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CLINICAL TRIALS

High-dose 7-hexanoyltaxol-eluting stent with polymer sleeves for coronary revascularization

One-year results from the SCORE randomized trial

Eberhard Grube, MD, FACC^*,*, Alexandra Lansky, MD, FACC, Karl Eugen Hauptmann, MD, Carlo Di Mario, MD, FACC, Germano Di Sciascio, MD, FACC^||, Antonio Colombo, MD, FACC^¶, Sigmund Silber, MD, FACC^#, Juergen Stumpf, MD^**, Nicolaus Reifart, MD, FACC, Jean Fajadet, MD, Antonio Marzocchi, MD, Joachim Schofer, MD^||||, Pierre Dumas, MD^¶¶, Rainer Hoffmann, MD^##, Giulio Guagliumi, MD^***, Mark Pitney, MD and Mary E. Russell, MD, FACC

^* Herzzentrum, Siegburg, Germany
Cardiovascular Research Foundation, New York, New York
Krandkenhaus Barmherzige Brueder, Trier, Germany
San Raffaele Hospital, Milan, Italy
^|| University Campus Biomedico of Rome, Rome, Italy
^¶ Columbus Hospital, Milan, Italy
^# Cardiology Clinic, Munich, Germany
^** Praxisklinik Kardiologie Angiologie Radiologie, Dresden, Germany
Main-Taunus Heart Institute, Bad Soden, Germany
Clinique Pasteur, Toulouse, France
Universita degli Studi Policlinico S. Orsola Istituto di Cardiologia, Bologna, Italy
^|||| Center for Cardiology and Vascular Intervention, Hamburg, Germany
^¶¶ Clinique du boise de Verriers, Antony, France
^## Universitatsklinikum der RWTH Aachen, Aachen, Germany
^*** Azienda Ospedaliera Ospedali Riuniti di Bergamo, Bergamo, Italy
Prince of Wales Hospital, New South Wales, Australia
Boston Scientific Corporation, Natick, Massachusetts

Manuscript received March 8, 2004; revised manuscript received April 8, 2004, accepted June 14, 2004.

^* Reprint requests and correspondence: Dr. Eberhard Grube, Herzzentrum, Ringstrasse 49, D-53721 Siegburg, Germany (Email: GrubeE{at}aol.com).

OBJECTIVES: The Study to COmpare REstenosis Rate between QueST and QuaDDS-QP2 (SCORE) trial was a multicenter, randomized, open-label trial comparing the safety and performance of 13- and 17-mm QuaDDS stents (n = 126) (Quanam Medical Corp., Santa Clara, California/Boston Scientific Corp., Natick, Massachusetts) versus uncoated control stents (n = 140) in focal, de novo coronary lesions.

BACKGROUND: The pioneering drug-delivery QuaDDS stent used four to six acrylate polymer sleeves, each loaded with 800 µg of the paclitaxel derivative 7-hexanoyltaxol.

METHODS: Clinical end points were assessed at 1, 6, and 12 months post procedure. Quantitative coronary angiography and intravascular ultrasound were performed post procedure and at six-month follow-up.

RESULTS: In the QuaDDS group, early stent thrombosis and myocardial infarction (MI) rates were significantly higher, leading to premature cessation of enrollment. For the QuaDDS group, the stent thrombosis rate increased from 3.2% to 10.3% between 1 and 12 months, associated with increased non–Q-wave MI and death rates. The angiographic restenosis rate at six months was reduced from 32.7% (control) to 7.4% (p < 0.0001). However, the primary end point was not met with six-month target vessel revascularization (TVR) rate as well as the composite major adverse cardiac event rates (cardiac death, MI, and TVR) comparable between groups.

CONCLUSIONS: Despite angiographic indications of potential anti-restenotic benefit, increased rates of stent thrombosis, MI, and cardiac death associated with the QuaDDS stent show an unacceptable safety profile.

Abbreviations and Acronyms   IVUS = intravascular ultrasound   MACE = major adverse cardiac event   MI = myocardial infarction   QCA = quantitative coronary angiography   TLR = target lesion revascularization   TVR = target vessel revascularization

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