Ischemic And Bleeding Risk Assessment After TAVR

NCT06000943 | Recruiting

• 1 other identifier: F1R
• Study Type: observational
• Target: 2,500
• Locations: 5 countries
• Sites: 12

Brief Summary

Transcatheter aortic valve replacement (TAVR) represents an effective treatment to improve symptoms and prognosis in patients with symptomatic severe aortic stenosis (AS) (1-2). Giving an established uniform approach towards anticoagulation and antithrombotic therapy after TAVR in the post POPULAR-TAVI era, recent data coming from the analysis of different trials, highlight the relevance of the patient's background on the occurrence of ischemic and bleeding events. Despite this a targeted antithrombotic strategy remains unexplored and all patients undergoing TAVR without other indication to DAPT or OAC, were currently treated according with the concept of "less is more" (only SAPT or only OAC) regardless the risk level (5-6). The keys points of the project will be 1) the assessment of ischemic and bleeding risk after TAVR stratified according with antithrombotic therapy and surgical risk; 2) the evaluation of the impact of prostheses type and the complete blood count variables (hemoglobine and platelets) on the daily average ischemic and bleeding risk and 3) the evaluation of the dynamic therapeutic changes after TAVR during the follow up.

Conditions

Aortic Valve Stenosis; Transcatheter Aortic Valve Replacement

Outcome Measures

Primary Outcomes (2)

• Trend of average daily ischemic risk (ADIR) and average daily bleeding risk (ADBR)

  ADIR was calculated as the total number of ischemic events (CV deaths, MI, ischemic stroke and other thrombotic events-including repeat events) divided by the number of patients-day at risk. ADBR was calculated as the total number of bleeding events (including repeat events) divided by the number of the number of patients-day at risk.

  At 30-days, 90-days and 1 year

• Average daily risks (ADRs) in different type of valve prosthesis

  Trend and prevalence of ADIR and ADBR in different type and number of prosthesis (long frame vs short frame, balloon versus self-expandable, porcine vs bovine, Single Valve vs Valve in Valve) and calculated as the total number of events divided by the number of patients-day at risk

  At 30-days, 90-days and 1 year

Secondary Outcomes (5)

• Average daily risks (ADRs) in different type of valve prosthesis

  At 30-days, 90-days and 1 year

• Average daily risks (ADRs) in anaemic and thrombocytopenic patients

  In hospital up to 1 year

• Rate of antithrombotic regimen changes after TAVR

  At 30-days, 90-days and 1 year

• Timing of antithrombotic regimen changes after TAVR

  At 30-days, 90-days and 1 year

• Type of antithrombotic regimen changes after TAVR

  At 30-days, 90-days and 1 year

Study Arms (3)

Lower Surgical Risk

Surgical risk stratification. All the following groups will be define according with STS and Euroscore II score and stratified based on antithrombotic strategy in all possible combinations (SAPT, DAPT, OAC, OAC+SAPT)

Other: Low vs Intermediate vs High surgical risk stratified according with SAPT/DAPT/OAC and OAC+SAPT

Intermediate Surgical Risk

Surgical risk stratification. All the following groups will be define according with STS and Euroscore II score and stratified based on antithrombotic strategy in all possible combinations (SAPT, DAPT, OAC, OAC+SAPT)

Other: Low vs Intermediate vs High surgical risk stratified according with SAPT/DAPT/OAC and OAC+SAPT

High Surgical Risk

Surgical risk stratification. All the following groups will be define according with STS and Euroscore II score and stratified based on antithrombotic strategy in all possible combinations (SAPT, DAPT, OAC, OAC+SAPT)

Other: Low vs Intermediate vs High surgical risk stratified according with SAPT/DAPT/OAC and OAC+SAPT

Interventions

Low vs Intermediate vs High surgical risk stratified according with SAPT/DAPT/OAC and OAC+SAPT OTHER

All patients undergoing TAVR will be stratified according with surgical risk level and all combination of antithrombotic therapy at discharge Low risk (SAPT vs DAPT and OAC vs OAC+SAPT) Intermediate risk (SAPT vs DAPT and OAC vs OAC+SAPT) High risk (SAPT vs DAPT and OAC vs OAC+SAPT)

High Surgical Risk; Intermediate Surgical Risk; Lower Surgical Risk

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with severe aortic stenosis diagnosed according to ESC guidelines, undergoing TAVR

You may qualify if:

• All patients with severe aortic stenosis undergoing TAVR.
• Availability of changes in antithrombotic therapy at 1 month, 90 days, and 1 year after TAVR.

