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

NCT ID: NCT01781715

Last Updated: 2013-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2014-12-31

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.

Conditions

ST Elevation Myocardial Infarction, Multivessel Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Multivessel stenting

This group comprises the patients who undergo a one-time primary percutaneous coronary intervention (PCI) of the culprit and nonculprit lesions

Group Type: EXPERIMENTAL

Zotarolimus-eluting coronary stent

Intervention Type: DEVICE

Multivessel stenting or Staged PCI with Zotarolimus-eluting coronary stent in STEMI patients

Staged revascularization

This group comprises the patients who undergo PCI of only the culprit lesion and staged nonculprit PCI at a later date (3-15 days)

Group Type: ACTIVE_COMPARATOR

Zotarolimus-eluting coronary stent

Intervention Type: DEVICE

Multivessel stenting or Staged PCI with Zotarolimus-eluting coronary stent in STEMI patients

Interventions

Zotarolimus-eluting coronary stent

Multivessel stenting or Staged PCI with Zotarolimus-eluting coronary stent in STEMI patients

Intervention Type: DEVICE

Other Intervention Names

Resolute Integrity stent

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Russian Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Dr. Vladimir Ganyukov

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

State Research Institute for Complex Issues of Cardiovascular Diseases

Kemerovo, Kemerovo Oblast, Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Vladimir Ganyukov, MD, PhD

Role: CONTACT

ganyukov@mail.ru

+79131273905

Roman Tarasov, MD, PhD

Role: CONTACT

roman.tarasov@mail.ru

+79235260446

Facility Contacts

Vladimir Ganyukov, MD, PhD

Role: primary

ganyukov@mail.ru

+79131273905

Roman Tarasov, MD, PhD

Role: backup

roman.tarasov@mail.ru

+79235260446

Other Identifiers

ZES for STEMI

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Resolute Integrity for STEMI

Identifier Type: -

Identifier Source: org_study_id