NAPLES (Tavano) trial

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Systematic review and meta-analysis

This trial is included in the following systematic reviews and meta-analyses:

percutaneous coronary intervention - anticoagulant - all type of patients

percutaneous coronary intervention - antithrombotics - all type of patients

TRA-PCI, 2009 - SCH 530348 vs placebo

NAPLES (Tavano), 2009 - bivalirudin vs actionated heparin plus tirofiban

CHAMPION-PCI, 2009 - cangrelor up front vs clopidogrel up front

CHAMPION-PLATFORM, 2009 - cangrelor up front vs delayed clopidogrel

ISAR-REACT 3, 2008 - bivalirudin vs UFH

HORIZONS-AMI (Stone), 2008 - bivalirudin vs heparin + GP2b3a inhibitors

STEEPLE, 2006 - enoxaparin vs UFH

ACUITY (Stone) (bivalirudin alone), 2006 - bivalirudin vs heparin + GP2b3a inhibitors

JUMBO-TIMI 26, 2005 - prasugrel vs clopidogrel

REPLACE-1, 2004 - bivalirudin vs UFH

Natarajan (without antiGp2b3a), 2003 - Dalteparin vs UFH

REPLACE-2, 2003 - bivalirudin vs hepatin + anti Gp2b3a

CRUISE, 2003 - Enoxaparin vs UFH

Natarajan (+ antiGp2b3a), 2003 - Dalteparin vs UFH + anti Gp2b3a

Petronio, 2002 - Abciximab vs placebo

Tamburino, 2002 - Abciximab vs placebo

Kleiman, 2002 - bivalirudin + eptifibatide vs heparin + eptifibatide

CADILLAC, 2002 - Abciximab vs placebo

Galeote, 2001 - Enoxaparin vs UFH

Drozd, 2001 - Enoxaparin vs UFH

Kini, 2001 - Abciximab vs placebo

Dubek b (+abciximal), 2001 - Enoxaparin+abciximab vs UFH

ADMIRAL, 2001 - Abciximab vs placebo

ESPRIT, 2000 - Eptifibatide vs placebo

Treatments

Studied treatment	bivalirudin monotherapy
Control treatment	unfractionated heparin plus tirofiban

Patients

Patients	patients with diabetes mellitus undergoing elective percutaneous coronary intervention
Inclusion criteria	age >=18 years old, biabetes treated with insulin and/or oral agents, de novo coronary lesion in a native coronary artery, and elective PCI
Exclusion criteria	PCI performed as reperfusion therapy for acute myocardial infarction; pregnancy; recent (<1 month) PCI; restenotic lesion; saphenous venous graft and/or mammary artery lesion intervention; acute coronary syndrome with basal creatine kinase or creatine kinase-myocardial band value greater than the upper limit of local normal;recent (<=12 weeks) active internal bleeding or bleeding diathesis, surgery, trauma, or gastrointestinal or genitourinary tract bleeding; previous intracranial bleeding or structural abnormality; platelet count <=125 10^3/�l; history of heparininduced thrombocytopenia; chronic kidney disease with serum creatinine levels >3 mg/dl or dependency on renal dialysis; warfarin therapy; and administration of UFH within 6 hours, low-molecular-weight heparin within 8 hours, abciximab within 7 days, or eptifibatide or tirofiban within 12 hours before randomization

Method and design

Randomized effectives	167 / 168 (studied vs. control)
Design	Parallel groups
Blinding	open
Follow-up duration	30 days
Number of centre	single center
Geographic area	Italy
Primary endpoint	MACE

Results

Endpoints and data reported in the trial's publication(s)

Endpoint	Events (%)		Relative Risk	95% CI
Endpoint	Studied treat.	Control treat.	Relative Risk	95% CI
death, urgent revascularization, myocardial infarction, bleeding	30 / 167 (18,0%)	53 / 168 (31,5%)	0,57	[0,38;0,84]
Death	0 / 167 (0,3%)	0 / 168 (0,3%)	1,01	[0,02;50,41]
	Not calculable (data not available)
Q-wave myocardial infarction	0 / 167 (0,3%)	0 / 168 (0,3%)	1,01	[0,02;50,41]
Non�Q-wave myocardial infarction	17 / 167 (10,2%)	21 / 168 (12,5%)	0,81	[0,45;1,49]
Urgent coronary revascularization	0 / 167 (0,3%)	0 / 168 (0,3%)	1,01	[0,02;50,41]
Stent thrombosis	0 / 167 (0,3%)	0 / 168 (0,3%)	1,01	[0,02;50,41]
any bleeding	14 / 167 (8,4%)	35 / 168 (20,8%)	0,40	[0,22;0,72]
Major Bleeding	1 / 167 (0,6%)	4 / 168 (2,4%)	0,25	[0,03;2,23]
Mino rBleeding	13 / 167 (7,8%)	31 / 168 (18,5%)	0,42	[0,23;0,78]

Endpoints used by the meta-analysis and data retained for this trial

Endpoint Studied treat.
n/N Control treat.
n/N Graph RR [95% CI]

All cause death

0 / 167
0 / 168
classic 1,01 [0,00;256,10]

Minor bleeding

13 / 167
31 / 168
0,42 [0,23;0,78]

Major bleeding

1 / 167
4 / 168
classic 0,25 [0,03;2,23]

Unplanned revascularisation for ischaemia

0 / 167
0 / 168
classic 1,01 [0,00;256,10] 0 2 1.0

Endpoint	Events (%)		Relative Risk	95% CI	Endpoint definition in the trial	Ref
Relative risks
Endpoint	Studied treat.	Control treat.	Relative Risk	95% CI	Endpoint definition in the trial	Ref
Minor bleeding	13 / 167 (7,8%)	31 / 168 (18,5%)	0,42	[0,23;0,78]	Mino rBleeding
Major bleeding	1 / 167 (0,6%)	4 / 168 (2,4%)	0,25	[0,03;2,23]	Major Bleeding
All cause death	0 / 167 (0,3%)	0 / 168 (0,3%)	1,01	[0,02;50,41]	Death
Unplanned revascularisation for ischaemia	0 / 167 (0,3%)	0 / 168 (0,3%)	1,01	[0,02;50,41]	Urgent coronary revascularization
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction:

Endpoint	Events rate		Absolute risk reduction (ARR)
Absolute risk reduction
Endpoint	Studied treat.	Control treat.	Absolute risk reduction (ARR)
Minor bleeding	7,78%	18,45%	-106,7‰
Major bleeding	5,99‰	2,38%	-17,8‰

Meta-analysis of all similar trials:

anticoagulant in percutaneous coronary intervention for all type of patients

antithrombotics in percutaneous coronary intervention for all type of patients

Reference(s)

Trials register #

Tavano D, Visconti G, D'Andrea D, Focaccio A, Golia B, Librera M, Caccavale M, Ricciarelli B, Briguori C. Comparison of bivalirudin monotherapy versus unfractionated heparin plus tirofiban in patients with diabetes mellitus undergoing elective percutaneous coronary intervention.. Am J Cardiol 2009;104:1222-8
Pubmed | Hubmed | Fulltext

NAPLES (Tavano) study, 2009