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Table 2 Study endpoints

From: Randomized evaluation of 5-month Ticagrelor monotherapy after 1-month dual-antiplatelet therapy in patients with acute coronary syndrome treated with drug-coated balloons: REC-CAGEFREE II trial rationale and design

Primary efficacy endpoint

 Net adverse clinical events (NACE), defined as a composite clinical endpoint of all-cause death, any stroke, any MI, any revascularization, and BARC-defined type 3 or 5 bleeding events (Time Frame: 12 months)

Primary Safety Endpoint

 Patient-oriented composite endpoint (PoCE), defined as a composite clinical endpoint of all-cause death, any stroke, any MI, any revascularization (Time Frame: 12 months)

Secondary endpoints

 1. Any ischemic or bleeding event, including any death, any stroke, any MI, BARC-defined type 3 bleeding events, any revascularization, and BARC type 2 bleeding events, will be treated as having hierarchical clinical importance and analyzed using the win ratio method (Time Frame: 12 months)

 2. NACE (Time Frame: 1 and 6 months)

Bleeding endpoints

 3. BARC defined type 3 or 5 bleeding events (Time Frame: 1, 6, and 12 months)

 4. BARC defined type 2, 3 or 5 bleeding events (Time Frame: 1, 6, and 12 months)

 5. BARC defined type 2 bleeding events (Time Frame: 1 and 12 months)

Ischemic endpoints

 6. POCE (Time Frame: 1, 6, and 12 months)

 7. Individual components of PoCE (Time Frame: 1, 6, and 12 months)

 8. Device-oriented Composite Endpoint (DoCE) (Time Frame: 1, 6, and 12 months)

  DoCE is a composite clinical endpoint of cardiac cause death, target vessel myocardial infraction (TV-MI), and Clinically indicated target lesion revascularization (CI-TLR)

 9. Individual components of DoCE (Time Frame: 1, 6, and 12 months)

 10. Target vessel failure (TVF) (Time Frame: 1, 6, and 12 months)

  Target vessel failure is defined as cardiovascular death, target vessel myocardial infraction (TV-MI), and clinically-indicated target vessel revascularization

 11. Clinical indicated target vessel revascularization (Time Frame: 1, 6, and 12 months)

 12. Definite/Probable Stent thrombosis rates according to ARC-II classification (Time Frame: 1, 6, and 12 months)

  1. NACE net adverse clinical events, MI myocardial infarction, BARC Bleeding Academic Research Consortium, SCAI Society for Cardiovascular Angiography and Interventions, FUD Fourth Universal Definition, DoCE Device-oriented Composite Endpoint, TV-MI target vessel myocardial infarction, CI-TLR clinically indicated target lesion revascularization, PoCE patient-oriented composite endpoint, TVF Target vessel failure, CI-TVR clinically indicated target vessel revascularization, ST stent thrombosis, ARC Academic Research Consortium
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BMC Cardiovascular Disorders

ISSN: 1471-2261

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