Titanium-nitride-oxide-coated coronary stents: insights from the available evidence

Figures & data

Table 1. Studies of surrogate angiographic endpoints following titanium-nitride-oxide-coated stent implantation.

Study	Ref.	Study type	No of patients	Cohort	Endpoints	Follow-up duration	Results
Windecker et al.	(23)	randomized trial: BAS versus BMS of identical design	92	unselected patients	LLL Percent diameter stenosis binary restenosis neointimal volume (IVUS)	6 months	LLL lower with BAS versus BMS (0.55 ± 0.63 versus 0.90 ± 0.76 mm, p = .03) Percent diameter stenosis lower with BAS versus BMS (26 ± 17% versus 36 ± 24%, p = .04) Binary restenosis lower with BAS versus BMS (15% versus 33%, p = .07) Neointimal volume smaller with BAS versus BMS (18 ± 21 versus 48 ± 28 mm3, p < .0001)
Sansa et al.	(24)	non-randomized study: BAS versus BMS of other design		patients with acute coronary syndrome	Binary restenosis	6 months	71% reduction of binary restenosis with BAS versus BMS
Pilgrim et al.	(25)	randomized non-inferiority study: BAS versus ZES	302	unselected patients	In-stent LLL (non-inferiority margin 0.15 mm) In-stent binary restenosis In-segment binary	6 to 8 months	In-stent LLL higher with BAS versus ZES (0.64 ± 0.61 versus 0.47 ± 0.48 mm, p non-inferiority = 0.54) In-stent binary restenosis higher with BAS (19.4% versus 10.5%, p = .06) In-segment binary restenosis higher with BAS (20.5% versus 11.1%, p = .04)
López-Mínguez et al.	(26)	randomized study: BAS versus EES	173	diabetic patients	In-stent LLL In-segment LLL	9 months	In-stent LLL higher with BAS versus EES (0.76 ± 0.54 versus 0.13 ± 0.31 mm, p < .0001) In-segment LLL higher with BAS versus EES (0.52 ± 0.58 versus -0.05 ± 0.32 mm, p < .0001)
Valdés Chavarri et al.	(27)	observational study	45 (72 stents)	diabetic patients	LLL by QCA LLL by IVUS	9 months	LLL by QCA 0.56 mm LLL by IVUS 0.5 mm Binary restenosis 15.5%

BAS: indicates bioactive stents; BMS: bare-metal stents; EES: everolimus-eluting stents; IVUS: intravascular ultrasound; LLL: late lumen loss; ZES: zotarolimus-eluting stents.

Table 2. Observational studies of clinical outcome following titanium-nitride-oxide-coated stent implantation.

Study	Ref.	Stent type	No of patients	Cohort	Endpoints	Follow-up duration	Results
Mosseri et al.	(28)	Titan	100 (103 stents)	unselected patients (35% diabetics, 68% ACS)	MACE	6 months	TLR 2% TVR 3%
Mosseri et al.	(29)	Titan	296 (333 stents)	unselected patients (36% diabetics, 81% ACS)	MACE	6 months	Death 0.7% MI 0.6% TLR 5.4% MACE 7.6% ST: acute 0.3%, subacute 0.3%
Karjalainen et al.	(30)	Titan	193 (212 stents)	unselected patients (17% diabetics, 66% ACS)	MACE	9 months	Death 2.1% MI 4.1% TLR 5.2% MACE 10.4% ST 0%
Angioi et al.	(31)	Titan 2	356 (546 stents)	real-world patients (18.3% diabetics, 39.3% ACS)	MACE	12 months	Death 1.2% MI 1.5% TLR 5.1% MACE 7.2% ST (late) 0.3%
Valdesuso et al.	(32)	Titan 2	311 (356 stents)	patients with small vessels (2.0–2.75 mm)	MACE	average 8 ± 2 months	Death 0.7% MI 2.1% TLR 4.2% MACE 8.7% 1 patient suffered subacute ST.
Valdés Chavarri et al.	(27)	Titan	156	diabetic patients	MACE	6 months	Death 1.9% MI 1.3% TLR 7.1% MACE 10.3% ST 0%
Karjalainen et al.	(33)	Optimax	184 (184 stents)	unselected patients (15.2% diabetics, 57.1% ACS)	MACE	6 months	Death 0.5% MI 2.2% TLR 2.7% MACE 4.3% ST 0%
Karjalainen et al.	(34)	Optimax	224 (224 stents)	unselected patients (15.6% diabetics, 62.1% ACS)	MACE	12 months	Death 1.3% MI 3.1% TLR 3.1% MACE 6.3% ST 0%

