Ignite Creation Date:
2024-05-05 @ 11:21 PM
Last Modification Date:
2024-10-26 @ 10:32 AM
Study NCT ID:
NCT01311323
Status:
NOT_YET_RECRUITING
Last Update Posted:
2020-05-01
First Post:
2011-03-08
Brief Title:
Revascularization Strategies in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome NSTE-ACS and Severe Coronary Artery Disease
Sponsor:
American Heart of Poland
Organization:
American Heart of Poland
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MILESTONE
Brief Summary:
MILESTONE STUDY is dedicated to problems connected with patients with multivessel coronary artery disease andor with left main narrowing who present symptoms of acute ischemia For such kind of patients according to current ACCAHA 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
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 1011 Furthermore a steady decline in ST elevation ACS incidence and increase in non-ST elevation acute coronary syndrome NSTE-ACS has been observed 101213 associated with poorer long term prognosis 1415 This is related to the complexity of coronary artery disease in patients with NSTE-ACS as nearly half of them have multivessel disease MVD 15 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 1617 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 18 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 7-919 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 TeleDICOM 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
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 TeleDICOM 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None