Outcomes in elderly and young patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention with bivalirudin versus heparin: Pooled analysis from the EUROMAX and HORIZONS-AMI trials

Qaderdan, Khalid; Vos, G.A.; McAndrew, Thomas; Steg, Philippe Gabríel; Hamm, Christian W.; Hof, Arnoud van’t; Mehran, Roxana; Deliargyris, Efthymios N.; Bernstein, Debra; Stone, Gregg W.; Berg, Jürrien M. ten

doi:10.1016/j.ahj.2017.08.009

Cited by 15 publications

(13 citation statements)

References 39 publications

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“…Both before and after PSM, we found that periprocedural use of bivalirudin during PCI in elderly patients with CAD could reduce the incidence of NACE events compared with UFH, mainly due to the reduced risk of any bleeding events and cardiac mortality, which was consistent with the results of the BRIGHT study in elderly subgroups 12 and a pooled analysis of the HORIZONS-AMI and EUROMAX trials (13.7% vs. 17.2%，p < 0.05). 19 Although MACCE was higher in the bivalirudin group before PSM in the current study, these effects disappeared after PSM, which was also in accordance with previous RCTs. 11,18,19 Previous studies showed that bivalirudin increased the risk of ST events compared with UFH, 10,[13][14][15] which is contradictory to our results.…”

Section: Discussionsupporting

confidence: 92%

“…19 Although MACCE was higher in the bivalirudin group before PSM in the current study, these effects disappeared after PSM, which was also in accordance with previous RCTs. 11,18,19 Previous studies showed that bivalirudin increased the risk of ST events compared with UFH, 10,[13][14][15] which is contradictory to our results. However, herein, full dose bivalirudin was routinely administered for approximately 4 h after PCI according to the recommendations of the BRIGHT study, 12 while in the EUROMAX and MATRIX studies, bivalirudin was terminated immediately after PCI or its use extended at a low-dose in a cohort of patients.…”

Section: Discussionsupporting

confidence: 92%

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Effectiveness and safety of bivalirudin in elderly patients with coronary artery disease undergoing percutaneous coronary intervention: A real‐world study

Liu

et al. 2022

Cathet Cardio Intervent

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Objective: To assess the effectiveness and safety of bivalirudin compared with heparin monotherapy in elderly patients undergoing percutaneous coronary intervention (PCI).Background: Bivalirudin is recommended for periprocedural use in patients undergoing PCI who are of high bleeding risk. However, its safe and efficacious use in elderly patients, a typical high bleeding risk cohort, in real world practice is yet to be reported. Methods:In this single center, real-world observational study, 4736 consecutive elderly patients who underwent PCI were enrolled. Of these, 1240 were treated with bivalirudin and 3496 with heparin according to the periprocedural anticoagulation strategies of PCI. The primary outcome was 12-month net adverse clinical events (NACE) defined as a composite of cardiac death, myocardial infarction, stroke, revascularization, or any bleeding. Propensity score matching (PSM) was used to balance baseline characteristics between groups.Results: After PSM, bivalirudin was found to be associated with lower rates of NACE (19.1% vs. 24.7%, p = 0.002), cardiac death (2.7% vs. 4.3%, p = 0.038), and any bleeding (10.0% vs. 12.9%, p = 0.023) compared to heparin monotherapy. No differences were found in the incidences of myocardial infarction, stroke, revascularization, stent thrombosis (0.1% vs. 0.1%, p = 1.000), and major bleedings (0.5% vs. 0.5%, p = 1.000) between the two patient groups. Conclusion:In this real-world observational study, periprocedural use of bivalirudin in elderly patients who underwent PCI was associated with less cardiac death and any bleeding compared to heparin monotherapy, without increased risk of stent thrombosis.

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Section: Discussionsupporting

confidence: 92%

Section: Discussionsupporting

confidence: 92%

Effectiveness and safety of bivalirudin in elderly patients with coronary artery disease undergoing percutaneous coronary intervention: A real‐world study

Liu

et al. 2022

Cathet Cardio Intervent

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“…28 In an age-based subgroup analysis of the combined HORIZONS-AMI and EUROMAX datasets, bivalirudin was associated with a lower 30-day incidence of non-coronary artery bypass grafting major bleeding and NACEs, with a similar 30-day incidence of acute stent thrombosis and mortality in patients aged 65 years and older with acute STEMI. 8 The studies described above enrolled any patient with coronary heart disease who underwent selective PPCI or PPCI. However, our study enrolled older patients with STEMI who underwent PPCI, and we found that bivalirudin consistently showed clinical benefits across the older population.…”

