Trials Flashcards
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)
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%
Best bypass
.
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
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
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
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
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%.
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
HeartMate II Study
NEJM 2009;361:2241-51
NYHA IIIb/IV
HM XVE (66) vs HM II (134)
2y survival 58% vs 24%
Fewer adverse events/malfunctions with HM II
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
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%
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
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
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.
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
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
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
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)
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
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
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
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
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.
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).
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)
