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Articles by M. B Leon
Total Records ( 3 ) for M. B Leon
  R. J Russo , P. D Silva , P. S Teirstein , M. J Attubato , C. J Davidson , A. C DeFranco , P. J Fitzgerald , S. L Goldberg , J. B Hermiller , M. B Leon , F. S Ling , J. E Lucisano , R. A Schatz , S. C Wong , N. J Weissman , D. M Zientek and for the AVID Investigators

Background— AVID (Angiography Versus Intravascular ultrasound-Directed stent placement) is a multicenter, randomized controlled trial designed to assess the effect of intravascular ultrasound (IVUS)-directed stent placement on the 12-month rate of target lesion revascularization (TLR).

Methods and Results— After elective coronary stent placement and an optimal angiographic result (<10% stenosis), 800 patients were randomized to Angiography- or IVUS-directed therapy. Blinded IVUS was performed in the Angiography group without further therapy. In the IVUS group, IVUS criteria for optimal stent placement (<10% area stenosis, apposition, and absence of dissection) were applied. Final minimum stent area was 6.90±2.43 mm2 in the Angiography group and 7.55±2.82 mm2 in the IVUS group (P=0.001). In the IVUS group, only 37% with inadequate expansion (<90%) received further therapy. The 12-month TLR rate was 12.0% in the Angiography group and 8.1% in the IVUS group (P=0.08, 95% confidence level [CI], [–8.3% to 0.5%]). When vessels with a distal reference diameter <2.5 mm by core laboratory angiography measurement were excluded from analysis, the 12-month TLR rate was 10.1% in the Angiography group and 4.3% in the IVUS group (P=0.01, 95% CI, [–10.6% to –1.2%]). With a prestent angiographic stenosis of ≥70%, the TLR rate was lower in the IVUS group compared with the Angiography group (3.1% versus 14.2%; P=0.002; 95% CI, [–18.4% to –4.2%]).

Conclusions— IVUS-directed bare-metal stent placement results in larger acute stent dimensions without an increase in complications and a significantly lower 12-month TLR rate for vessels ≥2.5 mm by angiography and for vessels with high-grade prestent stenosis. However, for the entire sample analyzed on an intention-to-treat basis, IVUS-directed bare-metal stent placement does not significantly reduce the 12-month TLR rate when compared with stent placement guided by angiography alone. In addition, IVUS evaluation of adequate stent expansion is underutilized by experienced operators.

  C Oviedo , A Maehara , G. S Mintz , H Araki , S. Y Choi , K Tsujita , T Kubo , H Doi , B Templin , A. J Lansky , G Dangas , M. B Leon , R Mehran , S. J Tahk , G. W Stone , M Ochiai and J. W. Moses

Background— Angiographic classifications of the location and severity of disease in the main vessel and side branch of coronary artery bifurcations have been proposed and applied to distal left main coronary artery (LMCA) bifurcation.

Methods and Results— We reviewed 140 angiograms of distal LMCA and ostial left anterior descending (LAD) and left circumflex (LCX) artery lesions with preintervention intravascular ultrasound (IVUS) of both the LAD and LCX arteries as well as the LMCA. Of 140 patients, 92.9% had at least 1 cross section with ≥40% IVUS plaque burden versus 57.2% of patients with an angiographic diameter stenosis ≥50%. Contrary to angiographic classifications, IVUS showed that bifurcation disease was rarely focal and that both sides of the flow divider were always disease-free. Continuous plaque from the LMCA into the proximal LAD artery was seen in 90%, from the LMCA into the LCX artery in 66.4%, and from the LMCA into both the LAD and LCX arteries in 62%. Plaque localized to either the LAD or LCX ostium and not involving the distal LMCA was seen in only 9.3% of LAD arteries and 17.1% of LCX arteries. Plaque distribution was not influenced by the LAD/LCX angiographic angle, lesion severity, LMCA length, or remodeling. We proposed an IVUS classification for bifurcation lesions illustrating longitudinal and circumferential spatial plaque distribution.

Conclusions— Angiographic classification of LMCA bifurcation lesions is rarely accurate. IVUS shows that the carina is always spared and that the disease is diffuse rather than focal.

Clinical Trial Registration— URL: Unique identifier: NCT00180466.

  J. F Granada , S Inami , M. S Aboodi , A Tellez , K Milewski , D Wallace Bradley , S Parker , S Rowland , G Nakazawa , M Vorpahl , F. D Kolodgie , G. L Kaluza , M. B Leon and R. Virmani

We aimed to demonstrate that, by separating endothelial progenitor cell capture from sirolimus delivery through the application of drug to the abluminal surface of the stent, the degree of endothelialization can be enhanced.

Methods and Results—

Stainless steel R Stents, with biodegradable SynBiosys polymer coating with sirolimus abluminally applied and surface modified with anti-CD34 antibody were prepared at 2 dosages (low-dose sirolimus [LD-Combo, 2.5 µg sirolimus/mm] and full-dose sirolimus [Combo, 5 µg sirolimus/mm). These Combo stents and the Cypher stent (10 µg sirolimus/mm) were deployed in 98 normal porcine arteries and harvested for pharmacokinetic analysis at 0.25, 1, 3, 7, 14, 28, and 35 days. The LD-Combo stents showed faster early release (50%total dose in 72 hours) than the Combo and Cypher. At 30 days, drug release was near complete with both Combo stents, whereas 20% of drug remained on the Cypher stents. To assess efficacy, a total of 50 stents (Xience V=8, Cypher=8, Genous bioengineered R stent=6, LD-Combo=14, and Combo=14) were implanted in 18 pigs for 14 and 28 days. Optical coherence tomography was performed, and stents were harvested for histology. At 28 days, there was less neointimal thickness with Combo (0.173±0.088 mm) compared with Cypher (0.358±0.225 mm), LD-Combo (0.316±0.228 mm), and Xience V (0.305±0.252 mm; P<0.00001). Immunohistochemical analysis of endothelialization showed that Genous bioengineered R stent had the highest degree of platelet endothelial cell adhesion molecule expression (87%) followed by the Combo (75%), LD-Combo (65%), and Cypher (58%).


Both optical coherence tomography and histology demonstrate that anti-CD34 sirolimus-eluting stents promote endothelialization while reducing neointimal formation and inflammation.

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