sirolimus eluting stent trial summary

Endpoint	TE [95% CI]	p val	I2	n	k	trials
2 yr Death (all cause)	no data
4 yr mortality from all causes	no data
myocardial infarction (fatal and non fatal)	0.87 [0.70 1.09]	p=1.00	0	9504	18	TAXi,ISAR-DESIRE (SES vs PES),ISAR-DIABETES,SIRTAX (Windecker),CORPAL,REALITY,ISAR-SMART 3,Zhang (SES vs PES),LONG DES II,PROSIT,SORT OUT II,Cervinka,Petronio et al,Han,BASKET (vs paclitaxel),Di Lorenzo et al.,ISAR-LEFT-MAIN,Pan,
cardiac death	0.83 [0.44 1.57]	p=1.00	0	5268	5	SIRTAX (Windecker),REALITY,LONG DES II,PROSIT,SORT OUT II,
4 yr MI	no data
4 yr death or MI	no data
MACE	0.77 [0.63 0.96]	p=0.04	0	5790	6	SIRTAX (Windecker),REALITY,Zhang (SES vs PES),PROSIT,SORT OUT II,ISAR-LEFT-MAIN,
2 yr MACE	no data
target-vessel revascularization	0.63 [0.45 0.89]	p=0.04	0	5163	5	ISAR-DESIRE (SES vs PES),SIRTAX (Windecker),REALITY,LONG DES II,SORT OUT II,
2 yr TLR	no data
4 yr TLR	no data
target lesion revascularisation	0.71 [0.59 0.87]	p=0.04	0	8697	16	BASKET (vs paclitaxel),Di Lorenzo et al.,TAXi,ISAR-DIABETES,SIRTAX (Windecker),CORPAL,REALITY,ISAR-SMART 3,Zhang (SES vs PES),LONG DES II,PROSIT,SORT OUT II,Cervinka,Petronio et al,Han,Pan,
CABG	2.94 [0.12 73.07]	p=1.00	0	202	1	TAXi,
in-lesion binary restenosis	0.88 [0.65 1.19]	p=1.00	0	1911	1	REALITY,
angiographic restenosis	0.77 [0.59 0.99]	p=0.04	0	3018	3	REALITY,LONG DES II,ISAR-LEFT-MAIN,
All cause death	0.86 [0.66 1.12]	p=1.00	0	9954	19	TAXi,ISAR-DESIRE (SES vs PES),ISAR-DIABETES,SIRTAX (Windecker),CORPAL,REALITY,ISAR-SMART 3,Zhang (SES vs PES),LONG DES II,PROSIT,SORT OUT II,Cervinka,Petronio et al,Han,BASKET (vs paclitaxel),Di Lorenzo et al.,ISAR-TEST-1,ISAR-LEFT-MAIN,Pan,
Stent thrombosis (any, end of follow up)	0.79 [0.56 1.13]	p=1.00	0	9108	17	TAXi,ISAR-DESIRE (SES vs PES),ISAR-DIABETES,SIRTAX (Windecker),CORPAL,REALITY,ISAR-SMART 3,Zhang (SES vs PES),LONG DES II,PROSIT,SORT OUT II,Cervinka,Petronio et al,Han,BASKET (vs paclitaxel),Di Lorenzo et al.,ISAR-TEST-1,
4y stent thrombosis (ARC)	0.67 [0.47 0.96]	p=0.04	0	8692	16	TAXi,ISAR-DESIRE (SES vs PES),ISAR-DIABETES,SIRTAX (Windecker),CORPAL,REALITY,ISAR-SMART 3,Zhang (SES vs PES),LONG DES II,PROSIT,SORT OUT II,Cervinka,Petronio et al,Han,BASKET (vs paclitaxel),Di Lorenzo et al.,
4 yr stent thrombosis	no data
Acute stent thrombosis (<=24h)	0.45 [0.10 2.02]	p=1.00	0	1661	2	REALITY,PROSIT,
sub acute stent thrombosis (1-30 days)	0.40 [0.12 1.41]	p=1.00	0	1661	2	REALITY,PROSIT,
late stent thrombosis (31days - 1year)	0.77 [0.11 5.28]	p=1.00	0	1911	3	ISAR-DIABETES,REALITY,PROSIT,

TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients

All type of patients: 52 trials - Tomai - Kochiadakis - RAVEL - SIRIUS - C-SIRIUS - E-SIRIUS - SES-SMART - DIABETES - Pache et al - PRISON II - SCANDSTENT - TYPHOON - SESAMI - DECODE - SCORPIUS - MISSION - Ortolani et al - TAXi - ISAR-DESIRE (SES vs PES) - ISAR-DIABETES - SIRTAX (Windecker) - CORPAL - REALITY - ISAR-SMART 3 - Zhang (SES vs PES) - LONG DES II - PROSIT - SORT OUT II - Cervinka - Petronio et al - Han - BASKET (vs paclitaxel) - Di Lorenzo et al. - Pasceri - DES-ISR - GISSOC II - FOCUS - Lipsia-Yukon-DM - ISAR-TEST-1 - ISAR-LEFT-MAIN - MIDCAB Versus DES in Proximal LAD Lesions - Munich Study - BASKET-PROVE - Kim - ISAR-DESIRE (SES vs PTCA) - Pan - DES-DIABETES - Gao - Thiele - DEBATER (SES vs BMS) - BASKET-PROVE (SES) - PRECOMBAT

No demonstrated result

suggested target-vessel revascularization by 76% (not demonstrated)

No demonstrated result

suggested myocardial infarction (fatal and non fatal) by 33% (not demonstrated)

suggested MACE by 62% (not demonstrated)

suggested 2 yr MACE by 44% (not demonstrated)

suggested target-vessel revascularization by 59% (not demonstrated)

suggested target lesion revascularisation by 74% (not demonstrated)

suggested CABG by 58% (not demonstrated)

suggested angiographic restenosis by 81% (not demonstrated)

Endpoint	TE [95% CI]	p val	I2	n	k	trials
2 yr Death (all cause)	no data
4 yr mortality from all causes	no data
myocardial infarction (fatal and non fatal)	0.67 [0.46 0.97]	p=0.04	0	4362	9	RAVEL,SIRIUS,C-SIRIUS,E-SIRIUS,SES-SMART,PRISON II,SESAMI,MISSION,BASKET-PROVE (SES),
cardiac death	0.62 [0.32 1.19]	p=1.00	0	1850	2	MISSION,BASKET-PROVE (SES),
4 yr MI	no data
4 yr death or MI	no data
MACE	0.38 [0.32 0.46]	p=0.04	0	5344	12	RAVEL,SIRIUS,C-SIRIUS,E-SIRIUS,SES-SMART,DIABETES,Pache et al,PRISON II,SCANDSTENT,SESAMI,MISSION,BASKET-PROVE (SES),
2 yr MACE	0.56 [0.42 0.75]	p=0.04	0	2568	3	DIABETES,DEBATER (SES vs BMS),BASKET-PROVE (SES),
target-vessel revascularization	0.41 [0.33 0.51]	p=0.04	0	4127	6	SIRIUS,PRISON II,TYPHOON,SESAMI,MISSION,BASKET-PROVE (SES),
2 yr TLR	1.11 [0.57 2.17]	p=1.00	0	310	2	DIABETES,GISSOC II,
4 yr TLR	no data
target lesion revascularisation	0.26 [0.20 0.33]	p=0.04	0	3884	12	RAVEL,SIRIUS,C-SIRIUS,E-SIRIUS,SES-SMART,DIABETES,Pache et al,PRISON II,SCANDSTENT,SESAMI,DECODE,MISSION,
CABG	0.42 [0.18 0.98]	p=0.04	0	2315	6	RAVEL,SIRIUS,C-SIRIUS,E-SIRIUS,SES-SMART,MISSION,
in-lesion binary restenosis	no data
angiographic restenosis	0.19 [0.15 0.24]	p=0.04	0	3895	13	RAVEL,SIRIUS,C-SIRIUS,E-SIRIUS,SES-SMART,DIABETES,PRISON II,SCANDSTENT,SESAMI,SCORPIUS,MISSION,GISSOC II,DEBATER (SES vs BMS),
All cause death	0.85 [0.59 1.21]	p=1.00	0	5976	13	RAVEL,SIRIUS,C-SIRIUS,E-SIRIUS,SES-SMART,Pache et al,PRISON II,SCANDSTENT,TYPHOON,SESAMI,DECODE,MISSION,BASKET-PROVE (SES),
Stent thrombosis (any, end of follow up)	0.81 [0.52 1.29]	p=1.00	0	5479	12	RAVEL,SIRIUS,C-SIRIUS,E-SIRIUS,SES-SMART,PRISON II,SCANDSTENT,TYPHOON,SESAMI,DECODE,MISSION,BASKET-PROVE (SES),
4y stent thrombosis (ARC)	0.73 [0.24 2.22]	p=1.00	0	2157	3	SESAMI,MISSION,BASKET-PROVE (SES),
4 yr stent thrombosis	no data
Acute stent thrombosis (<=24h)	0.98 [0.02 49.74]	p=1.00	0	1058	1	SIRIUS,
sub acute stent thrombosis (1-30 days)	0.73 [0.13 3.90]	p=1.00	0	468	2	DIABETES,MISSION,
late stent thrombosis (31days - 1year)	0.44 [0.11 1.76]	p=1.00	0	1906	5	RAVEL,SIRIUS,C-SIRIUS,E-SIRIUS,DIABETES,

TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients

No demonstrated result

suggested MACE by 25% (not demonstrated)

suggested target-vessel revascularization by 40% (not demonstrated)

suggested target lesion revascularisation by 31% (not demonstrated)

suggested angiographic restenosis by 32% (not demonstrated)

suggested 4y stent thrombosis (ARC) by 33% (not demonstrated)

Endpoint	TE [95% CI]	p val	I2	n	k	trials
2 yr Death (all cause)	no data
4 yr mortality from all causes	no data
myocardial infarction (fatal and non fatal)	0.87 [0.70 1.09]	p=1.00	0	10073	20	TAXi,ISAR-DESIRE (SES vs PES),ISAR-DIABETES,SIRTAX (Windecker),CORPAL,REALITY,ISAR-SMART 3,Zhang (SES vs PES),LONG DES II,PROSIT,SORT OUT II,Cervinka,Petronio et al,Han,BASKET (vs paclitaxel),Di Lorenzo et al.,ISAR-LEFT-MAIN,Kim,Pan,DES-DIABETES,
cardiac death	0.80 [0.43 1.50]	p=1.00	0	5668	6	SIRTAX (Windecker),REALITY,LONG DES II,PROSIT,SORT OUT II,DES-DIABETES,
4 yr MI	no data
4 yr death or MI	no data
MACE	0.75 [0.61 0.92]	p=0.04	0	6190	7	SIRTAX (Windecker),REALITY,Zhang (SES vs PES),PROSIT,SORT OUT II,ISAR-LEFT-MAIN,DES-DIABETES,
2 yr MACE	no data
target-vessel revascularization	0.60 [0.44 0.83]	p=0.04	0	5563	6	ISAR-DESIRE (SES vs PES),SIRTAX (Windecker),REALITY,LONG DES II,SORT OUT II,DES-DIABETES,
2 yr TLR	no data
4 yr TLR	no data
target lesion revascularisation	0.69 [0.57 0.83]	p=0.04	0	9266	18	BASKET (vs paclitaxel),Di Lorenzo et al.,TAXi,ISAR-DIABETES,SIRTAX (Windecker),CORPAL,REALITY,ISAR-SMART 3,Zhang (SES vs PES),LONG DES II,PROSIT,SORT OUT II,Cervinka,Petronio et al,Han,Kim,Pan,DES-DIABETES,
CABG	1.28 [0.27 6.00]	p=1.00	0	771	3	TAXi,Kim,DES-DIABETES,
in-lesion binary restenosis	0.76 [0.57 1.02]	p=1.00	0	2311	2	REALITY,DES-DIABETES,
angiographic restenosis	0.68 [0.53 0.87]	p=0.04	0	3587	5	REALITY,LONG DES II,ISAR-LEFT-MAIN,Kim,DES-DIABETES,
All cause death	0.85 [0.66 1.11]	p=1.00	0	10523	21	TAXi,ISAR-DESIRE (SES vs PES),ISAR-DIABETES,SIRTAX (Windecker),CORPAL,REALITY,ISAR-SMART 3,Zhang (SES vs PES),LONG DES II,PROSIT,SORT OUT II,Cervinka,Petronio et al,Han,BASKET (vs paclitaxel),Di Lorenzo et al.,ISAR-TEST-1,ISAR-LEFT-MAIN,Kim,Pan,DES-DIABETES,
Stent thrombosis (any, end of follow up)	0.81 [0.57 1.14]	p=1.00	0	9508	18	TAXi,ISAR-DESIRE (SES vs PES),ISAR-DIABETES,SIRTAX (Windecker),CORPAL,REALITY,ISAR-SMART 3,Zhang (SES vs PES),LONG DES II,PROSIT,SORT OUT II,Cervinka,Petronio et al,Han,BASKET (vs paclitaxel),Di Lorenzo et al.,ISAR-TEST-1,DES-DIABETES,
