Dual Anti-Platelet Optimized Stent for High Bleeding Risk Patient

N/ANot Yet RecruitingNCT07140133

University Hospital, Grenoble1,200 enrolled

Overview

High risk of bleeding (HBR) is a determining factor for the duration of dual antiplatelet therapy (DAPT). Recent studies have shown that the use of one-month DAPT is beneficial in terms of ischemic as well as hemorrhagic events, particularly in HBR patients, compared with longer DAPT. European guidelines therefore authorize one-month DAPT in HBR patients presenting even an acute coronary syndrome. The HT Supreme Drug Coated Coronary Stent System (HT Supreme DES) is designed to promote reendothelialization as quickly as possible. That's why the stent is called "HT" Supreme, with "HT" standing for "Healing Targeted", enabling a DAPT of just 1 month in all-comers HBR patients. Thanks to these features, the investigators aim to demonstrate ischemic and hemorrhagic complication rates lower than those found in the literature with other stent.

Study Type

OBSERVATIONAL

Enrollment

1,200

Conditions

High Bleeding Risk Patients Cardiology Stent Implantation DAPT(Dual Antiplatelet Therapy)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient aged ≥ 18 years * Male or female patient requiring a coronary angioplasty procedure according to European recommendations, * Patients undergoing revascularization with HT-supreme stents * Patient at high risk of bleeding according to ARC HBR definition (9). * Patient affiliated to or benefiting from a social security scheme * Patient who does not object to research Exclusion Criteria: * Estimated lifespan \<1 year, * Allergy and any other contraindication to aspirin and/or clopidogrel listed in the summary of product characteristics, * Allergy to iodinated contrast media * Adults under legal protection (guardianship, curatorship or safeguard of justice). * Persons deprived of their liberty by judicial or administrative decision, * Patient in a period of relative exclusion from another research protocol,

Outcomes

Primary Outcomes

Rate of occurrence of combined endpoint at 335 days: net averse clinical event (death from any cause, infarction and non-fatal stroke) + (BARC major bleeds >3)).

Validate the non-inferiority of the frequency of occurrence at 335 days after a short DAPT (1 month) of a combined endpoint, net averse clinical event (all-cause death, non-fatal MI and non-fatal stroke) + (BARC major bleeds \>3) occurring in patients implanted with an HT supreme™ coronary stent in HBR patients to the ultimaster stent (Terumo)

Time frame: At 335 days

Secondary Outcomes

Comparison of primary endpoint (net averse clinical event (all-cause death, non-fatal MI and non-fatal stroke) + (BARC major bleeds >3) ) frequency in patients with HBR and high ischemic risk.

the rate of occurrence of the primary endpoint (net averse clinical event (all-cause death, non-fatal MI and non-fatal stroke) + (BARC major bleeds \>3) ) in patients with HBRand high ischemic risk