| 2. |
- Omerovic, Elmir, 1968, et al.
(author)
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Rationale and Design of Switch Swedeheart: A Registry-Based, Stepped-Wedge, Cluster-Randomized, Open-Label Multicenter Trial to Compare Prasugrel and Ticagrelor for Treatment of Patients with Acute Coronary Syndrome.
- 2022
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In: American heart journal. - : Elsevier BV. - 0002-8703 .- 1097-6744. ; 251, s. 70-77
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Journal article (peer-reviewed)abstract
- European treatment guidelines recommend prasugrel over ticagrelor for treating patients with non-ST-elevation acute coronary syndrome (ACS), prompting several Swedish administrative regions to transition from ticagrelor to prasugrel as the preferred treatment for patients with ACS. We aim to systematically evaluate this transition to determine the relative efficacy of prasugrel versus ticagrelor in a real-world cohort of patients with ACS.The SWITCH SWEDEHEART trial is a prospective, multicenter, open-label, cross-sectional, stepped-wedge cluster-randomized clinical trial, in which administrative regions in Sweden will constitute the clusters. At the start of the study, all clusters will use ticagrelor as the P2Y12 inhibitor drug of choice for ACS. The order in which the clusters will implement the transition from ticagrelor to prasugrel will be randomly assigned. Every nine months, one cluster will switch from ticagrelor to prasugrel as the P2Y12 inhibitor of choice for patients with ACS. The primary endpoint is the composite one-year death rate, stroke, or myocardial infarction.The SWITCH SWEDEHEART study will provide an extensive randomized comparison between ticagrelor and prasugrel to date. Novel therapies are frequently costly and supported by evidence from few or small studies, and systematic evaluation after the introduction is rare. This study will establish an important standard for introducing and evaluating the effects of healthcare changes within our societies.
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| 3. |
- Sabbah, Muhammad, et al.
(author)
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Routine revascularization with percutaneous coronary intervention in patients with coronary artery disease undergoing transcatheter aortic valve implantation - the third Nordic Aortic Valve Intervention Trial - NOTION-3.
- 2022
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In: American heart journal. - : Elsevier BV. - 1097-6744 .- 0002-8703.
-
Journal article (peer-reviewed)abstract
- Coronary artery disease (CAD) frequently coexists with severe aortic valve stenosis (AS) in patients planned for transcatheter aortic valve implantation (TAVI). How to manage CAD in this patient population is still an unresolved question. In particular, it is still not known whether fractional flow reserve (FFR) guided revascularization with percutaneous coronary intervention (PCI) is superior to medical treatment for CAD in terms of clinical outcomes.The third Nordic Aortic Valve Intervention (NOTION-3) Trial is an open-label investigator-initiated, multicenter multinational trial planned to randomize 452 patients with severe AS and significant CAD to either FFR-guided PCI or medical treatment, in addition to TAVI. Patients are eligible for the study in the presence of at least one significant PCI-eligible coronary stenosis. A significant stenosis is defined as either FFR ≤0.80 and/or diameter stenosis >90%. The primary endpoint is a composite of first occurring all-cause mortality, myocardial infarction, or urgent revascularization (PCI or coronary artery bypass graft performed during unplanned hospital admission) until the last included patient have been followed for 1 year after the TAVI.NOTION-3 is a multicenter, multinational randomized trial aiming at comparing FFR-guided revascularization vs medical treatment of CAD in patients with severe AS planned for TAVI.
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