ImportanceIn patients with severe aortic valve stenosis at intermediate surgical risk, transcathe... more ImportanceIn patients with severe aortic valve stenosis at intermediate surgical risk, transcatheter aortic valve replacement (TAVR) with a self-expanding supra-annular valve was noninferior to surgery for all-cause mortality or disabling stroke at 2 years. Comparisons of longer-term clinical and hemodynamic outcomes in these patients are limited.ObjectiveTo report prespecified secondary 5-year outcomes from the Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI) randomized clinical trial.Design, Setting, and ParticipantsSURTAVI is a prospective randomized, unblinded clinical trial. Randomization was stratified by investigational site and need for revascularization determined by the local heart teams. Patients with severe aortic valve stenosis deemed to be at intermediate risk of 30-day surgical mortality were enrolled at 87 centers from June 19, 2012, to June 30, 2016, in Europe and North America. Analysis took place between August ...
Journal of the American College of Cardiology, 2013
Background: Predictors of one year mortality in 30-day survivors after acute myocardial infarctio... more Background: Predictors of one year mortality in 30-day survivors after acute myocardial infarction (AMI) has not been elucidated yet. Recently, several studies reported that ACEF (age, creatinine, ejection fraction) score could provide a prognostic information in patients undergoing percutaneous coronary intervention (PCI) after AMI. Accordingly, the aim of this study is to assess whether ACEF score could predict one year mortality in 30-day post-MI survivors. Methods: Between November 2005 and August 2011, 12,000 30-day post-MI survivors (8760 men; mean age ¼ 62.2AE12.4 year-old) underwent PCI were analyzed in this study from Korea AMI registry. ACEF score was calculated on the basis of the modified formula; [age/left ventricular ejection fraction] + 1 if serum creatinine >2mg/dL. Patients were categorized into 3 groups according to tertiles of ACEF score; ACEF_low (<1.0, n¼3,755), ACEF_mid (1.0-1.39, n¼4,470), and ACEF_high (!1.4, n¼3,775). Results: During the follow-up, ACEF score was significantly higher in 30-day post-MI survivors with 12-month mortality (1.28AE5.04 versus 1.95AE0.82, p <0.001). In Cox proportional hazards model, ACEF score (hazards ratio [HR] 2.26, 95% confidence interval [CI] 2.03-2.51; p <0.001) was an independent predictor of 12-month mortality after adjusting for conventional clinical risk factors. In receiver operating characteristics curves, area under the curve (AUC) of ACEF score for predicting 12-month mortality was 0.788 (sensitivity 71.2% and specificity 74.4%), and optimum cutoff value was 1.47. Kaplan-Meier survival curve showed the patients with ACEF score of 1.47 or more (6.9% versus 1.0%; log-rank p <0.001) had significantly higher 12-month mortality compared with patients with ACEF score <1.47. The 12-month mortality was 0.4% in ACE-F_low, 1.4% in ACEF_mid, and 6.1% in ACEF_high, respectively (p<0.001). Adjusted HRs for 12-month mortality were 1 (reference), 3.11 (95%CI 1.70-5.70; p<0.001), and 10.38 (95%CI 5.83-18.47; p<0.001), respectively. Conclusions: The ACEF score provides useful prognostic information for clinicians to advise patients who have survived the acute phase of AMI. More intensive management is required in post-MI survivors with high ACEF score.
Objectives This study evaluates outcomes and complications in patients treated with drug-eluting ... more Objectives This study evaluates outcomes and complications in patients treated with drug-eluting stents (DES) for "off-label" indications. Background Drug-eluting stents have been effective in randomized trials, but their safety and efficacy for off-label indications has not been well studied. Methods The STENT (Strategic Transcatheter Evaluation of New Therapies) Registry is the largest multicenter U.S. registry evaluating outcomes of DES. Off-label indications included ostial, left main, long, bifurcation, and in-stent restenotic lesions, saphenous vein grafts, chronic total occlusions, small or large vessels, multilesion or multivessel percutaneous coronary interventions, and STsegment elevation myocardial infarction. Outcomes were adjusted using Cox proportional hazards regression and propensity analyses. Results Drug-eluting stents were used in an off-label manner in 59% of patients. The patients who received off-label treatment were more often male, had a higher incidence of prior infarction and bypass surgery, and lower ejection fractions. Off-label versus "on-label" use of DES was associated with higher rates of death, myocardial infarction, target vessel revascularization, major adverse cardiac events, and stent thrombosis at 9 months and 2 years. Off-label use of DES compared with offlabel use of bare-metal stents (BMS) had lower rates of death, myocardial infarction, target vessel revascularization, and major adverse cardiac events at 9 months and 2 years and lower rates of stent thrombosis at 9 months. Conclusions Off-label use of DES is associated with higher event rates compared with on-label use of DES, which is consistent with a higher risk clinical and lesion profile. However, event rates with off-label use of DES are lower compared with off-label use of BMS. Pending results from randomized trials, our data support the use of DES for off-label indications in selected patients.
