摘要
The Study to COmpare REstenosis Rate between QueST and QuaDDS QP2 (SCORE) tri al was a multicenter, randomized, open label trial comparing the safety and per formance of 13-and 17-mm QuaDDS stents(n=126) (Quanam Medical Corp., Santa Cla ra, California/Boston Scientific Corp., Natick, Massachusetts) versus uncoated c ontrol stents (n=140) in focal, de novo coronary lesions. The pioneering drug d elivery QuaDDS stent used four to six acrylate polymer sleeves, each loaded with 800 μg of the paclitaxel derivative 7-hexanoyltaxol. Clinical end points were assessed at 1, 6, and 12 months post procedure. Quantitative coronary angiograp hy and intravascular ultrasound were performed post procedure and at six month follow up. In the QuaDDS group, early stent thrombosis and myocardial infarctio n(MI) rates were significantly higher, leading to premature cessation of enrollm ent. 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 r ates. The angiographic restenosis rate at six months was reduced from 32.7%(con trol) 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 group s. Despite angiographic indications of potential anti restenotic benefit, incre ased rates of stent thrombosis, MI, and cardiac death associated with the QuaDDS stent show an unacceptable safety profile.
The Study to COmpare REstenosis Rate between QueST and QuaDDS QP2 (SCORE) tri al was a multicenter, randomized, open label trial comparing the safety and per formance of 13-and 17-mm QuaDDS stents(n=126) (Quanam Medical Corp., Santa Cla ra, California/Boston Scientific Corp., Natick, Massachusetts) versus uncoated c ontrol stents (n=140) in focal, de novo coronary lesions. The pioneering drug d elivery QuaDDS stent used four to six acrylate polymer sleeves, each loaded with 800 μg of the paclitaxel derivative 7-hexanoyltaxol. Clinical end points were assessed at 1, 6, and 12 months post procedure. Quantitative coronary angiograp hy and intravascular ultrasound were performed post procedure and at six month follow up. In the QuaDDS group, early stent thrombosis and myocardial infarctio n(MI) rates were significantly higher, leading to premature cessation of enrollm ent. 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 r ates. The angiographic restenosis rate at six months was reduced from 32.7%(con trol) 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 group s. Despite angiographic indications of potential anti restenotic benefit, incre ased rates of stent thrombosis, MI, and cardiac death associated with the QuaDDS stent show an unacceptable safety profile.
