Multicenter Prospective Nonrandomized Registry Study for Drug-Eluting Stents in Very Long Coronary Lesions (Cypher vs Taxus) - LONG-DES

Nov 08, 2004
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Date Presented:
01/01/2004
Date Updated:
11/08/2004
Original Posted Date:
11/08/2004
References

Description:

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.

Hypothesis:

Implantation of drug eluting stents in long coronary lesions would be associated with lower rates angiographic and clinical progression of disease than BMS.

Study Design

Study Design:

Patients Enrolled: 637
Mean Follow Up: 6 months

Patient Populations:

  • de novo coronary lesion
  • 24 mm or greater lesion length
  • Reference vessel diameter of at least 2.5 mm
  • Diameter stenosi of at least 70%
  • Total stent length of at least 28 mm

    Exclusions:

  • Left main coronary lesion
  • Lesion in saphenous vein graft
  • In stent restenosis
  • Chronic total occlusion
  • MI within 48 hours
  • Reduced left ventricular ejection fraction
  • Unable to take anti-platelet therapy

    Primary Endpoints:

    6-month angiographic restenosis

    Secondary Endpoints:

  • Late loss
  • MACE (death, MI, and TLR)at 6 months

    Drug/Procedures Used:

    Stent implantation with either BMS (n=177), C-DES (294) or P-DES (166).

    Concomitant Medications:

    Clopidogrel was continued for 6 months in all patients.

    • Principal Findings:

    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).

    Interpretation:

    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.

    References:

    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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