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1

2 year partner b

Factor Standard TAVI
All cause mortality 68 43
stroke 5.5 13.8
repeat hosp 72 35
Cardiac death 62 31

2

Criteria for partner B

TAVI vs med therapy
AVA 0.8, NYHA class II or more, inoperable
Inclusion = inoperable i.e. deemed inoperable by 2 surgeons/1 cardiologist (STS risk of morb/mort >50%, STS >8
Exclusion – Bicuspid valve, MI, 3+ MR, annulus <18 or >25, LVEF <20%, recent TIA stroke, sever CRF

Death from any cause = 43% vs 68%, rehosp 35.0 vs 72.5%

3

2 year partner a

Outcome SurgAVR TAVI
Death 35 33
Stroke 6.5 11.2
Major vascular 3.8 11.6

4

PARTNER A

Severe symptomatic AS, high risk
Multicentre RCT, TAVI vs Surgery
TF (244)/TA(104), surgery (351),
age 84, NYHA 3/4, STS score 11.8%, 2 y follow up

5

SYNTAX

Multicentre randomized trial (USA/Europe)
3VD or LM or both , complexity defined by SYNTAX score (mean 29)
897 CABG 903 PCI
If suitable for one treatment only, put into registry
Primary endpoint=MACCE @1y (all cause death,stroke, MI, repeat revasc)
Secondary= MACCE rates at 1mo, 6,mo, 3y, 5 y, rates of stent thrombosis/graft occlusion

At 5 y MACCE 27% vs 37%
Rates of all cause death and stroke were ns
Repeat revasc PCI 26% vs 14%
Rates of cardiac death higher in PCI (9% vs 5.3%)
Registry data confirm randomized group results

Conc: CABG standard of care with complex MV disease
For LM or low SYNTAX score, PCI reasonable
Disease

6

Describe the syntax 3 year results

1800 patients, 85 centers, LM or 3vd
Decreased MACCE with CABG (20.2 vs 28.0%)
Revasc 10.7 vs 19.7
MI 3.6 vs 7.1%
Cardiac death favors CABG 3.6 vs 6.0%
Composite safety (death/stroke/MI) 12.0 vs 14.1% no difference
Stroke 3.4 vs 2.0% (p=0.07)
LM – MACCE not different 22.3 vs 26.8%
3vd – MACCE favors CABG 18.8 vs 28.8%
MACCE increased with PCI in entire cohort and 3vd with sntax score >22, in LM with syntax >33
LIMITATIONS – inadequately powered to detect low frequency evetns (stroke, MI), short term followup for now, LM and 3vd not prespecified
Worse outcomes with 3vd, syntax >22

7

Syntax outcomes summary

All cause mortality 13.9% for PCI 11.4% for CABG
Cardiac Death 9.0% vs 5.3% for PCI and CABG
MI 9.7% vs 3.8 % for PCI and CABG
CVA 2.4% vs 3.7 % for PCI and CABG
All-Cause Death CVA/MI 20.8% for PCI and 16.7% for CABG
Repeat revascuar 25.9% and 13.7% for PCI and CABG
MACE 37.3% PCI and 26.9% for PCI and CABG

8

Syntax < 22 ouutcomes

Low scores (0-22) [about 300 patients in each arm)
Death 10.1% CABG and 8.9% PCO
overall no different in PCI and CABG

9

What are outcomes of 5 year syntax in DM

25% of patients in syntax were DM 1800 pts of which 452 had dabete; No difference in the composite outcome of all-cause mortality/stroke/MI (PCI 23.9% and CABG 19.1%)

Individual mortality (19.5% PCI and 12% CABG)
Rate of MI was 9.0% PCI and 5.4% for CABG
MACCE was higher in PCI 46.5% vs CABG 29.0%

Overall PCI results in higher of MACCE and repeat revascularization at 5 years.

10

FREEDOM study--Future Revascularization Evaluation in patients with Diabetes mellitus: Optimal management of multivessel disease

NEJM 2012 Dec 20: 367 (25) 2375-84

Randomized trial of 1900 patients with diabetes and multivessel coronary artery disease to undergo either PCI (drug-eluting stents) or CABG

Followed for 5 years (median among survivors 3.8 years).

from 2005 to 2010--enrolled 1900 patients at 140 international centers.

Primary outcome of death, non fatal myocardial infarction and stroke was

26.6% in PCI in 18.7% in CABG. (5 year outcome)
stroke 2.4% in PCI and 5.2% in CABG
All cause mortality 16.3% in PCI vs 10. CABG
MI 13.9% in PCI vs 6.0% in CABG

11

What are details of freedom

5 year primary endpoint was 18.7% in CABG and 26.6% in PCI
Death 10.9% in CABG and 16.3% in PCI
MI 6% in CABG and 13% in PCI
stroke 5.2% in CABG and 2.4% in PCI

12

CORONARY study: Off-pump or on-pump coronary artery bypass grafting at 30 days

NEJM 2012 April 19

70 centers in 10 countries
4752 patients in whom CABG was planned to undergo the procedure off-pump or on pump.

