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| ID | Type | Description | Link |
|---|---|---|---|
| ZES for STEMI | Other Grant/Funding Number | Medtronic |
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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multivessel stenting | Experimental | This group comprises the patients who undergo a one-time primary percutaneous coronary intervention (PCI) of the culprit and nonculprit lesions |
|
| Staged revascularization | Active Comparator | This group comprises the patients who undergo PCI of only the culprit lesion and staged nonculprit PCI at a later date (3-15 days) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zotarolimus-eluting coronary stent | Device | Multivessel stenting or Staged PCI with Zotarolimus-eluting coronary stent in STEMI patients |
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| Measure | Description | Time Frame |
|---|---|---|
| All death including cardiac and non cardiac death | 30 days, 6 months and 12 montrhs | |
| Recurrent MI | 30 days, 6 months and 12 months | |
| Any revascularizations (TLR or TVR) | 30 days, 6 months and 12 months | |
| Composite rate of all death, any MI and any repeat revascularization | 30 days, 6 months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| stent thrombosis | The incidence of stent thrombosis was assessed throughout the follow-up period, according to the conventional ARC (Academic Research Consortium) classification. | 30 days. 6 months and 12 months |
| Non-TVR |
| Measure | Description | Time Frame |
|---|---|---|
| Composite rate of all death, any MI and any repeat revascularization | 30 days, 6 months and 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vladimir Ganyukov, MD, PhD | Contact | +79131273905 | ganyukov@mail.ru | |
| Roman Tarasov, MD, PhD | Contact | +79235260446 | roman.tarasov@mail.ru |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State Research Institute for Complex Issues of Cardiovascular Diseases | Recruiting | Kemerovo | Kemerovo Oblast | 650002 | Russia |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Any repeat revascularization of non target vessels
| 30 days, 6 months and 12 months |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |