Table 2

Primary outcome for the different analyses at 1, 2 and 5 years of follow-up, according to treatment

Number1 year2 years5 yearsp Value
OutcomeLHMPDLHMPDLHMPDLHMPD
Treatment success—mean % (95% CI)
Main analysis
 Full analysis set1059694 (87 to 97)90 (82 to 95)89 (81 to 94)86 (77 to 92)84 (84 to 90)82 (73 to 89)0.92
  <40423895 (80 to 99)83 (66 to 92)89 (73 to 96)77 (59 to 88)80 (63 to 90)66 (46 to 80)0.3
  ≥40635893 (83 to 97)94 (84 to 98)88 (77 to 94)92 (81 to 97)87 (75 to 93)92 (81 to 97)0.2
 Per protocol set1078594 (87 to 97)95 (87 to 98)89 (81 to 94)94 (86 to 97)84 (75 to 90)91 (82 to 86)0.08
  <40423195 (81 to 99)90 (72 to 97)89 (74 to 96)86 (67 to 95)81 (64 to 90)77 (55 to 89)0.89
  ≥40655493 (83 to 97)98 (87 to 100)88 (77 to 94)98 (87 to 100)87 (75 to 93)98 (87 to 100)0.01
Best-case scenario analysis
 Full analysis set1059694 (88 to 97)96 (90 to 99)89 (81 to 94)95 (89 to 98)84 (76 to 91)92 (85 to 96)0.02
 Per protocol set1078594 (88 to 98)95 (89 to 98)89 (82 to 94)94 (87 to 98)84 (76 to 91)91 (83 to 96)0.06
Worst-case scenario analysis
 Full analysis set1059694 (87 to 97)86 (77 to 98)89 (81 to 94)83 (73 to 89)84 (75 to 90)78 (68 to 85)0.47
  Per protocol set1078594 (97 to 97)91 (82 to 95)89 (81 to 94)89 (80 to 94)84 (76 to 90)85 (75 to 91)0.52
  • Best-case scenario analysis: in the PD group, perforations and refusals were considered as competing risks.

  • Worst-case scenario analysis: in the PD group, perforations and refusals were considered as failures.

  • LHM, laparoscopic Heller myotomy; PD, pneumodilation.