J Cardiovasc Interv.  2022 Apr;1(2):61-71. 10.54912/jci.2021.0007.

A Comparative Analysis of Two Biolimus-Eluting Biodegradable Stents: Evaluation of the Equivalence of 6 Months Versus 12 Months of DAPT Following Biolimus-Eluting Stent Implantation in Acute Coronary Syndrome (EQUUS)

• Cha JJ
• Jang AY
• Lim S
• Suh SY
• Oh PC
• Lee K
• Kang WC
• Han SH
• Kim JW
• Kim SJ
• Lee SW
• Choi JW
• Kim HY
• Yoon MH
• Woo Si
• Jin DK
• Choi HH
• Kim W
• Cho YH
• Lee JB
• Ahn TH
• for the EQUUS Investigators

• KMID: 2561243
• DOI: http://doi.org/10.54912/jci.2021.0007

Abstract

Background
Despite data from trials proving the safety and efficacy of biodegradable biolimus-eluting stents (BESs) over first- or second-generation durable polymer stents, there are no data regarding the differences within the BES family. To investigate their safety profiles, we randomly assigned Biomatrix Flex™ (Biomatrix) and Nobori™ (Nobori) BES with biodegradable polymers to patients presenting with acute coronary syndrome.
Methods
A total of 666 patients were randomized to either the Biomatrix (n = 329) or Nobori BES (n = 337) (non-inferior margin of 4.0%). Finally, 620 patients were included for intention-to-treat analysis in either the Biomatrix (n = 305) or Nobori (n = 315) group. All patients were subsequently randomized to either a 6-month or 12-month dual-antiplatelet (DAPT) regimen. The primary endpoint was major adverse cardiovascular events (MACE) at 12 months, which was defined as a composite of cardiac death, non-fatal myocardial infarction (MI), and target lesion revascularization.
Results
The incidence of MACE in the Nobori (1 patient; 0.3%) BES group was noninferior to that in the Biomatrix (3 patients; 1.0%) group (95% confidence interval, −0.6, 2.0; P_{non-inferiority} < 0.0001). Secondary endpoints, such as bleeding, total death, MI, stent thrombosis, revascularization, stroke, and major cardiac and cerebrovascular events did not differ between the BES groups. Additionally, the ischemia-driven and bleeding events were comparable in both the 6-month and 12-month DAPT regimen groups.
Conclusions
Nobori BES was non-inferior to Biomatrix BES for MACE at 1 year. Additionally, the 6-month DAPT regimen showed comparable ischemia-driven and bleeding events compared with the conventional 12-month DAPT regimen.

Keyword

Coronary artery disease; Percutaneous coronary intervention; Drug-eluting stents; Dual anti-platelet therapy