Four-year follow-up of TYPHOON (trial to assess the use of the CYPHer sirolimus-eluting coronary stent in acute myocardial infarction treated with BallOON angioplasty).
OBJECTIVE
The aim of this study was to assess the long-term safety and efficacy of the CYPHER (Cordis, Johnson and Johnson, Bridgewater, New Jersey) sirolimus-eluting coronary stent (SES) in percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI).


BACKGROUND
Concern over the safety of drug-eluting stents implanted during PCI for STEMI remains, and long-term follow-up from randomized trials are necessary. TYPHOON (Trial to assess the use of the cYPHer sirolimus-eluting stent in acute myocardial infarction treated with ballOON angioplasty) randomized 712 patients with STEMI treated by primary PCI to receive either SES (n = 355) or bare-metal stents (BMS) (n = 357). The primary end point, target vessel failure at 1 year, was significantly lower in the SES group than in the BMS group (7.3% vs. 14.3%, p = 0.004) with no increase in adverse events.


METHODS
A 4-year follow-up was performed. Complete data were available in 501 patients (70%), and the survival status is known in 580 patients (81%).


RESULTS
Freedom from target lesion revascularization (TLR) at 4 years was significantly better in the SES group (92.4% vs. 85.1%; p = 0.002); there were no significant differences in freedom from cardiac death (97.6% and 95.9%; p = 0.37) or freedom from repeat myocardial infarction (94.8% and 95.6%; p = 0.85) between the SES and BMS groups. No difference in definite/probable stent thrombosis was noted at 4 years (SES: 4.4%, BMS: 4.8%, p = 0.83). In the 580 patients with known survival status at 4 years, the all-cause death rate was 5.8% in the SES and 7.0% in the BMS group (p = 0.61).


CONCLUSIONS
In the 70% of patients with complete follow-up at 4 years, SES demonstrated sustained efficacy to reduce TLR with no difference in death, repeat myocardial infarction or stent thrombosis. (The Study to Assess AMI Treated With Balloon Angioplasty [TYPHOON]; NCT00232830).
Cochin Hospital, Assistance-Publique Hôpitaux de Paris, Paris Descartes University and INSERM U 970, Paris, France. cspauldi@its.jnj.com
Christian
C
Spaulding
Emmanuel
E
Teiger
Philippe
P
Commeau
Olivier
O
Varenne
Ezio
E
Bramucci
Michel
M
Slama
Keavin
K
Beatt
Ashok
A
Tirouvanziam
Lech
L
Polonski
Pieter R
PR
Stella
Richard
R
Clugston
Jean
J
Fajadet
Xavier
X
de Boisgelin
Christophe
C
Bode
Didier
D
Carrié
Andrejs
A
Erglis
Bela
B
Merkely
Stefan
S
Hosten
Ana
A
Cebrian
Patrick
P
Wang
Hans-Peter
HP
Stoll
Patrick
P
Henry
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D001315:Australia; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D018572:Disease-Free Survival; D054855:Drug-Eluting Stents; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008670:Metals; D008875:Middle Aged; D009203:Myocardial Infarction / Q000401:mortality / Q000628:therapy*; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D012008:Recurrence; D018570:Risk Assessment; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents; D015996:Survival Rate; D013927:Thrombosis / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome
D002317:Cardiovascular Agents; D008670:Metals; D020123:Sirolimus