Multivessel Coronary Artery DiseaseMILESTONENCT01311323
Revascularization Strategies in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) and Severe Coronary Artery Disease
A study testing PCI and CABG in people with Multivessel Coronary Artery Disease and Acute Coronary Syndrome, run by American Heart of Poland at 9 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multivessel Coronary Artery Disease, Acute Coronary Syndrome
- What is being tested?
- PCI and CABG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 9 sitesPoland
- Study dates
- 25 Aug 2025to Nov 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 17Show fewer
- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Poland9 sites, 9 recruiting
- Recruiting
Polish-American Heart Clinics Center for Cardiology and Cardiac Surgery Outpatient Specialist Care in Bielsko-Biała
Bielsko-Biala, Silesian Voivodeship, 43-316
Piotr Buszman, MD, PhD, Prof, (+48) 33 472 63 20, Piotr.Buszman@ahop.pl
Monika Filary, 33 472 6334, monika.filary@ahop.pl
- Recruiting
Małopolska Cardiovascular Center, Polish-American Heart Clinic in Chrzanów
Chrzanów, Malopolska, 32-500
Aleksander Żurakowski, MD, PhD, +48 32 758 69 00, a.zurakowski@ahop.pl
Urszula Walczyk, + 48 513560204, urszula.walczyk@ahop.pl
- Recruiting
Polish-American Heart Clinics III Department of Invasive Cardiology, Angiology and Electrocardiology
Dąbrowa Górnicza, Silesian Voivodeship, 41-300
Łukasz Konarski, MD, (+48) 32 764 30 30, lukasz.konarski@ahop.pl
Łukasz Konarski, MD
- Recruiting
Upper Silesian Medical Center in Katowice
Katowice
Piotr Duraj, pduraj1975@gmail.com
Radosław Gocoł, MD, PhD
- Recruiting
Polish-American Heart Clinics Cardiovascular Center in Kędzierzyn-Koźle
Kędzierzyn-Koźle
Dorota Bartoszewska, 77 443 93 00, dorota.bartoszewska@ahop.pl
Janusz Prokopczuk, MD,PhD, Prof
- Recruiting
University Clinical Hospital in Opole
Opole
Barbara Piróg, barbara.pirog@usk.opole.pl
Marek Cisowski, MD, PhD
- Recruiting
Polish-American Heart Clinics X Department of Invasive Cardiology, Electrophysiology and Electrostimulation in Tychy
Tychy, 43-100
Adam Janas, MD, PhD, +48 32 7586700, adam.janas@ahop.pl
Magdalena Jureczko-Jadczyk, magdalena.jadczyk@ahop.onmicrosoft.com
- Recruiting
Polish-American Heart Clinics, 1st Department of Cardiology and Angiology in Ustroń
Ustroń, Silesian Voivodeship, 43-450
Michał Wróbel, MD,PhD, (+48) 33 472 28 10, michal.wrobel@ahop.pl
Iwona Wisełka, +48 885 800 321, iwona.wiselka@ahop.pl
- Recruiting
National Medical Institute of the Ministry of the Interior and Administration
Warsaw
Piotr Witkowski, 47 722-2012, piotr.witkowski@pimmswia.gov.pl
Mariusz Kowalewski, MD,PhD, Prof
About this study
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)
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.
Read the detailed description
Within last decade, aging of the population and coexistence of multiple comorbidities influenced a risk of patients presenting with acute coronary syndrome (ACS). Furthermore, a steady decline in ST elevation ACS incidence and increase in non-ST elevation acute coronary syndrome (NSTE-ACS) has been observed, associated with poorer long term prognosis. This is related to the complexity of coronary artery disease in patients with NSTE-ACS, as nearly half of them have multivessel disease (MVD). The optimal revascularization strategy in this group of patients remains unknown. Due to clinical presentation in most of cases early or delayed invasive strategy is preferred by both American and European guidelines, however the method of revascularization is not specified. Due to high surgical risk presentation, immediate stenting of the culprit lesion and delayed complete percutaneous revascularization is becoming a common practice. On the other hand, basing on the anatomical criteria coronary artery bypass grafting (CABG) should be the standard of care . Very few reports addressed so far the problem of optimal revascularization strategy in patients presenting with MVD and NSTE-ACS. A hypothesis of a positive outcome can be derived from some previous studies comparing PCI and CABG in which most of patients enrolled presented with NSTE-ACS, including our experience.
