Beatriz Vaquerizo

Hospital del Mar, Barcelona

Pros y Contras del Stent Ultrafino

Drug Eluting Stents (2001)

• The shortcomings of first-generation drugeluting stents (DES) were overcome by the development of second-generation DES that had thinner stent struts and a biocompatible polymer coating

Drug

Polymer

Stent platform

Second generation DES

• The use of second-generation DES over the past decade has substantially improved clinical outcomes, which have reached the present safety plateau

2% to 3% annual rate of MACE beyond the first year after index PCI remains concerning

Dangas GD, et al. Meta-analysis of everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease: final 3-year results of the SPIRIT clinical trials program (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions). J Am Coll Cardiol Intv. 2013;6:914–922.

Ultra-thin Stent = (<70 µm)

The Thin Strut Hypothesis

• Thinner stent struts produce less inflammation, vessel injury, neointimal proliferation and thrombus formation compared with thicker struts and may ultimately promote further improvement in clinical outcomes

1.- Kolandaivelu. Cirulation 2011; 2.- Soucy. EuroIntervention 2010; 3.- Kastrati. Circulation 2001; 4.- Pache. JACC 2003

Ultra-thin Stent = (<70 µm)

Benefit of Strut Thickness Reduction: A Class Effect?

• All RCT were designen for non-inferiority
• Mostly: Osiro vs Xience
• 2on G DES: Evolution. (No=Resolute Integrity, Biofredoom, Nobory…)

RCT: Osiro vs Xience

• All RCT were designed to establish non-inferiority of the bioresorbable polymer sirolimus-eluting stent compared with the durable polymer everolimus-eluting stent for the primary endpoint

• All these individaul RCT probed non-inferiority of the bioresorbable polymer sirolimus-eluting stent compared with the durable polymer everolimus-eluting stent for the primary endpoint

Cassese S et al. Outcomes of patients treated with ultrathin-strut biodegradable polymer sirolimus-eluting stents versus fluoropolymer-based everolimus-eluting stents: a metaanalysis of randomised trials. EuroIntervention 2018;14:224-231.

RCT: Osiro vs Onyx

• RCT was designed to establish non-inferiority of the bioresorbable polymer sirolimus-eluting stent compared with the durable polymer resolute-ONYX (Zotarolimus) stent for the primary endpoint

RCT: Osiro vs Onyx

• As the study is not powered for rare adverse events, such as stent thrombosis, these data are hypothesis generating only and should be interpreted with great caution.

Initial Comments

1. DES second G: have reached a plateau: 2% to 3% annual rate of MACE beyond the first year after index PCI remains concerning
2. 2on G DES: Evolution (No=Resolute Integrity, Biofredoom, Nobory…)
3. The thin strut principle is good!!
4. All individual ultra-thin RCT were designen for non-inferiority
5. No class effect: Most frequent comparison: Osiro vs Xience

Second round 

Technical Limitation: Ultra-thin DES

¹ Based on bench test data on file at Medtronic. [University of Budapest Visibility Testing, V0.1, 28-Sep-2021; 10166182DOC Competitive Analysis Test Report, Rev AC, 08-Jun-2021] May not be indicative of clinical performance. � Stents tested include Resolute Onyx DES, SYNERGY DES, XIENCE Sierra^™* DES, and Orsiro DES.

UC202303015EE

EXPANSIÓN MÁXIMA DE LOS DES

COMPLEX PCI: Complex Bif, CTO, calcified lesion…

• When a high radial force is required, such as CTO or calcific lesions, the presence of the ultrathin struts might potentially reduce the performance of the stent in terms of stent expansion
• Stent expansion capacity is more limited with ultrathin DESs than other new-generation DESs, and therefore, their use in large vessels may be challenging (LM PCI)

D’Ascenzo, F, et al. Impact of Final Kissing Balloon and of Imaging on Patients Treated on Unprotected Left Main Coronary Artery With Thin-Strut Stents (From the RAIN-CARDIOGROUP VII Study). Am. J. Cardiol. 2019, 123, 1610–1619

Calcified lesion

CTO

Bifurcated lesion

Teeuwen, K.; et al. Randomized Multicenter Trial Investigating Angiographic Outcomes of Hybrid Sirolimus-Eluting Stents With Biodegradable Polymer Compared With Everolimus-Eluting Stents With Durable Polymer in Chronic Total Occlusions: The PRISON IV Trial. JACC Cardiovasc. Interv. 2017, 10, 133–143.

CASTLE RCT: OSIRO VS XIENCE + OCT/IVUS (2022)

• The CASTLE: 1440 patients. Osiro: 60-80¨ vs Xience: 81¨. 98% OCT.

Nakamura M et al. Ultrathin, Biodegradable-Polymer Sirolimus-Eluting Stent vs Thin, Durable-Polymer Everolimus-Eluting Stent. J Am Coll Cardiol Intv 2022;15:1324–1334)

• TLF at 1 year, composite of: cardiac death, target vessel–related MI, and clinically driven TLR

Final Comments

1. Radial force, stent expansion capacity and visibility is more limited with ultrathin DESs
2. Last Data from RCT: Osiro was not inferior to Xience with respect to 1-year clinical outcomes (TLF) under IVUS or OCT guidance
3. Ultra-thin struts DES could be better in: Long lesions, small vessels, STEMI/ACS
4. Independently of stent thickness: PCI guided (IVUS/OCT) and plaque modification (when needed), might improve DES results at long-term

CASTLE RCT: OSIRO VS XIENCE (2022)

Nakamura M et al. Ultrathin, Biodegradable-Polymer Sirolimus-Eluting Stent vs Thin, Durable-Polymer Everolimus-Eluting Stent. J Am Coll Cardiol Intv 2022;15:1324–1334)

Evolución Tecnológica

RCT: Osiro vs Onyx

• The study population included many patients with increased clinical, lesión related, or procedural risk, suggesting that it reflects well the wide spectrum of patients treated in routine clinical practice