Update on stents: Recent studies on the TAXUS^® stent system in small vessels

Figures & data

Table 1 An overview of the TAXUS trials

	TAXUSI (Grube et al 2003)	TAXUS II (Colombo et al 2003)	TAXUS III (Tanabe et al 2003)
Published year	2003	2003	2003
Trial design	Randomized	Randomized	Single arm
Used device	TAXUS NIRx	TAXUS NIRx	TAXUS NIRx
Release kinetics	SR	SR and MR	SR
Patient number	TAXUS 31 Control 30	TAXUS SR 131, SR control 136 TAXUS MR 135, MR control 134	TAXUS 28
Lesion morphology	Single de novo or restenotic lesion in a native coronary artery	Single de novo lesion in a native coronary artery	In-stent restenosis in a native coronary artery with evidence of ischemia
Lesion length	= 12 mm	= 12 mm	= 30 mm
Vessel diameter	3.0 to 3.5 mm	3.0 to 3.5 mm	3.0 to 3.5 mm
Primary endpoint	MACE at 30 days	Mean % stent volume obstructed by neointimal proliferation measured by IVUS at 6 months	N/A
	TAXUS IV (Stone et al 2004a)	TAXUS V (Stone et al 2005)	TAXUS VI (Dawkins et al 2005)
Published year	2004	2005	2005
Trial design	Randomized	Randomized	Randomized
Used device	TAXUS EXPRESS	TAXUS EXPRESS^2	TAXUS EXPRESS^2
Release kinetics	SR	SR	MR
Patient number	TAXUS 662 Control 652	TAXUS 577 Control 579	TAXUS 219 Control 227
Lesion morphology	Single de novo lesion in a native coronary artery	Single de novo lesion in a native coronary artery	De novo lesion within a single native coronary artery
Lesion length	10 to 28 mm	10 to 46 mm	18 to 40 mm
Vessel diameter	2.5 to 3.75 mm	2.25 to 4.0 mm	2.5 to 3.75 mm
Primary endpoint	Ischemia driven TVR at 9 months	Ischemia driven TVR at 9 months	TVR at 9 months

IVUS, intravascular ultrasound; MACE, major adverse cardiac events; N/A, not available; MR, moderate release; SR, slow release; TVR, target vessel revascularization.

Table 2 Clinical and angiographic results in patients with small vessel disease in the TAXUS trials

	TAXUS IV subanalysis RVD <2.5 mm (Stone et al 2004a, 2004b)			TAXUS V subanalysis 2.25 mm stent implantation (Stone et al 2005)			TAXUS VI subanalysis RVD <2.5 mm (Dawkins et al 2005)
	PES	BMS	p value	PES	BMS	p value	PES	BMS	p value
Clinical outcomes
Acute phase				30 days
Death				0	0
MI				5.6%	1.1%	0.12
TLR				0.9%	1.1%	1.00
TVR				1.9%	2.1%	1.00
MACE				5.6%	2.1%	0.29
Stent thrombosis				0.9%	1.1%	1.00
Follow up		12 months		9 months			9 months
Death				1.9%	1.1%	1.00
MI				5.7%	2.2%	0.29
TLR	5.6%	20.6%	<0.0001	10.4%	21.5%	0.03	5.0%	29.7%	0.0003
TVR				16.0%	24.7%	0.16
MACE				18.9%	26.9%	0.23
Stent thrombosis				1.0%	1.1%	1.00
Baseline QCA
RVD				2.07 ± 0.31	2.10 ± 0.33	0.46
Lesion length				16.6 ± 9.7	16.4 ± 9.2	0.91
Follow-up QCA		9 months			9 months			9 months
Late Loss (instent)				0.49 ± 0.61	0.90 ± 0.63	<0.001	0.23 ± 0.45	0.95 ± 0.52	<0.0001
Late Loss (segment)				0.36 ± 0.53	0.61 ± 0.59	0.004
Restenosis (instent)				24.7%	44.7%	0.007	7.3%	40.4%	<0.0001
Restenosis (segment)	10.2%	38.5%	<0.001	31.2%	49.4%	0.01

BMS, bare metal stent; MACE, major adverse cardiac events; MI, myocardial infarction; PES, paclitaxel-eluting stent; QCA, quantitative coronary angiography; RVD, reference vessel diameter; TLR, target lesion revascularization; TVR, target vessel revascularization.

Table 3 Silver score system

Evaluation Parameter	Possible points
Clinical Primary Endpoint (TLR, TVR, TVF, MACE)	Yes = 3 No = 0
Double-Blind (including physicians)	Yes = 1 No = 0
Evaluation Interval of Primary Endpoint ≥6 Months	Yes = 1 No = 0
Multi-Center (at least 3 centers)	Yes = 1 No = 0
Clinical Events Committee/Data Safety Monitoring Board Independent and External from Steering Committee	Yes = 1 No = 0
Primary Endpoint Reached	Yes = 1 No = 0
Power of ≥80% for Primary Endpoint Achieved	Yes = 1 No = 0
Follow-up Percentage ≥80% for Angiographic Primary Endpoint or Follow-up Percentage of ≥95% for Clinical Primary Endpoint	Yes = 1 No = 0
Maximum Silber Score	10
Minimum Silber Score	0

TLR, target lesion revascularization; TVF, target vessel failure; TVR, target vessel revascularization; MACE, major adverse cardiac events.

