Seminal Articles Flashcards
RE-ALIGN
Dabigatran versus Warfarin in Patients with
Mechanical Heart Valves
NEJM 2013
DESIGN: Phase-2 dose validation open-label blinded randomized trial. 39 centers in 10 countries. Sponsored by Boehringer Ingelheim. 252 Pts from 2011-12 (premature termination) with mechanical AVR or MVR in last 7 days or greater than 3 months. 2:1 Randomization to dabigatran (150, 220 or 300 mg bid to plasma level of 50ng/mL) or warfarin. Primary endpoint: trough plasma level of dabigatran over 12 weeks. Secondary safety endpoints: included stroke, systemic embolism, TIA, valve thrombosis, bleeding, DVT, MI and death. As treated analysis.
RESULTS: 70% AVR. 70% with INR target of 2.5-3.5. 50% received 220mg dabigatran. Dose adjustment or d/c required in 30% of pts. Safety outcomes DOAC vs warfarin: stroke 5% vs. 0%; MI 2% vs. 0%; valve thrombosis 3% vs. 0%; death <1%; major bleeding (all pericardial in the acute group) 4% vs. 2%; any bleeding 27% vs. 12%.
CRITICAL APPRAISAL: Dose/target trough level of 50ng/mL choice. Cross-over to warfarin 8%. Majority of patients were AVR with high INR target; not our typical target for AVR. Industry funded.
TAKEHOME: Dabigatran assoc. with higher bleeding and thromboembolism compared to warfarin acutely or subacutely following mechanical AVR or MVR.
PROACT
Anticoagulation and Antiplatelet Strategies After On-X Mechanoical Aortic Valve Replacement
JACC 2018
DESIGN:
RESULTS:
CRITICAL APPRAISAL: Mean INR in lower target group 1.9. Home INR measurments used; better control.
TAKEHOME: Lower INR target of 1.5-2.0 is not inferior to 2.0-3.0
ARISTOTLE
Apixaban versus Warfarin in Patients with Atrial Fibrillation
NEJM 2011
DESIGN:
RESULTS:
CRITICAL APPRAISAL: Industry funded. INRs only within target 60% of the time.
TAKEHOME:
BRIDGE
Perioperative Bridging Anticoagulation in Patients with Atrial Fibrillation
NEJM 2015
DESIGN:
RESULTS:
CRITICAL APPRAISAL: Underpowered. No analysis stratified by CHADs Score
TAKEHOME:
DAPT
Twelve of 30 Months of Dual Antiplatelet Therapy after Drug-Eluting Stents
NEJM 2014
DESIGN:
RESULTS:
CRITICAL APPRAISAL:
TAKEHOME:
PLATO
Ticagrelor versus Clopidogrel in PAtients with Acute Coronary Syndromes
NEJM 2009
DESIGN:
RESULTS: Primary endpoint: MACE. Secondary endpoints: major bleeding
CRITICAL APPRAISAL: Very minimal loss to followup. Loading doses were variable (some including plavix). Cross-over or termination of therapy due to SOB. Patients who received CABG within 24hrs of Ticagrelor had significantly higher bleeding rates than Plavix.
TAKEHOME: Patients should receive 12 months of DAPT with ASA and Ticagrelor following ACS.
IABP-SHOCK-6
Intraaortic Balloon Pump in Cardiogenic Shock Complicating Acute Myocardial Infarction:
Long-Term 6-Year Outcomes of the Randomized IABP SHOCK II Trial
CIRC 2019
DESIGN:
RESULTS:
CRITICAL APPRAISAL:
TAKEHOME:
TRITON
Prasugrel versus Clopidogrel in PAtients with Acute Coronary Syndromes
NEJM 2007
DESIGN:
RESULTS:
CRITICAL APPRAISAL:
TAKEHOME:
FREEDOM-10Yr
DESIGN:
RESULTS:
CRITICAL APPRAISAL:
TAKEHOME:
STICH-10Yr
2018
DESIGN:
RESULTS:
CRITICAL APPRAISAL:
TAKEHOME:
