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

NCT01311323 | Recruiting DMC

• 1 other identifier: AHP-1
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Multivessel Coronary Artery Disease; Acute Coronary Syndrome

Keywords

Multivessel Coronary Artery Disease; Left Main Narrowing; Percutaneous Coronary Intervention; Coronary Artery Bypass Grafting; Drug-Eluting Stent; Fractional Flow Reserve; Instant wave-free ratio; virtual Fractional Flow Reserve

Outcome Measures

Primary Outcomes (1)

• MACCE - Major Adverse Cardiac and Cerebral Events

  The primary endpoint is a composite of all cause death, spontaneous myocardial infarction, hospitalization due to heart failure or heart failure decompensation and stroke occurring within 12 months after PCI or CABG. The hypothesis test is designed to show non-inferiority of PCI to CABG for the primary endpoint

  One year after revascularization procedure

Secondary Outcomes (7)

• SAE - Serious Adverse Events

  peri-hospital period, one month and one year and two years after revascularization procedure

• Procedural and post procedural complication

  peri-hospital period, one month and one year after revascularization procedure

• Overall costs of treatment strategies.

  one year ofter revascularization procedure

• Occurence of stent thrombosis or graft occlusion

  peri-hospital period, one month and one year after revascularization procedure

• Hemorrhagic complications.

  peri-hospital period, one month and one year after revascularization procedure

Study Arms (2)

PCI with DES implantation

EXPERIMENTAL

Percutaneous Coronary Intervention Implantation of Drug-Eluting Stents

Procedure: PCI

CABG

ACTIVE COMPARATOR

Coronary Artery Bypass Grafting.On-pump or Off-pump CABG

Procedure: CABG

Interventions

PCI PROCEDURE

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

Also known as: •Percutaneous coronary intervention, •Multivessel coronary disease, •Left main narrowing

PCI with DES implantation

CABG PROCEDURE

Coronary Artery Bypass Graft

Also known as: Multivessel coronary artery disease, Coronary artery bypass graft, Left Main narrowing

CABG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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),

Sponsors & Collaborators

• Andrzej Frycz Modrzewski Krakow University: collaborator
• American Heart of Poland: lead

Study Sites (7)

Małopolska Cardiovascular Center, Polish-American Heart Clinic in Chrzanów

Chrzanów, Malopolska, 32-500, Poland

RECRUITING

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

Bielsko-Biala, Silesian Voivodeship, 43-316, Poland

RECRUITING

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

Dąbrowa Górnicza, Silesian Voivodeship, 41-300, Poland

RECRUITING

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

Ustroń, Silesian Voivodeship, 43-450, 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, 43-100, Poland

RECRUITING

National Medical Institute of the Ministry of the Interior and Administration

Warsaw, Poland

RECRUITING

Related Publications (5)

• Park DW, Kim YH, Yun SC, Lee JY, Kim WJ, Kang SJ, Lee SW, Lee CW, Kim JJ, Choo SJ, Chung CH, Lee JW, Park SW, Park SJ. Long-term outcomes after stenting versus coronary artery bypass grafting for unprotected left main coronary artery disease: 10-year results of bare-metal stents and 5-year results of drug-eluting stents from the ASAN-MAIN (ASAN Medical Center-Left MAIN Revascularization) Registry. J Am Coll Cardiol. 2010 Oct 19;56(17):1366-75. doi: 10.1016/j.jacc.2010.03.097.

  PMID: 20946993 BACKGROUND

• Park DW, Seung KB, Kim YH, Lee JY, Kim WJ, Kang SJ, Lee SW, Lee CW, Park SW, Yun SC, Gwon HC, Jeong MH, Jang YS, Kim HS, Kim PJ, Seong IW, Park HS, Ahn T, Chae IH, Tahk SJ, Chung WS, Park SJ. Long-term safety and efficacy of stenting versus coronary artery bypass grafting for unprotected left main coronary artery disease: 5-year results from the MAIN-COMPARE (Revascularization for Unprotected Left Main Coronary Artery Stenosis: Comparison of Percutaneous Coronary Angioplasty Versus Surgical Revascularization) registry. J Am Coll Cardiol. 2010 Jul 6;56(2):117-24. doi: 10.1016/j.jacc.2010.04.004. Epub 2010 May 6.

  PMID: 20451344 BACKGROUND

• Buszman PE, Buszman PP, Kiesz RS, Bochenek A, Trela B, Konkolewska M, Wallace-Bradley D, Wilczynski M, Banasiewicz-Szkrobka I, Peszek-Przybyla E, Krol M, Kondys M, Milewski K, Wiernek S, Debinski M, Zurakowski A, Martin JL, Tendera M. Early and long-term results of unprotected left main coronary artery stenting: the LE MANS (Left Main Coronary Artery Stenting) registry. J Am Coll Cardiol. 2009 Oct 13;54(16):1500-11. doi: 10.1016/j.jacc.2009.07.007. Epub 2009 Aug 21.

  PMID: 19699048 BACKGROUND

• Buszman PP, Bochenek A, Konkolewska M, Trela B, Kiesz RS, Wilczynski M, Cisowski M, Krejca M, Banasiewicz-Szkrobka I, Krol M, Kondys M, Wiernek S, Orlik B, Martin JL, Tendera M, Buszman PE. Early and long-term outcomes after surgical and percutaneous myocardial revascularization in patients with non-ST-elevation acute coronary syndromes and unprotected left main disease. J Invasive Cardiol. 2009 Nov;21(11):564-9.

  PMID: 19901409 BACKGROUND

• Buszman PE, Kiesz SR, Bochenek A, Peszek-Przybyla E, Szkrobka I, Debinski M, Bialkowska B, Dudek D, Gruszka A, Zurakowski A, Milewski K, Wilczynski M, Rzeszutko L, Buszman P, Szymszal J, Martin JL, Tendera M. Acute and late outcomes of unprotected left main stenting in comparison with surgical revascularization. J Am Coll Cardiol. 2008 Feb 5;51(5):538-45. doi: 10.1016/j.jacc.2007.09.054.

  PMID: 18237682 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Percutaneous Coronary Intervention; Coronary Artery Bypass

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Myocardial Revascularization; Cardiac Surgical Procedures; Vascular Grafting; Thoracic Surgical Procedures

Study Officials

• Piotr P Buszman, MD,PhD, Prof

  American Heart of Poland

  PRINCIPAL INVESTIGATOR

• Krzysztof Sanetra, MD, PhD

  American Heart of Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natalia Pydyn, PhD

CONTACT

+48 667 132 233; natalia.pydyn@ahop.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., PhD, Professor

Study Record Dates

• First Submitted: March 8, 2011
• First Posted: March 9, 2011
• Study Start: August 25, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): November 1, 2030
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

PL (7)