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At present, a variety of antithrombotic regimens are prescribed in the early postprocedure period after transcatheter aortic valve implantation (TAVI). Dual antiplatelet therapy (DAPT) using aspirin and a thienopyridine in the initial period after TAVI is the recommended strategy; however, mono antiplatelet therapy using aspirin is suggested not to be inferior. In patients with atrial fibrillation (AF) or another indication for oral anticoagulation (OAC), no recommendations on best treatment regimen currently exist although triple therapy (OAC + DAPT) is best avoided due to increased bleeding risk.
We hypothesise that the omission of clopidogrel in the first 3 months after TAVI is safer and not less beneficial than the addition of clopidogrel to aspirin (cohort A) or OAC (cohort B).
The trial consists of two cohorts:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin + Clopicogrel (Cohort A) | Active Comparator | Cohort A: patients will receive clopidogrel (75mg quaque die (qD), 3 months) on top of low-dose aspirin (≤100mg qD, at least 1 year but recommended lifelong). When a patient in Cohort A doesn't already takes aspirin, a loading dose of 300mg will be given within 24 hours prior to TAVI. The loading dose for clopidogrel is 300mg, and will be given within 24 hours prior to TAVI. |
|
| Aspirin monotherapy (Cohort A) | Active Comparator | Cohort A: patients will receive low-dose aspirin (≤100mg qD, at least 1 year but recommended lifelong). When a patients doesn't already takes aspirin, a loading dose of 300mg will be given within 24 hours prior to TAVI. It is recommended to omit other antiplatelet therapy (e.g. clopidogrel) at least 5 days prior to the TAVI procedure. |
|
| OAC + Clopicogrel (Cohort B) | Active Comparator | Cohort B: patients will receive clopidogrel (75mg qD, 3 months) on top of OAC (according to its indication). The loading dose for clopidogrel is 300mg, and will be given within 24 hours prior to TAVI. It is recommended to omit other antiplatelet therapy (e.g. aspirin) at least 5 days prior to the TAVI procedure. |
|
| OAC monotherapy (Cohort B) | Active Comparator | Cohort B: patients will receive OAC according to its indication. It is recommended to continue the OAC therapy peri-procedural (International Normalized Ratio aimed at 2.0). It is recommended to omit antiplatelet therapy (e.g. clopidogrel) at least 5 days prior to the TAVI procedure. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin + clopidogrel | Drug |
| ||
| Aspirin monotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoint | The primary outcome is a safety endpoint, defined as freedom of all bleeding complications at 1 year after TAVI. The co-primary outcome is the safety endpoint defined as freedom of non-procedure related bleeding complications at 1 year after TAVI. For the classification of bleeding complications the Bleeding Academic Research Consortium Definition for Bleeding (BARC) bleeding classification is primarily used according to the Valve Academic Research Consortium (VARC). | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Net-clinical benefit endpoint | The secondary outcome is a net-clinical benefit endpoint, defined as freedom of the non-hierarchical composite of cardiovascular mortality, non-procedure related bleeding, stroke, or myocardial infarction at 1 year after TAVI. | 1 year |
| Efficacy endpoint |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacoeconomics endpoint | Outcome measure is quality-adjusted life years | 1 year |
Inclusion Criteria:
