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Drug eluting stent in coronary artery disease for unparticular patients, clinical trials results

bioabsorbable polymer EES versus everolimus eluting stent
EVOLVE, 2012
NCT01135225
bioabsorbable polymer everolimus-eluting stent
versus
polymer EES
patients with a de novo lesion ¡Ü28 mm in length, in a coronary artery of ¡Ý2.25 to ¡Ü3.5 mm diametersingle blind
Follow-up duration: 30 days
biolimus eluting stent versus sirolimus eluting stent
LEADERS, 2008
NCT00389220
BioMatrix III (biolimus-eluting stent withbiodegradable polymer)
versus
Cypher SELECT (sirolimus-eluting stent with durable polymer)
patients aged 18 years or older with chronic stable coronary artery disease or acute coronary syndromesopen assessor-blind
Follow-up duration: 9 months
Europe
CoStar stent versus paclitaxel eluting stent
Costar II, 2008
NCT00165035
CoStar stent (Conor MedSystems) PES
versus
Taxus (Boston Scientific) PES
patient undergoing percutaneous coronary intervention for a single lesion per vessel in up to three native epicardial vesselssingle-blind
Follow-up duration: 8 months (1 year)
US, Germany, Belgium, and New Zealand
dactinomycin eluting stent versus bare-metal stent
ACTION, 2004
Multilink Tetra stent
versus
uncoated Multilink Tetra stent
Patients with stable angina pectoris orsilent ischemia and a single de novo lesion in a nativecoronary artery >=3.0 mm and <=4.0 mm in diameter thatcould be covered by an 18-mm stentsingle-blind
Follow-up duration: 6 months
worldwide
everolimus eluting stent versus bare-metal stent
FUTURE I, 2004
everolimus coated S-Stent
versus
S-Stent
de novo coronary lesionssingle-blind
Follow-up duration: 12 months
Germany
FUTURE II, 2006
CHAMPION
versus
bare-metal stent
Patients with de novo lesions in vessels with a reference diameter of 2.75-4.0 mm and length double-blind
Follow-up duration: 6 months
NA
SPIRIT I, 2005
NCT00180453
everolimus eluting sent, XIENCE
versus
bare etal stent, MULTI-LINK VISION
patients with de novo native coronary artery lesionssingle-blind
Follow-up duration: 6 months (5yr)
everolimus eluting stent versus paclitaxel eluting stent
COMPARE, 2009
NCT01016041
polymer based, everolimus-eluting stent (Xience V)
versus
polymer-based, paclitaxel-eluting stent (Taxus Liberte)
unselected patientsopen
Follow-up duration: 1 y (2y)
the Netherlands
SPIRIT II, 2006
NCT00180310
everolimus eluting stent, XIENCE V
versus
placitaxel eluting stent, TAXUS EXPRESS2
De novo lesions (maximim two)single-blind (patient)
Follow-up duration: 6 months
SPIRIT III, 2008
NCT00180479
everolimus-eluting stent, XIENCE V
versus
paclitaxel-eluting stent, Taxus
lesions 28 mm or less in length and with reference vessel diameter between 2.5 and 3.75 msingle-blind
Follow-up duration: 12 months
US
SPIRIT IV, 2010
NCT00307047
XIENCE V Everolimus Eluting Coronary Stent System
versus
TAXUS EXPRESS2 Paclitaxel Eluting Coronary Stent System (TAXUS).