4y stent thrombosis (ARC)	0.67 [0.47 0.96]	p=0.04	0	8692	16	TAXi,ISAR-DESIRE (SES vs PES),ISAR-DIABETES,SIRTAX (Windecker),CORPAL,REALITY,ISAR-SMART 3,Zhang (SES vs PES),LONG DES II,PROSIT,SORT OUT II,Cervinka,Petronio et al,Han,BASKET (vs paclitaxel),Di Lorenzo et al.,
4 yr stent thrombosis	no data
Acute stent thrombosis (<=24h)	0.63 [0.16 2.47]	p=1.00	0	2061	3	REALITY,PROSIT,DES-DIABETES,
sub acute stent thrombosis (1-30 days)	0.44 [0.13 1.45]	p=1.00	0	2061	3	REALITY,PROSIT,DES-DIABETES,
late stent thrombosis (31days - 1year)	0.81 [0.14 4.56]	p=1.00	0	2311	4	ISAR-DIABETES,REALITY,PROSIT,DES-DIABETES,

TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients

Bifurcation lesion: 1 trials - Pan

No demonstrated result

suggested target lesion revascularisation by 70% (not demonstrated)

Bypass graft lesion: 1 trials - RRISC

No demonstrated result

suggested 2 yr Death (all cause) by 2139% (not demonstrated)

suggested target-vessel revascularization by 81% (not demonstrated)

Diabetic patients : 14 trials - Tomai - DIABETES - DECODE - ISAR-DIABETES - Ravel (diabetics) - SES-SMARt (diabetics) - Lipsia-Yukon-DM - SIRTAX diabetics - DESSERT - Kim - TAxi (diabetics) - REALITY (diabetics) - SIRIUS (diabetics) - DES-DIABETES

No demonstrated result

suggested MACE by 55% (not demonstrated)

suggested 2 yr MACE by 69% (not demonstrated)

suggested target-vessel revascularization by 75% (not demonstrated)

suggested 2 yr TLR by 78% (not demonstrated)

suggested target lesion revascularisation by 75% (not demonstrated)

suggested angiographic restenosis by 88% (not demonstrated)

No demonstrated result

suggested target lesion revascularisation by 36% (not demonstrated)

suggested in-lesion binary restenosis by 79% (not demonstrated)

suggested angiographic restenosis by 75% (not demonstrated)

In stent restenosis: 7 trials - SISR - ISAR-DESIRE (SES vs PES) - CRISTAL - DES-ISR - FOCUS - ISAR-DESIRE-2 - RIBS-II

No demonstrated result

suggested MACE by 48% (not demonstrated)

suggested target-vessel revascularization by 50% (not demonstrated)

suggested target lesion revascularisation by 56% (not demonstrated)

suggested CABG by 92% (not demonstrated)

