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BIODEGRADE: Cobalt-chromium DES noninferior to stainless steel DES for ACS

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SAN FRANCISCO — A cobalt-chromium drug-eluting stent was noninferior to a stainless steel DES in patients with ACS who were undergoing PCI, according to 18-month results from the BIODEGRADE trial presented at TCT 2019.

Both groups of patients had favorable clinical outcomes, according to the presenter, In-Ho Chae, MD, PhD, professor of internal medicine at Seoul National University College of Medicine in South Korea and director of cardio-and-neurovascular catheterization laboratory at Seoul National University Bundang Hospital in South Korea.

In this prospective, open-label, randomized multicenter trial, researchers analyzed data from 2,327 patients (mean age, 64 years; 72% men) with a significant lesion in any of the coronary arteries, venous or arterial bypass grafts and evidence of myocardial ischemia or diameter stenosis greater than 70%. After undergoing coronary angiography, patients were assigned PCI with one of two stents: cobalt-chromium DES (Orsiro, Biotronik; n = 1,167) or stainless steel DES (BioMatrix; Biosensors International; n = 1,160).

The stainless steel DES is made of 316 L stainless steel with a stent strut thickness of 120 µm, whereas the cobalt-chromium DES consists of cobalt-chromium with a passive silicon carbide coating and a stent strut thickness of either 60 µm or 80 µm, according to the presentation. The biodegradable polymer of the stainless steel DES is made of polylactic acid and takes approximately 9 months to degrade. The cobalt-chromium DES stent has a poly-L-lactic polymer that takes between 12 and 24 months to degrade.

The primary endpoint was target lesion failure at 18 months, defined as a composite of cardiac death, target vessel-related MI and ischemia-driven target lesion revascularization. Secondary endpoints included individual components of TLF, definite or probable stent thrombosis and patient-oriented composite outcome, defined as all-cause MI, all-cause death and all repeat revascularizations.

At 18 months, TLF occurred in more patients assigned the stainless steel DES compared with the cobalt-chromium DES (HR = 0.7; 95% CI, 0.42-1.18), which confirmed that the cobalt-chromium DES was noninferior to the stainless steel DES (P for noninferiority < .001; P for superiority = .176).

The differences between the stainless steel DES and cobalt-chromium DES groups regarding clinical outcomes at 18 months did not reach statistical significance:

• TLF (2.9% vs. 2.1%, respectively; P = .222);
• cardiac death (1.4% vs. 1%, respectively; P = .558);
• target vessel-related MI (0% vs. 0.3%, respectively; P = .25);
• ischemia-driven TLR (1.6% vs. 0.9%, respectively; P = .124);
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• ischemia-driven target vessel revascularization (2.3% vs. 2%, respectively; P = .553);
• definite stent thrombosis (0% vs. 0.2%, respectively; P = .5); and
• patient-oriented composite endpoint (6.4% vs. 5.9%, respectively; P = .702).

“The clinical efficacy of the [biodegradable polymer] DES may not be dependent on the stent design including strut thickness,” Chae said during the presentation. – by Darlene Dobkowski

Reference:

Chae I-H. Late-Breaking Science 4. Presented at: TCT Scientific Symposium; Sept. 25-29, 2019; San Francisco.

Disclosure: Chae reports no relevant financial disclosures.