Abstract

Abstract Background Compare-Acute trial showed a 1-year superior outcome of FFR-guided acute complete revascularization (FFR-CR) compared to culprit-lesion-only revascularization (CLO) in patients presenting with ST-segment elevation myocardial infarction (STEMI) and multi-vessel disease (MVD). Long-term results and financial impact of this strategy are unknown. Purpose To evaluate if FFR-CR strategy is superior to CLO strategy in terms of health care costs at 3 year follow-up. Methods Compare-Acute is a multicenter, investigator-initiated prospective randomized controlled trial that involved 24 sites. Patients with STEMI and MVD were randomized 1:2 after successful primary PCI, towards FFR-CR or CLO treatment strategies (295 vs 590 pts). All stenosis ≥50% by angiography in the non-infarct artery were investigated by FFR in both arms. In the FFR-CR arm, all non-culprit (NC) lesions with a FFR ≤0.80 were treated by PCI. In the CLO arm pts underwent blinded FFR procedure of the NC lesions. Further treatment of these lesions was based on symptoms and/or ischemia testing during follow-up with an allowed treatment window of 45 days. The primary endpoint was defined as a composite of all-cause mortality, non-fatal myocardial infarction, any revascularization and cerebrovascular events (MACCE) at 12 months. The major secondary endpoints are MACCE and health care costs from both strategies up to 3-year follow-up. Cost-analysis is done from an insurance/governmental perspective in countries that use Diagnosis Related Group (DRG) costs: the Netherlands, Germany, Sweden and Poland. Results 1-year results have already been published and showed superior outcome of patients in the FFR-CR arm. According to the Dutch system, at 1 year of follow-up the average cost per patient was 8.150€ in the FFR-CR arm, and 10.319€ in the CLO arm (−21%). The better cost-effectiveness of FFR-CR strategy remained at 3 years of follow-up: average cost per patient was 8.653€ in the FFR-CR arm and 11.100€ in the CLO arm (−22%). Same 3-year data was confirmed using DRG analysis according to the German system (FFR-CR 4.887€ vs CLO 5.200€; −6.0%) and the Swedish system (FFR-CR 6.205€ vs CLO 8.133€; −23.7%). FFR-CR strategy was not more costly according to the Polish system (FFR-CR 3.704€ vs CLO 3.685€; +0.5%). Moreover, the better outcome of the FFR-CR group was mantained at 3 year follow-up (data not shown). Figure 1 Conclusion Our cost-analysis of the Compare Acute Trial shows that the strategy of FFR-guided complete revascularization in patients with STEMI and MVD is not only superior in terms of outcome, but also in terms of health care costs at 1 year. This benefit is maintained at 3 years follow-up.

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