Resolute zotarolimus‐eluting stent in ST‐elevation myocardial infarction (resolute‐STEMI): A prespecified prospective register from the DAPT‐STEMI trial

To evaluate the safety and efficacy outcomes after primary percutaneous coronary intervention (pPCI) with second‐generation Resolute™ zotarolimus‐eluting stent (R‐ ZES) in patients enrolled in the DAPT‐STEMI Trial (NCT01459627).Background: R‐ ZES is one of the most used drug eluting stents worldwide. To date, the safety and efficacy data of this stent in setting of STEMI is limited.Methods: The Resolute‐STEMI is a prespecified prospective register that reports the safety and efficacy of R‐ZES in setting of ST‐Elevation Myocardial Infarction (STEMI) at 6 months for the following endpoints: a composite endpoint of all‐cause mortality, any myocardial infarction (MI), any (unscheduled) revascularization, stroke and TIMI major bleeding, as well as target lesion failure and stent thrombosis (ST).Results: From a total of 1,100 STEMI patients enrolled in the trial, 998 received a R‐ZES. At 6 months the PE occurred in 42 (4.2%) patients. All‐cause death, MI, revascularization, stroke and TIMI major bleeding was respectively 8 (0.8%), 9 (0.8%), 34 (3.4%), 2 (0.2%), and 4 (0.4%). The rate of target lesion revascularizations involving the culprit lesion was 1.1%. Target lesion failure was 1.5%. The rate of definite ST was 0.5%. The rate of both definite or probable ST was 0.7%.Conclusions: The present analysis is the largest to date reporting short‐ term and mid‐term clinical outcomes with the R‐ZES stent in setting of STEMI. At 30  days and 6‐months R‐ZES has an outstanding safety and efficacy even in this high‐ risk category of patients

Early or late intervention in patients with transient ST-segment elevation acute coronary syndrome: Subgroup analysis of the ELISA-3 trial

Item does not contain fulltextOBJECTIVES: To investigate incidence and patient characteristics of transient ST-segment elevation (TSTE) ACS and to compare outcome of early versus late invasive treatment. BACKGROUND: Optimal timing of treatment in TSTE-ACS patients is not outlined in current guidelines and no prospective randomized trials have been done so far. METHODS: Post hoc subgroup analysis of patients with TSTE randomized in the ELISA 3 trial. This study compared early (48 h) angiography and revascularization in 542 patients with high-risk NSTE-ACS. Primary endpoint was incidence of death, reinfarction, or recurrent ischemia at 30 days follow-up. RESULTS: TSTE was present in 129 patients (24.2%) and associated with male gender, smoking and younger age. The primary endpoint occurred in 8.9% of patients with and 13.0% of patients without TSTE (RR = 0.681, P = 0.214). Incidence of death or MI after 2 year follow-up was 5.7 and 14.6% respectively (RR = 0.384, P = 0.008). Within the group of patients with TSTE, incidence of the primary endpoint was 5.8% in the early and 12.7% in the late treatment group (RR = 0.455, P = 0.213), driven by reduction in recurrent ischemia. Enzymatic infarct size, bleeding and incidence of death or recurrent MI at 2 years follow-up was comparable between the treatment groups. CONCLUSIONS: In high-risk patients with NSTE-ACS, TSTE is frequently seen. Similar to findings in patients with high-risk NSTE-ACS, immediate angiography and revascularization in these patients is feasible but not superior to later treatment. Prospective randomized trials are needed to provide more evidence in the optimal timing of treatment in patients with TSTE-ACS. (c) 2016 Wiley Periodicals, Inc

Clinical outcomes of deferred revascularisation using fractional flow reserve in patients with and without diabetes mellitus

Objective: Deferred revascularisation based upon fractional flow reserve (FFR >0.80) is associated with a low incidence of target lesion failure (TLF). Whether deferred revascularisation is also as safe in diabetes mellitus (DM) patients is unknown. Methods: All DM patients and the next consecutive Non-DM patients who underwent a FFR-assessment between 1/01/2010 and 31/12/2013 were included, and followed until 1/07/2015. Patients with lesions FFR >0.80 were analysed according to the presence vs. absence of DM, while patients who underwent index revascularisation in FFR-assessed or other lesions were excluded. The primary endpoint was the incidence of TLF; a composite of target lesion revascularisation (TLR) and target vessel myocardial infarction (TVMI). Results: A total of 250 patients (122 DM, 128 non-DM) who underwent deferred revascularisation of all lesions (FFR >0.80) were compared. At a mean follow up of 39.8 \ub1 16.3 months, DM patients compared to non-DM had a higher TLF rate, 18.1 vs 7.5 %, logrank p 64 0.01, Cox regression-adjusted HR 3.65 (95 % CI 1.40-9.53, p < 0.01), which was largely driven by a higher incidence of TLR (17.2 vs. 7.5 %, HR 3.52, 95 % CI 1.34-9.30, p = 0.01), whilst a non-significant but numerically higher incidence of TVMI (6.1 vs. 2.0 %, HR 3.34, 95 % CI 0.64-17.30, p = 0.15) was observed. Conclusions: This study, the largest to directly compare the clinical outcomes of FFR-guided deferred revascularisation in patients with and without DM, shows that DM patients are associated with a significantly higher TLF rate. Whether intravascular imaging, additional invasive haemodynamics or stringent risk factor modification may impact on this higher TLF rate remains unknown