Multicenter Prospective Nonrandomized Registry Study for Drug-Eluting Stents in Very Long Coronary Lesions (Cypher vs Taxus) - LONG-DES
This study was a nonrandomized registry comparing angiographic and clinica outcomes in patients undergoing stent placement with either bare metal stents (BMS), the Cypher rapamycin drug eluting stent (C-DES) or the Taxus paclitaxel drug eluting stent (P-DES) in long coronary lesions.
Implantation of drug eluting stents in long coronary lesions would be associated with lower rates angiographic and clinical progression of disease than BMS.
Patients Enrolled: 637
Mean Follow Up: 6 months
6-month angiographic restenosis
Stent implantation with either BMS (n=177), C-DES (294) or P-DES (166).
Clopidogrel was continued for 6 months in all patients.
Baseline characteristics were similar in the three arms including the number of high-risk and diabetic patients. Stent length was similar (42.8 mm C-DES v. 43.1 mm -DES; p=NS). DES patients received more stents with longer lengths when compared to BMS. Patients in the Cypher arm had smaller reference vessel diameter (2.80 mm C-DES v. 2.90 mm P-DES).
At 6-month angiographic follow-up, completed in approximately 80% of all patients, there was 65% less in-stent late loss in the C-DES patients compared to P-DES (0.27 mm v. 0.78 mm, p<0.0001), and 65% less in-segment restenosis in C-DES patients compared to P-DES (7.4% v. 21.3%, P<0.001). Diameter stenosis was was less in the C-DES group compared to P-DES (10.4% v. 29.3%, p<0.001).
The rates of TLR were significantly lower with DES compared to BMS (2.7% C-DES, 5.4% P-DES and 18.6% BMS; p<0.001) but the difference between C-DES and P-DES was not statistically significant (p=0.14).
Use of C-DES and P-DES in very long lesions was associated with reduced rates of angiographic and clinical restenosis when compared to bare metal stents in this unselected group of patients. While angiographic measures of restenosis were higher with P-DES when compared to C-DES, this did not translate into a significant difference in the rates of clinical restenosis. Randomized comparisons of P-DES and C-DES are underway to further define differences in rates of restenosis and adverse events.
Hong, MK. Long-DES-A Multicenter Prospective Nonrandomized Registry Study for Drug-Eluting Stents in Very Long Coronary Lesions (Cypher vs Taxus). Presented at Transcatheter Therapeutics 2004, Sept. 30, Washington, D.C.
Keywords: Paclitaxel, Registries, Follow-Up Studies, Coronary Restenosis, Drug-Eluting Stents, Constriction, Pathologic, Sirolimus, Angioplasty, Balloon, Coronary, Diabetes Mellitus
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