Impact of stent deployment procedural factors on long-term effectiveness and safety of sirolimus-eluting stents (final results of the multicenter prospective STLLR trial).
Drug-eluting stent failures were associated with various clinical factors. However, the clinical impact of stent deployment technique was unknown. This study was designed to evaluate the frequency and impact of suboptimal percutaneous coronary intervention on long-term outcomes of 1,557 patients treated with sirolimus-eluting stents (SESs) in 41 US hospitals. All steps of the interventional procedure were scrutinized by an independent core laboratory to determine the occurrence of geographic miss (GM). GM included longitudinal (LGM; injured or diseased segment not covered by SES) or axial GM (balloon-artery size ratio <0.9 or >1.3) mismatches. Patients with and without GM were stratified (GM vs no-GM group). Patients, investigators, and the independent clinical event adjudication committee were blind to study group assignments. The primary end point was 1-year target-vessel revascularization (TVR) rate. Incidences and predictors of GM and safety outcomes were secondary end points. GM occurred in 943 patients (66.5%): 47.6% had LGM, 35.2% had axial GM, and 16.5% had both. One-year TVR rates were 5.1% in the GM group versus 2.5% in the no-GM group (p=0.025). TVR was 6.1% in the LGM versus 2.6% in the no-LGM subgroups (p=0.001). The association of GM with 1-year TVR was independent of clinical or anatomic factors (hazard ratio 2.0, 95% confidence interval 1.0 to 4.02, p=0.05). There was a 3-fold increase in myocardial infarction rates associated with GM (2.4% vs 0.8%; p=0.04). In conclusion, GM occurred frequently during SES implantation and was associated with increased risk of TVR and myocardial infarction at 1 year. These results emphasized the need for improvement in contemporary percutaneous coronary intervention practices and technologies.
Division of Cardiovascular Medicine, Heart and Vascular Institute, University Hospitals of Cleveland, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA. marco.costa@uhhospitals.org
Marco A
MA
Costa
Dominick J
DJ
Angiolillo
Mark
M
Tannenbaum
Mitchell
M
Driesman
Alan
A
Chu
John
J
Patterson
William
W
Kuehl
Joseph
J
Battaglia
Samir
S
Dabbons
Fayez
F
Shamoon
Bruce
B
Flieshman
Alan
A
Niederman
Theodore A
TA
Bass
D000368:Aged; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D003327:Coronary Disease / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D004562:Electrocardiography; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D009204:Myocardial Revascularization / Q000295:instrumentation*; D011446:Prospective Studies; D020123:Sirolimus / Q000627:therapeutic use*; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome
D020099:Coated Materials, Biocompatible; D007166:Immunosuppressive Agents; D020123:Sirolimus