Complete two-year follow-up with formal non-inferiority testing on primary outcomes of the AIDA trial comparing the Absorb bioresorbable scaffold with the XIENCE drug-eluting metallic stent in routine PCI

Q: What are the key findings of this study?

Absorb BVS was non-inferior to XIENCE EES for 2-year target vessel failure (11.0% vs 9.9%; HR 1.12; p_non-inferiority=0.003), despite higher scaffold thrombosis (3.3% vs 0.9%, p<0.001).

Q: What is the clinical evidence from this study?

Study design: RCT. Population: Coronary artery disease undergoing routine PCI (n=1845). Intervention: Absorb everolimus-eluting bioresorbable vascular scaffold (Absorb BVS) vs. XIENCE everolimus-eluting metallic stent (XIENCE EES). Primary outcome: Target vessel failure (composite of cardiac death, myocardial infarction, and target vessel revascularisation) at 2 years (HR 1.12, 95% CI 0.94-1.49, p=0.003 for non-inferiority (0.436 for superiority)).

Q: What does this research mean for the field?

The Absorb bioresorbable vascular scaffold is non-inferior to the XIENCE everolimus-eluting metallic stent for two-year target vessel failure, but is associated with significantly higher rates of device thrombosis and target vessel myocardial infarction. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Robin P. Kraak; Sjoerd H. Hofma; René J. van der Schaaf; E. Karin Arkenbout; Auke P. J. D. Weevers; Joëlle Elias; Ivo M. van Dongen; Karel T. Koch; Jan Baan; Marije M. Vis; Robbert J. de Winter; Jan J. Piek; Jan G.P. Tijssen; Josè P.S. Henriques; Joanna J. Wykrzykowska

doi:10.4244/eij-d-18-00335

July 1, 2018EuroInterventionOpen Access

Complete two-year follow-up with formal non-inferiority testing on primary outcomes of the AIDA trial comparing the Absorb bioresorbable scaffold with the XIENCE drug-eluting metallic stent in routine PCI

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Key result

Absorb BVS meets non-inferiority for 2-year TVF vs XIENCE, despite higher scaffold thrombosis.

HR 1.12
95% CI 0.94-1.49
P=0.003 for non-inferiority (0.436 for superiority)
n=1,845

Why the study?

This report of the AIDA trial aimed to provide complete two-year outcomes for the primary endpoint of target vessel failure with formal non-inferiority testing and an update on device thrombosis.

Is the Absorb everolimus-eluting bioresorbable vascular scaffold non-inferior to the XIENCE everolimus-eluting metallic stent for preventing target vessel failure at 2 years in patients undergoing routine PCI?

Key Points

To evaluate complete two-year outcomes for target vessel failure and device thrombosis comparing the Absorb bioresorbable scaffold with the XIENCE metallic drug-eluting stent.
Single-blind, multicenter, investigator-initiated, randomized (1:1) noninferiority trial enrolling 1,845 patients undergoing routine percutaneous coronary intervention (924 Absorb BVS, 921 XIENCE EES).
Followed patients through complete two-year follow-up to evaluate the primary composite endpoint of target vessel failure (TVF) and device thrombosis.
Target vessel failure occurred in 100 patients (11.0% Kaplan-Meier estimate) in the Absorb BVS arm versus 90 patients (9.9%) in the XIENCE EES arm, meeting noninferiority criteria (HR 1.12, 95% CI: 0.94-1.49; pnon-inferiority=0.003; psuperiority=0.436).
Definite or probable device thrombosis at two years occurred in 30 patients (3.3%) receiving Absorb BVS versus eight patients (0.9%) receiving XIENCE EES (HR 5.22, 95% CI: 2.00-13.59; p<0.001).
Target vessel myocardial infarction occurred in 5.1% of patients with Absorb BVS compared to 3.1% with XIENCE EES (HR 1.65, 95% CI: 1.03-2.64; p=0.034).

Study Design

Type

RCT (n=1,845)

Blinding

Single-blind (patients blinded, operators unblinded)

Randomization

1:1 centralised web-based system in random block sizes

Multicenter

Yes

Structured PICO

Is the Absorb everolimus-eluting bioresorbable vascular scaffold non-inferior to the XIENCE everolimus-eluting metallic stent for preventing target vessel failure at 2 years in patients undergoing routine PCI?

P

Population

1,845 adults with coronary artery disease undergoing routine PCI (mean age 64.2 years, 25.7% female) across multiple centers in the Netherlands, excluding lesions >70 mm or vessels <2.5 mm or >4.0 mm, followed for 2 years.

