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Chronic Arterial Responses to Overlapping Paclitaxel-Eluting Stents

Insights From Serial Intravascular Ultrasound Analyses in the TAXUS-V and -VI Trials

Jiro Aoki, MD, PhD^_*, Gary S. Mintz, MD, FACC^_*,_*, Neil J. Weissman, MD, FACC, J. Tift Mann, MD, FACC, Louis Cannon, MD, FACC, Joel Greenberg, MD, FACC^||, Eberhard Grube, MD, FACC^¶, A.R. Zaki Masud, MD, FACC^#, Joerg Koglin, MD^_**, Lazar Mandinov, MD, PhD^_**, Gregg W. Stone, MD, FACC^_*

^_* Columbia University Medical Center and Cardiovascular Research Foundation, New York, New York
Cardiovascular Research Institute, Washington Hospital Center, Washington, DC
Wake Heart Research, Raleigh, North Carolina
Cardiac & Vascular Research Center of Northern Michigan, Petoskey, Michigan
^|| Florida Heart Institute, Orlando, Florida
^¶ Helios Klinikum, Siegburg, Germany
^# Buffalo General Hospital, Buffalo, New York
^_** Boston Scientific Corp., Natick, Massachusetts.

^_* Reprint requests and correspondence: Dr. Gary S. Mintz, Cardiovascular Research Foundation, 111 East 59th Street, 11th Floor, New York, New York 10022. (Email: gmintz{at}crf.org).

Objectives: The purpose of this study was to use intravascular ultrasound (IVUS) to investigate chronic arterial responses at the site of and adjacent to overlapping paclitaxel-eluting TAXUS stents (PES) compared with overlapping bare-metal stents (BMS).

Background: Increased paclitaxel dose in the PES-overlap region might be associated with arterial toxicity expressed as excessive expansive remodeling, incomplete stent apposition, or aneurysm formation.

Methods: In the TAXUS-V and -VI trials, 51 patients with overlapping stents (27 PES and 24 BMS) were imaged with serial IVUS immediately after procedure and at 9 months. The IVUS measurements included intimal hyperplasia (IH), peri-stent plaque plus media (P&M), and external elastic membrane (EEM) areas. Vascular responses were assessed at the proximal and distal single stent strut regions and the central overlap region.

Results: Compared with BMS, all 3 PES stent regions showed: 1) significantly decreased IH (proximal: 0.97 ± 1.06 mm² vs. 3.12 ± 2.40 mm², overlap: 0.74 ± 0.91 mm² vs. 3.23 ± 1.75 mm², distal: 0.88 ± 0.85 mm² vs. 2.69 ± 1.49 mm², all p < 0.05); and 2) increased P&M and EEM areas (Delta P&M; proximal: 0.96 ± 1.36 mm² vs. –0.02 ± 1.48 mm², overlap: 1.56 ± 1.88 mm² vs. 0.29 ± 1.82 mm², distal: 1.03 ± 1.81 mm² vs. 0.11 ± 0.89 mm², all p < 0.05). The IH and changes in EEM and P&M areas were not significantly different in both the BMS and PES groups comparing the single stent strut and overlap regions. Incomplete stent apposition did not occur at the site of overlapping PES in any patient.

Conclusions: Nine months after stent implantation, neointimal tissue growth was reduced and expansive remodeling was greater with PES compared with BMS—effects that were not exaggerated at the overlap region of PES.

Abbreviations and Acronyms   BMS = bare-metal stent(s)   CSA = cross-sectional area   DES = drug-eluting stent(s)   EEM = external elastic membrane   IH = intimal hyperplasia (area)   ISA = incomplete stent apposition   IVUS = intravascular ultrasound system   PES = paclitaxel-eluting stent(s)   P&M = plaque and media (area)   SES = sirolimus-eluting stent(s)