Grant: Operating Grant

Background: In patients experiencing a heart attack, percutaneous coronary intervention (PCI) promptly relieves the blockage in the "culprit" coronary artery that caused the heart attack. However, in one-third of patients, doctors discover additional "non-culprit" narrowings that did not cause the heart attack. These patients are at high-risk and have a much worse prognosis compared with patients who only have a culprit narrowing. However, doctors are not certain whether opening these additional narrowings with further PCI is beneficial versus just treating with proven medications alone. Some studies in non-heart attack patients have suggested that there is no advantage for an additional PCI procedure, whereas other smaller studies have suggested that there may be a benefit. Unfortunately, there have been no randomized studies large enough to address this very common question. As a result, doctors have widely varying opinions on how to treat these high-risk patients. Methods: The COMPLETE trial is a large, multinational, randomized clinical trial designed to determine whether opening residual narrowings or blockages with an additional PCI procedure is beneficial compared with just treating with medications alone. After the culprit narrowing has been treated with PCI, we will randomly assign patients to either PCI to the additional narrowings or optimal medical therapy alone. We will enroll 3,900 patients and will follow them up for an average of 4 years to determine whether additional PCI saves lives or prevents more heart attacks. Significance: COMPLETE will be a definitive clinical trial that will determine whether additional PCI to non-culprit narrowings is superior to optimal medial therapy alone in reducing subsequent death or recurrent heart attacks. This landmark international trial, designed and led by Canadian researchers, has critical implications for the optimal care of high risk patients experiencing a heart attack in Canada and worldwide.