No demonstrated result

suggested MACE by 62% (not demonstrated)

suggested target-vessel revascularization by 65% (not demonstrated)

Long or complex lesion: 4 trials - PRISON II - SCANDSTENT - CORPAL - LONG DES II

No demonstrated result

suggested MACE by 86% (not demonstrated)

suggested target-vessel revascularization by 64% (not demonstrated)

suggested target lesion revascularisation by 87% (not demonstrated)

suggested angiographic restenosis by 87% (not demonstrated)

No demonstrated result

suggested target-vessel revascularization by 58% (not demonstrated)

suggested target lesion revascularisation by 38% (not demonstrated)

suggested angiographic restenosis by 75% (not demonstrated)

Single vessel disease: 1 trials - Thiele

No demonstrated result

Small vessels: 3 trials - SES-SMART - ISAR-SMART 3 - SIRTAX (small vessels subgroup)

No demonstrated result

suggested myocardial infarction (fatal and non fatal) by 80% (not demonstrated)

suggested MACE by 70% (not demonstrated)

suggested target lesion revascularisation by 67% (not demonstrated)

suggested angiographic restenosis by 82% (not demonstrated)

No demonstrated result

suggested MACE by 51% (not demonstrated)

suggested target-vessel revascularization by 60% (not demonstrated)

suggested target lesion revascularisation by 52% (not demonstrated)

Total occlusion: 3 trials - PRISON II - GISSOC II - SCANDSTENT (subgroup)

No demonstrated result

suggested MACE by 83% (not demonstrated)

suggested target-vessel revascularization by 73% (not demonstrated)

suggested 2 yr TLR by 453% (not demonstrated)

suggested target lesion revascularisation by 79% (not demonstrated)

suggested angiographic restenosis by 85% (not demonstrated)

Unparticular patients: 20 trials - Kochiadakis - RAVEL - SIRIUS - C-SIRIUS - E-SIRIUS - Pache et al - Ortolani et al - TAXi - SIRTAX (Windecker) - REALITY - Zhang (SES vs PES) - SORT OUT II - Han - BASKET (vs paclitaxel) - ISAR-TEST-1 - MIDCAB Versus DES in Proximal LAD Lesions - Munich Study - Wessely - BASKET-PROVE - Gao

No demonstrated result

suggested MACE by 60% (not demonstrated)

suggested target-vessel revascularization by 59% (not demonstrated)

suggested target lesion revascularisation by 74% (not demonstrated)

suggested angiographic restenosis by 81% (not demonstrated)

No demonstrated result

Unprotected left main artery stenosis: 1 trials - ISAR-LEFT-MAIN

No demonstrated result

Stable angina

All type of patient: 38 trials - Tomai - Kochiadakis - RAVEL - SIRIUS - C-SIRIUS - E-SIRIUS - SES-SMART - DIABETES - Pache et al - PRISON II - SCANDSTENT - DECODE - SCORPIUS - Ortolani et al - TAXi - ISAR-DESIRE (SES vs PES) - ISAR-DIABETES - SIRTAX (Windecker) - CORPAL - REALITY - ISAR-SMART 3 - Zhang (SES vs PES) - LONG DES II - Cervinka - Petronio et al - Han - BASKET (vs paclitaxel) - Di Lorenzo et al. - Pasceri - DES-ISR - GISSOC II - FOCUS - Lipsia-Yukon-DM - ISAR-TEST-1 - ISAR-LEFT-MAIN - MIDCAB Versus DES in Proximal LAD Lesions - Kim - Thiele

No demonstrated result

suggested MACE by 65% (not demonstrated)

suggested 2 yr MACE by 69% (not demonstrated)

suggested target-vessel revascularization by 60% (not demonstrated)

suggested target lesion revascularisation by 75% (not demonstrated)

suggested angiographic restenosis by 83% (not demonstrated)

No demonstrated result

suggested MACE by 20% (not demonstrated)

suggested target-vessel revascularization by 37% (not demonstrated)

suggested target lesion revascularisation by 27% (not demonstrated)

suggested angiographic restenosis by 25% (not demonstrated)

suggested 4y stent thrombosis (ARC) by 44% (not demonstrated)

