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Articles by K. D Dawkins
Total Records ( 5 ) for K. D Dawkins
  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.

  S Garg , G Sarno , H. M Garcia Garcia , C Girasis , J Wykrzykowska , K. D Dawkins , P. W Serruys and on behalf of the ARTS II Investigators
  Background—

Presently, no effective risk model exists to predict long-term mortality or other major adverse cardiovascular and cerebrovascular events (MACCE) in those patients undergoing percutaneous coronary intervention (PCI). This study aimed to assess whether the Clinical SYNTAX Score (CSS) calculated by multiplying the SYNTAX Score to a modified ACEF score (age/ejection fraction +1 for each 10 mL the creatinine clearance <60 mL/min per 1.73 m2) would improve the ability of either score to predict mortality and MACCE.

Methods and Results—

The CSS was calculated in 512 patients enrolled in the ARTS-II study who had serum creatinine levels, ejection fraction, and body weight recorded at baseline. Clinical outcomes in terms of MACCE and mortality at 1- and 5-year follow-up were stratified according to CSS tertiles: CSSLOW≤15.6 (n=170), 15.6<CSSMID≤27.5 (n=171), and CSSHIGH>27.5 (n=171). At 1-year follow-up, rates of repeat revascularization and MACCE were significantly higher in the highest tertile group. At 5-year follow-up, CSSHIGH had a comparable rate of myocardial infarction, a trend toward a significantly higher rate of death, and significantly higher rates of repeat revascularization and overall MACCE compared with patients in the lower 2 tertiles. The respective C-statistics for the CSS, SYNTAX Score, and ACEF score for 5-year mortality were 0.69, 0.62, and 0.65 and for 5-year MACCE were 0.62, 0.59, and 0.57.

Conclusions—

An improvement in the ability of the SYNTAX Score to predict MACCE and mortality can be achieved by combining the SYNTAX Score with a simple clinical risk score incorporating age, ejection fraction, and creatinine clearance to produce the Clinical SYNTAX score.

Clinical Trial Registration—

URL: http://www.clinicaltrials.gov. Unique identifier: NCT00235170.

  G Guagliumi , V Sirbu , G Musumeci , H. G Bezerra , A Aprile , H Kyono , L Fiocca , A Matiashvili , N Lortkipanidze , A Vassileva , J. J Popma , D. J Allocco , K. D Dawkins , O Valsecchi and M. A. Costa
  Background—

Polymer-coated drug-eluting stents are effective in preventing restenosis but have been associated with delayed healing and incomplete strut coverage. It is unknown whether paclitaxel-eluting stents (PES) with minimal biodegradable abluminal coating enhances strut coverage while preventing neointimal hyperplasia. Using optical coherence tomography (OCT) as a primary imaging modality, we assessed the proportion of uncovered struts at 6-month follow-up in PES coated with durable versus ultrathin (<1 µm) biodegradable abluminal polymers.

Methods and Results—

In this pilot trial, 60 patients with de novo lesions (≤25 mm) in native coronary vessels were randomly assigned to receive either TAXUS Liberté PES or JACTAX PES, a Liberté stent with polymer deposited abluminally as microdots (JACTAX HD: 9.2 µg each of polymer and paclitaxel per 16-mm stent; JACTAX LD: 5 µg each). OCT follow-up occurred at 6 months with clinical follow-up through 1 year. The primary end point was percent uncovered struts by OCT. An independent core laboratory blinded to stent assignment analyzed images. The 6-month rate of uncovered struts per patient was 5.3±14.7% for TAXUS Liberté, 7.0±12.2% for JACTAX HD, and 4.6±7.3% for JACTAX LD (P=0.81); percent malapposed struts was 1.4±4.4%, 0.8±1.9%, and 1.1±2.8%, respectively (P=0.86). Strut-level intimal thickness was 0.20±0.10, 0.22±0.15, and 0.24±0.15 mm (P=0.64); percent volume obstruction by OCT was 22.2±12.8, 22.5±16.2, and 25.8±15.2 (P=0.69). There were no deaths, Q-wave myocardial infarctions, or stent thromboses through 1 year.

Conclusions—

JACTAX PES with an ultrathin microdot biodegradable abluminal polymer did not result in improved strut coverage at 6 months compared with TAXUS Liberté.

Clinical Trial Registration—

URL: http://www.clinicaltrials.gov. Unique identifier: NCT00776204.

 
 
 
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