Biotronik has announced that enrolment for its SPIRIT-ICD study has been completed with 503 patients from 37 sites in 11 countries worldwide registered.
The SPIRIT-ICD study was initiated based on findings from the MADIT II trial, which showed that patients who received an appropriate therapy from an implantable cardioverter defibrillator (ICD)that was implanted for primary prevention had a significantly increased risk for all-cause mortality. SPIRIT-ICD is a prospective, uncontrolled, multicentre trial to investigate whether this high-risk group might benefit from an intensified diagnostic follow-up and timely therapeutic intervention.
Study patients will be closely monitored for at least one year after enrolment via Biotronik Home Monitoring.
If an appropriate therapy (shock or antitachycardia pacing [ATP]) is delivered, the study protocol requires a hospital visit within 72 hours to undergo intensified diagnostics and, at the investigator’s discretion, to receive state-of-the-art therapeutic interventions. If an appropriate therapy is delivered during the patient’s observation period, monitoring is to be extended for an additional 12 months after the event.
“The main objective of this study,” said Robert Hatala, principal investigator and head of the Department of Cardiology at the National Cardiovascular Institute in Bratislava, Slovakia, “is to investigate whether early intervention can significantly reduce the hazard ratio for patients who receive an appropriate therapy compared to those who do not. We hope that early intervention and intensified diagnostic follow-ups will reduce the hazard ratio and, ultimately, reduce the increased mortality risk in this high-risk group. Furthermore, this trial will yield important new data on the incidence of ICD therapies in a patient population treated for acute myocardial infarction and thereafter with state-of-the-art therapeutic interventions.”
Further parameters to be compared and analysed between the groups are sudden cardiac death, non-sudden cardiac death, risk of first heart failure hospitalisation, number of ventricular tachycardia (VT) storms and number of delivered ICD therapies. In addition, the large study sample of the SPIRIT-ICD study allows for conclusions to be drawn on the current standard of care as compared to the findings of the MADIT II trial. Final results of the SPIRIT-ICD study are expected in early 2015.
The MADIT II trial was the first study of its kind to examine survival benefits of ICD implantation in patients with a history of myocardial infarction and left ventricular dysfunction.
“Biotronik is committed to supporting excellent research that will provide valuable clinical evidence for physicians. The SPIRIT-ICD study will enhance our body of knowledge of ICD therapy and provide valuable insights into how early intervention after an appropriate shock may be beneficial to the patient,” commented Christoph Böhmer, managing director, Biotronik.