THEMIS is a double-blind, randomized trial of 19,220 patients with diabetes mellitus and stable coronary artery disease (CAD) comparing ticagrelor to placebo, in addition to aspirin. The present study aimed to describe the proportion of patients eligible and reasons for ineligibility for THEMIS within a population of patients with diabetes and CAD included in the Reduction of Atherothrombosis for Continued Health (REACH) registry.The THEMIS eligibility criteria were applied to REACH patients. THEMIS included patients ≥50 years with type 2 diabetes and stable CAD as determined by either a history of previous percutaneous coronary intervention, coronary artery bypass grafting, or documentation of angiographic stenosis of ≥50% of at least one coronary artery. Patients with prior myocardial infarction or stroke were excluded. In REACH, 10,156 patients had stable CAD and diabetes. Of these, 6515 (64.1%) patients had at least one exclusion criteria. From the remaining population, 784 patients did not meet inclusion criteria (7.7%) mainly due to absence of aspirin treatment (7.2%), yielding a 'THEMIS-eligible population' of 2857 patients (28.1% of patients with diabetes and stable CAD). The main reasons for exclusion were a history of myocardial infarction (53.1%), use of oral anticoagulation (14.5%), or history of stroke (12.9%). Among the 4208 patients with diabetes and a previous PCI, 1196 patients (28.4%) were eligible for inclusion in the THEMIS-PCI substudy.In a population of patients with diabetes and stable coronary artery disease, a sizeable proportion appear to be 'THEMIS eligible.'http://www.gov identifier: NCT01991795.
Patients' responses to oral antiplatelet therapy are subject to variation. Bedside monitoring offers the opportunity to improve outcomes after coronary stenting by individualizing therapy.
Background: Obese patients have been shown to have a "paradoxical" good outcome after PCI despite more frequent poor response to antiplatelet agents. In the ARCTIC study, which failed to demonstrate any clinical benefit of platelet function testing with drug adjustment before stent PCI, obese patients was a pre-specified subgroup. We therefore sought to address the relation between platelet response, obesity and clinical outcome after PCI. Results: Of the 2440 patients randomized in the ARCTIC study, 533 were obese (BMI> 30 kg/m2, 22%) of whom 274 were randomized in the "conventional" group (without bedside platelet function monitoring) and 259 in the "monitoring" group (with bedside platelet function monitoring). Compared to non-obese patients (median BMI=25.4 [23.7-27.5]), obese patients (median BMI=32.5[31.1-34.5]) were younger (median 61[55-69] vs 64[56-71], p=.0001), had more frequently hypertension (72.5% v.58.1%, p=0.0001), dyslipidemia (75.1% vs 65.9%; p=0.0001) and diabetes mellitus (51.8% vs 32.0%, p=0.0001). At the time of stent implantation, high on-aspirin platelet reactivity was more frequent in obese than in non-obese patients (11.2% versus 6.4%, p=0.01) whereas and unexpectedly, there was no difference in the rate of high on-thienopyridine platelet reactivity (37.8% versus 33.5%, respectively, p=0.20). As a consequence, in the "monitoring" group, intensification of antiplatelet therapy using aspirin reloading (10% versus 5.4%, p=0.01) was more frequently performed in obese than in non-obese patients while clopidogrel reloading was similar in obese and non-obese patients (23.6% versus 25.4%, p=0.99). In obese patients the risk of primary end point (any death, MI, stent thrombosis, stroke, TIA or urgent revascularization) at one-year follow-up was not reduced in the "monitoring" group compared to the "conventional" group (28.6% vs 32.1%, p=0.42). The same was true for the main secondary endpoint ([stent thrombosis or urgent revascularization], 5.1% vs 5.5%, p=0.96). Conclusion: Compared to non-obese, obese patients display a 2-fold increase in the rate of high on-aspirin platelet reactivity but no difference in the rate of high on-thienopyridine platelet reactivity. As a consequence, no thienopyridine dose adjustment is needed and no difference in clinical outcome is observed. This finding reinforces the hypothesis that high platelet reactivity, although a good marker of risk, is not a modifiable risk factor.
Temporary dual antiplatelet therapy (DAPT) is recommended following patent foramen ovale (PFO) percutaneous closure although its benefit, compared to single antiplatelet therapy (SAPT), has not been demonstrated in this setting. We aimed at assessing outcomes following PFO closure according to the antiplatelet strategy at discharge.The ambispective AIR-FORCE cohort included consecutive patients from seven centres in France and Canada undergoing PFO closure and discharged without anticoagulation. Patients treated in French and Canadian centres were mostly discharged with DAPT and SAPT, respectively. The primary endpoint was the composite of death, stroke, transient ischaemic attack, peripheral embolism, myocardial infarction, or BARC type ≥2 bleeding with up to 5 years of follow-up. The impact of the antiplatelet strategy on outcomes was evaluated with a marginal Cox model (cluster analyses per country) with inverse probability weighting according to propensity score. A total of 1532 patients (42.2% female, median age: 49 [40-57] years) were included from 2001 to 2022, of whom 599 (39.1%) were discharged with SAPT and 933 (60.9%) with DAPT, for ≤3 months in 894/923 (96.9%) cases. After a median follow-up of 2.4 [1.1-4.4] years, a total of 58 events were observed. In the weighted analysis, the rate of the primary endpoint up to 5 years was 7.8% in the SAPT strategy and 7.3% in the DAPT strategy (weighted hazard ratio 1.04, 95% confidence interval 0.59-1.83).The antiplatelet strategy following PFO closure did not seem to impact clinical outcomes, thus challenging the current recommendations of temporary DAPT.
Hot topics in valvular disease 847 independent predictor of mortality, mitral valve surgery or LV dysfunction each (all p<0.05).In contrast, ECHO-derived integrative assessment only tended to predict all-cause mortality (p 0.08) while it predicted mitral valve surgery (p<0.05). Conclusions:The findings of the present study suggest that the MRI-derived assessment of organic MR is more accurate to identify patients with truly severe organic MR and adverse outcome.In contrast, ECHO-based integrative approach overestimates the severity of MR in one third of patients.
