The Evaluation of eQuivalence of biolimUs-eluting stent implantation in acute coronary Syndrome (EQUUS)

Not Applicable

Completed

Conditions: Diseases of the circulatory system

Registration Number: KCT0004883

Lead Sponsor: Gachon University Gil Medical Center

Brief Summary: In total, 666 patients were randomized 1:1 to either a Biomatrix or Nobori stent. Intention to treat (ITT) analysis was available for 305 patients in the Biomatrix Flex™ group and 315 in the Nobori™ group. The mean age of the patients was 64.1 ± 11.0 years and 69.8% were men. The primary endpoint, major cardiovascular adverse events (MACE), was reached by 3 patients (1.0%) in the Biomatrix group and 1 patient (0.3%) in the Nobori group, with a 1.2% difference between groups (95% CI: -0.60 – 1.94; p noninteriority<0.0001). MACCE (3.9% in Biomatrix group vs. 2.8% in Nobori group; p=0.457) was similar among both groups.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 666

Inclusion Criteria

(1) age >= 19 years
(2) patients diagnosed with acute coronary syndrome
(3) lesions with a reference diameter between 2.5 and 4.0 mm, where stent implantation was technically feasible
(4) lesions with more than 50% stenosis; and
(5) agreement to be enrolled after giving written informed consent

Exclusion Criteria

(1) chronic total obstruction lesions and in-stent restenosis lesions
(2) cardiogenic shock or systolic blood pressure < 80 mmHg
(3) impaired hepatic function, defined as liver cirrhosis or liver enzyme (aspartate aminotransferase or alanine aminotransferase) levels beyond 5-fold of normal limits
(4) pregnancy, breastfeeding, or females planning pregnancy in the near future
(5) patients with bleeding tendency
(6) left ventricular ejection fraction = 25%
(7) serum creatinine = 3.0 mg/dL
(8) life expectancy < 1 year
(9) allergic to antiplatelet medication
(10) lack of suitability for enrollment, as determined by the investigator
(11) a PCI procedure for an ISR or chronic total occlusion (CTO) lesion(s) within 6 months prior to enrollment

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
major adverse cardiovascular events (MACE), defined as the composite of cardiac death, non-fatal myocardial infarction (MI), and target lesion revascularization (TLR).

Secondary Outcome Measures