Comparison of Anti-Ischemic Drug Therapy and Percutaneous Transluminal Angioplasty After Myocardial Infarction

Study Overview
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Brief Summary
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Silent ischemia has been shown to negatively affect prognosis in patients after myocardial infarction. However, long-term outcome data in totally asymptomatic patients is missing and it is unknown whether angioplasty in addition to secondary preventive measures is superior to antiischemic drug therapy in these patients. Therefore, the SWISSI 2 study was started 15 years ago with the aim of comparing the effects of angioplasty with medical therapy on long-term outcome in patients with recent myocardial infarction and silent ischemia.

Detailed Description
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Silent ischemia has been shown to negatively affect prognosis in patients after myocardial infarction (MI). Despite these consistent findings, there are almost no prospective data unequivocally documenting a benefit of antiischemic therapy on prognosis in patients with silent ischemia. There is some indirect evidence of a better outcome after repeat angioplasty for silent restenosis. In patients with a recent MI, the Asymptomatic Cardiac Ischemia Pilot study documented a short-term benefit of antiischemic drug therapy and angioplasty in patients with silent and symptomatic ischemic episodes. However, long-term outcome data in totally asymptomatic patients is missing and it is unknown whether angioplasty in addition to secondary preventive measures is superior to antiischemic drug therapy in these patients. Therefore, the (SWISSI 2) study was started 15 years ago with the aim of comparing the effects of angioplasty with medical therapy, each combined with secondary preventive advice, aspirin and statin therapy, on long-term outcome in patients with recent MI and an exercise test without symptoms but silent ischemia verified by stress imaging.

Official Title
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Swiss Interventional Study on Silent Ischemia (SWISSI 2)

Conditions
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Myocardial Ischemia

Intervention / Treatment
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* Procedure: Percutaneous coronary angioplasty/intervention (PCI)
* Drug: Anti-ischemic drug therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recent myocardial infarction within last 3 months Documented silent myocardial ischemia (type I) Exclusion Criteria: Symptomatic myocardial ischemia

Ages Eligible for Study
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Minimum Age: 0 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Percutaneous coronary angioplasty/intervention (PCI)|nan|
|Drug: Anti-ischemic drug therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combination of cardiac death, non-fatal myocardial infarction, and symptom-driven revascularization |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall mortality; Cardiac death; Non-fatal myocardial infarction; Symptom-driven revascularization. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial Ischemia, Randomized Controlled Trials, Angioplasty, Transluminal, Percutaneous Coronary, Drug Therapy