Comparison of Supraflex Cruz 60 μm Versus Ultimaster Tansei 80 μm Stent Struts in High Bleeding Risk PCI Patients: Study design and Rational of Compare 60/80 HBR trial

Paradies, Valeria; Maurina, Matteo; Tonino, Pim; Hofma, Sjoerd H.; Vos, Jeroen; van Kuijk, Jan-Peter; Oemrawsingh, Rohit M.; Mafragi, Amar Al; Spano, Fabrizio; Pisters, Ron; Polad, Jawed; Ijsselmuiden, Sander; Cambero, Maribel Madeira; Smits, Pieter C.

doi:10.1016/j.amjcard.2023.08.046

Cited by 3 publications

(1 citation statement)

References 38 publications

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“…The COMPARE 60/80 trial randomised 732 patients at high bleeding risk to an ultrathin (60 µm) strut stent (Supraflex Cruz; SMT) vs a thicker (80 µm) strut stent (Ultimaster, Terumo) although with an abbreviated DAPT duration (mean duration 30 days). The ultrathin Supraflex stent met criteria for non-inferiority of 4.0% with similar incidence of the primary outcome of CV death, MI, TVR, stroke or major bleeding (17.1% 15.4% vs 17.1%; HR 0.89; 95% CI 0.62–1.28) [ 32 ].…”

Section: Methodsmentioning

confidence: 99%

Advances in Clinical Cardiology 2023: A Summary of Key Clinical Trials

Savage,

Cox,

Shahmohammadi

et al. 2024

Adv Ther

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Introduction Over the course of 2023, numerous key clinical trials with valuable contributions to clinical cardiology were published or presented at major international conferences. This review seeks to summarise these trials and reflect on their clinical context. Methods The authors collated and reviewed clinical trials presented at major cardiology conferences during 2023 including the American College of Cardiology (ACC), European Association for Percutaneous Cardiovascular Interventions (EuroPCR), European Society of Cardiology (ESC), Transcatheter Cardiovascular Therapeutics (TCT), American Heart Association (AHA), European Heart Rhythm Association (EHRA), Society for Cardiovascular Angiography and Interventions (SCAI), TVT-The Heart Summit (TVT) and Cardiovascular Research Technologies (CRT). Trials with a broad relevance to the cardiology community and those with potential to change current practice were included. Results A total of 80 key cardiology clinical trials were identified for inclusion. Key trials in acute coronary syndrome (ACS) and antiplatelet management such as HOST-IDEA, T-PASS and STOP-DAPT3 were included in addition to several pivotal interventional trials such as ORBITA 2, MULTISTARS-AMI, ILUMIEN-IV, OCTIVUS and OCTOBER. Additionally, several trials evaluated new stent design and technology such as BIOSTEMI, PARTHENOPE and TRANSFORM. Structural intervention trials included long-term data from PARTNER 3, new data on the durability of transcatheter aortic valve intervention (TAVI), in addition to major new trials regarding transcatheter tricuspid valve intervention from TRISCEND II. Heart failure (HF) and prevention covered several key studies including DAPA-MI, STEP-HF, ADVOR, DICTATE HF and CAMEO-DAPA. In cardiac devices and electrophysiology, several trial exploring novel ablation strategies in atrial fibrillation (AF) such as PULSED AF and ADVENT were presented with further data evaluating the efficacy of anticoagulation in subclinical AF in NOAH-AFNET 6, FRAIL AF and AZALEA-TIMI 71. Conclusion This article presents a summary of key clinical cardiology trials published and presented during the past year and should be of interest to both practising clinicians and researchers.

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Section: Methodsmentioning

confidence: 99%

Advances in Clinical Cardiology 2023: A Summary of Key Clinical Trials

Savage,

Cox,

Shahmohammadi

et al. 2024

Adv Ther

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Stent type selection in high bleeding risk patients

Greco,

Spagnolo,

Capodanno

2024

Expert Review of Medical Devices

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Comparison of Ultrathin- Versus Thin-Strut Stents in Patients With High Bleeding Risk PCI: Results From the COMPARE 60/80 HBR Trial: An Open-Label, Randomized, Controlled Trial

Smits,

Tonino,

Hofma

et al. 2024

Circ: Cardiovascular Interventions

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BACKGROUND: No randomized data exist on ultrathin-strut stents in patients at high bleeding risk (HBR) undergoing an abbreviated dual antiplatelet therapy after coronary stenting. The aim of this study was to compare the safety and effectiveness of the ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent with the thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent in patients at HBR with abbreviated dual antiplatelet therapy after stenting. METHODS: In the investigator-initiated, randomized, open-label COMPARE 60/80 HBR trial (Comparison of the Supraflex Cruz 60 Micron Stent Strut Versus the Ultimaster Tansei 80 Micron Stent Strut in HBR Percutaneous Coronary Intervention Population), 741 patients at HBR according to the Academic Research Consortium HBR criteria were randomized to receive either the ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent or thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent. Dual antiplatelet therapy was recommended according to the applicable guidelines and trial data for patients at HBR. The primary outcome was net adverse clinical events, the composite of cardiovascular death, myocardial infarction, target vessel revascularization, stroke, and major bleeding, and was powered for noninferiority with an absolute margin of 4.0% at 1-sided 2.5% alpha. RESULTS: Between September 2020 and August 2022, 371 patients were randomized to the ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent and 370 patients to the thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent at 11 sites in the Netherlands. At 1 year, the primary outcome was observed in 56 (15.4%) patients in the ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent group and 61 (17.1%) in the thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent group (risk difference, −1.65%; upper boundary of the 1-sided 95% CI, 3.74; P =0.02 for noninferiority at a 0.025 significance level and P =0.55 for 2-sided superiority at a 0.05 significance level). CONCLUSIONS: Among patients at HBR with abbreviated dual antiplatelet therapy post-stenting, the use of an ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent was noninferior compared with the use of a thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04500912.

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Comparison of Supraflex Cruz 60 μm Versus Ultimaster Tansei 80 μm Stent Struts in High Bleeding Risk PCI Patients: Study design and Rational of Compare 60/80 HBR trial

Cited by 3 publications

References 38 publications

Advances in Clinical Cardiology 2023: A Summary of Key Clinical Trials

Advances in Clinical Cardiology 2023: A Summary of Key Clinical Trials

Stent type selection in high bleeding risk patients

Comparison of Ultrathin- Versus Thin-Strut Stents in Patients With High Bleeding Risk PCI: Results From the COMPARE 60/80 HBR Trial: An Open-Label, Randomized, Controlled Trial

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