Clinical trial NCT01781715: Multivessel Stenting Versus Staged Revascularization With Zotarolimus-eluting Stent for STEMI
Official title: Multivessel Stenting and Staged Revascularization for ST-elevation Myocardial Infarction Patients With Resolute Integrity Stents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: ST Elevation Myocardial Infarction, Multivessel Coronary Artery Disease
Keywords: STEMI, Multivessel Coronary Artery Disease, Primary PCI, multivessel stenting, zotarolimus-eluting stent
Lead sponsor: Russian Academy of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2013-02-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine outcomes (death, myocardial infarction, target vessel revascularization (TVR), non-target vessel revascularization (non-TVR), stent-thrombosis) of 120 consecutive patients with ST elevation myocardial infarction and multivessel coronary artery disease undergoing multivessel stenting or staged percutaneous coronary intervention with Zotarolimus-eluting stents

Detailed description: Multivessel coronary artery disease has been reported to occur in 40 to 67% of ST elevation myocardial infarction (STEMI) patients. Multivessel coronary artery disease (MVCD) patients, who have experienced STEMI, are at a high risk of major cardiovascular events (MACE) within one year after primary PCI. While MACE incidence in patients with one-vessel coronary artery disease is about 14.5%, patients with two- and three-vessel lesions experience MACE in 19.5% and 23.6% of cases, respectively. The risk of death in a 5-year follow-up increases two-fold in MVCD patients. This risk can be partly explained by slower recovery of left ventricular function and progression of left ventricular pathological remodeling process after MI. In addition, the mere presence of MVCD has been shown to be associated with MACE development in the long-term period. There are several treatment strategies for ST-elevation myocardial infarction (STEMI) patients with MVCD: infarct related artery (IRA)-only percutaneous coronary intervention (PCI), multivessel stenting in the primary PCI setting and staged revascularisation. The current guidelines for STEMI revascularisation give no definite instructions on the need for concurrent non-IRA intervention in patients with stable haemodynamics. At present, there are not clinical trials testing the current Zotarolimus-eluting stents (ZES) in STEMI patients with MVCD undergoing primary PCI for different strategies of revascularization.

Eligibility criteria: Inclusion Criteria:

* Subject must be at least 18 years of age.
* Subject is able to verbally confirm understandings of risks, benefits of treatment of either multivessel stenting or staged PCI using the zotarolimus-eluting stent (Resolute Integrity™ Stent, Medtronic) and he or she or his or her legally authorized representative provides written informed consent prior to any study related procedure.
* Subject must have significant stenoses (≥ 70%) of two or more than two of coronary arteries and requiring primary PCI for acute ST elevation myocardial infarction (STEMI) within 12hrs
* Target lesion(s) must be located in a native coronary artery with visually estimated diameter of less than 2.5 mm and more than 4.0 mm.
* Target lesion(s) must be amenable for percutaneous coronary intervention

Exclusion Criteria:

* The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin Aspirin Both Clopidogrel and Ticlopidine, Zotarolimus
* Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
* An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 6 months post enrollment.
* Non-cardiac comorbid conditions are present with life expectancy over 1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
* Acute heart failure Killip III-IV
* ≥ 50% left main stenosis

Primary outcomes:
measure: All death including cardiac and non cardiac death
timeFrame: 30 days, 6 months and 12 montrhs
measure: Recurrent MI
timeFrame: 30 days, 6 months and 12 months
measure: Any revascularizations (TLR or TVR)
timeFrame: 30 days, 6 months and 12 months
measure: Composite rate of all death, any MI and any repeat revascularization
timeFrame: 30 days, 6 months and 12 months
Secondary outcomes:
measure: stent thrombosis
timeFrame: 30 days. 6 months and 12 months
measure: Non-TVR
timeFrame: 30 days, 6 months and 12 months
Other outcomes:
measure: Composite rate of all death, any MI and any repeat revascularization
timeFrame: 30 days, 6 months and 12 months
Locations:
city: Kemerovo
country: Russian Federation
facility: State Research Institute for Complex Issues of Cardiovascular Diseases
state: Kemerovo Region
Study officials:
References: