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Articles by D. A Cox
Total Records ( 4 ) for D. A Cox
  D. E Forman , D. A Cox , S. G Ellis , J. M Lasala , J. A Ormiston , G. W Stone , M. A Turco , J. Y Wei , A. A Joshi , K. D Dawkins and D. S. Baim
 

Background— Although drug-eluting stents have become a mainstay of percutaneous coronary intervention, information about drug-eluting stents outcomes in elderly patients is limited. Data from the paclitaxel-eluting stent (PES) trials and registries were pooled to assess PES benefits relative to advancing patient age, including comparison with bare-metal stents.

Methods and Results— Data from 5 randomized trials (2271 patients with PES, 1397 patients with bare-metal stents) and from 2 postmarket registries (7492 patients with PES) were pooled separately. Each dataset was stratified into age groups: <60, 60 to 70, and >70 years. At baseline, patients aged >70 years in both datasets had significantly more adverse characteristics than younger patients. Through 5 years, trial data showed that patients aged >70 years had higher death rates, but comparable rates of myocardial infarction, stent thrombosis, and target lesion revascularization with younger patients. Compared with patients with bare-metal stents, patients with PES aged >70 years had comparable rates of death, myocardial infarction, and stent thrombosis but a significantly lower target lesion revascularization rate (22.2 versus 10.2, P<0.001). These findings were echoed in the registry data through 2 years that showed that PES patients aged >70 years had significantly higher death rates, but lower myocardial infarction, stent thrombosis, and target lesion revascularization rates, compared with younger patients. Although the mortality rates of patients aged >70 years were higher than those of younger patients, they were comparable with those of age- and gender-matched norms in the general population.

Conclusions— This analysis of almost 10 000 patients demonstrated that percutaneous coronary intervention with PES is a safe and an effective treatment option that should not be withheld based on age.

  J. M Lasala , D. A Cox , D Dobies , K Baran , W. B Bachinsky , E. W Rogers , J. A Breall , D. H Lewis , A Song , R. M Starzyk , S. R Mascioli , K. D Dawkins , D. S Baim and for the ARRIVE 1 and ARRIVE 2 Participating Physicians
 

Background— Stent thrombosis (ST) is an uncommon but serious complication of drug-eluting and bare metal stents. To assess drug-eluting stent ST in contemporary practice, we analyzed 2-year data from the 7492-patient ARRIVE registry.

Methods and Results— Patients were enrolled at the initiation of percutaneous coronary intervention with no inclusion/exclusion criteria beyond use of the paclitaxel-eluting TAXUS stent. Two-year follow-up was 94% with independent adjudication of major cardiac events. A second, autonomous committee adjudicated Academic Research Consortium (ARC) definite/probable ST. Cumulative 2-year ARC-defined ST was 2.6% (1.0% early ST [<30 days], 0.7% late ST [31 to 365 days], and 0.8% very late ST [>1 year]). Simple-use (single-vessel and single-stent) cases had lower rates than expanded use (broader patient/lesion characteristics, 2-year cumulative: 1.4% versus 3.3%, P<0.001; early ST: 0.4% versus 1.4%, P<0.001; late ST: 0.5% versus 0.8%, P=0.14; very late ST: 0.4% versus 1.0%, P=0.008). Within 7 days of ST, 23% of patients died; 28% suffered Q-wave myocardial infarction. Mortality was higher with early ST (39%) than late ST (12%, P<0.001) or very late ST (13%, P<0.001). Multivariate analysis showed anatomic factors increased early ST (lesion >28 mm, lesion calcification) and late ST (vessel <3.0 mm); biological factors increased very late ST (renal disease, prior brachytherapy). Although early ST (71.4%) and very late ST (23.1%) patients had dual antiplatelet therapy at the time of ST, premature thienopyridine discontinuation was a strong independent predictor of both.

Conclusions— The relative risks of early and late ST differ. Knowledge of ST risk for specific subgroups may guide revascularization options until the completion of randomized trials in these broad populations.

