Evaluation of a Novel Antiplatelet Therapy Strategy in Patients Undergoing Elective Percutaneous Coronary Intervention

2020 ◽  
pp. 089719002093346
Author(s):  
Kayla Giang ◽  
Holly E. Stallings ◽  
Paul Clopton ◽  
Maria K. Stubbs ◽  
William F. Penny
Keyword(s):  
Antiplatelet Therapy ◽  
Academic Research ◽  
Bleeding Event ◽  
Bleeding Risk ◽  
Coronary Intervention ◽  
Type I ◽  
Cardiac Events ◽  
Thrombotic Risk ◽  
Safety And Efficacy ◽  
Therapy Strategy

Background Ticagrelor presents less thrombotic risk compared to clopidogrel in acute coronary syndromes. However, its role in dual antiplatelet therapy (DAPT)-naive patients with stable ischemic heart disease (SIHD) undergoing elective percutaneous intervention (PCI) remains unclear, including uncertainty in the method of conversion to clopidogrel for adequate coverage without increased bleeding risk. Objective Determine the safety and efficacy of ticagrelor loading and transitioning to clopidogrel in patients with SIHD undergoing elective PCI. Methods This is a retrospective cohort review of patients with SIHD who underwent elective PCI. The Switch Rx patients were treated with ticagrelor immediately before PCI, converted to clopidogrel 300 mg the day after, and discharged with clopidogrel 75 mg daily. Standard Rx patients, who received a clopidogrel load and received clopidogrel 75 mg daily after the procedure, were analyzed as a matched comparator cohort. The safety outcomes were any bleeding event at 24 hours and 30 days. The efficacy outcomes included major adverse cardiac events (MACE) at 24 hours and 30 days. Results Five Switch Rx patients (n = 54) experienced bleeding academic research consortium type I bleeding within 24 hours, with no subsequent bleeding observed out to 30 days. When comparing the Switch Rx patients (n = 39) to their matched Standard Rx cohort (n = 39), no MACEs occurred within 30 days and there were no significant differences in safety and efficacy outcomes. Conclusion In DAPT-naive patients undergoing elective PCI for SIHD, a strategy of in-lab ticagrelor transitioning to clopidogrel with a 300-mg load was not associated with increased bleeding or other adverse events.

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

TH Open ◽  
2020 ◽  
Vol 04 (04) ◽  
pp. e437-e445
Author(s):  
Roberta Rossini ◽  
Giulia Masiero ◽  
Claudia Fruttero ◽  
Enrico Passamonti ◽  
Elba Calvaruso ◽  
...  
Keyword(s):  
Antiplatelet Therapy ◽  
Real World ◽  
Bleeding Risk ◽  
Coronary Intervention ◽  
Thrombotic Risk ◽  
Fatal Bleeding ◽  
Coronary Stent Implantation ◽  
Life Threatening ◽  
Bridging Strategy ◽  
High Bleeding Risk

Abstract Objective The aim of the study is to describe the real-world use of the P2Y12 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.

scholarly journals 817 Potent P2Y12 inhibitors in elderly population, insigth from praise registry

2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Edoardo Elia ◽  
Fabrizio D’Ascenzo ◽  
Susanna Breviario ◽  
Francesco Bruno ◽  
Giorgio Marengo ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Academic Research ◽  
Coronary Intervention ◽  
Cardiac Events ◽  
Safety And Efficacy ◽  
P2y12 Inhibitors ◽  
Coronary Syndrome ◽  
Increased Risk ◽  
All Cause Mortality ◽  
Neutral Effect

Abstract Background The safety and efficacy of potent P2Y12 inhibitors (Ticagrelor and Prasugrel) in dual antiplatelet therapy (DAPT) with aspirin in elderly patients with acute coronary syndrome (ACS) remains unclear. Methods All ACS patients aged 75 years and older treated with Percutaneous Coronary Intervention (PCI) from PRAISE dataset were included. The safety and efficacy of Ticagrelor vs Clopidogrel was evaluated with inverse probability of treatment weighting (IPTW). Sensitivity analysis was performed for patients older or equal than 85 years old. All-cause mortality was the primary endpoint, while myocardial infarction (MI), Bleeding Academic Research Consortium (BARC) 3-5 bleedings and Major and Net Adverse Clinical and Cardiac Events (MACE and NACE) were the secondary ones. Results 4287 patients were included, 3197 treated with Clopidogrel and 1090 with Ticagrelor. After 16±3 months, Ticagrelor showed neutral effect on NACE and mortality (HR 0.98; 0.63-1.52, p=0.94 and HR 0.38; 0.14-1.04, p=0,06), reduced risk of MACE and MI (HR 0.82; 0.23-0.91, p=0.03 and HR 0.43; 0.14-0.89, p=0.04) and increased risk of BARC 3-5 bleeding (HR 2.14; 1.19-3.85, p=0.001). In very elderly patients (≥85 years) Ticagrelor decreased risk of MI and increased risk of bleeding (HR 0.69; 0.22-0.95, p=0.04 and HR 2.36; 1.02-5.52, p=0.04, all 95%CI) with neutral effect on NACE and MACE. Conclusions In elderly ACS patients treated with PCI, Ticagrelor was associated with neutral effect on all-cause mortality, lower risk MACE and MI compared with Clopidogrel. Such benefit was counterbalanced by increased risk of major bleedings. These results were consistent among patients aged 85 years and older. 817 Figure 1