patients with de novo native coronary artery lesions and reference vessel diameters between 2.5 mm to 4.25 mm and lesion lengths <= 28 mm270 days (5 years)
Follow-up duration: 1 y (2y)
USA
everolimus eluting stent versus sirolimus eluting stent
ISAR-TEST 4 (EES vs SES),
everolimus-eluting stent
versus
sirolimus-eluting stent
patients with de novo coronary artery stenosis >50% and symptoms or objective evidence of ischemia
Follow-up duration: 2 years
SORT OUT IV, 2012
NCT00552877
everolimus-eluting stents
versus
sirolimus-eluting stents
unselected patients with coronary artery diseaseopen
Follow-up duration: 9 months (3 years)
Denmark
paclitaxel eluting stent versus bare-metal stent
SCORE, 2004
QuaDDS stents (paclitaxel)
versus
uncoated control stents
patients with focal, de novo coronary lesionsopen
Follow-up duration: 12 months
Worldwide
TAXUS I, 2003
TAXUS NIR
versus
NIR stent
Stable or unstable AP, silent ischaemia; single de novo or restenotic coronary lesionsdouble-blind
Follow-up duration: 12 months
Germany
TAXUS II, 2003
NCT00299026
TAXUS
versus
NIR stent
Stable or unstable AP, silent ischaemia; single de novo target lesion with estimatedstenosis >50% and <99%,double-blind
Follow-up duration: 12 months
Global
TAXUS IV, 2004
NCT00292474
TAXUS
versus
EXPRESS
Stable or unstable AP, provokable ischaemia with a single, previously untreated coronary-artery stenosis (vessel diameter, 2.5 to 3.75 mm; lesion length, 10 to 28 mm)double-blind
Follow-up duration: 9 months
United States
paclitaxel, non-polymeric eluting stent versus bare-metal stent
ASPECT, 2003
NCT00196079
coated Supra-G stent
versus
Supra-G stent
patientswith discrete coronary lesions (<15 mm in length, 2.25 to 3.5 mm in diameter)double-blind
Follow-up duration: 6 months
NA
DELIVER, 2004
non-polymer-based paclitaxel-coated ACHIEVE stent
versus
stainless steel Multi-Link (ML) PENTA stent
patients with focal de novo coronary lesions, <25 mm in length, in 2.5- to 4.0-mm vesselssingle-blind
Follow-up duration: 9 months
US
ELUTES, 2004
coated V-Flex Plus
versus
V-Flex Plus
single de novo type A or type B1 lesions 15 mm length in a nativecoronary arteryopen
Follow-up duration: 12 months
Europe
PATENCY, 2002
Logic PTX paclitaxel Eluting CoronaryStents
versus
uncoated control stents
Patients with de novo lesions of 2.7- to 4.0-mm diameter and 25-mm length received 3.0, 3.5, or 4.0 mm 10- or 15-mmdouble blind
Follow-up duration: 9 months
sirolimus biodegradable polymer versus sirolimus eluting stent
ISAR-TEST-4 (biodegradable polymer), 2009
NCT00598676).
biodegradable polymer rapamycin-eluting stent
versus
permanent polymer-based rapamycin-eluting or everolimus-eluting
patients with stable coronary disease or acute coronary syndromes with de novo native-vessel stent implantationopen
Follow-up duration: 12 mo
Germany
sirolimus eluting stent versus bare-metal stent
C-SIRIUS, 2004
NCT00381420
coated Bx-VELOCITY
versus
Bx-VELOCITY
Stable or unstable AP, silent ischaemiadouble-blind
Follow-up duration: 9 months
Canada
E-SIRIUS, 2003
NCT00235144
coated Bx Velocity
versus
Bx Velocity
Stable or unstable AP, silent ischaemia; single-vessel or multivessel coronary disease but with only one new lesion with an estimated stenosis of more than 50% but less than 100% in a major native coronary artery requiring treatmentopen
Follow-up duration: 9 months
Europe
Kochiadakis, 2007
sirolimus-eluting stents
versus
bare metal stent
one-vesseldisease (>70% narrowing of the lumen of one major epicardialcoronary artery); stable coronary artery disease, age <70 years, and vessel referencediameter >=2.5 mmopen
Follow-up duration: 4.8 months (mean)
Greece
Ortolani et al, 2007
Cypher
versus
Vision
symptomatic coronary artery disease and target vessel diameter appropriate for implantation a 3-mm stentsingle-blind
Follow-up duration: 9 months
Pache et al, 2005
Cypher
versus
BeStent 2
with symptomatic coronary artery disease and significant angiographic stenosis in native coronary vesselsopen
Follow-up duration: 12 months
Germany
RAVEL, 2002
NCT00233805
coated Bx Velocity
versus
Bx Velocity
