Contemporary randomized controlled trials in uncomplicated type B aortic dissection: a comparative methodological analysis.
The management of uncomplicated type B aortic dissection (uTBAD) remains a subject of ongoing debate. While best medical therapy (BMT) has been the conventional approach, thoracic endovascular aortic repair (TEVAR) has been proposed as an alternative due to its potential to promote aortic remodeling and reduce long-term complications. However, conflicting evidence regarding its survival benefits, procedural risks, and long-term durability has limited its widespread adoption. Three contemporary randomized controlled trials, IMPROVE-AD, EARNEST, and SUNDAY, are currently evaluating the role of TEVAR in uTBAD management. IMPROVE-AD, conducted across North America, aims to determine whether TEVAR reduces all-cause mortality and major aortic complications over six years in a cohort of 1,100 patients. The Scandinavian SUNDAY trial focuses on the subacute phase of uTBAD, investigating aortic remodeling, procedural safety, and long-term survival. EARNEST, based in the UK, integrates clinical, anatomical, and economic endpoints, assessing cost-effectiveness alongside patient-reported quality-of-life outcomes. This article provides a comparative analysis of these trials, examining their study designs, inclusion criteria, intervention protocols, and outcome measures. By synthesizing their methodologies and expected findings, this review contextualizes the evolving role of TEVAR in uTBAD and highlights key considerations for future clinical practice. The results of these trials are expected to shape guideline recommendations, refine patient selection criteria, and clarify TEVAR's long-term benefits in uTBAD management.
- Front Matter
- 10.1016/j.jtcvs.2021.04.044
- Apr 21, 2021
- The Journal of Thoracic and Cardiovascular Surgery
Commentary: Delaying the inevitable? Interventions for medically managed, uncomplicated type B aortic dissection.
- Research Article
15
- 10.1177/1526602818759339
- Mar 18, 2018
- Journal of Endovascular Therapy
Purpose: To compare uncomplicated acute type B aortic dissection (UATBAD) patients with intractable pain/refractory hypertension treated with thoracic endovascular aortic repair (TEVAR) to UATBAD subjects without these features receiving best medical therapy (BMT). Methods: Interrogation of the hospital database identified 101 consecutive UATBAD patients admitted between January 2011 and December 2014. Of these, 74 patients (mean age 62±13 years; 44 men) were treated with BMT; the other 27 UATBAD patients (mean age 63±13 years; 17 men) were subsequently treated with TEVAR for intractable pain (24, 89%) and/or refractory hypertension (3, 11%) at a mean 2.4±3.3 days (median 1, range 0–12) after admission. Mixed models were employed to determine differences in centerline measured aortic remodeling. Propensity analysis was employed to mitigate selection bias. Kaplan-Meier methodology was used to estimate reintervention and survival. Results: The groups were well matched; there was no difference in demographics, comorbidities, or proportion with visceral involvement (70% for TEVAR vs 86% for BMT, p=0.08). There was no significant difference in length of stay (9.6±6.3 for TEVAR vs 10.3±7.8 for BMT, p=0.3), complications (19% for TEVAR vs 24% for BMT, p=0.6), or 30-day mortality (0 for TEVAR vs 7% for BMT, p=0.1). One (4%) TEVAR patient experienced retrograde dissection. BMT resulted in greater mean increase in discharge antihypertensive medications (1.7±1.9 vs 0.7±1.7 for TEVAR, p=0.03), but there was no difference in narcotic utilization. Mean follow-up was greater in the TEVAR group (17.9±16.0 months) compared with BMT patients (11.5±10.8 months, p=0.05). TEVAR significantly improved rates of aortic diameter change (1.5% vs 12.9% for BMT, p=0.007), complete false lumen thrombosis (41% vs 11% for BMT, p=0.004), and true lumen expansion (85% vs 7% for BMT, p<0.01). However, there was no difference in reintervention (25.9% for TEVAR vs 23% for BMT, p=0.2) or survival (log-rank p=0.8). Conclusion: TEVAR for UATBAD with intractable pain/refractory hypertension is safe but offers no short-term outcome advantage when compared to UATBAD patients without these features receiving BMT. A significant improvement in aortic remodeling was identified after TEVAR. The potential long-term reintervention and aorta-related mortality benefits of this favorable remodeling have yet to be defined and randomized trials are warranted.
