Abstract 18745: Major Adverse Cardiac Events After Non-cardiac Surgery Following Previous Percutaneous Coronary Intervention With Stent Implantation

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Marcin Wasowicz ◽  
Summer Syed ◽  
Lukasz Starzyk ◽  
Duminda Wijeysundera ◽  
Scott W Beattie

Introduction: It is estimated that 5-16% of patients (pts) previously treated with percutaneous coronary interventions (PCI) and stent implantation will present for elective non-cardiac surgery (NCS) within 1 year. Despite ACC/AHA recommendations on antiplatelet therapy (ATP) the incidence of perioperative major cardiovascular events (MACE) is high. The objective of this multi-center prospective, cohort study was to determine if APT continued throughout perioperative period decreases the incidence of MI in this population and to determine the mechanism of MACE in post-PCI pts undergoing NCS. Hypothesis: There is an association between inadequate platelet inhibition and the incidence of MACE in pts undergoing NCS after previous PCI. Method: After REB approval pts after previous PCI scheduled for elective NCS were recruited. The primary outcome was Major Adverse Cardiac Event (defined as MI, stent thrombosis, need for revascularization or 30 day mortality). The incidence of MI was blindly adjudicated in duplicate using the 3 rd Univ. definition of MI. Troponin levels were measured every 8h for 2 days, then once daily until discharge in addition to ECG measurements. All pts patient was followed up for any clinical symptoms of MI. The location of MI was also judged based on its location (area of stent or not). The platelet inhibition by aspirin (ASA) and/or clopidogrel was measured using the Platelet Mapping Assay (PMA) performed preoperatively, 1h and 24h after surgery. Results: A total of 201 pts were recruited. The incidence of MACE was 21%. Additionally, 11 pts (5%) had isolated troponin elevation. The location of the MI occurred frequently in the area of the stent placement (71%). Pts. exposed to ASA with 5 days of surgery had better platelet inhibition than pts no exposed. There was no difference in platelet inhibition between pts suffering from MI and those who did not. Several factors were associated with increased MACE. These included higher Revised Cardiac Risk Index and pre- and post-operative anemia. 30 patients (15%) suffered from major bleeding complications. Conclusions: Results of this study indicated that use of ASA, or its withdrawal, was not associated with MACE in post PCI patients undergoing NCS.

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Renata Rogacka ◽  
Alaide Chieffo ◽  
Iassen Michev ◽  
Flavio Airoldi ◽  
Azeem Latib ◽  
...  

Objectives: To evaluate the safety of dual antiplatelet therapy in patients in whom long-term anticoagulation (AC) with warfarin is recommended. Background: It is well established that antiplatelet therapy with aspirin ad thienopiridines is required following percutaneous coronary intervention (PCI) with stent implantation. Some patients have also indication for long-term AC. The optimal antithrombotic strategy following PCI in such patients is unclear. Methods: All consecutive patients who underwent PCI with stent implantation discharged on triple therapy (defined as the combination of aspirin and thienopyridines and AC with warfarin) were analyzed. Results One-hundred and twenty-seven patients with 224 lesions: 86.6% males, mean age 69.9±8.8 years were included in the study. Drug-eluting stents (DES) were positioned in 71 (55.9%) and bare metal stent (BMS) in 53 (41.7%) patients. Atrial fibrillation (AF) was the main indication (59.1%) for AC treatment, followed by prosthetic valves (12.4%) and mural left ventricular (LV) thrombus (9.1%). Average risk of thromboembolic events in the subgroup with AF was 1.79 ± 1.23 according to CHADS2 score. The mean triple therapy duration was 5.6±4.6 and clinical follow-up 21.0±19.8 months. During the triple therapy period, 6 patients (4.7%) developed major bleeding complications; 67% of which occurred within the first month. No significant differences between DES and BMS were observed in the incidence of major (respectively 5.6% vs. 3.8%, p=1.0) and minor bleeding (respectively 1.4% vs. 3.8%, p=0.57) and mortality (respectively 5.6% vs. 1.9%, p=0.39). Four patients died in DES group: 3 of major bleeding complications and one of ischemic stroke. The only death in the BMS group was due to subarachnoid hemorrhage. A significant difference was observed in favor of DES in target vessel revascularization (14.1% vs. 28.3%, p=0.041). Conclusions: While on triple therapy, major bleeding complications occurred in 4.7% of patients, half of them were lethal and most (67%) occurred within the first month.


