P2BiTO: P2Y12 Inhibitors Utilization in Bifurcation and Chronic Total Occlusion PCI

Sponsor

G. d'Annunzio University (Other)

Overall Status

Completed

CT.gov ID

NCT01967615

Collaborator

(none)

4,500

Enrollment

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Arteriosclerosis

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:

Death from any cause.
Myocardial infarction.
Stent thrombosis, defined as definite, probable or possible following the Academic Research Consortium.

Sample size 3150 patients.

Study Design

Study Type:

Observational

Actual Enrollment :

4500 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

May 1, 2015

Actual Study Completion Date :

Apr 1, 2017

Outcome Measures

Primary Outcome Measures

Death, Myocardial infarction, Stent Thrombosis [30 months]
Death from any cause. Myocardial infarction, defined as an elevation of the creatine kinase MB fraction or cardiac troponins by a factor of 3 or more, or the development of new Q waves in 2 or more contiguous leads at surface ECG7. Levels of total creatine kinase and the creatine kinase MB fraction will be measured in all patients between 12 and 24 hours after PCI. Stent thrombosis, defined as definite, probable or possible3 following the Academic Research Consortium