Cardiovascular trials

 

CARP 2004

Question

PCI/CABG pre-vascular surgery

Type

·      Multi-centre RCT

Upshot

·      ↔AMI

·      ↔Mortality

Comments

·      High risk patients excluded (e.g. LMCA disease, LVEF <20%, severe AS)

·      98% male

 

POISE 2008

Question

Metoprolol in patients undergoing non-cardiac surgery

Background

·      Discredited DECREASE studies supported peri-op b-blocker

Type

·      Multi-national RCT

Upshot

·      ↓Non-fatal AMI

·      ↑Significant bradycardia

·      ↑Significant hypotension

·      ↑Stroke

·      ↑Death

 

Summary of TAVI evidence:

PARTNER B 2010

·      TAVI > nothing in inoperable patients

PARTER A 2011

·      TAVI = SAVR in high risk patients

US Corevalve Pivotal Trial 2014

·      TAVI > SAVR in high risk patients

PARTER 2A 2016

·      TAVI = SAVR in intermediate risk patients

PARTER 3 2019

·      TAVI > SAVR in low risk patients at 1 year

Upshot

·      TAVI is for high risk candidates with easy anatomy

·      Need an MDT to decide

·      Need cardiac surgeon + perfusionist + gear on-site

 

PARTNER 3 2019

Type

·      Multi-national trial

Patients

·      Symptomatic severe AS

·      Low surgical risk

Pros

·      ↓Stroke (both early and late)

·      ↓Death

·      ↓AKI

·      ↓New AF

·      ↓Major bleeding

Cons

·      ↑Major vascular complications

·      ↑Pacemaker requirement (for BBB)

·      ↑Paravalvular regurgitation

·      ↑Re-intervention rate

·      ?↑Mean valve gradient (no P value published)

Caveats

·      Exclusions: poor femoral access, bicuspid valves, difficult anatomy

·      TAVI patients more likely to develop valve thrombosis (? significance)

 

POISE 2 Aspirin 2014

Question

Peri-op aspirin

Type

·      Multi-national, 2x2 factorial placebo-controlled RCT

Subjects

·      Non-cardiac surgery

Upshot

·      ↔Mortality

·      ↔AMI

·      ↑Major bleeding in those not already taking aspirin

 

POISE 2 Clonidine 2014

Question

Peri-op low dose clonidine

Upshot

·      ↔AMI

·      ↑Hypotension

·      ↑Non-fatal cardiac arrest

 

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