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Antiplatelet Therapy with Cangrelor in Patients Undergoing Surgery after Coronary Stent Implantation: A Real-World Bridging Protocol Experience.

ABSTRACT: Objective ?The aim of the study is to describe the real-world use of the P2Y ₁₂ inhibitor cangrelor as a bridging strategy in patients at high thrombotic risk after percutaneous coronary intervention (PCI) and referred to surgery requiring perioperative withdrawal of dual antiplatelet therapy (DAPT). Materials and Methods ?We collected data from nine Italian centers on patients with previous PCI who were still on DAPT and undergoing nondeferrable surgery requiring DAPT discontinuation. A perioperative standardized bridging protocol with cangrelor was used. Results ?Between December 2017 and April 2019, 24 patients (mean age 72 years; male 79%) were enrolled. All patients were at high thrombotic risk after PCI and required nondeferrable intermediate to high bleeding risk surgery requiring DAPT discontinuation (4.6?±?1.7 days). Cangrelor infusion was started at a bridging dose (0.75 µg/kg/min) 3 days before planned surgery and was discontinued 6.6?±?1.5?hours prior to surgical incision. In 55% of patients, cangrelor was resumed at 9?±?6?hours following surgery for a mean of 39?±?38?hours. One cardiac death was reported after 3?hours of cangrelor discontinuation prior to surgery. No ischemic outcomes occurred after surgery and up to 30-days follow-up. The mean hemoglobin drop was <2?g/dL; nine patients received blood transfusions consistent with the type of surgery, but no life-threatening or fatal bleeding occurred. Conclusion ?Perioperative bridging therapy with cangrelor is a feasible approach for stented patients at high thrombotic risk and referred to surgery requiring DAPT discontinuation. Larger studies are warranted to support the safety of this strategy.

SUBMITTER: Rossini R

PROVIDER: S-EPMC7758156 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Antiplatelet Therapy with Cangrelor in Patients Undergoing Surgery after Coronary Stent Implantation: A Real-World Bridging Protocol Experience.

Rossini Roberta R Masiero Giulia G Fruttero Claudia C Passamonti Enrico E Calvaruso Elba E Cecconi Moreno M Carlucci Cesare C Mojoli Marco M Guido Parodi P Talanas Giuseppe G Pierini Simona S Canova Paolo P De Cesare Nicoletta N Luceri Stefania S Barzaghi Nicoletta N Melloni Giulio G Baralis Giorgio G Locatelli Alessandro A Musumeci Giuseppe G Angiolillo Dominick J DJ

TH open : companion journal to thrombosis and haemostasis 20201001 4

Objective The aim of the study is to describe the real-world use of the P2Y 12 inhibitor cangrelor as a bridging strategy in patients at high thrombotic risk after percutaneous coronary intervention (PCI) and referred to surgery requiring perioperative withdrawal of dual antiplatelet therapy (DAPT). Materials and Methods We collected data from nine Italian centers on patients with previous PCI who were still on DAPT and undergoing nondeferrable surgery requiring DAPT d ...[more]

PMID: 33376943

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Project description:Thienopyridines are among the most widely prescribed medications, but their use can be complicated by the unanticipated need for surgery. Despite increased risk of thrombosis, guidelines recommend discontinuing thienopyridines 5 to 7 days prior to surgery to minimize bleeding.To evaluate the use of cangrelor, an intravenous, reversible P2Y(12) platelet inhibitor for bridging thienopyridine-treated patients to coronary artery bypass grafting (CABG) surgery.Prospective, randomized, double-blind, placebo-controlled, multicenter trial, involving 210 patients with an acute coronary syndrome (ACS) or treated with a coronary stent and receiving a thienopyridine awaiting CABG surgery to receive either cangrelor or placebo after an initial open-label, dose-finding phase (n = 11) conducted between January 2009 and April 2011. Interventions Thienopyridines were stopped and patients were administered cangrelor or placebo for at least 48 hours, which was discontinued 1 to 6 hours before CABG surgery.The primary efficacy end point was platelet reactivity (measured in P2Y(12) reaction units [PRUs]), assessed daily. The main safety end point was excessive CABG surgery-related bleeding.The dose of cangrelor determined in 10 patients in the open-label stage was 0.75 ?g/kg per minute. In the randomized phase, a greater proportion of patients treated with cangrelor had low levels of platelet reactivity throughout the entire treatment period compared with placebo (primary end point, PRU <240; 98.8% (83 of 84) vs 19.0% (16 of 84); relative risk [RR], 5.2 [95% CI, 3.3-8.1] P < .001). Excessive CABG surgery-related bleeding occurred in 11.8% (12 of 102) vs 10.4% (10 of 96) in the cangrelor and placebo groups, respectively (RR, 1.1 [95% CI, 0.5-2.5] P = .763). There were no significant differences in major bleeding prior to CABG surgery, although minor bleeding episodes were numerically higher with cangrelor.Among patients who discontinue thienopyridine therapy prior to cardiac surgery, the use of cangrelor compared with placebo resulted in a higher rate of maintenance of platelet inhibition.clinicaltrials.gov Identifier: NCT00767507.

