Genotype-Guided P2Y 12 Inhibitor Therapy After Percutaneous Coronary Intervention: A Bayesian Analysi

2021 ◽  
Author(s):  
Vibhu Parcha ◽  
Brittain F. Heindl ◽  
Peng Li ◽  
Rajat Kalra ◽  
Nita A. Limdi ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Percutaneous Coronary Intervention ◽  
Posterior Probability ◽  
Coronary Intervention ◽  
Cardiovascular Death ◽  
Minor Bleeding ◽  
Informative Priors ◽  
Noninformative Priors ◽  
Percutaneous Coronary ◽  
Guided Therapy

Background: Among patients receiving percutaneous coronary intervention (PCI), the role of a genotype-guided approach for antiplatelet therapy compared with usual care is unclear. We conducted a Bayesian analysis of the entire TAILOR-PCI (Tailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased Clopidogrel Response After Percutaneous Coronary Intervention) randomized clinical trial population to evaluate the effect of the genotype-guided antiplatelet therapy post-PCI compared with the usual care on the risk of major adverse cardiovascular events (MACE). Methods: The primary outcome for our study was the composite of MACE (myocardial infarction, stroke, and cardiovascular death). Secondary outcomes included cardiovascular death, stroke, myocardial infarction, stent thrombosis, and major/minor bleeding. Bayesian modeling was used to estimate the probability of clinical benefit of genotype-guided therapy using (1) noninformative priors (ie, analyzing the TAILOR-PCI trial) and (2) informative priors derived from the ADAPT, POPular Genetics, IAC-PCI, and PHARMCLO trials (ie, analyzing TAILOR-PCI trial in the context of prior evidence). Risk ratio (RR: ratio of cumulative outcome incidence between genotype-guided and conventional therapy group) and 95% credible interval (CrI) were estimated for the study outcomes, and probability estimates for RR <1 were computed. Results: Using noninformative priors, in TAILOR-PCI the RR for MACE was 0.78 (95% CrI, 0.55–1.07) in genotype-guided therapy after PCI, and the probability of RR <1 was 94%. Using noninformative priors, the probability of RR <1 for cardiovascular death (RR, 0.95 [95% CrI, 0.52–1.74]), stroke (RR, 0.68 [95% CrI, 0.44–1.06]), myocardial infarction (RR, 0.84 [95% CrI, 0.37–1.89]), stent thrombosis (RR, 0.75 [95% CrI, 0.37–1.45]), and major or minor bleeding (RR, 1.22 [95% CrI, 0.84–1.77]) were 57%, 96%, 67%, 94%, and 15%, respectively. Using informative priors, the posterior probability of RR <1 for MACE, from genotype-guided therapy, was 99% (RR, 0.69 [95% CrI, 0.57–0.84]). Using informative priors, the posterior probability of RR <1 for cardiovascular death (RR, 0.86 [95% CrI, 0.61–1.19]), stroke (RR, 0.69 [95% CrI, 0.48–0.99]), myocardial infarction (RR:0.56 [95% CrI, 0.40–0.78]), stent thrombosis (RR, 0.59 [95% CrI, 0.38–0.94]), and major or minor bleeding (RR, 0.84 [95% CrI, 0.70–0.99]) were 81%, 99%, 99%, 99%, and 99%, respectively. Conclusions: Bayesian analysis of the TAILOR-PCI trial provides clinically meaningful data on the posterior probability of reducing MACE using genotype-guided P2Y 12 inhibitor therapy after PCI.

scholarly journals Individualising dual antiplatelet therapy after percutaneous coronary intervention: the IDEAL-PCI registry

BMJ Open ◽  
2014 ◽  
Vol 4 (10) ◽  
pp. e005781 ◽  
Author(s):  
Günter Christ ◽  
Jolanta M Siller-Matula ◽  
Marcel Francesconi ◽  
Cornelia Dechant ◽  
Katharina Grohs ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Percutaneous Coronary Intervention ◽  
Antiplatelet Therapy ◽  
Dual Antiplatelet Therapy ◽  
Coronary Intervention ◽  
Cardiovascular Death ◽  
Minor Bleeding ◽  
End Point ◽  
Percutaneous Coronary ◽  
St Elevation