scholarly journals Impact of Bleeding and Myocardial Infarction on Mortality in All-Comer Patients Undergoing Percutaneous Coronary Intervention

2020 ◽  
Vol 13 (9) ◽  
Author(s):  
Hironori Hara ◽  
Kuniaki Takahashi ◽  
Norihiro Kogame ◽  
Mariusz Tomaniak ◽  
Laura S.M. Kerkmeijer ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Percutaneous Coronary Intervention ◽  
Antiplatelet Therapy ◽  
Academic Research ◽  
Bleeding Event ◽  
Coronary Intervention ◽  
Bleeding Events ◽  
Unique Identifier ◽  
Percutaneous Coronary ◽  
Net Clinical Benefit

Background: Bleeding and myocardial infarction (MI) after percutaneous coronary intervention are independent risk factors for mortality. This study aimed to investigate the association of all-cause mortality after percutaneous coronary intervention with site-reported bleeding and MI, when considered as individual, repeated, or combined events. Methods: We used the data from the GLOBAL LEADERS trial (GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-Platelet Therapy After Stent Implantation), an all-comers trial of 15 968 patients undergoing percutaneous coronary intervention. Bleeding was defined as Bleeding Academic Research Consortium (BARC) 2, 3, or 5, whereas MI included periprocedural and spontaneous MIs according to the Third Universal Definition. Results: At 2-year follow-up, 1061 and 498 patients (6.64% and 3.12%) experienced bleeding and MI, respectively. Patients with a bleeding event had a 10.8% mortality (hazard ratio [HR], 5.97 [95% CI, 4.76–7.49]; P <0.001), and the mortality of patients with an MI was 10.4% (HR, 5.06 [95% CI, 3.72–6.90]; P <0.001), whereas the overall mortality was 2.99%. Albeit reduced over time, MI and even minor BARC 2 bleeding significantly influenced mortality beyond 1 year after adverse events (HR of MI, 2.32 [95% CI, 1.18–4.55]; P =0.014, and HR of BARC 2 bleeding, 1.79 [95% CI, 1.02–3.15]; P =0.044). The mortality rates in patients with repetitive bleeding, repetitive MI, and both bleeding and MI were 16.1%, 19.2%, and 19.0%, and their HRs for 2-year mortality were 8.58 (95% CI, 5.63–13.09; P <0.001), 5.57 (95% CI, 2.53–12.25; P <0.001), and 6.60 (95% CI, 3.44–12.65; P <0.001), respectively. De-escalation of antiplatelet therapy at the time of BARC 3 bleeding was associated with a lower subsequent bleeding or MI rate, compared with continuation of antiplatelet therapy (HR, 0.32 [95% CI, 0.11–0.92]; P =0.034). Conclusions: The fatal impact of bleeding and MI persisted beyond one year. Additional bleeding or MIs resulted in a poorer prognosis. De-escalation of antiplatelet therapy at the time of BARC 3 bleeding could have a major safety merit. These results emphasize the importance of considering the net clinical benefit including ischemic and bleeding events. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01813435.

scholarly journals Ticagrelor Versus Clopidogrel in The Treatment of Elderly Chinese Chronic Total Occlusion Patients Undergoing PCI

2022 ◽  
Author(s):  
Peng Han ◽  
Ying Liang ◽  
Suining Xu ◽  
Shuai Zhao ◽  
Yan Chen ◽  
...  
Keyword(s):  
Chronic Total Occlusion ◽  
Academic Research ◽  
Bleeding Risk ◽  
Coronary Intervention ◽  
Study Data ◽  
Lower Percentage ◽  
Cardiac Events ◽  
Total Occlusion ◽  
Significant Difference ◽  
Elderly Chinese

