Update bioresorbierbare Scaffolds – Evidenz aus den randomisierten kontrollierten Studien und Erfahrungen in Deutschland

Zusammenfassung

Bioresorbierbare Scaffolds (BRS) stellen eine neue Behandlungsoption zur interventionellen Behandlung der koronaren Herzerkrankung dar. Deren Hauptziel ist es, das Risiko später Stentthrombosen zu minimieren. Die meisten und gängigsten BRS bestehen aus einem Poly-L-Milchsäure-Gerüst und sind medikamentös beschichtet. Ergebnisse sind vor allem für einen Everolimus-beschichteten BRS verfügbar. Sechs verschiedene randomisierte Studien konnte eine Nichtunterlegenheit gegenüber einem medikamentös beschichteten metallischen Stent (Drug eluting Stent, DES) der neusten Generation zeigen, wenngleich ein nicht signifikanter Trend zu höheren Ereignisraten in der BRS-Gruppe festzustellen war. Ein Novolimus-beschichteter BRS aus dem gleichen Material und ein Magnesium-basierter BRS sind ebenfalls CE-zertifiziert.

Abstract

Bioresorbable scaffolds (BRS) are a new option for the interventional treatment of coronary artery disease. The main goal of BRS is to reduce the risk of late stent thrombosis, observed after metallic stent implantation. The most widely investigated device is an Everolimus-eluted BRS made from poly-lactic acid. A total of 6 randomized trials are available, which reveal non-inferiority compared to a new generation of drug eluting stents, although a non-significant trend towards higher event-rates was noticed in the BRS-group. Presently, a Novolimus-eluted BRS manufactured from the same material and a Magnesium-based BRS are CE-certified as well.

Schlüsselwörter

randomisierte Studien - perkutane Koronarintervention - koronare Herzerkrankung - bioresorbierbare Scaffolds

Key words

randomized trials - percutaneous coronary intervention - coronary artery disease - bioresorbable scaffolds

• Literatur

• 1 Serruys PW, Garcia-Garcia HM, Onuma Y. From metallic cages to transient bioresorbable scaffolds: change in paradigm of coronary revascularization in the upcoming decade?. Eur Heart J 2012; 33: 16-25b
• 2 Wiebe J, Nef HM, Hamm CW. Current status of bioresorbable scaffolds in the treatment of coronary artery disease. J Am Coll Cardiol 2014; 64: 2541-2551
• 3 Puricel S, Arroyo D, Corpataux N et al. Comparison of everolimus- and biolimus-eluting coronary stents with everolimus-eluting bioresorbable vascular scaffolds. J Am Coll Cardiol 2015; 65: 791-801
• 4 Ellis SG, Kereiakes DJ, Metzger DC et al. Everolimus-eluting bioresorbable scaffolds for coronary artery disease. N Engl J Med 2015; 373: 1905-1915
• 5 Gao R, Yang Y, Han Y et al. Bioresorbable vascular scaffolds versus metallic stents in patients with coronary artery disease: ABSORB China trial. J Am Coll Cardiol 2015; 66: 2298-2309
• 6 Kimura T, Kozuma K, Tanabe K et al. A randomized trial evaluating everolimus-eluting Absorb bioresorbable scaffolds vs. everolimus-eluting metallic stents in patients with coronary artery disease: ABSORB Japan. Eur Heart J 2015; 36: 3332-3342
• 7 Serruys PW, Chevalier B, Dudek D et al. A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial. Lancet 2015; 385: 43-54
• 8 Sabate M, Windecker S, Iniguez A et al. Everolimus-eluting bioresorbable stent vs. durable polymer everolimus-eluting metallic stent in patients with ST-segment elevation myocardial infarction: results of the randomized ABSORB ST-segment elevation myocardial infarction-TROFI II trial. Eur Heart J 2016; 37: 229-240
• 9 Cassese S, Byrne RA, Ndrepepa G et al. Everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents: a meta-analysis of randomised controlled trials. Lancet 2016; 387: 537-544
• 10 Stone GW, Gao R, Kimura T et al. 1-year outcomes with the Absorb bioresorbable scaffold in patients with coronary artery disease: a patient-level, pooled meta-analysis. Lancet 2016; 387: 1277-1289
• 11 Abizaid A, Costa RA, Schofer J et al. Serial Multimodality Imaging and 2-Year Clinical Outcomes of the Novel DESolve Novolimus-Eluting Bioresorbable Coronary Scaffold System for the Treatment of Single De Novo Coronary Lesions. JACC Cardiovasc Interv 2016; 9: 565-574
• 12 Haude M, Ince H, Abizaid A et al. Safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de-novo coronary artery lesions (BIOSOLVE-II): 6 month results of a prospective, multicentre, non-randomised, first-in-man trial. Lancet 2016; 387: 31-39
• 13 Wiebe J, Liebetrau C, Dorr O et al. Impact of the learning curve on procedural results and acute outcome after percutaneous coronary interventions with everolimus-eluting bioresorbable scaffolds in an all-comers population. Cardiovasc Revasc Med 2015; 16: 455-460
• 14 Wiebe J, Bauer T, Dörr O et al. Implantation of a novolimus-eluting bioresorbable scaffold with a strut thickness of 100 μm showing evidence of self-correction. EuroIntervention 2015; 11: 204