ObjectiveTo evaluate the clinical utility of individualising dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in an all-comers population, including ST-elevation myocardial infarction (STEMI) patients.SettingTertiary care single centre registry.Participants1008 consecutive PCI patients with stent implantation, without exclusion criteria.InterventionPeri-interventional individualisation of DAPT, guided by multiple electrode aggregometry (MEA), to overcome high on-treatment platelet reactivity (HPR) to ADP-induced (≥50 U) and arachidonic acid (AA)-induced aggregation (>35 U).Outcome measuresThe primary efficacy end point was definite stent thrombosis (ST) at 30 days. The primary safety end point was thrombolysis in myocardial infarction (TIMI) major and minor bleeding. Secondary end points were probable ST, myocardial infarction, cardiovascular death and the combined end point: major cardiac adverse event (MACE).Results53% of patients presented with acute coronary syndrome (9% STEMI, 44% non-ST-elevation). HPR to ADP after 600 mg clopidogrel loading occurred in 30% of patients (73±19 U vs 28±11 U; p<0.001) and was treated by prasugrel or ticagrelor (73%), or clopidogrel (27%) reloading (22±12 U; p<0.001). HPR to ADP after prasugrel loading occurred in 2% of patients (82±26 U vs 19±10 U; p<0.001) and was treated with ticagrelor (34±15 U; p=0.02). HPR to AA occurred in 9% of patients with a significant higher proportion in patients with HPR to ADP (22% vs 4%, p<0.001) and was treated with aspirin reloading. Definite ST occurred in 0.09% of patients (n=1); probable ST, myocardial infarction, cardiovascular death and MACE occurred in 0.19% (n=2), 0.09% (n=1) and 1.8% (n=18) of patients. TIMI major and minor bleeding did not differ between patients without HPR and individualised patients (2.6% for both).ConclusionsIndividualisation of DAPT with MEA minimises early thrombotic events in an all-comers PCI population to an unreported degree without increasing bleeding. A randomised multicentre trial utilising MEA seems warranted.Trial registration numberhttp://www.clinicaltrials.gov; NCT01515345.

scholarly journals Discharge Hemoglobin Association with Long-Term Outcomes of ST-Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention

2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Ming Gao ◽  
Xinying Zhang ◽  
Ling Qin ◽  
Yang Zheng ◽  
Zhiguo Zhang ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Percutaneous Coronary Intervention ◽  
Primary Percutaneous Coronary Intervention ◽  
Bleeding Event ◽  
Coronary Intervention ◽  
Minor Bleeding ◽  
Percutaneous Coronary ◽  
All Cause Mortality ◽  
Lower Discharge

Background. Anemia following acute myocardial infarction (AMI) is associated with poor outcomes. While previous studies in patients with AMI have focused on anemia at admission, we hypothesized that hemoglobin (Hb) decline during hospitalization and lower discharge Hb would be associated with greater long-term mortality in patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI). Methods. We analyzed records of 983 STEMI patients who were treated with primary PCI. The primary end point was all-cause mortality at 1 year and 2 years. The relationship between discharge Hb levels, decline in Hb levels, bleeding event classification, and all-cause mortality was determined. Results. Overall, 16.4% of patients had bleeding events, which were classified by the Thrombolysis in Myocardial Infarction (TIMI) score as 7% minimal, 8.6% minor, and 0.9% major. No significant gastrointestinal bleed and cerebral hemorrhage occurred in hospitals among these patients. The incidence rate of the 2-year all-cause mortality increased with severity of the bleeding event score (8.78% for no bleeding vs. 11.59% for minimal bleeding vs. 20.24% for minor bleeding vs. 55.56% for major bleeding, P<0.001). Discharge Hb was significantly associated with 2-year mortality in an unadjusted model (hazard ratio (HR) per 1 g/L decrease in discharge Hb = 1.020, 95% confidence interval (CI): 1.006–1.034, P=0.004) and in a confounder-adjusted model (HR per 1 g/L decrease in discharge Hb = 1.024, 95% CI: 1.011–1.037, P<0.001). The odds ratio (OR) for all-cause mortality at 2 years for participants with Hb below the twentieth percentile was 3.529 (95% CI: 1.976–6.302) and 2.968 (95% CI: 1.614–5.456) after adjustment for age and gender and 2.485 (95% CI: 1.310–4.715) after adjustment for all covariates. Conclusions. In this population of patients hospitalized for STEMI, all-cause mortality increased with lower discharge Hb, and discharge Hb was a significant predictor of mortality risk.

