Two-Year Clinical Outcomes Yan Li MD., PhD. On behalf of FIREMAN Investigators Associated Professor of Department of Cardiology of Xijing Hospital Fourth.

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Presentation transcript:

Two-Year Clinical Outcomes Yan Li MD., PhD. On behalf of FIREMAN Investigators Associated Professor of Department of Cardiology of Xijing Hospital Fourth Military Medical University Xi’an, China

Background: FIREMAN at 1-Year

Study Design

FIREMAN Registry Prospective, Multicenter and Nationwide 45 Medical Centers

Patient Eligibility

Study Algorithm Patient enrollment ( ) n = 1078 Excluded pts due to hybrid stenting, n=49 (4.5%) Clinical follow-up Angiographic follow-up 12months 97.2% (1001/1029 pts) 8 months 51% (517/1013pts) Primary End Point : 12months Secondary End Point ： Binary Restenosis, Late loss at 8months, TVR, Stent thrombosis, Stroke 1029 pts Enrolled Diabetes 22.8% 24months 97.7% (1005/1029 pts ）

Frequency of Complex Coronary Lesions Criteria* % * Criteria are not mutually exclusive.

24 months (10) (12) (40) (36) (60) (2)

MACE-free Survival Rate Mace-free Survival rate,% Days after Procedure 94.2%

TLR-free Survival Rate TLR-free Survival rate % Days after Procedure 95.9%

MI-free Survival Rate,% Days after Procedure % MI-free Survival Rate

Cardiac death-free Survival Rate,% Days after Procedure % Cardiac death-free Survival Rate

2-Year %

Dual Anti-platelet Therapy 30d 6mo 12mo 18mo 24mo %

Stent 2-Year Stent Thrombosis-free Survival rate, % Days after Procedure 98.1%

4 cases ST were due to prematurely stopping dual anti-platelet therapy before 12 months. 1 case of VLST due to prematurely stopping dual anti-platelet therapy before 12 months. DualASA alone

Cumulative Incidence of Stent Thrombosis Stent Thrombosis Cumulative incidence, % Days after Procedure 1.55% 0.39%

Subgroup Analysis

Predictors of Cumulative Stent Thrombosis By Cox Regression Analysis VariablesHR(95%CI)P value Clinical variables Pre-MI2.776(1.007 ~8.329)0.211 Pre-PCI1.837(0.421~5.522)0.669 Hypercholesterima0.642(0.398~3.074)0.328 hypertension2.189(0.833~4.578)0.851 Diabetes8.651(2.393~21.543)0.008 Lesion characteristics Multi-vessel0.724 (0.152~2.299)0.416 Diffuse long2.023(0.898~6.244)0.347 Small vessel6..262(1.699~15.458)0.026 CTO5.171(1.881~12.369)0.035

J-CypherTaxusVIEndeavorIVFIREMAN DES Events CypherTaxusEndeavorFirebird Death MI TVR TLR ST Total MACE Comparison with other DES

Conclusions (1) 2-Year Efficacy ： 2-Year outcomes showed that FIREBIRD SES was effective and safe in the treatment of selectively complex lesions. 2-Year outcomes showed that FIREBIRD SES was effective and safe in the treatment of selectively complex lesions. 2-Year Safety ： No significant increase in very late stent thrombosis at 2 Years. No significant increase in very late stent thrombosis at 2 Years.

Conclusions (2) Very Late Stent Thrombosis Although the study population was a selective complex subsets, very late stent thrombosis was low at 0.39%. Diabetes, small vessel and CTO are still strongest predictors of stent thrombosis.. There was one case of VLST event in patients due to discontinuation of DAPT before 12 months.