Cardiology, DAPT(Dual Antiplatelet Therapy), High Bleeding Risk Patients, Stent Implantation
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Sino Medical Sciences Technology Inc.
University Hospital, Grenoble
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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)). | At 335 days | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the one-year frequency of death from any cause | At 335 days and one year | All-cause death rate |
| Evaluate the one-year frequency of cardiovascular deaths | At 335 days and one year | Cardiovascular death rate |
| Evaluate the one-year incidence of myocardial infarction | At 335 days and one year | Myocardial infarction rate |
| Evaluate the one-year incidence of ischemic stroke | At 335 days and one year | Ischemic stroke rate |
| 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. | At 335 days and one year | 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 |
| Evaluate the one-year incidence of defined stent thrombosis | One year | defined stent thrombosis rate |
| Assess the one-year frequency of minor and major bleeding according to Bleeding Academic Research Consortium (BARC) | One year | minor and major bleeding according to Bleeding Academic Research Consortium (BARC) rate |
| Evaluate the frequency of other cardiovascular adverse events | at 335 days and One year | other cardiovascular adverse events rate |
| Evaluate the rate of serious adverse events related to the device and/or investigation procedure. | At 335 and One year | Rate of serious adverse events related to the device and/or investigation procedure |
| Evaluate the one-year frequency of ischemia-driven revascularizations | One year | ischemia-driven revascularizations rate |
Countries
France
Outcome results
None listed