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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
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The aim of this trial is to evaluate the safety and cost effectiveness of omission of percutaneous coronary intervention of significant coronary artery disease in patients scheduled to undergo transcatheter aortic valve implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAVI without routine PCI | Experimental | Patients who are randomized to the experimental or index group undergo TAVI without routine PCI |
|
| TAVI with routine PCI | No Intervention | Patients who are randomized to the control or reference group undergo TAVI with routine PCI |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No PCI | Procedure | Omission of PCI of significant coronary artery disease prior to TAVI |
|
| Measure | Description | Time Frame |
|---|---|---|
| composite of all-cause mortality, myocardial infarction, stroke and type 2-4 bleeding, in accordance to VARC-3 criteria | 12 months from randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of all-cause mortality, myocardial infarction, stroke, in accordance with VARC-3 criteria | 4 months - 12 months - total follow up 5 years | |
| all-cause mortality | VARC-3 | 4 months - 12 months - total follow up 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michiel Voskuil, MD PhD | UMC Utrecht | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RadboudUMC | Nijmegen | Gelderland | Netherlands | |||
| Maastricht UMC+ |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41921523 | Derived | Delewi R, Aarts HM, Broeze GM, Hemelrijk KI, van Ginkel DJ, Versteeg GAA, Grundeken MJ, Claessen BEPM, Tonino PAL, Schotborgh CE, Meuwissen M, van Houwelingen GK, Wykrzykowska JJ, Amoroso G, Vossenberg TN, Vriesendorp PA, van Royen N, Ten Berg JM, Tijssen JGP, Voskuil M; PRO-TAVI trial investigators. Deferral of percutaneous coronary intervention in patients undergoing transcatheter aortic valve implantation (PRO-TAVI): an investigator-initiated, multicentre, open-label, non-inferiority, randomised controlled trial. Lancet. 2026 Apr 11;407(10537):1429-1438. doi: 10.1016/S0140-6736(26)00308-9. Epub 2026 Mar 29. | |
| 39674524 |
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| myocardial infarction | VARC-3 | 4 months - 12 months - total follow up 5 years |
| stroke | VARC-3 | 4 months - 12 months - total follow up 5 years |
| VARC-3 bleeding | 4 months - 12 months - total follow up 5 years |
| BARC bleeding | BARC bleeding > type 1 | 4 months - 12 months - total follow up 5 years |
| urgent and elective revascularization | ACC/AHA Key Data Elements and Definitions for Cardiovascular Endpoint Events in Clinical Trials & ARC-2 | 4 months - 12 months - total follow up 5 years |
| Target lesion revascularization | ARC-2 | 4 months - 12 months - total follow up 5 years |
| Target vessel revascularization | ARC-2 | 4 months - 12 months - total follow up 5 years |
| rehospitalization | VARC-3 | 4 months - 12 months - total follow up 5 years |
| Left ventricular function measured by echocardiography | 12 months |
| Cost-effectiveness of omission of PCI using QALYs | 4 months - 12 months |
| Cost-effectiveness of omission of PCI using Incremental Cost Effectiveness Ratios | 4 months - 12 months |
| Quality of life assessed by Euro Quality of Life 5D Questionnaire | the system produces a 5-digit health status profile to describe quality of life in a descriptive manner. Therefore, no lowest and highest value can be stated. | 4 months - 12 months |
| Quality of life assessed by SF-36 Questionnaire | Questionnaire consists of eight sections. Each section is transformed into a 0 - 100 scale. The lower the score the more disability. | 4 months - 12 months |
| Anginal status (CCS) | 4 months - 12 months |
| NYHA classification | 4 months - 12 months |
| Acute kidney injury stage 3 and 4 | VARC-3 | 4 months - 12 months - total follow up 5 years |
| Maastricht |
| Limburg |
| Netherlands |
| Amphia Ziekenhuis Breda | Breda | North Brabant | Netherlands |
| Catharina Ziekenhuis Eindhoven | Eindhoven | North Brabant | Netherlands |
| Amsterdam UMC | Amsterdam | North Holland | Netherlands |
| OLVG | Amsterdam | North Holland | Netherlands |
| Medisch Spectrum Twente | Enschede | Overijssel | Netherlands |
| Medisch Centrum Leeuwarden | Leeuwarden | Provincie Friesland | Netherlands |
| UMC Groningen | Groningen | Provincie Groningen | Netherlands |
| Haga Ziekenhuis Den Haag | The Hague | South Holland | Netherlands |
| Antonius Ziekenhuis Nieuwegein | Nieuwegein | Utrecht | Netherlands |
| UMC Utrecht | Utrecht | Utrecht | 3508GA | Netherlands |
| Derived |
| Aarts HM, Hemelrijk KI, Broeze GM, van Ginkel DJ, Versteeg GAA, Overduin DC, Tijssen JG, Beijk MAM, Baan J, Vis MM, Lemkes JS, de Winter RJ, Dickinson MG, Kraaijeveld AO, Mokhles MM, Dessing TC, Grundeken MJ, Claessen BEPM, Tonino PAL, Schotborgh CE, Meuwissen M, van Houwelingen GK, Wykrzykowska JJ, Amoroso G, Vossenberg TN, Vriesendorp PA, van Royen N, Ten Berg JM, Delewi R, Voskuil M. Deferral of routine percutaneous coronary intervention in patients undergoing transcatheter aortic valve implantation: Rationale and design of the PRO-TAVI trial. Am Heart J. 2025 Mar;281:133-139. doi: 10.1016/j.ahj.2024.12.003. Epub 2024 Dec 16. |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D001024 | Aortic Valve Stenosis |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000082862 | Aortic Valve Disease |
| D014694 | Ventricular Outflow Obstruction |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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