Complete Lesion Versus Culprit Lesion Revascularization (COCUA)
To investigate the clinical outcomes of acute myocardial infarction (AMI) patients with multivessel disease undergoing percutaneous coronary intervention (PCI) either in infarct-related artery only or in multivessel in Drug eluting stents (DES) era, using the everolimus-eluting stent (Promus™ Element™ Stent, Boston Scientific) in real-world clinical practice.
Procedure: complete revascularization
Procedure: Culprit revasularization
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Comparison of Complete Lesion Versus Culprit Lesion Revascularization in Acute ST Elevation Myocardial Infarction Patients With Multivessel Disease Undergoing Primary Percutaneous Coronary Intervention|
- target vessel related major adverse cardiac events [ Time Frame: one year ] [ Designated as safety issue: Yes ]Cardiac death, ST elevation myocardiac infarction (STEMI), Ischemic driven target lesion revascularization (TLR) .
- total major cardiac adverse events [ Time Frame: one years ] [ Designated as safety issue: Yes ]
- All death including cardiac and non cardiac death
- Recurrent MI or any MI (STEMI or NSTEMI)
- Any revascularizations (TLR or TVR)
- Dye nephropathy, Procedure time, Complication (puncture site hematoma, bleeding)
- In hospital complication
- Composite rate of cardiac death and any MI
- Composite rate of all death and any MI
- Composite rate of all death, any MI and any repeat revascularization
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Experimental: complete revascularization
Complete revascularization (CR): This group comprises the patients who undergo a one-time primary percutaneous coronary intervention (PCI) of the culprit and nonculprit lesions
Procedure: complete revascularization
-Complete revascularization : one time primary percutaneous coronary intervention (PCI) of the culprit and nonculprit lesions in patient with ST elevateion myocardial infarction (STEMI) and multivessle disease
Active Comparator: Culprit revascularization
Culprit only revascularization (COR): This group comprises the patients who undergo PCI of only the culprit lesion and staged nonculprit PCI at a later date.
Procedure: Culprit revasularization
Culprit revascularization : PCI of only the culprit lesion and staged nonculprit PCI at a later date in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease.
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Acute ST segment elevation myocardial infarctions (STEMI) is a systemic prothrombotic milieu, often involves more than one coronary artery, even though it predominantly affects plaque rupture and its consequences in one coronary artery territory (culprit artery territory)(1). Also, Multivessel disease (MVD), a well known predictor of poor clinical outcomes occurs in acute myocardial infarction (AMI) patients (pts) between 40% and 65%(2, 3).
In acute STEMI, achieving the maximum myocardial reperfusion and salvage by primary percutaneous intervention of culprit lesion is the preferred reperfusion strategy as per the latest ACC/AHA and ESC guidelines(4, 5). At presently there is no consensus regarding the management of significant non culprit lesions during the initial presentation in hemodynamically stable STEMI pts(6, 7).Although multivessel revascularization seems to improve the myocardial reperfusion and its salvage by limiting infarct size, improving ejection fraction (EF) and stabilizing the vulnerable plaques in acute AMI presentation, revascularization of non IRAs yielded conflicting results in the BMS era(2, 7-13). Balancing the above merits with increased risk of having higher periprocedural MI due to multivessel stent implantations in non IRAs are paramount importance in deciding the revascularization strategy in MVD STEMI pts(13-15). Drug eluting stents (DES) implantations after primary PCI are increasing in the real world scenario after the establishment of its safety by the multiple Meta analyses and few randomized trials(16-19).Even though DES reduces recurrent revascularizations in acute STEMI pts, the merits and demerits of its usage in treating non IRAs in multivessel disease pts with STEMI are largely unknown in this modern PCI era(16, 19). The aim of the study was to compare the clinical outcomes between culprit lesion revascularization (CLR) group and complete revascularization (CR) group where CR group includes treatment of both IRA and non IRAs) strategy in MVD STEMI pts in the real world scenario utilizing DES.
Primary percutaneous coronary intervention (PCI) is established as the treatment of choice for acute ST segment elevation myocardial infarction (STEMI). During the procedure, the culprit artery recanalization allows reperfusion of the myocardium and improves healing of the injured tissue (20, 21). Recent studies showed that in the AMI setting, the pathophysiology involves the whole coronary artery tree (21), and nearly 40% to 65% patients presenting with AMI have multivessel disease (22), (23), (24), (25) and plaque instability might develop in a multifocal pattern, resulting in unstable plaques in anatomically remote locations and may emerge as the cause of recurrent acute coronary syndrome. Current guidelines of primary PCI recommend treating the culprit vessel in the urgent procedure, leaving the other untreated vessels to another elective procedure. Multivessel PCI is recommended only for patients with cardiogenic shock (20, 21, 26). By this strategy, the operator intends to avoid the potential procedural complications that may deteriorate the patient's left ventricular function and clinical condition during acute myocardial infarction. Therefore, only few reports describe the results of simultaneous non culprit vessel PCI for patients undergoing mechanical reperfusion for STEMI.
An early study of primary PCI for patients with multivessel disease showed favorable results with a strategy of staged percutaneous revascularization after acute recanalization of the culprit artery (24). In recent years with the use of stents and platelet glycoprotein IIb/IIIa inhibitors, the outcome of elective multivessel PCI has markedly improved (27, 28). More recent reports on simultaneous percutaneous revascularization of non-culprit arteries indicate that this may be a good strategy for patients with AMI found to have multivessel disease during primary angioplasty (29). According to some studies involving Coronary artery bypass graft (CABG) surgery, complete revascularization showed to be associated with better outcomes as compared with incomplete revascularizations (30), (31). In the Bare Metal Stent (BMS) era, long term event free survival rates of patients undergoing primary intervention for multivessel disease was shown to be as low as 48.5% (32). In-Stent Restenosis was seen as one of the major drawback which varied from 8% to as high as 80% at 6 months, according to both anatomic and clinical risk factors (33). However, introduction of Drug Eluting Stent (DES) showed promising results and similar results with either PCI with DES or CABG for patients with multivessel disease were seen(34), (35), .
|Contact: Seung Woon Rhafirstname.lastname@example.org|
|Contact: Ji Young Parkemail@example.com|
|Korea, Republic of|
|Seung Woon Rha||Recruiting|
|Seoul, Korea, Republic of|
|Contact: Seung Woon Rha, MD,PhD 82-2626-3020 firstname.lastname@example.org|
|Principal Investigator: Seung Woon Rha, MD,PhD|
|Principal Investigator:||Seung Woon Rha||professor|