Key result
PCI with the dual-therapy COMBO stent yields a ~15% five-year target lesion failure rate.
Why the study?
Data on the long-term safety and efficacy of the bio-engineered dual-therapy pro-healing COMBO stent were lacking.
Does the dual-therapy COMBO stent provide long-term safety and efficacy in unselected patients undergoing percutaneous coronary intervention?
Observational (n=1,000)
Yes
Does the dual-therapy COMBO stent provide long-term safety and efficacy in unselected patients undergoing percutaneous coronary intervention?
The dual-therapy COMBO stent shows sustained safety and efficacy with low rates of target lesion failure and stent thrombosis up to 5 years in a real-world population.
Low 5-year TLF and ST rates with COMBO stent in unselected patients; extends real-world evidence while leaving open randomized comparisons to contemporary DES.
OBJECTIVES: This final report from the REMEDEE Registry assessed the long-term safety and efficacy of the dual-therapy COMBO stent in a large unselected patient population. BACKGROUND: The bio-engineered COMBO stent (OrbusNeich Medical BV, The Netherlands) is a dual-therapy pro-healing stent. Data of long-term safety and efficacy of the this stent is lacking. METHODS: The prospective, multicenter, investigator-initiated REMEDEE Registry evaluated clinical outcomes after COMBO stent implantation in daily clinical practice. One thousand patients were enrolled between June 2013 and March 2014. RESULTS: Five-year follow-up data were obtained in 97.2% of patients. At 5-years, target lesion failure (TLF) (composite of cardiac death, target-vessel myocardial infarction, or target lesion revascularization) was present in 145 patients (14.8%). Definite or probable stent thrombosis (ST) occurred in 0.9%, with no additional case beyond 3-years of follow-up. In males, 5-year TLF-rate was 15.6 versus 12.6% in females (p = .22). Patients without diabetes mellitus (DM) had TLF-rate of 11.4%, noninsulin-treated DM 22.7% (p = .001) and insulin-treated DM 41.2% (p < .001). Patients presenting with non-ST segment elevation acute coronary syndrome (NSTE-ACS) had higher incidence of TLF compared to non-ACS (20.4 vs. 13.3%; p = .008), while incidence with STE-ACS was comparable to non-ACS (10.7 vs. 13.3%; p = .43). CONCLUSION: Percutaneous coronary intervention with the dual-therapy COMBO stent in unselected patient population shows low rates of TLF and ST to 5 years. Remarkably, no case of ST was noted beyond 3 years.
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Kerkmeijer et al. (2020) conducted an observational in Coronary artery disease requiring percutaneous coronary intervention (n=1,000). dual-therapy COMBO stent was evaluated on Target lesion failure (composite of cardiac death, target-vessel myocardial infarction, or target lesion revascularization). Percutaneous coronary intervention with the dual-therapy COMBO stent in an unselected patient population showed a 5-year target lesion failure rate of 14.8% and stent thrombosis rate of 0.9%.
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