Primary outcome was composite of Death, Nonfatal stroke, nonfatal MY, or new renal failure requiring dialysis at 30 days.

There was no significant difference in rate of primary outcome between off and on-pump 9.8% vs 10.3%).

Off pump was associated with significantly reduced rates of blood-product transfusion (50.7% vs 63%), acute kidney injue 28 vs 32%) and respiratory complication (5.9% vs 7.5%) but increased rate of revasculaizations 0.7% vs 0.2%.

13

1 year coronary trial results

4,752 coronary artery disease enrollees of the CORONARY trial, who were recruited from 79 centers in 19 countries, who were scheduled to undergo CABG.

The resulting findings showed similarities in the rate of the primary composite outcome between off-pump and on-pump CABG (12.1% vs.13.2%;

Moreover, the occurrence of coronary revascularization (CABG/PCI) was reported in 1.4% of the patients in the off-pump group and 0.8% of the patients in the on-pump

14

Shock II study

300 patients in the IABP group and 298 in the control group.

At 30 days, IABP group (39.7%) and 1control group (41.3%) had died.

No significant differences in secondary end points or in process-of-care measures, including the time to hemodynamic stabilization, the length of stay in the intensive care unit, serum lactate levels, the dose and duration of catecholamine therapy, and renal function.

15

Endocarditis--Early vs delayed surgery "EASE"

Randomized trial showing that early surgery is better than conventional therapy for patients with left-sided infective endocarditis

only patients with infective endocarditis and severe mitral-valve or aortic-valve disease and vegetation with a diameter greater than 10 mm.

primary end point of in-hospital death plus embolic events within six weeks of randomization (3% vs 23%, hazard ratio 0.10; p=0.03).

16

HeartMate II Study
NEJM 2009;361:2241-51

NYHA IIIb/IV
HM XVE (66) vs HM II (134)
2y survival 58% for heart mate ii vs 24% for HeartMate XVE
Fewer adverse events/malfunctions with HM II

17

Heartmate II

Prospective randomised study in 200 patients with advanced heart failure who were ineligible for transplantation
The patients were randomised in a 2:1 ratio
Group 1 (134) --implantation of a continuous flow left ventricular assist device (Thoratec Heartmate II)
Group 2 (66)--Pulsatile flow left ventricular assist device (Heartmate I)
Survival advantage at 2 years for patients in the continous flow (HEARTMATE II) 58% vs 24%
Reduced adverse events for patients in the continous flow LVAD group

18

SHOCK Trial

RCT - emergency revasc (plasty or cabg, n=152) vs med Tx (n=150) for cardiogenic shock 2ary to AMI
No diff in 30d mortality
Lower 6mo & 12mo mortality in revasc (50%vs63%, 53%vs66%)
Biggest benefit for age < 75y

19

Courage study
N Engl J Med 2007 Apr 12

2287 patients with stable CAD class IV angina stabilized medical

PCI (with BMS) vs medical therapy
No difference in composite all cause mortality and non-fatal MI
No difference in ACS hospitalization

20

REMATCH

NEJM 2001;345:1435-43

RCT: NYHA IV on max med Tx
LVEF<25%, not transplant candidates
Heartmate XVE (pulsatile) vs med
(N=68, n=61)
1y survival 52% vs 25%
2y survival 23% vs 8%
Improved QOL
More adverse events with VAD (infxn, bleeding, malfunction)

21

FAME II study

FAME II trial 1220 stable patients with suspected coronary disease and examined coronaries FFR to determine significant flow-limiting lesions, FFR <0.80.
Patients with at least one such lesion (n=888) were randomized to either PCI or optimal medical therapy
The primary end point of the study was a composite of death, MI, or urgent revascularization.
pts with significant disease on FFR in OMT alone had an urgent revascularization rate of 6% (p<0.0001).
Death and MI rates were similarly low for both groups.
12.7% of the medical-therapy-only group had had a primary end-point event 4.3% in PCI

22

What are details of raps

Initially 500+ pts but only 234 for 7.7 year follow-up
Overall rates of complete occlusion 18% for SVG and 9% for radial artery
Functional graft occlusion 12. 3% for radial and 19.9% for SVG

This was performed in 9 centers, 3VD, had to have high grade stenosis in left circumflex and right.

23

What is re-LY trial

150 mg of Dabigatran
significantly lower rate of stroke and embolism
similar rate of major bleeding
110 mg of Dabigatran
similar rate of stroke and embolism
lower rates of major bleeding
Both doses
significantly reduced risk of intracranial hemorrhage
increased risk of GI bleeding
dyspepsi most common side effect

24

Dr. David study on outcomes of reimplantation surgery

David TE 2012 JTCS

Mostly tricuspid (only 11% bicsupid)
Survival at 5,10 and 15 was 95%, 93% and

Freedom from reoperation
5, 10 , and 15 was 99%, 97% and 97%

Freedom from moderate or severe AI
5, 10, and 15 was 98%, 92% and 89%

25

Effect of Proshesis-patient mismatch on long-term survival with aortic valve replacement: assessment to 15 year

