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De-Escalation of Dual Antiplatelet Therapy in Patients With Acute Coronary Syndromes.
Shoji, S, Kuno, T, Fujisaki, T, Takagi, H, Briasoulis, A, Deharo, P, Cuisset, T, Latib, A, Kohsaka, S
Journal of the American College of Cardiology. 2021;(8):763-777
Abstract
BACKGROUND Balancing the effects of dual antiplatelet therapy (DAPT) in the era of potent P2Y12 inhibitors has become a cornerstone of acute coronary syndrome (ACS) management. Recent randomized controlled trials (RCTs) have investigated DAPT de-escalation to decrease the risk of bleeding outcomes. OBJECTIVES The aim of this study was to compare the efficacy and safety outcomes of various DAPT strategies in patients with ACS, including de-escalation from a potent P2Y12 inhibitor to clopidogrel or low-dose prasugrel. METHODS MEDLINE and EMBASE were searched through January 2021 for RCTs investigating the efficacy and safety of DAPT in patients with ACS, and a network meta-analysis was conducted. The primary efficacy outcome was a composite of cardiovascular death, myocardial infarction, and stroke. The primary bleeding outcome was trial-defined major or minor bleeding. RESULTS Our search identified 15 eligible RCTs, including 55,798 patients with ACS. De-escalation therapy was associated with reduced risk of primary bleeding outcomes (HR: 0.48 [95% CI: 0.30-0.77] vs clopidogrel; HR: 0.32 [95% CI: 0.20-0.52] vs ticagrelor; HR: 0.36 [95% CI: 0.24-0.55] vs standard-dose prasugrel; and HR: 0.40 [95% CI: 0.22-0.75] vs low-dose prasugrel) without negatively affecting primary efficacy outcomes. There were no significant differences in ischemic or bleeding outcomes between de-escalation to clopidogrel or low-dose prasugrel. CONCLUSIONS Compared with other established uses of DAPT, de-escalation was the most effective strategy for ACS treatment, resulting in fewer bleeding events without increasing ischemic events.
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[Antithrombotic Therapy in Patients with Acute Coronary Syndrome and Atrial Fibrillation].
Darius, H
Deutsche medizinische Wochenschrift (1946). 2020;(14):978-986
Abstract
The number of patients with atrial fibrillation (AF) is increasing due to the aging of the population. In addition, the number of patients with AF and an indication for oral anticoagulation (OAC) for the prevention of strokes increases, who are in need for a dual antiplatelet therapy (DAPT) with acetyl salicylic acid (ASA) plus a P2Y12-Inhibitor because of an acute coronary syndrome and/or coronary stent implantation. These patients did receive a triple therapy (TT) for 3-12 months in the past. Triple therapy never has been studied for efficacy or safety, however, the rate of bleeding complications in comparison to OAC or DAPT is significantly higher.Registries and smaller trials showed that dual therapy with an OAC plus a single platelet inhibitor may be sufficient to prevent strokes and stent thromboses/myocardial infarctions. Four prospective randomized trials involving all four NOACs (Non-Vitamin K oral anticoagulants) approved for stroke prevention in AF have been undertaken. The NOACs plus one antiplatelet agent were tested versus vitamin K-antagonists plus DAPT. In the meantime, the trials involving rivaroxaban (PIONEER AF-PCI), dabigatran (RE-DUAL PCI), apixaban (AUGUSTUS), and edoxaban (ENTRUST-AF-PCI) have been published. The current status is that a NOAC plus a single antiplatelet agent, mostly clopidogrel, is superior to TT with respect to the bleeding complications, without any obvious and statistically significant disadvantage for stroke rates or cardiac ischemic events. The international guidelines already recommend to treat with a NOAC and one antiplatelet agent instead of TT in case the patients bleeding risk is prevailing. Thus, TT seems not to be indicated anymore for most patients with AF and ACS or PCI.
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The need to improve cardiac care after acute coronary syndrome.
Kolovou, G
Hellenic journal of cardiology : HJC = Hellenike kardiologike epitheorese. 2019;(4):254-255
Abstract
Patients who experience acute coronary syndrome (ACS) are at increased risk of new cardiovascular (CV) events. The main strategies for prevention of recurrence of CV events is the protection from ruptured plaque, thrombus formation, occlusion or downstream embolization in the coronary artery. The percutaneous coronary intervention (PCI) with stenting and anticoagulants, 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase inhibitors (HMGCoAi, commonly called statins) and neurohormonal inhibition, has led to a notable decrease in 1-year mortality events. Today it is well documented that all patients with an ACS should be treated early, intensively and continuously for lowering the LDL-C values to the recommended goals. Regularly interviewing by trained health care personnel and post-discharge follow-up of patients after ACS seems to be more effective concerning adherence to statin for achieving LDL-C treatment goals compared with the standard of care.
