Key result
The COMBO stent resulted in a 12-month target lesion failure rate of 7.1% in acute coronary syndrome patients compared to 4.4% in stable angina patients, with no significant difference (p=0.07).
Why the study?
Does the COMBO stent result in similar target lesion failure rates between ACS and elective patients?
Observational (n=1,000)
Yes
Does the COMBO stent result in similar target lesion failure rates between ACS and elective patients?
Absolute Event Rate: 7.1% vs 4.4%
p-value: p=0.07
The COMBO stent demonstrates a low overall rate of target lesion failure and early stent thrombosis, with no significant difference in outcomes between ACS and elective patients.
Supports COMBO stent use across ACS and elective patients; hypothesis-generating and requires randomized confirmation before practice change.
BACKGROUND: Patients presenting with acute coronary syndrome (ACS) are at increased risk of complications after percutaneous coronary intervention with stent placement compared to patients with stable angina (SA) treated in an elective setting. The novel pro-healing COMBO stent is a bio-engineered drug eluting stent designed to promote vessel healing. Therefore, the stent may reduce this difference in clinical outcomes between elective and ACS-patients and prevent late stent thrombosis. METHODS AND RESULTS: The European, prospective, multicenter, 1000 all-comers patient REMEDEE registry evaluates clinical outcomes after COMBO stent placement in ACS- and elective patients. The primary endpoint at 12 months is target lesion failure (TLF), a composite of cardiac death, target-vessel myocardial infarction and target lesion revascularization. A total of 49.9% (n = 498) of patients presented with acute coronary syndrome. TLF was 7.1% in ACS patients, definite and probable stent thrombosis was observed in 0.5% of ACS patients and in all within 9 days post stenting. We found no significant difference in TLF between ACS and non-ACS patients and a low overall rate of TLF. CONCLUSIONS: The COMBO stent is a safe and efficient device for patients presenting with ACS. Low ST rate and only early stent thrombosis were observed.
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Kalkman et al. (2017) conducted an observational in Acute coronary syndrome and stable angina (n=1,000). COMBO stent vs. Stable angina patients treated with COMBO stent was evaluated on Target lesion failure (TLF) (p=0.07). The COMBO stent resulted in a 12-month target lesion failure rate of 7.1% in acute coronary syndrome patients compared to 4.4% in stable angina patients, with no significant difference (p=0.07).
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