High-dose 7-hexanoyltaxol-eluting stent with polymer sleeves for coronary revascularization: one-year results from the SCORE randomized trial.
OBJECTIVE
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 microg 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.
Grube
Eberhard
E
GrubeE@aol.com <GrubeE@aol.com>
Lansky
Alexandra
A
Hauptmann
Karl Eugen
KE
Di Mario
Carlo
C
Di Sciascio
Germano
G
Colombo
Antonio
A
Silber
Sigmund
S
Stumpf
Juergen
J
Reifart
Nicolaus
N
Fajadet
Jean
J
Marzocchi
Antonio
A
Schofer
Joachim
J
Dumas
Pierre
P
Hoffmann
Rainer
R
Guagliumi
Giulio
G
Pitney
Mark
M
Russell
Mary E
ME
D000368:Aged; D001952:Bridged-Ring Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D003327:Coronary Disease / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000401:mortality / Q000517:prevention & control*; D003328:Coronary Thrombosis / Q000209:etiology; D016757:Death, Sudden, Cardiac / Q000209:etiology; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D011108:Polymers; D015607:Stents / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome
D001952:Bridged-Ring Compounds; D020099:Coated Materials, Biocompatible; D011108:Polymers; C434083:7-hexanoyltaxol