Table 2.
Sensitivity Analyses
| Lost to Follow-up/Withdrawn | |||
|---|---|---|---|
| Models | Effect* (95% CI) | Paclitaxel | Control |
| VIVA original analyses | 23% | 24% | |
| Primary, intent-to-treat | 1.38 (1.06, 1.80) | ||
| As treated, unadjusted | 1.36 (1.04, 1.78) | ||
| As treated, adjusted | 1.37 (1.04, 1.80) | ||
| Censoring at control crossover to paclitaxel | 1.31 (1.00, 1.72) | ||
| Missing data sensitivity / weighted analysis | 1.36 (1.05, 1.77) | ||
| Fixed effect two-stage meta-analysis | 1.36 (1.05, 1.77) | ||
| Random effects two-stage meta-analysis | 1.34 (1.01, 1.78) | ||
| DCB only devices | 1.25 (0.92, 1.69) | ||
| Zilver PTX 2nd randomization instead of primary | 1.19 (0.89, 1.60) | ||
| Additional analyses | |||
| JAHA original, December 2018 (RR) | 1.93 (1.27, 2.93) | NR | NR |
| JAHA update, May 2019 (RR) | 1.62 (1.20, 2.17) | NR | NR |
| FDA, as treated (RR) | 1.72 (1.22, 2.38) | 24% | 24% |
| VIVA, additional follow-up #1 (Late May 2019) | 1.30 (1.03, 1.63) | 15% | 16% |
| VIVA, additional follow-up #2 (August 2019) | 1.27 (1.03, 1.58) | 9% | 10% |
*
Estimate is hazard ratio (HR) unless indicated otherwise
CI: Confidence interval; DCB: Drug-coated balloon; PTX: Paclitaxel; JAHA: Journal of the American Heart Association; RR: Relative Risk; NR: Not reported
JAHA/FDA analyses are based only on studies with 4–5 years of follow-up; VIVA analyses are based on survival analysis methods incorporating all available follow-up. Data for the FDA analysis and VIVA primary analysis were provided to the FDA in advance of the Circulatory Systems Advisory Panel meeting. The additional follow-up data sets in the VIVA analysis were based on additional follow-up for vital status that was provided by manufacturers.