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CLINICAL RESEARCH

Drug-Eluting Stents in the Treatment of Intermediate Lesions

Pooled Analysis From Four Randomized Trials

Jeffrey W. Moses, MD, FACC^_*,_*, Gregg W. Stone, MD, FACC^_*, Eugenia Nikolsky, MD, PhD, FACC^_*, Gary S. Mintz, MD, FACC^_*, George Dangas, MD, PhD, FACC^_*, Eberhard Grube, MD, Stephen G. Ellis, MD, FACC, Alexandra J. Lansky, MD, FACC^_*, Giora Weisz, MD^_*, Martin Fahy, MSc^_*, Yingbo Na, MSc^_*, Mary E. Russell, MD, FACC, Dennis Donohoe, MD^||, Martin B. Leon, MD, FACC^_* and Roxana Mehran, MD, FACC^_*

^_* Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York
Heart-Center Siegburg, Siegburg, Germany
Cleveland Clinic Foundation, Cleveland, Ohio
Boston Scientific Corp, Natick, Massachusetts
^|| Cordis Corp., Warren, New Jersey

Manuscript received September 19, 2005; revised manuscript received December 23, 2005, accepted January 9, 2006.

^_* Reprint requests and correspondence: Dr. Jeffrey W. Moses, Center for Interventional Vascular Therapy, Columbia University Medical Center, 161 Fort Washington Avenue, Irving Pavilion–5th Floor, New York City, New York 10032 (Email: jm2456{at}columbia.edu).

OBJECTIVES: To address the safety and efficacy of drug-eluting stents (DES) in the treatment of intermediate lesions, we performed a pooled analysis of four randomized DES versus bare-metal stent (BMS) trials and assessed outcomes among patients with intermediate lesions.

BACKGROUND: Before the introduction of DES, intermediate coronary lesions were commonly managed based on physiologic or anatomic assessment of lesion severity. The DES may challenge this paradigm.

METHODS: The study population involved 167 of 2,478 randomized patients (6.7%) with intermediate lesions (diameter stenosis <50% [mean 44%] by quantitative coronary angiography) from the Sirolimus-coated Bx Velocity Balloon Expandable Stent in the Treatment of Patients with De Novo Coronary Artery Lesions (SIRIUS), TAXUS-IV, and the First and Second First Use to Underscore Restenosis Reduction with Everolimus (FUTURE-I and -II) trials. End points examined included early (in-hospital and 30-day) and late (1-year) major adverse cardiac events (MACE), including cardiac death, myocardial infarction (MI), target vessel revascularization (TVR), stent thrombosis, and follow-up angiographic restenosis.

RESULTS: Patients with intermediate lesions randomized to DES versus BMS had low rates of 30-day MACE (1.1% vs. 4.0% respectively; p = 0.22). At one-year follow-up, patients treated with DES versus BMS had similar rates of cardiac death (0% vs. 2.7%, respectively; p = 0.11) and MI (3.4% vs. 5.4%; p = 0.49) but markedly lower rates of TVR (3.4% vs. 20.3%; p = 0.0004), MACE (5.6% vs. 25.4%; p = 0.0003), and binary angiographic restenosis (1.8% vs. 34.0%; p < 0.0001). No patient in either group developed stent thrombosis.

CONCLUSIONS: Compared with BMS, treatment of intermediate lesions with DES appears safe and results in a marked reduction in clinical and angiographic restenosis. The efficacy of DES may require a reevaluation of current treatment paradigms for intermediate lesions.

Abbreviations and Acronyms   BMS = bare-metal stent   DES = drug-eluting stent   FFR = fractional flow reserve   IVUS = intravascular ultrasound   MACE = major adverse cardiac events   MI = myocardial infarction   PCI = percutaneous coronary intervention   QCA = quantitative coronary angiography   TLR = target lesion revascularization   TVR = target vessel revascularization

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