Prise en charge des patients à haut risque hémorragique après l’implantation d’une endoprothèse en polymère biorésorbable avec un double traitement antiagrégant plaquettaire [DTAP] abrégé vs. prolongé

Drug: Aspirin;Drug: P2Y12 inhibitor

Inclusion Criteria:

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 <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 operator's opinion.

4. All stages of PCI are complete (if any) and no further PCI is planned.

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,

1. Patient is on a DAPT regimen of aspirin and a P2Y12 inhibitor

2. 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

1. Patient is on the same type of OAC (e.g. Vitamin K antagonist or NOAC) for at
least 7 days

2. 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 (<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 <100,000/mm3 (<100 x 109/L), or any known coagulation disorder associated with
increased bleeding risk.

- Documented anaemia defined as repeated haemoglobin levels <11 g/dl or transfusion
within 4 weeks before randomization.

- 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:

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