ACS: indicates acute coronary syndrome; MACE: major adverse cardiac effects; MI: myocardial infarction; ST: stent thrombosis; TLR: target lesion revascularization; TVR: target vessel revascularization.

Table 3. Non-randomized studies of clinical outcome following titanium-nitride-oxide-coated stent implantation.

Study	Ref.	No of patients	Cohort	Endpoints	Follow-up duration	Results
Karjalainen et al.	(35)	BAS (201) versus PES (204)	Unselected patients	MACE	12 months	BAS was associated with reduction of MI (4.5% versus 10.3%, p = .025) and ST (0% versus 3.4% respectively, p = .008), versus PES. TLR (5.0% versus 4.9%, p = .97) and MACE (10.9% versus 13.7%, p = .4) were comparable.
Karjalainen et al.	(36)	BAS (201) versus PES (204)	Unselected patients	adjusted MACE	3 years	BAS was associated with reduction of MI (7.5% versus 19.1%, p < .001), ST (0% versus 7.4%, p < .001), and MACE (13.9% versus 23.5%, p = 0. 008), versus PES. TLR (5.5% versus 9.3%, p = 0.4) was comparable.
Karjalainen et al.	(37)	BAS (201) versus PES (204)	Unselected patients	adjusted MACE	5 years	BAS was associated with reduction of MI (9.5% versus 20.6%, p < .001), ST (0% versus 7.8%, p < .001), and MACE (16.9% versus 26%, p = .005), versus PES. TLR (6% versus 10.3%, p = 0.4) was comparable.
Limacher et al.	(38)	BAS versus SES (319 matched pairs), BAS versus PES (337 matched pairs)	Unselected patients	MACE	3 years	MACE (death, MI and TVR) occurred in 20% of patients with BAS, 19% with SES, and 23% with PES. The HR for BAS was 1.0 versus SES (95% CI 0.69-1.45, p = 1.0), and 0.95 versus PES (95% CI 0.66-1.36, p = .78).
Osterne et al.	(39)	BAS (100) versus second-generation DES (100)	Patients with multi-vessel disease	MACE	12 months	MACE (21% versus 17%), death (3% versus 2%), MI (5% versus 4%), and repeat revascularization (13% versus 11%) were all comparable (p > . 05 for all). No cases of definite ST occurred in either group
Garcia-Gutierrez et al.	(40)	BAS (377) versus ZES (382)	Patients with single-vessel disease	MACE	12 months	MACE rates, as well as the individual endpoints, were comparable (p > .05 for all).

BAS: indicates bioactive stents; CI: confidence interval; DES: drug-eluting stents; HR: hazard ratio; MACE: major adverse cardiac effects; MI: myocardial infarction; PES: paclitaxel-eluting stents; SES: serolimus-eluting stents; ST: stent thrombosis; TLR: target lesion revascularization; TVR; target vessel revascularization; ZES: zotarolimus-eluting stents.

Table 4. Randomized studies of clinical outcome following titanium-nitride-oxide-coated stent implantation.

