Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regime
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0002974
- Lead Sponsor
- European Cardiovascular Research Institute
- Brief Summary
Among the 4434 patients in the per-protocol population, net adverse clinical events occurred in 165 patients (7.5%) in the abbreviated-therapy group and in 172 (7.7%) in the standard-therapy group (difference, -0.23 percentage points; 95% confidence interval [CI], -1.80 to 1.33; P<0.001 for noninferiority). A total of 133 patients (6.1%) in the abbreviated-therapy group and 132 patients (5.9%) in the standard-therapy group had a major adverse cardiac or cerebral event (difference, 0.11 percentage points; 95% CI, -1.29 to 1.51; P=0.001 for noninferiority). Among the 4579 patients in the intention-to-treat population, major or clinically relevant nonmajor bleeding occurred in 148 patients (6.5%) in the abbreviated-therapy group and in 211 (9.4%) in the standard-therapy group (difference, -2.82 percentage points; 95% CI, -4.40 to -1.24; P<0.001 for superiority).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 4434
After index percutaneous coronary intervention, 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 high bleeding risk 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 dual antiplatelet therapy duration based on operator's opinion.
4.All stages of percutaneous coronary intervention are complete (if any) and no further percutaneous coronary intervention is planned.
At randomization visit (one month after index percutaneous coronary intervention), the following criteria must be met:
1.Fulfilment of at least one HBR criterion (as defined below), or on the basis of post-percutaneous coronary intervention actionable (i.e. requiring medical attention) non-access site related bleeding episode
2.Uneventful 30-day clinical course, i.e. free from spontaneous myocardial infarction, symptomatic restenosis, stent thrombosis, stroke and any revascularization (coronary and non-coronary) requiring prolonged dual antiplatelet therapy
3.If not on oral anticoagulants,
1.Patient is on a dual antiplatelet therapy 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 oral anticoagulants
1.Patient is on the same type of oral anticoagulants (e.g. Vitamin K antagonist or novel oral anticoagulant (NOAC)) for at least 7 days
2.Patient is on clopidogrel for at least 7 days
Definition of high bleeding risk
Post-percutaneous coronary intervention patients are at high bleeding risk if at least one of the following criteria applies:
•Clinical indication for treatment with oral anticoagulants 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 transient ischemic attack in the previous 6 months
•PRECISE DAPT(PREdicting bleeding Complications In patients undergoing Stent implantation and subsEquent Dual Anti Platelet Therapy) score of 25 or greater
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 percutaneous coronary intervention 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 (The Bleeding Academic Research Consortium (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 percutaneous coronary intervention
11.Participation in another trial
12.Pregnant or breast feeding women
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Major adverse cardiac and cerebral events (MACCE) defined as a composite of all-cause death, myocardial infarction and stroke;Net adverse clinical endpoints (NACE) defined as a composite of all-cause death, myocardial infarction, stroke and bleeding events defined as The Bleeding Academic Research Consortium (BARC) 3 or 5;Major or clinically relevant non-major bleeding (MCB) defined as a composite of type 2, 3 and 5 BARC bleeding events
- Secondary Outcome Measures
Name Time Method All cause death;Death from cardiovascular cuases;Myocardial infarction;Stroke;Bleeding events;Definite or probable stent thrombosis;Any target vessel revascularization;Urgent target vessel revascularization;Urgent non-target vessel revascularization;Clinically indicated non-target vessel revascularization;Transfusion rates both in patients with and/or without clinically detected over bleeding