The primary objective of the trial is:To assess whether a non-surgical, fractional flow reserve (FFR) and optical coherence tomography (OCT)-guided treatment strategy* has a comparable outcome (MACE) with surgical revascularization of significant…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure:
MACE: cardiovascular mortality, myocardial infarction (MI), stroke, unplanned
revascularisation after the index procedure, or hospitalisation (>24 hours) due
to cardiac ischaemia after the index procedure
Secondary outcome
Angina status, physical limitations and quality of life (measured by the SAQ
summary score).
Background summary
Effective myocardial revascularization relies on the appropriate diagnosis of
functionally significant coronary artery disease and the selection of the
revascularisation modality. Besides the involvement of the left main stem (LM)
and multivessel disease, a significantly diseased proximal left anterior
descending artery (LAD) can also be considered for surgical revascularization.
And although percutaneous coronary intervention (PCI) is also a viable option,
medical experts agree that certain anatomical conditions and comorbidities,
together with excellent patency of arterial grafts, favour surgical treatment
in a significant number of cases. One of the numerous anatomical challenges is
a diffusely diseased LAD, which is easy to miss but has a marked detrimental
effect on PCI outcomes. In this special subgroup the utilisation of LIMA-grafts
are associated with a protective effect against disease progression as well.
But caution is also advised as diffusely diseased LADs are also known to have
impaired graft patency.
We hypothesize that discrimination between focal and diffuse LAD disease is
crucial to assign our patients to the treatment option from which they would
gain the most benefit.
Study objective
The primary objective of the trial is:
To assess whether a non-surgical, fractional flow reserve (FFR) and optical
coherence tomography (OCT)-guided treatment strategy* has a comparable outcome
(MACE) with surgical revascularization of significant left anterior descending
artery disease (LAD).
The key secondary objective of the trial is:
To compare the effect of the non-surgical, FFR- and OCT- guided treatment
strategy on the angina status, physical limitations and quality of life
(measured with the SAQ summary score) of our patients to the surgical arm.
Study design
Prospective, multicenter, randomized, open-label, comparative effectiveness
clinical trial. Patients will be screened during the heart team discussions and
randomized at the surgical centre after receiving the patient`s written
informed consent.
Intervention
Two treatment strategies:
Group 1: Cardiac surgery (bypass grafting of the left anterior descending [LAD]
coronary artery) and percutaneous coronary intervention of any other severe
stenosis of the other two major coronary arteries.
Group 2: Percutaneous coronary intervention of short coronary artery stenoses,
or pharmacological treatment of diffusely diseased LADs with percutaneous
coronary intervention of any other severe stenosis of the other two large
coronary arteries.
Study burden and risks
All treatments applied (pharmacological and nonpharmacological) are to be used
within their respective indications. Any study requested combination of
treatments is on-label and respects contemporary guidelines, recommendations
and users* manuals.
Additional measurements required prior to the draw. The measurements are part
of regular care, but are not always performed.
Participating in the study costs extra time.
The treatments used (also part of regular care) make use of radiation. In this
study, the patient receives a total of about 10 mSv of radiation.
Within the framework of the study, patients will be contacted 4 times in 12
months. A call lasts ~15-20 minutes. Patients are sent short questionnaires
about their quality of life and complaints 4 times in 12 months. The
questionnaires can be completed very quickly and completion should not take
longer than 30 minutes.
H. Dunantstraat 5
Heerlen 6419PC
NL
H. Dunantstraat 5
Heerlen 6419PC
NL
Listed location countries
Age
Inclusion criteria
Stable coronary artery disease OR
Hemodynamically stable patients with a Non-STE Acute Coronary Syndrome AND
Hemodynamically significant LAD disease, as assessed by fractional flow reserve
(FFR, <= 0.80) measurements; OR >90% lesion; OR non-invasive evidence of ischemia.
Eligibility for complete revascularization (defined as a British Cardiovascular
Intervention Society [BCIS] revascularisation index >0.8). Please be aware that
in the case of a diffusely diseased LAD and randomisation for the percutaneous
arm, optimal medical therapy is seen as LAD-revascularization.
The local Heart Team must conclude that:
The LAD, irrespective of focal or diffuse disease, is suitable for both
LIMA-LAD grafting and PCI (in the case of focal LAD disease).
Focally diseased LADs are suitable for PCI.
In the case of multivessel disease (2VD or 3VD) CABG not better than one of the
study related treatments (for a medical reason e.g. porcelain aorta, poor
conduits, comorbidities, frailty etc.). All NON-LAD lesions and coronary
arteries must be suitable for FFR guided percutaneous coronary intervention.
Age >= 18 and <= 85 years
Signed informed consent.
Ability to tolerate and no plans to interrupt relevant medical treatment during
the duration of the study.
Willing to comply with protocol required follow-up.
Exclusion criteria
Previous CABG
Any target lesion with in-stent restenosis within 1 year
Significant Left Main involvement
Significant valvular heart disease
Prior anterior myocardial infarction with clear evidence of residual akinesia
and/or dyskinesia
Extremely calcified or tortuous vessels precluding LAD FFR measurement or OCT
of the LAD.
Planned major surgery within the next 12 months
Extra-cardiac illness that is expected to limit survival to less than 1 years
Allergy or hypersensitivity to any of the study related drugs or devices (e.g.
metals, antithrombotic agent etc.)
Active participation in another randomized trial
Unable to give informed consent or potential for noncompliance with the study
protocol in the judgment of the investigator
Pregnant at the time of screening or unwilling to use effective birth control
measures while dual antiplatelet therapy is required.
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 | NL79703.096.21 |