Briguori Carlo, Donahue Michael, Visconti Gabriella, Focaccio Amelia, Pennacchi Mauro, Lucisano Luigi, Stio Rocco, Mancone Massimo, Calcagno Simone, Di Palma Vito, Labalestra Nicola, Signoriello Giuseppe, Sardella Gennaro
Laboratory of Interventional Cardiology and Department of Cardiology, Clinica Mediterranea, Naples, Italy.
Department of Cardiovascular, Respiratory, Nephrologic, Anesthesiologic and Geriatric Sciences, Policlinico Umberto I, "Sapienza" University of Rome.
Catheter Cardiovasc Interv. 2017 Mar 1;89(4):E112-E123. doi: 10.1002/ccd.26659. Epub 2016 Jul 29.
To compare the safety and efficacy of the Axxess™ biolimus-eluting stent with the second-generation drug-eluting stent (DES) in the treatment of bifurcation lesions.
The Axxess™ is a dedicated bifurcation stent, designed to cover the lesion at the carina level.
Between April 2012 and August 2014, 165 patients with de novo bifurcation lesions were treated with the Axxess™ stent (Axxess group). A propensity-score matched group of 165 patients treated with DES in the same period was selected (Control group). The primary objectives were (1) the procedural complication rate, including side branch (SB) occlusion and trouble in SB access after main vessel stenting; and (2) the device, the angiographic, and the procedural success rate.
Procedural complications occurred in 1 patient (0.6%) in the Axxess group and in 20 patients (12%) in the Control group (OR = 0.03; 95% confidence interval 0.005-0.27; P < 0.001). Device success was obtained in 164 (99.5%) patients in the Axxess group and in all in the Control group (P = 1.00). Angiographic success was obtained in all patients. Inaccurate Axxess™ stent position occurred in 21 (13%) patients, and was more often associated with moderate-to-severe calcifications and distal lesion site. Procedural success was obtained in 91.5% patients in the Axxess group and in 90% patients in the Control group (P = 0.72).
The present registry suggests that the Axxess™ stent (1) may represent a valid alternative approach for the treatment of bifurcation lesions and (2) should be avoided in moderate-to-severe calcifications and/or in distal lesions. © 2016 Wiley Periodicals, Inc.
比较Axxess™生物雷帕霉素洗脱支架与第二代药物洗脱支架（DES）治疗分叉病变的安全性和有效性。
Axxess™是一款专用分叉支架，设计用于覆盖隆突水平的病变。
2012年4月至2014年8月期间，165例新发分叉病变患者接受了Axxess™支架治疗（Axxess组）。选取同期165例接受DES治疗的患者作为倾向评分匹配组（对照组）。主要目标为：（1）手术并发症发生率，包括边支（SB）闭塞以及主支血管支架置入术后SB入路困难；（2）器械、血管造影及手术成功率。
Axxess组1例患者（0.6%）发生手术并发症，对照组20例患者（12%）发生手术并发症（OR = 0.03；95%置信区间0.005 - 0.27；P < 0.001）。Axxess组164例（99.5%）患者获得器械成功，对照组所有患者均获得器械成功（P = 1.00）。所有患者均获得血管造影成功。21例（13%）患者Axxess™支架位置不准确，且更常与中重度钙化和病变远端部位相关。Axxess组91.5%的患者获得手术成功，对照组90%的患者获得手术成功（P = 0.72）。
本注册研究表明，Axxess™支架（1）可能是治疗分叉病变的一种有效替代方法；（2）在中重度钙化和/或病变远端部位应避免使用。© 2016威利期刊公司
