Absorb bioresorbable vascular scaffold vs. everolimus‐eluting metallic stent in small vessel disease: A propensity matched analysis of COMPARE II, RAI, and MAASSTAD‐ABSORB studies

Tarantini, Giuseppe; Masiero, Giulia; Barioli, Alberto; Paradies, Valeria; Vlachojannis, Georgios J.; Tellaroli, Paola; Cortese, Bernardo; Varricchio, Attilio; Ielasi, Alfonso; Loi, Bruno; Steffenino, Giuseppe; Ueshima, Daisuke; Mojoli, Marco; Smits, Pieter C.

doi:10.1002/ccd.27522

Cited by 9 publications

(6 citation statements)

References 39 publications

(75 reference statements)

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“…In the era of bare metal stents (BMS) and first‐generation DES, a RVD ≤3 mm has often been used as cut‐off . However, in more recent years, as smaller stent diameters have become available, lower thresholds for RVD (e.g., <2.75 mm or ≤2.5 mm), have more frequently been used to define small vessel PCI . Consequently, for this study we used RVD ≤2.5 mm to define SV‐PCI .…”

Section: Discussionmentioning

confidence: 99%

Small‐vessel PCI outcomes in men, women, and minorities following platinum chromium everolimus‐eluting stents: Insights from the pooled PLATINUM Diversity and PROMUS Element Plus Post‐Approval studies

Guedeney

Claessen

Kandzari

et al. 2019

Cathet Cardio Intervent

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Objective We evaluated 1‐year outcomes after platinum chromium everolimus‐eluting stents (PtCr‐EES) in small versus non‐small coronary arteries within a large, diverse sample of men, women, and minorities. Background There exists limited outcomes data on the use of second‐generation drug‐eluting stent to treat small diameter coronary arteries. Methods We pooled patients from the PLATINUM Diversity and PROMUS Element Plus stent registries. Small‐vessel percutaneous coronary intervention (SV‐PCI) was defined as ≥1 target lesion with reference vessel diameter (RVD) ≤2.5 mm. Endpoints included major adverse cardiac event (MACE; death, myocardial infarction [MI] or target vessel revascularization [TVR]), target vessel failure (TVF; death related to the target vessel, target vessel MI or TVR) and definite/probable stent thrombosis (ST). Multivariable Cox regression was used to risk‐adjust outcomes. Results We included 4,155/4,182 (99%) patients with available RVD, of which 1,607 (39%) underwent small‐vessel PCI. SV‐PCI was not associated with increased MACE (adjHR 1.02; 95%CI 0.81–1.30) or TVF (adjHR 1.07; 95%CI 0.82–1.39). MI risk was lower in white men compared to women and minorities, both in the setting of SV‐PCI (adjHR 0.41; 95%CI 0.23–0.74 and adjHR 0.39; 95%CI 0.20–0.75, respectively) and for non‐SV‐PCI (adjHR 0.61; 95%CI 0.38–0.99 and adjHR 0.45; 95%CI 0.27–0.74, respectively). There was no significant interaction between RVD and sex or minority status for any endpoint. Conclusion In a large diverse contemporary PCI outcomes database, SV‐PCI with PtCr‐EES was not associated with increased MACE or TVR and did not account for the increased MI risk noted in women and minorities compared to white men.

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Section: Discussionmentioning

confidence: 99%

Small‐vessel PCI outcomes in men, women, and minorities following platinum chromium everolimus‐eluting stents: Insights from the pooled PLATINUM Diversity and PROMUS Element Plus Post‐Approval studies

Guedeney

Claessen

Kandzari

et al. 2019

Cathet Cardio Intervent

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“…The higher rates of MI mainly driven by periprocedural events may be explained by the larger extension of CAD and once again by the structural characteristics of the device, with consequent higher risk of small branch occlusion and distal embolization [21][22][23] . Finally, these studies reported a lower rate of ST especially when a carefully lesion selection and predefined implantation technique were performed [24][25][26] . As a matter of fact, Regazzoli et al demonstrated a very low incidence of TLF and ST at 4-year follow-up adopting a dedicated implantation strategy of BRS in a real-world cohort of patients with a high prevalence of complex lesions (69.4% of type B2 or C lesions; 10.3% of severe calcific lesions; 26.1% of bifurcations) 27 .…”

Section: Longer Follow-up In Complex Scenariosmentioning

confidence: 97%

Percutaneous Coronary Intervention with Everolimus-Eluting Bioresorbable Vascular Scaffolds in Diffuse Coronary Artery Disease: Current Knowledge and Future Perspectives

Masiero¹,

Fovino²,

Schiavo³

et al. 2018

J Cardiol and Cardiovasc Sciences

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The optimal percutaneous treatment of diffuse coronary artery disease (CAD) remains an unsolved issue. Bioresorbable scaffold (BRS) technology has been developed to overcome the disadvantages of metallic drug-eluting stents (DES) due to their permanent struts. Through the resorption process, BRS may provide complete vascular restoration, which appears very attractive in the treatment of diffuse CAD. However, robust evidence on the use of BRS in this setting is lacking and recent data have raised concerns about the safety of this novel technology, especially when BRS are used in complex CAD or without adequate protocol implantation. This review aims at summarizing current evidence and future perspectives on Absorb BRS implantation in complex CAD, such as in distal coronary segments involvement and diffused disease.

