platelet aggregation response to 150-mg maintenance dose of clopidogrel compared to the conventional...

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Conclusion: In view of infrequent major ischemic complications with contemporary PCI, emerging data appear to support selective GPI administration (to patients at high ischemic risk and low bleeding propensity) and more abbreviated GPI administration. These strategies, along with other strategies to reduce bleeding, should be subject to high- quality RCTs. doi:10.1016/j.carrev.2011.04.306 Discrepancy between long-term clinical events and the level of platelet aggregation post-PCI: is it the drug or the test? Ayman Magd a , Mohamad Sobhy b , Nereen Okasha a , Mounir Osman a , Hany Ragy a , Yasser Abdelgelil a a Azhar University, Cairo, Egypt b Alexandria University, Cairo, Egypt Background: Late DES thrombosis has emerged as an important issue. At present, light transmission aggregometry (LTA) remains the gold standard for determining adequate platelet inhibition for DES patients on clopidogrel. However, multiple studies have shown considerable interpatient variability response with poor correlation to subsequent clinical events. Moreover, little data exist regarding the long-term inhibition of patients initially inhibited and compliant with clopidogrel. The aim of this study is to determine the long-term effect of clopidogrel on platelets by serial LTA in patients showing an initial adequate response. Methods: Ninety-two patients with an initial adequate response to clopidogrel by LTA were included in this study. Serial LTA studies were performed at 2 weeks, 3 months and 6 months postprocedure. The primary endpoint was clinical events at 6 months. Results: The mean age was 61 years, 39 were diabetic and 12 had renal dysfunction. All patients had an initial loading dose of 600 mg clopidogrel preprocedure. Fifty-two patients were on 75 mg and 42 were on 150 mg clopidogrel at 2 weeks and continued on their dose at the end of the study. All were also on 75 mg ASA. All patients were compliant with study medication for the duration of the study. At 2 weeks, all were adequately inhibited on clopidogrel;, however, at 3 months, only 46/92 (50%) were adequately inhibited (Pb .01). The platelet aggregation response range was 5%82% (mean=56%). At 6 months, only 51/92 (55%) remained adequately inhibited (range=15%79%, mean=51%, Pb .01). There were no adverse clinical events detected at 6 months. Conclusion: In this small initial study, nearly 50% of patients with an initial adequate platelet inhibition by LTA on clopidogrel/ASA therapy were not adequately inhibited at 3 and 6 months. Thus, perhaps intermittent reloading may be required .The absence of any adverse clinical events implies either that clopidogrel works by other unmeasurable mechanisms or a deficiency in the technique of LTA. doi:10.1016/j.carrev.2011.04.307 Platelet aggregation response to 150-mg maintenance dose of clopidogrel compared to the conventional dose of 75 mg for patients scheduled for elective PCI. Six-month follow-up study Ahmed Mowafy Cairo University, Cairo, Egypt Aim: Our prospective in this study to test whether increase in the clopidogrel maintenance dose results in increased platelet inhibition that may be reflected in decreasing major adverse cardiac effects after PCI. Introduction: Dual-antiplatelet therapy consisting of aspirin and clopido- grel is currently the therapy of choice to prevent thrombosis after percutaneous coronary intervention (PCI). A considerable interindividual variability in response to clopidogrel has been observed after administration of loading doses of clopidogrel. In a significant proportion of patients (10%30%), no or little inhibition of platelet aggregation is achieved with the currently used dosing regimens. Some authors suggest that the antiplatelet effect achieved with the currently recommended maintenance dose can be augmented. In fact, administration of a 150-mg daily maintenance dose is now broadly discussed and occasionally used in clinical practice. Methods and results: Sixty-two patients after pretreatment with 600-mg loading dose of Plavix and after successful elective PCI were included in the trial. They were allocated to receive one of two clopidogrel daily maintenance doses (75 or 150 mg) for 30 days in a nonrandomized manner. Platelet function was evaluated 30 days after the intervention with the impact R device that measures the surface coverage (SC%) and average particle size (AS Um 2 ) as reflection of platelet adhesion and aggregation. SC% after 30 days was 2.4±0.52 and AS was 23.9±3.5 in pts treated with 150 mg/day, whereas it was 3.6±0.88 and AS was 33.8+4.2 in pts treated with 75 mg/day, with P values of SC=.02 and AS=.7. Conclusion: The main message of our study was to demonstrate that doubling of the conventional maintenance dose of clopidogrel may be an option to improve platelet inhibition that might lead to decreased thrombotic complication after PCI. This study shows that administration of 150-mg daily maintenance dose of clopidogrel results in more intense inhibition of platelet function when compared with administration of the currently recommended daily maintenance dose of 75 mg. The intensified clopidogrel effect of the high oral maintenance dose used in this trial has the potential to further reduce the incidence of ischemic events after PCI. Recently, it was shown that the 150-mg daily maintenance dose is also more effective than the 75-mg daily maintenance dose in diabetic patients with a suboptimal response to clopidogrel. doi:10.1016/j.carrev.2011.04.308 Safety of bivalirudin in primary percutaneous coronary intervention following thrombolytic therapy Gabriel L. Sardi, Michael A. Gaglia Jr., Manuel A. Gonzalez, Gabriel Maluenda, Ana Laynez-Carnicero, Rafael Romaguera, Michael Mahmoudi, Kohei Wakabayashi, Itsik Ben-Dor, Rebecca Torguson, William O. Suddath, Augusto D. Pichard, Lowell F. Satler, Ron Waksman Washington Hospital Center, Washington, DC, USA Background: Thrombolytic therapy is still used for patients presenting with ST-elevation myocardial infarction. The safety and efficacy of bivalirudin (BIV) for primary percutaneous coronary intervention (PCI) in these patients have not been established. This study aimed to compare the safety of BIV vs. unfractionated heparin (UFH) in patients undergoing primary PCI following initial management with thrombolytic therapy. Methods: A series of 104 consecutive patients treated with primary PCI, who received full-dose thrombolytic therapy within 6 h prior to the intervention, was identified and retrospectively analyzed. The use of intraprocedural UFH and BIV was compared for in-hospital bleeding and ischemic events. Results: This series includes 47 patients (45%) treated with BIV and 57 patients (55%) treated with UFH. The baseline characteristics were Table 1 Comparison of bivalirudin and UFH: basic demographics, adjunctive therapy and in-hospital outcomes Bivalirudin Heparin P value Age (years) 56.6 ±14.7 55.4 ±10.8 .636 Male (%) 83.0 86.0 .647 Low-molecular-weight heparin (%) 42.6 21.4 .021 Intraprocedural IIb/IIIa Inhibitor (%) 0.0 31.6 b.001 Preload with clopidogrel (%) 56.5 28.1 .003 TIMI major bleed (%) 4.3 3.5 1.0 TIMI minor bleed (%) 2.1 7.0 .375 CVA/TIA (%) 0.0 3.5 .5 Death (%) 2.1 5.3 .625 e24 Abstracts / Cardiovascular Revascularization Medicine 12 (2011) e1e46

