dream trial journal presentation

7/30/2019 Dream Trial journal presentation

1/30

Long-Term Outcome of

Open or Endovascular Repair ofAbdominal Aortic Aneurysm

Jorg L. De Bruin, M.D., Annette F. Baas,M.D., Jaap Buth, M.D., Monique Prinssen,

M.D., et al

The New England Journal of Medicine

May 2010 vol 362

Presented by Ram Kumar Shrestha

DREAM TRIAL


2/30

AAA- a pathological focal dilatation of the aorta

>30mm 1.5 times the adjacent diameter of the normal aorta

90 % of AAA is infrarenal, fusiform morphology

Juxtarenal and suprarenal AAA F>M

EtiologyAtherosclerosis

But clinically significant peripheral occlusivedisease is unusual and present in


3/30

Clinical presentation-Symptomatic Back pain/abdominal pain

+- pulsatile abdominal massAsymptomatic

Natural history of AAA

Expand -------> Rupturestaccato pattern of growthAverage aggregate growth 3-4mm/yearLarge aneurysm expand faster

Rupture Risk directly related to aneurysm sizeRupture risk low for M

A rapid expansion >0.5cm/6 months

Fleming C et al: Ann Intern Med 142:203,2005

Lederle FA et al: Arch Intern Med 160:1117, 2000


4/30

Indication for RepairRuptured AAA mortality rate- 71-77%

Elective Surgical Repair MR 2-6

Symptomatic AAA80% 1 year Mortality rate without repair80% 1 year survival rate with repair

Asymtomatic AAASize AP diameter >55mm

Rupture risk


5/30

Management Option

1. Regular USG assessment of aneurysmsize for asymtomatic


6/30

Advantage of Open Surgical RepairAAA permanently eliminated

Risk of aneurysm recurrance/delayed rupture -nilDirect assessment of Colon integrity

Disadvantage/ComplicationsCardiac arrhythmias, MI

GI Complications- , Ischaemic Colitis, aortoentericfistula

Renal FailureProsthesis infection


7/30

Advantage of Endoluminal ProcedureMinimally invasive procedure

Superior in pts unfit for surgery due to age/comorbiditiesShort convalescence period

Disadvantage/complications

Anatomic Eligibility requiredEndoleaks/ruptureMigrationcost


8/30

Endovascular Repair is superior to Open repairin perioperative survival benefit.

Long term data lackingConcerns regarding durability of this procedure

Delayed risk of ruptureReinterventions


9/30

AIM-To provide long term data on compare EVAR and Open Repair


10/30

Methodology:

A multicentered 26 centre in Netherland+ 4 in Belgium

Long term median duration 6.4 years

Randomized controlled trial Computer generated Permuated block sequence Stratification in blocks of 4 patients


11/30

Study Patients

Patients with AAA >= 5 cm

Suitable for both Open and Endovascular Repair

Suitability determined by cardiologist or internist for open repairand for endovascular repair determined by means of endograftdependent anatomical criteria


12/30

Neck length (mm) >15

Neck diameter (mm) >18,


13/30

EXCLUSION CRITERIA

-emergency aneurysm repair-inflammatory aneurysm-anatomical variation eg horse shoe kidney-connective tissue disease-hx of organ transplantation-life expectancy of less than 2 yrs


14/30

DATA COLLECTION AND FOLLOW UP

F/U Schedule:30 days, 6,12,18 and 24 months

Questionnaire about physical and mental health

Every 6 months thereafter

EVAR Group- annual f/u with CT YearlyOpen Group- advised to see physician

At 5 year: Both group f/u with CT Scan


15/30

PRIMARY OUTCOME

A. Rate of Death from any causeInhospital Death: any death occurring within 30daysAfter the original procedure or any death occurring morethan 30 days after procedure but during same hospital

stayCardiovascular cause: MI, CHF, Cardiac arrest,

Stroke, ruptured aneurysmNoncardiovascular: cancer, Pulmonary conditions,

miscellaneous disorder


16/30

B. Reintervention:Any surgical or reintervention procedure that was

related to the primary aneurysm repair procedure.

