AimsThis double-blind, randomized, parallel, placebo-controlled investigation evaluated the effects of cross-linked polyelectrolyte (CLP) on serum potassium and measures of congestion in patients with heart failure (HF) and chronic kidney disease (CKD). Methods and resultsThe primary endpoint was change in serum potassium over time. Exploratory endpoints included: weight, physician and patient assessment of exertional dyspnoea, effect on N-terminal pro brain natriuretic peptide (NT-proBNP) levels, New York Heart Association (NYHA) classification, 6 min walk test (6MWT), and quality of life by Kansas City Cardiomyopathy Questionnaire (KCCQ). Serum potassium was similar in CLP (n ¼ 59) and placebo (n ¼ 52) groups throughout the 8-week study. Weight loss was greater in the CLP than in the placebo group at Weeks 1 (P ¼ 0.014) and 2 (P ¼ 0.004), and this trend continued until the end of the study. After 8 weeks, by physician assessment, the percentage of patients experiencing marked or disabling dyspnoea tended to be lower in the CLP than in the placebo group (7.3% vs. 23.9%, P ¼ 0.128). Fewer patients in the CLP than in the placebo group had NT-proBNP levels .1000 pg/mL at Week 4 (P ¼ 0.039) and Week 8 (P ¼ 0.065). The proportion of patients improving by at least one NYHA functional class over the study was higher in the CLP than in the placebo group (48.8% vs. 17.4%; P ¼ 0.002). Effects on 6MWT at Week 8 (p ¼ 0.072) and quality of life (overall KCCQ score) at Week 4 ( p ¼ 0.005) and 8 (P ¼ 0.062) all favoured the CLP cohort. Four treatment-unrelated deaths occurred in the CLP group and none in the placebo group (P ¼ 0.056). ConclusionIn advanced, symptomatic HF with CKD, CLP is associated with beneficial clinical effects without significant serum potassium changes.

Background: Thrombotic events are reduced with cangrelor, an intravenous P2Y 12 inhibitor. We sought to characterize the timing, number, and type of early events (within 2 hours of randomization) in CHAMPION PHOENIX (A Clinical Trial Comparing Cangrelor to Clopidogrel Standard of Care Therapy in Subjects Who Require Percutaneous Coronary Intervention). Methods: CHAMPION PHOENIX was a double-blind, placebo-controlled trial that randomized patients undergoing percutaneous coronary intervention to cangrelor or clopidogrel. For this analysis, we evaluated the efficacy of cangrelor in the first 2 hours postrandomization with regards to the primary end point (death, myocardial infarction, ischemia-driven revascularization, or stent thrombosis). Sensitivity analyses were performed evaluating a secondary, post hoc end point (death, Society of Coronary Angiography and Intervention myocardial infarction, ischemia-driven revascularization, or Academic Research Consortium definite stent thrombosis). Results: The majority of events (63%) that occurred in the trial occurred within 2 hours of randomization. The most common early event was myocardial infarction; next were stent thrombosis, ischemia driven revascularization, and death. In the first 2 hours after randomization, cangrelor significantly decreased the primary composite end point compared with clopidogrel (4.1% versus 5.4%; hazard ratio, 0.76 [95% CI, 0.64–0.90], P =0.002). Similar findings were seen for the composite end point of death, Society of Coronary Angiography and Intervention myocardial infarction, ischemia-driven revascularization, or Academic Research Consortium stent thrombosis at 2 hours (0.9% versus 1.6%; hazard ratio, 0.57 [95% CI, 0.40–0.80], P =0.001). Between 2 and 48 hours, there was no difference in the primary composite end point (0.6% versus 0.5%; odds ratio, 1.17 [95% CI, 0.71–1.93]; P =0.53). Early (≤2 hours of randomization) GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) moderate or severe bleeding events were infrequent, and there was no significant difference with cangrelor compared with clopidogrel (0.2% [n=10] versus 0.1% [n=4]; adjusted odds ratio, 1.41 [95% CI, 0.37–5.40]; P =0.62). Conclusions: The reductions in ischemic events and overall efficacy seen with cangrelor in CHAMPION PHOENIX occurred early and during the period of time in which patients were being actively treated with cangrelor. These findings provide evidence that supports the importance of potent platelet inhibition during percutaneous coronary intervention. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01156571.

BACKGROUND.The growing evidence indicates the importance of non-obstructive coronary artery disease (NOCAD), with a high-risk of MACEs. The relevance of antiplatelet therapy is high and depends on a type of MINOCA. However, the effectiveness of different antiplatelet treatment regimens and secondary prevention strategies for patients with non-obstructive coronary artery disease is still unclear. OBJECTIVES In our previous cohort study, we found that secondary prevention with dual antiplatelet therapy with aspirin and P2Y12 receptor antagonist clopidogrel in patients with NOCAD was not significantly effective than aspirin alone in reducing 1-year MACEs. Because the development and validation cohorts of patients with NOCAD were heterogeneous in terms of cardiovascular risk, in the current study we aimed to compare the preventive effect of DAPT with aspirin alone in high cardiovascular-risk patients. METHODS Following the aim of our study, we selected 15 of 55 MINOCA patients with a high 10-year risk for ASCVD (≥20%) from the DAPT group and 19 of 60 patients with the same risk from the no-DAPT group. RESULTSThe results of our previous and present studies corroborate previously published data. DAPT had no secondary preventive effect on one-year MACE in MINOCA patients with different cardiovascular risks. CONCLUSIONS The use of DAPT in patients with MINOCA is a topic for discussion and requires further investigations with a long-term follow-up period. KEYWORDS Atherosclerotic cardiovascular disease (ASCVD) risk; dual antiplatelet therapy (DAPT); myocardial infarction with non-0bstructive coronary artery (MINOCA) disease; non-obstructive coronary disease (NOCAD).

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