- Research Article
3
- 10.1016/j.ejvs.2013.06.014
- Jul 23, 2013
- European Journal of Vascular and Endovascular Surgery
Part One: For the Motion. Level 1 Evidence is Necessary Comparing TEVAR and Medical Management of Uncomplicated Type B Aortic Dissection
- Front Matter
9
- 10.1016/j.jvs.2016.08.002
- Nov 18, 2016
- Journal of Vascular Surgery
Thoracic endovascular aneurysm repair for uncomplicated type B dissection
- Supplementary Content
47
- 10.1161/jaha.111.000075
- May 3, 2012
- Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease
The modern open surgical management of abdominal aortic aneurysm (AAA) has changed little since its inception in the 1950s. Endoaneurysmorrhaphy, first described by Rudolph Matas in 1888, involved ligating the branches of an aneurysm from within the aneurysm sac. Approximately 25 years later at the
- Research Article
21
- 10.1016/j.jtcvs.2021.01.027
- Jan 21, 2021
- The Journal of Thoracic and Cardiovascular Surgery
Endovascular treatment of complicated versus uncomplicated acute type B aortic dissection
- Research Article
69
- 10.1016/j.jvs.2012.12.046
- Mar 7, 2013
- Journal of Vascular Surgery
Compliance with long-term surveillance recommendations following endovascular aneurysm repair or type B aortic dissection
- Research Article
- 10.1161/circ.148.suppl_1.13161
- Nov 7, 2023
- Circulation
Background and aim: Techniques in endovascular therapy have evolved offering a promising alternative to medical therapy alone in Type B aortic dissections (TBADs). The aim of this meta-analysis is to compare mortality and overall complications in thoracic endovascular aortic repair (TEVAR) with best medical therapy (BMT) in patients with TBADs. Methods: We included any randomized control trials, case controls, prospective or retrospective cohort and cross sectional studies that compared TEVAR versus BMT for the treatment of type B aortic dissection. Multiple electronic databases were searched to identify relevant articles including PubMed, Scopus, and Web of Science. Review Manager (RevMan) software, version 5.4 was used to perform the analysis. Results: A total of 1966 studies were screened with 32 studies included. Thirty-two cohort studies including 150836 patients (19512 TEVAR and 131324 BMT) were included. TEVAR was associated with a significantly lower 30-day mortality rate compared to BMT (RR= 0.79, CI= 0.63, 0.99, P = 0.04) notably in patients ≥ 65 years of age (RR=0.78, CI=0.64, 0.95, P=0.01). TEVAR group had a statistically significant prolonged length of hospital (MD= 3.42, CI= 1.69, 5.13, P = 0.0001), and ICU stay (MD= 3.18, CI= 1.48, 4.89, P = 0.0003) compared to BMT. BMT was associated with increased overall complications (RR= 1.50, CI= 1.20, 1.86, P = 0.0003) and stroke (RR= 1.52, CI= 1.29, 1.79, P < 0.00001). No statistically significant difference in late mortality (1, 3, and 5 year), intervention-related (acute renal failure, spinal cord ischemia, myocardial infarction, respiratory failure, and sepsis), was noted between both groups. Conclusion: In patients with TBAD, TEVAR was associated with a decreased risk of 30-day mortality rate and overall complications compared to BMT. More randomized control trials are needed to support our findings.
- Research Article
48
- 10.1016/j.ejvs.2019.08.003
- Dec 30, 2019
- European Journal of Vascular and Endovascular Surgery
Endovascular vs. Medical Management for Uncomplicated Acute and Sub-acute Type B Aortic Dissection: A Meta-analysis
- Research Article
17
- 10.1016/j.avsg.2019.02.017
- May 8, 2019
- Annals of Vascular Surgery
Thoracic Endovascular Aortic Repair on Zone 2 Landing for Type B Aortic Dissection
- Research Article
2
- 10.1186/s12893-024-02555-4
- Sep 12, 2024
- BMC Surgery
BackgroundTechniques in endovascular therapy have evolved to offer a promising alternative to medical therapy alone for Type B aortic dissections (TBADs).AimThe aim of this meta-analysis was to compare mortality and overall complications between thoracic endovascular aortic repair (TEVAR) and best medical therapy (BMT) in patients with TBADs.MethodsWe included randomized control trials and prospective or retrospective cohort studies that compared TEVAR and BMT for the treatment of type B aortic dissection. Multiple electronic databases were searched.ResultsThirty-two cohort studies including 150,836 patients were included. TEVAR was associated with a significantly lower 30-day mortality rate than BMT (RR = 0.79, CI = 0.63, 0.99, P = 0.04), notably in patients ≥ 65 years of age (RR = 0.78, CI = 0.64, 0.95, P = 0.01). The TEVAR group had a significantly prolonged hospital stay (MD = 3.42, CI = 1.69, 5.13, P = 0.0001) and ICU stay (MD = 3.18, CI = 1.48, 4.89, P = 0.0003) compared to the BMT. BMT was associated with increased stroke risk (RR = 1.52, CI = 1.29, 1.79, P < 0.00001). No statistically significant differences in late mortality (1, 3, and 5 years) or intervention-related factors (acute renal failure, spinal cord ischemia, myocardial infarction, respiratory failure, and sepsis) were noted between the groups.ConclusionOur meta-analysis revealed a significant association between the TEVAR group and a decreased mortality rate of TBAD compared to the medical treatment group, especially in patients aged 65 years or older. Further randomized controlled trials are needed to confirm our findings.