Study	Ref.	No of patients	Cohort	Endpoints	Follow-up duration	Results
Windecker et al.	(23)	BAS (45) versus BMS (47)	unselected patients	MACE	6 months	BAS was associated with reduction of overall MACE (7% versus 27%, p = .02) and a trend to lower TLR (7% versus 23%, p = .07), versus BMS. The other endpoints were comparable (p > .05 for all).
Moschovitis et al.	(41)	BAS (42) versus BMS (44)	unselected patients	MACE	5 years	BAS was associated with reduction of overall MACE (16% versus 39%, p = .03) and a trend to lower TLR (9% versus 25%, p = .05), versus BMS. The other endpoints were comparable (p > .05 for all).
Sant’Anna et al.	(42)	BAS (100) versus BMS (100)	unselected patients	MACE	2 years	BAS was associated with reduction of overall MACE (6.4% versus 17.6%, p = .036), versus BMS. The other endpoints were comparable (p > .05 for all).
Karjalainen et al.	(43)	BAS (214) versus PES (211)	patients with acute MI	MACE	12 months	BAS was associated with reduction of definite ST (0.5% versus 3.3%, p = .031), versus PES. Overall MACE and the other endpoints were comparable (p > .05 for all).
Karjalainen et al.	(44)	BAS (214) versus PES (211)	patients with acute MI	MACE	2 years	BAS was associated with reduction of overall MACE (11.2% versus 21.8%, p = .004), cardiac death (0.9% versus 4.7%, p = .02), recurrent MI (5.1% versus 15.6%, p < .001), definite ST (0.5% versus 6.2%, p = .001), versus PES. TLR rates were comparable (9.3% versus 10%, p = .87).
Tuomainen et al.	(45)	BAS (214) versus PES (211)	patients with acute MI	MACE	5 years	BAS was associated with reduction of overall MACE (16.4% versus 25.1%, p = .03), cardiac death (1.9% versus 5.7%, p = .04), recurrent MI (8.4% versus 18%, p = .004), definite ST (0.9% versus 7.1%, p = .001), versus PES. Ischemia-driven TLR rates were comparable (11.2% versus 10.9%, p = .92).
Karjalainen et al.	(47)	BAS (417) versus EES (410)	patients with ACS	MACE	12 months	Overall MACE rates were comparable (9.6% versus 9.0%, p = .5), BAS was associated with reduction of MI (2.2% versus 5.9%, p = .007), and a trend toward reduction of definite ST (0.7% versus 2.2%, p = .07), versus EES. Cardiac death (1.9% versus 1.0%, p = .39), and ischemia-driven TLR rates were comparable (6.5% versus 4.9%, p = .37).
Romppanen et al.	(48)	BAS (417) versus EES (410)	patients with ACS	MACE	2 years	Overall MACE rates were comparable (11.3% versus 12.7%, p = .53), BAS was associated with reduction of MI (2.9% versus 7.1%, p = .005), and a trend toward reduction of definite ST (1.0% versus 2.7%, p = .05), versus EES. Cardiac death (2.2% versus 1.7%, p = .64), and ischemia-driven TLR rates were comparable (7.4% versus 7.1%, p = .84).
Karjalainen et al.	(49)	BAS (417) versus EES (410)	patients with ACS	MACE	4 years	Overall MACE rates were comparable (12.9% versus 14.9%, p = .42), BAS was associated with reduction of MI (3.8% versus 7.3%, p = .021), and definite ST (1.0% versus 2.9%, p = .034), versus EES. Cardiac death (2.6% versus 2.4%, p = .86), and ischemia-driven TLR rates were comparable (7.7% versus 8.3%, p = .74).
Karjalainen et al.	(50)	BAS (417) versus EES (410)	patients with ACS	MACE	5 years	Overall MACE rates were comparable (14.4% versus 17.8%, p = .26), BAS was associated with reduction of MI (5.9% versus 9.7%, p = .028), and definite ST (1.1% versus 3.8%, p = .015), versus EES. Cardiac death (2.8% versus 3.8%, p = .76), and ischemia-driven TLR rates were comparable (8.3% versus 9.9%, p = .58).
Pilgrim et al.	(25)	BAS (152) versus ZES (150)	unselected patients	MACE	12 months	Overall MACE (death, non-fatal MI, clinically indicated TVR) rates were comparable (21.1% versus 18%, p = .5). Death (0.7% versus 0.7%, p = 1.0), MI (5.3% versus 6.7%, p = .6), clinically indicated TLR rates (14.5% versus 8.7%, p = .11), and definite/probable ST (0.7% versus 0%, p = .51) were comparable.
Pilgrim et al.	(57)	BAS (152) versus ZES (150)	unselected patients	MACE	5 years	Overall MACE (death, non-fatal MI, clinically indicated TVR) rates were comparable (27.6% versus 25.3%, p = .6). Cardiac death (3.3% versus 2.7%, p = .74), MI (5.3% versus 7.3%, p = .46), clinically indicated TLR rates (15.8% versus 12.7%, p = .38), and definite/probable ST (0.7% versus 0%, p = .51) were comparable.
López-Mínguez et al.	(26)	BAS (83) versus EES (90)	diabetic patients	MACE	12 months	Overall MACE (death, non-fatal MI, stroke, TVR) rates were higher with BAS versus EES (14.5% versus 4.4%, p = .2). MI (1.2% versus 2.2%, p = .6), and TLR rates (8.4% versus 3.3%, p = .15), were comparable. No cases of death or ST occurred.

