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Six-Year Outcomes After Sirolimus-Eluting Stent Implantation (SIRIUS Study)

The SIRIUS study evaluated the efficacy and safety of the Sirolimus-Eluting Bx VELOCITY™ Stent over 6 years. Results show sustained benefit in clinical endpoints with no significant differences in adverse events between the Sirolimus and control stents.

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Six-Year Outcomes After Sirolimus-Eluting Stent Implantation (SIRIUS Study)

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  1. Six-Year Outcomes After Sirolimus-Eluting Stent Implantation (SIRIUS Study) Martin B. Leon, David R. Holmes, Dean J. Kereiakes, Jeffrey J. Popma, Paul S. Teirstein, Jeffrey W. Moses, Huong P. Wang, Sidney A. Cohen, Donald E. Cutlip, for the SIRIUS Investigators CRT 2009

  2. Background • In the SIRIUS trial, the Sirolimus-Eluting Bx VELOCITY™ Stent (SES) showed significant benefit compared to the bare-metal Bx VELOCITY™ control in short-term safety and efficacy, and this significant improvement has been sustained for all clinical endpoints (TLR, TVR, TVF, and MACE) at 5 years of follow-up • A total of 1,058 patients were initially enrolled and randomized at 53 sites for 5 years of follow-up • 46 of the 53 sites agreed to extend follow-up and provided data on a total of 526 patients (~50%) at 6 years

  3. Study Design n = 1058 Sirolimus-eluting Bx VELOCITYTM n = 533 De Novo Coronary Lesions Diameter: 2.5 - 3.5 mm Length: 15 - 30 mm Control Bx VELOCITYTM n = 525 Primary Endpoint:Target vessel failure (TVF) defined as cardiac death, MI or TVR (F/U 9 mos) Angiographic Substudy:First 850 pts (F/U 8 mos) IVUS Substudy:250 pts at selected sites (F/U 8 mos)

  4. Patient Demographics

  5. Clinical Events @ 9 months

  6. Clinical Events @ 5 Years

  7. Protocol Amendment • On December 7, 2006, a protocol amendment was issued extending the follow-up period for an additional 3 years for a total of 8 years • At 6 years post-procedure, 527 patients were re-consented and assessed for angina status, all adverse events, concomitant medications, and any repeat revascularization since the previous contact

  8. Patient Flow (Clinical) Study population(n=1,058) Control(n=525) Sirolimus(n=533) 1-year F/Un=1,042 (98.5%) Control(n=519) Sirolimus(n=523) 2-year F/Un=1,032 (97.5%) Control(n=515) Sirolimus(n=517) 3-year F/Un=1,013 (95.7%) Control(n=506) Sirolimus(n=507) 4-year F/Un=992 (93.8%) Sirolimus(n=495) Control(n=497) 5-year F/Un=960 (90.7%) Control(n=478) Sirolimus(n=482) 526 pts consented for 6-year F/U (49.7%) Control(n=255) Sirolimus(n=271)

  9. Clinical Events @ 6 Years

  10. 100% 80% 60% Freedom From TLR 40% 20% Sirolimus-Eluting Stent Bx Control 0% 0 360 720 1080 1440 1800 2160 Time After Initial Procedure (days) Survival-Free Target Lesion Revascularization LR p <0.0001 SES 533 492 482 467 450 433 391Control 531 418 392 379 361 342 305

  11. 100% 80% 60% Freedom From TVR 40% 20% Sirolimus-Eluting Stent Bx Control 0% 0 360 720 1080 1440 1800 2160 Time After Initial Procedure (days) Survival-Free Target Vessel Revascularization LR p <0.0001 SES 533 490 484 465 439 417 367Control 531 427 404 391 368 342 300

  12. 100% 80% 60% Freedom From TVF 40% 20% Sirolimus-Eluting Stent Bx Control 0% 0 360 720 1080 1440 1800 2160 Time After Initial Procedure (days) Survival-Free Target Vessel Failure LR p <0.0001 SES 533 479 473 453 427 406 355Control 525 413 391 377 354 330 289

  13. 100% 80% 60% Freedom From MACE 40% 20% Sirolimus-Eluting Stent Bx Control 0% 0 360 720 1080 1440 1800 2160 Time After Initial Procedure (days) Survival-Free Major Adverse Cardiac Events LR p <0.0001 SES 533 491 485 468 449 429 385Control 525 422 400 388 367 348 311

  14. Stent Thrombosis Definitions

  15. Stent Thrombosis @ 6 Years

  16. 100% 80% 60% Cumulative Incidence of Protocol ST 40% 20% Sirolimus-Eluting Stent Bx Control 0% 0 360 720 1080 1440 1800 2160 Time After Initial Procedure (days) Cumulative Incidence of Protocol Defined Stent Thrombosis LR p = 0.5390 SES# at risk 533 521 515 503 488 460 349# events 0 2 1 1 1 1 0Control# at risk 525 516 512 503 487 455 338# events 0 4 0 0 0 0 0

  17. 100% 80% 60% Cumulative Incidence of ARC Definite/Probable ST 40% 20% Sirolimus-Eluting Stent Bx Control 0% 0 360 720 1080 1440 1800 2160 Time After Initial Procedure (days) Cumulative Incidence of ARC Definite/Probable ST LR p = 0.3027 SES# at risk 533 521 515 503 488 460 349# events 0 2 1 1 1 1 0Control# at risk 525 515 511 501 485 453 337# events 0 6 1 1 0 1 1

  18. Limitations 6-year clinical follow-up was completed on only 50% of the originally enrolled patients While Kaplan-Meier analysis partially adjusts for this, the possibility of bias cannot be ruled out as patients who did receive follow-up were not a random subset of the original cohort

  19. Conclusions • The 6-year results of the SIRIUS trial demonstrate that the treatment benefit and safety of the Sirolimus-Eluting Stent are preserved in longer-term follow up • There is no evidence of late “catch-up restenosis” • The highly significant differences (p<0.001) between Sirolimus-Eluting and control stents for all clinical endpoints were sustained at 6-year follow-up • Furthermore, the cumulative event rates of death, MI and stent thrombosis (both protocol and ARC definitions) show no significant differences between Sirolimus-Eluting and control stents

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