Intravenous Enoxaparin Versus Unfractionated Heparin in Elderly Patients Undergoing Primary Percutaneous Coronary Intervention

Angiology ◽  
2016 ◽  
Vol 68 (1) ◽  
pp. 29-39 ◽  
Author(s):  
Zhenyu Liu ◽  
Johanne Silvain ◽  
Mathieu Kerneis ◽  
Olivier Barthélémy ◽  
Laurent Payot ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Percutaneous Coronary Intervention ◽  
Elderly Patients ◽  
Unfractionated Heparin ◽  
Primary Percutaneous Coronary Intervention ◽  
Coronary Intervention ◽  
The Elderly ◽  
Minor Bleeding ◽  
End Point ◽  
Percutaneous Coronary

Elderly (≥75 years old) patients with ST-segment elevation myocardial infarction (STEMI) have higher ischemic and bleeding risk compared with those <75 years old. We investigated the efficacy and safety of intravenous (IV) enoxaparin versus IV unfractionated heparin (UFH) in elderly patients undergoing primary percutaneous coronary intervention (PCI) for STEMI. A prespecified analysis of the Acute Myocardial Infarction Treated with Primary Angioplasty and Intravenous Enoxaparin or Unfractionated Heparin to Lower Ischemic and Bleeding Events at Short- and Long-term Follow-up (ATOLL) study was performed examining the 30-day outcomes in the elderly patients. Of the 165 elderly patients in the ATOLL study, 85 patients received IV enoxaparin 0.5 mg/kg and 80 patients received IV UFH. Intravenous enoxaparin did not reduce the primary end point, the main secondary efficacy end point, major bleeding, major or minor bleeding, and all-cause mortality compared with IV UFH. The rate of minor bleeding (5.9% vs 22.8%, Padjusted = .01) was significantly lower with IV enoxaparin compared with IV UFH. Intravenous enoxaparin appears to be a safe alternative to IV UFH in primary PCI of the elderly patients with STEMI.

Long versus short dual antiplatelet therapy in acute coronary syndrome patients treated with prasugrel or ticagrelor and coronary revascularization: Insights from the RENAMI registry

2019 ◽  
Vol 27 (7) ◽  
pp. 696-705 ◽  
Author(s):  
Fabrizio D'Ascenzo ◽  
Maurizio Bertaina ◽  
Francesco Fioravanti ◽  
Federica Bongiovanni ◽  
Sergio Raposeiras-Roubin ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Percutaneous Coronary Intervention ◽  
Acute Coronary Syndrome ◽  
Propensity Score ◽  
Dual Antiplatelet Therapy ◽  
Coronary Intervention ◽  
Cardiovascular Death ◽  
Coronary Syndrome ◽  
Increased Risk ◽  
Percutaneous Coronary

Introduction The benefits of short versus long-term dual antiplatelet therapy (DAPT) based on the third generation P2Y12 antagonists prasugrel or ticagrelor, in patients with acute coronary syndromes treated with percutaneous coronary intervention remain to be clearly defined due to current evidences limited to patients treated with clopidogrel. Methods All acute coronary syndrome patients from the REgistry of New Antiplatelets in patients with Myocardial Infarction (RENAMI) undergoing percutaneous coronary intervention and treated with aspirin, prasugrel or ticagrelor were stratified according to DAPT duration, that is, shorter than 12 months (D1 group), 12 months (D2 group) and longer than 12 months (D3 group). The three groups were compared before and after propensity score matching. Net adverse clinical events (NACEs), defined as a combination of major adverse cardiac events (MACEs) and major bleedings (including therefore all cause death, myocardial infarction and Bleeding Academic Research Consortium (BARC) 3–5 bleeding), were the primary end points, MACEs (a composite of all cause death and myocardial infarction) the secondary one. Single components of NACEs were co-secondary end points, along with BARC 2–5 bleeding, cardiovascular death and stent thrombosis. Results A total of 4424 patients from the RENAMI registry with available data on DAPT duration were included in the model. After propensity score matching, 628 patients from each group were selected. After 20 months of follow up, DAPT for 12 months and DAPT for longer than 12 months significantly reduced the risk of NACE (D1 11.6% vs. D2 6.7% vs. D3 7.2%, p = 0.003) and MACE (10% vs. 6.2% vs. 2.4%, p < 0.001) compared with DAPT for less than 12 months. These differences were driven by a reduced risk of all cause death (7.8% vs. 1.3% vs. 1.6%, p < 0.001), cardiovascular death (5.1% vs. 1.0% vs. 1.2%, p < 0.0001) and recurrent myocardial infarction (8.3% vs. 5.2% vs. 3.5%, p = 0.002). NACEs were lower with longer DAPT despite a higher risk of BARC 2–5 bleedings (4.6% vs. 5.7% vs. 6.2%, p = 0.04) and a trend towards a higher risk of BARC 3–5 bleedings (2.4% vs. 3.3% vs. 3.9%, p = 0.06). These results were not consistent for female patients and those older than 75 years old, due to an increased risk of bleedings which exceeded the reduction in myocardial infarction. Conclusion In unselected real world acute coronary syndrome patients treated with percutaneous coronary intervention, DAPT with prasugrel or ticagrelor prolonged beyond 12 months markedly reduces fatal and non-fatal ischaemic events, offsetting the increased risk deriving from the higher bleeding risk. On the contrary, patients >75 years old and female ones showed a less favourable risk–benefit ratio for longer DAPT due to excess of bleedings.