ACS: indicates acute coronary syndrome; BAS: bioactive stents; BMS: bare-metal stents; EES: everolimus-eluting stents; MACE: major adverse cardiac effects; MI: myocardial infarction; PES: paclitaxel-eluting stents; ST: stent thrombosis; TLR: target lesion revascularization; TVR; target vessel revascularization; ZES: zotarolimus-eluting stents.

Table 5. Studies of optical coherence tomography following titanium-nitride-oxide-coated stent implantation.

Study	Ref.	No of patients	Cohort	Follow-up duration	Results
Lehtinen et al.	(61)	BAS (9) versus PES (9)	patients with acute MI	average 47 months	BAS was associated with a lower percentage of uncovered struts (0.4% versus 10.8%, p < .001), a lower percentage of malapposed struts (0.2% versus 13.8%, p < .001), versus PES. NIH thickness was greater with BAS (265 ± 165 versus 126 ± 126 μm, p < .001).
Karjalainen et al.	(62)	BAS (13) versus EES (15)	patients with ACS	9 months	BAS was associated with a lower percentage of uncovered struts (0.6% versus 10.8%, p < .001), a lower percentage of malapposed struts (0.2% versus 4.6%, p < .001), versus EES. NIH thickness was greater with BAS (274 ± 168 versus 100 ± 101 μm, p < .001).
Karjalainen et al. (personal communication)		BAS (20) versus EES (20)	patients with ACS	18 months	BAS was associated with a lower percentage of uncovered struts (0.5% versus 5.8%, p < .001), a lower percentage of malapposed struts (0.6% versus 2.5%, p < .001), versus EES. NIH thickness was greater with BAS (237 ± 125 versus 108 ± 62 μm, p < .001).
Varho et al.	(63)	CoCr-BAS (19) versus PtCr-EES (19)	patients with ACS	2 months	CoCr-BAS was associated with a lower percentage of uncovered struts (1.2% versus 11.3%, p < .001), a lower percentage of malapposed struts (0% versus 0.6%, p = 0.026), versus PtCr-EES. NIH thickness was greater with CoCr-BAS (240 ± 127 versus 65 ± 59 μm, p < .001).

ACS: indicates acute coronary syndrome; BAS: bioactive stents; CoCr: Cobalt-Chromium-based; EES: everolimus-eluting stents; MI: myocardial infarction; NIH: neointimal hyperplasia; PES: paclitaxel-eluting stents; PtCr: platinum-chromium-based.

Table 6. Compelling indications for the use of the titanium-nitride-oxide-coated stents.

• Patients presenting with acute coronary syndrome who undergo early percutaneous coronary intervention (evidence based on a single randomized controlled trial with adequate statistical power: the BASE ACS trial)

• Patients unwilling or unlikely to be compliant on long-term dual antiplatelet therapy

• Patients receiving life-long oral anticoagulation therapy (especially, those receiving novel oral anticoagulants)

• Patients scheduled for or expected to undergo elective non-cardiac surgery during the period of 6 months following stent implantation

• Patients with increased (or so perceived by the attendant physician) risk of bleeding: those with active peptic ulcer or other conditions associated with gastrointestinal bleeding, those with bleeding disorders, those with recent stroke or intracranial bleeding, those with severe anemia, etc.

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