Future of Bioresorbable Scaffolds Is Now in Doubt

Summary and Comment |
November 4, 2016

Future of Bioresorbable Scaffolds Is Now in Doubt

  1. Howard C. Herrmann, MD

The 3-year follow-up in ABSORB II failed to show any benefit for bioresorbable scaffolds and indicated potential risk.

  1. Howard C. Herrmann, MD

Using fully bioresorbable scaffolds (BRSs) in treating coronary artery disease might theoretically solve the problems of metallic stents — limited later surgery at the stent site and adverse effects on vasomotor tone in the distal vessel. However, previous studies suggested a signal with BRS to more adverse events, including vessel thrombosis, compared with contemporary drug-eluting metallic stents. Now, researchers report the 3-year follow-up of the ABSORB II study involving 501 patients randomized in a 2:1 ratio to an everolimus-eluting BRS or an everolimus-eluting metallic stent (EES).

Regarding vasomotor reactivity, analyzed in 388 paired lesions, the treatment groups did not differ in mean lumen diameter after intracoronary nitrate administration (BRS, 0.047 mm; EES, 0.056 mm). Other endpoints significantly favored the metallic stent, including late lumen loss (BRS, 0.37 mm vs. EES, 0.25 mm), minimum lumen diameter (1.86 mm vs. 2.25 mm), and binary in-segment restenosis rate (8.4% vs. 3.3%); however, target-vessel revascularization rates were similar. The rate of myocardial infarction was higher with BRS than with EES (8% vs. 3%); about half of those with BRS were periprocedural. Regarding very late definite thrombosis, the BRS group had six and the EES group had none (P=0.03). About 30% of patients were on dual antiplatelet therapy at follow-up.

Comment

At 3 years, BRS did not show superior vasomotor tone and was associated with more late lumen loss and thromboses resulting in myocardial infarction. BRS proponents might note that outcomes could improve with meticulous implantation techniques using intravascular ultrasound or optical coherence tomography, slow and graded balloon inflations, and careful patient and vessel selection. However, the lack of any long-term benefit plus the signals of greater risk for vessel thrombosis indicate that this device should have very limited clinical use.

Editor Disclosures at Time of Publication

  • Disclosures for Howard C. Herrmann, MD at time of publication Consultant / Advisory board Gerson Lehrman Group; Leerink Swann; Wells Fargo; Edwards Lifesciences; Coleman Research Group Speaker's bureau American College of Cardiology Foundation; American Association for Thoracic Surgery; Beaumont Hospital Cardiovascular Research Foundation; Inova Health Care; Medintelligence; Medinol; Society for Cardiovascular Angiography and Interventions; Northwestern University; Washington Hospital St. Louis; Westchester Medical Center Equity Micro Interventional Devices, Inc. Grant / Research support Abbott Vascular; Boston Scientific; Edwards Lifesciences; St. Jude Medical; Medtronic; Gore; Siemens; Cardiokinetix; University of Laval; Mitraspan Editorial boards Catheterization and Cardiovascular Interventions; Circulation: Cardiovascular Interventions; Journal of Interventional Cardiology; Journal of Invasive Cardiology; Journal of the American College of Cardiology

Citation(s):

Reader Comments (5)

Massimo Leoncini MD Physician, Cardiology, SSD Cardiologia Invasiva Endovascolare Sanremo

Far from being conclusive, this study is a brilliant example of how a BRS should not be implanted. Adequate vessel preparation was not done (undersized balloon predilation per protocol) and postdilation rate only 60% and not at very high atmosphere, on top of that (if it's not enough) the study was not powered for clinical events. Registry with an adequate implant technique (like IT DISAPPEARS) and the experience of high rate BRS implant centers are going in the opposite direction.

Kartik Mani Physician, Cardiology

Three years is more than enough to show that these are probably harmful. As an interventional cardiologist, the whole point of the BVS was to have been a decreased dependence on DAPT in the intermediate term. That is clearly not the case. Why would I choose to use a clunky device that is harder to position, deploy and visualize, if my patient has a greater risk of having an MI.

Rajeev Gupta,MD,DM Physician, Cardiology, Al Jowhara-mediclinic Hospital, Al Ain, UAE

The clear and correct picture is emerging: the broth is settling down. BRS is an expensive affair, used initially with presumption of preservation of coronary vasomotor function and better outcomes. The authors deserve congratulations for such meticulous study. Now I am not going to implant BRS.

Nicholas G Kounis MD, PhD Physician, Cardiology, Department of Cardiology University of Patras Medical School, Patras, Greece

We have already suggested] that the FDA recommendations for coronary stent implantation should be applied also to bioresorbable scaffolds. These recommendations stated clearly that careful history of hypersensitivity reactions with monitoring of inflammatory mediators as well as lymphocyte transformation studies to detect material hypersensitivity must be undertaken before implantation of such devices. Unfortunately only few physicians read the package sheet supplied by the manufacturing companies

Richard E.T. Seet Physician, Emergency Medicine, Private Practice

Three years may be too short a period to say that there is no benefit.

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