To investigate whether FFR-guided PCI and TAVI strategy for treatment of MVD and AS will be non-inferior to CABG and SAVR for a composite primary endpoint of all-cause mortality, stroke, myocardial infarction, coronary or valve re-intervention and…
ID
Source
Brief title
Condition
- Other condition
- Cardiac valve disorders
Synonym
Health condition
meervatslijden
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is a composite of all-cause mortality, myocardial
infarction, disabling stroke, unscheduled clinically-driven target vessel
revascularization, valve re-intervention, and life threatening or disabling
bleeding at one year
Secondary outcome
- MACE (a composite of cardiovascular mortality, all stroke, myocardial
infarction, unscheduled coronary or valve re-intervention) at one year
- All-cause mortality and all stroke at 30 days and at one year
Background summary
Patients with multivessel coronary disease (MVD) frequently have concomitant
moderate or severe Aortic Stenosis (AS). The current guidelines indicate
coronary artery by-pass graft (CABG) as the gold standard for treatment of MVD.
If moderate to severe or severe AS is present at the time of CABG, surgical
aortic valve replacement (SAVR) is performed in the same setting as CABG.
The treatment of MVD has undergone significant evolution in the last decade. In
patients with low Syntax score (SS), percutaneous coronary intervention (PCI)
is considered as equivalent treatment with CABG and widely performed in the
real life. In patients with high risk for CABG such approach is applied also
for patients with a high SS.
Fractional Flow Reserve (FFR) is at the present the gold standard technique to
detect ischemia and guide revascularization in the cathlab. It is believed that
an FFR-guided PCI for MVD might be non-inferior to CABG.
Parallel to SAVR, minimal invasive approaches by use of Transcatheter Aortic
Valve Implantation (TAVI) have been introduced and are being widely used
especially in older patients and patients with high risk or contraindication
for SAVR.
At the present, no trial has focused on patients with concomitant MVD and AS.
We therefore propose a prospective randomized controlled multicenter
international clinical trial comparing TAVI and staged FFR guided PCI versus
conventional CABG and SAVR in a population of patients with MVD and concomitant
moderate to severe or severe AS.
Study objective
To investigate whether FFR-guided PCI and TAVI strategy for treatment of MVD
and AS will be non-inferior to CABG and SAVR for a composite primary endpoint
of all-cause mortality, stroke, myocardial infarction, coronary or valve
re-intervention and life-threatening or disabling bleeding at one year.
Study design
The TCW trial is a prospective, randomized, controlled, open label,
multicenter, international, non-inferiority trial. Angiography and
echocardiography of all patients with MVD and AS will be discussed in the local
site Heart Team (HT: composed of at least one cardiac surgeon and one
interventional cardiologist with TAVI experience). If patients comply with
inclusion and exclusion criteria they will be randomized in a 1:1 fashion
between FFR-guided PCI and TAVI (experimental arm) and CABG and SAVR
(comparative arm).
Intervention
FFR-guided PCI and TAVI
Study burden and risks
There is no additional risk for patients associated with study participation,
besides the risks of the procedures (both treatment arms are standard
procedures).
Dokter van Heesweg 2
Zwolle 8025AB
NL
Dokter van Heesweg 2
Zwolle 8025AB
NL
Listed location countries
Age
Inclusion criteria
1) Symptomatic patients aged >=70 years with AS fulfilling one of these criteria
(AVA <=1 cm2; mean gradient >=40mmHg; Aortic jet velocity >4 m/sec; or Velocity
index <= 0.25) feasible for treatment by both trans femoral or subclavian
approach TAVI as well as conventional SAVR and where the HT decides that
treatment is needed (final decision is left to the HT)
2) Presence of >=2 de novo coronary lesions of >=50% diameter stenosis on visual
estimation located in any of main epicardial coronary arteries or side branches
of a lumen caliber of more than 2 mm or single LAD lesion with more than 20 mm
length or involving a bifurcation (complex), feasible for treatment with CABG
as well as PCI (HT decision)
3) Patients willing and capable to provide written informed consent
Exclusion criteria
1) Patients in cardiogenic shock or acute heart failure, requiring inotropic
agents during procedure and/or i.v. diuretics <48 hours before procedure
2) Left ventricular ejection fraction <30%
3) Concomitant presence of other than aortic valve disease requiring
intervention
4) Previous CABG, SAVR, TAVI or thoracotomy for any other reason
5) Bicuspid or unicuspid aortic valve
6) Recent myocardial infarction (less than 2 weeks)
7) Involvement of left main trifurcation (all three branches being larger than
2 mm)
8) Expected total stent length more 60mm per vessel
9) FFR measurement judged impossible
10) Life expectancy <1 year
11) Known malignancy
12) Contraindication for dual antiplatelet therapy or expected surgical
intervention requiring interruption of Dual Antiplatelet Therapy (DAPT) in the
first 6 months
13) Reduced renal function (GFR <29 ml/min/1.73m2; KDOQI stage 4 and 5)
14) Previous disabling stroke, TIA in the last 6 months, or known severe
stenosis of carotid or vertebral arteries
15) Participation in other investigational clinical trials
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL62994.075.17 |