Cohort A
1. Patient has provided written informed consent.
Cohort B
Exclusion Criteria:
Cohort A
Cohort B
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| Name | Affiliation | Role |
|---|---|---|
| Jurrien M ten Berg, PhD, MD | St. Antonius Hospital | Principal Investigator |
| Pieter R Stella, MD, PhD | University Medical Center Utrecht (UMCU) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Algemeen Stedelijk Ziekenhuis | Aalst | Belgium | ||||
| Onze Lieve Vrouwe Ziekenhuis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32865376 | Derived | Brouwer J, Nijenhuis VJ, Delewi R, Hermanides RS, Holvoet W, Dubois CLF, Frambach P, De Bruyne B, van Houwelingen GK, Van Der Heyden JAS, Tousek P, van der Kley F, Buysschaert I, Schotborgh CE, Ferdinande B, van der Harst P, Roosen J, Peper J, Thielen FWF, Veenstra L, Chan Pin Yin DRPP, Swaans MJ, Rensing BJWM, van 't Hof AWJ, Timmers L, Kelder JC, Stella PR, Baan J, Ten Berg JM. Aspirin with or without Clopidogrel after Transcatheter Aortic-Valve Implantation. N Engl J Med. 2020 Oct 8;383(15):1447-1457. doi: 10.1056/NEJMoa2017815. Epub 2020 Aug 30. | |
| 32223116 |
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|
| Drug |
|
| OAC + clopicogrel | Drug |
|
| OAC monotherapy | Drug |
|
The co-secondary outcome is an efficacy endpoint, defined as freedom of the non-hierarchical composite of cardiovascular mortality, ischemic stroke, or myocardial infarction at 1 year after TAVI. |
| 1 year |
| Aalst |
| Belgium |
| Imelda Ziekenhuis | Bonheiden | Belgium |
| Algemeen Ziekenhuis Sint Jan | Bruges | Belgium |
| Ziekenhuis Oost-Limburg | Genk | Belgium |
| Universitair Ziekenhuis Leuven | Leuven | Belgium |
| Charles university, Third Faculty of Medicine | Prague | Czechia |
| National Institute Surgery Cardiaque Et De Cardiologie Interventionnelle | Luxembourg | Luxembourg |
| Academic Medical Centre (AMC) | Amsterdam | North Holland | 1105 AZ | Netherlands |
| Isala Clinics | Zwolle | Overijssel | 8011 JW | Netherlands |
| St. Antonius Hospital | Nieuwegein | Utrecht | 3435CM | Netherlands |
| Medisch Spectrum Twente | Enschede | Netherlands |
| University Medical Center | Groningen | 9700 RB | Netherlands |
| Universitair Medisch Centrum Leiden | Leiden | Netherlands |
| Academic Hospital | Maastricht | 6229 HX | Netherlands |
| Haga Ziekenhuis | The Hague | Netherlands |
| University Medical Center Utrecht (UMCU) | Utrecht | 3584 CX | Netherlands |
| Derived |
| Nijenhuis VJ, Brouwer J, Delewi R, Hermanides RS, Holvoet W, Dubois CLF, Frambach P, De Bruyne B, van Houwelingen GK, Van Der Heyden JAS, Tousek P, van der Kley F, Buysschaert I, Schotborgh CE, Ferdinande B, van der Harst P, Roosen J, Peper J, Thielen FWF, Veenstra L, Chan Pin Yin DRPP, Swaans MJ, Rensing BJWM, van 't Hof AWJ, Timmers L, Kelder JC, Stella PR, Baan J, Ten Berg JM. Anticoagulation with or without Clopidogrel after Transcatheter Aortic-Valve Implantation. N Engl J Med. 2020 Apr 30;382(18):1696-1707. doi: 10.1056/NEJMoa1915152. Epub 2020 Mar 29. |
| 26920599 | Derived | Nijenhuis VJ, Bennaghmouch N, Hassell M, Baan J Jr, van Kuijk JP, Agostoni P, van 't Hof A, Kievit PC, Veenstra L, van der Harst P, van den Heuvel AF, den Heijer P, Kelder JC, Deneer VH, van der Kley F, Onorati F, Collet JP, Maisano F, Latib A, Huber K, Stella PR, Ten Berg JM. Rationale and design of POPular-TAVI: antiPlatelet therapy fOr Patients undergoing Transcatheter Aortic Valve Implantation. Am Heart J. 2016 Mar;173:77-85. doi: 10.1016/j.ahj.2015.11.008. Epub 2015 Dec 1. |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D009203 | Myocardial Infarction |
| D020521 | Stroke |
| D006470 | Hemorrhage |
| D001024 | Aortic Valve Stenosis |
| D000083242 | Ischemic Stroke |
| D013927 | Thrombosis |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D016769 | Embolism and Thrombosis |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014694 | Ventricular Outflow Obstruction |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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