Catheterization and Cardiovascular Interventions, 2005
W. (2005). Poor long term patient and graft survival after primary percutaneous coronary interven... more W. (2005). Poor long term patient and graft survival after primary percutaneous coronary intervention for acute myocardial infarction due to saphenous vein graft occlusion. Catheterization and Cardiovascular Interventions, 65(4), 505-509.
Journal of the American College of Cardiology, 2004
Background: Paclitaxel-eluting stents (PES) have been shown to markedly reduce restenosis in elec... more Background: Paclitaxel-eluting stents (PES) have been shown to markedly reduce restenosis in elective patients. To date, there have been no studies evaluating their role in the treatment of ST-Elevation Myocardial Infarction. Method: Paclitaxel-eluting stents have been utilised as the default strategy for all patients at our institution as part of the Taxus-Stent Evaluated At Rotterdam Cardiology Hospital (T-SEARCH) Registry. Patients who received other types of drug eluting stents were not eligible for the registry. From 10 March 2003 to 11 July 2003, ninety seven consecutive patients were treated for ST elevation acute myocardial infarction with at least one PES. One patient was excluded from the analysis as his acute myocardial infarction was secondary to subacute thrombosis. Results: Seventy-eight patients underwent primary PCI while the remainder were treated following failed thrombolytic therapy. Multi vessel disease was present in 39% of patients, with an average of 1.26 vessels treated per patient. The RCA and LAD accounted for 44% and 39% of vessels treated respectively. Forty one percent of patients received glycoprotein IIb/IIIa inhibitors. Subacute thrombosis was seen in one patient an hour after the index procedure while a second patient required thrombolytic therapy for new ST elevation four days after the index procedure. A further two patients developed symptoms four and six days following bifurcation stenting. These patients had angiographic evidence of subacute thrombosis. Six-month follow-up data will be available for these patients at the time of presentation. Conclusion: This is the first study to evaluate the safety and feasibility of PES in the setting of acute myocardial infarction. Bifurcation stenting in acute myocardial infarction appears to predispose to the development of subacute stent thrombosis.
ImportanceIn patients with severe aortic valve stenosis at intermediate surgical risk, transcathe... more ImportanceIn patients with severe aortic valve stenosis at intermediate surgical risk, transcatheter aortic valve replacement (TAVR) with a self-expanding supra-annular valve was noninferior to surgery for all-cause mortality or disabling stroke at 2 years. Comparisons of longer-term clinical and hemodynamic outcomes in these patients are limited.ObjectiveTo report prespecified secondary 5-year outcomes from the Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI) randomized clinical trial.Design, Setting, and ParticipantsSURTAVI is a prospective randomized, unblinded clinical trial. Randomization was stratified by investigational site and need for revascularization determined by the local heart teams. Patients with severe aortic valve stenosis deemed to be at intermediate risk of 30-day surgical mortality were enrolled at 87 centers from June 19, 2012, to June 30, 2016, in Europe and North America. Analysis took place between August ...
Journal of the American College of Cardiology, 2013
Background: Predictors of one year mortality in 30-day survivors after acute myocardial infarctio... more Background: Predictors of one year mortality in 30-day survivors after acute myocardial infarction (AMI) has not been elucidated yet. Recently, several studies reported that ACEF (age, creatinine, ejection fraction) score could provide a prognostic information in patients undergoing percutaneous coronary intervention (PCI) after AMI. Accordingly, the aim of this study is to assess whether ACEF score could predict one year mortality in 30-day post-MI survivors. Methods: Between November 2005 and August 2011, 12,000 30-day post-MI survivors (8760 men; mean age ¼ 62.2AE12.4 year-old) underwent PCI were analyzed in this study from Korea AMI registry. ACEF score was calculated on the basis of the modified formula; [age/left ventricular ejection fraction] + 1 if serum creatinine >2mg/dL. Patients were categorized into 3 groups according to tertiles of ACEF score; ACEF_low (<1.0, n¼3,755), ACEF_mid (1.0-1.39, n¼4,470), and ACEF_high (!1.4, n¼3,775). Results: During the follow-up, ACEF score was significantly higher in 30-day post-MI survivors with 12-month mortality (1.28AE5.04 versus 1.95AE0.82, p <0.001). In Cox proportional hazards model, ACEF score (hazards ratio [HR] 2.26, 95% confidence interval [CI] 2.03-2.51; p <0.001) was an independent predictor of 12-month mortality after adjusting for conventional clinical risk factors. In receiver operating characteristics curves, area under the curve (AUC) of ACEF score for predicting 12-month mortality was 0.788 (sensitivity 71.2% and specificity 74.4%), and optimum cutoff value was 1.47. Kaplan-Meier survival curve showed the patients with ACEF score of 1.47 or more (6.9% versus 1.0%; log-rank p <0.001) had significantly higher 12-month mortality compared with patients with ACEF score <1.47. The 12-month mortality was 0.4% in ACE-F_low, 1.4% in ACEF_mid, and 6.1% in ACEF_high, respectively (p<0.001). Adjusted HRs for 12-month mortality were 1 (reference), 3.11 (95%CI 1.70-5.70; p<0.001), and 10.38 (95%CI 5.83-18.47; p<0.001), respectively. Conclusions: The ACEF score provides useful prognostic information for clinicians to advise patients who have survived the acute phase of AMI. More intensive management is required in post-MI survivors with high ACEF score.