Stable or unstable AP, silent ischaemia; single primary target lesion in a native coronary arterydouble-blind
Follow-up duration: 12 months
Global
SIRIUS, 2003
NCT00232765
SES
versus
Bx Velocity
Stable or unstable AP, signs of myocardial ischaemiadouble-blind
Follow-up duration: 9 months
United States
sirolimus eluting stent versus paclitaxel eluting stent
BASKET (vs paclitaxel), 2005
Cypher
versus
Taxus
Unselected patients; de-novo lesionsopen
Follow-up duration: 6 months
Switzerland,
Han, 2006
Cypher
versus
Taxus
Multivessel disease. Stable or unstable AP, no AMIopen
Follow-up duration: 19.5 months (mean)
China
ISAR-TEST-1, 2006
NCT00140530
rapamycin-eluting stent Yukon
versus
Taxus
stable or unstable anginaor a positive stress test, stable or unstable anginaor a positive stress testopen
Follow-up duration: 9 months
Germany
REALITY, 2006
NCT00235092
Cypher
versus
Taxus
Relatively unselected patients. Stable or unstable documented silent ischaemia, no AMI with 1 or 2 de novo lesions (2.25-3.00 mm in diameter) in native coronary arteriesopen
Follow-up duration: 12 months
Europe, Latin America, and Asiam
SIRTAX (Windecker), 2005
sirolimus-eluting stents (Cypher)
versus
paclitaxel-eluting stents (Taxus)
Unselected patients. Stable AP, ACS, including AMI. at least one lesion with stenosis of at least 50 percent in a vessel with a reference diameter between 2.25 and 4.00 mm that was suitable for stent implantationsingle-blind
Follow-up duration: 9 mo (5y)
Switzerland
SORT OUT II, 2008
NCT00388934
Cypher stent
versus
Taxus stent(Boston Scientific Corp)
Unselected patients (included ST-segment elevation myocardial infarction (STEMI), non-STEMI or unstable angina pectoris, and stable angina)open
Denmark.
TAXi, 2005
Cypher
versus
Taxus
Unselected patientsopen
Follow-up duration: 6 months
Switzerland.
Wessely, 2008
rapamycin polymer-coated drug-eluting stent
versus
paclitaxel polymer-coated drug-eluting stent
NA
Follow-up duration: 9 months
Germany
Zhang (SES vs PES), 2006
Cypher
versus
Taxus
Unselected patients. Stable or unstable AP, ACS with de novo coronary lesionsopen
Follow-up duration: 1y
China
zotarolimus eluting stent versus bare-metal stent
ENDEAVOR II, 2006
AVE Zotarolimus-Eluting Driver
versus
Driver
single de novo native coronary artery stenosisdouble-blind
Follow-up duration: 12 months
worldwide
zotarolimus eluting stent versus everolimus eluting stent
RESOLUTE All comers, 2010
NCT00617084.)
zotarolimus-eluting stent
versus
everolimus-eluting stent (Xience)
adult patients with chronic, stable coronary artery disease or acute coronary syndromes, including myocardial infarction with or without ST-segment elevationopen
Follow-up duration: 12 months (5y)
TWENTE, 2012
NCT01066650
zotarolimus-eluting stent
versus
everolimus-eluting stent
"real-world" patients single (patient-blinded)
Follow-up duration: 1 year
zotarolimus eluting stent versus paclitaxel eluting stent
ENDEAVOR IV, 2009
NCT00217269
zotarolimus-eluting stent (Endeavor)
versus
paclitaxel-eluting stent (Taxus)
single de novo lesions in native coronary arteries with a reference vessel diameter of 2.5-3.5 mmopen
Follow-up duration: mean 36 mo
US
ZEST (vs PES), 2009
NCT00418067
zotarolimus-eluting stents
versus
paclitaxel-eluting stents
Patients with coronary artery disease NA
Follow-up duration: 1 year
zotarolimus eluting stent versus sirolimus eluting stent
ENDEAVOR III, 2006
NCT00217256
ABT-578 coated Endeavor
versus
Cypher
single de novo lesions in native coronary arteries 2.5-3.5 mm in diameteropen
Follow-up duration: 12 months (and 24 months)
US
PROTECT, 2012
NCT00476957
Medtronic Endeavor Zotarolimus Eluting Coronary Stent System
versus
Cordis Cypher Sirolimus-eluting Coronary Stent
unselected patients (patients 18 years or older who were undergoing stenting for elective, unplanned, or emergency procedures in native coronary arteries)open-label
ZEST (vs SES), 2009
NCT00418067
zotarolimus-eluting stents
versus
sirolimus-eluting stents
Patients with coronary artery disease Open
Follow-up duration: 1 year
Korea

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