Evaluation of Eptifibatide Treatment in Patients Undergoing Percutaneous Coronary Intervention

2002 ◽  
Vol 18 (6) ◽  
pp. 316-318
Author(s):  
Marwan T Sheikh-Taha ◽  
Warren L Strickland
Keyword(s):  
Myocardial Infarction ◽  
Percutaneous Coronary Intervention ◽  
Coronary Angioplasty ◽  
Coronary Intervention ◽  
Low Risk ◽  
Minor Bleeding ◽  
Duration Of Treatment ◽  
Percutaneous Coronary ◽  
Risk Patients ◽  
Electrocardiographic Leads

Background: Abrupt closure and restenosis remain serious and costly consequences of coronary angioplasty procedures. Eptifibatide (Integrilin) has been shown to decrease the rate of combined endpoint of death, new myocardial infarction, or the need for urgent intervention in this setting. Platelet aggregation is inhibited by eptifibatide in a dose-dependent manner, with more than 80% receptor occupancy required to prevent thrombus formation. Objective: To evaluate the safety and efficacy of a shorter duration of treatment with eptifibatide in low-risk patients undergoing percutaneous coronary intervention. Methods: We compared low-risk patients undergoing percutaneous coronary intervention who received either conventional eptifibatide dosing or a bolus dose that was sufficient to produce more than 80% platelet inhibition. All patients were followed for major adverse cardiovascular events (MACE) for 90 days after the procedure. MACE complications included death, myocardial infarction (defined as elevation of the creatine kinase-MB fraction at least 3 times the upper limit of normal or new Q-waves in 2 electrocardiographic leads), or any treatment for recurrent angina (percutaneous transluminal coronary angioplasty, stent placement, or coronary artery bypass grafting). Safety was assessed by the incidence of bleeding and thrombocytopenia. Results and Conclusions: None of the patients in either study group had a MACE or thrombocytopenia during the follow-up period. Patients who received a conventional eptifibatide dose had a higher incidence of minor bleeding. It appears that, in low-risk patients, a shorter duration of treatment with eptifibatide may prevent the ischemic complications of percutaneous coronary intervention.

scholarly journals Cardiovascular and Noncardiovascular Death After Percutaneous Coronary Intervention

2018 ◽  
Vol 11 (7) ◽  
Author(s):  
Sorin J. Brener ◽  
Giuseppe Tarantini ◽  
Martin B. Leon ◽  
Patrick W. Serruys ◽  
Pieter C. Smits ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Percutaneous Coronary Intervention ◽  
Confidence Interval ◽  
Large Scale ◽  
Randomized Clinical Trials ◽  
Coronary Intervention ◽  
Cardiovascular Death ◽  
Individual Patient Level ◽  
Relative Ratio ◽  
Percutaneous Coronary

