Fig. 1.

A causal diagram demonstrating the total effect of dabigatran on stroke in patients with atrial fibrillation using the Fine-Gray approach in a randomized trial. The direct effect of dabigatran (pharmacological effect) is shown with an arrow from dabigatran to stroke head-to-tail. The arrow from dabigatran to DGIB implies the effect of dabigatran on death secondary to gastrointestinal bleeding (DGIB), and the arrow from DGIB to stroke reflects that the stroke occurrence is precluded by death due to GI bleeding. The causal path Dabigatran→DGIB→Stroke shows the indirect effect of dabigatran on stroke through DGIB.