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Landmark Trials in Cardiology

Summary of Landmark Trials in Cardiology on which current cardiology practice is based. These trials must be prepared for any cardiology exam:  

EMPA-REG OUTCOME Trial Summary - Cardiology Landmark Trials

 

SHOCK

Early Revascularization in Acute Myocardial Infarction Complicated by Cardiogenic Shock - The New England Journal of Medicine - 1999 Brief Summary: Compared to initial medical stabilization, early revascularization was associated with a nonsignificant trend towards improved survival at 30 days among patients who developed cardiogenic shock during acute MI. However, early revascularization did confer a significant benefit by 6 months. Reference: http://www.ncbi.nlm.nih.gov/pubmed/10460813

IABP-SHOCK II

Intraaortic Balloon Support for Myocardial Infarction with Cardiogenic Shock - The New England Journal of Medicine - 2012 Brief Summary: In patients with acute MI complicated by cardiogenic shock, there was no difference in 30-day mortality with IABP placement. Reference: http://www.ncbi.nlm.nih.gov/pubmed/22920912

EMPA-REG OUTCOME

Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes - The New England Journal of Medicine - 2015 Brief Summary: In this industry sponsored trial, empagliflozin reduced the rate of CV events and slowed the progression of kidney disease among patients with T2DM and high CV risk. Reference: http://www.ncbi.nlm.nih.gov/pubmed/26378978

CANVAS

Canagliflozin and cardiovascular and renal events in type 2 diabetes - The New England Journal of Medicine - 2017 Brief Summary: Among patients with T2DM at high risk for CV events, canagliflozin had a lower risk of cardiovascular events and reduced the rate of renal decline and heart failure hospitalization compared to those who received placebo but a greater risk of amputation. Reference: http://www.ncbi.nlm.nih.gov/pubmed/28605608

LEADER

Liraglutide and cardiovascular outcomes in type 2 diabetes - The New England Journal of Medicine - 2016 Brief Summary: Among patients with T2DM at increased risk for CVD, liraglutide was associated with a reduction in CV events when compared to placebo. Reference: http://www.ncbi.nlm.nih.gov/pubmed/27295427

EUCLID

Ticagrelor versus clopidogrel in symptomatic peripheral artery disease - New Engl J Med - 2017 Brief Summary: In patients with symptomatic PAD, ticagrelor is not superior to clopidogrel with regard to the primary outcome of cardiovascular death, MI, or ischemic stroke. The rate of the primary outcome was very similar with either agent (10.6% with ticagrelor and 10.8% with clopidogrel) at median follow-up 30 months. The rate of major bleeding was 1.6% in each group. Reference: http://www.ncbi.nlm.nih.gov/pubmed/27959717

ICAP

A Randomized Trial of Colchicine for Acute Pericarditis - The New England Journal of Medicine - 2013 Brief Summary: In patients experiencing their first episode of acute pericarditis, the addition of colchicine to NSAID or glucocorticoid therapy significantly reduces the rate of incessant or recurrent pericarditis. Reference: http://www.ncbi.nlm.nih.gov/pubmed/23992557

AIRTRIP

Effect of Anakinra on recurrent pericarditis among patients with colchicine resistance and corticosteroid dependence - Journal of the American Medical Association - 2016 Brief Summary: In a small open label trial, patients with colchicine resistant, steroid dependent recurrent pericarditis, the IL-1B antagonist anakinra was associated with a dramatic reduction in the pericarditis recurrence rate. At 14 months, only 2 out of 11 patients on anakinra experienced recurrent pericarditis (18%) compared to 9 out of 10 (90%) in the placebo group. Reference: http://www.ncbi.nlm.nih.gov/pubmed/27825009

PRECISION

Cardiovascular safety of Celecoxib, Naproxen, or Ibuprofen for arthritis - The New England Journal of Medicine - 2016 Brief Summary: Among patients with RA and osteoarthritis and elevated CV risk requiring daily NSAID therapy, celecoxib is noninferior to ibuprofen and naproxen with regard to a primary safety outcome of cardiovascular death, nonfatal MI, and nonfatal stroke after mean follow up of nearly 3 years. Primary outcome events were low (approximately 2-3%) and similar among the three NSAIDs. GI events were significantly lower with celecoxib versus either naproxen or ibuprofen. Renal events were significantly lower with celecoxib versus ibuprofen. Reference: http://www.ncbi.nlm.nih.gov/pubmed/27959716

