Bioresorbierbare Scaffolds – Therapiekonzept mit Zukunft?

Zusammenfassung

Drug eluting Stents (DES) sind aufgrund ihrer hohen Effektivität und Sicherheit die Standardtherapie im Rahmen der perkutanen Koronarintervention. Bioresorbierbare Scaffolds (BRS) bestehen aus einem resorbierbaren Grundgerüst und einer antiproliferativen Beschichtung. Sie wurden mit dem Ziel der Wiederherstellung der Gefäßintegrität und Vasomotion konzipiert. Die aktuellen Daten zum Absorb-BRS weisen jedoch auf vermehrte Sicherheits- (Thrombosen) und Effizienzlimitationen (Revaskularisationen) im Vergleich zu DES hin. Ein routinemäßiger Einsatz von BRS im Rahmen der PCI kann aktuell nicht empfohlen werden. Eine individuelle Indikationsstellung unter Abwägung der potenziellen Vorteile und Risiken sollte vor Implantation eines BRS erfolgen. Eine Weiterentwicklung der Technologie mit dünneren Streben und besseren mechanischen Eigenschaften könnten diese Limitationen allerdings überwinden und den Stellenwert der BRS neu definieren.

Abstract

Drug eluting stents remain the standard therapy in percutaneous coronary intervention (PCI) due to their high efficacy and good safety profile. Bioresorbable scaffolds (BRS) are made of a bioresorbable backbone coated with an antiproliferative drug. They were designed to restore vasomotion and vascular integrity after PCI. Due to safety and efficacy issues the Absorb BRS is no longer commercially available outside of clinical trials or registries in Europe. A routine usage of BRS in PCI is currently not indicated based on scientific data. Further improvement of this technology with reduced strut thickness, better mechanical properties and shorter duration of absorption could overcome these limitations. The future role of BRS has to be determined by randomized clinical trials with next generation BRS technology.

Schlüsselwörter

koronare Herzkrankheit - Myokardinfarkt - perkutane Koronarintervention - bioresorbierbare Scaffolds

Key words

coronary artery disease - myocardial infarction - percutaneous coronary intervention - bioresorbable scaffolds

• Literatur

• 1 Windecker S, Kolh P, Alfonso F. et al. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J 2014; 35: 2541-2619
• 2 Stone GW, Maehara A, Lansky AJ. et al. A prospective natural-history study of coronary atherosclerosis. N Engl J Med 2011; 364: 226-235
• 3 Otsuka F, Byrne RA, Yahagi K. et al. Neoatherosclerosis: overview of histopathologic findings and implications for intravascular imaging assessment. Eur Heart J 2015; 36: 2147-2159
• 4 Koskinas KC, Chatzizisis YS, Antoniadis AP. et al. Role of endothelial shear stress in stent restenosis and thrombosis: pathophysiologic mechanisms and implications for clinical translation. J Am Coll Cardiol 2012; 59: 1337-1349
• 5 Serruys PW, Chevalier B, Sotomi Y. et al. Comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II): a 3 year, randomised, controlled, single-blind, multicentre clinical trial. Lancet 2016; 388: 2479-2491
• 6 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
• 7 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
• 8 Sabaté M, Windecker S, Iñiguez 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 Wykrzykowska J, Kraak R, Hofma S. et al. Bioresorbable scaffolds versus metallic stents in routine PCI. N Engl J Med 2017; 376: 2319-2328
• 10 Sorrentino S, Giustino G, Mehran R. et al. Everolimus-eluting bioresorbable scaffolds versus everolimus-eluting metallic stents. J Am Coll Cardiol 2017; 69: 3055-3066
• 11 Ishibashi Y, Nakatani S, Sotomi Y. et al. Relation between bioresorbable scaffold sizing using QCA-Dmax and clinical outcomes at 1 year in 1,232 patients from 3 study cohorts (ABSORB Cohort B, ABSORB EXTEND, and ABSORB II). JACC Cardiovasc Interv 2015; 8: 1715-1726
• 12 Ormiston JA, Serruys PW, Onuma Y. et al. First serial assessment at 6 months and 2 years of the second generation of absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study. Circ Cardiovasc Interv 2012; 5: 620-632
• 13 Puricel S, Cuculi F, Weissner M. et al. Bioresorbable coronary scaffold thrombosis: multicenter comprehensive analysis of clinical presentation, mechanisms, and predictors. J Am Coll Cardiol 2016; 67: 921-931
• 14 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
• 15 Wiebe J, Dörr O, Ilstad H. et al. Everolimus-versus novolimus-eluting bioresorbable scaffolds for the treatment of coronary artery disease: a matched comparison. JACC Cardiovasc Interv 2017; 10: 477-485
• 16 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
• 17 Haude M, Ince H, Abizaid A. et al. Sustained safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de novo coronary lesions: 12-month clinical results and angiographic findings of the BIOSOLVE-II first-in-man trial. Eur Heart J 2016; 37: 2701-2709
• 18 Haude M, Erbel R, Erne P. et al. Safety and performance of the DRug-Eluting Absorbable Metal Scaffold (DREAMS) in patients with de novo coronary lesions: 3-year results of the prospective, multicentre, first-in-man BIOSOLVE-I trial. EuroIntervention 2016; 12: e160-e166
• 19 Valgimigli M, Bueno H, Byrne RA. et al. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J 2017; DOI: 10.1093/eurheartj/ehx419.
• 20 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