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APPOSITION III: Self-apposing stent linked to low mortality rate
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SAN FRANCISCO — New results from the APPOSITION III trial of 1,000 patients after severe MI demonstrate a low rate of MACE at 1 year with a self-apposing stent.
The prospective, single-arm, multicenter post-market trial was designed to assess the long-term performance of the Stentys Self-Apposing stent in routine clinical practice in patients with STEMI. At 1 year, the rate of MACE, which included cardiac death, target vessel recurrent MI, emergent bypass or clinically driven target vessel revascularization, was 9.3% for the full study population and 8.4% when post-dilation was performed vs. 11.3% without post-dilatation. In a pooled analysis from the ACTION Study Group of the most recent randomized trials in primary PCI, the cardiac death rate at 1 year in APPOSITION III (2%) was half of the average death rate in these randomized studies. The composite endpoint of cardiac death or target vessel MI was 5% and 2.4% when post-dilatation was performed.
Gilles Montalescot
“The very low rates of mortality and reinfarction in the APPOSITION III study clearly highlight the excellent safety profile of self-apposing stents,” Gilles Montalescot, MD, PhD, head of the cardiac care unit at Pitié-Salpêtrière Hospital, Paris, stated in a press release. “The results from our pooled analysis showed average mortality of 3.9% with conventional stents, with the lowest published trial at 2.2%.”
At a press conference, Montalescot added: “It is best to have post-dilation after impantation of the self-apposing stent.”
For more information:
Montalescot G. Poster #2667-7. Presented at: American College of Cardiology Scientific Sessions; March 9-11, 2013; San Francisco.
Disclosure: Montalescot reports research grants or consulting or lecture fees from Abbott, Astra-Zeneca, Bayer, Biotronik, Boehringer-Ingelheim, BMS, CCC, CME Resources, Daiichi-Sankyo, Danish Society of Cardiology, Eli-Lilly, Europa, DCRI, Fondation Recherche Medicale, Fondation de France, GLG, INSERM, Iroko, Lead-up, Mayo Clinic, The Medicines Company, Medtronic, Menarini, Nanospheres, Pfizer, Roche, Sanofi-Aventis, Société Française de Cardiologie, Springer, Stentys, TIMI group, Web MD and Wolters.
Perspective
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Gary Mintz, MD
The vessels in this study were relatively large; typical MI studies do not have 3.5-mm angiographic vessel sizes. This is a large registry with a self-expanding stent. The takeaway message from the study is that the researchers should do a randomized trial to prove that it works. It is a question of what a self-expanding stent does in the setting of an MI. The No. 1 mechanism that Dr. Montalescot discussed is that since the vessels tend to be small at the time of the infarct, the self-expanding stent overcomes it, except that the vessels in this study were 3.5 mm.
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