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RECRUITING
NCT01311323
NA

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

Sponsor: American Heart of Poland

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1000

Start Date

2025-08-25

Completion Date

2030-11

Last Updated

2026-02-23

Healthy Volunteers

No

Interventions

PROCEDURE

PCI

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

PROCEDURE

CABG

Coronary Artery Bypass Graft

Locations (7)

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

Polish-American Heart Clinics Cardiovascular Center in Kędzierzyn-Koźle

Kędzierzyn-Koźle, 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