title: Fully bioresorbable drug-eluting coronary scaffolds: A review.
abstract: Following the development of stents, then drug-eluting stents (DES), bioresorbable scaffolds are proposed as a third evolution in coronary angioplasty, aiming to reduce the incidence of restenosis and stent thrombosis and to restore vascular physiology. At least 16 such devices are currently under development, but published clinical data were available for only three of them in September 2014. The first device is Abbott's BVS(®), a poly-L-lactic acid (PLLA)-based everolimus-eluting device, which has been tested in a registry and two non-randomized trials. Clinical results seem close to what is expected from a modern DES, but possibly with more post-procedural side-effects. Two randomized trials versus DES are underway. This device is already marketed in many European countries. The second device is Elixir's DESolve(®), a PLLA-based novolimus-eluting device, which has been evaluated in two single-arm trials. Results are not widely different from those expected from a DES. The third device is Biotronik's DREAMS(®), a metallic magnesium-based paclitaxel-eluting device, which has been assessed in an encouraging single-arm trial; its second version is currently undergoing evaluation in a single-arm trial. The available results suggest that the technological and clinical development of bioresorbable scaffolds is not yet complete: their possible clinical benefits are still unclear compared with third-generation DES; the impact of arterial physiology restoration has to be assessed over the long term; and their cost-effectiveness has to be established. From the perspective of a health technology assessment, there is no compelling reason to hasten the clinical use of these devices before the results of ongoing randomized controlled trials become available.
authors.affiliation: Comité d'évaluation et de diffusion des innovations technologiques (CEDIT), Assistance Publique-Hôpitaux de Paris (AP-HP), 3, avenue Victoria, 75186 Paris cedex 16, France. Electronic address: emmanuel.charpentier@sap.aphp.fr.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Charpentier
authors.affiliation: Comité d'évaluation et de diffusion des innovations technologiques (CEDIT), Assistance Publique-Hôpitaux de Paris (AP-HP), 3, avenue Victoria, 75186 Paris cedex 16, France.
authors.forename: Alexandre
authors.initials: A
authors.lastname: Barna
authors.affiliation: Comité d'évaluation et de diffusion des innovations technologiques (CEDIT), Assistance Publique-Hôpitaux de Paris (AP-HP), 3, avenue Victoria, 75186 Paris cedex 16, France.
authors.forename: Loïc
authors.initials: L
authors.lastname: Guillevin
authors.affiliation: Comité d'évaluation et de diffusion des innovations technologiques (CEDIT), Assistance Publique-Hôpitaux de Paris (AP-HP), 3, avenue Victoria, 75186 Paris cedex 16, France; Département de cardiologie, département hospitalo-universitaire FIRE, université Paris-Diderot, Sorbonne Paris-Cité, Inserm U-1148, Hôpital Bichat, AP-HP, 75877 Paris, France.
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Juliard
mesh_terms: D020341:Absorbable Implants; D000497:Alloys; D002986:Clinical Trials as Topic; D003327:Coronary Disease / Q000188:drug therapy / Q000601:surgery*; D023903:Coronary Restenosis / Q000517:prevention & control*; D003328:Coronary Thrombosis / Q000517:prevention & control*; D004343:Drug Implants; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D019344:Lactic Acid; D018942:Macrolides / Q000008:administration & dosage / Q000627:therapeutic use*; D008274:Magnesium; D017239:Paclitaxel / Q000008:administration & dosage / Q000627:therapeutic use*; D062645:Percutaneous Coronary Intervention; D011091:Polyesters; D011108:Polymers; D016032:Randomized Controlled Trials as Topic; D012042:Registries; D054457:Tissue Scaffolds; D016896:Treatment Outcome; D014654:Vascular Patency
chemical_list: D000497:Alloys; D004343:Drug Implants; D018942:Macrolides; D011091:Polyesters; D011108:Polymers; C534800:novolimus; D019344:Lactic Acid; C033616:poly(lactide); D000068338:Everolimus; D008274:Magnesium; D017239:Paclitaxel
keywords: Angioplastie coronaire percutanée; Bioresorbable scaffolds; Percutaneous coronary angioplasty; Randomized controlled trials; Stents coronaires bioresorbables; Études contrôlées