PMID- 25703878
OWN - NLM
STAT- MEDLINE
DCOM- 20160331
LR  - 20220318
IS  - 1876-7605 (Electronic)
IS  - 1936-8798 (Linking)
VI  - 8
IP  - 3
DP  - 2015 Mar
TI  - Novel approaches for preventing or limiting events (Naples) III trial: randomized 
      comparison of bivalirudin versus unfractionated heparin in patients at increased 
      risk of bleeding undergoing transfemoral elective coronary stenting.
PG  - 414-423
LID - S1936-8798(14)01759-2 [pii]
LID - 10.1016/j.jcin.2014.10.015 [doi]
AB  - OBJECTIVES: This study sought to assess the safety and the efficacy of 
      bivalirudin compared with unfractionated heparin (UFH) alone in the subset of 
      patients at increased risk of bleeding undergoing transfemoral elective 
      percutaneous coronary intervention (PCI). BACKGROUND: Bivalirudin, a synthetic 
      direct thrombin inhibitor, determines a significant decrease of in-hospital 
      bleeding following PCI. METHODS: This is a single-center, investigator-initiated, 
      randomized, double-blind, controlled trial. Consecutive biomarker-negative 
      patients at increased bleeding risk undergoing PCI through the femoral approach 
      were randomized to UFH (UFH group; n = 419) or bivalirudin (bivalirudin group; n 
      = 418). The primary endpoint was the rate of in-hospital major bleeding. RESULTS: 
      The primary endpoint occurred in 11 patients (2.6%) in the UFH group versus 14 
      patients (3.3%) in the bivalirudin group (odds ratio: 0.78; 95% confidence 
      interval: 0.35 to 1.72; p = 0.54). Distribution of access-site and 
      non-access-site bleeding was 18% and 82% in the UFH group versus 50% and 50% in 
      the bivalirudin group (p = 0.10). CONCLUSIONS: The results of this randomized 
      study, carried out at a single institution, suggest that there is no difference 
      in major bleeding rate between bivalirudin and UFH in increased-risk patients 
      undergoing transfemoral PCI. (Novel Approaches in Preventing and Limiting Events 
      III Trial: Bivalirudin in High-Risk Bleeding Patients [NAPLES III]; NCT01465503).
CI  - Copyright (c) 2015 American College of Cardiology Foundation. Published by Elsevier 
      Inc. All rights reserved.
FAU - Briguori, Carlo
AU  - Briguori C
AD  - Department of Cardiology, Clinica Mediterranea, Naples, Italy. Electronic 
      address: carlobriguori@clinicamediterranea.it.
FAU - Visconti, Gabriella
AU  - Visconti G
AD  - Department of Cardiology, Clinica Mediterranea, Naples, Italy.
FAU - Focaccio, Amelia
AU  - Focaccio A
AD  - Department of Cardiology, Clinica Mediterranea, Naples, Italy.
FAU - Donahue, Michael
AU  - Donahue M
AD  - Department of Cardiology, Clinica Mediterranea, Naples, Italy.
FAU - Golia, Bruno
AU  - Golia B
AD  - Department of Cardiology, Clinica Mediterranea, Naples, Italy.
FAU - Selvetella, Lucio
AU  - Selvetella L
AD  - Vascular Surgery Unit, Clinica Mediterranea, Naples, Italy.
FAU - Ricciardelli, Bruno
AU  - Ricciardelli B
AD  - Department of Cardiology, Clinica Mediterranea, Naples, Italy.
LA  - eng
SI  - ClinicalTrials.gov/NCT01465503
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20150218
PL  - United States
TA  - JACC Cardiovasc Interv
JT  - JACC. Cardiovascular interventions
JID - 101467004
RN  - 0 (Hirudins)
RN  - 0 (Peptide Fragments)
RN  - 0 (Recombinant Proteins)
RN  - 9005-49-6 (Heparin)
RN  - TN9BEX005G (bivalirudin)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Coronary Artery Disease/diagnosis/*therapy
MH  - Double-Blind Method
MH  - Female
MH  - *Femoral Artery
MH  - Hemorrhage/*chemically induced
MH  - Heparin/*adverse effects
MH  - Hirudins/*adverse effects
MH  - Humans
MH  - Italy
MH  - Male
MH  - Peptide Fragments/*adverse effects
MH  - Percutaneous Coronary Intervention/adverse effects/instrumentation/*methods
MH  - Prospective Studies
MH  - Punctures
MH  - Recombinant Proteins/adverse effects
MH  - Risk Assessment
MH  - Risk Factors
MH  - Time Factors
MH  - Treatment Outcome
OTO - NOTNLM
OT  - anticoagulant
OT  - bivalirudin
OT  - bleeding
OT  - heparin
OT  - percutaneous coronary intervention
EDAT- 2015/02/24 06:00
MHDA- 2016/04/01 06:00
CRDT- 2015/02/24 06:00
PHST- 2014/08/15 00:00 [received]
PHST- 2014/10/07 00:00 [revised]
PHST- 2014/10/08 00:00 [accepted]
PHST- 2015/02/24 06:00 [entrez]
PHST- 2015/02/24 06:00 [pubmed]
PHST- 2016/04/01 06:00 [medline]
AID - S1936-8798(14)01759-2 [pii]
AID - 10.1016/j.jcin.2014.10.015 [doi]
PST - ppublish
SO  - JACC Cardiovasc Interv. 2015 Mar;8(3):414-423. doi: 10.1016/j.jcin.2014.10.015. 
      Epub 2015 Feb 18.