Trials Flashcards

Question

Endocarditis--Early vs delayed surgery "EASE"

Answer 1

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).

Answer 2

``` 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) ```

Answer 3

``` 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 ```

Answer 4

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.

Answer 5

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

Answer 6

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.

Answer 7

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)

Answer 8

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

Answer 9

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

Answer 10

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

Answer 11

Randomized trial of assigned patients with diabetes and multivessel coronary artery disease to undergo either PCI with drug-eluting stents or CABG Followed for 2 years (median among survivors 3.8 years). from 2005 to 2010--enrolled 1900 patients at 140 international centers. Primary outcome of death, myocardial infarction and stroke was 26.6% in PCI in 18.7% in CABG. (5 year outcome) Stroke was more frequent in CABG and benefit of CABG was driven by improved rates of

Answer 12

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

Answer 13

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

Answer 14

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

Answer 15

``` 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) ```

Answer 16

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

Answer 17

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%

Answer 18

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

Answer 19

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.

Answer 20

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

Answer 21

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

Answer 22

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)

Answer 23

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

Answer 24

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%.

Answer 25

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

Answer 26

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

Answer 27

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.

Answer 28

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

Answer 29

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

Answer 30

``` 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 ```

Answer 31

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.

Answer 32

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).

Answer 33

Freedom from OR/Sx/death at 5 yr is 50%

Answer 34

Type depend on number of raphe Then precise fusion Then precise function S or I More frequent is 1 raphe, left-right fusion and stenotic So type 1, L-R , S

Answer 35

``` 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

Answer 36

30 d mortality 10% 1 yr mortality 22% Stroke 2,5 % Risk factor of death COPD Renal Pulmonary hypertension

Answer 37

Survival 97% ``` Freedom from Reop Auto 92% Homo 97% Any 85% ``` Risk factor for reop IA Male Annulus > 27

Answer 38

Preop increase mortality, inotropes need, renal insufficiency, AF Postop Quovadis (pt CHF, HBP, MI) reduce ischemic event APRES (pt EF 30-50) reduce MI, death, CHF IMAGINE : no benefit in low risk patient

Answer 39

Postop MANGANO trial reduce death, MI, stroke, renal ins., bowel infarct Preop Reduce death without increasing bleeding or transfusion

Answer 40

Mortality benefit for everybody | Also reduces AF

Answer 41

Reduce mortality, ischemic events and repeat revasc | Also reduces atherosclerosis in grafts

Answer 42

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