Early and Late Outcomes With the Absorb Bioresorbable Vascular Scaffold: Final Report From the ABSORB Clinical Trial Program

Power, DA; Camaj, A; Kereiakes, DJ; Ellis, SG; Gao, R; Kimura, T; Ali, ZA; Stockelman, KA; Dressler, O; Onuma, Y; Serruys, PW; Stone, GW; ABSORB Investigators

doi:10.1016/j.jcin.2024.08.050

Coronary disease & ACS

Early and Late Outcomes With the Absorb Bioresorbable Vascular Scaffold: Final Report From the ABSORB Clinical Trial Program

JACC Cardiovasc IntervPublished 13 Jan 2025Individual-patient-data pooled analysis of randomised trials

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Authors' conclusion

Compared with EES treatment, BVS increased TLF and DT rates through 5-year follow-up. However, the period of excess risk for the first-generation Absorb BVS ended at 3 years, when poly-L-lactic acid bioresorption is complete. Thereafter event rates were comparable or lower with BVS.

Study context

Population: Patients undergoing PCI
Participants: 5,988 patients5 RCTs

Comparison: Absorb bioresorbable vascular scaffold (BVS) vs cobalt-chromium everolimus-eluting stents (EES)
Outcome: Effectiveness: TLF (cardiac death, target vessel MI or ischemia-driven target lesion revascularization); safety: device thrombosis
Follow-up: 0–5 years

Methodological details5 RCTs, 5-year follow-up

5 RCTs
5-year follow-up

Pooled result

As reported in the abstract

5 years

BVS

Target lesion failure (TLF): 15.9%
Device thrombosis (DT): 2.2%

EES

TLF: 13.1%
DT: 1.0%

Target lesion failure (TLF)

BVS15.9%

EES13.1%

Device thrombosis (DT)

BVS2.2%

EES1.0%

BVS vs EESHazard ratio (95% CI)P value

TLF

1.25(1.08–1.43)

P = 0.002

DT

2.38(1.49–3.79)

P = 0.0002

Further pooled results

Outcome	BVS	EES	← Lower risk with BVS ←→ Higher risk with BVS →	HR (95% CI)	P value
TLF and DT, 0–3 yearsTLF			0.10.31310	1.35 (1.15–1.59)	P = 0.0002
TLF	12.4%	9.3%
DT	2.0%	0.6%
TLF and DT, 0–3 yearsDT			0.10.31310	3.58 (2.01–6.36)	P < 0.0001
TLF and DT, 3–5 yearsTLF			0.10.31310	0.99 (0.76–1.27)	P = 0.91
TLF	4.5%	4.7%
DT	0.2%	0.4%
TLF and DT, 3–5 yearsDT			0.10.31310	0.49 (0.18–1.38)	P = 0.17
			0.10.31310Hazard ratio (log scale)

TLF hazard by spline analysis · by 5 years

TLF hazard by 5 years lower with BVS than EES

Safety

Outcome	BVS	EES	← Lower risk with BVS ←→ Higher risk with BVS →	HR (95% CI)	P value
Device thrombosis (primary safety endpoint), 0–5 years	2.2%	1.0%	0.20.5125	2.38 (1.49–3.79)	P = 0.0002
			0.20.5125Hazard ratio (log scale)

Original publication

Early and Late Outcomes With the Absorb Bioresorbable Vascular Scaffold: Final Report From the ABSORB Clinical Trial Program. JACC Cardiovasc Interv. Published 13 January 2025. doi:10.1016/j.jcin.2024.08.050

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