NCT01967615

P2Y12 Inhibitors Utilization in Bifurcation and Chronic Total Occlusion PCI

P2Y12 Inhibitors Utilization in Bifurcation and Chronic Total Occlusion PCI With Biologically Active Stents (P2BiTO) Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4,500 (actual)
• Sponsor: G. d'Annunzio University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Prasugrel and ticagrelor were both associated with a significant reduction in the risk of MACE in patients undergoing PCI for an ACS, mostly through a reduced stent thrombosis. The 1-year relative risk reduction (RRR) of definite of probable stent thrombosis in patients receiving a DES were fairly different in TRITON-TIMI 38 and PLATO trials. The incidence of "biologically active" stent (DES or BVS) thrombosis is largely variable according to different lesion settings. We aim to verify the translation of the postulated different reduction in thrombosis rate among various P2Y12 inhibitors (clopidogrel, prasugrel and ticagrelor) in a high-risk setting such as the PCI with DES or BVS in CTO and bifurcating lesions.

Detailed description

All patients aged 18-80 who underwent PCI of a CTO or bifurcating lesion (all Medina types, side branch ≥2 mm) with "biologically active stents" (DES or BVS) between January 2012 and december 2014 at participating centers will be deemed eligible to enter the registry. In-hospital outcomes will be recorded; all patients discharged alive will be followed up with a telephone interview (minimum follow-up 6 months). The primary end-point will be the occurrence of a cluster of major adverse cardiovascular events at 1 year: 1. Death from any cause. 2. Myocardial infarction. 3. Stent thrombosis, defined as definite, probable or possible following the Academic Research Consortium. Sample size 3150 patients.

Conditions

• Coronary Arteriosclerosis

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-05-01
• Completion: 2017-04-01
• First posted: 2013-10-23
• Last updated: 2017-10-30