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The SSTARS (STeroids and Stents Against Re-Stenosis) Trial: Different stent alloys and the use of peri-procedural oral corticosteroids to prevent in-segment restenosis after percutaneous coronary intervention.
Adam, Z, Turley, A, Mason, JM, Kasim, AS, Newby, D, Mills, N, Padfield, G, Thompson, L, Morley, R, Hall, JA, et al
International journal of cardiology. 2016;:1-8
Abstract
BACKGROUND Stent design and technological modifications to allow for anti-proliferative drug elution influence restenosis rates following percutaneous coronary intervention (PCI). We aimed to investigate whether peri-procedural administration of corticosteroids or the use of thinner strut cobalt alloy stents would reduce rates of binary angiographic restenosis (BAR) after PCI. METHODS This was a two centre, mixed single and double blinded, randomised controlled trial using a factorial design. We compared (a) the use of prednisolone to placebo, starting at least six hours pre-PCI and continued for 28days post-PCI, and (b) cobalt chromium (CoCr) to stainless steel (SS) alloy stents, in patients admitted for PCI. The primary end-point was BAR at six months. RESULTS 315 patients (359 lesions) were randomly assigned to either placebo (n=145) or prednisolone (n=170) and SS (n=160) or CoCr (n=160). The majority (58%) presented with an ACS, 11% had diabetes and 287 (91%) completed angiographic follow up. BAR occurred in 26 cases in the placebo group (19.7%) versus 31 cases in the prednisolone group (20.0%) respectively, p=1.00. For the comparison between SS and CoCr stents, BAR occurred in 32 patients (21.6%) versus 25 patients (18.0%) respectively, p=0.46. CONCLUSION Our study showed that treating patients with a moderately high dose of prednisolone for 28days following PCI with BMS did not reduce the incidence of BAR. In addition, we showed no significant reduction in 6month restenosis rates with stents composed of CoCr alloy compared to SS (http://www.isrctn.com/ISRCTN05886349).
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[ACUTE CORONARY SYNDROME AND LIPID-LOWERING THERAPY. DOES THE IMPROVE-IT STUDY MAKE ANY DIFFERENCE?].
Lancellotti, P, Pierard, LA, Scheen, AJ
Revue medicale de Liege. 2015;(9):450-5
Abstract
Statins reduce both LDL cholesterol (LDL-C) levels and the risk of cardiovascular events in patients with and without cardiovascular disease. Intensive statin therapy, compared with moderate-dose statin therapy, incrementally lowers LDL-C levels and rates of cardiovascular events in patients presenting with acute coronary syndrome. Ezetimibe, by diminishing the absorption of cholesterol from the intestine, additionally reduces LDL-C when added to statins. In this article, we discuss the potential benefits of the combination of simvastatin and ezetimibe for the long-term management of patients with acute coronary syndrome through an analysis of the IMPROVE-IT results (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial). This randomised double blind trial included 18,144 patients with a LDL-C of 50 to 100 (with statin) or 125 (without statin) mg/dl and had a median follow-up of 6 years. The objective of the study was to test the efficacy of simvastatin 40 mg versus simvastatin 40 mg and 10 mg ezetimibe. The primary endpoint included cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina and coronary revascularization. The addition of ezetimibe to simvastatin resulted in an incremental lowering of LDL-C (reached value 53.2 versus 69.9 mg/dl, p < 0.001) and a further improvement of the patient prognosis (relative reduction of primary endpoint: -6.4%, p = 0.016). In addition, the combined therapy showed no significant adverse effects, particularly regarding the risk of cancers, which confirms the safety of ezetimibe. In acute coronary syndrome, the prescription of ezetimibe should be considered (class HA, level of evidence B) in patients with a LDL-C a 70 mg/dl despite maximally tolerated dose of statin.
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The different association of epicardial fat with coronary plaque in patients with acute coronary syndrome and patients with stable angina pectoris: analysis using integrated backscatter intravascular ultrasound.
