Revascularization in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) With Multivessel and/or Unprotected Left Main Coronary Disease (MILESTONE)
|ClinicalTrials.gov Identifier: NCT01311323|
Recruitment Status : Unknown
Verified July 2010 by American Heart of Poland.
Recruitment status was: Not yet recruiting
First Posted : March 9, 2011
Last Update Posted : March 9, 2011
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 or disease||Intervention/treatment|
|Multi Vessel Coronary Artery Disease Acute Coronary Syndrome||Procedure: PCI Procedure: CABG|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2011|
|Estimated Primary Completion Date :||January 2015|
|Estimated Study Completion Date :||January 2016|
Experimental: PCI with DES implantation
Percutaneous Coronary Intervention Implantation of Drug-Eluting Stents
Percutaneous Coronary Intervention
Active Comparator: CABG
Coronary Artery Bypass Grafting.On-pump or Off-pump CABG
Coronary Artery Bypass Graft
- All cause death [ Time Frame: One year after revascularization procedure ]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
- Composite of MACCE [ Time Frame: peri-hospital period, one month and one year after revascularization procedure ]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 ]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 ]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 ]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 ]Hemorrhagic complications will be clasified according to TIMI scale.
- Frequency and impact of complete revascularization [ Time Frame: one year after revascularization procedure ]Complete revascularization will be defined on an anatomic basis and by revascularization of all significant ischemic areas.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01311323
|Contact: Iwona Banasiewicz-Szkrobka, MD,PhDfirstname.lastname@example.org|
|Contact: Stanislaw Trznadel, MDemail@example.com|
|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 firstname.lastname@example.org|
|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 email@example.com|
|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|
|Principal Investigator:||Pawel E Buszman, Prof||American Heart of Poland|
|Study Director:||Stanislaw Trznadel, MD||American Heart of Poland|