Jamieson WR, Ye J, Higgins J, Cheung A, etc..Lichtenstein SV
Annals of thoracic surgery 2010 Jan;89 (1) 51-8

Controversy exists as the predictors of mortality after AVR and influence of PPM

Between 1982-2003 in just over 3000 pts this group from Vancouver showed at 15 year survival that PPM is not a predictor after AVR regardless of EOAi

This was adjusted when Ejection fraction was > 50%. Also, there did appear to be a worsening outcome in those with a severe EOAi (so this might be a bad omen)

26

Risk of late aortic events after an isolated aortic valve replacement for bicuspid arortic valve stenosis with concomitant ascending aortic dilation

Evaldas, (Borger) EJCTS 2012;42(5) 832:838

Instiutional database of 153 BAV with stenosis and concomitant ascending aortic dilation of 40 to 50mm who underwent isolated AVR from 1995 to 2000. mean age was 54

Follow-up was 100% complete. Mean follow-up was 11.5years +/- 3.2 years. Survival rates of 86 and 78% at 10 and 15 years. Ascending aortic surgery was required in 5 patients (For progressive aortic aneurysm).

Freedom from aortic interventions at 10 and 15 years was 97 and 94% for the AS group (slightly lower for the AI group 88 and 70% at 10 and 15 years).

Suggest that BAV with AS and mild to moderate ascending dilation are at considerable low risk for adverse events at 15 years. BAV phenotype should be considered.

27

Update on Reintervention and risk factors for re-operation in 2000 patients after the Ross Procedure--Results of the German-Dutch Ross Registry

AATS

2023 pts mean age of 39 underwent a Ross.
Mean f/u was 71. +/- 4.5 years
Freedom from autograft reintervention was 87% at 10 years and 83% at 12 years

The risk for reoperation depends on the utilized techqniue. The subcoronary Ross technique appears to result in superior durability.
Freedom from homograft reoperation was 93% at 10 years and 91% at 12 years

28

Study on outcomes of Aortic valve reimplantation

Munir Boodwani et al (El Khoury) JTCS 2009;137:286-94

Freedom from aortic valve re-operation at 5 and 8 year were 92 and 91 (n= 214 pts)
Freedom from AI of 2+ at 5 and 8 years was 88 and 79%

1 pt with aortic valve endocarditis
4 strokes

29

BARI

CABG vs bms
Overall mortality and MI : no difference
Subgroup diabetes : advantage CABG

Bari2d (only diabetes)
Meds vs revasc ( CABG or pci)
Reduce MACE in cabg vs meds but not pci vs meds

30

Stitch II

Same as 1 but CABG vs CABG and SVR, n=1000' mean fu 48mo

Primary endpoint death and rehospit for cardiac cause CABG 59% SVR 58%
SVR reduce ESVI by 19% vs 6% in CABG alone
SVR increase CPB and clamp time and LOS

Limitations
Not blind
Surgeons biased to randomize or not

31

Stitch 1

CABG vs meds in LV < 35%
N=1212 mean fu 56 mo
Primary endpoint death from any cause. Med 41% CABG 36% ns
Secondary endpoint cardiac death med 33% vs CABG 28% flush 0,05
Secondary endpoint death any cause + hospit for cardiac cause meds 68% CABG 58% significant

Limitation
Crossover 17% from med to CABG
Not blinded
Primary endpoint neg

32

PPM
Priabory 2009 JACC

Moderate PPM associated with increased mortality in patients with LV dysfunction
Severe PPM increase mortality in LV dysfunction, young < 70, and slim BMI < 30

33

What is aortic valve classification

Type 1 Normal,leaflet motion
A dil STJ
B dil STJ and sinus
C dil AVJ
D perforation

Type 2 excess motion

Type 3 restriction


Best result after repair with type 1 and 2

34

Quick facts about Syntax

MACE PCI = 37.3 CABG = 26.9
MI PCI = 9.7 3.8%
Rept reva 25.9 13.7
All cause death 13.9 11.4
stroke 2.4 3.7
low syntax 32.1 28.6
Left main 36.9 31%
Intermediate 36.0 25.8
High 44.0 26.8

35

What is Prevent IV study
JAMA 2005
3000 pts

Edifoligide, acts as a "decoy" to block and prevent gene transactivation and potential increase in medial hypertrophy in the SVG, causing it to mimic a natural artery that may lead to the endurance of SVGs.

Angiographic vein graft failure, defined as ≥ 75% stenosis in at least 1 vein graft, was nearly identical when assessing on either a per-patient or per-graft basis in both the edifoligide and placebo arms (Table 2). The vast majority of vein graft failures was attributed to graft occlusion. By multivariate analysis, independent predictors of SVG failure were target artery quality, surgery duration, endoscopic harvest, multitarget graft, and patient weight.

36

Define Partner A and Partner B cohorts.

Partner A: high risk patients with AS who were eligible for surgery

Partner B: high risk patients NOT ELIGIBLE for surgery (TAVI vs Med Rx)

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