Drug-eluting stent fracture and acute coronary syndrome.
BACKGROUND
Coronary stent fracture is an underrecognized entity but has been reported more frequently in the drug-eluting stent (DES) era. Nevertheless, the clinical implications of coronary stent fracture remain unclear.


METHODS
A literature search for reports of DES fracture was conducted via MEDLINE, and the US Food and Drug Administration Manufacturer and User facility Device Experience (MAUDE) database was accessed via the internet and interrogated for reports of stent fracture between January 1, 2003, and April 30, 2008. Each report was reviewed, and clinical information was extracted for analysis.


RESULTS
The MEDLINE search identified 202 cases of coronary DES fracture, with 95% of cases involving Cypher sirolimus-eluting stents. Clinical information regarding patient presentation was available in 96 cases. Patients presented with ST-elevation myocardial infarction (STEMI) or stent thrombosis in six cases (6%) and with unstable angina or non-STEMI (NSTEMI) in 40 cases (42%). The MAUDE database search identified 337 stent fracture reports, with 97% of cases involving Cypher stents. Clinical information regarding patient presentation was available 193 cases. Patients presented with STEMI or stent thrombosis in 24 cases (12%) and with unstable angina or NSTEMI in 36 cases (19%).


CONCLUSIONS
Most reports of drug-eluting stent fracture involve Cypher stents. DES fracture can be associated with stent thrombosis, myocardial infarction and angina. However, whether the incidence of such events reported in the literature and in the MAUDE database is representative of all patients experiencing stent fracture remains unclear.
Chhatriwalla
Adnan K
AK
Division of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio 44195, USA.
Cam
Akin
A
Unzek
Samuel
S
Bhatt
Deepak L
DL
Raymond
Russell E
RE
Lincoff
A Michael
AM
Whitlow
Patrick L
PL
Ellis
Stephen G
SG
Tuzcu
E Murat
EM
Kapadia
Samir R
SR
D054058:Acute Coronary Syndrome / Q000209:etiology*; D000789:Angina, Unstable / Q000209:etiology*; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects* / Q000295:instrumentation*; D003324:Coronary Artery Disease / Q000628:therapy*; D019992:Databases as Topic; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D019317:Evidence-Based Medicine; D006801:Humans; D011474:Prosthesis Design; D011475:Prosthesis Failure; D018570:Risk Assessment; D013927:Thrombosis / Q000209:etiology; D017211:Treatment Failure; D014481:United States; D014486:United States Food and Drug Administration