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The e-Ultimaster all-comer registry enrolls patients treated with the Ultimaster drug-eluting stent (DES) to further validate its safety and efficacy in every day clinical practice. We investigated 1-year clinical outcomes in a predefined subset of high-risk patients with acute coronary syndrome (ACS).
e-Ultimaster recruitment started in 2014 and is still ongoing. To date, 5468 patient have been treated with the Ultimaster sirolimus eluting, thin strut (80um) cobalt chromium, stent coated with a bioresorbable polymer, who either reached 1 year follow-up, or died.
A total of 3205 high-risk patients with unstable angina (18.9%), non-ST segment elevation myocardial infarction (NSTEMI; 43.6%) or ST segment elevation myocardial infarction (STEMI; 37.5%) were included. Mean ± SD age was 64.5 ± 11.4 years and 76% were men, with a mean BMI of 27.9 kg/m2, 31% smokers, 24% with diabetes and 59% had hypertension. Radial access was used in 85.9%. 48.3 % of patients had multi-vessel disease and the mean number of lesion per patient was 1.4 ± 0.7. Chronic total occlusion was present in 2% of patients and bifurcation lesions in 13%, while 42% had long lesions. At 1 year follow-up, rates of cardiac death, MI and target vessel MI were 1.8%, 1.1% and 0.97%, respectively. Clinically driven (CD) target vessel revascularization (TVR) was performed in 2.8% of patients and CD target lesion revascularization (TLR) in 1.6%. Target lesion failure (TLF), a composite of cardiac death, TV-related MI and CD-TLR, was 3.7% and TVR, a composite of cardiac death, TV-related MI and CD-TVR was 4.7%. Definite and probable stent thrombosis at 1 year occurred in 1% of the patients. Bleeding rate was 2.9%. At 3 months follow-up, 95% of patients were on dual antiplatelet therapy (DAPT), while 69% of patients were on DAPT at 1 year. 90% of patients were free of angina at 1 year follow-up.
These results from a large, real-world registry show that this challenging subgroup of high-risk patients with ACS can be effectively treated with a new generation DES with bioresorbable polymer. The low rates of stent thrombosis supports the safe use of the Ultimaster DES.
CORONARY: Acute Coronary Syndromes