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

Not Applicable

Completed

• Conditions: Myocardial Ischemia

• Registration Number: NCT00387231
• Lead Sponsor: Luzerner Kantonsspital

Brief Summary

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

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.

Study Timeline

• Study Start: 1991-06
• Study Completion: 2006-05
• Status Verified: 2006-10
• Study First Submitted: 2006-10-10
• Study First Submitted QC: 2006-10-10
• Last Update Submitted: 2006-10-10
• Study First Posted: 2006-10-12
• Last Update Posted: 2006-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Recent myocardial infarction within last 3 months
• Documented silent myocardial ischemia (type I)

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Exclusion Criteria

• Symptomatic myocardial ischemia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Combination of cardiac death, non-fatal myocardial infarction, and symptom-driven revascularization

Secondary Outcome Measures

Name	Time	Method
Overall mortality; Cardiac death; Non-fatal myocardial infarction; Symptom-driven revascularization.

Trial Locations

Locations (1)

Department of Cardiology, Hospital Lucerne; 🇨🇭 Lucerne, Switzerland