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Three-Year Results of the Endurant Stent Graft System Post Approval Study.

ABSTRACT: BACKGROUND:Long-term data following endovascular aneurysm repair (EVAR) exist but are limited to endografts that are no longer in use. The aim of the ENGAGE Post Approval Study is to describe the long-term safety and effectiveness data following EVAR using the Endurant stent graft system. METHODS:From August 2011 to June 2012, 178 patients were enrolled and treated with the Endurant stent graft system. Clinical and radiologic data were prospectively collected and analyzed. The primary end point was abdominal aortic aneurysm (AAA)-related mortality, and secondary end points were overall mortality, endoleak, secondary interventions, and device-related complications. Kaplan-Meier estimates were used for late outcomes. RESULTS:A total of 178 patients underwent EVAR with the Endurant stent graft across 24 centers (82% men; median age 71, interquartile range [IQR] 66-79). Median aortic diameter was 55 mm (IQR 51-58 mm). There was a 98.9% technical success rate. Three-year clinical and radiographic follow-up data were available for 87% and 74% of patients, respectively. Median follow-up was 37 months (IQR 30-38 months). Three-year aneurysm-related mortality rate was 1.1%, with 2 deceased patients in the perioperative period. All-cause mortality rate at 3 years was 13%. No patients suffered from aneurysm rupture or underwent conversion to open repair through 3 years of follow-up. Only 11 patients (6.2%) had undergone reintervention at 3 years. Younger age was associated with reintervention (HR 3.3 per younger decade, 95% confidence interval 1.3-7.6, P < 0.01), but neck diameter, length, and angulation were not significantly associated with reintervention. CONCLUSIONS:The Endurant stent graft system provides a safe, durable approach to treating infrarenal AAA. No patients experienced late rupture or aneurysm-related mortality, and only 1 in 16 patients underwent reintervention by 3 years. The rate of reintervention with the Endurant graft appears to be lower than other contemporary grafts, despite more liberal "Instructions For Use" parameters, but further research including direct graft comparisons will be necessary to guide appropriate graft selection.

SUBMITTER: Deery SE

PROVIDER: S-EPMC6014884 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Three-Year Results of the Endurant Stent Graft System Post Approval Study.

Deery Sarah E SE Shean Katie E KE Pothof Alexander B AB O'Donnell Thomas F X TFX Dalebout Barbara A BA Darling Jeremy D JD Bodewes Thomas C F TCF Schermerhorn Marc L ML

Annals of vascular surgery 20180302

<h4>Background</h4>Long-term data following endovascular aneurysm repair (EVAR) exist but are limited to endografts that are no longer in use. The aim of the ENGAGE Post Approval Study is to describe the long-term safety and effectiveness data following EVAR using the Endurant stent graft system.<h4>Methods</h4>From August 2011 to June 2012, 178 patients were enrolled and treated with the Endurant stent graft system. Clinical and radiologic data were prospectively collected and analyzed. The pri ...[more]

PMID: 29505865

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Project description:Purpose: To report the outcomes from the observational SURPASS registry, which was created to assess the performance of the Conformable TAG (CTAG) stent-graft with the Active Control System (ACS) in patients undergoing thoracic endovascular aortic repair (TEVAR) in a real-world setting. Materials and Methods: The SURPASS registry (ClinicalTrials.gov; identifier NCT03286400) was an observational, prospective, single-arm, post-market, international study that enrolled patients undergoing TEVAR using the CTAG with ACS for both acute and chronic thoracic aortic disease between October 2017 and July 2018. The CTAG with ACS features 2-stage deployment of the stent-graft and an optional angulation mechanism that modifies only the proximal end of the stent-graft. During the observation period, 127 patients (mean age 67.1±12.1 years, range 27-86; 92 men) were enrolled and treated for an array of aortic pathologies, including chronic and acute lesions and 4 ruptured descending thoracic aneurysms. The primary outcome of this study was technical success; secondary outcomes were clinical success and major adverse events at 30 days and 12 months. The numbers of 2-stage device deployments and applications of the angulation mechanism were recorded, along with the reasons for use. Results: Technical success of the TEVAR was 97.6% owing to unintentional partial coverage of supra-aortic branches in 3 cases (the vessels were patent on imaging). The stent-graft was repositioned at its intermediate diameter in 79 patients (62.2%), and the angulation feature was applied in 64 cases (50.4%), mainly to improve proximal wall apposition and orthogonality in the aorta. The desired effect was achieved in 60 cases (93.8%). There was no device compression, bird-beak configuration, fracture, or graft occlusion. The 30-day and 12-month clinical success rates were 97.6% and 92.9%, respectively. There were 3 aorta-related deaths at 30 days and a further 3 at 12 months. Fatalities were due to a retrograde type A dissection (0.8%), paraplegia, bowel ischemia, sepsis in the setting of a mycotic aneurysm, aneurysm rupture post aortoesophageal fistula, and multiorgan dysfunction syndrome. Three endoleaks (2 type Ia and 1 type III) required reintervention. Conclusion: In the SURPASS registry, the use of the CTAG device with ACS showed promising outcomes despite the challenging pathologies. The new delivery system enables a controlled staged delivery with in situ adjustments during positioning, facilitating the treatment of complex aortic disease.

