Thirty-day incidence and six-month clinical outcome of thrombotic stent occlusion after bare-metal, sirolimus, or paclitaxel stent implantation.
OBJECTIVE
We sought to determine the real-world incidence of angiographically confirmed and possible stent thrombosis (ST) in an unrestricted population during the first 30 days after bare-metal stent (BMS), sirolimus-eluting stent (SES), and paclitaxel-eluting stent (PES) implantation.


BACKGROUND
Current data on ST in drug-eluting stents (DES) have come from randomized trials with strict entry criteria, which limits their generalizability to daily practice.


METHODS
The study population comprised three sequential cohorts of 506 consecutive patients with BMS, 1,017 consecutive patients with SES, and 989 consecutive patients treated with PES.


RESULTS
In the first 30 days after stent implantation, 6 BMS (1.2%, 95% confidence interval [CI] 0.5% to 2.6%; p = 0.9), 10 SES (1.0%, 95% CI 0.5% to 1.8%), and 10 PES (1.0%, 95% CI 0.6% to 1.9%) patients developed angiographically proven ST. Multiple potential risk factors were identified in most patients with ST. Bifurcation stenting in the setting of acute myocardial infarction was an independent risk factor for angiographic ST in the entire population (odds ratio [OR] 12.9, 95% CI 4.7 to 35.8, p < 0.001). In patients with DES who had angiographic ST, 30-day mortality was 15%, whereas another 60% suffered a nonfatal myocardial infarction; no further deaths occurred during six months of follow-up. Including possible cases, 7 BMS (1.4%, 95% CI 0.7% to 2.8%), 15 SES (1.5%, 95% CI 0.9% to 2.4%), and 16 PES (1.6%, 95% CI 1.0% to 2.6%) patients had ST.


CONCLUSIONS
The unrestricted use of SES or PES is associated with ST rates in the range expected for BMS. Stent thrombosis was associated with a high morbidity and mortality. Bifurcation stenting, when performed in patients with acute myocardial infarction, was associated with an increased risk of ST.
Ong
Andrew T L
AT
Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.
Hoye
Angela
A
Aoki
Jiro
J
van Mieghem
Carlos A G
CA
Rodriguez Granillo
Gaston A
GA
Sonnenschein
Karel
K
Regar
Evelyn
E
McFadden
Eugene P
EP
Sianos
Georgios
G
van der Giessen
Willem J
WJ
de Jaegere
Peter P T
PP
de Feyter
Pim
P
van Domburg
Ron T
RT
Serruys
Patrick W
PW
D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000627:therapeutic use*; D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use*; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects*; D020099:Coated Materials, Biocompatible / Q000627:therapeutic use*; D015331:Cohort Studies; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000453:epidemiology / Q000628:therapy; D003328:Coronary Thrombosis / Q000000981:diagnostic imaging / Q000453:epidemiology* / Q000209:etiology*; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000000981:diagnostic imaging / Q000453:epidemiology* / Q000209:etiology*; D020123:Sirolimus / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D015607:Stents / Q000009:adverse effects*; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome
D000903:Antibiotics, Antineoplastic; D000972:Antineoplastic Agents, Phytogenic; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel; D020123:Sirolimus