Revascularization options for adults with multivessel coronary disease and non-ST-elevation ACS
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)
This trial will test whether stenting (PCI) or bypass surgery (CABG) is better for adults who present with non-ST-elevation acute coronary syndrome and severe multivessel coronary artery disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | American Heart of Poland Academic / other |
| Locations | 7 sites (Chrzanów, Malopolska and 6 other locations) |
| Trial ID | NCT01311323 on ClinicalTrials.gov |
What this trial studies
This randomized interventional trial compares contemporary percutaneous coronary intervention (PCI) using drug-eluting stents with coronary artery bypass grafting (CABG) in adults presenting with non-ST-elevation acute coronary syndrome (NSTE-ACS) and multivessel coronary disease, including possible left main involvement. Eligible patients present within an urgent window (typically within 72 hours) and have angiographic multivessel disease or left main narrowing with anatomical limits such as a SYNTAX score below predefined thresholds. The protocol allows contemporary invasive strategies including culprit-lesion PCI with possible staged complete PCI versus surgical revascularization, with follow-up for early procedural outcomes and longer-term event-free survival. The trial is conducted at multiple Polish cardiac centers affiliated with the American Heart of Poland and collaborating universities.
Who should consider this trial
Good fit: Adults over 18 with non-ST-elevation ACS (unstable angina or NSTEMI) requiring invasive management within about 72 hours and angiographic multivessel disease or left main narrowing, with anatomy suitable for either PCI or CABG, are ideal candidates.
Not a fit: Patients with ST-elevation myocardial infarction, very high anatomic complexity (e.g., SYNTAX score above trial cutoff), or clear contraindications to either PCI or surgery are unlikely to benefit from this trial.
Why it matters
Potential benefit: If positive, the trial could show that a less invasive PCI approach offers similar or better short-term safety and comparable long-term outcomes to CABG for high-risk NSTE-ACS patients, expanding treatment options.
How similar studies have performed: Previous nonrandomized registries and the randomized LEMANS program have suggested that left-main PCI can have lower periprocedural events and similar long-term outcomes compared with CABG, but evidence specifically focused on multivessel NSTE-ACS remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Subjects must meet ALL of the inclusion criteria to be considered for the trial. If ANY of the exclusion criteria are met, the subject is excluded from the trial and cannot be randomized. * Age over 18 years, * Written patient consent, * Acute Coronary Syndrome without ST-segment elevation of high, intermediate and low risk, including NSTEMI and unstable angina requiring urgent (within 72 hours) invasive strategy, * Qualification for invasive treatment, * Multivessel coronary disease, defined as angiographic narrowing \>50%DS on investigator's visual assessment in at least two major coronary artery territories (RCA, LAD, LCX), including involvement of the proximal segment of the left anterior descending artery or three-vessel disease with a Syntax Score \< 33. Intermediate lesions (40-70%) will need to be assessed with either FFR, iFR, or VFFR). Patient may have left main coronary artery disease, defined as narrowing \>50%DS (but this is not obligatory). For borderline changes, IVUS (MLA \<6 mm2 or iFR=\<0,90 or FFR=\<0,80, with an anatomic Syntax Score \<33 will be decisive, * Feasibility of complete revascularization on both the CABG and PCI sides, * Consent within the Heart Team for both CABG by the cardiothoracic surgeon and PCI by the interventional cardiologist. Exclusion Criteria: * Age under 18 years, * ST-segment elevation myocardial infarction (STEMI) or new left bundle branch block (LBBB), * Stable coronary syndrome, * Single- or two-vessel coronary disease without involvement of the proximal LAD, defined as narrowing above 50%DS, * Qualification for conservative treatment, * Anticipated surgery other than CABG due to severe valvular defect or other structural defect, particularly moderate or severe mitral regurgitation, * Need for immediate coronary angioplasty treatment, * Syntax Score equal or above 33 (\>=33), * Contraindications to short-term and long-term antiplatelet therapy, * Acute heart failure in class IV (cardiogenic shock), * Previous CABG procedure, * Previous PCI procedure within the last 6 months, * Ischemic or hemorrhagic stroke within 6 months prior to inclusion, * End-stage chronic kidney disease on dialysis, * Pregnancy or intention to become pregnant (women of child bearing age must have a recent negative pregnancy test prior to randomization), * Non cardiac co-morbidities with life expectancy less than 3 years, * Participation in other clinical trial that have not reached their primary endpoint.
Where this trial is running
Chrzanów, Malopolska and 6 other locations
- Małopolska Cardiovascular Center, Polish-American Heart Clinic in Chrzanów — Chrzanów, Malopolska, Poland (Recruiting)
- Polish-American Heart Clinics Center for Cardiology and Cardiac Surgery Outpatient Specialist Care in Bielsko-Biała — Bielsko-Biala, Silesian Voivodeship, Poland (Recruiting)
- Polish-American Heart Clinics III Department of Invasive Cardiology, Angiology and Electrocardiology — Dąbrowa Górnicza, Silesian Voivodeship, Poland (Recruiting)
- Polish-American Heart Clinics, 1st Department of Cardiology and Angiology in Ustroń — Ustroń, Silesian Voivodeship, Poland (Recruiting)
- Polish-American Heart Clinics Cardiovascular Center in Kędzierzyn-Koźle — Kędzierzyn-Koźle, Poland (Not_yet_recruiting)
- Polish-American Heart Clinics X Department of Invasive Cardiology, Electrophysiology and Electrostimulation in Tychy — Tychy, Poland (Recruiting)
- National Medical Institute of the Ministry of the Interior and Administration — Warsaw, Poland (Recruiting)
Study contacts
- Principal investigator: Piotr P Buszman, MD,PhD, Prof — American Heart of Poland
- Study coordinator: Natalia Pydyn, PhD
- Email: natalia.pydyn@ahop.pl
- Phone: +48 667 132 233
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.