Key result
Long-term hospital-based secondary preventive follow-up improved composite endpoint-free survival compared to primary care follow-up (HR 0.80), driven by a lower rate of new PCI.
Why the study?
Despite established guidelines on cardiovascular secondary prevention, practical implementation of treatment targets remains deficient even in high-income countries.
Does long-term hospital-based secondary preventive follow-up improve composite endpoint-free survival and all-cause mortality in patients with coronary artery disease compared to primary health care follow-up?
RCT (n=1,540)
Open-label
Simple randomization by random number generator
No
Does long-term hospital-based secondary preventive follow-up improve composite endpoint-free survival and all-cause mortality in patients with coronary artery disease compared to primary health care follow-up?
Hazard Ratio: 0.8 (95% CI 0.66–0.96)
Absolute Event Rate: 27% vs 31%
p-value: p=0.02
Long-term hospital-based secondary preventive follow-up improved composite endpoint-free survival primarily by reducing the need for repeat PCI, though it did not reduce all-cause mortality.
Hospital-based follow-up may reduce repeat PCI without lowering mortality; leaves open optimal long-term model for secondary prevention.
BACKGROUND AND AIMS: Despite established guidelines on secondary prevention of cardiovascular disease, practical implementation of treatment targets is deficient even in high-income countries. This study compared long-term hospital-based treatment with follow-up at primary health care regarding new cardiovascular events and achievement of treatment targets. METHODS: This randomized controlled trial at Sørlandet Hospital, Norway 2007-2021 included patients hospitalized due to myocardial infarction (n = 760) or after scheduled percutaneous coronary intervention (PCI) (n = 677) or coronary artery bypass grafting (n = 103). Patients were randomized to hospital-based secondary preventive care with consultations 2 weeks, 3 months, 6 months and 1 year after the index event and annually for up to 5 years, or follow-up at primary health care. Final data was collected after 10 years and hazard ratios were calculated using Cox regression analyses. RESULTS: Composite endpoint-free survival due to a lower rate of PCI improved in patients with hospital-based follow-up (n = 788) compared to patients followed-up at primary health care (n = 752) (HR 0.80, 95% CI 0.66-0.96; p = 0.02) but all-cause mortality was not reduced (HR 0.96, 95% CI 0.59-1.56; p = 0.86). At 1 year, LDL-cholesterol (2.1 [SD 0.7] versus 2.3 [SD 0.8] mmol/l; p < 0.001) and systolic blood pressure (132 [SD 16] versus 142 [SD 20] mm/Hg; p < 0.001) were lower in the hospital-based group, and the differences remained significant during the first 5 years. Other secondary preventive measures (smoking cessation, physical activity, body weight, glucose control, drug adherence) did not differ. CONCLUSIONS: Long-term hospital-based secondary preventive follow-up improved composite endpoint-free survival, but not mortality. Substantial risk factors remained unaddressed. The beneficial effects on blood pressure and LDL-cholesterol disappeared after annual consultations ceased. TRIAL REGISTRATION: The study is registered in ClinicalTrials.gov (NCT00679237) May 16, 2008.
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Kaldal et al. (2021) conducted an RCT in Coronary artery disease (n=1,540). Long-term hospital-based secondary preventive follow-up vs. Follow-up at primary health care was evaluated on Composite of all-cause mortality, PCI, CABG, non-fatal stroke or non-fatal MI (HR 0.80, 95% CI 0.66-0.96, p=0.02). Long-term hospital-based secondary preventive follow-up improved composite endpoint-free survival compared to primary care follow-up (HR 0.80), driven by a lower rate of new PCI.
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