P1948 - Combination Therapy Yields Similar Efficacy and Improved Safety Compared to Surgical Revision for the Management of Weight Regain Following Roux-en-Y Gastric Bypass

Award: Outstanding Research Award in the Obesity Category
Award: Presidential Poster Award

Award: Outstanding Research Award in the Obesity Category

Award: Presidential Poster Award

Pichamol Jirapinyo, MD, MPH¹, Joyce C. Zhou, ², Christopher C. Thompson, MD, MSc, FACG^1
1Brigham & Women's Hospital, Boston, MA; ²Harvard Medical School, Boston, MA

Introduction: Traditionally, weight regain after Roux-en-Y gastric bypass (RYGB) was treated with surgical revision of gastrojejunal anastomosis (GJA). Recently, transoral outlet reduction (TORe) and pharmacotherapy have emerged as less invasive alternatives. While the efficacy of TORe and pharmacotherapy have been established, the effect of combination therapy and how it compares to surgery are unknown.

Methods: This was a retrospective study of RYGB patients with weight regain who underwent TORe, pharmacotherapy, combination therapy or surgical revision of GJA. Combination therapy was defined as initiation of at least one weight loss medication within 6 months prior to or after TORe. TORe was performed using a Food and Drug Administration (FDA)-cleared endoscopic suturing or plication device to reduce GJA and/or pouch size. Part I: (1) Percent total weight loss (TWL) at 6 and 12 months from initiation of the first therapy (a weight loss medication or TORe) for patients who underwent combination therapy and (2) Proportion of combination therapy patients with clinically significant weight loss (TWL≥5%). Part II: Comparison of the efficacy and safety of combination therapy to that of pharmacotherapy alone, TORe alone and surgical revision of GJA.

Results: 100 consecutive RYGB patients underwent combination therapy for weight regain (Table 1). Of these, 47% and 53% were started on weight loss medication prior to and after TORe, respectively, with the duration between initiation of the two therapies being 4±2 months. Prescribed medications were topiramate (34%), phentermine/topiramate (32%), phentermine (15%), liraglutide (14), bupropion/naltrexone (6%) and lorcaserin (1%). Part I: At 6 and 12 months, patients experienced 11.2±5.8% and 16.2±6.7% TWL, respectively. The proportion of patients who achieved clinically significant weight loss at 6 and 12 months were 87% and 97%, respectively. Part II: Compared to other approaches, combination therapy was associated with greater weight loss than pharmacotherapy alone (16.2±6.7% vs 6.8±8.2% TWL, p< 0.001) or TORe alone (16.2±6.7% vs 8.7±8.1% TWL, p< 0.001), with a similar serious adverse event (SAE) rate (4% vs 6.6% vs 2.6%, p=0.08). Combination therapy yielded similar weight loss to surgical revision (16.2±6.7% vs 16.4±13.1% TWL, p=0.90), with a lower SAE rate (4% vs 18.2%, p=0.002) (Figure 1).

Discussion: Combination of TORe with pharmacotherapy is superior to either therapy alone and provides similar efficacy to surgical revision with a better safety profile.


Figure: Figure 1. Efficacy and safety of combination therapy of TORe and pharmacotherapy in comparison to pharmacotherapy alone, TORe alone and surgical revision of GJA for the treatment of weight regain. Figure 1A: Percent total weight loss at 12 months. Figure 1B: Serious adverse event rates. Pharm: pharmacotherapy, TORe: transoral outlet reduction, TWL: total weight loss, AEs: adverse events.

	TORe + Pharmacotherapy (n = 100)	Pharmacotherapy Alone (n = 211)	TORe Alone (n = 304)	Surgical Revision of GJA (n = 77)
Demographics
Age (years)	49 ± 11	47 ± 10	50 ± 11	50 ± 9
Sex (female, %)	90	91	86	70
BMI (kg/m2)	40.2 ± 8.0	38.7 ± 8.0	39.2 ± 8.4	42.6 ± 10.8
Amount of weight regain (% of maximal lost weight)	62.3 ± 65.7	44.8 ± 28.2	51.0 ± 44.4	53.6 ± 29.3
Efficacy and Safety
TWL at 12 months (%)	16.2 ± 6.7	6.8 ± 8.2	8.7 ± 8.1	16.4 ± 13.1
≥5% TWL at 12 months (%)	96.6	63.0	66.3	80.6
Serious adverse events (%)	4 - GJA stenosis (3) - Pneumonia	6.6 - CNS effects (10) - Blurry vision (2) - GI bleeding (2)	2.6 - GJA stenosis (7) - GI bleeding	18.2 - Leak (3) - Infected wound (3) - GJA stenosis (2) - Subcutaneous emphysema - Pleural effusion - Pancreatitis - Pulmonary embolism - Pneumonia - SBO

Table: Table 1. Patient demographics, efficacy and safety profile of combination therapy, pharmacotherapy alone, TORe alone and surgical revision of GJA for the treatment of weight regain. TORe: transoral outlet reduction, GJA: gastrojejunal anastomosis, BMI: body mass index: TWL: total weight loss, CNS: central nervous system, SBO: small bowel obstruction.


Disclosures:
Pichamol Jirapinyo: Apollo Endosurgery – Grant/Research Support. Endogastric Solutions – Consultant. Fractyl – Grant/Research Support. GI Dynamics – Consultant, Grant/Research Support.
Joyce Zhou indicated no relevant financial relationships.
Christopher Thompson: Apollo Endosurgery – Consultant, Grant/Research Support. BlueFlame Healthcare – Other Financial or Material Support, Venture Fund/General Partner. Boston Scientific – Consultant, Grant/Research Support. Covidien/Medtronic – Consultant. Enterasense Ltd – Advisory Committee/Board Member, Consultant. EnVision Endoscopy – Advisory Committee/Board Member, Stockholder/Ownership Interest (excluding diversified mutual funds). ERBE – Grant/Research Support. Fractyl – Advisory Committee/Board Member, Consultant. Fujifilm – Grant/Research Support. GI Dynamics – Consultant, Grant/Research Support. GI Windows – Consultant, Stockholder/Ownership Interest (excluding diversified mutual funds). Lumendi – Consultant, Grant/Research Support. Olympus/Spiration – Consultant, Grant/Research Support. USGI Medical – Advisory Committee/Board Member, Consultant, Grant/Research Support.


Pichamol Jirapinyo, MD, MPH¹, Joyce C. Zhou, ², Christopher C. Thompson, MD, MSc, FACG¹. P1948 - Combination Therapy Yields Similar Efficacy and Improved Safety Compared to Surgical Revision for the Management of Weight Regain Following Roux-en-Y Gastric Bypass, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.