The Peripheral Arterial Bleeding (PAB) classification: a novel classification for safety reporting in peripheral arterial disease - an international Delphi consensus study.

OBJECTIVE: Multiple bleeding classifications are used to classify major bleeding in patients with peripheral arterial disease (PAD), but none have been widely accepted or validated for this disease. Consequently, trials report safety outcomes numbers derived from different classifications, limiting homogeneity as well as comparability. The goal of this study was to achieve expert consensus on a definition for major bleeding for PAD. DESIGN: The Delphi method was used to acquire expert opinions in a structured manner. METHODS: Fifty experts in the field of PAD were invited to participate. Questions were formulated by a Delphi Steering committee and presented to the panel. The expert panel consisted of mostly vascular surgeons (85%), as well as interventional radiologists (9%) and vascular medicine experts (6%). Consensus was defined at ≥75% on close-ended questions. RESULTS: Thirty-three (66%) of invitees agreed to participate in the Delphi study. Rounds 1-3 amounted to five main features included in the classification, which were resurveyed in rounds 4 and 5. The panel was also consulted on A) the form of the classification as well as B) definitions used. After a total of five rounds, consensus was achieved on a three-tier classification system containing definitions for major, moderate, and minor bleeding. CONCLUSION: Expert consensus was reached on a new classification for bleeding in patients with PAD. Application of this proposed bleeding classification on existing cohorts would be a next step in validation and adoption of this classification in the future.