Clinical trial NCT00387231: Comparison of Anti-Ischemic Drug Therapy and Percutaneous Transluminal Angioplasty After Myocardial Infarction
Official title: Swiss Interventional Study on Silent Ischemia (SWISSI 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Ischemia
Keywords: Myocardial Ischemia
Randomized Controlled Trials
Angioplasty, Transluminal, Percutaneous Coronary
Drug Therapy
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
First posted: 2006-10-12
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Symptomatic myocardial ischemia

Primary outcomes:
measure: Combination of cardiac death, non-fatal myocardial infarction, and symptom-driven revascularization
Secondary outcomes:
measure: Overall mortality; Cardiac death; Non-fatal myocardial infarction; Symptom-driven revascularization.
Other outcomes:
Locations:
city: Lucerne
country: Switzerland
facility: Department of Cardiology, Hospital Lucerne
Study officials:
affiliation: Department of Cardiology, Hospital Lucerne
name: Paul Erne, MD
role: STUDY_CHAIR
affiliation: Department of Cardiology, Hospital Lucerne
name: Paul Erne, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schoenenberger AW, Jamshidi P, Kobza R, Zuber M, Stuck AE, Pfisterer M, Erne P. Progression of coronary artery disease during long-term follow-up of the Swiss Interventional Study on Silent Ischemia Type II (SWISSI II). Clin Cardiol. 2010 May;33(5):289-95. doi: 10.1002/clc.20775.
citation: Erne P, Schoenenberger AW, Burckhardt D, Zuber M, Kiowski W, Buser PT, Dubach P, Resink TJ, Pfisterer M. Effects of percutaneous coronary interventions in silent ischemia after myocardial infarction: the SWISSI II randomized controlled trial. JAMA. 2007 May 9;297(18):1985-91. doi: 10.1001/jama.297.18.1985.