Using Registry Data to Fill Blind Spots From Randomized Trials of Abdominal Aortic Aneurysm Repair

Abstract

The study by Yei and coauthors 1 describes 6-year results of abdominal aortic aneurysm (AAA) repair performed via open aneurysm repair (OAR) vs endovascular aneurysm repair (EVAR) using the Vascular Quality Initiative (VQI) Vascular Implant Surveillance and Interventional Outcomes Network (VISION) registry, a multicenter registry that collects granular clinical data on the patients and procedures and links it with Medicare claims for long-term follow up. Among a cohort of more than 32 000 patients, Yei et al 1 determined that despite an increased perioperative mortality associated with OAR compared with EVAR, patients treated with OAR experienced superior long-term outcomes. Specifically, patients who underwent OAR, compared with propensity score-matched patients who underwent EVAR, had decreased 6-year mortality (548 deaths [35.6%] vs 608 deaths [41.2%]; hazard ratio [HR], 0.83; 95% CI, 0.74-0.94; P = .002), were less likely to experience late AAA rupture after their index repair (117 participants [5.8%] vs 149 participants [8.3%]; HR, 0.76; 95% CI, 0.60-0.97; P < .001), and were less likely to require reinterventions (additional procedures after the initial repair to treat their AAA) (190 participants [11.6%] vs 267 participants [16.0%]; HR, 0.67; 95% CI, 0.55-0.80; P < .001). These important findings highlight the need for studying both clinical results after AAA repair and long-term surveillance among patients who undergo EVAR.AAAs remain 1 of the most commonly treated vascular diseases in the United States and around the world. If untreated, aneurysm rupture confers a near-certain risk of mortality. Accordingly, surgical repair is performed to prevent this event in patients who are candidates for surgery.Currently, 2 primary repair options exist: OAR, in which a patient undergoes direct surgical reconstruction of the aorta via a laparotomy or a retroperitoneal incision, and the less invasive EVAR, in which the aorta is lined with stent-grafts to exclude the aneurysm sac from systemic pressurized perfusion. Randomized trials comparing these surgical techniques among patients who were candidates for either procedure have documented increased perioperative mortality for patients who underwent OAR, but no difference in the long-term risk of mortality were reported. 2 As such, EVAR has been rapidly adopted since its inception in the 1990s and currently represents 3 of every 4 AAA repairs performed in the United States. 3 However, patients who are included in randomized trials do not always reflect patients treated in clinical practice, where significant comorbidities and unfavorable anatomy are common. In these settings, many patients who may not be ideal physiologic candidates for conventional OAR may be offered EVAR. Likewise, some patients may undergo EVAR outside the anatomic instructions for use criteria for that device. In both instances, these patients would not be eligible for inclusion in most randomized trials. Therefore, current seminal results documented from earlier randomized trials of AAA repai...