Harada, K, Harada, K, Uetani, T, Kataoka, T, Takeshita, M, Kunimura, A, Takayama, Y, Shinoda, N, Kato, B, Kato, M, et al
Atherosclerosis. 2014;(2):301-6
Abstract
OBJECTIVES We assessed the hypothesis that the epicardial fat is associated with coronary lipid plaque. BACKGROUND Epicardial fat volume (EFV) is increased in patients with acute coronary syndrome (ACS), and lipid-rich plaques have been associated with acute coronary events. METHODS We enrolled 112 individuals who underwent percutaneous coronary intervention (PCI) (66 with ACS; 46 with stable angina pectoris [SAP]) and classified plaque components using integrated backscatter intravascular ultrasound as calcified, fibrous, or lipid. Possible effects of PCI on plaque data were minimized by assessing 10-mm vessel lengths proximal to the culprit lesions. Total plaque volume and percentage volumes of individual plaque components were calculated. EFV and abdominal visceral fat area were measured using 64-slice computed tomography. RESULTS ACS patients had significantly higher EFV than did SAP patients (118 ± 44 vs.101 ± 41 mL, p = 0.019). In ACS patients, EFV was correlated with total plaque volume and percentage of lipid plaque (r = 0.27 and 0.31, respectively; p < 0.05). Moreover, an independent interaction between EFV and lipid-rich plaque (odds ratio, 1.04; 95% confidence interval, 1.00-1.07) were revealed. In contrast, in SAP patients, EFV was positively correlated with body mass index and abdominal visceral fat area but not with plaque characteristics. CONCLUSIONS EFV was associated with lipid-rich plaque in patients with ACS, whereas no correlation between EFV and coronary plaque profile was apparent in SAP patients. Epicardial fat may have a role in the development of lipid plaque, which contributes to the pathogenesis of ACS.
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Randomized comparison of biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents for percutaneous coronary revascularization: rationale and design of the BIOSCIENCE trial.
Pilgrim, T, Roffi, M, Tüller, D, Muller, O, Vuilliomenet, A, Cook, S, Weilenmann, D, Kaiser, C, Jamshidi, P, Heg, D, et al
American heart journal. 2014;(3):256-61
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Abstract
BACKGROUND Biodegradable polymers for release of antiproliferative drugs from metallic drug-eluting stents aim to improve long-term vascular healing and efficacy. We designed a large scale clinical trial to compare a novel thin strut, cobalt-chromium drug-eluting stent with silicon carbide-coating releasing sirolimus from a biodegradable polymer (O-SES, Orsiro; Biotronik, Bülach, Switzerland) with the durable polymer-based Xience Prime/Xpedition everolimus-eluting stent (EES) (Xience Prime/Xpedition stent, Abbott Vascular, IL) in an all-comers patient population. DESIGN The multicenter BIOSCIENCE trial (NCT01443104) randomly assigned 2,119 patients to treatment with biodegradable polymer sirolimus-eluting stents (SES) or durable polymer EES at 9 sites in Switzerland. Patients with chronic stable coronary artery disease or acute coronary syndromes, including non-ST-elevation and ST-elevation myocardial infarction, were eligible for the trial if they had at least 1 lesion with a diameter stenosis >50% appropriate for coronary stent implantation. The primary end point target lesion failure (TLF) is a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization within 12 months. Assuming a TLF rate of 8% at 12 months in both treatment arms and accepting 3.5% as a margin for noninferiority, inclusion of 2,060 patients would provide more than 80% power to detect noninferiority of the biodegradable polymer SES compared with the durable polymer EES at a 1-sided type I error of 0.05. Clinical follow-up will be continued through 5 years. CONCLUSION The BIOSCIENCE trial will determine whether the biodegradable polymer SES is noninferior to the durable polymer EES with respect to TLF.
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Preloading with atorvastatin before percutaneous coronary intervention in statin-naïve Asian patients with non-ST elevation acute coronary syndromes: A randomized study.
Jang, Y, Zhu, J, Ge, J, Kim, YJ, Ji, C, Lam, W
Journal of cardiology. 2014;(5):335-43
Abstract
BACKGROUND Data on atorvastatin pretreatment in Asian patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI) are limited. However, there have been studies in other populations in Asia which demonstrated that statins can reduce the risk of periprocedural myocardial infarction (MI). METHODS AND RESULTS Statin-naïve patients with non-ST-segment-elevation (NSTE)-ACS scheduled for PCI were randomized to usual care or atorvastatin preloading groups. All patients received usual care including atorvastatin 40 mg/day. The atorvastatin group received atorvastatin 80 mg 12 h and 40 mg 2 h pre-PCI. Of 499 patients randomized, 247 were assigned to atorvastatin preloading. Following coronary angiography, 335 patients (163 atorvastatin) received PCI. During the 30 days post-PCI, major adverse cardiac events (death, MI, and target vessel revascularization) occurred in 24 (15%) atorvastatin and 27 (16%) usual care patients (p=NS). Post hoc analyses showed that at 8 h post-PCI, 3.82% of the atorvastatin group and 7.22% of the usual care group had a post-procedural creatine kinase-myocardial band (CK-MB) above 3 times the upper limit of normal (p=0.27) and at 24 h post-PCI, the rate was 7.64% versus 9.47% (p=1.0). Safety profile suggests that high-dose atorvastatin (40 mg) for up to 1 month, in conjunction with usual care, is relatively safe and well tolerated. CONCLUSIONS This study of statin-naïve Korean and Chinese patients with NSTE-ACS who received additional atorvastatin loading doses of 80 mg at 12 h, and 40 mg at 2 h, pre-PCI did not find a beneficial effect compared with usual post-PCI atorvastatin 40 mg/day treatment. Atorvastatin was found to be well tolerated in Asian patients with NSTE-ACS undergoing PCI. Results of the current study merit further investigation of the early use of statins in patients with NSTE-ACS to delineate patient subgroups who may benefit from this therapy.