Objectives This study evaluates outcomes and complications in patients treated with drug-eluting ... more Objectives This study evaluates outcomes and complications in patients treated with drug-eluting stents (DES) for "off-label" indications. Background Drug-eluting stents have been effective in randomized trials, but their safety and efficacy for off-label indications has not been well studied. Methods The STENT (Strategic Transcatheter Evaluation of New Therapies) Registry is the largest multicenter U.S. registry evaluating outcomes of DES. Off-label indications included ostial, left main, long, bifurcation, and in-stent restenotic lesions, saphenous vein grafts, chronic total occlusions, small or large vessels, multilesion or multivessel percutaneous coronary interventions, and STsegment elevation myocardial infarction. Outcomes were adjusted using Cox proportional hazards regression and propensity analyses. Results Drug-eluting stents were used in an off-label manner in 59% of patients. The patients who received off-label treatment were more often male, had a higher incidence of prior infarction and bypass surgery, and lower ejection fractions. Off-label versus "on-label" use of DES was associated with higher rates of death, myocardial infarction, target vessel revascularization, major adverse cardiac events, and stent thrombosis at 9 months and 2 years. Off-label use of DES compared with offlabel use of bare-metal stents (BMS) had lower rates of death, myocardial infarction, target vessel revascularization, and major adverse cardiac events at 9 months and 2 years and lower rates of stent thrombosis at 9 months. Conclusions Off-label use of DES is associated with higher event rates compared with on-label use of DES, which is consistent with a higher risk clinical and lesion profile. However, event rates with off-label use of DES are lower compared with off-label use of BMS. Pending results from randomized trials, our data support the use of DES for off-label indications in selected patients.
Catheterization and Cardiovascular Interventions, 2005
W. (2005). Poor long term patient and graft survival after primary percutaneous coronary interven... more W. (2005). Poor long term patient and graft survival after primary percutaneous coronary intervention for acute myocardial infarction due to saphenous vein graft occlusion. Catheterization and Cardiovascular Interventions, 65(4), 505-509.
Journal of the American College of Cardiology, 2004
Background: Paclitaxel-eluting stents (PES) have been shown to markedly reduce restenosis in elec... more Background: Paclitaxel-eluting stents (PES) have been shown to markedly reduce restenosis in elective patients. To date, there have been no studies evaluating their role in the treatment of ST-Elevation Myocardial Infarction. Method: Paclitaxel-eluting stents have been utilised as the default strategy for all patients at our institution as part of the Taxus-Stent Evaluated At Rotterdam Cardiology Hospital (T-SEARCH) Registry. Patients who received other types of drug eluting stents were not eligible for the registry. From 10 March 2003 to 11 July 2003, ninety seven consecutive patients were treated for ST elevation acute myocardial infarction with at least one PES. One patient was excluded from the analysis as his acute myocardial infarction was secondary to subacute thrombosis. Results: Seventy-eight patients underwent primary PCI while the remainder were treated following failed thrombolytic therapy. Multi vessel disease was present in 39% of patients, with an average of 1.26 vessels treated per patient. The RCA and LAD accounted for 44% and 39% of vessels treated respectively. Forty one percent of patients received glycoprotein IIb/IIIa inhibitors. Subacute thrombosis was seen in one patient an hour after the index procedure while a second patient required thrombolytic therapy for new ST elevation four days after the index procedure. A further two patients developed symptoms four and six days following bifurcation stenting. These patients had angiographic evidence of subacute thrombosis. Six-month follow-up data will be available for these patients at the time of presentation. Conclusion: This is the first study to evaluate the safety and feasibility of PES in the setting of acute myocardial infarction. Bifurcation stenting in acute myocardial infarction appears to predispose to the development of subacute stent thrombosis.
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Papers by William Downey