Multivessel Stenting Versus Staged Revascularization With Zotarolimus-eluting Stent for STEMI

Launched by RUSSIAN ACADEMY OF MEDICAL SCIENCES · Jan 30, 2013

Keywords

ClinConnect Summary

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...

Gender

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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