- Email: [email protected]
Su1467 Compliance With High-Dose Acid Suppression Does Not Appreciably Alter the Efficacy or Safety of Radiofrequency Ablation (RFA) in Barrett's Esophagus (BE): Results From the U.S. RFA Registry
Abstracts
Su1467 Compliance With High-Dose Acid Suppression Does Not Appreciably Alter the Efficacy or Safety of Radiofrequency Ablation (RFA) in Barrett’s Esophagus (BE): Results From the U.S. RFA Registry Ryan D. Madanick*1, William J. Bulsiewicz1, Herbert C. Wolfsen2, Charles J. Lightdale3, William D. Lyday4, George Triadafilopoulos5, Evan S. Dellon1, Richard I. Rothstein6, Nicholas J. Shaheen1 1 University of North Carolina School of Medicine, Chapel Hill, NC; 2 Mayo Clinic Florida, Jacksonville, FL; 3Columbia University School of Medicine, New York, NY; 4Atlanta Gastroenterology Associates, Atlanta, GA; 5Stanford University School of Medicine, Palo Alto, CA; 6 Dartmouth University School of Medicine, Hanover, NH Background/Aim: Radiofrequency ablation (RFA) for Barrett’s esophagus (BE) requires adequate esophageal acid control to permit the growth of neosquamous epithelium. Currently patients are placed on high-doses of PPI (twice daily) during and after RFA treatment. However the effect of nonadherence to this regimen is unknown. The aim of this study was to assess the relationship between adherence to PPI and the efficacy and safety of RFA in BE in a nationwide registry. Methods: The U.S. RFA Registry is a prospective study of patients with BE treated with RFA at 148 institutions. Information collected includes demographic data, histology prior to treatment, endoscopic findings, date and number of treatment sessions, ablation outcomes, and complications. Self-reported PPI compliance with a regimen of twice daily PPI was assessed at each visit before therapy was given. Analysis was performed comparing those compliant at all visits to those partially or non-compliant. Our safety cohort consisted of all patients treated with RFA, while our efficacy cohort was restricted to subjects who had a biopsy performed 12 months or more after initial treatment. We compared safety and efficacy outcomes among those who were PPI compliant versus those partially/non-compliant using parametric tests for statistical comparisons. Safety outcomes included rates of stricture, GI bleeding, and hospitalization. Efficacy outcomes included complete eradication of intestinal metaplasia (CEIM), complete eradication of dysplasia (CED), and the number of treatment sessions to CEIM. Results: Among 5530 treated with RFA, 4580 (82%) were PPI compliant at all visits while 950 (17%) were partially (n⫽930) or noncompliant (n⫽20). There were no deaths. Rates of stricture (2.4% if compliant, 3.0% if partially or non-compliant), GI bleeding (0.4% if compliant, 0.5% if partially or non-compliant), and hospitalization (1.7% if compliant, 1.7% if partially or non-compliant) were similar regardless of PPI adherence (p⬎0.05). 2936 patients (53%) had a biopsy performed 12 months or more after treatment and were included in the efficacy analysis, including 2546 (81%) who were PPI compliant and 590 (19%) who were partially or non-compliant. The rates of CED (90%) were similar regardless of PPI adherence, however there was a trend toward higher rates of CEIM if PPI compliant (75% vs 71%, p⫽0.06). The mean number of treatments necessary to achieve CEIM was greater in patients who were PPI compliant (2.8) compared to those partially or non-compliant (2.6) (p⫽0.03). Conclusions: In a large, nationwide registry, most patients were compliant with a high dose (twice daily) PPI regimen. Among the over 700 patients who were not fully compliant, poor adherence to a high dose acid suppression regimen did not significantly alter the risk of complications or the likelihood of successful eradication of BE.