Table 4 Clinical and angiographic results of the studies comparing PES to SES implantation in patients with small vessel disease

	ISAR-SMART 3 (Mehilli et al 2006)			Park et al (Park et al 2006)			RESEARCH and T-SEARCH subanalysis (Rodriguez-Granillo et al 2005; Tanimoto et al 2006)
	SES	PES	p value	SES	PES	p value	SES	PES	p value
Patient number	n = 180	n = 180		n = 121	n = 76		n = 107	n = 92
Trial design	Randomized trial			Non-randomized trial			Non-randomized trial
Clinical outcomes
Acute phase	30 days			In hospital			30 days
Death				0%	0%	1	0.9%	2.2%	0.59
MI	3.9%	3.3%	0.78	12.4%	13.2%	0.54	2.8%	6.7%	0.31
TLR	0%	0.6%	0.32	0%	0%	1	2.8%	5.6%	0.47
TVR							2.8%	5.6%	0.47
MACE				12.4%	13.2%	0.54	4.7%	12.2%	0.07
Stent thrombosis	0%	0%	>0.99	0%	0%	1	0%	2.2%	0.21
Follow up	12 months			9 months			12 months
Death	1.7%	2.2%	>0.99	0%	0%	1	0.9%	4.3%	0.18
MI	3.9%	3.3%	0.78	12.4%	13.2%	0.54	2.8%	7.8%	0.19
TLR	6.6%	14.7%	0.008	3.3%	14.4%	<0.01	6.5%	11.1%	0.31
TVR							7.5%	12.2%	0.33
MACE				15.7%	27.6%	<0.01	9.3%	18.9%	0.06
Stent thrombosis							0%	2.2%	0.21
Baseline QCA
RVD	2.44 ± 0.34	2.40 ± 0.38	0.34	2.47 ± 0.21	2.44 ± 0.25	0.19	1.86 ± 0.37	1.95 ± 0.38	0.15
MLD	0.99 ± 0.40	1.03 ± 0.39	0.33	0.86 ± 0.33	0.81 ± 0.42	0.31	0.47 ± 0.38	0.57 ± 0.38	0.06
DS	59.4 ± 15.3	57.2 ± 14.4	0.15	65.4 ± 13.0	67.5 ± 16.0	0.22	74.8 ± 20.1	70.3 ± 19.3	0.10
Lesion length	12.9 ± 8.0	11.7 ± 6.7	0.12	25.2 ± 14.7	27.1 ± 12.7	0.34	13.0 ± 8.5	16.4 ± 10.4	0.02
Post-PCI QCA
MLD (instent)	2.44 ± 0.36	2.44 ± 0.37	0.8				1.73 ± 0.31	1.82 ± 0.36	0.06
MLD (segment)	2.04 ± 0.47	2.00 ± 0.47	0.41	2.52 ± 0.33	2.42 ± 0.35	0.45	12.3 ± 10.0	14.0 ± 9.8	0.19
DS (instent)	5.6 ± 7.5	6.3 ± 7.7	0.36
DS (segment)	16.7 ± 7.7	18.5 ± 7.2	0.05	3.7 ± 7.1	5.8 ± 8.3	0.06
Follow-up QCA	6 months			6 months
MLD (instent)	2.21 ± 0.66	1.88 ± 0.67	<0.001
MLD (segment)	1.91 ± 0.61	1.67 ± 0.63	<0.001	2.32 ± 0.56	1.77 ± 0.77	<0.01
DS (instent)	17.2 ± 21.5	26.7 ± 21.8	<0.001
DS (segment)	28.4 ± 19.7	35.0 ± 20.6	<0.002	5.38 ± 22.5	31.7 ± 34.9	<0.01
Late loss (instent)	0.25 ± 0.55	0.56 ± 0.59	<0.001
Late loss (segment)	0.13 ± 0.56	0.34 ± 0.57	<0.001	0.29 ± 0.42	0.69 ± 0.62	<0.01
Restenosis (instent)	8.0%	14.9%	0.04
Restenosis (segment)	11.4%	19.0%	0.047	6.7%	27.7%	<0.01

DS, diameter stenosis; MACE, major adverse cardiac events; MI, myocardial infarction; MLD, minimal lumen diameter; PES, paclitaxel-eluting stent; QCA, quantitative coronary angiography; RVD, reference vessel diameter; SES, sirolimus-eluting stent; TLR, target lesion revascularization; TVR, target vessel revascularization.

Table 5 Long-term clinical follow-up trials in small vessel DES stenting

	SIRIUS subanalysis RVD < 2.75 mm (Weisz et al 2006)			RESEARCH and T-SEARCH subanalysis (Tanimoto et al 2006)
	SES	BMS	p value	SES	BMS	p value
Patient number	n = 533	n = 525		n = 107	n = 92
Trial design	Randomized trial			Non-randomized trial
1-year follow up
death				0.9%	4.3%	0.18
MI				2.8%	7.8%	0.19
TLR	6.6%	22.3%	<0.0001	6.5%	11.1%	0.31
TVR				7.5%	12.2%	0.33
MACE				9.3%	18.9%	0.06
Stent thrombosis				0%	2.2%	0.21
2-year follow up
death				1.9%	7.6%	0.08
MI				2.8%	7.6%	0.19
TLR	8.3%	23.0%	<0.0001	6.5%	12.2%	0.22
TVR				7.5%	13.3%	0.24
MACE				10.3%	23.3%	0.02
Stent thrombosis				0%	2.2%	0.21
1-year to 2-year
death				0.9%	3.3%	0.33
MI				0%	0%
TLR	1.7%	0.8%	0.17	0%	1.1%	0.46
TVR				0%	1.1%	0.46
MACE				0.9%	4.3%	0.18
Stent thrombosis				0%	0%

BMS, bare metal stent; MI, myocardial infarction; MACE, major adverse cardiac events; PES, paclitaxel-eluting stent; SES, sirolimus-eluting stent; TLR, target lesion revascularization; TVR, target vessel revascularization.

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