Indication for reintervention:

1. Graft related indications: thrombo-occlusive disease,

Endoleak type 1 or endotension, endograft migration, prosthesisinfection, graft material failure, paraanastomotic aneurysm andaneurysm rupture

2. Wound related indications: incisional hernia and wound

infection

3.Local or sytemic indications: bleeding, endoleak type 2, Ileus


17/30

RESULT


18/30

Enrollment and Outcome

Baseline Characteristics


19/30

Baseline Characteristics

Characteristics Open repair n= 178Endovascular repairn = 173

P value

Age- yr 69.6+-6.8 70.7+-6.6 0.13

Male sex-no(%) 161(90.4) 161(93.1) 0.44

Pts with SVC/ISCVS risk factor score-%

DM 9.6 10.4 .86

Tobacco use 55.1 64.2 .10

Hypertension 54.5 58.4 .52

Hyperlipidemia 52.6 47 .33

Carotid Disease 15.2 14.5 .88

Cardiac disease 46.6 41.0 .33

Renal Disease 8.4 7.5 .85

Pulmonary disease 18.5 27.7 .04

Sum of SVS/ISVC Risk Factor scores 4.5+-2.5 4.4+-2.5 .61

FEV1 L/sec 2.6+-0.7 2.5+-0.7 .27

BMI 26.6+-4.1 26.3+-3.4 .47

ASA class- no(%)

I Healthy 44(24.7) 37(21.4) .53

II Mild Systemic Disease 110(61.8) 122(70.5) .09

IIISevere Systemic disease 24(13.5) 14(8.1) .12


20/30

Medications use no(%)

Beta Blocker 92(51.7) 76(43.9) .17

Statin 72(41.9) 63(37.3) .44

Antiplatelet agent 72(40.4) 70(40.5) 1.00

ACEi 50(28.1) 58(33.5) .30

CCB 32(18) 30(17.3) .89

Anticoagulant 27(15.2) 20(11.6) .35


21/30

Overall Survival

Cumulative survival rate after 6 yearsOpen repair 69.9%Endovascular -68.9%p=0.97

Kaplan-Meier estimateOf survival


22/30

Cause of Death

Open repairoverall 60

Inhospital death 8, after discharge 51, 1prior to surgery

20 cardiovascular cause40 non cardiovascular

Endovascular repair-Overall 58

Inhospital death 2 after discharge 55, 1prior to surgery

16 cardiovascular cause42 non cardiovascular)


23/30

ReinterventionCumulative rate of freedom from reintervention

Open repair 81.9%Endovascular repair 70.4%P=0.03

ReinterventionOpen Group: Correction of incisional hernia

EVAR Group: Endograft related complicationssuch as Endoleak and Endograft

Migration


24/30


25/30

Discussion

Inhospital Death is less in Endovascular group in thisstudy and consistent with the findings of other studies.study Open % Endovascular %

DREAM TRIAL 4.6 1.2

EVAR-1 TRIAL 4.7 1.7

OVER TRIAL 3.0 0.5ACE Trial

The pulmonary comlications has beenimplicated as the cause of death in Opengroup


26/30

Short term Survival benefit counterbalanced by mid termRise in mortality in Endovascular group.

However the rise in mortality observed were because ofMiscellaneous cause rather than endograft related.

The Midterm rise in mortality in endovascular group wereNot found in OVER Trial.

Endovascular Repair is Durable, and there is noDisadvantage in overall long term survival.


27/30

Stastically significant high reintervention rate inEndovascular repair is Due to Graft related

indications

Thromboocclusive diseaseEndoleak

But the most of the reintervention were occurred after 4 yrsafter the procedure.

OVER TRIAL and EVAR 1 Trial reported less interventionIn Endovascular group- Short term data reported, no 4yearData included.

Incisional hernia is the most common wound relatedIndication for reintervention in Open repair.


28/30

Conclusion:

Endovascular and Open Repair of AAASimilar Rate of long term survival

Rate of secondary intervention is higher in

endovascular repair in long run.

Both types of repair complement each other in AAAManagement. The Comorbid conditions and anatomicCriterion needed to be considered before selecting the

Repair method


29/30

Limitation

1. Outcome based on size not studied.

2. Device specific Outcome- reintervention rate

3. QOL other than reintervention ??

4. Biasness on follow up Less Ct reporting in Opengroup Might have affected finding of more graft relatedproblem in Endovascular group


30/30

Thank You

dream trial journal presentation

Documents