Safety analysis N Stricture GI bleed Perforation Hospitalization Efficacy analysis N CED CEIM RFA treatment sessions, mean⫾SD
www.giejournal.org
PPI Compliant
Non- or Partially Compliant
p-value
4580 2.4% (109) 0.4% (18) 0.04% (2) 1.7% (79)
950 3.0% (28) 0.5% (5) 0 1.7% (16)
0.31 0.56 0.52 0.93
2389 90% (1058/1182) 75% (1787) 2.8 ⫾ 1.5
388 90% (225/250) 71% (388) 2.6 ⫾ 1.6
0.82 0.06 0.03
Su1468 Time to Complete Remission of Intestinal Metaplasia After Radiofrequency Ablation in Patients With Barrett’s Esophagus Bashar J. Qumseya*1, Edgar C. Aranda-Michel1, Marta Mccrum2, Yan Dong2, Wassem J. David1, Lois L. Hemminger1, Timothy A. Woodward1, Michael B. Wallace1, Herbert C. Wolfsen1 1 Gastroenterology, Mayo Clinic- Florida, Jacksonville, FL; 2Harvard School of Public Health, Boston, MA Background: Among the available ablative modalities, radiofrequency ablation (RFA) is the most commonly used for treatment of Barrett’s esophagus (BE). Several studies have assessed the usefulness of RFA in achieving complete remission from intestinal metaplasia (CRIM). Few studies have assessed the time needed to achieve CRIM and possible predictors for this time. Aims: To assess the effect of BE length on the time to achieve CRIM in patients with BE who underwent RFA and to identify additional patient characteristics that may be associated with time to achieve CRIM. Methods: This was a retrospective, observational study using large RFA database in a tertiary referral center. The primary outcome was time to CRIM compared between short- (⬍ 3cm, SSBE) and long-segment BE (⬎ 3cm, LSBE). Candidate predictor variables included patient age, sex, race, smoking history, use of endoscopic mucosal resection (EMR), and histology of initial biopsy before RFA. Time to CRIM (in months) was calculated using the Kaplan-Meier method, stratifying for category of BE length, and comparing differences using the log-rank test. Multivariable cox-proportional hazard model was used with backwards selection method to assess the association between CRIM and predictor variables. Proportional hazards assumption was tested by calculating Martingale residuals for the variables included in the final model. Results: 265 patients underwent RFA for BE between May 2005 and June 2012. Baseline patient characteristics are reported in Table 1. The two groups (SSBE vs. LSBE) were similar with respect to age, sex, and race. Of patients who reached CRIM, patients with LSBE were more likely than those with SSBE to require 4 or more RFA treatments (p⬍0.001) (Fig. 1). The median time to CRIM for all patients was 12.7 months [95% CI: 10.5-16.2] for LSBE and 12.8 months [95% CI: 8.1-15] for SSBE (Fig. 2). The Log Rank 2 statistic for the difference in time to CRIM was 2.65, with p⫽ 0.10. Survival curves for study population stratified by BE segment length are presented in Figure 2. When controlling for age, sex, EMR, and pathology before RFA, LSBE is associated with a 25% decrease in rate of CRIM compared to patients with SSBE, HR ⫽ 0.75 [95% CI: 0.56 -0.99], p⫽0.048. An increase in age by one year is associated with a 2% decrease in the rate of CRIM, HR⫽0.98 [95% CI: 0.960.99], p⫽0.005. Conclusion: In patients undergoing radiofrequency ablation for Barrett’s Esophagus, length of BE segment greater than 3cm appears to be associated with a 25% decrease in the rate of complete remission of intestinal metaplasia, which indicates that these patients take longer to reach resolution. Increasing age was also significantly associated with decreased rate of CRIM. Our findings demonstrate that age and length of BE segment are important prognostic factors for RFA therapy outcome.
Volume 77, No. 5S : 2013
GASTROINTESTINAL ENDOSCOPY
AB335
Su1467 Compliance With High-Dose Acid Suppression Does Not Appreciably Alter the Efficacy or Safety of Radiofrequency Ablation (RFA) in Barrett’s Esophagus (BE): Results From the U.S. RFA Registry Ryan D. Madanick*1, William J. Bulsiewicz1, Herbert C. Wolfsen2, Charles J. Lightdale3, William D. Lyday4, George Triadafilopoulos5, Evan S. Dellon1, Richard I. Rothstein6, Nicholas J. Shaheen1 1 University of North Carolina School of Medicine, Chapel Hill, NC; 2 Mayo Clinic Florida, Jacksonville, FL; 3Columbia University School of Medicine, New York, NY; 4Atlanta Gastroenterology Associates, Atlanta, GA; 5Stanford University School of Medicine, Palo Alto, CA; 6 Dartmouth University School of Medicine, Hanover, NH Background/Aim: Radiofrequency ablation (RFA) for Barrett’s esophagus (BE) requires adequate esophageal acid control to permit the growth of neosquamous epithelium. Currently patients are placed on high-doses of PPI (twice daily) during and after RFA treatment. However the effect of nonadherence to this regimen is unknown. The aim of this study was to assess the relationship between adherence to PPI and the efficacy and safety of RFA in BE in a nationwide registry. Methods: The U.S. RFA Registry is a prospective study of patients with BE treated with RFA at 148 institutions. Information collected includes demographic data, histology prior to treatment, endoscopic findings, date and number of treatment sessions, ablation outcomes, and complications. Self-reported PPI compliance with a regimen of twice daily PPI was assessed at each visit before therapy was given. Analysis was performed comparing those compliant at all visits to those partially or non-compliant. Our safety cohort consisted of all patients treated with RFA, while our efficacy cohort was restricted to subjects who had a biopsy performed 12 months or more after initial treatment. We compared safety and efficacy outcomes among those who were PPI compliant versus those partially/non-compliant using parametric tests for statistical comparisons. Safety outcomes included rates of stricture, GI bleeding, and hospitalization. Efficacy outcomes included complete eradication of intestinal metaplasia (CEIM), complete eradication of dysplasia (CED), and the number of treatment sessions to CEIM. Results: Among 5530 treated with RFA, 4580 (82%) were PPI compliant at all visits while 950 (17%) were partially (n⫽930) or noncompliant (n⫽20). There were no deaths. Rates of stricture (2.4% if compliant, 3.0% if partially or non-compliant), GI bleeding (0.4% if compliant, 0.5% if partially or non-compliant), and hospitalization (1.7% if compliant, 1.7% if partially or non-compliant) were similar regardless of PPI adherence (p⬎0.05). 2936 patients (53%) had a biopsy performed 12 months or more after treatment and were included in the efficacy analysis, including 2546 (81%) who were PPI compliant and 590 (19%) who were partially or non-compliant. The rates of CED (90%) were similar regardless of PPI adherence, however there was a trend toward higher rates of CEIM if PPI compliant (75% vs 71%, p⫽0.06). The mean number of treatments necessary to achieve CEIM was greater in patients who were PPI compliant (2.8) compared to those partially or non-compliant (2.6) (p⫽0.03). Conclusions: In a large, nationwide registry, most patients were compliant with a high dose (twice daily) PPI regimen. Among the over 700 patients who were not fully compliant, poor adherence to a high dose acid suppression regimen did not significantly alter the risk of complications or the likelihood of successful eradication of BE.