Background: Despite advances in technology and technique, a substantial proportion of patients still die within several years after percutaneous coronary intervention (PCI). The relative rates of cardiovascular and noncardiovascular death after PCI remain uncertain. Methods and Results: We pooled individual patient-level data from 21 randomized clinical trials of PCI performed in 32 882 patients. All studies had independent adjudication of clinical events. We calculated the relative ratio of cardiovascular to noncardiovascular death in each trial up to 5 years and identified predictors of all-cause, cardiovascular, and noncardiovascular death. At the end of the follow-up period, 1980 patients had died (Kaplan-Meier estimated mortality rate, 9.19%). The rates of cardiovascular and noncardiovascular mortality at 5 years were 4.23% (945) and 5.17% (1035), respectively. The rate of cardiovascular death was higher than noncardiovascular death in the first 30 days after PCI (relative ratio, 6.99; 95% confidence interval, 3.16–15.42; P <0.001), similar between 30 days and 1 year, and lower between 1 and 5 years (relative ratio, 0.70; 95% confidence interval, 0.58–0.84; P =0.0005). Any adverse cardiac event (definite stent thrombosis, spontaneous myocardial infarction, or repeat revascularization) preceded cardiovascular and noncardiovascular mortality in 292 (30.9%) and 151 (14.6%) patients, respectively. In a multivariable model with adverse events entered as time-adjusted covariates, myocardial infarction and definite ST were associated with early and late all-cause and cardiovascular mortality but not noncardiovascular mortality. Conclusions: In this large-scale study of patients undergoing PCI, the 5-year rates of cardiovascular and noncardiovascular mortality were similar, but their relative timing was different.

scholarly journals Clinical Impact of Intraprocedural Stent Thrombosis During Percutaneous Coronary Intervention in Patients Treated With Potent P2Y12 inhibitors ‐ a VALIDATE‐SWEDEHEART Substudy

2021 ◽  
Author(s):  
Sofia Bergman ◽  
Moman A. Mohammad ◽  
Stefan K. James ◽  
Oskar Angerås ◽  
Henrik Wagner ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Percutaneous Coronary Intervention ◽  
Stent Thrombosis ◽  
Coronary Intervention ◽  
Cardiovascular Death ◽  
St Segment Elevation ◽  
P2y12 Inhibitors ◽  
End Point ◽  
St Segment ◽  
Percutaneous Coronary

Background The clinical importance of intraprocedural stent thrombosis (IPST) during percutaneous coronary intervention in the contemporary era of potent oral P2Y12 inhibitors is not established. The aim of this study was to assess IPST and its association with clinical outcome in patients with myocardial infarction undergoing percutaneous coronary intervention with contemporary antithromboticmedications. Methods and Results The VALIDATE‐SWEDEHEART study (Bivalirudin Versus Heparin in ST‐Segment and Non–ST‐Segment Elevation Myocardial Infarction in Patients on Modern Antiplatelet Therapy in the Swedish Web System for Enhancement and Development of Evidence‐Based Care in Heart Disease Evaluated According to Recommended Therapies Registry Trial) included 6006 patients with myocardial infarction, treated with potent P2Y12 inhibitors during percutaneous coronary intervention. IPST, defined as a new or worsening thrombus related to a stent deployed during the procedure, was reported by the interventional cardiologist in 55 patients (0.9%) and was significantly associated with ST‐segment elevation myocardial infarction presentation, longer stents, bailout glycoprotein IIb/IIIa inhibitors, and final Thrombolysis in Myocardial Infarction flow <3. The primary composite end point included cardiovascular death, myocardial infarction, out‐of‐laboratory definite stent thrombosis and target vessel revascularization within 30 days. Secondary end points were major bleeding and the individual components of the primary composite end point. Patients with versus without IPST had significantly higher rates of the primary composite end point (20.0% versus 4.4%), including higher rates of cardiovascular death, target vessel revascularization, and definite stent thrombosis, but not myocardial infarction or major bleeding. By multivariable analysis, IPST was independently associated with the primary composite end point (hazard ratio, 3.82; 95% CI, 2.05–7.12; P <0.001). Conclusions IPST is a rare but dangerous complication during percutaneous coronary intervention, independently associated with poor prognosis, even in the current era of potent antiplatelet agents. Future treatment studies are needed to reduce the rate of IPST and to improve the poor outcome among these patients. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02311231.

scholarly journals Time to percutaneous coronary intervention in patients with ST-elevation myocardial infarction undergoing successful systemic fibrinolysis: does early or late make a difference?