2020 ◽  
Vol 14 ◽  
pp. 175394472091132
Author(s):  
Matthias Waliszewski ◽  
Mark Rosenberg ◽  
Harald Rittger ◽  
Viktor Breul ◽  
Florian Krackhardt

Background: The objective of this review is to provide a practical update on endpoint selection for noninferiority (NI) studies in percutaneous coronary intervention studies. Methods: A PubMed search was conducted for predefined terms to explore the use of NI designs and intrapatient comparisons to determine their current importance. Sample size calculations for the most frequently used endpoints with NI hypotheses were done to increase statistical awareness. Results: Reported NI trials, with the most frequently chosen clinical endpoint of major adverse cardiac events (MACE), had NI margins ranging from 1.66% to 5.00%, resulting in patient populations of 400–1500 per treatment group. Clinical study endpoints comprising of MACE complemented with rates of bleeding complications and stent thrombosis (ST) are suggested to conduct a statistically and clinically meaningful NI trial. Study designs with surrogate endpoints amenable to intrapatient randomizations, are a very attractive option to reduce the number of necessary patients by about half. Comparative clinical endpoint studies with MACE and ST/bleeding rates to study a shortened dual antiplatelet therapy (DAPT) in coronary stent trials are feasible, whereas ST as the sole primary endpoint is not useful. Conclusions: Expanded composite clinical endpoints (MACE complemented by ST and bleeding rates and intrapatient randomization for selected surrogate endpoints) may be suitable tools to meet future needs in device approval, recertification and reimbursement.


2021 ◽  
Vol 10 (15) ◽  
pp. 3370
Author(s):  
Gwang-Seok Yoon ◽  
Sun-Hwa Kim ◽  
Si-Hyuck Kang ◽  
Chang-Hwan Yoon ◽  
Young-Seok Cho ◽  
...  

There are limited data evaluating conformation of antithrombotic therapy usage to the guideline recommendations. We investigated clinical trends and prognoses of patients with atrial fibrillation (AF) according to anticoagulants and antiplatelet agents beyond 1 year after percutaneous coronary intervention (PCI). We analyzed the records of patients with AF who underwent PCI using the Korean National Health Insurance Service database. The primary endpoint was a composite of major adverse cardiac events (MACE). The safety outcome was bleeding complications. Of 4193 participants, 81.6% received antiplatelet therapy, whereas 27.3% had oral anticoagulant (OAC)-based therapy at 18 months after PCI. The dominant therapy was dual antiplatelet therapy (37.2%), and only 3.3% of participants had OAC monotherapy. At the 1-year follow-up, the incidence of MACE was significantly lower among those receiving a combination of OAC and single antiplatelet therapy (SAPT) than among those receiving OAC monotherapy (4.78% vs. 9.42%, p = 0.017). Bleeding complication events (5.01% vs. 5.80%, p = 0.587) did not differ between the groups. In clinical practice, most patients with AF who underwent PCI continued to receive antiplatelet agents beyond 1-year post-PCI. OAC with SAPT seemed to be more effective than OAC monotherapy, without a difference in safety.


2021 ◽  
Vol 10 (Supplement_1) ◽  
Author(s):  
M Chiarito ◽  
U Baber ◽  
D Cao ◽  
Z Zhang ◽  
J Nicholas ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. OnBehalf PARIS (patterns of non-adherence to antiplatelet regimen in stented patients) INTRODUCTION In patients with myocardial infarction (MI) predisposition to atherothrombosis may persist for years, and prolonged DAPT could be beneficial in these high-risk group. Similarly, premature dual antiplatelet therapy (DAPT) cessation seems to increase the risk of adverse events after percutaneous coronary intervention (PCI). If DAPT non-adherence could have an enhanced impact on prognosis in patients with prior MI is still an uncharted territory. METHODS in this  prospective, observational, multicentre registry we enrolled all patients undergoing PCI with stent implantation in 15 clinical sites in USA and Europe and discharged with DAPT. Prespecified categories for DAPT cessation included physician recommended discontinuation, brief interruption (for surgery), or disruption (non-compliance or because of bleeding). Using Cox models with time-varying covariates, we examined the effect of DAPT cessation on major adverse cardiac events (MACE, primary endpoint, composite of cardiac death, definite or probable stent thrombosis, myocardial infarction, or target-lesion revascularization), its single components, and if patients with prior MI had different rate of DAPT cessation or MACE. RESULTS patients with prior MI (n = 1214; 24.2%) presented more often with cardiovascular risk factors compared to patients without prior MI (n = 3804, 75.8%). Interruption rate was similar among the two groups. Patients with prior MI had lower rate of any DAPT discontinuation and disruption compared to patients without prior MI. This notwithstanding, patients with prior MI had increased 2-year rates of MACE (adjusted hazard ratio 1.41, 95% confidence interval 1.20 - 1.67) and its single components (with the exception of definite or probable stent thrombosis), irrespective of DAPT non-adherence (p interaction= 0.983). CONCLUSION in this real world cohort of patients undergoing PCI with stent implantation, patients with prior MI, despite lower rate of DAPT non-adherence, had worse prognosis than patients without prior MI. New antithrombotic strategies are needed to improve the bleeding/ischemic trade-off in patients with prior MI and their outcome after PCI.


