Structural and Functional Evaluation of Coronary Arteries Treated With ABSORB Bioresorbable Vascular Scaffold at 5-Year Follow-Up

https://doi.org/10.1016/j.amjcard.2022.07.038Get rights and content

Although complete bioresorbable vascular scaffold (BVS) resorption has been demonstrated at 5-year follow-up, whether corresponding vasomotor function restoration occurs remains unknown. The objective was to simultaneously assess the structural healing response along with vasomotor responses at 5-year follow-up of BVS implantation. We studied consecutive patients treated with ABSORB-BVS at 5-year follow-up (n = 31), who were recruited from a multicenter registry and were contacted to undergo a research protocol-driven repeat coronary angiogram involving intracoronary optical coherence tomography (OCT) and invasive coronary endothelial function testing. Epicardial endothelium-dependent vasomotion was defined as any vasodilatation after intracoronary acetylcholine (ACh), whereas endothelium-independent vasomotion was defined as any vasodilatation after intracoronary nitroglycerine (NTG), using quantitative coronary angiography. The mean implantation time point was 60.5 ± 4.6 months. OCT imaging demonstrated complete scaffold resorption in all patients. New coronary lesions (stenosis >50%) were found in 5 patients (16.1%), 3 of them underwent ad hoc percutaneous revascularization (9.7%). Intracoronary ACh (27 patients) and NTG testing (30 patients) was performed. Quantitative coronary angiography analysis demonstrated vasoconstriction after ACh administration and lack of response to NTG in BVS segments (mean lumen diameter = 2.00 ± 0.61 mm at baseline vs 1.74 ± 0.70 mm post-ACh, p <0.001; 2.05 ± 0.54 mm at baseline vs 2.03 ± 0.50 mm post-NTG, p = 0.69). OCT lumen analysis demonstrated similar vasoconstrictive responses to ACh (mean lumen area = 5.31 ± 2.26 mm2 at baseline vs 5.12 ± 2.55 mm2 post-ACh, p = 0.007) but had a vasodilatory response to NTG (5.96 ± 2.35 mm2 at baseline vs 6.17 ± 2.55 mm2 post-NTG, p<0.001). In conclusion, complete ABSORB-BVS resorption was demonstrated at 5-year follow-up. However, this healing response was associated with endothelium-dependent vasomotor dysfunction within the BVS segment.

Introduction

The everolimus-eluting bioresorbable vascular scaffold (Absorb-BVS; Abbott Vascular, California) was the backbone of poly-L-lactic acid coated with poly-DL-lactic polymer, which eluted everolimus.1 Although good early outcomes were initially described,2,3 more recent data have questioned its safety, with higher rates of short-term scaffold thrombosis, myocardial infarction, and target-vessel revascularization.4, 5, 6, 7 Whether these findings relate to the device per se or to suboptimal implantation technique remains contentious, but still lead to the ABSORB-BVS market withdrawal.8,9 However, many questions remain unresolved regarding the longer-term performance of the ABSORB-BVS implanted in real-world patients. Although the resorption capacity was demonstrated in some ABSORB-BVS recipients, less is known of whether this healing response correlates with functional restoration of the vessel (theoretical advantage of BVS).2,3,10, 11, 12, 13, 14, 15 Therefore, we characterized coronary structural changes and epicardial vasomotor responses in patients with ABSORB-BVS at 5-year follow-up, using quantitative coronary angiography (QCA) and optical coherence tomography (OCT).

Section snippets

Methods

Patients were selected from a multicenter registry of consecutive ABSORB-BVS recipients who were ≥3 years postimplant, who agreed to undergo a follow-up research-protocol intracoronary imaging and vasomotor testing protocol. Patients with a new percutaneous coronary intervention (PCI) within the culprit artery/segment or patients with a contraindication for intracoronary acetylcholine (ACh) provocation testing were excluded from enrollment. In total, 125 patients were enrolled to undergo OCT

Results

Baseline clinical characteristics and procedural data of the included patients are shown in Table 1. The follow-up was 60.5 ± 4.6 months. A total of 5 patients underwent new PCI, 3 of whom were performed on scaffolded arteries. A late thrombosis of the device and a restenosis at 6 months of follow-up were described. Regarding control coronary angiography, new coronary lesions (stenosis >50%) were found in 5 patients, 3 of whom underwent ad hoc PCI. Both patients who underwent PCI and those with

Discussion

Although Absorb-BVS market withdrawal was undertaken due to a higher incidence of scaffold thrombosis, myocardial infarction, and target-vessel revascularization,4, 5, 6, 7 several alternative BVS technologies cautiously remain in the spotlight. Questions remain, however, regarding long-term structural and functional changes of coronary segments after complete scaffold resorption. In fact, whether coronary vasomotion recovers in vivo, remains a controversial issue since few studies (if any)

Acknowledgment

The authors would like to thank Roman Poliszczuk of the angio/IVUS Core Laboratory of the Cleveland Clinic Coordinating Center for Clinical Research for his contribution toward imaging analysis.

Disclosures

The authors have no conflicts of interest to declare.

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  • Cited by (0)

    CIBERCV Valladolid received a nonconditional grant from Abbott Vascular (Spain) for REPARA and REPARA-QALY studies.

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