6 weeks after carotid artery stenting. Cardiac surgeons would rather not perform CABG in patients taking clopidogrel, so waiting 6 weeks raises the question as to the urgency of the coronary revascularization in these patients. Indeed, the authors emphasize a weakness of their retrospective review is that patients who underwent concomitant CEA/CABG required urgent surgery more commonly than those who underwent CEA followed by delayed CABG, which raises questions about conclusions from this paper.But, as I mentioned in the last review, what about the option of CABG followed by CEA? There is no convincing evidence that CEA offers a protective benefit during CABG. Not surprisingly, the authors of this article (cardiac surgeons) prefer that vascular surgeons perform CEA first to potentially decrease the perioperative stroke risk of CABG. I take the opposite viewpoint. Without a well-defined benefit of performing CEA before or concomitantly with CABG, I still recommend performing CABG first unless a stenotic carotid artery is symptomatic or a patient has bilateral greater than 80% internal carotid artery stenoses. I await a plethora of emails disagreeing with me (especially from cardiac surgeons).
In this interim report, the nitinol retrievable IVC filter provided protection against pulmonary embolism, and the device could be retrieved with a low rate of complications.
Purpose
To assess safety and patency of the Venovo venous stent for the treatment of iliofemoral vein obstruction.
Materials and Methods
Twenty-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.
Results
Freedom 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.
Conclusion
The 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 Evidence
Level 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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