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Trial record 14 of 203 for:    Open Studies | coronary artery bypass

Revascularization in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) With Multivessel and/or Unprotected Left Main Coronary Disease (MILESTONE)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2010 by American Heart of Poland
Sponsor:
Information provided by:
American Heart of Poland
ClinicalTrials.gov Identifier:
NCT01311323
First received: March 8, 2011
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Multi Vessel Coronary Artery Disease
Acute Coronary Syndrome
Procedure: PCI
Procedure: CABG

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Revascularization Strategy (PCI With DES Implantation vs CABG) in Patients With Non ST Elevation Acute Coronary Syndrome With Multivessel and/or Unprotected Left Main Coronary Disease

Resource links provided by NLM:


Further study details as provided by American Heart of Poland:

Primary Outcome Measures:
  • All cause death [ Time Frame: One year after revascularization procedure ] [ Designated as safety issue: No ]
    The primary endpoint is a composite of all death one year after revascularization procedure: PCI or CABG. The hypothesis test is designed to show non-inferiority of PCI to CABG for the primary endpoint


Secondary Outcome Measures:
  • Composite of MACCE [ Time Frame: peri-hospital period, one month and one year after revascularization procedure ] [ Designated as safety issue: No ]
    MACCE is defined as: all death, myocardial infarction, stroke, or unplanned revascularization

  • Procedural and post procedural complication [ Time Frame: peri-hospital period, one month and one year after revascularization procedure ] [ Designated as safety issue: No ]
    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.

  • Overall costs of treatment strategies. [ Time Frame: one year ofter revascularization procedure ] [ Designated as safety issue: No ]
    Hospital costs and long-term cost-effectiveness.

  • Occurence of stent thrombosis or graft occlusion [ Time Frame: peri-hospital period, one month and one year after revascularization procedure ] [ Designated as safety issue: No ]
    Stent trombosis will be defined in accordance with ARC definition.

  • Hemorrhagic complications. [ Time Frame: peri-hospital period, one month and one year after revascularization procedure ] [ Designated as safety issue: No ]
    Hemorrhagic complications will be clasified according to TIMI scale.

  • Frequency and impact of complete revascularization [ Time Frame: one year after revascularization procedure ] [ Designated as safety issue: No ]
    Complete revascularization will be defined on an anatomic basis and by revascularization of all significant ischemic areas.


Estimated Enrollment: 1000
Study Start Date: June 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PCI with DES implantation
Percutaneous Coronary Intervention Implantation of Drug-Eluting Stents
Procedure: PCI
Percutaneous Coronary Intervention
Other Names:
  • •Percutaneous coronary intervention
  • •Multivessel coronary disease
  • •Left main narrowing
Active Comparator: CABG
Coronary Artery Bypass Grafting.On-pump or Off-pump CABG
Procedure: CABG
Coronary Artery Bypass Graft
Other Names:
  • Multivessel coronary artery disease
  • Coronary artery bypass graft
  • Left Main narrowing

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute Coronary Syndrome without ST elevation (NSTE-ACS): Unstable Angina (Braunwald's class IB,IC,IIB,IIC,IIIB,IIIC) or Non ST Elevation Myocardial Infarction (NSTEMI)
  • Two vessel disease with proximal LAD stenosis or three vessel disease
  • Unprotected Left Main Coronary Artery (ULMCA) de novo disease with or without concomitant single or multivessel coronary artery disease
  • Patient eligible both for CABG and PCI, confirmed by interventional cardiologist and surgeon offering similar extension of revascularisation
  • Signed informed consent

Exclusion Criteria:

  • age <21
  • ST Elevation Myocardial Infarction;
  • Stable angina;
  • Patients in Killip IV class;
  • Patients required immediate PCI procedure (e.g. electric instability);
  • Patients unable to tolerate, obtain or comply with dual antiplatelet therapy for at least 1 year
  • History of haemorrhagic stroke
  • Ischemic stroke or TIA within past 6 weeks.
  • Hematocrit <30%
  • Platelet Count <100.000/mm3
  • Chronic renal insufficiency with creatinine clearance<30 ml/min/1,73m2,
  • Concomitant structural or valve disease requiring cardiac surgery
  • Prior PCI of left main trunk at any time prior to randomization
  • Prior PCI of any other coronary artery lesion within 1 year prior to randomization
  • Prior CABG at any time prior to randomization
  • Need for any concomitant cardiac surgery other than CABG (e.g. valve surgery, aortic repair, etc.), or intent that if the patient will be randomized to surgery, any cardiac surgical procedure other than isolated CABG will be performed
  • Patients requiring additional surgery (cardiac or non cardiac) within 1 year
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01311323

Contacts
Contact: Iwona Banasiewicz-Szkrobka, MD,PhD 0048602457602 wilenka@wp.pl
Contact: Stanislaw Trznadel, MD strznadel@vp.pl

Locations
Poland
American Heart of Poland, Malopolska Centre for Heart and Vascular Disease Not yet recruiting
Chrzanow, Malopolska, Poland, 32-500
Contact: Iwona Banasiewicz-Szkrobka, MD, PhD    0048602457602    wilenka@wp.pl   
Principal Investigator: Iwona Banasiewicz-Szkrobka, MD, PhD         
Sub-Investigator: Aleksander Zurakowski, MD,PhD         
American Heart of Poland, 2-nd Department of Cardiology Not yet recruiting
Bielsko-Biala, Silesia, Poland, 43-316
Contact: Bogdan Gorycki, MD,PhD    (+48) (33) 829 08 63; (33) 810      
Principal Investigator: Bogdan Gorycki, MD,PhD         
American Heart of Poland,3-rd Depatment of Invasive Cardiology, Angiology and Electrophysiology Not yet recruiting
Dabrowa Gornicza, Silesia, Poland, 41-300
Contact: Marek Kondys, MD,PhD    (+48) (33) 829 08 63; (33) 810      
Principal Investigator: Marek Kondys, MD,PhD         
Sub-Investigator: Marcin Debinski, MD,PhD         
American Heart of Poland 1-st Department of Cardiology and Angiology Not yet recruiting
Ustron, Silesia, Poland, 43-450
Contact: Marek Krol, MD,PhD    (+48) (33) 854 58 57, (33) 854    m.krol@klinikiserca.pl   
Principal Investigator: Marek Krol, MD,PhD         
Silesian Centre for Heart Disease, Department of Cardiosurgery and Transplantation Not yet recruiting
Zabrze, Silesia, Poland, 41-800
Contact: Mariusz Gasior, Prof    004832 273 26 81      
Principal Investigator: Marian Zembala, Prof.         
Principal Investigator: Mariusz Gasior, Prof         
Sponsors and Collaborators
American Heart of Poland
Investigators
Principal Investigator: Pawel E Buszman, Prof American Heart of Poland
Study Director: Stanislaw Trznadel, MD American Heart of Poland
  More Information

Publications:

Responsible Party: Professor Pawel E. Buszman, MD, PhD, FESC, FACC, FSCAI,, American Heart of Poland
ClinicalTrials.gov Identifier: NCT01311323     History of Changes
Other Study ID Numbers: AHP-1
Study First Received: March 8, 2011
Last Updated: March 8, 2011
Health Authority: Poland: Ethics Committee

Keywords provided by American Heart of Poland:
Multivessel Coronary Artery Disease
Left Main Narrowing
Percutaneous Coronary Intervention
Coronary Artery Bypass Grafting
Drug-Eluting Stent

Additional relevant MeSH terms:
Acute Coronary Syndrome
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Syndrome
Angina Pectoris
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Chest Pain
Disease
Heart Diseases
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014