PMID- 19840566
OWN - NLM
STAT- MEDLINE
DCOM- 20091124
LR  - 20220318
IS  - 1879-1913 (Electronic)
IS  - 0002-9149 (Linking)
VI  - 104
IP  - 9
DP  - 2009 Nov 1
TI  - Comparison of bivalirudin monotherapy versus unfractionated heparin plus 
      tirofiban in patients with diabetes mellitus undergoing elective percutaneous 
      coronary intervention.
PG  - 1222-8
LID - 10.1016/j.amjcard.2009.06.035 [doi]
AB  - Bivalirudin demonstrated similar efficacy but resulted in a lower rate of 
      bleeding compared to unfractionated heparin (UFH) plus platelet glycoprotein 
      IIb/IIIa inhibitors in patients undergoing percutaneous coronary intervention. It 
      has not been clearly evaluated whether this can also be applied to patients with 
      diabetes mellitus. A total of 335 consecutive patients with diabetes mellitus 
      referred for elective percutaneous coronary intervention were randomized in the 
      Novel Approaches for Preventing or Limiting EventS (NAPLES) trial to receive 
      bivalirudin monotherapy or UFH plus routine tirofiban. The primary composite end 
      point (30-day composite incidence of death, urgent repeat revascularization, 
      myocardial infarction, and all bleeding) was lower in the bivalirudin group than 
      in the UFH plus tirofiban group (18.0% vs 31.5%, odds ratio 0.47, 95% confidence 
      interval 0.28 to 0.79, p = 0.004). No death, urgent revascularization, or Q-wave 
      myocardial infarction occurred. The rate of non-Q-wave myocardial infarction was 
      similar in the 2 groups (10.2% in the bivalirudin group vs 12.5% in the UFH plus 
      tirofiban group, p = 0.606). In contrast, fewer patients in the bivalirudin group 
      experienced bleeding (8.4% vs 20.8%, odds ratio 0.34, 95% confidence interval 
      0.18 to 0.67, p = 0.002). This difference was mainly ascribed to the lower rate 
      of minor bleeding (7.8% in the bivalirudin group vs 18.5% in the UFH plus 
      tirofiban group, odds ratio 0.37, 95% confidence interval 0.19 to 0.74, p = 
      0.005), although the rate of major bleeding in the 2 groups was comparable (0.6% 
      vs 2.4%, respectively; p = 0.371). In conclusion, in patients with diabetes 
      mellitus undergoing elective percutaneous coronary intervention, the strategy of 
      bivalirudin monotherapy compared to UFH plus routine tirofiban is safe and 
      feasible and associated with a significant reduction of in-hospital bleeding.
FAU - Tavano, Davide
AU  - Tavano D
AD  - Clinica Mediterranea, Naples, Italy.
FAU - Visconti, Gabriella
AU  - Visconti G
FAU - D'Andrea, Davide
AU  - D'Andrea D
FAU - Focaccio, Amelia
AU  - Focaccio A
FAU - Golia, Bruno
AU  - Golia B
FAU - Librera, Mariateresa
AU  - Librera M
FAU - Caccavale, Mario
AU  - Caccavale M
FAU - Ricciarelli, Bruno
AU  - Ricciarelli B
FAU - Briguori, Carlo
AU  - Briguori C
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - Am J Cardiol
JT  - The American journal of cardiology
JID - 0207277
RN  - 0 (Anticoagulants)
RN  - 0 (Hirudins)
RN  - 0 (Peptide Fragments)
RN  - 0 (Platelet Aggregation Inhibitors)
RN  - 0 (Recombinant Proteins)
RN  - 42HK56048U (Tyrosine)
RN  - 9005-49-6 (Heparin)
RN  - GGX234SI5H (Tirofiban)
RN  - TN9BEX005G (bivalirudin)
SB  - IM
MH  - Aged
MH  - *Angioplasty, Balloon, Coronary
MH  - Anticoagulants/*therapeutic use
MH  - Coronary Artery Disease/epidemiology/*therapy
MH  - Diabetes Mellitus/*epidemiology
MH  - Drug Therapy, Combination
MH  - Female
MH  - Hemorrhage/epidemiology
MH  - Heparin/therapeutic use
MH  - Hirudins
MH  - Humans
MH  - Male
MH  - Myocardial Infarction/epidemiology/prevention & control
MH  - Peptide Fragments/therapeutic use
MH  - Platelet Aggregation Inhibitors/*therapeutic use
MH  - Prospective Studies
MH  - Recombinant Proteins/therapeutic use
MH  - Retreatment
MH  - Thrombocytopenia/chemically induced/epidemiology
MH  - Tirofiban
MH  - Tyrosine/analogs & derivatives/therapeutic use
EDAT- 2009/10/21 06:00
MHDA- 2009/12/16 06:00
CRDT- 2009/10/21 06:00
PHST- 2009/04/27 00:00 [received]
PHST- 2009/06/09 00:00 [revised]
PHST- 2009/06/09 00:00 [accepted]
PHST- 2009/10/21 06:00 [entrez]
PHST- 2009/10/21 06:00 [pubmed]
PHST- 2009/12/16 06:00 [medline]
AID - S0002-9149(09)01261-2 [pii]
AID - 10.1016/j.amjcard.2009.06.035 [doi]
PST - ppublish
SO  - Am J Cardiol. 2009 Nov 1;104(9):1222-8. doi: 10.1016/j.amjcard.2009.06.035.