Aim and hypothesis:
Hence, the purpose of this study will be to compare contemporary coronary angioplasty with coronary artery bypass grafting in a prospective, clinical, multicenter, randomized trial. The hypothesis of this study is the non-inferiority of PCI compared to CABG in terms of the primary composite endpoint (death, myocardial infarction, stroke).
Method:
Patients with multivessel coronary artery disease, left main and acute coronary syndrome without ST segment elevation, qualified for early invasive treatment, with a Syntax Score below 33, and in whom the invasive cardiologist and cardiac surgeon will recognize both PCI and CABG as possible to achieve complete revascularization will be enrolled to the study. In the case of centers without the Cardiac Surgery Department, "Heart Team" consultations will take place via videoconference, and records of coronarography and echocardiography will be shared via the PACS (ang. Picture Archiving and Communication System system). The main exclusion criteria will be the qualification for conservative treatment, surgery other than CABG due to structural heart defect, ST segment elevation myocardial infarction, stable coronary artery disease, immediate need for PCI. After fulfilling the inclusion criteria and lack of exclusion criteria, the patient will be randomized in a 1: 1 ratio to either PCI or CABG. The PCI procedure will be performed after assessing the hemodynamic significance of all lesions with vFFR, FFR or iFR or using the latest generation drug eluting stents, and the implantation will be optimized based on intravascular imaging. CABG procedures will be performed based on the experience of the respective center, including the OPCAB technique, and the internal mammary artery will be used in each case. The primary endpoint of the study will be all cause death, myocardial infarction, and stroke in one-year follow-up. To prove the assumed hypothesis of the study, with the test power of 80% alpha error 5% and the percentage of lost to follow-up at the level of 5%, the study should include 500 patients in each group. Secondary endpoints will be ischemia driven revascularization, left ventricular ejection fraction, major and minor bleeding incidence, new onset of atrial fibrillation, de novo heart failure, unscheduled re-hospitalization, quality of life, and cost effectiveness. After the hospitalization, patients will be subjected to strict secondary prevention principles, including cardiac and cardiac surgery rehabilitation, and will undergo four specialistic follow-up visits with cardiac echo and stress tests at selected time points.
Anticipated outcomes:
In the case of positive results of the study, the efficacy and safety of PCI in the studied group of patients will be confirmed. This will contribute to the creation of a new guidelines in a given area, translating into faster and easier access to rapid invasive treatment. It will also facilitate the decision-making process in centers without cardiac surgery.
- Being tested
- PCI, CABG
- 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
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCIProcedure or surgery
Also called •Percutaneous coronary intervention, •Multivessel coronary disease, •Left main narrowing
Percutaneous Coronary Intervention with contemporary drug eluting stent, fractional flow reserve or iFR measurement and optimisation with intravascular imaging
CABGProcedure or surgery
Also called Multivessel coronary artery disease, Coronary artery bypass graft, Left Main narrowing
Coronary Artery Bypass Graft
| Study group | Role | What they receive |
|---|---|---|
| PCI with DES implantation | Experimental | Percutaneous Coronary Intervention Implantation of Drug-Eluting Stents Receives: Procedure: PCI |
| CABG | Active comparator | Coronary Artery Bypass Grafting.On-pump or Off-pump CABG Receives: Procedure: CABG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One year after revascularization procedure
Secondary outcomes (7)
SAE - Serious Adverse Events
ischemia driven revascularization, left ventricular ejection fraction, major and minor bleeding incidence, new onset of atrial fibrillation, de novo heart failure, unscheduled re-hospitalization
Measured: peri-hospital period, one month and one year and two years after revascularization procedure
Procedural and post procedural complication
Procedural and post procedural complication: length of hospital stay and frequency of prolonged hospitalization ; return to work; readmissions and cause of readmissions; angina and functional status; medications.
