Table 3.
Occurrence of adverse events
| Safety endpoints (patients at risk) | PP (72) | 3 M (71) | 6 M (71) | 1Y (71) | 2Y (67) | 3Y (55) | 4Y (36) | 5Y (30) | Cumulative | Incidence rate (cases per 1,000 person-years) |
|---|---|---|---|---|---|---|---|---|---|---|
| Major vascular complication | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 3.9 |
| Post-procedural hypotension | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 3.9 |
| Renal atrophy | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 3.9 |
| Stroke | 0 | 0 | 1 | 2 | 5 | 2 | 0 | 0 | 10 | 38.6 |
| Myocardial infarction | 0 | 0 | 1 | 1 | 1 | 1 | 0 | 0 | 4 | 15.4 |
| Coronary revascularization | 0 | 1 | 1 | 2 | 1 | 1 | 1 | 1 | 8 | 30.9 |
| Hospitalization for hypertensive emergency | 0 | 2 | 1 | 2 | 0 | 0 | 0 | 0 | 5 | 19.3 |
| Newly acquired renal artery stenosis and/or repeat renal artery intervention | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 7.7 |
| Renal failure | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 2 | 7.7 |
| All-cause mortality | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 0 | 3 | 11.6 |
| Cardiovascular mortality | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 0 | 3 | 11.6 |
PP periprocedural, M months, Y years. Total number of observed person-years = 259