MAnagement of high bleeding risk patients post bioresorbable polymer coated STEnt implantation with an abbReviated versus prolonged DAPT regime

Phase 4

• Conditions: coronary artery disease (CAD) patients undergoing coronary stent implantation.

• Registration Number: JPRN-jRCTs042180003
• Lead Sponsor: Ozaki Yukio

Brief Summary

One month of dual antiplatelet therapy was noninferior to the continuation of therapy for at least 2 additional months with regard to the occurrence of net adverse clinical events and major adverse cardiac or cerebral events; abbreviated therapy also resulted in a lower incidence of major or clinically relevant nonmajor bleeding.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-03
• Study Completion: 2021-03-30
• Results First Posted: 2021-08-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 189

Inclusion Criteria

Inclusion criteria after index PCI
After index PCI, patients aged 18 years or more are eligible for inclusion into the study if the following criteria are met.
1) At least one among the HBR criteria (as defined below) is met.
2) All lesions are successfully treated with Ultimaster stent in the context of routine clinical care, i.e. post-procedural angiographic diameter stenosis less than 20% by visual estimation
3) Free from any flow-limiting angiographic complications (i.e. significant untreated dissection or major side-branch occlusion), which require prolonged DAPT duration based on operators opinion.
4) All stages of PCI are complete (if any) and no further PCI is planned.

Inclusion criteria at one-month randomization visit
At randomization visit (one month after index PCI), the following criteria must be met
1) Fulfilment of at least one HBR criterion (as defined below), or on the basis of post-PCI actionable (i.e. requiring medical attention) non-access site related bleeding episode
2) Uneventful 30-day clinical course, i.e. free from spontaneous MI, symptomatic restenosis, stent thrombosis, stroke and any revascularization (coronary and non-coronary) requiring prolonged DAPT
3) If not on OAC,
a. Patient is on a DAPT regimen of aspirin and a P2Y12 inhibitor
b. Patient with one type of P2Y12 inhibitor for at least 7 days (i.e. no switching between oral P2Y12 inhibitors has occurred in the previous 7 days)
4) If on OAC
a. Patient is on the same type of OAC (e.g. Vitamin K antagonist or NOAC) for at least 7 days
b. Patient is on clopidogrel for at least 7 days

Definition of HBR
Post-PCI patients are at HBR if at least one of the following criteria applies
-Clinical indication for treatment with oral anticoagulants (OAC) for at least 12 months
-Recent (within 12 months) non-access site bleeding episode(s), which required medical attention (i.e. actionable bleeding).
-Previous bleeding episode(s) which required hospitalization if the underlying cause has not been definitively treated (i.e. surgical removal of the bleeding source)
-Age equal or greater than 75 years
-Systemic conditions associated with an increased bleeding risk (e.g. haematological disorders, including a history of or current thrombocytopaenia defined as a platelet count less than 100,000/mm3 (100 x 109/L), or any known coagulation disorder associated with increased bleeding risk.
-Documented anaemia defined as repeated haemoglobin levels below 11 g/dl or transfusion within 4 weeks before inclusion.
-Need for chronic treatment with steroids or non-steroidal anti-inflammatory drugs -Diagnosed malignancy (other than skin) considered at high bleeding risk including gastro-intestinal, genito-urethral/renal and pulmonary.
-Stroke at any time or TIA in the previous 6 months
-PRECISE DAPT score of 25 or greater

Exclusion Criteria

Patients are not eligible if any of the following applies
1) Treated with stents other than Ultimaster stent within 6 months prior to index procedure
2) Treated for in-stent restenosis or stent thrombosis at index PCI or within 6 months before
3) Treated with a bioresorbable scaffold at any time prior to index procedure
4) Cannot provide written informed consent
5) Under judicial protection, tutorship or curatorship
6) Unable to understand and follow study-related instructions or unable to
comply with study protocol
7) Active bleeding requiring medical attention (BARC=>2) on randomization visit
8) Life expectancy less than one year
9) Known hypersensitivity or allergy for aspirin, clopidogrel, ticagrelor,
prasugrel, cobalt chromium or sirolimus
10) Any planned and anticipated PCI
11) Participation in another trial
12) Pregnant or breast feeding women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Net adverse clinical endpoints (NACE) defined as a composite of all-cause death, myocardial infarction, stroke and bleeding events defined as BARC 3 or 5<br>2) Major adverse cardiac and cerebral events (MACCE) defined as a composite of all-cause death, myocardial infarction and stroke<br>3) Major or clinically relevant non-major bleeding (MCB) defined as a composite of type 2, 3 and 5 BARC bleeding events<br><br>The main analyses evaluate the occurrence of the primary endpoints between randomization and 11 months thereafter. In secondary analyses, the occurrence of primary endpoints between randomization and 15 months after index PCI is evaluated.