Randomized Comparison of Novel Low-Dose Sirolimus-Eluting Biodegradable Polymer Stent vs Second-Generation DES: TARGET-IV NA Trial

Yeh, RW; Bertrand, OF; Mahmud, E; Barbato, E; Falah, B; Issever, MO; Redfors, B; Popma, A; Curtis, M; van Royen, N; Tanguay, JF; Janssens, L; Newman, WN; Teeuwen, K; Choi, JW; Dirksen, MT; Maehara, A; Leon, MB

doi:10.1016/j.jacc.2024.10.074

Coronary disease & ACS

Randomized Comparison of Novel Low-Dose Sirolimus-Eluting Biodegradable Polymer Stent vs Second-Generation DES: TARGET-IV NA Trial

J Am Coll CardiolPublished 30 Oct 2024Randomised controlled trial

Primary result · TLFResultAbsolute risk difference 0.13% 97.5% CI upper bound 2.03

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Authors' conclusion

The biodegradable polymer sirolimus-eluting stent was noninferior to currently used second-generation DES with regard to TLF at 1 year.

Study context

Population: Patients undergoing PCI for chronic or acute coronary syndromes, North America and Europe
Participants: 1,720 patients · 2,159 lesions

Comparison: Biodegradable polymer sirolimus-eluting stent (BP-SES) vs second-generation DES
BP-SESn = 860
Controln = 860reference
Primary endpoint: Target lesion failure (TLF) (cardiac death, target vessel-related MI or ischemia-driven target lesion revascularization)
Follow-up: 12 months

Methodological detailsprospective, multicentre, single-blind, non-inferiority

Prospective
Multicentre
Single-blind
Non-inferiority

Primary result

TLF

Absolute risk difference

0.13%

97.5% CI upper bound 2.03

P < 0.0001 for non-inferiority

By group

BP-SES3.4%

Control3.3%

BP-SES vs Control

absolute risk difference 0.13% (97.5% CI upper bound 2.03); P for non-inferiority < 0.0001

As reported in the abstract

Secondary outcomes

Mean, mm

Outcome	BP-SES	Control	← Lower with BP-SES ←→ Higher with BP-SES →	Least squares mean difference (90% CI)	P value
In-stent late lumen loss (angiography substudy) · 13 months	0.149 (SD 0.263)	0.327 (SD 0.463)	−0.4−0.200.2	−0.178 (−0.2943 to −0.0632)	P for non-inferiority < 0.0001
			−0.4−0.200.2Difference (linear scale)

In-stent late lumen loss (angiography substudy): 104 patients (97.2%), 128 (94.1%) lesions with angiographic follow-up

Mean neointimal hyperplasia thickness (OCT substudy, 37 patients, 42 lesions) · 13 months

No difference between groups: P for non-inferiority = 0.01

Cardiac death, MI, stent thrombosis

Rates similar between groups

Original publication

Randomized Comparison of Novel Low-Dose Sirolimus-Eluting Biodegradable Polymer Stent vs Second-Generation DES: TARGET-IV NA Trial. J Am Coll Cardiol. Published 30 October 2024. doi:10.1016/j.jacc.2024.10.074

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Summarised from the published abstract; every number is checked against it