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

Launched by AMERICAN HEART OF POLAND · Mar 8, 2011

Keywords

ClinConnect Summary

The MILESTONE STUDY is looking at different treatment options for patients with severe coronary artery disease who are experiencing acute coronary syndrome (ACS). Specifically, it compares two main procedures: CABG, which is a type of heart surgery, and PCI, a less invasive procedure where a small balloon is used to open blocked arteries. Current guidelines suggest CABG is the standard treatment, but recent findings indicate that PCI may have fewer immediate complications and similar long-term outcomes for certain patients. This study aims to gather more information on how these treatments perform, especially in patients who have not experienced ST elevation in their heart attacks.

To be eligible for the trial, participants need to be adults over 21 who have been diagnosed with ACS without ST elevation and have specific types of coronary artery blockages. They should also be suitable for both CABG and PCI procedures. Participants will receive careful monitoring and follow-up to track their health outcomes after being treated with either method. It’s important to note that certain conditions, like recent strokes or kidney disease requiring dialysis, will exclude individuals from participating. This research could help improve treatment strategies for patients with serious heart conditions in the future.

Gender

ALL

Eligibility 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 very high, high, and intermediate 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 in at least two arteries, including involvement of the proximal segment of the left anterior descending artery or three-vessel disease with a Syntax Score \< 33. For borderline stenoses (40-70%), vFFR, FFR, or iFR will be decisive,
• • Left main coronary artery disease defined as narrowing \>50%DS. For borderline changes, IVUS (MLA \<6 mm2 or vFFR, FFR, or iFR) with a Syntax Score \< 32 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 above 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.