The sirolimus-eluting Cypher Select coronary stent for the treatment of bare-metal and drug-eluting stent restenosis: insights from the e-SELECT (Multicenter Post-Market Surveillance) registry.
OBJECTIVE
This study sought to compare the 1-year safety and efficacy of Cypher Select or Cypher Select Plus (Cordis Corporation, Bridgewater, New Jersey) sirolimus-eluting stents (SES) with the treatment of bare-metal stents (BMS) and drug-eluting stent (DES) in-stent restenosis (ISR) in nonselected, real-world patients.


BACKGROUND
There is paucity of consistent data on DES for the treatment of ISR, especially, DES ISR.


METHODS
The e-SELECT (Multicenter Post-Market Surveillance) registry is a Web-based, multicenter and international registry encompassing virtually all subsets of patients and lesions treated with at least 1 SES during the period from 2006 to 2008. We enrolled in this pre-specified subanalysis all patients with at least 1 clinically relevant BMS or DES ISR treated with SES. Primary endpoint was major adverse cardiac events and stent thrombosis rate at 1 year.


RESULTS
Of 15,147 patients enrolled, 1,590 (10.5%) presented at least 1 ISR (BMS group, n = 1,235, DES group, n = 355). Patients with DES ISR had higher incidence of diabetes (39.4% vs. 26.9%, p < 0.001), renal insufficiency (5.8% vs. 2.3%, p = 0.003), and prior coronary artery bypass graft (20.5% vs. 11.8%, p < 0.001). At 1 year, death (1.4% for BMS vs. 2.1% for DES, p = 0.3) and myocardial infarction (2.4% for BMS and 3.3% for DES, p = 0.3) rates were similar, whereas ischemia-driven target lesion revascularization and definite/probable late stent thrombosis were higher in patients with DES ISR (6.9% vs. 3.1%, p = 0.003, and 1.8% vs. 0.5%, p = 0.04, respectively).


CONCLUSIONS
Use of SES for either BMS or DES ISR treatment is safe and associated with low target lesion revascularization recurrence and no apparent safety concern.
Department of Interventional Cardiology, Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil. aabizaid@uol.com.br
Alexandre
A
Abizaid
J Ribamar
JR
Costa
Adrian
A
Banning
Antonio L
AL
Bartorelli
Vladimir
V
Dzavik
Stephen
S
Ellis
Runlin
R
Gao
David R
DR
Holmes
Muyng Ho
MH
Jeong
Victor
V
Legrand
Franz-Josef
FJ
Neumann
Maria
M
Nyakern
Amy
A
Orlick
Christian
C
Spaulding
Stephen
S
Worthley
Philip M
PM
Urban
D015906:Angioplasty, Balloon, Coronary; D023903:Coronary Restenosis / Q000401:mortality / Q000517:prevention & control*; D016208:Databases, Factual; D054855:Drug-Eluting Stents / Q000009:adverse effects / Q000706:statistics & numerical data*; D005060:Europe; D005260:Female; D006305:Health Status Indicators; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D038622:Internationality; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011358:Product Surveillance, Postmarketing; D012042:Registries; D020123:Sirolimus / Q000627:therapeutic use*; D013223:Statistics as Topic
D007166:Immunosuppressive Agents; D020123:Sirolimus