Clinical Trials of Acute and Chronic Dissections. Gregory Landry MD
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1 Clinical Trials of Acute and Chronic Dissections Gregory Landry MD
2 No disclosures
3 Acute vs chronic dissection: Definitions 1950s: Acute < 2 weeks, Chronic > 2 weeks 2013: European Interdisciplinary Consensus Acute < 2 weeks Subacute 2-6 weeks Chronic > 6 weeks 2013: International Registry of Acute Aortic Dissection (IRAD) Hyperacute < 24 hours Acute 2-7 days Subacute 8-30 days Chronic > 30 days
4 Survival based on time and treatment modality Booher, Am J Med, 2013
5 Randomized Controlled Trials ADSORB (acute) N=61 INSTEAD (subacute/chronic) N=140
6 ADSORB 61 patients randomized to BMT (n=31) vs TAG (n=30) Symptom duration < 2 weeks Uncomplicated 1º composite endpoint incomplete false lumen thrombosis, aortic dilatation (>5mm), rupture at 1 year Brunkwall, Eur J Vasc Endovasc Surg, 2014
7 ADSORB Sponsored by Gore Treatment within 48 hours of randomization 2cm proximal landing zone Device at least 15cm long Oversizing 10%
8 No difference in demographics or number/type of antihypertensive drugs
9 ADSORB: Composite Endpoint
10 ADSORB True Lumen False Lumen
11 INSTEAD Trial 140 patients > 2 weeks post acute type B dissection Uncomplicated Randomized to TEVAR (n=72) vs BMT (n=68) 1º endpoint 2 yr all cause death 2º endpoints aneurysmrelated death, progression, remodeling Nienaber, Circulation, 2009
12 INSTEAD Sponsored by Medtronic Progressive aortic pathology crossover Additional procedures Remodeling False lumen thrombosis True/false lumen diameter
13 INSTEAD Trial
14 INSTEAD: Remodeling
15 INSTEAD: Remodeling 2 year complete false lumen thrombosis 19% BMT 91% TEVAR BMT true TEVAR true BMT False TEVAR False 5 0 Baseline 3 month 1 year 2 year
16 INSTEAD: criticism Initial power calculations were based on the assumption of a late death rate up to 30% Needed 28 deaths for adequate power Since the observed number of deaths was only 11 (7.9%), it is underpowered for its primary endpoint Four patients included in TEVAR group despite violation of inclusion criteria, all four of whom suffered aneurysm related death
17 INSTEAD-XL: Long Term Same patient group followed out to five years. All cause mortality Nienaber, Circ Cardiovasc Interv, 2013
18 INSTEAD-XL Aneurysm-related mortality Progression and adverse events
19 INSTEAD-XL: Remodeling BMT aneurysm TEVAR aneurysm BMT true TEVAR true BMT false TEVAR false 10 0 baseline 2 year 5 year
20 Registry Data VIRTUE IRAD VQI TALENT GenTAC SVS Advantages Large numbers Real world experience Disadvantages Heterogeneous Acute/chronic Complicated/uncomplicated Not consecutive (selection bias)
21 SVS Outcomes Committee Results of 5 single center IDE trials 99 patients 85 acute, 11 subacute, 3 chronic Symptoms Pain 77% Malperfusion 72% Rupture 32% White, J Vasc Surg, 2011
22 SVS Registry: Morbidity/mortality 30 day mortality 10% 1 year mortality 30% Early adverse events in 38% Death 10% Stroke 9% Renal failure 9% Paralysis 9%
23 VIRTUE Registry Multicenter European registry Medtronic Valiant 1º endpoint all cause mortality at 12 months 2º endpoints Aneurysm related mortality Complications Reintervention Acute: 0-14 days Subacute: days Chronic: >92 days Complicated and uncomplicated NOT consecutive patients
24 VIRTUE Registry: Early Results Eur J Vasc Endovasc Surg, 2011
25 VIRTUE Registry: Mid-term results Eur J Vasc Endovasc Surg, 2014
26 VIRTUE Registry: Mid-term results Change in True and False Lumen
27 VIRTUE registry: mid-term results False lumen thrombosis Descending thoracic aorta Celiac axis
28 Systematic review of type B dissection Thrumurthy, Eur J Vasc Endovasc Surg, 2011 Pooled data on 17 studies, 567 patients Median time from dissection to intervention 18 months (20 days-129 months) 90% technical success
29 Systematic Review Results Survival Aneurysm formation Endoleaks False lumen thrombosis
30 What have we learned from clinical trials so far Early intervention effective in treating complicated dissections. Early benefits (first two years) primarily in favorable remodeling Survival benefits start to occur after the first 2-3 years Subacute treatment (>2 weeks) may be beneficial in reducing complications without negatively affecting remodeling.
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