Abstract Background: Taking thrombosis and bleeding risks into consideration, little real world study data is available to dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in elderly Chinese chronic total occlusion (CTO) patients. Methods: We assigned 504 CTO patients aged ≥75 years who successfully underwent PCI from December 2009 to May 2020. The patients were randomized to Clopidogrel and Ticagrelor group and received DAPT for up to 12 months. Efficacy endpoints were evaluated by major adverse cardiac events (MACE) consisting of all-cause death, nonfatal myocardial infarction (MI) and clinically driven revascularization. The safety endpoints were recorded as the incidence of Bleeding Academic Research Consortium (BARC) bleeding. Results: Patients in Clopidogrel group were older, they had a higher percentage of BMI, diastolic blood pressure and HDL-C than those in Ticagrelor group. Clopidogrel group had a lower percentage of hyperlipidemia, prior PCI, glucose, TG and LDL-C. No significant difference was found as to the Angiographic and procedural characteristics (P＞0.05 for all). After 12 months' follow-up, the incidence of MACE (12.19% vs. 11.04%, P=0.763) and bleeding (9.38% vs. 13.64%, P=0.205) had no significant difference. After clinical characteristics balanced matching by IPTWs model, we found that Ticagrelor had an unfavorable effect on reducing the incidence of bleeding with the IPTWs model (IPTW-OR, 1.81, 95% CI: 1.18-2.76, P=0.006). Conclusions: This clinical study demonstrated that Clopidogrel should be recommended to elderly CTO patients after PCI, especially those with a high bleeding risk. Trial registration: The study protocol was approved by the Ethics Committee of Air Force Medical University (KY20172019-1).

scholarly journals Dual Antiplatelet Therapy Can Be Discontinued at Three Months after Implantation of Zotarolimus-Eluting Stent in Patients with Coronary Artery Disease

2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Tadashi Wada ◽  
Makoto Nakahama ◽  
Hironobu Toda ◽  
Atsuyuki Watanabe ◽  
Katsushi Hashimoto ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Coronary Artery Disease ◽  
Coronary Artery ◽  
Antiplatelet Therapy ◽  
Dual Antiplatelet Therapy ◽  
Bleeding Risk ◽  
Coronary Intervention ◽  
Cardiac Events ◽  
Bleeding Events ◽  
Artery Disease

Dual antiplatelet therapy (DAPT) after percutaneous coronary intervention increases the risk of bleeding. We studied the safety and clinical outcomes of switching from DAPT to aspirin monotherapy at 3 months after ZES implantation. We retrospectively evaluated 168 consecutive patients with coronary artery disease who had been implanted with a ZES from June 2009 through March 2010. After excluding 40 patients according to exclusion criteria such as myocardial infarction, 128 patients were divided into a 3-month DAPT group (67 patients, 88 lesions) and a 12-month conventional DAPT group (61 patients, 81 lesions). Coronary angiographic followup and clinical followup were conducted at more than 8 months and at 12 months after ZES implantation, respectively. Minor and major bleeding events, stent thrombosis (ST), and major adverse cardiac events (MACE) (death, myocardial infarction, cerebrovascular accident, target lesion revascularization, and target vessel revascularization) were evaluated. There were no statistically significant differences in the incidences of ST and MACE between the two groups. The incidence of bleeding events was significantly lower in the 3-month group than in the 12-month group (1.5% versus 11.5%, ). DAPT can be safely discontinued at 3 months after ZES implantation, which reduces bleeding risk.

scholarly journals Sex-based outcomes in contemporary antiplatelet therapy trials

Open Heart ◽  
2021 ◽  
Vol 8 (2) ◽  
pp. e001761
Author(s):  
Mirvat Alasnag ◽  
Tara L Jones ◽  
Yasmin Hanfi ◽  
Nicola Ryan
Keyword(s):  
High Risk ◽  
Antiplatelet Therapy ◽  
Bleeding Risk ◽  
Coronary Intervention ◽  
Representation Of Women ◽  
Percutaneous Coronary ◽  
Risk Patients ◽  
High Risk Populations ◽  
High Bleeding Risk ◽  
Randomised Controlled

Balancing ischaemic and bleeding risks in high-risk populations undergoing percutaneous coronary interventions has become an everyday dilemma for clinicians. It is particularly difficult to make decisions concerning combinations and duration of antiplatelet regimens in women given the poor representation of women in trials that have shaped current practice. Several contemporary landmark trials have recently been presented at the American College of Cardiology. The trials included the Harmonising Optimal Strategy for Treatment of coronary artery diseases-EXtended Antiplatelet Monotherapy, Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention and the TicAgrelor versus CLOpidogrel in Stabilised Patients With Acute Myocardial Infarction. In this article, we summarise the main findings of these trials and include the The Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk (LEADERS FREE) in search for evidence based best practices for women patients. Although some of these trials had prespecified a subanalysis of sex differences, women constituted only 17%–30% of participants making sex-specific analyses challenging. Data suggest that women benefit from de-escalation to both ticagrelor and clopidogrel monotherapy. However, given the increased bleeding risks observed in women further randomised controlled trials are necessary to determine the most appropriate combination and duration of dual antiplatelet therapy as well as maintenance single antiplatelet therapy.

