TIcaGrEloR and Absorb bioresorbable vascular scaffold implantation for recovery of vascular function after successful chronic total occlusion recanalization (TIGER‐BVS trial): Rationale and study design

Brugaletta, Salvatore; Gomez‐Lara, Josep; Caballero, Juan de Dios; Ortega‐Paz, Luis; Teruel, Luís; Fernández, Miriam Jiménez; Romaguera, Rafael; Martínez, Vicente Alcalde; Ñato, Marcos; Navarro, Eduardo Molina; Gómez‐Hospital, Joan Antoni; Vilches, Concepción Correa; Joyera, Maria; Cequier, Ángel; Sabaté, Manel

doi:10.1002/ccd.27196

Cited by 7 publications

(3 citation statements)

References 31 publications

(37 reference statements)

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“…Several catheterization laboratories intensify platelet inhibition through the routine prescription of the newer potent P2Y 12 receptor blockers for a longer duration (up to 3 years) to reduce the rates of ST after BVS implantation. A currently ongoing study on the administration of ticagrelor after the use of BVS in coronary vessels is believed to elucidate this matter [154,155].…”

Section: Niche For Bvs and Optimization Of Bvs Actionmentioning

confidence: 99%

Bioresorbable Vascular Scaffolds—Dead End or Still a Rough Diamond?

Jeżewski

Kubisa

Eyileten

et al. 2019

JCM

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Percutaneous coronary interventions with stent-based restorations of vessel patency have become the gold standard in the treatment of acute coronary states. Bioresorbable vascular scaffolds (BVS) have been designed to combine the efficiency of drug-eluting stents (DES) at the time of implantation and the advantages of a lack of foreign body afterwards. Complete resolution of the scaffold was intended to enable the restoration of vasomotor function and reduce the risk of device thrombosis. While early reports demonstrated superiority of BVS over DES, larger-scale application and longer observation exposed major concerns about their use, including lower radial strength and higher risk of thrombosis resulting in higher rate of major adverse cardiac events. Further focus on procedural details and research on the second generation of BVS with novel properties did not allow to unequivocally challenge position of DES. Nevertheless, BVS still have a chance to present superiority in distinctive indications. This review presents an outlook on the available first and second generation BVS and a summary of results of clinical trials on their use. It discusses explanations for unfavorable outcomes, proposed enhancement techniques and a potential niche for the use of BVS.

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Section: Niche For Bvs and Optimization Of Bvs Actionmentioning

confidence: 99%

Bioresorbable Vascular Scaffolds—Dead End or Still a Rough Diamond?

Jeżewski

Kubisa

Eyileten

et al. 2019

JCM

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“…Chronic total occlusion (CTO) is defined as total coronary stenosis with no distal flow for more than 3 months duration . CTOs are frequently encountered in coronary interventions, and the field has grown significantly in the last decade.…”

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confidence: 99%

“…In the study by Brugaletta et al , the authors discuss the study design of the TIGER‐BVS trial. They go on to discuss how CTO procedures are associated with a higher MACE rate compared to non‐CTO PCI.…”

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confidence: 99%

Chronic total occlusion: Does anti‐platelet choice impact outcomes?

Shatila

Krajcer

2018

Cathet Cardio Intervent

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Chronic total occlusion (CTO) is associated with worse outcomes compared to non CTO percutaneous coronary intervention (PCI). CTO might be associated with vasomotor dysfunctionTicagrelor is a novel P2Y12 inhibitor that increases local adenosine The TIGER-BVS trial plans to assess the impact of using ticagrelor vs. clopidogrel on vasomotor activity and outcomes after successful CTO PCI.Chronic total occlusion (CTO) is defined as total coronary stenosis with no distal flow for more than 3 months duration [1]. CTOs are frequently encountered in coronary interventions, and the field has grown significantly in the last decade. The rationale behind performing CTO percutaneous coronary intervention (PCI) is to improve clinical outcomes by decreasing major adverse cardiac event (MACE), need for coronary artery bypass graft, myocardial infarction, and all-cause mortality as shown in a meta-analysis performed by Gao et al. This study plans to enroll only patients who have a successful PCI. However, even if procedural success has been achieved, different CTO parameters might impact outcomes. This was looked at in a study done by Kim et al. [3]. Age above 65, diabetes mellitus, heart failure, left main involvement, lesion length of at least 20 mm, and at least three implanted stents were all associated with worse outcomes. With a total sample size of 50 patients, it will be hard to ensure similar distribution of those parameters between both groups increasing the risk for confounding variables being responsible for any perceived difference in primary outcomes. Also given this study will only include the use of BVS, it would be difficult to incur any conclusions on the impact of BVS on vasomotor activity as there is no drug eluting stent control. Furthermore, this study will only be powered to look at immediate improvement in vasomotor activity post successful CTO PCI and 3-day anti-platelet load. It will be an initial step for future studies that are powered to discuss long-term outcomes of the use of different antiplatelet agents after CTO PCIs. CONFLICT OF INTERESTNothing to report. ORCID

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