Cardiovascular Atlas
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ISCHEMIA (initial invasive or conservative strategy for stable coronary disease)

A large trial of 5179 people with stable coronary disease and moderate or severe ischemia. Half were assigned to an invasive strategy (a heart catheter test, then a stent or bypass surgery when possible, plus medicines) and half to medicines alone, with a catheter test only if medicines failed. After a median of 3.2 years the invasive strategy had not reduced heart events or death.

Also called ISCHEMIA · International Study of Comparative Health Effectiveness With Medical and Invasive Approaches

  • Study
  • In this atlas

Overview

Design
Allocation: randomized. Intervention model: parallel. Masking: none. Primary purpose: treatment. (Registry values, in lower case.)
Phase
Not applicable
Enrolled
  • 5,179 participants (enrolled count) (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA), retrieved )
Sponsor
Funder
Not recorded
Registry
  • NCT NCT01471522
Started
(International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA), retrieved )
Primary completion
(actual) (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA), retrieved )
Completion
(actual) (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA), retrieved )
Results first posted
(actual) (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA), retrieved )
Countries
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Egypt, France, Germany, Hungary, India, Israel, Italy, Japan, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, North Macedonia, Peru, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA), retrieved )
Care setting
Not reported
Registry status
  • “COMPLETED” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

Technical summary

Open-label randomized strategy trial (NCT01471522), 5179 participants enrolled, 2012-07 to 2019-06-30 primary completion, funded by the NHLBI among others. The abstract reports 318 primary events with the invasive strategy against 352 with the conservative strategy, a higher 6-month rate with the invasive strategy (5.3% against 3.4%) and a lower 5-year rate (16.4% against 18.2%, interval including zero), and says the findings depended on the definition of myocardial infarction. Study chair named on the registry: Judith S Hochman. The invasive arm covered PCI and coronary bypass, so the result is not about stents alone.

Arms

  • Invasive Strategy (INV)

    Intervention None named

    Routine invasive strategy with cardiac catheterization followed by revascularization plus optimal medical therapy.

  • Conservative Strategy

    Intervention None named

    Optimal medical therapy with cardiac catheterization and revascularization reserved for patients with acute coronary syndrome, ischemic heart failure, resuscitated cardiac arrest or refractory symptoms.

Findings

No findings are published for this study.

Record details

Record id
cardio:ischemia-trial
Content hash
23610e93eacb7d331849b25042794f89ab1f252a2086425a0c59b671fa67fd8a