NCT01781715

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

Multivessel Stenting and Staged Revascularization for ST-elevation Myocardial Infarction Patients With Resolute Integrity Stents

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Russian Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Zotarolimus-eluting coronary stent	Multivessel stenting or Staged PCI with Zotarolimus-eluting coronary stent in STEMI patients

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-12-01
• Completion: 2014-12-01
• First posted: 2013-02-01
• Last updated: 2013-02-01

Locations

1 site across 1 country: Russia