Trials

Revascularisation

 

CABG vs OMT

  1. ECSS – European Coronary Surgery Study
  2. CASS – Coronary Artery Surgery Study

CABG vs POBA

  1. BARI Bypass Angioplasty Revascularization Investigation 1997 RCT n=1829
  2. RITA 1 Randomised Intervention Treatment of Angina
  3. ERACI Argentine Randomized Trial of Percutaneous Transluminal Coronary Angioplasty Versus Coronary Artery Bypass Surgery in Multivessel Disease 1996 RCT n=1011
  4. MASS Medicine, Angioplasty or Surgery Study 1995 RCT n=214
  5. CABRI Coronary Angioplasty versus Bypass Revascularisation Investigation 1995 RCT n=1054
  6. SIMA Stenting vs Internal Mammary Artery 2000 n=123
  7. FMS
  8. GABI

CABG vs BMS

  1. ERACI II
  2. ARTS
  3. AWESOME
  4. SOS
  5. MASS II

CABG vs DES

  1. Park NEJM 2015 – DES vs CABG
  2. SYNTAX
  3. EXCEL
  4. ASCERT registry

CABG vs PCI – Left Main

  1. MAIN-COMPARE – Revascularization for Unprotected Left Main Coronary Artery Stenosis: Comparison of Percutaneous Coronary Angioplasty Versus Surgical Revascularization
  2. LE MANS – Study of Unprotected Left Main Stenting versus Bypass Surgery
  3. NOBLE – Nordic-Baltic-British Left Main Revascularization Study – CABG superior to DES for unprotected LMS
  4. SYNTAX
  5. PRECOMBAT – Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease –
  6. Athappan meta-analysis DES vs CABG 2013 –

CABG vs PCI – Diabetics

  1. FREEDOM (Farkouh, NEJM 2012) – RCT:n=1900 – DES vs CABG in multi-vessel diabetics – mortality/MI/repeat lower in CABG at 5y, stroke higher (2.4 vs 5.2%)
  2. BARI2D
  3. CARDia BMS/DES vs CABG in multivessel diabetics at 1y
  4. VA CARDS

CABG vs PCI – Impaired LV

  1. STICH Surgical Treatment for Ischemic Heart Failure –

Minimally invasive

  1. Blazek JACC 2015 – DES vs MIDCAB
  2. Blazek JACC 2013 – BMS vs MIDCAB

Timing

  1. FRISC-II – early revasc in NSTEMI

PCI without on-site CTS

  1. CPORT-E (NEJM 2012) – RCT n=18,867; non-inferior mortality at 6w, MACE at 9 months.
  2. MASS-COM (NEJM 2013) – RCT n=3691; non-inferior MACE at 30d, 12 months.

Off-pump

  1. BHACAS1, 2  (Angelini Lancet 2002) – Beating Heart Against Cardioplegic Arrest Studies – RCT:n=401
  2. Nathoe NEJM 2003 RCT:n=281
  3. SMART (Puskas JTCVS 2003)
  4. ROOBY (Shroyer NEJM 2009) –
  5. BBS Best Bypass Surgery Trial (Moller Circ 2010) – RCT:n=341 no difference at 30d, but all-cause mortality worse in OPCAB
  6. DOORS
  7. CORONARY
  8. GOPCABE
  9. MASS III

Conduits

  1. RAPCO
  2. RAPS
  3. Lytle (Cleveland Clinic 1999) – BIMA better than SIMA n=8000.

Valve

Aortic Valve

  1. MAVRIC – RCT: mini-sternotomy vs full sternotomy for isolated AVR; pts receiving RBC within 12 weeks.
  2. AVATAR – RCT: AVR vs watchful waiting in asymptomatic severe AS; MACE at 36mo
  3. COMMENCE (EJCTS 2017) – Cohort n=689: Magna-ease with Resilia bovine tissue valve (blocks Ca-binding aldehyde, preserved in glycerol); n=689; valve explant 0.2%, thromboembolism 2.1%, thrombosis 0%, endocarditis 0.9%, SVD 0% at 2 years.
  4. PROACT – Onyx valve
  5. VA RCT mechanical vs bio
  6. SALTIRE 2005 – statin in aortic calcification

TAVI

  1. PARTNER
  2. SURTAVI
  3. STACCATO
  4. PRAGMATIC
  5. CHOICE
  6. NOTION

Mitral Valve

  1. COAPT
  2. EVEREST
  3. POINT – MVA in moderate ischaemic M
  4. Reyes NEJM 1994 – RCT n=60 Mitral Balloon Valvuloplasty vs Open – PBMV better at 3y
  5. Turi NEJM 1991 – RCT n=40 percutaneous vs closed valvuloplasty- similar outcomes

 

AF Ablation/LA Appendage

  1. PROTECT AF 2013 – device closure non-inferior to warfarin
  2. PREVAIL AF 2014 – device closure non-inferior to warfarin >7d
  3. FAST Atrial Fibrillation Catheter Ablation Versus Surgical Ablation Treatment – 36.5% vs 65.6% freedom from AF
  4. LAACS Left Atrial Appendage Closure by Surgery 2017 –

IABP

  1. BCIS-1
  2. PROTECT II
  3. IABP-SHOCK

Embolic protection devices

Cardiogard/EmbolX in AVR

Cardiopulmonary Bypass

Retrograde Autologous Priming

CPBVent – awaiting

Chi 2017 Medicine – MA:n=1162 CPB ventilation improves gases but not lung complications/hospital stay

Ranucci 2015 JAHA –  RCT:n=116 Fibrinogen vs placebo in reducing RBC tx – OR 0.4

Siepe 2010 EJCTS – RCT:n=92 High perfusion pressure 80-90 vs 50-60 reduces MMSE decline

EVOLUTION-ON EValuation of Patients during Coronary Artery Bypass Graft Operation: Linking UTilization of Bivalirudin to Improved Outcomes and New Anticoagulant Strategies – RCT:n=150 Bivalirudin vs Heparin for CPB showed similar outcomes but trending towards heparin being better.

Saczkowski 2012 Art Organs – MA:18 RCTs, centrifugal vs roller pumps, no difference

SIRS Steroids In caRdiac Surgery – methylpred vs placebo showed no difference in death/infection

McGuinness 2016 Anaesth – avoiding hyperoxaemia showed no difference in AKI/LOS

 

Congenital

  • SVR I Single Ventricle Reconstruction (NEJM 2010) – RV-PA (Sano) shunt vs Subclavian-PA (modified Blalock-Taussig) shunt during stage 1 Norwood procedure – Sano better survival at 12 months (74% vs 64%)
  • SVR II (Circ 2014) – transplant-free survival same. Sano worse hazard ratio/intervention-freedom at 3 years.
  • CLARINET – Clopidogrel vs placebo in systemic-PA shunt
  • Lacro NEJM 2014 – Losartan vs atenolol – no difference in dilatation in Marfan’s
  • Marfan Sartan 2015 – RCT – Losartan does not limit aortic dilatation
  • du Pleissis JTCVS 1997 – RCT:n=182 pH-stat vs alpha-stat showed lower morbidity/quicker recovery of EEG activity

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