2021 ◽  
Vol 10 (Supplement_1) ◽  
Author(s):  
C Jackson-Pedroza ◽  
A Gallardo-Grajeda ◽  
C Dattoli-Alejo ◽  
R Gopar-Nieto ◽  
D Alfaro-Ponce ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Heart Failure ◽  
Congestive Heart Failure ◽  
Percutaneous Coronary Intervention ◽  
Composite Endpoint ◽  
Coronary Intervention ◽  
Cardiovascular Death ◽  
Primary Composite Endpoint ◽  
Percutaneous Coronary ◽  
Reduced Risk

Abstract Funding Acknowledgements Type of funding sources: None. OnBehalf PHASE-MX Background/Introduction: Early routine angiography with subsequent Percutaneous Coronary Intervention (PCI) (if needed) after fibrinolysis reduced the rates of reinfarction and recurrent ischemia compared with a ‘watchful waiting’ strategy. A crucial issue is the optimal time delay between successful lysis and PCI, there is a wide variation in delay in trials from a median of 1.3 h to 17h (CAPITAL AMI, GRACIA-1 and STREAM trials). At present a time window of 2-24h after successful lysis is recommended. Purpose   To analyze the incidence of major cardiovascular outcomes in patients with ST-segment elevation myocardial infarction (STEMI) according to the timing of PCI after lysis (pharmacoinvasive strategy, less/more than 24h). Methods A retrospective analysis of the PHASE-MX study (ClinicalTrials.gov Identifier: NCT03974581) including patients with STEMI whom underwent pharmacoinvasive strategy during the first 12h since symptom onset. Patients were further stratified according to the time from the use of fibrinolysis to sheat insertion (&lt;24h or &gt;24h) in the completion of pharmacoinvasive strategy. The primary composite endpoint included the occurrence of cardiovascular death, cardiogenic shock, recurrent myocardial infarction or congestive heart failure at 30 days of follow-up. Results A total of 171 patients were included, of whom 34 underwent PCI after fibrinolysis in less than 24 hours and 137 underwent PCI in more than 24 hours (95% CI 24-120h). Mostly were male (86.4%), mean age was 56.4 ±12.1 years. The primary composite endpoint occurred in 2 patients (5.8%) in PCI &lt; 24 hours and 12 patients (8.6%) in PCI &gt;24 hours (p 0.58). PCI in &lt;24h after lysis was not associated with a reduced risk of the primary endpoint (HR 0.66 95%CI: 0.14-2.97). Conclusion In patients with successful fibrinolysis undergoing to PCI the first 24 h was not associated with a reduced risk of cardiovascular death, cardiogenic shock, recurrent MI or congestive heart failure at 30 days comparing with PCI after 24 h. Abstract Figure. Kaplan-Meier in primary endpoint

Abstract 3342: Adequacy of Inclusion of Post-Procedural Bleeding in a Composite End Point for Assessment of Outcome After Percutaneous Coronary Intervention.

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Stefanie Schulz ◽  
Gjin Ndrepepa ◽  
Julinda Mehilli ◽  
Raisuke Iijima ◽  
Olga Bruskina ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Percutaneous Coronary Intervention ◽  
Adverse Events ◽  
Unfractionated Heparin ◽  
Coronary Intervention ◽  
Minor Bleeding ◽  
End Point ◽  
Prediction Of Mortality ◽  
Percutaneous Coronary ◽  
One Year

Objective: To assess the adequacy of inclusion of post-procedural bleeding in a quadruple composite end point for the prediction of mortality after percutaneous coronary intervention (PCI). Methods: This study included 5384 patients from 4 ISAR randomized trials on the value of abciximab: ISAR-REACT, ISAR-SWEET, ISAR-SMART 2 and ISAR-REACT 2. Common inclusion criteria were the presence of native coronary artery disease requiring PCI and pretreatment with 600 mg of clopidogrel at least 2 hours prior to the intervention. Patients were randomized to receive either the standard dose of abciximab plus unfractionated heparin or placebo plus unfractionated heparin. Bleeding was defined according to the Thrombolysis in Myocardial Infarction (TIMI) criteria. Primary end point was one-year mortality. Results: Within the first 30 days there were 314 myocardial infarctions (5.8%), 52 urgent revascularizations (1.0%) and 215 TIMI major or minor bleeding (4.0%). One-year mortality was 3.6% (n=197). Table shows one-year mortality among patients with or without 30-day adverse events (myocardial infarction, urgent revascularization or bleeding). Cox proportional hazard model that included all of the 3 adverse events along with baseline characteristics of the patients showed that 30-day myocardial infarction, urgent revascularization or bleeding were all independently associated with one-year mortality with adjusted hazard ratios displayed in the table . The prognostic value of bleeding was not dependent on its classification as major or minor. Conclusion: Our study supports the inclusion of post-procedural bleeding in a quadruple end point along with death, myocardial infarction and urgent revascularization to assess outcome after percutaneous coronary intervention. Table.

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