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“…From analysis of clinical data, it is learned that most of the ST happened within 6 months after BVS implantation and many ST would have not occurred if small vessels were excluded (3,4), pretreatment, sizing, post-dilation (PSP) techniques were applied (5), and longer dual-antiplatelet therapy (DAPT) regimen were followed (6,7). These learnings were confirmed by the Absorb BVS 5-year follow-up studies, which showed that starting from the third year, when the BVS has diminished, target lesion failure (TLF) and ST of BVS have lowered down to the levels of that of DES (8,9).…”

Section: Introductionmentioning

confidence: 99%

Five-year comparative study of thin-strut rapamycin-eluting bioabsorbable scaffold with metallic drug-eluting stent in porcine coronary artery

Liu

Zheng

Zhang

et al. 2022

Front. Cardiovasc. Med.

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ObjectivesUsing quantitative coronary angiography (QCA), optical coherence tomography (OCT), histomorphometry, and pharmacokinetics, this study tried to evaluate the safety and efficacy of Biomagic rapamycin-eluting bioabsorbable scaffold (BVS) in non-atherosclerotic porcine coronary arteries.BackgroundBiomagic BVS is a new generation of thin-strut bioabsorbable scaffold. We conducted comparative study detailing pathological response, safety and efficacy of Biomagic BVS and the Firebird2 rapamycin-eluting cobalt-based alloy stent (DES) in a porcine coronary artery model. The animals were followed up at 14 days, 1, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months after stent implantation.MethodsA total of 143 devices (95 Biomagic and 48 Firebird2) were implanted in 2 or 3 main coronary arteries of 76 nonatherosclerotic swine and examined by QCA, OCT, light microscopy, and pharmacokinetics analyses at various time points.ResultsVascular responses to Biomagic and Firebird2 were largely comparable at all time points, with struts being sequestered within the neointima. The degree of inflammation of both devices was mild to moderate, although the Biomagic score was higher at 14 days to 24 months. However, there was no statistical difference between the two groups except 14 days. At each follow-up time point, the percentage of area stenosis in the Biomagic group was greater than that in the Firebird 2 group, but there was no statistical difference between the two groups at 3 and 12 months. The extent of fibrin deposition was similar between Biomagic and Firebird2, which peaked at 1 month and decreased rapidly thereafter. Pharmacokinetic study showed that coronary tissue sirolimus concentration remained above 2 ng/mg of tissue at 28 day. Histomorphometry showed expansile remodeling of Biomagic-implanted arteries starting after 12 months, and lumen area was significantly greater in Biomagic than Firebird2 at 36 and 42 months. These changes correlated with dismantling of Biomagic seen after 12 months. OCT images confirmed that degradation of Biomagic was complete by 36 months.ConclusionsBiomagic demonstrates comparable long-term safety to Firebird2 in porcine coronary arteries with mild to moderate inflammation. Although Biomagic was associated with greater percent stenosis relative to Firebird2 within 36 months, expansile remodeling was observed after 12 months in Biomagic with significantly greater lumen area at ≥36 months. Scaffold resorption is considered complete at 36 months.

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Absorb bioresorbable vascular scaffold vs. everolimus‐eluting metallic stent in small vessel disease: A propensity matched analysis of COMPARE II, RAI, and MAASSTAD‐ABSORB studies

Abstract: In this propensity-matched analysis pooling SVD patients of three large prospective studies, incidence of composite device-related events was comparable between BVS and EES up to 2 years follow-up. However, higher rates of stent thrombosis were found in the BVS group.

Cited by 9 publications

References 39 publications

Small‐vessel PCI outcomes in men, women, and minorities following platinum chromium everolimus‐eluting stents: Insights from the pooled PLATINUM Diversity and PROMUS Element Plus Post‐Approval studies

Small‐vessel PCI outcomes in men, women, and minorities following platinum chromium everolimus‐eluting stents: Insights from the pooled PLATINUM Diversity and PROMUS Element Plus Post‐Approval studies

Percutaneous Coronary Intervention with Everolimus-Eluting Bioresorbable Vascular Scaffolds in Diffuse Coronary Artery Disease: Current Knowledge and Future Perspectives

Five-year comparative study of thin-strut rapamycin-eluting bioabsorbable scaffold with metallic drug-eluting stent in porcine coronary artery

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