Safety of FFR-guided revascularisation deferral in Anatomically prognostiC diseasE (FACE: CARDIOGROUP V STUDY): A prospective multicentre study.

BACKGROUND: FFR-guided coronary intervention is recommended for patients with intermediate stenoses. However, concerns exist with this approach in anatomically prognostic disease. METHODS: In this prospective, multicentre study, we consecutively enrolled patients found to have FFR negative lesions in anatomically significant sites: left main; proximal LAD; last remaining patent vessel; and multiple vessels with concomitant impaired left ventricular systolic function (EF < 40%). As per recommendation, revascularisation was deferred, and patients included into a registry. The primary endpoint was MACE (death, myocardial infarction and unplanned target lesion revascularization). Secondary endpoints were the above individual components. Subgroup analyses were performed for clinical presentation (stable vs. ACS), localization of lesion (ostial vs. non ostial) and renal function. RESULTS: The registry included 292 patients with 297 deferred stenoses. After 1-year, the primary endpoint occurred in 5% of patients, mainly driven by TLR (2.7%). Cardiovascular death occurred in 0.8% and AMI in 0.8%. During a follow-up of 22.2 ±â€¯11 months, MACE occurred in 11.6%. Cardiovascular death occurred in 1.8% and AMI in 2.1%. After multivariate analysis, impaired renal function (OR 1.99; CI 95% 1.74-5.41; p = 0.046) and ostial disease (OR 2.88; CI 95% 1.04-7.38; p = 0.041) were found to be predictors of MACE. Impaired renal function also predicted TLR (OR 2.43; CI 95% 1.17-5.02; p = 0.017). CONCLUSION: FFR-guided revascularisation deferral is safe in the majority of anatomically prognostic disease. However, further evaluation is required in the risk stratification of those patients with ostial disease and renal disease. Registered on ClinicalTrials, NCT02590926.

Impact of blood transfusion on in-hospital myocardial infarctions according to patterns of acute coronary syndrome: Insights from the BleeMACS registry.

BACKGROUND: Blood transfusions (BTs) may worsen the prognosis of patients affected by acute coronary syndromes (ACS), although few data detail their impact on short-term events according to clinical presentation (ST Segment Elevation Myocardial Infarction, STEMI vs. Non-ST Segment Elevation ACS, NSTE-ACS). METHODS: Patients undergoing percutaneous coronary intervention (PCI) for ACS, with data on BTs, were selected from the BleeMACS registry. The primary end point was the incidence of myocardial infarction during hospitalization (reAMI), the secondary end-points were 30-day mortality and the combined end-point of 30-day mortality and reAMI. Sensitivity analyses were performed according to clinical presentation (STEMI vs. NSTE-ACS). RESULTS: Overall, 13,975 patients were included: mean age was 64.1years, 10,651 (76.2%) were male and 7711 (55.2%) had STEMI. BTs were administered during hospitalization to 465 (3.3%) patients, who were older and presented a more relevant burden of risk factors. The primary end-point of reAMI occurred in 197 (1.4%) patients, of whom 102 (1.1%) with STEMI. After controlling for confounding variables, BTs independently predicted the primary end-point reAMI in patients admitted for STEMI (OR 4.059, 95% CI 2244-7.344) and not in those admitted for NSTE-ACS. Moreover, BTs independently related to 30-day mortality in STEMI and NSTE-ACS patients and to the composite of 30-day mortality and reAMI in STEMI patients. CONCLUSIONS: In patients undergoing PCI for ACS, BTs increase the risk of reAMI only in those admitted for STEMI, and not in those with NSTE-ACS. These results may help physicians to choose appropriate BT administration according to the admission diagnosis.

Assessing Risk in Patients with Stable Coronary Disease: When Should We Intensify Care and Follow-Up? Results from a Meta-Analysis of Observational Studies of the COURAGE and FAME Era.

Background. A large number of clinical and laboratory markers have been appraised to predict prognosis in patients with stable angina, but uncertainty remains regarding which variables are the best predictors of prognosis. Therefore, we performed a meta-analysis of studies in patients with stable angina to assess which variables predict prognosis. Methods. MEDLINE and PubMed were searched for eligible studies published up to 2015, reporting multivariate predictors of major adverse cardiac events (MACE, a composite endpoint of death, myocardial infarction, and revascularization) in patients with stable angina. Study features, patient characteristics, and prevalence and predictors of such events were abstracted and pooled with random-effect methods (95% CIs). Major adverse cardiovascular event (MACE) was the primary endpoint. Results. 42 studies (104,559 patients) were included. After a median follow-up of 57 months, cardiovascular events occurred in 7.8% of patients with MI in 6.2% of patients and need for repeat revascularization (both surgical and percutaneous) in 19.5% of patients. Male sex, reduced EF, diabetes, prior MI, and high C-reactive protein were the most powerful predictors of cardiovascular events. Conclusions. We show that simple and low-cost clinical features may help clinicians in identifying the most appropriate diagnostic and therapeutic approaches within the broad range of outpatients presenting with stable coronary artery disease.

Laboratory aspirin resistance reversibility in diabetic patients: a pilot study using different pharmaceutical formulations.

PURPOSE: Aspirin resistance occurs most frequently in diabetic patients and is associated with poor prognosis. The purpose of this study was to evaluate the prevalence of aspirin resistance in a cohort of diabetic patients and whether it can be reversed using more bioavailable aspirin formulations. METHODS: Platelets function of 163 diabetic patients taking acetyl salicylic acid (ASA) 100 mg daily has been evaluated with PFA100 and VerifyNow. Patients found resistant by at least one test received an infusion of 288 mg of lysine acetylsalicylate (Flectadol®) corresponding to ASA 160 mg. Platelets function was measured again after 1 and 24 h. Patients whose the resistance was reversed received 288 mg of soluble salt of lysine acetylsalicylate (Cardirene 160®) corresponding to ASA160 mg instead of aspirin and their aggregation status was re-evaluated after 1 month of therapy. RESULTS: Prevalence of aspirin resistance in our population was 18,4 % (30/163). In 27 out of 30 patients (90 %) aspirin resistance was reversed within 24 h from the infusion. 25 out of 27 patients (92 %) were found fully aspirin-sensitive after 1 month of oral therapy with soluble salt; two patients were found with borderline value. No adverse reactions were observed. CONCLUSIONS: A significant number of diabetic patients are resistant to aspirin therapy. A single intravenous dose of lysine acetylsalicylate can reverse the platelet hyper-aggregability and laboratory aspirin resistance in large majority of patients. The efficacy of antiaggregation can be maintained by chronic therapy with an oral drug with a more favourable pharmacokinetic profile.