  J. M Lasala , D. A Cox , D Dobies , K Baran , W. B Bachinsky , E. W Rogers , J. A Breall , D. H Lewis , A Song , R. M Starzyk , S. R Mascioli , K. D Dawkins , D. S Baim and for the ARRIVE 1 and ARRIVE 2 Participating Physicians
 

Background— Stent thrombosis (ST) is an uncommon but serious complication of drug-eluting and bare metal stents. To assess drug-eluting stent ST in contemporary practice, we analyzed 2-year data from the 7492-patient ARRIVE registry.

Methods and Results— Patients were enrolled at the initiation of percutaneous coronary intervention with no inclusion/exclusion criteria beyond use of the paclitaxel-eluting TAXUS stent. Two-year follow-up was 94% with independent adjudication of major cardiac events. A second, autonomous committee adjudicated Academic Research Consortium (ARC) definite/probable ST. Cumulative 2-year ARC-defined ST was 2.6% (1.0% early ST [<30 days], 0.7% late ST [31 to 365 days], and 0.8% very late ST [>1 year]). Simple-use (single-vessel and single-stent) cases had lower rates than expanded use (broader patient/lesion characteristics, 2-year cumulative: 1.4% versus 3.3%, P<0.001; early ST: 0.4% versus 1.4%, P<0.001; late ST: 0.5% versus 0.8%, P=0.14; very late ST: 0.4% versus 1.0%, P=0.008). Within 7 days of ST, 23% of patients died; 28% suffered Q-wave myocardial infarction. Mortality was higher with early ST (39%) than late ST (12%, P<0.001) or very late ST (13%, P<0.001). Multivariate analysis showed anatomic factors increased early ST (lesion >28 mm, lesion calcification) and late ST (vessel <3.0 mm); biological factors increased very late ST (renal disease, prior brachytherapy). Although early ST (71.4%) and very late ST (23.1%) patients had dual antiplatelet therapy at the time of ST, premature thienopyridine discontinuation was a strong independent predictor of both.

Conclusions— The relative risks of early and late ST differ. Knowledge of ST risk for specific subgroups may guide revascularization options until the completion of randomized trials in these broad populations.

  T. A Sanborn , R Ebrahimi , S. V Manoukian , B. T McLaurin , D. A Cox , F Feit , M Hamon , R Mehran and G. W. Stone
 

Background— The Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial demonstrated that bivalirudin monotherapy significantly reduces major bleeding compared with heparin (unfractionated or enoxaparin) or bivalirudin plus a glycoprotein IIb/IIIa inhibitor in acute coronary syndromes. Whether vascular closure devices (VCD) impact these results is unknown. Therefore, this study sought to determine whether VCD impact major access site bleeding (ASB) in patients with acute coronary syndromes undergoing early invasive management by the femoral approach.

Methods and Results— Major ASB in ACUITY was defined as ASB requiring interventional or surgical correction, hematoma ≥5 cm at the access site, retroperitoneal bleeding, or hemoglobin drop ≥3 g/dL with ecchymosis or hematoma <5 cm, oozing blood, or prolonged bleeding (>30 minutes) at the access site. Stepwise logistical regression was performed to identify the independent determinants of ASB. Of 11 621 patients undergoing angiography with or without percutaneous coronary intervention by the femoral approach, 4307 (37.1%) received a VCD and 7314 (62.9%) did not. Rates of major ASB were lower with VCD compared with no VCD (2.5% versus 3.3%, relative risk, 0.76; 95% CI, 0.61 to 0.94; P=0.01) and were lowest in patients treated with bivalirudin monotherapy and a VCD (0.7%). Stepwise logistic regression revealed that a VCD (odds ratio, 0.78; 95% CI, 0.61 to 0.99; P=0.04) and bivalirudin monotherapy (odds ratio, 0.35; 95% CI, 0.25 to 0.49; P<0.0001) were both independent determinates of freedom from major ASB.

Conclusion— In patients with acute coronary syndromes undergoing an early invasive management strategy by the femoral approach, the use of a VCD, bivalirudin monotherapy, or both minimizes rates of major ASB.

Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique Identifier: NCT00093158.

 
 
 
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