The American journal of cardiology
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Inappropriate shock is a frequently seen clinical problem despite advanced technologies used in modern implantable cardioverter-defibrillator (ICD) devices. Our aim was to investigate whether simply raising the ICD detection zones can decrease inappropriate therapies while still providing appropriate therapy. We randomized 223 patients with primary prevention to either the conventional programming group with 3 zones as VT1 (167 to 182 beats/min) with discriminators, VT2 (182 to 200 beats/min) with discriminators, and ventricular fibrillation (>200 beats/min) (n=100) or the high-zone programming group with 3 zones as VT1 (171 to 200 beats/min) with discriminators, VT2 (200 to 230 beats/min) with discriminators, and ventricular fibrillation (>230 beats/min; n=101). ⋯ During 12-month follow-up, the first episode of appropriate therapy was higher (22% vs 10%, hazard ratio [HR] 2.18, 95% confidence interval [CI], 1.09 to 4.36, p=0.028) and the first episode of inappropriate therapy was lower (5% vs 28%, HR 0.18 [95% CI 0.07 to 0.44], p<0.001) in the high-zone group compared with the conventional group. Although all-cause mortality did not differ (2% for the high-zone group vs 3% for the conventional group, HR 0.65 [95% CI 0.11 to 3.99], p>0.05), hospitalization for heart failure was significantly higher in the conventional group (13% vs 4%, HR 0.28 [95% CI 0.09 to 0.88], p=0.021). In conclusion, in a real-world population, high-zone settings of the single-, dual-, and triple-chamber ICDs were associated with reduction in inappropriate therapy while still providing appropriate therapy.
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Randomized Controlled Trial Multicenter Study
Five-year outcomes of percutaneous versus surgical coronary revascularization in patients with diabetes mellitus (from the CREDO-Kyoto PCI/CABG Registry Cohort-2).
We investigated the impact of diabetes mellitus on long-term outcomes of percutaneous coronary intervention (PCI) in the drug-eluting stent era versus coronary artery bypass grafting (CABG) in a real-world population with advanced coronary disease. We identified 3,982 patients with 3-vessel and/or left main disease of 15,939 patients with first coronary revascularization enrolled in the Coronary Revascularization Demonstrating Outcome Study in Kyoto PCI/CABG Registry Cohort-2 (patients without diabetes: n = 1,984 [PCI: n = 1,123 and CABG: n = 861], and patients with diabetes: n = 1,998 [PCI: n = 1,065 and CABG: n = 933]). Cumulative 5-year incidence of all-cause death after PCI was significantly higher than after CABG both in patients without and with diabetes (19.8% vs 16.2%, p = 0.01, and 22.9% vs 19.0%, p = 0.046, respectively). ⋯ There was no interaction between diabetic status and the effect of PCI relative to CABG for all-cause death, cardiac death, MI, and any revascularization. In conclusion, in both patients without and with diabetes with 3-vessel and/or left main disease, CABG compared with PCI was associated with better 5-year outcomes in terms of cardiac death, MI, and any coronary revascularization. There was no difference in the direction and magnitude of treatment effect of CABG relative to PCI regardless of diabetic status.
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Randomized Controlled Trial Multicenter Study Comparative Study
Comparison of plaque characteristics in narrowings with ST-elevation myocardial infarction (STEMI), non-STEMI/unstable angina pectoris and stable coronary artery disease (from the ADAPT-DES IVUS Substudy).
Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents (ADAPT-DES) was a prospective, multicenter registry of 8,582 consecutive stable and unstable patients who underwent percutaneous coronary intervention using a drug-eluting stent. We sought to identify key morphologic features leading to ST-segment elevation myocardial infarction (STEMI) versus non-STEMI (NSTEMI) or unstable angina pectoris (UA) versus stable coronary artery disease (CAD) presentation. In the prespecified grayscale and virtual histology (VH) substudy of ADAPT-DES, preintervention imaging identified 676 patients with a single culprit lesion. ⋯ Lesions with plaque rupture versus those without plaque rupture showed higher prevalence of VH-TCFA and larger plaque burden with positive remodeling, especially in patients with STEMI. Multivariate analysis showed that in the lesions with plaque rupture, plaque burden at the MLA site was the only independent predictor for STEMI (cutoff of plaque burden = 85%) and in lesions without plaque rupture, MLA was the only independent predictor for STEMI (cutoff of MLA = 2.3 mm(2)). In conclusion, culprit lesions causing STEMI have smaller lumen areas, greater plaque burden, and more plaque rupture or VH-TCFA compared with NSTEMI/UA or stable CAD; in lesions with plaque rupture, only plaque burden predicted STEMI, and in lesions without plaque rupture, only MLA area predicted STEMI.
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Randomized Controlled Trial Multicenter Study
Impact of female sex on lipid lowering, clinical outcomes, and adverse effects in atorvastatin trials.
The aim of this study was to evaluate the effect of atorvastatin on lipid lowering, cardiovascular (CV) events, and adverse events in women compared with men in 6 clinical trials. In the Incremental Decrease in End Points Through Aggressive Lipid Lowering (IDEAL) trial (atorvastatin 80 mg vs simvastatin 20 to 40 mg), the Treating to New Targets (TNT) trial (atorvastatin 80 vs 10 mg), the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial (atorvastatin 80 mg vs placebo), and the Collaborative Atorvastatin Diabetes Study (CARDS), the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT), and the Atorvastatin Study for Prevention of Coronary Heart Disease Endpoints in Non-Insulin-Dependent Diabetes Mellitus (ASPEN) (atorvastatin 10 mg vs placebo), lipid changes on treatment were compared between genders with studies grouped by dose. The association of on-study low-density lipoprotein (LDL) cholesterol and CV events by gender was evaluated in the combined studies and the impact of gender on adverse events in each study separately. ⋯ Myalgia rates were slightly higher in women in both statin and placebo groups. In conclusion, the response of women to atorvastatin was similar to that of men, with slightly more discontinuations due to adverse events. Higher on-treatment LDL cholesterol was significantly associated with more CV events in both genders, but the association was stronger for stroke in women and for coronary heart disease death in men.
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Randomized Controlled Trial Comparative Study
Comparison of safety of left atrial catheter ablation procedures for atrial arrhythmias under continuous anticoagulation with apixaban versus phenprocoumon.
Apixaban is increasingly used for stroke prevention in patients with atrial fibrillation. Data about the safety of left atrial radiofrequency ablation procedures under continuous apixaban therapy are lacking. We performed a matched-cohort study of patients undergoing left atrium ablation procedures for atrial fibrillation or left atrial flutter. ⋯ No patient in either group experienced a thromboembolic event and no patient died. In patients on apixaban, no clinical variable was predictive for bleeding complications. Left atrial ablation procedures under continuous oral anticoagulation with apixaban are feasible and as safe as under continuous oral anticoagulation with phenprocoumon.