Assessing the effects of stenting in significant coronary artery disease prior to transcatheter aortic valve implantation

Conditions

Coronary artery disease & aortic stenosis Circulatory System Aortic (valve) stenosis

Patterson T, Clayton T, Dodd M, Khawaja Z, Morice MC, Wilson K, Kim WK, Meneveau N, Hambrecht R, Byrne J, Carrié D, Fraser D, Roberts DH, Doshi SN, Zaman A, Banning AP, Eltchaninoff H, Le Breton H, Smith D, Cox I, Frank D, Gershlick A, de Belder M, Thomas M, Hildick-Smith D, Prendergast B, Redwood S, ACTIVATION Trial Investigators.

2021-09-01158 citations

10.1016/j.jcin.2021.06.041

The percutaneous coronary intervention prior to transcatheter aortic valve implantation (ACTIVATION) trial: study protocol for a randomized controlled trial.

Khawaja MZ, Wang D, Pocock S, Redwood SR, Thomas MR.

2014-07-2464 citations

10.1186/1745-6215-15-300

Successful rescue of a "suicide ventricle" during transfemoral transcatheter aortic valve implantation (TF-TAVI)

Muhammed Zeeshan Khawaja, William R. Davies, Kirsty Bolter, Karen M. Wilson, Jane Hancock et al. (9 authors)

European Heart Journal2013-08-02

10.1093/eurheartj/eht312.1709

Interventions

1:1 Randomisation of pre-TAVI PCI to no pre-TAVI PCI. The 310 patients will be enrolled from 20 - 30 UK and European centres plus 2 registries. 1. Coronary angiography will be used to

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients =18 years of age 2. Severe aortic stenosis, as defined by: 2.1. Peak transvalvular gradient of =40mmHg on transthoracic echocardiography (TTE) 2.2. Transoesophageal echocardiography (TOE) 2.3. Dobutamine stress echocardiography (DSE) 3. Aortic valve area of <1.0cm2 4. Symptoms suggestive of aortic stenosis (dyspnoea, syncope etc) 5. Deemed prohibitive risk for open aortic valve replacement (AVR) by a multi-disciplinary TAVI multidisciplinary team (MDT), as previously defined, and accepted for TAVI by said TAVI MDT 6. =1 proximal stenosis of =70% in a major epicardial artery deemed suitable for percutaneous coronary intervention (PCI) TAVI via any accepted approach (transfemoral, transapical, subclavian or transaortic) using any CE marked device 7. Written informed consent

Exclusion criteria

Exclusion criteria: 1. An obvious acute coronary syndrome within 30 days of randomisation 2. Left main stem disease 3. Pregnancy 4. Active internal bleeding (except menstruation) 5. Allergy to heparin or glycoprotein (GP) IIb/IIIa inhibitors 6. Thrombocytopoenia (platelet count < 100,000 cells/mm3) 7. Patients who have previously been enrolled in this study 8. Patients who are currently enrolled in any other study where involvement in ACTIVATION would involve deviation from either protocol

Design outcomes

Primary

Measure	Time frame
A comparison of mortality and re-hospitalisation at 12 months	—

Secondary

Measure	Time frame
1. Mortality at 12 months 2. Major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days and 12 months 3. Hospitalisation for heart failure at 30 days and 12 months 4. Procedural complications 5. Procedural success 6. Bleeding Complications 7. Access site complications 8. Transient ischaemic attacks 9. Duration of hospital stay 10. Anginal burden	—

Countries

England, France, Germany, United Kingdom

Outcome results

None listed