Long-Term Safety and Efficacy of Durable Polymer Cobalt-Chromium Everolimus-Eluting Stents in Patients at High Bleeding Risk: A Patient-Level Stratified Analysis From Four Postapproval Studies.
Abstract | BACKGROUND: METHODS: We analyzed stratified data from 4 all-comers postapproval registries. Patients with at least 1 of the following criteria were categorized as HBR: age ≥75 years, history of major bleeding (MB), history of stroke, chronic oral anticoagulant use, chronic kidney disease, anemia, or thrombocytopenia. Additionally, in a separate analysis, patients were categorized according to the recently published Academic Research Consortium HBR criteria. The Kaplan-Meier method was used for time-to-event analyses. Coronary thrombotic events (CTE) included myocardial infarction or definite/probable stent thrombosis. MB was defined according to the TIMI (Thrombolysis in Myocardial Infarction) or GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) scales. Impact of CTE and MB on subsequent risk of mortality was assessed using multivariable Cox regression with MB and CTE included as time-updated covariates. RESULTS: Of the total 10 502 patients included, 3507 (33%) were identified as HBR. Compared with non-HBR patients, those at HBR had more comorbidities, higher lesion complexity, and a higher risk of 4-year mortality (Hazard Ratio [HR] 4.38 [95% CI, 3.76-5.11]). Results were qualitatively similar when using Academic Research Consortium criteria to define HBR. Risk of mortality was increased after CTE (HR 5.02 [95% CI, 3.93-6.41]), as well as after MB (HR 4.92 [95% CI, 3.82-6.35]). Of note, this effect was consistent across the spectrum of bleeding risk (P-interaction test 0.97 and 0.06, respectively). CONCLUSIONS:
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Authors | Sabato Sorrentino, Bimmer E Claessen, Rishi Chandiramani, Paul Guedeney, Birgit Vogel, Usman Baber, Vinuta Rau, Jin Wang, Mitchell Krucoff, Ken Kozuma, Junbo Ge, Ashok Seth, Raj Makkar, Yuqi Liu, Sripal Bangalore, Deepak L Bhatt, Dominick J Angiolillo, Shigeru Saito, Franz-Josef Neumann, James Hermiller, Marco Valgimigli, Roxana Mehran |
Journal | Circulation
(Circulation)
Vol. 141
Issue 11
Pg. 891-901
(03 17 2020)
ISSN: 1524-4539 [Electronic] United States |
PMID | 31992063
(Publication Type: Journal Article, Multicenter Study)
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Chemical References |
- Platelet Aggregation Inhibitors
- Polymers
- Chromium
- Cobalt
- Everolimus
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Topics |
- Aged
- Aged, 80 and over
- Cause of Death
- Chromium
- Cobalt
- Comorbidity
- Coronary Restenosis
(epidemiology, etiology)
- Coronary Stenosis
(complications, therapy)
- Coronary Thrombosis
(epidemiology, etiology)
- Drug Therapy, Combination
- Drug-Eluting Stents
(adverse effects)
- Everolimus
(administration & dosage, adverse effects, therapeutic use)
- Female
- Hemorrhage
(epidemiology, etiology)
- Hemorrhagic Disorders
(epidemiology)
- Humans
- Kaplan-Meier Estimate
- Male
- Metabolic Syndrome
(epidemiology)
- Middle Aged
- Mortality
- Myocardial Infarction
(epidemiology, etiology)
- Percutaneous Coronary Intervention
(instrumentation)
- Platelet Aggregation Inhibitors
(administration & dosage, adverse effects, therapeutic use)
- Polymers
- Prevalence
- Proportional Hazards Models
- Prospective Studies
- Registries
- Smoking
(epidemiology)
- Treatment Outcome
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