Section: Discussionmentioning

confidence: 99%

“…Unfractionated heparin (UFH) has been used for decades in patients with STEMI undergoing PPCI. 8 In addition to UFH, the use of aspirin, clopidogrel, and glycoprotein IIb/IIIa inhibitors (GPIs) has been shown to reduce early and late adverse cardiac events in patients with STEMI, with an unnecessary increase in bleeding events. 9,10 Bivalirudin is a novel direct thrombin inhibitor.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of bivalirudin application during primary percutaneous coronary intervention in older patients with acute ST-segment elevation myocardial infarction

Chen

Kong

et al. 2020

J Int Med Res

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Objective ST-segment elevation myocardial infarction (STEMI) is the most serious type of acute coronary syndrome. This study aimed to investigate the efficacy and safety of bivalirudin application during primary percutaneous coronary intervention (PPCI) in older patients with acute STEMI. Methods A total of 672 older patients with STEMI (>75 years) who underwent PPCI were studied. The primary endpoints were 30-day net adverse clinical events (NACEs) post-emergency percutaneous coronary intervention, including major adverse cardiac and cerebrovascular events (MACCEs) and Bleeding Academic Research Consortium grades 2 to 5 (BARC 2–5) bleeding events. Results The incidence of NACEs and BARC 2–5 bleeding events in the bivalirudin group was significantly lower than that in the unfractionated heparin group. Multivariate Cox regression analysis showed that bivalirudin significantly reduced 30-day NACEs (odds ratio: 0.700, 95% confidence interval: 0.492–0.995) and BARC 2–5 bleeding events (odds ratio: 0.561, 95% confidence interval: 0.343–0.918). At 1-year follow-up, these results were similar. Conclusions Bivalirudin can be safely and effectively used during PPCI in older patients with STEMI. Bivalirudin reduces the risks of NACEs and bleeding within 30 days after PPCI, without increasing the risks of MACCEs and stent thrombosis compared with heparin.

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“…Compared to younger patients, the elderly present with more comorbidities and are at higher risk of mortality and complications following percutaneous coronary intervention (PCI) [ 4 ], especially those with acute coronary syndromes or ST-elevation myocardial infarction (STEMI) [ 5 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 ]. Furthermore, elderly patients are more likely to present with atypical symptoms, increasing the risk of delay in treatment or misdiagnosis [ 14 , 15 ].…”

Section: Introductionmentioning

confidence: 99%

Elderly Suffering from ST-Segment Elevation Myocardial Infarction—Results from a Database Analysis from Two Mediterranean Medical Centers

Perl

Franzé

D’Ascenzo

et al. 2021

JCM

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Background: Little is known regarding primary percutaneous coronary intervention (pPCI) for ST-segment elevation myocardial infarction (STEMI) in the elderly. Methods: Data on 319 octogenarians, 641 septuagenarians, and 2451 younger patients was collected from an ongoing prospective registry of patients treated with pPCI for STEMI at two Mediterranean-area medical centers in 2009–2017. Results: More octogenarian patients were female (40.8 vs. 31.9 septuagenarians and 26.5% under 70 y, p < 0.01), had hypertension (79.5 vs. 69.5 and 45.9%, p < 0.01), renal failure (32.5 vs. 20.1 and 5.2%, p < 0.01), and a lower left-ventricular ejection fraction (42.0 vs. 44.9 and 47.6%, p = 0.012). At 1 month and 3 years after intervention, mortality was higher in the octogenarian patients (12.2 vs. 7.9%, p = 0.01; and 36.7 vs. 23.1%, p < 0.01, respectively), with no significant differences in the rates of recurrent myocardial infarction, target vessel revascularization, coronary artery bypass surgery, and cardiovascular death. Following adjustment for confounders, 3-year mortality was significantly higher in the octogenarians (HR 3.89 vs. 3.19 for septuagenarians, p < 0.01), but rates of major adverse cardiac events or cardiovascular death were not. Conclusions: Despite suffering from higher all-cause mortality, octogenarian patients treated with pPCI for STEMI do not suffer an increased risk of ischemic cardiac events relative to younger patients.

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Outcomes in elderly and young patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention with bivalirudin versus heparin: Pooled analysis from the EUROMAX and HORIZONS-AMI trials

Cited by 15 publications

References 39 publications

Effectiveness and safety of bivalirudin in elderly patients with coronary artery disease undergoing percutaneous coronary intervention: A real‐world study

Effectiveness and safety of bivalirudin in elderly patients with coronary artery disease undergoing percutaneous coronary intervention: A real‐world study

Efficacy and safety of bivalirudin application during primary percutaneous coronary intervention in older patients with acute ST-segment elevation myocardial infarction

Elderly Suffering from ST-Segment Elevation Myocardial Infarction—Results from a Database Analysis from Two Mediterranean Medical Centers

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