Measured: peri-hospital period, one month and one year after revascularization procedure
Overall costs of treatment strategies.
Hospital costs and long-term cost-effectiveness.
Measured: one year ofter revascularization procedure
Occurence of stent thrombosis or graft occlusion
Stent trombosis will be defined in accordance with ARC definition.
Measured: peri-hospital period, one month and one year after revascularization procedure
Hemorrhagic complications.
Hemorrhagic complications will be clasified according to TIMI scale.
Measured: peri-hospital period, one month and one year after revascularization procedure
Frequency and impact of complete revascularization
Complete revascularization will be defined on an anatomic basis and by revascularization of all significant ischemic areas.
Measured: one year after revascularization procedure
LVEF
Left Ventricle Ejection Fraction
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2011 (estimated)
- Study start25 Aug 2025
- Primary completionDec 2028 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Multivessel Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Heart of Poland
- Sponsor type
- University, hospital or other
- Collaborators
- Andrzej Frycz Modrzewski Krakow University
- Responsible party
- Principal investigator, Piotr P Buszman, MD, American Heart of Poland
- Investigators
- Piotr P Buszman, MD,PhD, Prof, Principal investigator, American Heart of PolandKrzysztof Sanetra, MD, PhD, Principal investigator, American Heart of Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01311323
- Sponsor's protocol ID
- AHP-1
- Acronym
- MILESTONE
- Status last verified
- Jul 2026
- First submitted
- 8 Mar 2011
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 20946993Park 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.
PubMed 20451344Buszman 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.
PubMed 19699048Buszman 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.
PubMed 19901409Buszman 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.
PubMed 18237682
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01311323
- Acronym / sponsor ID
- MILESTONE / AHP-1
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- American Heart of PolandUniversity, hospital or other
- Collaborators
- Andrzej Frycz Modrzewski Krakow University
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 9 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Within last decade, aging of the population and coexistence of multiple comorbidities influenced a risk of patients presenting with acute coronary syndrome (ACS). Furthermore, a steady decline in ST elevation ACS incidence and increase in non-ST elevation acute coronary syndrome (NSTE-ACS) has been observed, associated with poorer long term prognosis. This is related to the complexity of coronary artery disease in patients with NSTE-ACS, as nearly half of them have multivessel disease (MVD). The optimal revascularization strategy in this group of patients remains unknown. Due to clinical presentation in most of cases early or delayed invasive strategy is preferred by both American and European guidelines, however the method of revascularization is not specified. Due to high surgical risk presentation, immediate stenting of the culprit lesion and delayed complete percutaneous revascularization is becoming a common practice. On the other hand, basing on the anatomical criteria coronary artery bypass grafting (CABG) should be the standard of care . Very few reports addressed so far the problem of optimal revascularization strategy in patients presenting with MVD and NSTE-ACS. A hypothesis of a positive outcome can be derived from some previous studies comparing PCI and CABG in which most of patients enrolled presented with NSTE-ACS, including our experience.
Aim and hypothesis:
Hence, the purpose of this study will be to compare contemporary coronary angioplasty with coronary artery bypass grafting in a prospective, clinical, multicenter, randomized trial. The hypothesis of this study is the non-inferiority of PCI compared to CABG in terms of the primary composite endpoint (death, myocardial infarction, stroke).
