We Need Independent Clinical Trial Initiatives

By Javier Martín de la Torre-Hernández, MD

Drug-eluting stents (DES) have widely open the field of research in interventional cardiology. These devices are no longer “simple metallic springs” with minor and subtle differences in cell or strut geometry. Their platforms differ in material and architecture. There are many possible variations in polymer composition or durability, even it may be absent. New cytostatic drugs are used in different dosages and release patterns. There is not definitely a class effect for DES. Given all this, the need for multiple comparative trials is imperative. The newcomer DES has to be compared with the “gold standard” DES of the moment. However, the clinical differences between the new DES are becoming really narrow and large and quite expensive trials are needed. Finally when the trial is done, the restrictions to the inclusion limit its applicability. On the other side the penetration of new DES in practice is fast and precedes the availability of evidences from the trials. Off label usage is usual and may reveal new problems not previously noted in the trials. This has been the case for the new DES addressed in our study, the Promus Element. Some cases of longitudinal compression or shortening have been described with these stents and bench testing studies have reported particular mechanical properties.

Given all this, we need independent clinical trials initiatives. We have compared two DES sharing drug and polymer but differing in the platform. We are aware of the limited size of our randomized study but the trial scenario was really an “all comers”. We have observed in this sample a quite similar performance for both DES and no mechanical issues were appreciated for the new Promus Element stent. These results suggest that, even though these alterations are possible, their incidence will still be very low and with a very limited clinical impact. This is only a minor piece of knowledge, but it is better than nothing.

Further reading: Hernandez et al / April 2013 / Journal of Invasive Cardiology   A Real All-Comers Randomized Trial Comparing Xience Prime and Promus Element Stents

Read more:

Drug-Eluting Stent Strut Distribution: A Comparison between Cypher™ and Taxus® by Optical Coherence Tomography  Yoriyasu Suzuki, MD, Fumiaki Ikeno, MD, Alan C. Yeung, MD

 Comparison Between Sirolimus- and Paclitaxel-Eluting Stents for the Treatment of Chronic Total Occlusions   Jae-Sik Jang, MD, Myeong-Ki Hong, MD, PhD, Cheol Whan Lee, MD, PhD, Duk-Woo Park, MD, Bong-Ki Lee, MD, Young-Hak Kim, MD, PhD, Ki-Hoon Han, MD, PhD, Jae-Joong Kim, MD, PhD, Seong-Wook Park, MD, PhD, Seung-Jung Park, MD, PhD

Comparison of Multiple Drug-Eluting Stent Percutaneous Coronary Intervention and Surgical Revascularization in Patients with Multivessel Coronary Artery Disease: One Year Clinical Results and Total Treatment Costs    Elisabetta Varani, MD, Marco Balducelli, MD, Giuseppe Vecchi, MD, Matteo Aquilina, MD, Aleardo Maresta, MD

Comparison of Stainless-Steel Stents Coated with Turbostratic Carbon and Uncoated Stents for Percutaneous Coronary Interventions   Jürgen Haase, MD, PhD, Hans Störger, MD, Manfred Hofmann, MD, Claus-Eberhard Schwarz, MD, Harald Reinemer, MD, Franz Schwarz, MD, PhD

 Comparison of Nonuniform Strut Distribution between Two Drug-Eluting Stent Platforms Takao Hasegawa, MD, Junya Ako, MD, Fumiaki Ikeno, MD, Katsuhisa Waseda, MD, PhD, Yoriyasu Suzuki, MD, Yasuhiro Honda, MD, Peter J. Fitzgerald, MD, PhD

Mid-Term Results of Everolimus-Eluting Stent in a Japanese Population Compared With a US Randomized Cohort: SPIRIT III Japan Registry With Harmonization by Doing  Shigeru Saito, MD, Shigeru Nakamura, MD, Kenshi Fujii, MD, Masato Nakamura, MD, Takaaki Isshiki, MD, Haruo Hirayama, MD, Tadashi Kikuchi, MD, PhD, Hiroshi Fujita, MD, Hiroshi Nonogi, MD, PhD, Kazuaki Mitsudo, MD, Takeshi Kimura, MD, Keiichi Igarashi, MD, Kumiko Saito, MS, MPH, Alexandra J. Lansky, MD, Gregg W. Stone, MD, Yasuhiro Honda, MD, Katsuhisa Waseda, MD, PhD, Peter J. Fitzgerald, MD, PhD, Krishnankutty Sudhir, MD, PhD

A Randomized Comparison of Direct Stenting Versus Stenting with Predilatation in Native Coronary Artery Disease: Results from the multicentric Crosscut study  Flavio Airoldi, MD, Di Mario, MD, PhD, Giorgio Gimelli, MD, Antonio L. Bartorelli, MD, Francesco Bedogni, MD, Carlo Briguori, MD, PhD, Arian Frasheri, MD, Luigi Inglese, MD, Nino Rubino, MD, Angela Ferrari, PhD, Bernhard Reimers, MD, Antonio Colombo, MD

Extensive Thrombus of Distal Anastomosis of Saphenous Vein Graft  Javier Martín de la Torre-Hernández, MD, Dominick J. Angiolillo, MD, Rosana Hernández-Antolin, MD, PhD

We will never really EXCEL until we IVUS  By Scott Murray, MD

Chronic Total Occlusion Intervention: A Novel Antegrade Guidewire Probing Technique   Raymond Chi-Yan Fung, MBBS, FHKCP and Chi-Kin Chan, MBBS, FRCP (Glasgow), FRCP (Edinburgh)

De la Torre-Hernández JM, Alfonso F, Hernández F, et al., for the ESTROFA study group. Drug eluting stent thrombosis: Results from the multicenter Spanish registry ESTROFA. J Am Coll Cardiol 2008;51:986–990.

De la Torre-Hernandez JM, Sainz-Laso F, Burgos V, et al. Comparison of C-reactive protein levels after coronary stenting with bare metal versus sirolimus-eluting stents. Am J Cardiol 2005;95:748–751

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