RecruitingNot ApplicableNCT01311323

Revascularization Strategies in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) and Severe Coronary Artery Disease

Multivessel and Left Main Coronary Artery Stenting in Comparison With Surgical Revascularization in Patients With Non ST Elevation Acute Coronary Syndrome. Prospective, Clinical Randomized Trial (The MILESTONE Trial)


Sponsor

American Heart of Poland

Enrollment

1,000 participants

Start Date

Aug 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called CABG and a procedure called PCI for people with acute coronary syndrome and multivessel coronary artery disease. The study is currently recruiting participants at 7 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREPCI

Percutaneous Coronary Intervention with contemporary drug eluting stent, fractional flow reserve or iFR measurement and optimisation with intravascular imaging

PROCEDURECABG

Coronary Artery Bypass Graft


Locations(9)

Małopolska Cardiovascular Center, Polish-American Heart Clinic in Chrzanów

Chrzanów, Malopolska, Poland

Polish-American Heart Clinics Center for Cardiology and Cardiac Surgery Outpatient Specialist Care in Bielsko-Biała

Bielsko-Biala, Silesian Voivodeship, Poland

Polish-American Heart Clinics III Department of Invasive Cardiology, Angiology and Electrocardiology

Dąbrowa Górnicza, Silesian Voivodeship, Poland

Polish-American Heart Clinics, 1st Department of Cardiology and Angiology in Ustroń

Ustroń, Silesian Voivodeship, Poland

Upper Silesian Medical Center in Katowice

Katowice, Poland

Polish-American Heart Clinics Cardiovascular Center in Kędzierzyn-Koźle

Kędzierzyn-Koźle, Poland

University Clinical Hospital in Opole

Opole, Poland

Polish-American Heart Clinics X Department of Invasive Cardiology, Electrophysiology and Electrostimulation in Tychy

Tychy, Poland

National Medical Institute of the Ministry of the Interior and Administration

Warsaw, Poland

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NCT01311323


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