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Study to COmpare REstenosis Rate between QueST and QuaDDS-QP2 - SCORE
Description:
The goal of the trial was to evaluate the safety and efficacy of QuaDDS drug-eluting stents versus bare metal control stents in focal, de novo coronary lesions.
Hypothesis:
Use of the QuaDDS drug-eluting stent will be associated with less target vessel revascularization (TVR) at six months compared with bare metal control stents in focal, de novo coronary lesions.
Study Design
Study Design:
Patients Enrolled: 266
Mean Follow Up: 12 months
Mean Patient Age: Mean age 62 years
Female: 79
Patient Populations:
Age 51-79 years, documented de novo lesions in native coronary arteries, objective evidence of ischemia, and clinical, hemodynamic, and angiographic indications for percutaneous coronary intervention; and angiographic inclusion criteria were lesion length suitable for a single 13- or 17-mm stent with stenosis >50% and location in a native coronary vessel ≥3.0 mm and ≤3.5 mm in diameter
Exclusions:
Excessive tortuosity; involvement of side branch >2.0 mm in diameter; moderate or severe calcification of the target lesion or adjacent vessel; acute MI <1 week before the procedure; stroke or transient ischemic attack <6 months before the procedure; and allergy or contraindication to aspirin, clopidogrel, ticlopidine, heparin, or stainless steel
Primary Endpoints:
TVR at six months
Secondary Endpoints:
Major adverse cardiac events, quantitative coronary angiography, and intravascular ultrasound assessments of restenosis
Drug/Procedures Used:
Patients were randomized to either the QuaDDS drug-eluting stent (n=126) or bare metal control stents (n=140). The QuaDDS drug-eluting stent had four to six acrylate polymer sleeves, each loaded with 800 µg of the paclitaxel derivative 7-hexanoyltaxol.
Concomitant Medications:
Loading dose of ticlopidine (500 mg) or clopidogrel (150 to 300 mg) ≤24 hours before the procedure and heparin to maintain an active clotting time of ≥250 seconds. Post-procedure, all patients were to receive aspirin (100 mg daily) indefinitely and ticlopidine (250 mg twice a day) or clopidogrel (75 mg every day) for either one month (control) or one year (QuaDDS).
Principal Findings:
The trial was discontinued prior to the planned 400 patient enrollment due to unexpectedly high rates of adverse cardiac events. Stent thrombosis was higher in the QuaDDS drug-eluting stent group compared with the bare metal stent group at one month (3.2% vs. 0%, p=0.049), six months (7.1% vs. 0.7%, p=0.007), and 12 months (10.3% vs. 0.7%, p<0.001). Also of concern was the increase in stent thrombosis over time in the QuaDDS drug-eluting stent group. At 12 months, cardiac death was higher in the QuaDDS drug-eluting stent group versus the bare metal stent group (4.0% vs. 0%, p=0.023), as was myocardial infarction (MI) (19.0% vs. 2.1%, p<0.001). There was no difference in one-year TVR (19.8% vs. 23.6%, p=0.552) or target lesion revascularization (14.3% vs. 18.6%, p=0.410).
At six-month angiographic follow-up, the QuaDDS drug-eluting stent group had less late lumen loss (0.34 mm vs. 10.8 mm, p<0.0001) and smaller diameter stenosis (16.4% vs. 39.5%, p<0.0001). Binary restenosis (>50%) also occurred less frequently in the QuaDDS drug-eluting stent group (7.4% vs. 32.7%, p<0.0001).
Interpretation:
Among patients with focal, de novo coronary lesions, treatment with the QuaDDS drug-eluting stent was associated with an increase in stent thrombosis, MI, and cardiac death at one year compared with bare metal stent. These increases in adverse cardiac events were observed despite improvements in angiographic restenosis parameters at six months. Given this safety profile, the trial was discontinued early.
The high-dose paclitaxel-derivative 7-hexanoyltaxol drug-eluting stent contrasts with studies of the paclitaxel-eluting stents such as TAXUS trials, which used a different delivery system, lower dose of drug on the stent, and shorter elution duration. These findings, along with the recent ACTION trial, point to the importance of the differences between various novel drug-eluting stents.
References:
Grube E, Lansky A, Hauptmann KE, et al. High-dose 7-hexanoyltaxol-eluting stent with polymer sleeves for coronary revascularization: one-year results from the SCORE randomized trial. J Am Coll Cardiol 2004;44:1368-72.
Keywords: Myocardial Infarction, Follow-Up Studies, Drug-Eluting Stents, Coronary Disease, Constriction, Pathologic, Hemodynamics, Bridged-Ring Compounds, Percutaneous Coronary Intervention, Stents, Metals, Thrombosis, Polymers
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