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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Periprocedural and Late Consequences of Overlapping Cypher Sirolimus-Eluting Stents

Pooled Analysis of Five Clinical Trials

Dean J. Kereiakes, MD, FACC^_*,_*, Hong Wang, MD, MPH^,a, Jeffrey J. Popma, MD, Richard E. Kuntz, MD^,d, Dennis J. Donohoe, MD^,a, Joachim Schofer, MD, Erick Schampaert, MD^||, Bernhard Meier, MD, FESC, FACC^¶,b, Martin B. Leon, MD, FACC^#,c and Jeffrey W. Moses, MD, FACC^#

^_* Heart Center of Greater Cincinnati and the Lindner Center for Research and Education at The Christ Hospital, Ohio Heart and Vascular Center Inc., Cincinnati, Ohio
Cordis Corp., Warren, New Jersey
Brigham and Women’s Hospital, Boston, Massachusetts
Hamburg University Cardiovascular Center, Hamburg, Germany
^|| Hospital du Sacre’-Coeur de Montreal, Montreal, Canada
^¶ Swiss Cardiovascular Center Bern, Bern, Switzerland
^# Columbia University Medical Center, New York, New York

Manuscript received September 16, 2005; revised manuscript received January 25, 2006, accepted February 17, 2006.

^_* Reprint requests and correspondence: Dr. Dean J. Kereiakes, The Heart Center of Greater Cincinnati and The Lindner Center for Research and Education at the Christ Hospital, 2123 Auburn Avenue, Suite 424, Cincinnati, Ohio 45219. (Email: lindner{at}fuse.net).

OBJECTIVES: The purpose of this research was to determine the relative safety and efficacy of multiple (2) overlapping Cypher sirolimus-eluting stents (SES) (Johnson & Johnson, New Brunswick, New Jersey).

BACKGROUND: Overlapping coronary stents are common. The periprocedural and late clinical and angiographic consequences of overlapped coronary stents are not clearly defined, particularly for drug-eluting stents.

METHODS: All patients enrolled into five clinical trials of the SES were analyzed. Three of these trials were prospective randomized comparisons of the SES to the bare-metal stent (BMS), and two were prospective non-randomized trials of SES-treated patients with historical controls. All clinical and angiographic outcomes in overlap-stent–treated patients were compared by stent type and with single-stent–treated patients for the same stent device.

RESULTS: In all, 575 patients with stent overlap (337 SES, 238 BMS) and 1,162 patients with single stents (697 SES, 465 BMS) were analyzed. Stent overlap was associated with a greater late lumen loss in stent and more frequent angiographic restenosis regardless of stent type. Among overlap-stent–treated patients, the SES provided similar magnitude of restenosis benefit as observed for single-stent–treated patients. Overlapped SES was not associated with an increase in myocardial infarction.

CONCLUSIONS: The strategy of SES overlap, when required, is both safe and efficacious in reducing restenosis with no increase in the incidence of myocardial infarction or major adverse cardiovascular events, when compared with a bare metal coronary stent prosthesis.

Abbreviations and Acronyms   BMS = bare-metal stent   CK = creatine kinase   MACE = major adverse cardiovascular events   PES = paclitaxel-eluting stent   QCA = quantitative coronary angiography   SES = sirolimus-eluting stent   SIRIUS = Sirolimus-Eluting Stent in Coronary Lesions trial

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