late DES failure and life-threatening stent thrombosis, Alexandra Lansky, MD, FACC, FAHA, FSCAI, FESC, professor of medicine in the section of cardiology at Yale School of Medicine and a practicing cardiologist at Yale-New Haven Hospital, said during a presentation at the virtual American Heart Association Scientific Sessions. The supreme healing-targeted DES (HT-DES, Sinomed) emphasizes early restoration of endothelial function to minimize chronic inflammation through two primary mechanisms, she said.
“The first being rapid drug delivery and polymer degradation rather than the typical, prolonged suppression of smooth muscle cell proliferation and polymer exposure,” Lansky said. “The second being a biostable electrographic base layer that promotes endothelial migration and healing, and protects the underlying metallic stent from chronic corrosion and ion leaching.”
New combination, coating technology
The BuMA Supreme is a new evolution of DES with cobalt-chromium platform, developed to maximize functional healing of the blood vessels after stent implantation. It utilizes a combination of a novel drug release kinetic and proprietary coating technology to allow a quicker return of natural cellular functionality compared with other commercially available DES. The HT-DES has a European CE mark and is available for distribution in select regions; it is an investigational device in the United States and Japan.
For PIONEER III, researchers analyzed data from 1,632 patients with chronic coronary syndrome and ACS with up to three de novo native lesions in up to two major vessels (mean age, 64 years). Participants were recruited from 74 sites in North America, Europe and Japan. Researchers randomly assigned patients 2:1 to the HT-DES (n = 1,088) or any commercially available durable polymer everolimus-eluting stent (n = 544). Primary endpoint was target lesion failure at 12 months; participants were followed for 5 years. Additionally, the trial is powered for a long-term landmark analysis of TLF between 1 and 5 years, assessing superiority of the HT-DES vs. the control arm.
At 12 months, TLF rate was 5.4% in the HT-DES group and 5.1% among controls, for a risk difference of 0.32% (95% CI, 1.87-2.5; P = .002), meeting the primary noninferiority endpoint. Assessing secondary endpoints, there were no between-group differences in target vessel MI (P = .045), ischemic-driven target vessel revascularization (P = .06) or CV death (P = .18), Lansky said.
Safety measures of CV death, target vessel MI and late stent thrombosis numerically favored the HT-DES vs. controls, Lansky said.
“Whether these early safety measures actually translate into significant clinical benefit in the longer term will be assessed at 5 years,” Lansky said.
Assessing ‘new kid on the block’
In discussion after the presentation, Alexandre Abizaid, MD, PhD, director of invasive cardiology at Institute Dante Pazzanese de Cardiologia, interventional cardiologist at Hospital do Coração and Syrian-Lebanese Hospital, all in São Paulo, and a visiting professor of medicine at Columbia University, said it remains unclear whether the HT-DES technology will have superiority against current stent technology.
“This is a new kid on the block with a novel technology that is certainly going to be welcome,” Abizaid said. “This stent technology has great rationale to potentially impact the patient safety profile; however, current DES platforms are very advanced. We also introduced the fully bioresorbable scaffolds, and when we compare those with current platforms — Xience (Abbott Vascular) for instance — it is very difficult to get to 1% TLR.”
Lansky agreed, noting “tried and true” current technologies are associated with “outstanding” outcomes for patients.
“The question is whether we can show a difference at 5 years,” Lansky said. “We have embedded in this trial landmark analysis looking outcomes between 1 and 5 years. Of course, the treatment effect that we need to demonstrate is close to 50%. If that is not possible, it will require a larger [group]. There are many biodegradable polymer platform [studies] that have looked at this and, for the most part, they have not demonstrated much of a difference, precisely because the control event rates are so low.”
Lansky said the PIONEER researchers remain optimistic the early targeted therapy emphasizing healing will translate to long-term benefits.
“This is behaving like a workhorse stent,” Lansky said. “Based on the results that we are seeing, this could be used in the vast majority of patients, for sure.”
Perspective
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It is too early to get excited about this. As the long-term data come out, we will know if early restoration of endothelial function to minimize chronic inflammation is important. With this data, it appears that it would be, but we need the results.
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Lansky A, et al. LBS.05: Stents, valves and clots. Presented at: American Heart Association Scientific Sessions; Nov. 13-17, 2020 (virtual meeting).