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6. Second generation drug‐eluting stents <italic>versus</italic> bare‐metal stents for percutaneous coronary intervention of the proximal left anterior descending artery: An analysis of the BASKET‐PROVE I and II trials.

Author

Mangione, Fernanda Marinho, Biering‐Sørensen, Tor, Nochioka, Kotaro, Jatene, Tannas, Silvestre, Odilson Marcos, Hansen, Kim Wadt, Sørensen, Rikke, Jensen, Jan Skov, Jorgensen, Peter Godsk, Jeger, Raban, Kaiser, Christoph, Pfisterer, Matthias, and Galatius, Søren

Published
2018
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12. Investigator-Reported Bleeding Versus Post Hoc Adjudication of Bleeding: Lessons From the CHAMPION PHOENIX Trial.

Author

Jatene, Tannas, Harrington, Robert A., Stone, Gregg W., Steg, Ph. Gabriel, Gibson, C. Michael, Hamm, Christian W., Price, Matthew J., Prats, Jayne, Deliargyris, Efthymios N., Mahaffey, Kenneth W., White, Harvey D., Bhatt, Deepak L., and CHAMPION PHOENIX Investigators

Subjects
*HEMORRHAGE, *THROMBOLYTIC therapy, *MYOCARDIAL infarction, *CLINICAL trials, CARDIOVASCULAR disease related mortality
Published
2016
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13. TCT-312 Increased Cardiac Death and Stent Thrombosis in Chronic Obstructive Pulmonary Disease Patients Undergoing Percutaneous Coronary Intervention. An analysis of the BASKET-PROVE I and II trials.

Author

Jatene, Tannas, Biering-Sørensen, Tor, Nochioka, Kotaro, Mangione, Fernanda, Hansen, Kim, Sørensen, Rikke, Jensen, Jan Skov, Jørgensen, Peter, Jeger, Raban, Kaiser, Christoph, Pfisterer, Matthias, and Galatius, Soeren

Subjects
*CARDIAC arrest, *THROMBOSIS, *OBSTRUCTIVE lung diseases, *PERCUTANEOUS coronary intervention, *CLINICAL trials
Published
2016
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16. TCT-381 Effects Of Acute Kidney Injury and Chronic Kidney Disease on Mortality In Patients Undergoing Transcatheter Aortic Valve Replacement.

Author

Meneguz-Moreno, Rafael Alexandre, Ramos, Auristela, Castro-Filho, Antonio, Jatene, Tannas, Jeronimo, Andreia, Le Bihan, David, Barretto, Rodrigo, Siqueira, Dimytri, Arrais, Magaly, Moreira, Adriana, Abizaid, Alexandre, Sousa, Amanda, and Sousa, J. Eduardo

Subjects
*ACUTE kidney failure, *GLOMERULAR filtration rate, *MORTALITY, *DISEASE incidence, *DISEASE progression, *DIAGNOSIS, AORTIC valve surgery
Published
2016
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19. Impact of bleeding assessment and adjudication methodology on event rates and clinical trial outcomes: insights from the HORIZONS-AMI trial.

Author

Kosmidou I, Mintz GS, Jatene T, Embacher M, Redfors B, Wong SC, Dressler O, Mehran R, Ben-Yehuda O, Jenkins PL, and Stone GW

Subjects
Electrocardiography, Hemorrhage, Humans, Prospective Studies, Stents, Treatment Outcome, Myocardial Infarction, Percutaneous Coronary Intervention
Abstract

Aims: Bleeding is a major safety outcome in cardiovascular trials. The present study assessed the impact of the adjudication process of bleeding events on three-year outcomes in the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial., Methods and Results: HORIZONS-AMI enrolled 3,602 patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention. An independent CEC reviewed 445 potential bleeding events identified from three sources: 339 site-reported (SR), 35 CEC-identified, and 71 database (DB)-triggered events based on programmatic identification of a decline in haemoglobin of ≥3 g/dL or in haematocrit by ≥9%; of those, 383/445 (86.1%) met the protocol definition of major bleeding. By multivariable analysis, CEC-confirmed bleeding was an independent predictor of cardiovascular death (hazard ratio [HR] 2.84, 95% confidence interval [CI]: 1.81-4.45, p<0.0001) and all-cause death (HR 2.70, 95% CI: 1.92-3.79, p<0.0001) at three years. Non-CEC-confirmed bleeding was also a predictor of cardiovascular death (HR 3.45, 95% CI: 1.47-8.11, p=0.005) and all-cause death (HR 2.41, 95% CI: 1.11-5.23, p=0.03) at three years., Conclusions: In the HORIZONS-AMI trial, adjudication of bleeding via a centralised CEC process resulted in identification of a larger number of events than were SR. All CEC-confirmed bleeding events were independently predictive of three-year cardiovascular and all-cause mortality. The association of non-CEC-confirmed bleeding with mortality merits further investigation.

Published
2018
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20. Second generation drug-eluting stents versus bare-metal stents for percutaneous coronary intervention of the proximal left anterior descending artery: An analysis of the BASKET-PROVE I and II trials.

Author

Mangione FM, Biering-Sørensen T, Nochioka K, Jatene T, Silvestre OM, Hansen KW, Sørensen R, Jensen JS, Jorgensen PG, Jeger R, Kaiser C, Pfisterer M, and Galatius S

Subjects
Aged, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease mortality, Coronary Stenosis diagnostic imaging, Coronary Stenosis mortality, Drug Therapy, Combination, Female, Humans, Male, Middle Aged, Myocardial Infarction etiology, Percutaneous Coronary Intervention adverse effects, Percutaneous Coronary Intervention mortality, Platelet Aggregation Inhibitors therapeutic use, Prosthesis Design, Randomized Controlled Trials as Topic, Risk Factors, Time Factors, Treatment Outcome, Coronary Artery Disease surgery, Coronary Stenosis surgery, Drug-Eluting Stents, Metals, Percutaneous Coronary Intervention instrumentation, Stents
Abstract

Objectives: To compare mid-term outcomes between patients undergoing proximal left anterior descending artery (LAD) percutaneous coronary intervention (PCI) with second generation drug-eluting stent (DES) or bare-metal stent (BMS)., Background: PCI with BMS and first-generation DES have shown to be safe options for the treatment of proximal LAD stenosis, however associated with considerable reintervention rates. Overall, second-generation DES has proven to be superior to BMS and first-generation DES, nevertheless, its effect for proximal LAD PCI has not previously been reported., Methods: We analyzed 2-year outcomes of 1,100 patients from the BASKET-PROVE I and II trials, referred for proximal LAD PCI with second generation DES (n = 680) or BMS (n = 420)., Results: The cumulative 2-year incidence of major adverse cardiac events (MACE, composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR)) was lower in second generation DES than in BMS treated patients (7.3% vs. 12.3%; HR 0.57, 95% CI 0.39/0.85), mainly driven by a reduced rate of TVR (3.7% vs. 10.0%; HR 0.35, CI 0.21/0.58). No difference was found in cardiac death (1.9% vs. 1.9%; HR 1.01, CI 0.42/2.44) and MI (4.4% vs. 4.7%; HR 0.93, CI 0.53/1.64). The benefit of DES use seemed to be more prominent in female patients with a reduction in MACE (P for interaction = 0.025)., Conclusions: In patients with proximal LAD stenosis, treatment with second-generation DES was associated with reduced 2-year rates of adverse cardiac events and TVR compared to BMS, with reintervention rates similar to those earlier reported from bypass surgery., (© 2017 Wiley Periodicals, Inc.)

Published
2018
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