- Research Article
8
- 10.1161/circulationaha.110.961631
- Jun 14, 2010
- Circulation
Recently published long-term outcomes of the UK Endovascular Abdominal Aortic Aneurysm Repair (EVAR) trial investigators and the Dutch Randomized Endovascular Aneurysm Repair group have continued to demonstrate the superiority of EVAR in the perioperative period, but they have failed to establish long-term sustainable durability compared to open repair because of increased graft-related complications and reinterventions.1,2 In 2005, thoracic endovascular aneurysm repair (TEVAR) was approved in the United States for the treatment of descending thoracic aortic aneurysms (DTAAs). This approval, based on the results of a phase II trial3 evaluating the GORE TAG endovascular prosthesis (W.L. Gore and Associates, Newark, Delaware), led to a nationwide explosion in the use of thoracic endovascular techniques for managing DTAAs.4 Physicians had already been performing EVAR for more than a decade. Whereas EVAR was initially used to repair abdominal aneurysms with a favorable anatomy, its use later expanded to include complex cases involving a short aneurysmal neck, a tortuous aorta, and (more recently) aneurysmal rupture. Although TEVAR has only a brief history, a similar trend is obvious: This approach is being used with reasonable success to treat dissections and even ruptured aneurysms5; in addition, various new debranching techniques are allowing TEVAR to be applied to portions of the aorta previously deemed unapproachable. Article see p 2718 Najibi and colleagues6 reported the results of the first study to compare TEVAR with open aortic repair. Their series comprised 18 patients, and the control group included a historic cohort of patients who had undergone open aortic repair during the previous 3 years. Short-term follow-up data showed that the endovascular group had significantly shorter operative times, shorter hospital and intensive-care–unit stays, and less operative blood loss. Subsequently, Bavaria and associates7 reported the results of a phase II multicenter trial that assessed GORE …
- Front Matter
- 10.1016/j.jtcvs.2019.07.060
- Aug 22, 2019
- The Journal of Thoracic and Cardiovascular Surgery
Commentary: The secret life of aortic dissections
- Front Matter
- 10.1016/j.jtcvs.2019.07.068
- Aug 29, 2019
- The Journal of Thoracic and Cardiovascular Surgery
Commentary: Predicting adverse prognosis in chronic type B dissection: Are we there yet?
- Research Article
28
- 10.1111/jocs.16349
- Feb 21, 2022
- Journal of Cardiac Surgery
Uncomplicated type B aortic dissection (un-TBAD) has been managed conservatively with medical therapy to control the heart rate and blood pressure to limit disease progression, in addition to radiological follow-up. However, several trials and observational studies have investigated the use of thoracic endovascular aortic repair (TEVAR) in un-TBAD and suggested that TEVAR provides a survival benefit over medical therapy. Outcomes of TEVAR have also been linked with the timing of intervention. The scope of this review is to collate and summarize all the evidence in the literature on the mid- and long-term outcomes of TEVAR in un-TBAD, confirming its superiority. We also aimed to investigate the relationship between the timing of TEVAR intervention and results. We carried out a comprehensive literature search on multiple electronic databases including PubMed, Scopus, and EMBASE to collate and summarize all research evidence on the mid- and long-term outcomes of TEVAR in un-TBAD, as well as its relationship with intervention timing. TEVAR has proven to be a safe and effective tool in un-TBAD, offering superior mid- and long-term outcomes including all-cause and aorta-related mortality, aortic-specific adverse events, aortic remodeling, and need for reintervention. Additionally, performing TEVAR during the subacute phase of dissection seems to yield optimal results. The evidence demonstrating a survival advantage in favor TEVAR over medical therapy in un-TBAD means that with further research, particular trials and observational studies, TEVAR could become the gold-standard treatment option for un-TBAD patients.
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