Table 2.
Embolic Protection Devices: Summary of safety monitoring results.
| FilterWire | SpiderWire | |||||
|---|---|---|---|---|---|---|
|
| ||||||
| Device Type | Embolic protection device | Embolic protection device | ||||
| Manufacturer | Boston Scientific | ev3Inc | ||||
| Surveillance dates | 1/1/2008–12/31/2012 | 1/1/2008–12/31/2012 | ||||
| Total device exposure cases | 350 | 452 | ||||
| Number of quarterly analyses | 20 | 20 | ||||
| Mean exposures per study period (Quarter) | 18 | 23 | ||||
| Comparator group | Alternative embolic protection device, not Filterwire | Alternative embolic protection device, not Spiderwire | ||||
| Number of cases matched | 328 | 352 | ||||
| Proportion of cases matched | 93.7% | 77.9% | ||||
|
| ||||||
| Outcomes monitored | In Hospital Death | Post procedure myocardial infarction (MI) | Major adverse cardiac events (MACE) | In Hospital Death | Post procedure myocardial infarction (MI) | Major adverse cardiac events (MACE) |
|
| ||||||
| Observed Event Rate % (within propensity matched cohort) |
2.13% | 4.88% | 6.40% | 0.57% | 4.83% | 5.40% |
| Relative risk (95% CI) | 2.33 (0.61–8.95) | 1.00 (0.51–1.97) | 1.00 (0.56–1.80) | 0.25 (0.05–1.17) | 0.89 (.47–1.69) | 0.73 (0.41–1.30) |
| Safety Alerts Triggered | None | None | None | None | None | None |
| Time to first safety alert | NAa | NAa | NAa | NAa | NAa | NAa |
Abbreviations: CI, Confidence Interval
a
No repeated or sustained safety signal generated during the study