(pnoninferiority < )

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Sudden Cardiac Death in Heart Failure Trial Presented at American College of Cardiology Scientific Sessions 2004 Presented by Dr. Gust H. Bardy SCD-HeFTSCD-HeFT.
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CHARM-Preserved: Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity - Preserved Purpose To determine whether the angiotensin.
PARTNER Objective To compare surgical aortic valve replacement (AVR) with transcatheter aortic valve replacement (TAVR) in high-risk patients with severe.
ISAR-CABG Objective To compare the efficacy of DES with BMS in a randomized trial powered for clinical events Sample 610 patients with de novo SVG lesions.
(p for noninferiority = 0.01)
LEADER trial: Primary Outcome
Defibrillator in Acute Myocardial Infarction Trial
SOCRATES Trial design: Patients with acute ischemic stroke were randomized in a 1:1 fashion to receive either ticagrelor 180 mg load + 90 mg BID or aspirin.
EARLY-BAMI Trial design: Patients presenting with STEMI with a plan for primary PCI, and without evidence of cardiogenic shock, were randomized to either.
GAUSS-3 Trial design: Patients with objective evidence of intolerance to statin agents were randomized in a 2:1 fashion to either evolocumab 420 mg subcutaneously.
BENEFIT Trial design: Patients with positive serologic tests for T. Cruzi and cardiomyopathy were randomized to benznidazole 300 mg daily for days.
DANISH Trial design: Patients with nonischemic cardiomyopathy were randomized to ICD implantation (n = 556) versus usual care (n = 560). Results (p = 0.28)
AARDVARK Trial design: Patients with small abdominal aortic aneuryms (AAAs) were randomized in a 1:1:1 fashion to either perindopril 10 mg once daily,
LEVO-CTS Trial design: Patients undergoing cardiac surgery with the use of cardiopulmonary bypass were randomized to infusion of levosimendan 0.2 µg/kg/min.
(p for noninferiority = )
Angiography-guided PCI
BBK II Trial design: Patients undergoing a two-stent approach for a de novo bifurcation lesion were randomized in a 1:1 fashion to either culotte stenting.
EMPA-REG OUTCOME Trial design: Patients with type 2 diabetes mellitus (DM2) at high risk for CV events were randomized to receive in a 1:1:1 fashion either.
Primary endpoint at 1 year
EXCEL Trial design: Patients with unprotected left main disease were randomized to either PCI with an Xience everolimus-eluting stent (EES) or CABG. They.
MAGIC-AF Trial design: Patients with persistent atrial fibrillation (AF) and remaining in AF after pulmonary vein isolation alone were randomized to either.
MARFAN SARTAN Trial design: Marfan patients were randomized to losartan (n = 153) vs. placebo (n = 150). The dose of losartan was 50 mg for those
Losartan vs. Atenolol in Marfan Syndrome
Median total new lesion volume
OptiLink HF Trial design: Patients with heart failure who underwent implantation of an ICD were randomized to telemonitoring (n = 505) vs. usual care (n.
PARTNER 2A Trial design: Intermediate-risk patients with aortic stenosis (STS PROM score 4-8%) were randomized to undergo either TAVR or SAVR, stratified.
Compare-Acute Trial design: STEMI patients undergoing primary PCI were randomized to fractional flow reserve (FFR)-guided complete revascularization (n.
PRECISION Trial design: Patients with arthritis and increased cardiovascular risk were randomized to celecoxib 100 mg twice daily (n = 8,072) vs. ibuprofen.
ALPS Trial design: Patients with adult nontraumatic out-of-hospital cardiac arrest (OOHCA) and persistent or recurrent VT/VF after ≥1 shock were randomized.
FAIR Trial design: Patients with SFA in-stent restenosis (ISR) were randomized to either a paclitaxel-coated balloon (DCB) (dose 3.5 μg/mm2) or routine.
VALUE Trial design: Hypertensive patients at high cardiovascular risk were randomized to valsartan (n = 7,649) vs. amlodipine (n = 7,596). Results (p =
ANTARCTIC Trial design: Patients with acute coronary syndrome undergoing stenting were randomized to tailored antiplatelet therapy (n = 435) versus conventional.
SMILE Trial design: NSTEMI patients were randomized to complete revascularization during the index procedure (i.e., 1-stage revascularization; n = 264)
TUXEDO–India Trial design: Patients with type 2 diabetes mellitus (DM2) and coronary artery disease undergoing PCI were randomized to receive Taxus Element.
ATMOSPHERE Trial design: Patients with symptomatic heart failure were randomized in a 1:1:1 fashion to either aliskiren 300 mg once daily, enalapril 5.
EVERBIO II Trial design: Patients with CAD were randomized in a 1:1:1 fashion to either Absorb BVS, Biomatrix Flex stent [BES], or Promus Element EES.
