Vascular Trial Associated Registry Pilot

Vascular Trial Associated Registry Pilot: Antiplatelet Therapies for Patients Undergoing Lower Extremity Endovascular Revascularization

The purpose of this investigator-initiated, multicenter, open label, randomized trial is to evaluate 1 month vs. 6 months of dual antiplatelet therapy (DAPT) in patients undergoing lower extremity endovascular revascularization. We hypothesize that extending dual antiplatelet therapy (DAPT) to six months, compared to one month, will improve patency rates of target vessels following peripheral vascular intervention (PVI) without significantly increasing complications, particularly bleeding events.

The Main Objective of this study is to create an investigator-initiated, multicenter, open label, randomized trial to evaluate 1 month vs. 6 months of DAPT in patients undergoing lower extremity endovascular revascularization. The randomization will be 1:1 within one strata (diabetes yes/no), using blocks of varying sizes. All patients will be on DAPT for one month. At the time of the one-month visit, eligible patients who consent will be randomized to single antiplatelet therapy (SAPT) indefinitely (Arm 1) or to DAPT for 5 more months (followed by SAPT) (Arm 2). Follow-up will continue for 12-months post-procedure and will include assessment of MACE and MALE, as well as adverse bleeding events. Data for this trial will be collected via nested participation in the VQI Peripheral Vascular Intervention (PVI) registry's existing Procedural and Follow-up data collection modules.

Inclusion Criteria:

• Age greater than or equal to 45 at time of enrollment
• Patient is scheduled for a PVI or has recently had a PVI in the last 30 days
• Patient data is being submitted to Fivos, who is acting as the data collection subcontractor for the VQI-PVI registry.
• Atherosclerotic vascular disease

Exclusion Criteria:

• Patients who cannot consent for themselves

• Allergy to Clopidogrel

• Patients unable to stop clopidogrel for other medical reasons

• Patients on dual pathway inhibition (DPI) with low dose rivaroxaban (2.5mg twice a day) that are unable to stop these medications

• Allergy to aspirin

• Nonatherosclerotic vascular disease

• Patients undergoing open bypass at the same time as the peripheral transcutaneous angioplasty

• Patients with high bleeding risk (HBR) defined as:

  • History of major bleeding, active bleeding disorder, severe renal impairment (CrCl <30), concurrent anticoagulation, platelet count <100,000
  • Recent stroke (within 6 months)
  • Current warfarin therapy or full dose therapeutic direct oral anticoagulants (DOAC).

• Patients unwilling or unable to comply with standard of care follow-up visits

• Pregnant women

• Prisoners