Title: BIOFREEDOM: A Prospective Randomized Trial of Polymer-Free Biolimus A9-Eluting Stents and Paclitaxel-Eluting Stents in Patients with Coronary Artery Disease
Event: TCT 2010
Topic(s): Interventional Cardiology
Presenter: Eberhard Grube
Writer(s): Xiushui Ren
Date Posted: 09/25/2010
Summary
A new-generation polymer-free drug-eluting stents appears to be safe and efficacious as compared with standard drug-eluting stent.
Background
Due to concerns for stent thrombosis, newer generation coronary stents have been developed. A previous study showed noninferiority of a stent (Nobori) coated with bioresorbable polymer, polylactic acid, and Biolimus A9 as compared to the Taxus Liberté stent.
The BioFreedom Biolimus A9 (BA9) coated stent is the first polymer-free drug-eluting stent (DES) using a stainless steel platform that holds the antiproliferative agent Biolimus A9 on the abluminal surface. Thus this design may potentially reduce the risk of late stent thrombosis and the duration of dual antiplatelet therapy.
The current study compared the BioFreedom polymer-free stent with paclitaxel-eluting stent (PES) in patients with de novo coronary lesions.
Study Design
This was a prospective, randomized, noninferiority trial of 182 patients: 75 patients in the first cohort (enrolled between September 2008 and January 2009), and 107 patients in the second cohort (enrolled between January 2009 and June 2009.
Patients with single de novo coronary lesions (2.25-3 mm vessel size and ≤14 mm lesion length) were randomized (in a 1:1:1 ratio) to BA9 standard dose stent (15.6µg/mm), BA9 low-dose stent (7.8µg/mm), or PES. Dual antiplatelet therapy was recommended for a minimum of 6 months.
The primary end point was angiographic in-stent late lumen loss at 12 months (second cohort). Secondary end points included angiographic in-stent late lumen loss at 4 months (first cohort) and various clinical end points.
Results and Conclusions
At 12-month follow-up, the BA9 standard dose stent met the prespecified noninferiority criteria as compared with the Taxus Liberté stent (late loss 0.17 mm vs. 0.35 mm, p=0.001), whereas the BA9 low-dose stent did not. The BA9 stent had a numeric trend toward superiority as compared to the Taxus Liberté stent (p=0.11).
The rates of major adverse cardiac events (including all-cause death, MI, emergent bypass surgery, or target-lesion revascularization) were low in all groups and definitive conclusions cannot be drawn.
There was no incidence of stent thrombosis at 12 months among the entire 182 patients.
References
1. Chevalier B, Silber S, Park SJ, et al. Randomized comparison of the Nobori Biolimus A9-eluting coronary stent with the Taxus Liberté paclitaxel-eluting coronary stent in patients with stenosis in native coronary arteries: the NOBORI 1 trial--Phase 2. Circ Cardiovasc Interv 2009 Jun;2(3):188-95.
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Title: AVIO: A Prospective Randomized Trial of Intravascular Ultrasound-Guided Compared to Angiography-Guided Stent Implantation in Complex Coronary Lesions
Event: TCT 2010
Topic(s): Interventional Cardiology
Presenter: Antonio Colombo
Writer(s): Xiushui Ren
Date Posted: 09/25/2010
Summary
IVUS-guided stent implantation results in larger final minimal lumen diameter, but in a small group,no difference was seen in clinical endpoints, as compared to angiography-guided stent implantation in patients with complex coronary lesions.
Background
Angiographic assessment of coronary disease frequently results in inaccurate estimation of vessel size and disease severity. Thus angiography-guided stent implantation can lead to suboptimal stent sizing, expansion, and apposition, all of which can contribute to in-stent restenosis and stent thrombosis.
Study Design
The current study is a multicenter, randomized, open label, investigator-driven study comparing intravascular ultrasound (IVUS)-guided stent implantation to angiography-guided stent implantation in patients with complex coronary lesions.
Patients with complex coronary lesions (defined as bifurcations, long lesions (> 28 mm), chronic total occlusion, small vessels, and patients requiring 4 or more stents) were randomized to IVUS-guided or angiography-guided stent implantation. After stent implantation and post-dilatation, 49 patients from the angiography-guided group were randomized to final IVUS. An independent core-lab analyzed all data, including quantitative coronary angiography and IVUS data.
The primary end point was post-procedure in-lesion minimal lumen diameter (MLD). Secondary end points were target vessel revascularization (TVR) at 9 months and of major adverse cardiac events (MACE) at 1, 6, and 9 months.
Results and Conclusions
A total of 284 patients (142 patients in each group) were randomized. Baseline characteristics were similar in the 2 groups. The mean age was 64 years, and about 20% were women. About 25% of patients had diabetes, and 30% had unstable angina. About 15% of lesions were chronic total occlusions, 25% were bifurcations, 60% were long, and 20% involved small vessels.
The final MLD (primary endpoint) was larger in IVUS-guided patients (2.7±0.46 mm versus 2.51±0.46 mm, p=0.0002). There was no difference in 30-day or 9-month MACE.
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