You may not qualify if:

• Patients who died during the index procedure
• Patients in triple antithrombotic therapy at discharge
• Patients with a known prognosis less than 1 year at the time of TAVR

Sponsors & Collaborators

• Niguarda Hospital: lead

Study Sites (12)

OLV Hospital

Aalst, Belgium

RECRUITING

Complejo Asistencial Dr. Sótero del Río

Santiago, Chile

RECRUITING

Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady

Prague, 10034, Czechia

RECRUITING

ASST GOM Niguarda

Milan, Italia, 20162, Italy

RECRUITING

Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

RECRUITING

IRCCS Policlinico San Donato

San Donato Milanese, Milano, Italy

RECRUITING

IRCCS Ospedale Policlinico San Martino

Genova, Italy

RECRUITING

Ospedale Galeazzi Sant'Ambrogio

Milan, Italy

RECRUITING

San Carlo Hospital

Potenza, Italy

RECRUITING

Azienda Ospedaliera Sant'Andrea

Roma, Italy

RECRUITING

A.O.U. Città della Salute e della Scienza di Torino

Torino, Italy

RECRUITING

Puerto Real University Hospital, Puerto Real

Cadiz, Spain

RECRUITING

Related Publications (10)

• Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis M, De Paulis R, Delgado V, Freemantle N, Gilard M, Haugaa KH, Jeppsson A, Juni P, Pierard L, Prendergast BD, Sadaba JR, Tribouilloy C, Wojakowski W; ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022 Feb 12;43(7):561-632. doi: 10.1093/eurheartj/ehab395. No abstract available.

  PMID: 34453165 BACKGROUND

• Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A, Toly C. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2021 Feb 2;143(5):e35-e71. doi: 10.1161/CIR.0000000000000932. Epub 2020 Dec 17.

  PMID: 33332149 BACKGROUND

• Ko E, Park DW. Optimal Antithrombotic Strategy After Transcatheter Aortic Valve Replacement: Is the "Less Is More" Concept Always Better? J Am Heart Assoc. 2021 May 4;10(9):e021241. doi: 10.1161/JAHA.121.021241. Epub 2021 Apr 17. No abstract available.

  PMID: 33870701 BACKGROUND

• 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.

  PMID: 32865376 BACKGROUND

• 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.

  PMID: 32223116 BACKGROUND

• Capodanno D, Collet JP, Dangas G, Montalescot G, Ten Berg JM, Windecker S, Angiolillo DJ. Antithrombotic Therapy After Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2021 Aug 9;14(15):1688-1703. doi: 10.1016/j.jcin.2021.06.020.

  PMID: 34353601 BACKGROUND

• Esposito G, Montalto C, Crimi G, Grippo R, Morici N, Bruschi G, Testa L, De Marco F, Soriano F, Nava S, Stefanini G, Bedogni F, Oreglia JA. Time course of ischemic and bleeding burden in consecutive patients undergoing transcatheter aortic valve replacement (FOCUS-ONE Registry). Int J Cardiol. 2023 Jun 15;381:2-7. doi: 10.1016/j.ijcard.2023.03.009. Epub 2023 Mar 8.

  PMID: 36898584 BACKGROUND

• Mehran R, Baber U, Sharma SK, Cohen DJ, Angiolillo DJ, Briguori C, Cha JY, Collier T, Dangas G, Dudek D, Dzavik V, Escaned J, Gil R, Gurbel P, Hamm CW, Henry T, Huber K, Kastrati A, Kaul U, Kornowski R, Krucoff M, Kunadian V, Marx SO, Mehta SR, Moliterno D, Ohman EM, Oldroyd K, Sardella G, Sartori S, Shlofmitz R, Steg PG, Weisz G, Witzenbichler B, Han YL, Pocock S, Gibson CM. Ticagrelor with or without Aspirin in High-Risk Patients after PCI. N Engl J Med. 2019 Nov 21;381(21):2032-2042. doi: 10.1056/NEJMoa1908419. Epub 2019 Sep 26.

  PMID: 31556978 BACKGROUND

• Valgimigli M, Frigoli E, Heg D, Tijssen J, Juni P, Vranckx P, Ozaki Y, Morice MC, Chevalier B, Onuma Y, Windecker S, Tonino PAL, Roffi M, Lesiak M, Mahfoud F, Bartunek J, Hildick-Smith D, Colombo A, Stankovic G, Iniguez A, Schultz C, Kornowski R, Ong PJL, Alasnag M, Rodriguez AE, Moschovitis A, Laanmets P, Donahue M, Leonardi S, Smits PC; MASTER DAPT Investigators. Dual Antiplatelet Therapy after PCI in Patients at High Bleeding Risk. N Engl J Med. 2021 Oct 28;385(18):1643-1655. doi: 10.1056/NEJMoa2108749. Epub 2021 Aug 28.

  PMID: 34449185 BACKGROUND

• De Larochelliere H, Puri R, Eikelboom JW, Rodes-Cabau J. Blood Disorders in Patients Undergoing Transcatheter Aortic Valve Replacement: A Review. JACC Cardiovasc Interv. 2019 Jan 14;12(1):1-11. doi: 10.1016/j.jcin.2018.09.041.

  PMID: 30621965 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Central Study Contacts

Giuseppe Esposito, MD

CONTACT

+393278393131; giuseppe.esposito@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 21, 2023
• Study Start: August 1, 2023
• Primary Completion: November 1, 2024
• Study Completion (Estimated): December 15, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1); CL (1); BE (1); IT (8); ES (1)