A prospective, randomized trial of intravascular-ultrasound guided compared to angiography guided stent implantation in complex coronary lesions: The AVIO trial

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• 作者：Alaide Chieffo ; MD^a ; ^s ; Azeem Latib ; MD^a ; ^s ; Christophe Caussin ; MD^b ; ^s ; Patrizia Presbitero ; MD^c ; ^s ; Stefano Galli ; MD^d ; ^s ; Alberto Menozzi ; MD^e ; ^s ; Ferdinando Varbella ; MD^f ; ^s ; Fina Mauri ; MD^g ; ^s ; Marco Valgimigli ; MD^h ; ^s ; Chourmouzios Arampatzis ; MDⁱ ; ^s ; Manuel Sabate ; MD^j ; ^s ; Andrejs Erglis ; MD^k ; ^s ; Bernhard Reimers ; MD^l ; ^s ; Flavio Airoldi ; MD^m ; ^s ; Mika Laine ; MDⁿ ; ^s ; Ramon Lopez Palop ; MD^o ; ^s ; Ghada Mikhail ; MD^p ; ^s ; Philip MacCarthy ; MD^q ; ^s ; Francesco Romeo ; MD^r ; ^s ; Antonio Colombo ; MD ; FACC^a ; ^s ; ^{colombo.antonio@hsr.it}
• 刊名：American Heart Journal
• 出版年：2013
• 出版时间：January, 2013
• 年：2013
• 卷：165
• 期：1
• 页码：65-72
• 全文大小：515 K

文摘

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Background

No randomized studies have thus far evaluated intravascular ultrasound (IVUS) guidance in the drug-eluting stent (DES) era. The aim was to evaluate if IVUS optimized DES implantation was superior to angiographic guidance alone in complex lesions.

Methods

Randomized, multicentre, international, open label, investigator-driven study evaluating IVUS vs angiographically guided DES implantation in patients with complex lesions (defined as bifurcations, long lesions, chronic total occlusions or small vessels). Primary study endpoint was post-procedure in lesion minimal lumen diameter. Secondary end points were combined major adverse cardiac events (MACE), target lesion revascularization, target vessel revascularization, myocardial infarction (MI), and stent thrombosis at 1, 6, 9, 12, and 24 months.

Results

The study included 284 patients. No significant differences were observed in baseline characteristics. The primary study end point showed a statistically significant difference in favor of the IVUS group (2.70 mm ¡À 0.46 mm vs. 2.51 ¡À 0.46 mm; P = .0002). During hospitalization, no patient died, had repeated revascularization, or a Q-wave MI. No difference was observed in the occurrence of non-Q wave MI (6.3 % in IVUS vs. 7.0 % in angio-guided group). At 24-months clinical follow-up, no differences were still observed in cumulative MACE (16.9 % vs. 23.2 % ), cardiac death (0 % vs. 1.4 % ), MI (7.0 % vs. 8.5 % ), target lesion revascularization (9.2 % vs. 11.9 % ) or target vessel revascularization (9.8 % vs. 15.5 % ), respectively in the IVUS vs. angio-guided groups. In total, only one definite subacute stent thrombosis occurred in the IVUS group.

Conclusions

A benefit of IVUS optimized DES implantation was observed in complex lesions in the post-procedure minimal lumen diameter. No statistically significant difference was found in MACE up to 24 months.