Access-site complication rates
| Trial | Non-Major AEs | Serious AEs | TAEs |
|---|---|---|---|
| SWIFTa | NA | 4/144 (2.78%) | NA |
| ESCAPEb | 12/165 (7.27%) | 2/165 (1.21%) | 14/165 (8.48%) |
| REVASCATc | NA | NA | 12/103 (11.65%) |
| EXTEND-IAd | NA | 1/35 (2.86%) | NA |
| DAWNe | NA | 1/107 (0.93%) | NA |
| MR RESCUEf | NA | 0/64 (0%) | NA |
| THRACEg | NA | 3/145 (2.07%) | NA |
Note:—NA indicates not applicable; AE, adverse event; TAE, total adverse event.
↵a No AE reported. Table 1 reports 4 groin complications; Table 5 reports 9 major adverse events at the access site.
↵b Serious adverse events resulted in death, prolonged hospital stays, re-admission, or were severe or life-threatening. All minor events consisted of femoral hematomas.
↵c TAEs are not stratified on the basis of whether they were AEs or major adverse events.
↵d No AE reported. A major adverse event was a groin hematoma requiring transfusion.
↵e No AE reported. A major adverse event was a vessel puncture-site hemorrhage requiring intervention.
↵f No AE reported. A major adverse event consisted of 1 vessel dissection, though the vessel was not specified. There were no groin hematomas requiring intervention.
↵g No AE reported. Dissections and arterial perforations do not indicate a vessel.