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.
None
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,
Parallel
PCI
Procedure/SurgeryPercutaneous Coronary Intervention with contemporary drug eluting stent, fractional flow reserve or iFR measurement and optimisation with intravascular imaging
CABG
Procedure/SurgeryCoronary Artery Bypass Graft
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
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
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.
Overall costs of treatment strategies.
Hospital costs and long-term cost-effectiveness.
Occurence of stent thrombosis or graft occlusion
Stent trombosis will be defined in accordance with ARC definition.
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American Heart of Poland
Lead sponsor
Andrzej Frycz Modrzewski Krakow University
Collaborator