SUSTAIN-6 Trial design: Patients with DM2 at high risk for CV events were randomized in a 1:1:1:1 fashion to either semaglutide 0.5 mg, semaglutide 1 mg,
PROCAMIO Trial design: Patients with hemodynamically stable wide complex monomorphic tachycardia were randomized 1:1 to either intravenous procainamide.
BASKET-PROVE II Trial design: Subjects with stable or unstable coronary artery disease undergoing stent implantation were randomized to a biodegradable-polymer.
ISAR-SAFE Trial design: Patients with DES PCI received 6 months of open-label DAPT with aspirin and clopidogrel. At 6 months, they were randomized in a.
Belinda Gray et al. JCHF 2013;1:
BAT for HFrEF Trial design: Patients with chronic systolic HF were randomized in a 1:1 fashion to either baroreceptor activation therapy (BAT) or control.
David F. Katz et al. JACEP 2016;j.jacep
RIDDLE-NSTEMI Trial design: Patients with NSTEMI were randomized to either immediate (within 2 hours) intervention or delayed (within 72 hours) intervention.
(p = 0.32 for noninferiority)
AMACING Trial design: Patients with chronic kidney disease undergoing intravascular iodinated contrast administration were randomized to prophylactic hydration.
(p < for noninferiority)
BRAVO-3 Trial design: Patients undergoing transfemoral TAVR were randomized in a 1:1 fashion to bivalirudin or UFH. They were followed for 30 days. Results.
OSLER Trial design: Patients from five phase 2 trials and seven phase 3 trials with evolocumab were invited to participate in the OSLER extension program,
Impedence-guided management
Mancini JG, et al. Am J Cardiol.
Prabhat Kumar et al. JACEP 2016;j.jacep
(p = for noninferiority)
CHAMPION Trial design: Patients with recent hospitalization for heart failure were implanted with a pulmonary artery pressure monitor and randomized so.
David F. Katz et al. JACEP 2017;3:20-28
PREDICTORS OF APPROPRIATE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SHOCK AND DEATH: A COMPETING RISK ANALYSIS  D.S. Lee, J. Hardy, R. Yee, J.S. Healey,
ITALIC Trial design: Patients with Xience V (everolimus-eluting stent) PCI were randomized in a 1:1 fashion to receive 6 or 24 months of dual antiplatelet.
RUTHERFORD-2 Trial design: Patients with heterogeneous familial hypercholesterolemia (HeFH) on statins were randomized in a 2:2:1:1 fashion to subcutaneous.
The Heart Rhythm Society Meeting Presented by Dr. Johan De Sutter
DANAMI 3-DEFER Trial design: Patients presenting with STEMI and in whom the operators could establish TIMI 2-3 flow without stenting or those presenting.
Primary safety endpoint
Chest Pain Choice Trial design: Patients presenting to the ED with low risk chest pain were randomized to either use of a tailored decision aid or routine.
MOMENTUM 3 Trial design: Patients with advanced heart failure were randomized to a centrifugal-flow pump (n = 152) vs. an axial-flow pump (n = 142). Results.
IVUS-XPL Trial design: Patients undergoing drug-eluting stent implantation for long coronary lesions were randomized to IVUS-guided PCI (n = 700) vs. angiography-guided.
IMPRESS Trial design: Patients undergoing primary PCI for STEMI and cardiogenic shock were randomized in a 1:1 to either Impella CP or IABP. They were.
MATRIX: Radial vs. Femoral
NOBLE Trial design: Patients with unprotected left main disease were randomized to either PCI with a drug-eluting stent (DES) (88% biolimus) or CABG. They.
Demographic Characteristics of Patients Treated With Statins Versus Those Not Treated With Statins Goldberger JJ, et al. J Am Coll Cardiol 2006;48:
Recurrence of HF hospitalization Total-time approach
CIRCUS Trial design: Patients with anterior STEMI were randomized to IV cyclosporine 2.5 mg/kg (n = 475) vs. placebo (n = 495) immediately before coronary.
Presentation transcript:

(pnoninferiority < 0.0001) SIMPLE Trial design: Patients receiving an ICD implantation were randomized to routine defibrillation threshold (DFT) testing or no testing. They were followed for 3.1 years. Results (pnoninferiority < 0.0001) (psuperiority = 0.30) Primary outcome: Failed appropriate shock or arrhythmic death for no testing vs. routine DFT testing: 7.2% vs. 8.3%; pnoninferiority < 0.0001 Post-procedure: Chest compressions: 0% vs. 0.4%, p = 0.06; intubation: 0.1% vs. 0.6%, p = 0.03 CHF admission: 11.2% vs. 10.7%, p = 0.72 % Conclusions No DFT testing was noninferior to routine DFT testing at the time of ICD implantation for sub-sequent failed appropriate shocks/arrhythmic death Important finding; has the potential to simplify ICD implantation and lower costs Primary endpoint No DFT testing (n = 1,247) Routine DFT testing (n = 1,253) Healey JS, et al. Lancet 2015;Feb 22:[Epub]