Clinical trial NCT04915976: TAVI and Gender Outcomes Aortic Stenosis Undergoing Transfemoral Transcatheter Aortic Valve Implantation.
Official title: Gender-specific Temporal Trends in Survival in Patients With Severe Aortic Stenosis Undergoing Transfemoral Transcatheter Aortic Valve Implantation.
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Aortic Stenosis
Gender
Surgery
Keywords: aortic stenosis, TAVR, TAVI, Transcatheter aortic valve implantation, Gender differences
Lead sponsor: Imperial College Healthcare NHS Trust
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 14086
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All comers - national UK registry of all TAVI patients between 2007 - 2017

Brief summary: Severe aortic stenosis (AS) is the commonest form of valvular abnormality in the developed world and transcatheter aortic valve implantation (TAVI) is now widely practiced as in many cases is the preferred treatment option over conventional aortic surgery. Several studies have shown that females have an apparent better outcome with TAVI than males.

There are a number of possible reasons as to the apparent favourable benefit of TAVI in women including: having both lower rates of moderate / severe aortic regurgitation and peri-procedural mortality, lower rates of bleeding and renal failure, better patient prosthesis match and recovery of left ventricular function with more favourable left ventricular remodelling.

We aim to explore the long term outcomes of TAVI between males and females to try and identify specific tailored treatment options.

This data will be useful in providing important information regarding gender differences in patients who are treated with transcatheter aortic valve implantation. Data provided will include long term outcomes and predictors of outcome.

The study team will then identify and implement strategies to improve outcomes in patients being treated with transcatheter aortic valve implantation.

Detailed description: Severe aortic stenosis (AS) is the commonest form of valvular abnormality in the developed world and accounts for more than 40% of patients with native valvular disease with an approximately equal prevalence in males and females.

Transcatheter aortic valve implantation (TAVI) is now widely practiced with treatment of over 300,000 patients worldwide. Many centres now regularly implant devices in patients for whom conventional aortic valve replacement (AVR) is deemed high or intermediate risk. Several studies have shown that females have an apparent better outcome with TAVI than males.

There are numerous possible reasons as to the apparent favourable benefit of TAVI in women including: having both lower rates of moderate / severe aortic regurgitation and peri-procedural mortality, lower rates of bleeding and renal failure, better patient prosthesis match and recovery of left ventricular function with more favourable left ventricular remodelling.

Rationale for proposal:

Newer devices have reduced the introducer French size and are hence associated with reduced rates of vascular and bleeding complications. This may translate to an even higher survival benefit in female versus male patients with severe aortic stenosis treated with transfemoral TAVI. In the current study we will aim to investigate gender temporal survival trends, and complications including stroke and heart attack in aortic stenosis patients treated with current versus older generation transcatheter valves. We have already been successful in obtaining the periprocedural data from NICOR and and mortality data will be linked from NHS digital.

Objectives

The current study will aim to:

1. Compare the mid-long term survival of females versus males in patients with AS treated with current versus older TAVI technologies. Study design In the current study, all patients undergoing transfemoral TAVI in the UK (between 2007 and 2017) will be included.

Eligibility criteria: All comers - retrospective registry

Primary outcomes:
measure: All cause mortality
timeFrame: 3 years
measure: Cardiovascular Mortality
timeFrame: 3 years
Secondary outcomes:
measure: Major adverse cardiovascular events
timeFrame: 3 years
measure: Bleeding (according to BARC - life threatening, major, minor)
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References: