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myocardial revascularization in coronary artery disease for all type of patient, clinical trials results

abciximab-coated stent versus bare-metal stent
Kim, 2010
abciximab-coated stent
versus
bare metal stents
patients undergoing PCI for de novo coronary lesionsopen
Follow-up duration: 6 mo (2y)
Korea
angioplasty versus MIDCAB
AMIST (Reeves), 2004
percutaneous transluminal coronary angioplasty (PTCA) with or without stenting
versus
minimally invasive direct coronary artery bypass grafting (MIDCAB)
single-vessel disease (at least 50% stenosis) of the left anterior descending coronary artery (LAD). open
Follow-up duration: 12 months
England
balloon angioplasty versus CABG
EAST, 1994
NCT00000465
transluminal coronary angioplasty
versus
coronary-artery bypass grafting
patients with multivessels coronary artery diseaseopen
Follow-up duration: 3 y
USA
GABI, 1994
Percutaneous transluminal coronary angioplasty
versus
coronary-artery bypass grafting
patients with symptomatic multivessel coronary diseaseopen
Follow-up duration: 1 y
Germany
BARI, 1996
NCT00000462
PTCA
versus
CABG
Patients with multivessel disease open
Follow-up duration: 5.4 y
USA, Canada
RITA, 1993
percutaneous transluminal coronary angioplasty
versus
coronary artery bypass surgery
patients with one, two, or three diseased coronary arteriesopen
Follow-up duration: 2.5 y (6.5y)
UK
ERACI, 1992
Percutaneous transluminal coronary angioplasty
versus
coronary artery bypass grafting
patients with multivessel disease and lesions suitable for either form of therapyopen
Follow-up duration: 3.8 y
Argentina
MASS, 1995
percutaneous transluminal coronaryangioplasty
versus
mammary bypass surgery
patients with stable angina,normal ventricular function and a proximal stenosis of the leftanterior descending coronary artery >80%open
Follow-up duration: 3.2 y
Brazil
Toulouse, 1992
PTCA
versus
CABG
patients with multivessels coronary artery diseaseopen
Follow-up duration: 2.8 y
France
Lausanne, 1994
transluminal coronary angioplasty
versus
Coronary artery bypass grafting
patients with isolated proximal left anterior descending artery stenosis, conserved left ventricular function, and documented ischaemiaopen
Follow-up duration: 3.2 y
Switzerland
CABRI, 1995
percutaneous transluminal coronary angioplasty
versus
coronary artery bypass grafting
patients with symptomatic multivessel coronary diseaseopen
Follow-up duration: 1 y
Europe
balloon angioplasty versus medical treatment
RITA 2, 1997
PTCA within 3 mo of the randomisation
versus
medical treatment
Angina leading to admission within 90days, previous Q wave MI, no previousPTCA, no left main stem diseaseopen
Follow-up duration: 7y
UK
ACME, 1992
PTCA within 3 days of randomization
versus
medical treatment (nitrates, beta-blockers, calcium blockers)
Stable angina, history of angina, MIwithin 3 months, exercise test with STdepression >3 mm, no previous PTCA; Single or serial stenosis within sameartery 70% to 99% proximal twothirdsopen
Follow-up duration: 5y
US
ACME 2 (Folland), 1997
PTCA
versus
medical therapy
Stable angina, history of angina, MIwithin 3 months, exercise test with STdepression >3 mm, no previous PTCA; Stenosis >70% proximal two thirds,no main artery stenosis >50%, no 3vessel diseaseopen
Follow-up duration: 5y
ACIP, 1997
revascularization by angioplasty or bypass surgery
versus
angina-guided drug therapy or angina plus ischemia-guided drug therapy
clinically stable patients with angiographically documented coronary disease (50% stenosis in 1 major vessel or branch) suitable for revascularizationopen
Follow-up duration: 24 months
INSPIRE, 2006
coronary revascularization for suppressing scintigraphic ischemia
versus
intensive medical therapy strategy
Stable survivors of MI, total perfusion defect size 20%, ischemic defect size 10% (by adenosine SPECT), EF 35%t open
Follow-up duration: 60 months
SWISSI II, 2007
NCT00387231
Percutaneous coronary intervention aimed at full revascularization
versus
intensive anti-ischemic drug therapy
patients with a recent MI, silent myocardial ischemia verified by stress imaging, and 1- or 2-vessel coronary artery diseaseopen
Follow-up duration: 10.2y
Switzerland
MASS, 1995
PTCA
versus
medical treatment (aspirin, nitrates, beta-blockers and calcium channel blocking
Stable angina, no Q wave MI, no leftventricular dysfunction^¾„open
Follow-up duration: 5y
Brazil
Sievers, 1993
PTCA
versus
medical treatment
Previous non­Q wave MI, no angina indaily life, no previous Q wave MIopen
Follow-up duration: 2y
Germany
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
biodegradable-polymer versus BMS
PAINT (sirolimus), 2009
NCT00752362
biodegradable-polymer sirolimus-eluting (Supralimus)
versus
bare metal stent (matrix)
patients with de novo coronary lesions in native vessels scheduled for stent implantationopen
Follow-up duration: 12 mo (angiography 9 mo)
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
CABG versus medical treatment
STICH (vs med), 2011
NCT00023595
CABG
versus
medical therapy
patients with congestive heart failure and severe LV dysfunctionopen
Follow-up duration: 56 months
26 countries
ECSS (European), 1988
early coronary bypass surgery
versus
medical therapy
men with midl or moderate angina pectoris of at least 3 months duration and an obstruction of 50% or more in at least 2 major coronary arteries in the absence of marked LV dysfunctionopen
Follow-up duration: 12 y
Europe (6 countries)
CASS, 1983
NCT00000489
surgical
versus
nonsurgical
patients with stable ischemic heart disease open
Follow-up duration: 5y
USA, Canada
VA, 1984
coronary-artery bypass grafting
versus
medical treatment
patients with stable angina open
Follow-up duration: 7 y
Texas, 1977

versus
Oregon, 1979
surgical treatment
versus
medical treatment
patients with stable, disabling angina
New zealand 1, 1981
surgical
versus
nonsurgical
men 60 years of age or younger who had recovered from a recurrent myocardial infarction
Follow-up duration: 4.5 y
MASS II, 2007
coronary artery bypass graft (CABG)
versus
medical therapy
multivessel coronary artery disease with stable angina and preserved ventricular function.open
Follow-up duration: 5 years
CABG or PCI versus medical treatment
BARI 2D, 2009
NCT00006305
prompt revascularization with intensive medical therapy
versus
intensive medical therapy alone
patients with type 2 diabetes and heart diseaseopen
Follow-up duration: 5.3 y
US, Canada, Brazil, Mexico, Czech Republic, Austria
CABG+surgical ventricular reconstruction versus CABG
STICH (ventricular reconstruction), 2009
NCT00023595
CABG with surgical ventricular reconstruction
versus
CABG
patients with anterior-apical regional left ventricular dysfunction open
Follow-up duration: 48 months
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
DES versus CABG
Boudriot, 2008
DES
versus
CABG
open
Follow-up duration: 12 months
dual sirolimus, probucol eluting stent versus sirolimus eluting stent
ISAR TEST 2 (vs SES), 2009
NCT00332397
dual DES (polymer-free stent consisting of probucol and rapamycin)
versus
SES
patients with De novo lesions in native coronary arteries open
Follow-up duration: 12 months
Germany
dual sirolimus, probucol eluting stent versus zotarolimus eluting stent
ISAR TEST 2 (vs ZES), 2009
NCT00332397
dual DES (polymer-free stent consisting of probucol and rapamycin)
versus
permanent polymer zotarolimus-eluting stent (Endeavor)
patients with De novo lesions in native coronary arteriesopen
Follow-up duration: 12 months
Germany
ISAR TEST 5,
NCT00598533
polymer-free, rapamycin/probucol-eluting “Dual-DES” stent
versus
zotarolimus-eluting stent with a modified permanent polymer on a cobalt-chromium alloy platform
"all-comers" population
Follow-up duration: 1 year
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 everolimus eluting stent
PLATINUM, 2011
NCT00823212
platinum chromium everolimus-eluting stent
versus
cobalt chromium everolimus-eluting stent
patients with up to 2 de novo atherosclerotic coronary artery lesionssingle-blind
Follow-up duration: 12 months
worldwide
everolimus eluting stent versus paclitaxel eluting stent
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
RESET, 2011
NCT01035450

versus
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
FFR-guided PCI versus no PCI
FAME II, 2012
NCT01132495
fractional-flow-reserve (FFR)-guided stenting
versus
optimal medical therapy alone
patients patients with stable CAD found on FFR to have hemodynamically relevant disease
Europe, US, and Canada
FAME, 2008
NCT00267774
FFR-guided PCI (PCI with implantation of drug-eluting stents guided by FFR measurements in addition to angiography
versus
angiography-PCI (PCI with implantation of drug-eluting stents guided by angiography alone)
patients with multivessel coronary artery disease open
Follow-up duration: 1 year
USA, Europe
DEFER, 2001
PCI
versus
deferral (no PCI)
patients for whom PTCA was planned and who did not have documented ischemia and with fractional flow reserve >0.75open
Follow-up duration: 24 months
Genous stent versus paclitaxel eluting stent
TRIAS-HR, 2008
ISRCTN74297220
Genous stent (antibody-coated bare-metal stent) followed by one month of dual antiplatelet therapy
versus
Taxus or Cypher followed by at least six months of dual antiplatelet therapy
high-risk patients (long lesions, small vessels, chronic total occlusions, or any lesion in a diabetic patient)single-blind
Follow-up duration: 12 months
Nevo versus paclitaxel eluting stent
NEVO RES-ELUTION I, 0
NCT00714883
Nevo sirolimus eluting stent with bioresordable PLGA polymer
versus
placlitaxel eluting stent (Liberté)
patients with single, de novo lesions open
Follow-up duration: 6 months
Europe, Brazil, Australia, and New Zealand
paclitaxel eluting stent versus balloon angioplasty
ISAR-DESIRE (PES vs PTCA), 2005
TAXUS
versus
ballon angioplasty
In-stent restenosis. AP and/or positive test, previously stented, no AMIopen
Follow-up duration: 1y
germany
paclitaxel eluting stent versus bare-metal stent
HAAMU-STENT, 2006
Taxus Express
versus
Bare-metal-stent
AMI - STEMI patients undergoing PCIopen
Follow-up duration: 12 months
Finland
PASSION, 2006
ISRCTN65027270
Taxus Express2
versus
Express2 or Liberté
Myocardial Infarction with ST-Segment Elevationopen
Follow-up duration: 12 months (5y)
The Netherlands
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
TAXUS V (all patients), 2005
NCT00301522
TAXUS
versus
bare metal EXPRESS-2
Stable or unstable AP, silent ischaemia with single coronary artery stenosis including complex or previously unstudied lesions (requiring 2.25-mm, 4.0-mm, and/or multiple stents)double-blind
Follow-up duration: 9 months
United States
TAXUS VI, 2005
NCT00297804
TAXUS
versus
Express2 stent
Stable or unstable AP, silent ischaemia with long, complex coronary artery lesionsdouble-blind
Follow-up duration: 9 months (2y)
Europe
paclitaxel eluting stent versus CABG
SYNTAX, 2009
NCT00114972
paclitaxel (taxus Express SR)
versus
Coronary Artery Bypass Surgery (on- or off-pump bypass)
patients with previously untreated three-vessel or left main coronary artery disease (or both) (complex lesions)open
Follow-up duration: 1 year
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
PCI versus CABG
AWESOME, 2001
percutaneous coronary intervention
versus
coronary artery bypass graft
high-risk patients with medically refractory ischemia open
Follow-up duration: 5 years
US (Veterans Affairs Medical Centers)
PCI with drug-eluting stents versus CABG
FREEDOM, 2012
NCT00086450
percutaneous coronary stenting
versus
CABG
patients with diabetes and multivessel coronary artery diseaseopen
Follow-up duration: 3.8 yrs (median)
international
PCI with or without stent versus medical treatment
TIME, 2001
coronary angiography and revascularisation
versus
optimised medical therapy
patients aged 75 years or older with chronic angina of at least Canadian Cardiac Society class II despite at least two antianginal drugsopen
AVERT, 1995
angioplasty
versus
atorvastatin at 80 mg per day
Angina or asymptomatic, MI orunstable angina but not within 14 days,no triple vessel diseaseopen
Follow-up duration: 1.5y
Dakik, 1998
PTCA
versus
intensive medical therapy
stable survivors of AMIopen
Follow-up duration: 1y
MASS II, 2007
PCI
versus
medical therapy
patients with multivessel coronary artery disease with stable angina and preserved ventricular functionopen
Follow-up duration: 5y
COURAGE, 2007
NCT00007657
PCI coupled with optimal medical therapy
versus
optimal medical therapy aloneitm
patients with stable coronary artery diseaseopen
Follow-up duration: median 4.6 y
Canada, US
ALKK, 2003
angioplasty
versus
medical therapy
patients with single vessel disease of the infarct vessel and no or minor angina pectoris in the subacute phase (1 to 6 weeks) after an acute myocardial infarction open
Follow-up duration: 4.7y
Germany
Hambrecht, 2004
PCI
versus
12 months of exercise training (20 minutes of bicycle ergometry per day)
male patients aged 70 yearsopen
Follow-up duration: 1y
Bech, 2001
PTCA
versus
deferral of PTCA
patients with planned PTCA and no documented ischemia and with coronary pressure–derived fractional flow reserve >0.75open
Follow-up duration: 2y
PCI withdrug-eluting stents versus CABG
Hong, 2005
drug-eluting stents
versus
invasive direct coronary artery bypass (MIDCAB) surgery
proximal left anterior descending (LAD) coronary artery stenosisopen
Follow-up duration: 9 months
PCI withsirolimus ES versus MIDCAB
Thiele, 2009
NCT00299429
sirolimus-eluting stent
versus
MIDCAB surgery
isolated LAD diseaseopen
Follow-up duration: 12 months
Germany
polymer free sirolimus stent versus sirolimus eluting stent
ISAR TEST 3 (PF), 2009
polymer free 2% rapamycin (479 mg rapamycin/cm2) stent
versus
permanent-polymer rapamycin-eluting stent (Cypher) (140 mg rapamycin/cm2)
Patients with de novo coronary lesions in native vessels open
Follow-up duration: 12 months
Germany
polymer-free biolimus a9-eluting stents versus paclitaxel eluting stent
BIOFREEDOM,
NCT01172119
polymer-free biolimus A9-eluting stent
versus
paclitaxel-eluting stent
patients with symptomatic ischemic heart disease, and stenosis in native coronary arteries ranging in diameter from >=2.25 mm to <=3.0 mm
sirolimus biodegradable polymer versus sirolimus eluting stent
ISAR TEST 3 (BP), 2009
biodegradable-polymer 0.4% rapamycin stent (180 mg rapamycin/cm2)
versus
permanent-polymer rapamycin-eluting stent (Cypher) (140 mg rapamycin/cm2)
Patients with de novo coronary lesions in native vesselsopen
Follow-up duration: 12 months
Germany
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 balloon angioplasty
ISAR-DESIRE (SES vs PTCA), 2005
Cypher
versus
ballon angioplasty
In-stent restenosis. AP and/or positive test, previously stented, no AMIopen
Follow-up duration: 1y
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
DECODE, 2005
NCT00489164
CYPHER (Up to 3 stents per patient were allowed)
versus
Bx VELOCITY (Up to 3 stents per patient were allowed)
Stable or unstable angina in diabetic patients with with up to 2 de novo lesions in up to 2 native coronary vesselsopen
Follow-up duration: 1 year
US, Asia/Pacific
DIABETES, 2005
Cypher
versus
Bx Velocity/Sonic
de novo lesions in native coronary arteriesin 1, 2, or 3 native vessels with symptoms or objective evidence of ischemia; vessel size smaller than 4.0 mmopen
Follow-up duration: 9 months
Spanish
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
GISSOC II, 2010
NCT00220558
Sirolimus Eluting Stent
versus
Bare Metal Stent
patients with Chronic Total Occlusion older than 1 month, and successful recanalizationopen
Follow-up duration: 8 months
Italy
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
MISSION, 2008
ISRCTN62825862
Cypher
versus
Vision
primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (<9h)single-blind
Follow-up duration: 12 months
the Netherlands
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
Pasceri, 2003
Cypher
versus

Follow-up duration: 12 months
PRISON II, 2006
NCT00258596
Cypher
versus
BxVelocity
Chronic total occlusion, positive exercise stress testsingle-blind
Follow-up duration: 6 months
Belgium
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
SCANDSTENT, 2006
NCT00151658
Cypher
versus
Sonic
Stable or unstable AP, recent AMI (non ST-elevation); with one or more de novo complex lesions in native coronary vessels (occluded, bifurcational, ostial or angulated)open
Follow-up duration: 7 months
Denmark
SCORPIUS, 2007
NCT00495898
Cypher
versus
Bx-Velocity
patients with diabetes and de novo coronary artery lesionsopen
Follow-up duration: 12 months
Germany
SES-SMART, 2004
Cypher
versus
Bx Sonic
Stable AP, ACS, silent myocardial ischaemia as shown by exercise stress testsingle-blind
Follow-up duration: 8 months
Italian
SESAMI, 2007
NCT00288210
Cypher
versus
BX stent, Cordis
AMIopen
Follow-up duration: 12 months
Italy
SIRIUS, 2003
NCT00232765
SES
versus
Bx Velocity
Stable or unstable AP, signs of myocardial ischaemiadouble-blind
Follow-up duration: 9 months
United States
TYPHOON, 2006
NCT00232830
Cypher or CypherSelect
versus
any commerciallyavailable uncoated stent
AMIopen
Follow-up duration: 12 months
Worldwide (15 countries)
sirolimus eluting stent versus CABG
PRECOMBAT, 2011
NCT00422968
PCI with sirolimus-eluting stents
versus
CABG
patients with unprotected left main coronary artery stenosis
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,
Cervinka, 2006
sirolimus-eluting stent
versus
paclitaxel-eluting stent
Complex lesionsand patients. Signs and/or symptoms myocardial ischaemia, including AMIopen
Follow-up duration: 6 months
CORPAL, 2005
sirolimus
versus
paclitaxel
Documented myocardial ischaemia, no AMIopen
Spain
Di Lorenzo et al., 2005
sirolimus
versus
paclitaxel
ST-segment elevation myocardial infarctionopen
NA
Han, 2006
Cypher
versus
Taxus
Multivessel disease. Stable or unstable AP, no AMIopen
Follow-up duration: 19.5 months (mean)
China
ISAR-DESIRE (SES vs PES), 2005
Cypher
versus
Taxus
In-stent restenosis. AP and/or positive test, previously stented, no AMIopen
Follow-up duration: 1y
germany
ISAR-DIABETES, 2005
Taxus
versus
Cypher
Diabetic patients. AP or positive stress, no AMI with clinically significant angiographic stenosis in a native coronary vessel­open
Follow-up duration: 9 months
Germany
ISAR-LEFT-MAIN, 2009
NCT00133237
Paclitaxel-eluting stent
versus
Sirolimus-eluting stent
Unprotected Left Main Coronary Artery Diseaseopen
Follow-up duration: 1 year
ISAR-SMART 3, 2006
NCT00146575
Taxus
versus
Cypher
Small vessels, de novo lesions in native coronary vessels with a diameter of <2.80 mm nondiabetic patients. AP or positive stress, no AMINA
Germany
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
LONG DES II, 2006
SES
versus
PES
Long lesions. AP or positive stress, no AMIsingle-blind
Follow-up duration: 9 months
Korea
Pan, 2007
SES for provisional T-stenting
versus
PES for provisional T-stenting
patients with bifurcation lesionsopen
Follow-up duration: 24 months (mean)
Spain
Petronio et al, 2007
Cypher
versus
Taxus
Complex lesions. Stable AP or documented ischaemia, no AMIopen
Follow-up duration: 9 months
Italy
PROSIT, 2006
SES Cordis
versus
PES Boston Scientific
AMI or persistent ischaemia 12-24hopen
Follow-up duration: 1 year
Korea
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.
Tomai, 2008
sirolimus-eluting stent
versus
paclitaxel-eluting stent
diabetic patient with multiple de novo coronary artery lesionsNA
Follow-up duration: 8 months
Italy
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
stent versus balloon angioplasty
Lincoff (EPISTENT), 1999
NCT00271401
stent followed by aspirin 325 mg, abciximab
versus
balloon angioplasty followed by aspirin 325 mg, abciximab
patients with ischaemic heart disease and suitable coronary-artery lesions open
Follow-up duration: 6 months
USA, Canada
Hoher, 1999
Wiktor
versus
PTCA alone
patients with a thrombolysis in myocardial infarction grade 0 chronic coronary occlusion open
Follow-up duration: 6 months
Serruys Benestent, 1994
Palmaz-Schatz
versus
balloon angioplasty, aspirin 250-500 mg + dipyridamole 75 mgx3
Stable anginaOpen
Follow-up duration: 7 months
Europe
Fischman STRESS, 1994
Palmaz-Schatz
versus
ballon angioplasty aspirin, dipyridamol
Stable anginaOpen
Follow-up duration: 6 months
USA
Eeckout, 1996
Wiktor stent implantation
versus
conventional balloon angioplasty
Stable anginaopen
Follow-up duration: 6 months
Sirnes, 1996
Palmaz-Schatz
versus
PTCA alone
patients with a satisfactory result after successful recanalization by PTCA of a chronic coronary occlusion open
Follow-up duration: 6 months
Versaci , 1997
Palmaz-Schatz
versus
standard coronary angioplasty, aspirin and diltiazem indefinitely
patients with isolated stenosis of the proximal left anterior descending coronary arteryopen
Follow-up duration: 12 months
Italy
Savage, 1998
Palmaz-Schatz stent
versus
standard balloon angioplasty
patients with new lesions in aortocoronary-venous bypass grafts open
Follow-up duration: 6 months
Erbel, 1998
Palmaz-Schatz
versus
standard balloon angioplasty
patients with clinical and angiographic evidence of restenosis after at least one balloon angioplastyopen
Follow-up duration: 6 months
Rubartelli, 1998
Palmaz-Schatz stent implantation
versus
PTCA alone
patients with recanalized total occlusion open
Follow-up duration: 9 months
Hancock, 1998
Palmaz-Schatz
versus
angioplasty alone
patients with a total coronary occlusion successfully treated by PTCA open
Follow-up duration: 6 months
Serruys Benestent 2, 1998
Heparin-coated Palmaz-Schatz
versus
ballon angioplastyaspirin >=100mg 6 month
Stable and unstable anginaOpen
Follow-up duration: 12 months
Europe
Rodriguez, 1998
stent
versus
optimal PTCA
patients obtaining a good immediate angiographic result after percutaneous transluminal coronary angioplasty open
Follow-up duration: 6 months
Sievert, 1999
stent implantation
versus
angioplasty alone
Stable anginaopen
Follow-up duration: 4 months
Betriu, 1999
Palmaz-Schatz
versus
standard balloon angioplasty
Stable and unstable anginaopen
Follow-up duration: 6 months (4y)
Buller, 1999
Heparin-coated Palmaz-Schatz
versus
PTCA
patients with nonacute native coronary occlusions open
Follow-up duration: 6 months
Serruys, 2000
primary stenting
versus
balloon angioplasty
patients scheduled for single-vessel angioplastyopen
Follow-up duration: 12 months
Di Marlo, 2000
elective stent implantation
versus
guided PTCA
Stable and unstable angina; no AMI inprevious 24 hopen
Follow-up duration: 12 months
Kastrati, 2000
Multilink
versus
PTCA
Patients with symptomatic coronary artery disease with lesions situated in native coronary vessels between 2 and 2.8 mm in size open
Follow-up duration: 7 months
Witkowski, 2000
Palmaz-Schatz stent
versus
angioplasty
Symptomatic CAD; no AMI in previous 14 dopen
Follow-up duration: 6 months
Lafont, 2000
systematic stenting
versus
provisional stenting (group 1, in which stenting was performed if postangioplasty coronary velocity reserve was <2.2 and/or residual stenosis > or =35% or as bail-out)
patients undergoing elective coronary angioplasty open
Follow-up duration: 6 months
Fluck, 2000
Wiktor stent
versus
balloon angioplasty
Symptomatic CAD; no AMI in previous 7 dopen
Follow-up duration: 12 months
Dangas, 2000
elective stenting (Palmaz-Schatz stent)
versus
PTCA with prolonged perfusion balloon inflation
patients with discrete, de novo lesions in native coronary arteries > or =3 mm in diameter open
Follow-up duration: 8 months
Weaver, 2000
routine stent implantation (Palmaz-Schatz)
versus
balloon angioplasty and provisional stenting
patients undergoing single-vessel coronary angioplasty open
Follow-up duration: 6 months
Lotan, 2000
stent implantation (AVE Micro Stent)
versus
no further treatment
with total coronary artery occlusions who had an optimal PTCA result open
Follow-up duration: 6 months
Park, 2000
elective stent placement (7-cell NIR stent)
versus
balloon angioplasty
patients with lesions in small coronary arteries (de novo, non-ostial lesion and reference diameter <3 mm)open
Follow-up duration: 6 months (16 m)
Koning, 2001
stent implantation (beStent Small)
versus
standard balloon angioplasty
symptomatic patients with de novo focal lesion located on a small coronary segment vessel (<3 mm) open
Follow-up duration: 6 months
Doucet, 2001
stent implantation (beStent-Artist)
versus
angioplasty alone
symptomatic patients needing dilatation of 1 native coronary vessel between 2.3 and 2.9 mm in sizeopen
Follow-up duration: 6 months
Moer, 2001
elective stenting treatment with the heparin (Hepamed)-coated beStent
versus
PTCA
patients with stable or unstable anginaopen
Follow-up duration: 6 months
stent versus CABG
ARTS, 2001
Palmaz-Schatz Crown/Cross flex (Cordis)
versus
Conventional CABG
Multi vessel disease with 2 or more de novo lesion in different major arteries Total occlusion < 1monthopen
Follow-up duration: 1 year
International
CARDia (PCI), 2008
ISRCTN19872154
PCI plus stenting (and routine abciximab)
versus
CABG
Patients with diabetes and symptomatic multivessel coronary artery disease or complex single-vessel disease. open
Follow-up duration: 1 y
UK, Ireland
ERACI II, 2003
Gianturco Robin II (Cook) Primary device
versus
Conventional CABG
multi vessel disease Angina CSS III-IV; no angina but large area of heart at risk; unstable =1 vessel to be treated Lesion>3.0mmopen
Follow-up duration: 30d, 1year
Argentinad
LEMANS, 2002
NCT00375063
unprotected left main stenting
versus
coronary artery bypass grafting
patients with unprotected left main coronary artery stenosisopen
Follow-up duration: 1y
Poland
MASS II, 2007
PCI (73% stent)
versus
CABG
patients with multivessel coronary artery disease with stable angina and preserved ventricular functionopen
Follow-up duration: 5y (1y)
South America
Myoprotect, 2004
percutaneous transluminal coronary angioplasty/stent
versus
CABG
patients with symptomatic main-stem and main-stem-equivalent lesions with substantially increased risk for bypass surgeryopen
Follow-up duration: 1 year
Europe
SOS, 2002
NCT00475449
Stent
versus
CABG
multiple vessel disease Symptomatic 1 or more vessel suitable for stentingopen
Follow-up duration: 3 years
Canada, United Kingdom, Europe
stent versus E-ACAB
Cisowski, 0
Tristar, Tera, Penta (Guidant) (Cordis)
versus
endoscopic atraumatic coronary artery bypass grafting
single vessel disease ACC/AHA A or B lesion in proximal LAD Angina CCS II or higher Lesion diameter 3 mm orgreater/length 20mm or greateropen
Follow-up duration: 2 years
Poland
stent versus MIDCAB
Diegeler, 2002
Various stents
versus
minimally invasive direct coronary artery bypass (off-pump proceedure)
single vessel disease Lesion =75% stenosis in proximal LAD or between origin of left circumflex and 1st septal branchopen
Follow-up duration: 5 years
Germany
Drenth, 2002
Stent type not reported
versus
minimally invasive direct coronary artery bypass (off-pump proceedure
single vessel disease Angina II Lesion (Grade B2 or C) of proximal LAD Suitable for CABG or stentingopen
Follow-up duration: 6 months, 3 years
Netherlands
Grip, 2001
Stent type not reported
versus
minimally invasive direct coronary artery bypass (off-pump proceedure)
single vessel disease engaging LAD Stable or unstable anginaopen
Sweden
Kim, 2005
Stent
versus
MIDCAB using ministernotomy
patients with isolated proximal left anterior descending artery diseaseopen
Follow-up duration: 2 years
Korea
SIMA, 2000
Any CE marked, but Palmaz-Schatz recommended
versus
Conventional CABG or minimally invasive direct coronary artery bypass (off-pump proceedure) (10% of surgical procedures
single vessel disease Symptomatic or silent ischaemia 1 LAD lesion Ejection fraction >45% Vessel >3.0mmopen
Follow-up duration: 2.4 years
Europe
stent versus OPCAB
OCTOSTENT, 2003
NCT00975858
Stent type not reported
versus
off-pump coronary artery bypass
multi or single vessel disease Moderate LV function CABG or stenting to be considered feasibleopen
Follow-up duration: 1 year
Europe
titanium-nitride-oxide coated stent versus bare-metal stent
TINOX, 2005
titanium-nitride-oxide coated stents
versus
stainless steel stents of similar design
open
Follow-up duration: 6 mo
Switzerlanf, Germany
TMR versus medical treatment
Aaberge, 2000
transmyocardial revascularization with CO2-laser
versus
continued optimal medical treatment
patients with refractory angina not eligible for conventional revascularizationopen
Follow-up duration: 12 months
Norway
Allen, 1999
transmyocardial revascularization
versus
medical therapy alone
patients with medically refractory class IV angina and coronary disease that could not be treated with percutaneous or surgical revascularizationopen
Follow-up duration: 1 y
US
ATLANTIC (Burkhoff), 1999
Transmyocardial revascularisation
versus
medical treatment alone
patients with Canadian Cardiovascular Society Angina (CCSA) score III or IV, reversible ischaemia, and incomplete response to other therapiesopen
Follow-up duration: 1 y
US
Frazier, 1999
transmyocardial revascularization
versus
continued medical treatment
patients with end-stage coronary artery disease open
Follow-up duration: 12 months (4y)
US
Gray, 2003
percutaneous myocardial laser revascularization
versus
medical therapy alone
with stable angina pectoris (class III or IV) who were unsuitable for conventional revascularization and had evidence of reversible ischemia by thallium-201 scintigraphy, ejection fraction of > or =25%, and myocardial wall thickness > or =8 mmopen
Follow-up duration: 12 months
Huikeshoven, 2003
XeCl excimer transmyocardial laser revascularization
versus
optimal cardiac medication
open
Follow-up duration: 1y
March, 1999
Transmyocardial laser revascularization
versus
continued medical management
patients with symptomatic end-stage coronary artery disease open
Follow-up duration: 12 months
PACIFIC, 2000
Percutaneous transmyocardial laser revascularisation
versus
medical treatment only
patients with reversible ischaemia of Canadian Cardiovascular Society angina class III or IV and incomplete response to other therapiesopen
Follow-up duration: 12 months
US, UK
Salem, 2004
percutaneous myocardial laser revascularization
versus
optimal medical therapy
patients with stable angina pectoris (class III or IV) not amenable to conventional revascularization and with evidence of reversible ischemia, ejection fraction >/=25%, and myocardial wall thickness >/=8 mm double blind
Follow-up duration: 12 months
Norway
Schofield, 1999
Transmyocardial laser revascularisation
versus
medical management alone
patients with refractory anginaopen
Follow-up duration: 1 y
Stone, 2002
percutaneous transmyocardial revascularization
versus
maximal medical therapy
patients with class III or IV angina caused by one or more chronically occluded native coronary arteries in which a percutaneous coronary intervention had failed single blind (patient)
Follow-up duration: 6 months
US
van der Sloot, 2004
XeCl excimer transmyocardial laser revascularization
versus
maximal medication
patients with refractory angina open
Follow-up duration: 12 months
the Netherlands
TMR versus placebo
Leon (high dose), 2005
high-dose myocardial laser channels
versus
placebo (sham procedure)
patients with severe angina double blind
Follow-up duration: 6 months
US
Leon (low dose), 2005
low-dose myocardial laser channels
versus
placebo (sham procedure)
patients with severe angina double blind
Follow-up duration: 6 months
US
TMR versus thoracic sympathectomy
Galiñanes, 2004
Transmyocardial laser revascularization by holmium: yttrium aluminum garnet laser
versus
thoracic sympathectomy
patients with nonrevascularizable coronary arteries and intractable angina open
Follow-up duration: 42 months
TMR+CABG versus CABG
Allen, 2000
coronary bypass of suitable vessels plus transmyocardial revascularization to areas not graftable
versus
coronary bypass alone with nongraftable areas left unrevascularized
patients whose standard of care was coronary artery bypass grafting and who had one or more ischemic areas not amenable to bypass grafting single blind
Loubani, 2003
coronary artery bypass grafting plus transmyocardial laser revascularization with a holmium:YAG (yttrium-aluminum-garnet) laser to nongraftable areas
versus
coronary artery bypass grafting
Patients who had elective coronary artery bypass with one or more nongraftable coronary arteriesopen
Follow-up duration: 36 months
UK
Zhao, 2006
transmyocardial laser revascularization (holmium: YAG) combined with off-pump coronary artery bypass
versus
off-pump coronary artery bypass
patients with diffusely diseased target vessels open
Follow-up duration: 3.4y
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
ZEST AMI (vs PES), 2009
NCT00422565
zotarolimus-eluting stent (Endeavor)
versus
paclitaxel-eluting stent (Taxus Liberté)
Acute Myocardial Infarction Patients (STEMI)requiring primary angioplasty with symptom onset <= 12 hours open
Follow-up duration: 1 year (mean)
Korea
ZoMaxx I, 2008
ZoMaxx zotarolimus-eluting stent
versus
Taxus paclitaxel-eluting stent
patients with single de novo coronary lesions and with lesion length 10-30 mm and reference vessel diameter 2.5-3.5 mm open
Follow-up duration: 9 months
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
ZEST AMI (vs SES), 2009
NCT00422565
zotarolimus-eluting stent (Endeavor)
versus
sirolimus-eluting stents (Cypher)
Acute Myocardial Infarction Patients (STEMI)requiring primary angioplasty with symptom onset <= 12 hours open
Follow-up duration: 1 year (mean)
Korea

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