Project description:ObjectivesThe objective of this post hoc analysis was to analyze real-world dual antiplatelet therapy (DAPT) regimens following polymer-free sirolimus-eluting stent (PF-SES) implantations in an unselected patient population.MethodsPatient-level data from two all-comers observational studies (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were pooled and analyzed in terms of their primary endpoint. During the data verification process, we observed substantial deviations from DAPT guideline recommendations. To illuminate this gap between clinical practice and guideline recommendations, we conducted a post hoc analysis of DAPT regimens and clinical event rates for which we defined the net adverse event rate (NACE) consisting of target lesion revascularization (TLR, primary endpoint of all-comers observational studies) all-cause death, myocardial infarction (MI), stent thrombosis (ST), and bleeding events. A logistic regression was utilized to determine predictors why ticagrelor was used in stable coronary artery disease (CAD) patients instead of the guideline-recommended clopidogrel.ResultsFor stable CAD, the composite endpoint of clinical, bleeding, and stent thrombosis, i.e., NACE, between the clopidogrel and ticagrelor treatment groups was not different (5.4% vs. 5.1%, p = 0.745). Likewise, in the acute coronary syndrome (ACS) cohort, the NACE rates were not different between both DAPT strategies (9.2% vs. 9.3%, p = 0.927). There were also no differences in the accumulated rates for TLR, myocardial infarction ([MI], mortality, bleeding events, and stent thrombosis in elective and ACS patients. The main predictors for ticagrelor use in stable CAD patients were age < 65 years, smaller vessels, treatment of ostial and calcified lesions, and in-stent restenosis.ConclusionWithin the framework of a post hoc analysis based on a real-world, large cohort study, there were no differences in the combined endpoint of major adverse cardiac events (MACE), bleeding and thrombotic events for clopidogrel and ticagrelor in stable CAD or ACS patients. Despite the recommendation for clopidogrel by the European Society of Cardiology (ESC), real-world ticagrelor use was observed in subgroups of stable CAD patients that ought to be explored in future trials.

Project description:BackgroundEnd-stage renal disease yields susceptibility to both ischemia and bleeding. The optimal duration of dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation is not established in dialysis patients, who are usually excluded from randomized studies. Since recent studies implied the benefits of prolonged DAPT >12 months in chronic kidney disease, we investigated the effectiveness and safety of prolonged DAPT in dialysis patients with higher cardiovascular risks.MethodsIn this nationwide population-based study, we analyzed dialysis patients who underwent DES implantation from 2008 to 2015. Continued DAPT was compared with discontinued DAPT using landmark analyses, including free-of-event participants at 12 (n = 2246), 15 (n = 1925) and 18 months (n = 1692) after DES implantation. The primary outcome was major adverse cardiovascular events (MACEs): a composite of mortality, nonfatal myocardial infarction, coronary revascularization and stroke. Major bleeding was a safety outcome. Inverse probability of treatment weighting Cox regression was performed.ResultsMean follow-up periods were 278.3-292.4 days, depending on landmarks. Overall, incidences of major bleeding were far lower than those of MACE. Continued DAPT groups showed lower incidences of MACE and higher incidences of major bleeding, compared with discontinued DAPT groups. In Cox analyses, continued DAPT reduced the hazards of MACE at the 12- [hazard ratio (HR) = 0.74, 95% confidence interval (CI) 0.61-0.90; P = 0.003], 15- (HR = 0.78, 95% CI 0.64-0.96; P = 0.019) and 18-month landmarks (HR = 0.79, 95% CI 0.63-0.99; P = 0.041), but without a significant increase in major bleeding at 12 (HR = 1.39, 95% CI 0.90-2.16; P = 0.14), 15 (HR = 1.13, 95% CI 0.75-1.70; P = 0.55) or 18 months (HR = 1.27, 95% CI 0.83-1.95; P = 0.27).ConclusionsProlonged DAPT reduced MACE without significantly increasing major bleeding in patients who were event-free at 12 months after DES implantation. In deciding on DAPT duration, prolonged DAPT should be considered in dialysis patients.

