Using administrative claims to assess trial outcomes reproduced the noninferiority of TAVR compared to SAVR for primary endpoints (P<0.001 for noninferiority).
RCT (n=1,605)
Yes
Does the use of administrative claims data reproduce the treatment effect of TAVR versus SAVR compared to trial-adjudicated outcomes in adults ≥65 years of age?
Administrative claims data can validly reproduce the treatment effect for all-cause mortality and procedural outcomes in TAVR trials, but may be less suitable for nonfatal and nonprocedural secondary outcomes.
Hazard Ratio: 1.02 (95% CI 0.73–1.41)
Absolute Event Rate: 11.3% vs 12.5%
p-value: p=0.58
Background: Whether passively collected data can substitute for adjudicated outcomes to reproduce the magnitude and direction of treatment effect observed in cardiovascular clinical trials is not well known. Methods: We linked adults ≥65 years of age in the HiR (US CoreValve Pivotal High Risk) and SURTAVI trials (Surgical or Transcatheter Aortic Valve Replacement in Intermediate-Risk Patients) to 100% Medicare inpatient claims, January 1, 2011, to December 31, 2016. Primary (eg, death and stroke) and secondary trial end points were compared across treatment arms (eg, transcatheter aortic valve replacement TAVR versus surgical aortic valve replacement SAVR) using trial-adjudicated outcomes versus outcomes derived from claims at 1 year (HiR) or 2 years (SURTAVI). Results: Among 600 linked HiR participants (linkage rate, 80.0%), the rate of the trial’s primary end point of all-cause mortality occurred in 13.7% of patients receiving TAVR and 16.4% of patients receiving SAVR at 1 year by using both trial data (hazard ratio, 0.84 95% CI, 0.65–1.09; P =0.33) and claims data (hazard ratio, 0.86 95% CI, 0.66–1.11; P =0.34; interaction P value=0.80). Noninferiority of TAVR relative to SAVR was seen by using both trial- and claims-based outcomes ( P noninferiority <0.001 for both). Among 1005 linked SURTAVI trial participants (linkage rate, 60.5%), the trial’s primary end point was 12.9% for TAVR and 13.1% for SAVR using trial data (hazard ratio, 1.08 95% CI, 0.79–1.48; P =0.90), and 11.3% for TAVR and 12.5% for SAVR patients using claims data (hazard ratio, 1.02 95% CI, 0.73–1.41; P =0.58; interaction P value=0.89). TAVR was noninferior to SAVR when compared using both trial and claims ( P non inferiority <0.001 for both). Rates of procedural secondary outcomes (eg, aortic valve reintervention, pacemaker rates) were more closely concordant between trial and claims data than nonprocedural outcomes (eg, stroke, bleeding, cardiogenic shock). Conclusions: In the HiR and SURTAVI trials, ascertainment of trial primary end points using claims reproduced both the magnitude and direction of treatment effect in comparison with adjudicated event data, but nonfatal and nonprocedural secondary outcomes were not as well reproduced. Use of claims to substitute for adjudicated outcomes in traditional trial treatment comparisons may be valid and feasible for all-cause mortality and certain procedural outcomes but may be less suitable for other end points.
Strom et al. (Thu,) conducted a rct in Aortic valve disease (n=1,605). Transcatheter aortic valve replacement (TAVR) vs. Surgical aortic valve replacement (SAVR) was evaluated on Primary end point (death and stroke) at 2 years (SURTAVI claims data) (HR 1.02, 95% CI 0.73-1.41, p=0.58). Using administrative claims to assess trial outcomes reproduced the noninferiority of TAVR compared to SAVR for primary endpoints (P<0.001 for noninferiority).