Ignite Creation Date:
2024-05-06 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05353140
Status:
RECRUITING
Last Update Posted:
2023-06-29
First Post:
2022-04-22
Brief Title:
LAAO Versus NOAC in Patients With AF and PCI
Sponsor:
Xijing Hospital
Organization:
Xijing Hospital
Study Overview
Official Title:
Left Atrial Appendage Occlusion Versus Novel Oral Anti-coagulation in Patients With Atrial Fibrillation and Percutaneous Coronary Intervention a Randomized Multicentre Open-label Non-inferiority Trial
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Atrial fibrillation AF coincides with coronary artery disease CAD shared common risk factors and pathophysiologic pathways CAD affects approximately 25 of AF patient according to the trial Atrial Fibrillation Follow-up Investigation of Rhythm Management AFFIRM while in the Global Registry of Acute Coronary Events GRACE atrial fibrillation affected about 9 of patients with CAD It is reported that approximately 5-8 of the patients who underwent PCI had concomitated atrial fibrillation
For AF patients who underwent PCI both antiplatelet and antithrombotic medications are required for preventing stent thrombosis and ischemic stroke leading to an increased risk of bleeding Finding a safe and effective balance between the risk of ischaemic events and bleeding complications is challenged by the shared risk factors for either event such as advanced age congestive heart failure hypertension diabetes previous stroke etc
Previous pivotal trials have shown that in patients with atrial fibrillation and requiring antiplatelet treatment a NOAC plus clopidogrel regimen was associated with a lower incidence of bleeding events as compared with a warfarin-based triple antithrombotic strategy Therefore the current expert opinions and consensus of North American Societies recommend a NOAC plus a P2Y12 inhibitor in patients with AF and PCI However the NOAC plus clopidogrel strategy still led to 168 of clinically significant bleeding PIONEER AF-PCI Consequently the compliance of OACNOAC is commonly suboptimal among PCI patients who require an antithrombotic strategy for AF
Percutaneous left atrial appendage occlusion LAAO is a non-pharmacological strategy for stroke prevention in patients with AF Both randomized data and registries have confirmed it can be an alternative to oral anticoagulation in patients with nonvalvular AF Current guidelines recommend LAAO for patients with NVAF who have contraindications or are unsuitable for long-term OAC
Considering the unique high risk of AF patients with PCI LAAO may be an attractive treatment option by obviating the need for combined oral anticoagulation and antiplatelet therapy However so far there is no data from neither randomized cohorts nor real-world registries showing if LAAO can be a safe and effective alternative strategy compared to VKANOAC for stroke prevention in AF patients who underwent PCI The PROTECT AF and PREVAIL studies showed that the percutaneous LAAO was non-inferior to warfarin therapy and the PRAGUE-17 trial showed non-inferior to direct oral anticoagulants however the small sample size of these trials limited further subgroup analyses of the PCI sub-population In the NCDR registry which is the largest cohort of LAAO up to now 203 of the LAAO patients had a prior myocardial infarction However the proportion of stent implantation was not reported Among previous trials the proportion of patients with coronary artery disease ranged from 285 to 475 The large number of AF patients with CAD warrant the optimal stroke prevention strategy to be assessed in this population
The primary goal of the proposed study is to investigate if the non-inferiority would be met for the LAAO when compared to NOACs in NVAF patients with PCI in terms of a composite endpoint of any death any stroke any myocardial infarction systemic embolism at 12 months In addition the powered key secondary will also have 80 of power to show superiority for the LAAO when compared to NOACs in terms of BARC type 2 3 or 5 bleeding events at 36 months
For AF patients who underwent PCI both antiplatelet and antithrombotic medications are required for preventing stent thrombosis and ischemic stroke leading to an increased risk of bleeding Finding a safe and effective balance between the risk of ischaemic events and bleeding complications is challenged by the shared risk factors for either event such as advanced age congestive heart failure hypertension diabetes previous stroke etc
Previous pivotal trials have shown that in patients with atrial fibrillation and requiring antiplatelet treatment a NOAC plus clopidogrel regimen was associated with a lower incidence of bleeding events as compared with a warfarin-based triple antithrombotic strategy Therefore the current expert opinions and consensus of North American Societies recommend a NOAC plus a P2Y12 inhibitor in patients with AF and PCI However the NOAC plus clopidogrel strategy still led to 168 of clinically significant bleeding PIONEER AF-PCI Consequently the compliance of OACNOAC is commonly suboptimal among PCI patients who require an antithrombotic strategy for AF
Percutaneous left atrial appendage occlusion LAAO is a non-pharmacological strategy for stroke prevention in patients with AF Both randomized data and registries have confirmed it can be an alternative to oral anticoagulation in patients with nonvalvular AF Current guidelines recommend LAAO for patients with NVAF who have contraindications or are unsuitable for long-term OAC
Considering the unique high risk of AF patients with PCI LAAO may be an attractive treatment option by obviating the need for combined oral anticoagulation and antiplatelet therapy However so far there is no data from neither randomized cohorts nor real-world registries showing if LAAO can be a safe and effective alternative strategy compared to VKANOAC for stroke prevention in AF patients who underwent PCI The PROTECT AF and PREVAIL studies showed that the percutaneous LAAO was non-inferior to warfarin therapy and the PRAGUE-17 trial showed non-inferior to direct oral anticoagulants however the small sample size of these trials limited further subgroup analyses of the PCI sub-population In the NCDR registry which is the largest cohort of LAAO up to now 203 of the LAAO patients had a prior myocardial infarction However the proportion of stent implantation was not reported Among previous trials the proportion of patients with coronary artery disease ranged from 285 to 475 The large number of AF patients with CAD warrant the optimal stroke prevention strategy to be assessed in this population
The primary goal of the proposed study is to investigate if the non-inferiority would be met for the LAAO when compared to NOACs in NVAF patients with PCI in terms of a composite endpoint of any death any stroke any myocardial infarction systemic embolism at 12 months In addition the powered key secondary will also have 80 of power to show superiority for the LAAO when compared to NOACs in terms of BARC type 2 3 or 5 bleeding events at 36 months
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None