Endpoint	TE [95% CI]	p val	I2	n	k	trials
2 yr Death (all cause)	no data
4 yr mortality from all causes	no data
myocardial infarction (fatal and non fatal)	0.87 [0.69 1.09]	p=1.00	0	7065	16	TAXi,ISAR-DESIRE (SES vs PES),ISAR-DIABETES,SIRTAX (Windecker),CORPAL,REALITY,ISAR-SMART 3,Zhang (SES vs PES),LONG DES II,Cervinka,Petronio et al,Han,BASKET (vs paclitaxel),Di Lorenzo et al.,ISAR-LEFT-MAIN,Kim,
cardiac death	0.95 [0.44 2.04]	p=1.00	0	2865	3	SIRTAX (Windecker),REALITY,LONG DES II,
4 yr MI	no data
4 yr death or MI	no data
MACE	0.80 [0.64 0.99]	p=0.04	0	3384	4	SIRTAX (Windecker),REALITY,Zhang (SES vs PES),ISAR-LEFT-MAIN,
2 yr MACE	no data
target-vessel revascularization	0.63 [0.45 0.88]	p=0.04	0	3065	4	ISAR-DESIRE (SES vs PES),SIRTAX (Windecker),REALITY,LONG DES II,
2 yr TLR	no data
4 yr TLR	no data
target lesion revascularisation	0.73 [0.60 0.89]	p=0.04	0	6258	14	BASKET (vs paclitaxel),Di Lorenzo et al.,TAXi,ISAR-DIABETES,SIRTAX (Windecker),CORPAL,REALITY,ISAR-SMART 3,Zhang (SES vs PES),LONG DES II,Cervinka,Petronio et al,Han,Kim,
CABG	1.90 [0.16 22.87]	p=1.00	0	371	2	TAXi,Kim,
in-lesion binary restenosis	0.88 [0.65 1.19]	p=1.00	0	1911	1	REALITY,
angiographic restenosis	0.75 [0.58 0.97]	p=0.04	0	3187	4	REALITY,LONG DES II,ISAR-LEFT-MAIN,Kim,
All cause death	0.87 [0.66 1.15]	p=1.00	0	7515	17	TAXi,ISAR-DESIRE (SES vs PES),ISAR-DIABETES,SIRTAX (Windecker),CORPAL,REALITY,ISAR-SMART 3,Zhang (SES vs PES),LONG DES II,Cervinka,Petronio et al,Han,BASKET (vs paclitaxel),Di Lorenzo et al.,ISAR-TEST-1,ISAR-LEFT-MAIN,Kim,
Stent thrombosis (any, end of follow up)	0.74 [0.46 1.18]	p=1.00	0	6702	15	TAXi,ISAR-DESIRE (SES vs PES),ISAR-DIABETES,SIRTAX (Windecker),CORPAL,REALITY,ISAR-SMART 3,Zhang (SES vs PES),LONG DES II,Cervinka,Petronio et al,Han,BASKET (vs paclitaxel),Di Lorenzo et al.,ISAR-TEST-1,
4y stent thrombosis (ARC)	0.56 [0.36 0.86]	p=0.04	0	6289	14	TAXi,ISAR-DESIRE (SES vs PES),ISAR-DIABETES,SIRTAX (Windecker),CORPAL,REALITY,ISAR-SMART 3,Zhang (SES vs PES),LONG DES II,Cervinka,Petronio et al,Han,BASKET (vs paclitaxel),Di Lorenzo et al.,
4 yr stent thrombosis	no data
Acute stent thrombosis (<=24h)	0.49 [0.09 2.68]	p=1.00	0	1353	1	REALITY,
sub acute stent thrombosis (1-30 days)	0.42 [0.11 1.63]	p=1.00	0	1353	1	REALITY,
late stent thrombosis (31days - 1year)	0.71 [0.08 6.46]	p=1.00	0	1603	2	ISAR-DIABETES,REALITY,