Acute Coronary Syndrome Clinical Trial
— MILESTONEOfficial 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)
NCT number | NCT01311323 |
Other study ID # | AHP-1 |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2021 |
Est. completion date | June 2025 |
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.
Status | Not yet recruiting |
Enrollment | 1000 |
Est. completion date | June 2025 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility |
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) requiring prompt revascularization (within 72 hours) - 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 - Syntax Score =<33 - 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 within a year before procedure - Ischemic stroke or TIA within past 6 weeks. - End Stage Chronic renal insufficiency requiring dialysis - Concomitant structural or valve disease requiring cardiac surgery - Prior PCI of left main trunk one year 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 |
Country | Name | City | State |
---|---|---|---|
Poland | Clinical University Hospital | Bialystok | |
Poland | American Heart of Poland, 2-nd Department of Cardiology | Bielsko-Biala | Silesia |
Poland | American Heart of Poland, Malopolska Centre for Heart and Vascular Disease | Chrzanow | Malopolska |
Poland | American Heart of Poland,3-rd Depatment of Invasive Cardiology, Angiology and Electrophysiology | Dabrowa Gornicza | Silesia |
Poland | Upper Silesian Heart Center of Medical Univeristy of Silesia | Katowice | |
Poland | American Heart of Poland 1-st Department of Cardiology and Angiology | Ustron | Silesia |
Poland | Silesian Centre for Heart Disease, Department of Cardiosurgery and Transplantation | Zabrze | Silesia |
Lead Sponsor | Collaborator |
---|---|
American Heart of Poland | Andrzej Frycz Modrzewski Kraków University, Kraków, Poland, Clinical University Hospital, Bialystok, Poland, Silesian Centre for Heart Diseases, Upper Silesian Heart Center of Medical University of Silesia, Katowice, Poland |
Poland,
Buszman PE, Buszman PP, Kiesz RS, Bochenek A, Trela B, Konkolewska M, Wallace-Bradley D, Wilczynski M, Banasiewicz-Szkróbka 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. — View Citation
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. — View Citation
Buszman PP, Bochenek A, Konkolewska M, Trela B, Kiesz RS, Wilczynski M, Cisowski M, Krejca M, Banasiewicz-Szkróbka 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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MACCE - Major Adverse Cardiac and Cerebral Events | The primary endpoint is a composite of all cause death, revascularization procedure: 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 | 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 | peri-hospital period, one month and one year and two years after revascularization procedure | |
Secondary | 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. | peri-hospital period, one month and one year after revascularization procedure | |
Secondary | Overall costs of treatment strategies. | Hospital costs and long-term cost-effectiveness. | one year ofter revascularization procedure | |
Secondary | Occurence of stent thrombosis or graft occlusion | Stent trombosis will be defined in accordance with ARC definition. | peri-hospital period, one month and one year after revascularization procedure | |
Secondary | Hemorrhagic complications. | Hemorrhagic complications will be clasified according to TIMI scale. | peri-hospital period, one month and one year after revascularization procedure | |
Secondary | Frequency and impact of complete revascularization | Complete revascularization will be defined on an anatomic basis and by revascularization of all significant ischemic areas. | one year after revascularization procedure | |
Secondary | LVEF | Left Ventricle Ejection Fraction | 6 and 12 months |
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