Safety analysis N Stricture GI bleed Perforation Hospitalization Efficacy analysis N CED CEIM RFA treatment sessions, mean⫾SD
www.giejournal.org
PPI Compliant
Non- or Partially Compliant
p-value
4580 2.4% (109) 0.4% (18) 0.04% (2) 1.7% (79)
950 3.0% (28) 0.5% (5) 0 1.7% (16)
0.31 0.56 0.52 0.93
2389 90% (1058/1182) 75% (1787) 2.8 ⫾ 1.5
388 90% (225/250) 71% (388) 2.6 ⫾ 1.6
0.82 0.06 0.03
Su1468 Time to Complete Remission of Intestinal Metaplasia After Radiofrequency Ablation in Patients With Barrett’s Esophagus Bashar J. Qumseya*1, Edgar C. Aranda-Michel1, Marta Mccrum2, Yan Dong2, Wassem J. David1, Lois L. Hemminger1, Timothy A. Woodward1, Michael B. Wallace1, Herbert C. Wolfsen1 1 Gastroenterology, Mayo Clinic- Florida, Jacksonville, FL; 2Harvard School of Public Health, Boston, MA Background: Among the available ablative modalities, radiofrequency ablation (RFA) is the most commonly used for treatment of Barrett’s esophagus (BE). Several studies have assessed the usefulness of RFA in achieving complete remission from intestinal metaplasia (CRIM). Few studies have assessed the time needed to achieve CRIM and possible predictors for this time. Aims: To assess the effect of BE length on the time to achieve CRIM in patients with BE who underwent RFA and to identify additional patient characteristics that may be associated with time to achieve CRIM. Methods: This was a retrospective, observational study using large RFA database in a tertiary referral center. The primary outcome was time to CRIM compared between short- (⬍ 3cm, SSBE) and long-segment BE (⬎ 3cm, LSBE). Candidate predictor variables included patient age, sex, race, smoking history, use of endoscopic mucosal resection (EMR), and histology of initial biopsy before RFA. Time to CRIM (in months) was calculated using the Kaplan-Meier method, stratifying for category of BE length, and comparing differences using the log-rank test. Multivariable cox-proportional hazard model was used with backwards selection method to assess the association between CRIM and predictor variables. Proportional hazards assumption was tested by calculating Martingale residuals for the variables included in the final model. Results: 265 patients underwent RFA for BE between May 2005 and June 2012. Baseline patient characteristics are reported in Table 1. The two groups (SSBE vs. LSBE) were similar with respect to age, sex, and race. Of patients who reached CRIM, patients with LSBE were more likely than those with SSBE to require 4 or more RFA treatments (p⬍0.001) (Fig. 1). The median time to CRIM for all patients was 12.7 months [95% CI: 10.5-16.2] for LSBE and 12.8 months [95% CI: 8.1-15] for SSBE (Fig. 2). The Log Rank 2 statistic for the difference in time to CRIM was 2.65, with p⫽ 0.10. Survival curves for study population stratified by BE segment length are presented in Figure 2. When controlling for age, sex, EMR, and pathology before RFA, LSBE is associated with a 25% decrease in rate of CRIM compared to patients with SSBE, HR ⫽ 0.75 [95% CI: 0.56 -0.99], p⫽0.048. An increase in age by one year is associated with a 2% decrease in the rate of CRIM, HR⫽0.98 [95% CI: 0.960.99], p⫽0.005. Conclusion: In patients undergoing radiofrequency ablation for Barrett’s Esophagus, length of BE segment greater than 3cm appears to be associated with a 25% decrease in the rate of complete remission of intestinal metaplasia, which indicates that these patients take longer to reach resolution. Increasing age was also significantly associated with decreased rate of CRIM. Our findings demonstrate that age and length of BE segment are important prognostic factors for RFA therapy outcome.
Volume 77, No. 5S : 2013
GASTROINTESTINAL ENDOSCOPY
AB335