Abstract 15502: Clinical Outcomes in Patients Undergoing Non-cardiac Surgery Within 1 Year of Pci

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Davide Cao ◽  
Matthew A Levin ◽  
Samantha Sartori ◽  
Anastasios Roumeliotis ◽  
Rishi Chandiramani ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Antiplatelet Therapy ◽  
Care Center ◽  
Tertiary Care ◽  
Coronary Intervention ◽  
Secondary Outcome ◽  
Cardiac Events ◽  
Bleeding Events ◽  
Target Vessel Revascularization ◽  
Increased Risk

Introduction: Perioperative cardiovascular events are an important cause of morbidity and mortality associated with non-cardiac surgery (NCS), especially in patients with recent percutaneous coronary intervention (PCI) who require dual antiplatelet therapy. Objective: To illustrate the types and timing of different noncardiac surgeries occurring within 1 year of PCI, and to evaluate the risk of thrombotic and bleeding events according to perioperative antiplatelet management. Methods: All patients undergoing NCS within 1 year of PCI at a tertiary-care center between 2011 and 2018 were included. The primary outcome was major adverse cardiac events (MACE; composite of death, myocardial infarction, stent thrombosis or target vessel revascularization). The key secondary outcome was major bleeding, defined as ≥2 units of blood transfusion. All outcomes were evaluated at 30 days after NCS. Results: A total of 1092 NCS (corresponding to 747 patients) were included and classified by surgical risk (low: 50.9%, intermediate: 38.4%, high: 10.7%) and priority (elective: 88.5%, urgent/emergent: 11.5%). High-risk and urgent/emergent surgeries tended to occur earlier post-PCI compared to low-risk and elective ones ( Figure-A ). The incidence of MACE and bleeding was time-dependent, with an increased risk in surgeries occurring in the first 6 months post-PCI ( Figure-B ). Perioperative antiplatelet cessation occurred in 487 (44.6%) NCS and was more likely for intermediate-risk procedures and after 6 months of PCI. There was no significant association between antiplatelet cessation and cardiac events. Conclusions: Among patients undergoing NCS within 1 year of PCI, the perioperative risk of MACE is inversely related to time from PCI. Preoperative interruption of antiplatelet therapy was observed in less than half of all cases and was not associated with an increased risk of cardiac events.

Abstract 16570: Systemic Inflammation Alters the Bleeding-Ischemic Balance in High-Bleeding Risk Patients Undergoing Percutaneous Coronary Interventions

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Johny Nicolas ◽  
Davide Cao ◽  
Bimmer E Claessen ◽  
Mauro Chiarito ◽  
Samantha Sartori ◽  
...  
Keyword(s):  
Care Center ◽  
Tertiary Care ◽  
Academic Research ◽  
Bleeding Risk ◽  
Lesion Length ◽  
Syntax Score ◽  
Cardiac Events ◽  
Bleeding Events ◽  
Percutaneous Coronary ◽  
High Bleeding Risk

Introduction: Prognosis in high-bleeding risk (HBR) patients after percutaneous coronary intervention (PCI) is largely dependent on risk of ischemic/bleeding events. Inflammation is known to increase the ischemic risk following PCI in the general population, yet its impact on HBR patients remains unknown. Hypothesis: We assessed the hypothesis that inflammation, as reflected by elevated high-sensitivity C - reactive protein (hsCRP), increases the risk of ischemic and bleeding events in HBR patients undergoing PCI. Methods: We included patients who underwent PCI at a tertiary care center between 2014 and 2017. Patients were classified as HBR if they met ≥1 major or ≥2 minor criteria according to the Academic Research Consortium (ARC)-HBR consensus. Patients were then stratified into high (≥3 mg/l) and low (<3 mg/ml) baseline hsCRP level; those presenting with myocardial infarction (MI) or hsCRP >10 mg/l were excluded. The main outcomes of interest were major adverse cardiac events (MACE) (composite of all-cause death, MI, and target vessel revascularization) and bleeding events. Results: Out of 7,186 patients included, 3,403 (42.3%) fulfilled the ARC-HBR definition of whom 1,046 (34.4%) had high hsCRP. These patients were frequently female, younger, and had more cardiovascular risk factors (diabetes, kidney disease, and peripheral artery disease) yet similar angiographic features (multivessel disease, syntax score, and lesion length) than those with low hsCRP. Although risk of MACE at 1 year was similar in HBR patients with either high or low hsCRP, mortality risk was significantly higher in the former group ( Figure 1 ). In addition, HBR patients with high hsCRP were more likely to have periprocedural bleeding (OR 1.72, 95% CI [1.14-2.58], p=0.01) but similar risk of 1-year major bleeding as HBR patients with low hsCRP ( Figure 1 ). Conclusion: In conclusion, inflammation is associated with periprocedural bleeding and 1-year mortality in HBR patients undergoing PCI.

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