Project description:BackgroundPsychosocial stress and activation of neutrophil granulocytes are increasingly recognized as major risk factors of coronary artery disease (CAD), but the possible relationship of these two factors in CAD patients is largely unexplored. Activation of neutrophils was reported to be associated with stenting; however, the issue of neutrophil state in connection with percutaneous coronary intervention (PCI) is incompletely understood from the aspect of stress and its hypothalamic-pituitary-adrenal axis (HPA) background. Thus, we aimed to study cortisol- and ACTH-associated changes in granulocyte activation in patients undergoing PCI.Methodology/principal findingsBlood samples of 21 stable angina pectoris (SAP) and 20 acute coronary syndrome (ACS) patients were collected directly before (pre-PCI), after (post-PCI) and on the following day of PCI (1d-PCI). Granulocyte surface L-selectin, CD15 and (neutrophil-specific) lactoferrin were analysed by flow cytometry. Plasma cortisol, ACTH, and lactoferrin, IL-6 were also assayed. In both groups, pre- and post-PCI ratios of lactoferrin-bearing neutrophils were relatively high, these percentages decreased substantially next day; similarly, 1d-PCI plasma lactoferrin was about half of the post-PCI value (all p?0.0001). Post-PCI ACTH was reduced markedly next day, especially in ACS group (SAP: p<0.01, ACS: p?0.0001). In ACS, elevated pre-PCI cortisol decreased considerably a day after stenting (p<0.01); in pre-PCI samples, cortisol correlated with plasma lactoferrin (r?0.5, p<0.05). In 1d-PCI samples of both groups, ACTH showed negative associations with the ratio of lactoferrin-bearing neutrophils (SAP: r?=?-0.601, p<0.005; ACS: r?=?-0.541, p<0.05) and with plasma lactoferrin (SAP: r?=?-0.435, p<0.05; ACS: r?=?-0.609, p<0.005).Conclusions/significancePre- and post-PCI states were associated with increased percentage of activated/degranulated neutrophils indicated by elevated lactoferrin parameters, the 1d-PCI declines of which were associated with plasma ACTH in both groups. The correlation of plasma cortisol with plasma lactoferrin in the extremely stressed ACS before stenting, however, suggests an association of cortisol with neutrophil activation.

Project description:BACKGROUND:The correct perioperative management of antiplatelet therapy (APT) in patients undergoing non-cardiac surgery (NCS) is often debated by clinicians. American College of Cardiology (ACC) and American Heart Association (AHA) guidelines recommend postponing elective NCS at least 3 months after stent implantation. Regardless of the timing of surgery, ACC/AHA guidelines recommend continuing at least ASA throughout the perioperative period and ideally continuing dual APT (DAPT) therapy "unless surgery demands discontinuation." The objective of this review was to ascertain the risks and benefits of APT in the perioperative period, to assess how these risks and benefits vary by APT management, and the significance of length of time since stent implantation before operative intervention. METHODS:PubMed, Web of Science, and Scopus were searched from inception through October 2017. Articles were included if patients were post PCI with stent placement (bare metal [BMS] or drug eluting [DES]), underwent elective NCS, and had rates of major adverse cardiac events (MACE) or bleeding events associated with pre and perioperative APT therapy. RESULTS:Of 4882 screened articles, we included 16 studies in the review (1 randomized controlled trial and 15 observational studies). Studies were small (< 50: n = 5, 51-150: n = 5, >150: n = 6). All studies included DES with 7 of 16 also including BMS. Average time from stent to NCS was variable (< 6 months: n = 3, 6-12 months: n = 1, > 12 months: n = 6). At least six different APT strategies were described. Six studies further utilized bridging protocols using three different pharmacologic agents. Studies typically included multiple surgical fields with varying degrees of invasiveness. Across all APT strategies, rates of MACE/bleeding ranged from 0 to 21% and 0 to 22%. There was no visible trend in MACE/bleeding rates within a given APT strategy. Stratifying the articles by type of surgery, timing of discontinuation of APT therapy, bridging vs. no bridging, and time since stent placement did not help explain the heterogeneity. CONCLUSIONS:Evidence regarding perioperative APT management in patients with cardiac stents undergoing NCS is insufficient to guide practice. Other clinical factors may have a greater impact than perioperative APT management on MACE and bleeding events. SYSTEMATIC REVIEW REGISTRATION:PROSPERO CRD42016036607.

