MODEL U-SES

Overview

・MODEL U-SES trial demonstrated that 3-month DAPT was non-inferiority to adjusted cohort of longer DAPT after BP-SES implantation in net adverse clinical events.
・P2Y12 inhibitor monotherapy was almost equivalent to Aspirin monotherapy after 3 months in terms of both bleeding and thrombotic events.

Study Design

clinical_evidence_model_u_ses_study_design

Study Outline

Patient background comparison with historical control

  MODEL U-SES (n=1,695) CENTURY II (n=549) p-Value
Age, years 69.7 10.6 65.3 10.5 < 0.001
Age >75 years 36.2% 19.7% < 0.001
Male gender 76.8% 78.5% 0.41
Body mass index, kg/m? 24.313.5 27.0 4.1 < 0.001
Diabetes 39.3% 32.2% 0.003
Hypertension 79.9% 73.7% 0.002
Current smoker 21.7% 22.4% 0.72
Severe CKD 13.0% 4.0% < 0.001
Hemodialysis 5.3% 2.0% 0.001
Prior stroke 10.4% 3.8% < 0.001
Heart failure 27.2% 29.3% 0.35
Peripheral vascular disease 6.7% 9.7% 0.03

Result

Landmark analysis: Efficacy and Safety

Landmark Analysis at 90 days:
Cardiovascular death, MI, Stroke and ST

With Propensity Score Adjustment

Image

clinical_evidence_model_u_ses_efficacy_and_safety_880x544.png

Landmark Analysis at 90 days:
Bleeding (BARC 3 or 5)

With Propensity Score Adjustment

Image

clinical_evidence_model_u_ses_bleeding_1_880x544.png
 
 

Comparison of Single Antiplatelet Therapy: Aspirin and P2Y12 receptor inhibitor

Landmark Analysis at 90 days:
Cardiovascular death, MI, Stroke and ST

With IPTW Analysis

Image

clinical_evidence_model_u_ses_cardiovascular_death_880x544.png

Landmark Analysis at 90 days:
Bleeding (BARC 3 or 5)

With IPTW Analysis

Image

clinical_evidence_model_u_ses_bleeding_2_880x544.png

 

Reference