급성 심장사 발생 예방을 위한 혈관 외 이식형 심장 제세동기 삽입술에 관한 비교효과 연구: 매칭-보정 간접비교
Comparative Effectiveness of Extravascular Implantable Cardioverter Defibrillator for Prevention of Sudden Cardiac Death: A Matching-Adjusted Indirect Comparison
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Objectives: Sudden cardiac death is a condition in which a person experiences malignant ventricular arrhythmias, resulting in spontaneous death, usually within an hour of the onset of symptoms. Implantable cardioverter defibrillators (ICDs) are an effective treatment for the prevention of sudden cardiac death, but the clinical benefits of ICD use are often offset by a variety of adverse events associated with the transvenous leads, which are implanted inside cardiac chamber through the venous system. Recently, ICDs with electrodes inserted into extravascular (EV) sites, such as the substernal or parasternal area, have been developed. This study was conducted to compare the clinical safety and effectiveness of EV-ICD and subcutaneous ICD (S-ICD), using a matching-adjusted indirect comparison approach. Methods: The analysis included the EV-ICD Pivotal study (n=316) and the S-ICD System investigational device exemption (IDE) study (n=321). We analyzed the following outcome variables: major adverse events up to 6 months and defibrillation test success rates. We conducted an unanchored matching-adjusted indirect comparison analysis to estimate the relative treatment effect. Comparison of the incidence of major adverse events was performed by Kaplan- Meier survival function Cox proportional hazards model. For the comparison of defibrillation test success rates, odds ratios (ORs) between the treatments were estimated using logistic regression. Results: Baseline characteristics between treatment groups were adjusted to be equal through matching- adjusted indirect comparison approach. Kaplan-Meier survival analysis of the occurrence of major adverse events showed an unadjusted hazard ratio (HR) of 0.86 (95% confidence interval [CI]: 0.49–1.50, p=0.59), and an adjusted HR of 0.92 (95% CI: 0.58–1.44, p=0.49). The analysis of defibrillation test success rates showed an unadjusted OR of 0.93 (95% CI: 0.47–1.83, p=0.83), an adjusted OR estimated of 0.86 (95% CI: 0.50–1.48, p=0.52). Conclusion: A major adverse event rates and defibrillation test success rates between EV-ICD and S-ICD were analyzed using the matching-adjusted indirect comparison method and found no significant differences between the two treatments.
Abstract
Objectives: Sudden cardiac death is a condition in which a person experiences malignant ventricular arrhythmias, resulting in spontaneous death, usually within an hour of the onset of symptoms. Implantable cardioverter defibrillators (ICDs) are an effective treatment for the prevention of sudden cardiac death, but the clinical benefits of ICD use are often offset by a variety of adverse events associated with the transvenous leads, which are implanted inside cardiac chamber through the venous system. Recently, ICDs with electrodes inserted into extravascular (EV) sites, such as the substernal or parasternal area, have been developed. This study was conducted to compare the clinical safety and effectiveness of EV-ICD and subcutaneous ICD (S-ICD), using a matching-adjusted indirect comparison approach. Methods: The analysis included the EV-ICD Pivotal study (n=316) and the S-ICD System investigational device exemption (IDE) study (n=321). We analyzed the following outcome variables: major adverse events up to 6 months and defibrillation test success rates. We conducted an unanchored matching-adjusted indirect comparison analysis to estimate the relative treatment effect. Comparison of the incidence of major adverse events was performed by Kaplan- Meier survival function Cox proportional hazards model. For the comparison of defibrillation test success rates, odds ratios (ORs) between the treatments were estimated using logistic regression. Results: Baseline characteristics between treatment groups were adjusted to be equal through matching- adjusted indirect comparison approach. Kaplan-Meier survival analysis of the occurrence of major adverse events showed an unadjusted hazard ratio (HR) of 0.86 (95% confidence interval [CI]: 0.49–1.50, p=0.59), and an adjusted HR of 0.92 (95% CI: 0.58–1.44, p=0.49). The analysis of defibrillation test success rates showed an unadjusted OR of 0.93 (95% CI: 0.47–1.83, p=0.83), an adjusted OR estimated of 0.86 (95% CI: 0.50–1.48, p=0.52). Conclusion: A major adverse event rates and defibrillation test success rates between EV-ICD and S-ICD were analyzed using the matching-adjusted indirect comparison method and found no significant differences between the two treatments.
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