ISAR-TEST-4 study: Randomized trial of 3-limus agent-eluting stents with biodegradable or permanent polymer coating 

Read the press release

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	Presenter | see Discussant report
	Julinda Mehili (Germany)

List of Authors:

J. Mehilli, A. Kastrati, R.A. Byrne, S. Kufner, S. Massberg, K.A. Birkmeier, K-L. Laugwitz, S. Schulz, J. Pache, M. Fusaro, M. Seyfarth, A. Schömig

Abstract:

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	Discussant | see Presenter abstract
	Aaron Kugelmass (United States of America)

Report:

Dr.Mehilli and colleagues are to be congratulated on the ISAR-TEST-4 trial. The study of over 2600 patients is the largest randomized trial of a biodegradable polymer based DES to date.

The study population is comparatively “non-idealized”, and reflects real world practice with both stable angina and acute coronary syndrome patients. The population mirrors that of contemporary practice both clinically, (patients with diabetes, prior infarction and/or multivessel disease), and angiographically, (mean vessel size of 2.8 mm and greater than 70% B2 or C lesions).

Current DES, which have durably reduced clinical and angiographic restenosis, utilize permanent polymers. It is thought that these polymers contribute to hypersensitivity reactions, ongoing inflammation, and thrombogenicity. Thus, current polymers likely contribute to delayed angiographic and clinical events such as late lumen creep, and delayed restenosis and stent thrombosis. Thus, the appeal of DES utilizing a biodegradable polymer. Conclusion At both 30 days and twelve months, the biodegradable polymer stent was significantly non-inferior to available limus stents for both safety (cardiac death/MI) and clinical restenosis (TLR). Each of the contributing endpoints appeared similar. This is encouraging, but begets the question as to what is the appropriate clinical and angiographic surveillance period for biodegradable polymer stents. As is evident from DES, attempts to reduce vascular inflammation can result in temporal shifts in angiographic and clinical sequellae. Will the results of biodegradable polymer stents prove as durable as current DES? Hopefully ISAR-TEST-4 includes longer term clinical and angiographic follow up. With additional follow up, this data can help drive this promising technology.

Notes to editor
This congress report accompanies a presentation given at the ESC Congress 2009. Written by the author himself/herself, this report does not necessarily reflect the opinion of the European Society of Cardiology.

The content of this article reflects the personal opinion of the author/s and is not necessarily the official position of the European Society of Cardiology.