Comprehensive Medical and Invasive Treatment strategy for patients with significant Left Anterior Descending artery disease

Phase 4

Completed

Conditions: angina pectoris
coronary artery disease
10011082

Registration Number: NL-OMON51591

Lead Sponsor: Zuyderland Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 460

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome measure:<br /><br>MACE: cardiovascular mortality, myocardial infarction (MI), stroke, unplanned<br /><br>revascularisation after the index procedure, or hospitalisation (>24 hours) due<br /><br>to cardiac ischaemia after the index procedure</p><br>

Secondary Outcome Measures