2005 ◽  
Vol 39 (5) ◽  
pp. 918-922 ◽  
Author(s):  
Kristen L Longstreth ◽  
James R Wertz

OBJECTIVE: To review the use of a 600-mg clopidogrel loading dose in patients undergoing percutaneous coronary intervention (PCI). DATA SOURCES: Human clinical trials and platelet studies available through PubMed (1966–March 2005), bibliographies of pertinent articles, and citations supplied by the drug manufacturer were accessed. DATA SYNTHESIS: The administration of a 600-mg loading dose of clopidogrel can decrease the time required for maximum platelet inhibition to 2 hours compared with ⩾6 hours achieved with 300 mg. This higher loading dose has been investigated in multiple platelet studies and one observational report. Several randomized controlled trials have used a 600-mg loading dose; however, these studies were not designed to evaluate the efficacy and safety of this loading regimen. To date, only one randomized trial has compared the 600-mg loading dose with a 300-mg loading dose. CONCLUSIONS: When compared with a conventional loading regimen of 300 mg in lower-risk patients, pretreatment with clopidogrel 600 mg was shown to be more effective in reducing periprocedural events and demonstrated similar safety. Studies are needed to clarify the use of a 600-mg loading dose in higher-risk patients, with concomitant glycoprotein IIb/IIIa receptor antagonism, or when administration is delayed until immediately before or after PCI.


2021 ◽  
Vol 10 ◽  
pp. 204800402199219
Author(s):  
Claire E Raphael ◽  
Peter D O’Kane

Bifurcation lesions are common and associated with higher risks of major cardiac events and restenosis after percutaneous coronary intervention (PCI). Treatment requires understanding of lesion characteristics, stent design and therapeutic options. We review the evidence for provisional vs 2-stent techniques. We conclude that provisional stenting is suitable for most bifurcation lesions. We detail situations where a 2-stent technique should be considered and the steps for performing each of the 2-step techniques. We review the importance of lesion preparation, intracoronary imaging, proximal optimization (POT) and kissing balloon inflation


Pharmacology ◽  
2021 ◽  
pp. 1-5
Author(s):  
David Naguib ◽  
Carolin Helten ◽  
Saif Zako ◽  
Philipp Mourikis ◽  
René M’Pembele ◽  
...  

Additional loading dose of acetylsalicylic acid (ASA) during percutaneous coronary interventions (PCIs) despite permanent oral ASA medication is frequently applicated. The impact on platelet reactivity and clinical events is not known. In this pilot study, we aimed to analyze high on-treatment platelet reactivity (HTPR) to aspirin in patients undergoing elective PCI. Platelet reactivity was measured using light-transmission aggregometry in 100 patients on permanent low-dose ASA medication undergoing elective PCI. Platelet reactivity measured by arachidonic acid-induced maximum of aggregation (MoA) in patients with versus without additional peri-procedural ASA loading (500 mg i.v.) was compared. HTPR was defined as MoA &#x3e;20% for ASA. Major adverse cerebro- and cardiovascular events (MACCEs) and bleeding events were evaluated during hospital course. HTPR rate was similar in both groups (HTPR to ASA: loading vs. control 6% vs. 16%, odds ratio [OR] = 0.33, 95% confidence interval [CI] 0.08–1.35, <i>p</i> = 0.12). In-hospital MACCEs were not different between groups (MACCE: loading vs. control: 0 vs. 0 patient, OR = 1.32, 95% CI 0.03–67.95, <i>p</i> = 0.89). Thrombolysis in myocardial infarction minimal bleedings were numerically higher in patients without ASA loading dose. In this pharmacodynamic pilot study, additional ASA loading did not reduce HTPR to ASA. Furthermore, ASA loading did not increase in-hospital MACCE and bleeding complications.


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