Acute Coronary Syndrome Clinical Trial
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)
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.
Within last decade, aging of the population and coexistence of multiple comorbidities
influenced a risk of patients presenting with acute coronary syndrome (ACS) 10,11.
Furthermore, a steady decline in ST elevation ACS incidence and increase in non-ST elevation
acute coronary syndrome (NSTE-ACS) has been observed 10,12,13, associated with poorer long
term prognosis 14,15. 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 16,17, 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 7-9,19, 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.
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