Stent thrombosis after sirolimus- and paclitaxel-eluting stent implantation in daily clinical practice: analysis of a single center registry.
OBJECTIVE
To evaluate stent thrombosis (ST) rate after sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) implantation in daily clinical practice.


BACKGROUND
The safety profile of drug-eluting stents (DES) was predominantly determined in randomized clinical trials with narrow inclusion criteria. Concerns about ST have been raised in unselected patients treated with DES.


METHODS
We prospectively evaluated 867 patients undergoing DES implantation, 618 patients with SES, and 249 with PES, in a single academic center.


RESULTS
Multivessel disease was present in 72% of patients, multivessel stenting was performed in 17%, long (>18 mm) lesions were treated in 30%, and multiple stents per lesion were needed in 31%. On average, 1.7 +/- 0.8 stents per patient were implanted (stented segment length: 32 +/- 25 mm/vessel). IIb/IIIa inhibitors were used in 7.5%. Intravascular ultrasound (IVUS) guidance was employed in 65% of SES and 50% of PES implantations, and the procedural success rate was 100% in SES and 99% in PES cases. Six-month follow-up was performed in all patients, whereas one-year follow-up was completed in 87% patients of the SES group and in 95% of the PES group. We considered that ST occurred when angiographic evidence of thrombus was available, or when patients experienced sudden cardiac death or either ST-elevation or non-ST-elevation myocardial infarction (MI) through the 12-month follow-up period. The overall incidence of ST was 0.9% (0.4% in SES and 2% in PES, P = 0.03). Of the eight ST, two (25%) were acute, four (50%) subacute, one (12.5%) was a late event, and one (12.5%) a very late event. Seven ST were confirmed by angiography. No IVUS guidance was used in 4/8 (50%) ST patients, while antiplatelet therapy was prematurely discontinued in 3/8 (37.5%). Among ST patients, mortality and nonfatal MI rates were 25% and 37.5%, respectively. No ST was diagnosed between 6 and 12 months, while one very late thrombosis occurred at 15 months.


CONCLUSIONS
The incidence of ST after DES use in daily clinical practice is low and similar to that observed in randomized clinical trials.
Trabattoni
Daniela
D
Centro Cardiologico Monzino, IRCCS, Institute of Cardiology, University of Milan, Milan, Italy.
Fabbiocchi
Franco
F
Montorsi
Piero
P
Ravagnani
Paolo
P
Galli
Stefano
S
Teruzzi
Giovanni
G
Calligaris
Giuseppe
G
De Martini
Stefano
S
Bartorelli
Antonio L
AL
D000787:Angina Pectoris / Q000601:surgery; D000903:Antibiotics, Antineoplastic / Q000494:pharmacology; D000972:Antineoplastic Agents, Phytogenic / Q000494:pharmacology; D019917:Blood Vessel Prosthesis Implantation / Q000295:instrumentation*; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D003328:Coronary Thrombosis / Q000000981:diagnostic imaging / Q000453:epidemiology / Q000209:etiology*; D005260:Female; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000000981:diagnostic imaging / Q000453:epidemiology / Q000209:etiology*; D006801:Humans; D015994:Incidence; D007558:Italy / Q000453:epidemiology; D008297:Male; D017239:Paclitaxel / Q000494:pharmacology*; D011446:Prospective Studies; D020123:Sirolimus / Q000494:pharmacology*; D015607:Stents
D000903:Antibiotics, Antineoplastic; D000972:Antineoplastic Agents, Phytogenic; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel; D020123:Sirolimus