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Comparative coronary risks of apixaban, rivaroxaban and dabigatran: a meta-analysis and adjusted indirect comparison.
Loke, YK, Pradhan, S, Yeong, JK, Kwok, CS
British journal of clinical pharmacology. 2014;(4):707-17
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Abstract
AIMS: There are concerns regarding increased risk of acute coronary syndrome with dabigatran. We aimed to assess whether alternative treatment options such as rivaroxaban or apixaban carry a similar risk as compared with dabigatran. METHODS We searched MEDLINE and EMBASE for randomized controlled trials of apixaban, dabigatran or rivaroxaban against control (placebo, heparin or vitamin K antagonist). We pooled odds ratios (OR) for adverse coronary events (acute coronary syndrome or myocardial infarction) using fixed effect meta-analysis and assessed heterogeneity with I(2) . We conducted adjusted indirect comparisons to compare risk of adverse coronary events with apixaban or rivaroxaban vs. dabigatran. RESULTS Twenty-seven randomized controlled trials met the inclusion criteria. Dabigatran was associated with a significantly increased risk of adverse coronary events in pooled analysis of nine trials (OR 1.45, 95% CI 1.14, 1.86). There was no signal for coronary risk with apixaban from nine trials (pooled OR 0.89, 95% CI 0.78, 1.03) or rivaroxaban from nine trials (pooled OR 0.81, 95% CI 0.72, 0.93). Overall, adjusted indirect comparison suggested that both apixaban (OR 0.61, 95% CI 0.44, 0.85) and rivaroxaban (OR 0.54; 95% CI 0.39, 0.76) were associated with lower coronary risk than dabigatran. Restricting the indirect comparison to a vitamin K antagonist as a common control, yielded similar findings, OR 0.57 (95% CI 0.39, 0.85) for apixaban vs. dabigatran and 0.53 (95% CI 0.37, 0.77) for rivaroxaban vs. dabigatran. CONCLUSIONS There are significant differences in the comparative safety of apixaban, rivaroxaban and dabigatran with regards to acute coronary adverse events.
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Safety and effectiveness of the association ezetimibe-statin (E-S) versus high dose rosuvastatin after acute coronary syndrome: the SAFE-ES study.
Deharo, P, Pankert, M, Quilici, J, Grosdidier, C, Verdier, V, Bonnet, G, Morange, P, Alessi, MC, Bonnet, JL, Cuisset, T
Annales de cardiologie et d'angeiologie. 2014;(4):222-7
Abstract
BACKGROUND Statin therapy is a cornerstone therapy for secondary prevention after acute coronary syndrome (ACS). However, the use of these drugs can be limited by side effects, mainly muscular pain. Ezetimibe is a newer lipid-lowering agent, with fewer side effects. AIMS The present study was designed to compare a commercially available association of ezetimibe and simvastatin (E-S) to high dose Rosuvastatin on cholesterol and muscular enzyme levels and occurrence of muscular pain. METHODS All consecutive ACS statin-naïve patients with LDL cholesterol (LDL-C)>100mg/dL randomly received either high dose statin (Rosuvastatin 20mg) or E-S 10/40-mg. All patients had one-month follow-up with biological testing and clinical examination. We compared the two groups on the biological efficiency and incidence of muscular pain. RESULTS One hundred and twenty-eight patients were randomized; 64 received E-S and 64 Rosuvastatin. In the two groups, the lowering of LDL-C level (Δ=51%) at one month was significant (P<0.01) without any difference in the rate of lowering on LDL-C or HDL-C suggesting that E-S is as effective as high dose Rosuvastatin (P=0.77 and P=0.99). The rate of patients reaching the objective of LDL-C<100mg/dL (45%) and LDL-C<70mg/dL (51%) was not different in the two clusters (P=0.65). Incidence of muscular pain was 15% higher in patients treated with Rosuvastatin (P=0.01) without any difference on CPK level (P=0.6). CONCLUSION Using an association of E-S in an effective alternative strategy to high dose Rosuvastatin with a lower incidence of muscular pain, which might impact adherence to medication after ACS.