Method:
Patients with multivessel coronary artery disease, left main and acute coronary syndrome without ST segment elevation, qualified for early invasive treatment, with a Syntax Score below 33, and in whom the invasive cardiologist and cardiac surgeon will recognize both PCI and CABG as possible to achieve complete revascularization will be enrolled to the study. In the case of centers without the Cardiac Surgery Department, "Heart Team" consultations will take place via videoconference, and records of coronarography and echocardiography will be shared via the PACS (ang. Picture Archiving and Communication System system). The main exclusion criteria will be the qualification for conservative treatment, surgery other than CABG due to structural heart defect, ST segment elevation myocardial infarction, stable coronary artery disease, immediate need for PCI. After fulfilling the inclusion criteria and lack of exclusion criteria, the patient will be randomized in a 1: 1 ratio to either PCI or CABG. The PCI procedure will be performed after assessing the hemodynamic significance of all lesions with vFFR, FFR or iFR or using the latest generation drug eluting stents, and the implantation will be optimized based on intravascular imaging. CABG procedures will be performed based on the experience of the respective center, including the OPCAB technique, and the internal mammary artery will be used in each case. The primary endpoint of the study will be all cause death, myocardial infarction, and stroke in one-year follow-up. To prove the assumed hypothesis of the study, with the test power of 80% alpha error 5% and the percentage of lost to follow-up at the level of 5%, the study should include 500 patients in each group. Secondary endpoints will be ischemia driven revascularization, left ventricular ejection fraction, major and minor bleeding incidence, new onset of atrial fibrillation, de novo heart failure, unscheduled re-hospitalization, quality of life, and cost effectiveness. After the hospitalization, patients will be subjected to strict secondary prevention principles, including cardiac and cardiac surgery rehabilitation, and will undergo four specialistic follow-up visits with cardiac echo and stress tests at selected time points.
Anticipated outcomes:
In the case of positive results of the study, the efficacy and safety of PCI in the studied group of patients will be confirmed. This will contribute to the creation of a new guidelines in a given area, translating into faster and easier access to rapid invasive treatment. It will also facilitate the decision-making process in centers without cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCI with DES implantation | Experimental | Procedure: PCIPercutaneous Coronary Intervention Implantation of Drug-Eluting Stents |
| CABG | Active comparator | Procedure: CABGCoronary Artery Bypass Grafting.On-pump or Off-pump CABG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (17 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCIAlso: •Percutaneous coronary intervention, •Multivessel coronary disease, •Left main narrowingPercutaneous Coronary Intervention with contemporary drug eluting stent, fractional flow reserve or iFR measurement and optimisation with intravascular imaging | Procedure or surgery | PCI with DES implantation |
| CABGAlso: Multivessel coronary artery disease, Coronary artery bypass graft, Left Main narrowingCoronary Artery Bypass Graft | Procedure or surgery | CABG |
Primary outcome
MACCE - Major Adverse Cardiac and Cerebral Events
Time frame: One year after revascularization procedure
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
7 secondary outcomes
SAE - Serious Adverse Events
Time frame: peri-hospital period, one month and one year and two years after revascularization procedure
Procedural and post procedural complication
Time frame: peri-hospital period, one month and one year after revascularization procedure
Overall costs of treatment strategies.
Time frame: one year ofter revascularization procedure
Occurence of stent thrombosis or graft occlusion
Time frame: peri-hospital period, one month and one year after revascularization procedure
Hemorrhagic complications.
Time frame: peri-hospital period, one month and one year after revascularization procedure
Frequency and impact of complete revascularization
Time frame: one year after revascularization procedure
LVEF
Time frame: 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Background: PubMed 20946993Park 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.
- Background: PubMed 20451344Park 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.
- Background: PubMed 19699048Buszman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Piotr P Buszman, MD,PhD, Prof principal investigator
American Heart of Poland
Krzysztof Sanetra, MD, PhD principal investigator
American Heart of Poland
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCI and CABG in people with Multivessel Coronary Artery Disease and Acute Coronary Syndrome, run by American Heart of Poland at 9 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalia Pydyn, PhD (+48 667 132 233, natalia.pydyn@ahop.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACCE - Major Adverse Cardiac and Cerebral Events (time frame: One year after revascularization procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01311323, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.