MIDCAB Versus DES in Proximal LAD Lesions

University of Leipzig

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Procedure: PCI with DES; Procedure: Stenting and minimally invasive bypass surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT00299429

2-Thiele

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

MIDCAB Surgery

Active Comparator group

Description:

MIDCAB Surgery

Treatment:

Procedure: Stenting and minimally invasive bypass surgery

PCI with drug-eluting stent

Experimental group

Description:

PCI with DES

Treatment:

Procedure: PCI with DES