Project description:Background: Patients with diabetes mellitus (DM) are known to be at high-risk for both ischemic and bleeding complications post-percutaneous coronary intervention (PCI). The ischemic benefit vs. bleeding risk associated with extended dual antiplatelet therapy (DAPT) in high-risk "TWILIGHT-like" patients with diabetes mellitus after PCI has not been established. Methods: All consecutive high-risk patients fulfilling the "TWILIGHT-like" criteria undergoing PCI from January 2013 through December 2013 were identified from the prospective Fuwai PCI Registry. High-risk "TWILIGHT-like" patients were defined by at least one clinical and one angiographic feature based on the TWILIGHT trial selection criteria. The present analysis evaluated 3,425 diabetic patients with concomitant high-risk angiographic features who were event-free at 1 year after PCI. Median follow-up was 2.4 years. The primary effectiveness endpoint was a composite of death, myocardial infarction, or stroke (termed major adverse cardiac and cerebrovascular events), and primary safety endpoint was clinically relevant bleeding according to the Bleeding Academic Research Consortium types 2, 3, or 5. Results: On inverse probability of treatment weighting (IPTW) analysis, prolonged-term (>1-year) DAPT with aspirin and clopidogrel decreased the risk of primary effectiveness endpoint compared with shorter ( ≤ 1-year) DAPT [1.8 vs. 4.3%; hazard ratio (HR)IPTW: 0.381; 95% confidence interval (CI): 0.252-0.576; P < 0.001] and reduced cardiovascular death [0.1% vs. 1.8%; HRIPTW: 0.056 (0.016-0.193)]. Prolonged DAPT was also associated with a reduced risk of definite/probable stent thrombosis [0.2 vs. 0.7%; HRIPTW: 0.258 (0.083-0.802)] and non-significantly lower rate of myocardial infarction [0.5 vs. 0.8%; HRIPTW: 0.676 (0.275-1.661)]. There was no significant difference between groups in clinically relevant bleeding [1.1 vs. 1.1%; HRIPTW: 1.078 (0.519-2.241); P = 0.840). Similar results were observed in multivariable Cox proportional hazards regression model. Conclusion: Among high-risk PCI patients with diabetes mellitus without an adverse event through 1 year, extending DAPT >1-year significantly reduced the risk of major adverse cardiac and cerebrovascular events without an increase in clinically relevant bleeding, suggesting that such high-risk diabetic patients may be good candidates for long-term DAPT.

Project description:BackgroundRandomized controlled trials are the gold standard for evaluating therapy; however, controversy exists regarding the applicability of such results to daily practice, as patients are often pre-selected and may not reflect real-world clinical settings. We studied the eligibility criteria for 3102 "real-life" patients with stable coronary artery disease (SCAD) according to the ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) trial exclusion criteria. The aim of our analysis was to estimate the percentage of real-life patients who would have met the exclusion criteria for the ISCHEMIA trial.MethodsWe analyzed 3102 patients with SCAD referred to the Silesian Center for Heart Disease who underwent both coronary angiography and stent implantation between January 2006 and December 2011. The patients were divided into two groups. Group A was composed of patients with SCAD who would have been excluded from the ongoing ISCHEMIA trial, whereas group B represented the remaining patients.ResultsA total of 1900 (61.3%) patients met at least one of the exclusion criteria. The most frequent exclusion criterion noted was revascularization within the previous 12 months (938 patients; 49.4%), followed by unacceptable level of angina symptoms (532 patients; 28 %), low ejection fraction (467 patients; 24.6%), and acute coronary syndrome within the previous 2 months (456 patients; 24%). Patients from our cohort who would have been excluded from the ISCHEMIA trial were older, had more comorbidities, and experienced worse long-term outcomes.ConclusionsThe ISCHEMIA trial exclusion criteria ruled out the majority of the patients with SCAD undergoing percutaneous coronary intervention in "real life". Our cohort of patients who would have been excluded from the ISCHEMIA trial had more comorbidities and experienced significantly worse long-term outcomes than patients who did not meet the ISCHEMIA trial exclusion criteria.Trial registrationClinicalTrials.gov NCT01471522.

Dataset Information

Antiplatelet Therapy with Cangrelor in Patients Undergoing Surgery after Coronary Stent Implantation: A Real-World Bridging Protocol Experience.

Publications

Antiplatelet Therapy with Cangrelor in Patients Undergoing Surgery after Coronary Stent Implantation: A Real-World Bridging Protocol Experience.

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