Actively Recruiting
Revascularization Strategies in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) and Severe Coronary Artery Disease
Led by American Heart of Poland · Updated on 2026-02-23
1000
Participants Needed
7
Research Sites
270 weeks
Total Duration
On this page
Sponsors
A
American Heart of Poland
Lead Sponsor
A
Andrzej Frycz Modrzewski Krakow University
Collaborating Sponsor
AI-Summary
What this Trial Is About
MILESTONE STUDY is dedicated to problems connected with patients with multivessel coronary artery disease and/or with left main narrowing who present symptoms of acute ischemia. For such kind of patients according to current ACC/AHA guidelines CABG (surgical revascularization) is recommended as a treatment method. In comparison with CABG, recent studies have shown that PCI (percutaneous coronary intervention) is associated with a lower rate of periprocedural adverse events and similar long term event-free survival in patients with left main disease. Our latest non randomized registry and randomized LEMANS study, comparing LMCA (left main coronary artery) stenting with CABG confirmed above findings. LEMANS ACS (acute coronary syndrome) retrospective registry of patients with UPLMCA (unprotected LMCA) disease and non ST elevation ACS showed lower 30 day and trend toward lower one year mortality after PCI when compared with CABG. It should be stressed, that acute ischemia substantially increase the risk of CABG. In fact, there are limited data on the outcome of ULMCA stenting or CABG in patients with acute coronary syndromes (ACS). Similarly, all randomized studies comparing PCI vs CABG in multivessel disease included mainly patients with stable angina, small cohort of patients with unstable angina and they excluded patients with non ST elevation Myocardial infarction. In the SYNTAX study -largest PCI vs CABG trial, randomized patients were patients with low perioperative risk (logistic EUROSCORE \<5) and ACS patients routinely excluded. High perioperative risk patients were included only in PCI registry.
CONDITIONS
Official Title
Revascularization Strategies in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) and Severe Coronary Artery Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Written consent from the patient
- Acute coronary syndrome without ST-segment elevation including NSTEMI and unstable angina needing urgent invasive treatment within 72 hours
- Suitable for invasive treatment
- Multivessel coronary artery disease with more than 50% narrowing in at least two major coronary arteries, possibly including left main disease
- Syntax Score below 33
- Feasibility of complete revascularization by both PCI and CABG
- Agreement by both cardiothoracic surgeon and interventional cardiologist (Heart Team consent)
You will not qualify if you...
- Age under 18 years
- ST-segment elevation myocardial infarction (STEMI) or new left bundle branch block
- Stable coronary artery disease
- Single- or two-vessel coronary disease without proximal left anterior descending artery involvement
- Suitable only for conservative treatment
- Planned surgery other than CABG for structural heart defects
- Need for immediate coronary angioplasty
- Syntax Score of 33 or higher
- Contraindications to antiplatelet therapy
- Acute heart failure in class IV or cardiogenic shock
- Previous CABG surgery
- PCI procedure within last 6 months
- Stroke within last 6 months
- End-stage kidney disease requiring dialysis
- Pregnancy or intention to become pregnant
- Other serious illnesses with life expectancy less than 3 years
- Participation in other ongoing clinical trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Małopolska Cardiovascular Center, Polish-American Heart Clinic in Chrzanów
Chrzanów, Malopolska, Poland, 32-500
Actively Recruiting
2
Polish-American Heart Clinics Center for Cardiology and Cardiac Surgery Outpatient Specialist Care in Bielsko-Biała
Bielsko-Biala, Silesian Voivodeship, Poland, 43-316
Actively Recruiting
3
Polish-American Heart Clinics III Department of Invasive Cardiology, Angiology and Electrocardiology
Dąbrowa Górnicza, Silesian Voivodeship, Poland, 41-300
Actively Recruiting
4
Polish-American Heart Clinics, 1st Department of Cardiology and Angiology in Ustroń
Ustroń, Silesian Voivodeship, Poland, 43-450
Actively Recruiting
5
Polish-American Heart Clinics Cardiovascular Center in Kędzierzyn-Koźle
Kędzierzyn-Koźle, Poland
Not Yet Recruiting
6
Polish-American Heart Clinics X Department of Invasive Cardiology, Electrophysiology and Electrostimulation in Tychy
Tychy, Poland, 43-100
Actively Recruiting
7
National Medical Institute of the Ministry of the Interior and Administration
Warsaw, Poland
Actively Recruiting
Research Team
N
Natalia Pydyn, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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