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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01967615

Acronym

P2BiTO

Enrollment

4500

Registered

2013-10-23

Start date

2015-01-31

Completion date

2017-04-30

Last updated

2017-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Arteriosclerosis

Keywords

PCI,, CTO,, bifurcation,, clopidogrel,, prasugrel,, ticagrelor

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Age between 18-80 years old * PCI of a CTO or bifurcating lesion (all Medina types, side branch ≥2 mm) with biologically active stents

Exclusion criteria

-none

Design outcomes

Primary

Measure	Time frame	Description
Death, Myocardial infarction, Stent Thrombosis	30 months	1. Death from any cause. 2. 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. 3. Stent thrombosis, defined as definite, probable or possible3 following the Academic Research Consortium

Outcome results