Abstract 3625: Do Patients Who Meet SCD-HeFT Criteria in Clinical Practice Differ from Patients Enrolled in SCD-HeFT?
Background: Many studies have demonstrated the lack of generalizability of randomized clinical trials’ findings to clinical practice. We conducted this study to determine whether the baseline characteristics of patients meeting SCD-HeFT criteria in the ACC-NCDR ICD Registry are similar to those of patients enrolled in SCD-HeFT.
Methods: Of the 1,438 US hospitals participating in the ICD Registry, 85% submit data on all ICD implants. We identified patients with NYHA class II or III symptoms and an LVEF ≤ 35%. We excluded patients with an MI within 40 days, CABG within 1 month, and PCI within 3 months prior to ICD implantation. We also excluded patients who received an ICD for secondary prevention or an ICD with cardiac resynchronization therapy. Baseline characteristics were compared using the t-test for continuous variables and the chi-square test for categorical variables.
Results: Patients in the ICD Registry are significantly older and have more co-morbidities than patients enrolled in SCD-HeFT (Table⇓). The rates of use of ACE-inhibitors and digoxin were significantly lower in the Registry than in the trial (p <0.01 for both). The rates of use of beta-blockers, aspirin and statins were significantly higher in the Registry than in the trial (p <0.01 for all)
Conclusions: The baseline characteristics and medical management of patients who receive an ICD in clinical practice are significantly different from those of patients enrolled in SCD-HeFT. Future studies should investigate whether these differences translate into differences in ICD effectiveness.