Project description:ImportanceThere exist limited outcomes data for women and minorities after contemporary percutaneous coronary intervention (PCI).ObjectiveTo examine 1-year outcomes in women and minorities vs white men after PCI with everolimus-eluting stents.Design, settings, and participantsThe PLATINUM Diversity study was a single-arm study enrolling women and minorities. Patient-level pooling with the PROMUS Element Plus Post-Approval Study was prespecified. Data on social determinants of health and language were collected in the PLATINUM Diversity cohort, which included 1501 patients at 52 US sites. The PROMUS Element Plus Post-Approval study enrolled 2681 patients at 52 US sites with some site overlap and included an "all-comers" population. All patients were enrolled beginning in October 2014 and were followed for 12 months. Analyses began in August 2016.InterventionsPatients received 1 or more everolimus-eluting stent implantation.Main outcomes and measuresThe primary end point was 1-year major adverse cardiac events (MACE), which included death/myocardial infarction (MI)/target vessel revascularization. Secondary ischemic end points were also evaluated.ResultsThe pooled study consisted of 4182 patients: 1635 white men (39.1%), 1863 women (white and minority) (44.5%), and 1059 minority patients (women and men) (25.3%). Women and minorities had a higher prevalence of diabetes, prior stroke, hypertension, renal disease, and congestive heart failure than white men but lower rates of multivessel disease, prior coronary artery bypass graft surgery, prior MI, and smoking. Unadjusted 1-year MACE rates (white men, 7.6%; women, 8.6%; minorities, 9.6%) were similar between groups with no significant differences after risk adjustment. The adjusted risk of death/MI was higher among women (odds ratio, 1.6; 95% CI, 1.1-2.4) and minorities (odds ratio, 1.9; 95% CI, 1.2-2.8) compared with white men and the adjusted risk of MI was higher in minorities (odds ratio, 2.6; 95% CI, 1.4-4.8). These differences were driven primarily by nonstent-related MIs. Within the PLATINUM Diversity cohort, the independent predictors of MACE were cardiogenic shock, renal disease, history of peripheral vascular disease, multivessel disease, widowhood, and lack of private insurance.Conclusions and relevanceAfter contemporary everolimus-eluting stent implantation, women and minorities experience a similar risk of 1-year MACE but a higher adjusted risk of recurrent ischemic events primarily because of nonstent-related MIs. Both clinical and angiographic factors and social determinants of health, including widowhood and insurance status, contribute to 1-year MACE among women and minorities.

Project description:PurposeTo assess safety and patency of the Venovo venous stent for the treatment of iliofemoral vein obstruction.Materials and methodsTwenty-two international centers enrolled 170 patients in the VERNACULAR study (93 post-thrombotic syndrome; 77 non-thrombotic iliac vein lesions). Primary outcome measures were major adverse events at 30 days and 12-month primary patency (freedom from target vessel revascularization, thrombotic occlusion, or stenosis > 50%). Secondary outcomes included the Venous Clinical Severity Score Pain Assessment and Chronic Venous Quality-of-Life Questionnaire assessments (hypothesis tested). Secondary observations included primary patency, target vessel and lesion revascularization (TVR/TLR), and assessment of stent integrity through 36 months.ResultsFreedom from major adverse events through 30 days was 93.5%, statistically higher than a pre-specified performance goal of 89% (p = 0.032) while primary patency at 12 months was 88.6%, also statistically higher than a performance goal of 74% (p < 0.0001). Mean quality-of-life measures were statistically improved compared to baseline values at 12 months (p < 0.0001). Primary patency at 36 months was 84% (Kaplan-Meier analysis) while freedom from TVR/TLR was 88.1%. There was no stent embolization/migration, and no core laboratory assessed stent fractures reported through 36 months. Six deaths were reported; none adjudicated as device or procedure related.ConclusionThe Venovo venous stent was successfully deployed in obstructive iliofemoral vein lesions and met the pre-specified primary outcome measures through 12 months. At 3 years, primary patency was 84%, reintervention rates were low, standardized quality-of-life and pain measures improved from baseline, and there was no stent migration or fractures.Level of evidenceLevel 2-prospective, multicenter, controlled clinical study without a concurrent control or randomization. Pre-specified endpoints were hypothesis-tested to performance goals derived from peer-reviewed clinical literature. REGISTRATION CLINICALTRIALS.GOV: Unique Identifier NCT02655887.

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Three-Year Results of the Endurant Stent Graft System Post Approval Study.

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Three-Year Results of the Endurant Stent Graft System Post Approval Study.

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