Clinical trial NCT00299429: MIDCAB Versus DES in Proximal LAD Lesions
Official title: Randomised Comparison of Minimally Invasive Direct Coronary Artery Bypass Grafting and Percutaneous Coronary Intervention With Drug-eluting Stents in Patients With Proximal Stenosis of the Left Anterior Descending Coronary Artery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Stent
drug-eluting stent
Minimally invasive bypass surgery
left anterior descending
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: Cordis Medizinische Apparate GmbH
First posted: 2006-03-06
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Percutaneous coronary intervention with a sirolimus-coated stent compared to minimally invasive bypass surgery in patients with isolated proximal left anterior descending coronary arteries in terms of non-inferiority of an end point combining mortality, acute myocardial infarction and rate of reintervention of the target vessel within one year.


Eligibility criteria: Inclusion Criteria:

1. Single-vessel disease of the proximal LAD with a stenosis \> 50% (multivessel disease only if further coronary vessel stenoses do not require treatment)
2. Patients with angina pectoris (CCS 1-4)
3. Asymptomatic patients if clear signs of ischemia in the segments supplied by the LAD as assessed by bicycle ergometry or treadmill and/or scintigraphically and/or stress echo
4. Patients for whom both methods of treatment are equally possible
5. Consensus between the cardiac surgeon and the cardiologist that both inclusion and exclusion criteria are met in the selected case
6. Informed consent of the patient.

Exclusion Criteria:

1. Patients \< 18 years
2. Pregnancy
3. Previous coronary artery bypass surgery
4. Concomitant diseases that lead to a greater risk for each of the treatment strategies
5. Significant peripheral arterial occlusive disease
6. Concomitant disease with limited life expectancy (e.g. malignant tumours that have not been curatively treated)
7. Objective follow-up examination not possible due to physical or mental handicap
8. Participation in another study.

Angiographical exclusion criteria:

1. Left main stem stenosis
2. Multivessel disease for which surgical or interventional therapy on other vessel areas is required.
3. Diagonal/septal branch \> 1.5 mm, which might be compromised by a stent
4. Need for acute intervention (e.g. acute myocardial infarction)
5. Total occlusion of the LAD

Primary outcomes:
measure: Major adverse cardiac events
timeFrame: 12 months
Secondary outcomes:
measure: Perioperative complications
timeFrame: 30 days
measure: CCS-Classification
timeFrame: 12 months
measure: cost-effectiveness
timeFrame: 12 months
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University of Leipzig - Heart Center
Study officials:
affiliation: Heart Center Leipzig - University Hospital
name: Holger Thiele, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blazek S, Rossbach C, Borger MA, Fuernau G, Desch S, Eitel I, Stiermaier T, Lurz P, Holzhey D, Schuler G, Mohr FW, Thiele H. Comparison of sirolimus-eluting stenting with minimally invasive bypass surgery for stenosis of the left anterior descending coronary artery: 7-year follow-up of a randomized trial. JACC Cardiovasc Interv. 2015 Jan;8(1 Pt A):30-8. doi: 10.1016/j.jcin.2014.08.006. Epub 2014 Dec 10.
citation: Thiele H, Neumann-Schniedewind P, Jacobs S, Boudriot E, Walther T, Mohr FW, Schuler G, Falk V. Randomized comparison of minimally invasive direct coronary artery bypass surgery versus sirolimus-eluting stenting in isolated proximal left anterior descending coronary artery stenosis. J Am Coll Cardiol. 2009 Jun 23;53(25):2324-31. doi: 10.1016/j.jacc.2009.03.032.