Efficacy And Safety Of The Adjustable Gastric Band - Pooled Interim Analysis Of The Apex And Hero Studies At 48 Weeks

Objective:This 48 week combined analysis reports safety and clinical effectiveness of the LAP-BAND AP* laparoscopic adjustable gastric band (LAGB) in severely obese patients enrolled in the 5 year, prospective, observational, open-label APEX (NCT00501085) and HERO (NCT00953173) studies.Methods:The studies enrolled 1620 patients (APEX: N = 514; HERO: N = 1106), 1140 patients in the US (including all APEX patients), and 480 patients in the European Union (EU), Canada or Australia. APEX and HERO are non-randomized, non-comparator, open-label studies with differences in study management practices and follow-up. Notably, laboratory data were not collected during the APEX study.Results:After 48 weeks, mean (SD) percentage weight loss (%WL) was for APEX: 18.7% (7.9); HERO-US: 17.9% (8.5); HERO-EU: 16.5% (10.3); HERO-Canada: 13.4% (8.9); and HERO-Australia: 12.3% (6.9). After 48 weeks, there were no significant differences in %WL for APEX vs. HERO-US. After 48 weeks in the combined analysis (APEX_HERO): (1) patients without vs. with type 2 diabetes at baseline had greater % WL (18% [8.7] vs. 16% [8.5], P = 0.002); (2) female patients had greater % WL vs. male patients (17.9% [8.5] vs. 15.9% [9.3], P = 0.003); (3) younger patients had greater %WL vs. older patients (<50 years: 17.8% [8.7] vs. >= 50 years: 16.7% [8.6], P = 0.035); (4) baseline BMI did not affect % WL (<= 35 to <45 kg/m(2) : 17.7% [8.4] vs. 445 kg/m(2) : 17.1% [9.1], P = 0.272). Device-related serious adverse events and adverse events were reported in 1.9% and 17.7% of patients, respectively. Revision and explantation surgeries were carried out on 3.4% and 2.3% of patients, respectively during the 48 weeks of follow-up.Conclusions:This analysis demonstrates the effective weight loss and safety profile of the current LAGB system, with US patients achieving better weight loss than patients from outside the US.