I

Intervention

Coronary PCI with the Absorb everolimus-eluting bioresorbable vascular scaffold (Absorb BVS) plus DAPT (recommended for at least 1 year in ACS, later advised up to 3 years per DSMB).

C

Comparator

Coronary PCI with the XIENCE everolimus-eluting metallic stent (XIENCE EES) plus guideline-directed DAPT.

O

Outcome

Target vessel failure (TVF), a composite of cardiac death, myocardial infarction, and target vessel revascularisation at complete 2-year follow-up (powered for non-inferiority with a pre-specified margin of 4.5 percentage points), adjudicated by an independent clinical events committee.composite

Main Result

Hazard Ratio: 1.12 (95% CI 0.94–1.49)

Absolute Event Rate: 11% vs 9.9%

p-value: p=0.003 for non-inferiority (0.436 for superiority)

Although the Absorb bioresorbable vascular scaffold formally met non-inferiority criteria for 2-year target vessel failure compared with the XIENCE metallic stent in routine PCI, it carried a significantly higher risk of scaffold thrombosis and target vessel myocardial infarction.

Limitations

Intracoronary imaging was not performed routinely, preventing distinction between successful and unsuccessful lesion preparation or scaffold implantation.
Post-procedural cardiac enzymes were only measured when clinically indicated, potentially missing post-procedural myocardial infarctions.
DSMB recommendation to restart or prolong DAPT up to 3 years and patient unblinding after preliminary results may have influenced thrombosis-related outcomes.
Intracoronary imaging was not performed routinely, making it impossible to distinguish between successful and unsuccessful lesion preparation and/or scaffold implantation.
Post-procedural cardiac enzymes were only measured when clinically indicated, so potential post-procedural myocardial infarctions could have been missed.
Restarting or prolonging DAPT therapy up to three years after scaffold implantation was recommended at the request of the DSMB, which might have influenced thrombosis-related outcomes.

Implication

Absorb BVS should not replace metallic stents in routine PCI due to excess thrombosis; challenges bioresorbable scaffold safety assumptions.

Abstract

AIMS: The aim of this report of the AIDA trial is to provide full two-year outcomes for the primary endpoint of target vessel failure (TVF) and an update on device thrombosis. METHODS AND RESULTS: AIDA was a single-blind, multicentre, investigator-initiated, non-inferiority, randomised (1:1) clinical trial. At complete two-year follow-up, the primary endpoint of TVF had occurred in 100 patients in the Absorb BVS arm versus 90 patients in the XIENCE EES arm (HR 1.12, 95% CI: 0.94-1.49; psuperiority=0.436). Estimated two-year Kaplan-Meier event rates of TVF were 11.0% and 9.9%, respectively (95% CI: -0.9%-3.0%; pnon-inferiority=0.003). Definite or probable device thrombosis at two years occurred in 30 patients in the Absorb BVS arm and in eight patients in the XIENCE EES arm. Kaplan-Meier estimates of device thrombosis were 3.3% in the Absorb BVS arm and 0.9% in the XIENCE EES arm (HR 5.22, 95% CI: 2.00-13.59; p<0.001). CONCLUSIONS: AIDA formally met its criterion for non-inferiority of Absorb BVS versus XIENCE EES in terms of the combined endpoint of TVF. The Absorb BVS, however, was associated with higher rates of scaffold thrombosis and target vessel myocardial infarction at complete two-year follow-up.

Discussion

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Cite This Study

Kraak et al. (2018) conducted an RCT in Coronary artery disease undergoing routine PCI (n=1,845). Absorb everolimus-eluting bioresorbable vascular scaffold (Absorb BVS) vs. XIENCE everolimus-eluting metallic stent (XIENCE EES) was evaluated on Target vessel failure (composite of cardiac death, myocardial infarction, and target vessel revascularisation) at 2 years (HR 1.12, 95% CI 0.94-1.49, p=0.003 for non-inferiority (0.436 for superiority)). Absorb BVS was non-inferior to XIENCE EES for 2-year target vessel failure (11.0% vs 9.9%; HR 1.12; p_non-inferiority=0.003), despite higher scaffold thrombosis (3.3% vs 0.9%, p<0.001).

synapsesocial.com/papers/6ae116d7f9f8ef1ced83a66f https://doi.org/10.4244/eij-d-18-00335

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Complete two-year follow-up with formal non-inferiority testing on primary outcomes of the AIDA trial comparing the Absorb bioresorbable scaffold with the XIENCE drug-eluting metallic stent in routine PCI

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

Complete two-year follow-up with formal non-inferiority testing on primary outcomes of the AIDA trial comparing the Absorb bioresorbable scaffold with the XIENCE drug-eluting metallic stent in routine PCI

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

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