EASE

Early surgery versus conventional treatment for infective endocarditis - The New England Journal of Medicine - 2012 Brief Summary: Among patients with left sided native valve endocarditis at high risk of embolic events, early surgery reduces mortality and embolic events as compared to conventional treatment. Reference: http://www.ncbi.nlm.nih.gov/pubmed/22738096

ASCEND

Effects of aspirin for primary prevention in persons with diabetes mellitus - The New England Journal of Medicine - 2018 Brief Summary: In patients with well controlled diabetes (HbA1c < 8 in ~51% of patients), at 7.4 years primary prevention aspirin use was associated with a 1.1% absolute reduction in serious vascular events. Aspirin use was also associated with a 0.9% absolute increase in major bleeding. Aspirin use was not associated with any change in the incidence of gastrointestinal cancers or all cancers. Reference: http://www.ncbi.nlm.nih.gov/pubmed/30146931

HACA

Mild Therapeutic Hypothermia to Improve the Neurologic Outcome After Cardiac Arrest - The New England Journal of Medicine - 2002 Brief Summary: Among patients with return of spontaneous circulation after cardiac arrest due to VF or pulseless VT, mild therapeutic hypothermia (32-34° C) improved neurologic outcomes and reduced mortality at six months. Reference: http://www.ncbi.nlm.nih.gov/pubmed/11856793

DAVID

Dual chamber pacing or ventricular backup pacing in patients with an implantable defibrillator - Journal of the American Medical Association - 2002 Brief Summary: In patients with an indication for an implantable defibrillator, ventricular backup pacing is superior to dual-chamber pacing in terms of hospitalization rate and possibly overall survival. Reference: http://www.ncbi.nlm.nih.gov/pubmed/12495391

TTM

Target Temperature Management 33°C vs. 36°C after Out-of Hospital Cardiac Arrest - The New England Journal of Medicine - 2013 Brief Summary: In patients with out-of-hospital cardiac arrest, targeted temperature management to a goal of 33°C was not associated with reduction in all-cause mortality or improvement in neurologic outcomes when compared a goal of 36°C. Reference: http://www.ncbi.nlm.nih.gov/pubmed/24237006

BLOCK-HF

Biventricular versus Right Ventricular Pacing in Heart Failure Patients with Atrioventricular Block - The New England Journal of Medicine - 2013 Brief Summary: In patients with high grade AV block and mild to moderate heart failure, biventricular pacing is associated with a 10% absolute reduction in death, urgent heart failure care and adverse LV remodeling compared with right ventricular pacing, with the difference driven primarily by reduced heart failure hospitalizations and reduced LV remodeling. Reference: http://www.ncbi.nlm.nih.gov/pubmed/23614585

MUSTT

A randomized study of the prevention of sudden death in patients with coronary artery disease - New Engl J Med - 1999 Brief Summary: In patients with ischemic cardiomyopathy, EF <40%, and NSVT, EPS-guided therapy resulted in a 7% absolute reduction in the primary endpoint of cardiac arrest or arrhythmic death versus no intervention, driven primarily by ICD use. Patients with a known indication for ICD were not excluded, obscuring the degree to which benefit was derived for those with NSVT or by using EPS-guided therapy to direct ICD placement. Reference: http://www.ncbi.nlm.nih.gov/pubmed/10601507

VANISH

Ventricular Tachycardia Ablation versus Escalation of Antiarrhythmic Drugs - The New England Journal of Medicine - 2016 Brief Summary: In patients with ischemic cardiomyopathy and an implantable cardioverter-defibrillator (ICD) who experience recurrent ventricular tachycardia (VT) while receiving first-line antiarrhythmic therapy, VT ablation resulted in a 10% absolute reduction in death, VT storm, and appropriate ICD shocks when compared to escalation of antiarrhythmic drugs. This difference was driven largely by reductions in VT storm and ICD shocks with no significant difference in mortality. Reference: http://www.ncbi.nlm.nih.gov/pubmed/27149033

DANISH

Defibrillator implantation in patients with non-ischemic systolic heart failure - The New England Journal of Medicine - 2016 Brief Summary: In patients with non-ischemic cardiomyopathy with LVEF ≤35% with symptomatic heart failure, ICDs did not result in an overall mortality benefit versus standard care after 5.5 years of follow up. ICD implantation did result in a 3% absolute reduction in sudden cardiac death that was somewhat mitigated by device-related morbidity including an absolute 1.5% increase in device-related infection. Reference: http://www.ncbi.nlm.nih.gov/pubmed/27571011