Perspective:

The 4.1% risk of major bleeding is higher than might have been anticipated given the relatively specific endpoint definition. Bleeding complications such as pseudoaneurysm requiring a secondary procedure potentially would have been excluded but are undoubtedly considered major complications by patients nonetheless. These observations warrant consideration during treatment selection and counseling, especially for patients with claudication for whom PVI is not a must. When considering the observed incidence of major bleeding, it is noteworthy that it occurred within participants in a national registry and therefore may be conservative when compared to centers that are not actively engaged in similar safety and/or quality improvement initiatives. It should also be noted that this incidence reflects in-hospital bleeding only, and therefore, may be conservatively biased by omission of patients who experience bleeding complications post-discharge.

Several of the identified risk factors may have been confounders for related risk factors or transfusion cut-points. For example, preprocedure Hb <12 was associated with major bleeding, but may reflect transfusions based on absolute Hb rather than amount of blood loss or Hb decrease. A decrease in Hb from 9 to 7 g/dl would potentially prompt transfusion, while an even larger drop from 12 to 9 g/dl associated with a larger amount of bleeding might not, and only the former would be identified as major bleeding within the definitions used. Similarly, use of closure devices was a procedural factor associated with decreased bleeding risk, but was likely less common in the setting of nonfemoral access. Urgent procedures were also associated with bleeding risk, and probably had higher rates of intervention and periprocedural therapeutic anticoagulation.

In their discussions, the authors opine that a bleeding risk score specific for patients undergoing PVI might permit use of bleeding avoidance strategies (including avoidance of nonfemoral access and thrombolysis) for patients identified as high risk. Given the remarkable impact of major bleeding on in-hospital mortality observed in this registry, though, it is perhaps difficult to justify selective use of risk reduction strategies.