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Page 1: Platelet aggregation response to 150-mg maintenance dose of clopidogrel compared to the conventional dose of 75 mg for patients scheduled for elective PCI. Six-month follow-up study

Table 1Comparison of bivalirudin and UFH: basic demographics, adjunctivetherapy and in-hospital outcomes

Bivalirudin Heparin P value

Age (years) 56.6 ±14.7 55.4 ±10.8 .636Male (%) 83.0 86.0 .647Low-molecular-weight heparin (%) 42.6 21.4 .021Intraprocedural IIb/IIIa Inhibitor (%) 0.0 31.6 b.001Preload with clopidogrel (%) 56.5 28.1 .003TIMI major bleed (%) 4.3 3.5 1.0TIMI minor bleed (%) 2.1 7.0 .375CVA/TIA (%) 0.0 3.5 .5Death (%) 2.1 5.3 .625

e24 Abstracts / Cardiovascular Revascularization Medicine 12 (2011) e1–e46

Conclusion: In view of infrequent major ischemic complications withcontemporary PCI, emerging data appear to support selective GPIadministration (to patients at high ischemic risk and low bleedingpropensity) and more abbreviated GPI administration. These strategies,along with other strategies to reduce bleeding, should be subject to high-quality RCTs.

doi:10.1016/j.carrev.2011.04.306

Discrepancy between long-term clinical events and the level of plateletaggregation post-PCI: is it the drug or the test?Ayman Magda, Mohamad Sobhyb, Nereen Okashaa, Mounir Osmana,Hany Ragy a, Yasser Abdelgelil aaAzhar University, Cairo, EgyptbAlexandria University, Cairo, Egypt

Background: Late DES thrombosis has emerged as an important issue. Atpresent, light transmission aggregometry (LTA) remains the gold standardfor determining adequate platelet inhibition for DES patients on clopidogrel.However, multiple studies have shown considerable interpatient variabilityresponse with poor correlation to subsequent clinical events. Moreover, littledata exist regarding the long-term inhibition of patients initially inhibitedand compliant with clopidogrel. The aim of this study is to determine thelong-term effect of clopidogrel on platelets by serial LTA in patients showingan initial adequate response.Methods: Ninety-two patients with an initial adequate response toclopidogrel by LTA were included in this study. Serial LTA studies wereperformed at 2 weeks, 3 months and 6 months postprocedure. The primaryendpoint was clinical events at 6 months.Results: The mean age was 61 years, 39 were diabetic and 12 had renaldysfunction. All patients had an initial loading dose of 600 mg clopidogrelpreprocedure. Fifty-two patients were on 75 mg and 42 were on 150 mgclopidogrel at 2 weeks and continued on their dose at the end of the study. Allwere also on 75 mg ASA. All patients were compliant with study medicationfor the duration of the study. At 2 weeks, all were adequately inhibited onclopidogrel;, however, at 3 months, only 46/92 (50%) were adequatelyinhibited (Pb.01). The platelet aggregation response range was 5%–82%(mean=56%). At 6 months, only 51/92 (55%) remained adequately inhibited(range=15%–79%, mean=51%, Pb.01). There were no adverse clinical eventsdetected at 6 months.Conclusion: In this small initial study, nearly 50% of patients with an initialadequate platelet inhibition by LTA on clopidogrel/ASA therapy were notadequately inhibited at 3 and 6 months. Thus, perhaps intermittent reloadingmay be required .The absence of any adverse clinical events implies eitherthat clopidogrel works by other unmeasurable mechanisms or a deficiency inthe technique of LTA.

doi:10.1016/j.carrev.2011.04.307

Platelet aggregation response to 150-mg maintenance dose ofclopidogrel compared to the conventional dose of 75 mg for patientsscheduled for elective PCI. Six-month follow-up studyAhmed MowafyCairo University, Cairo, Egypt

Aim: Our prospective in this study to test whether increase in theclopidogrel maintenance dose results in increased platelet inhibition thatmay be reflected in decreasing major adverse cardiac effects after PCI.Introduction: Dual-antiplatelet therapy consisting of aspirin and clopido-grel is currently the therapy of choice to prevent thrombosis afterpercutaneous coronary intervention (PCI). A considerable interindividualvariability in response to clopidogrel has been observed after administrationof loading doses of clopidogrel. In a significant proportion of patients (10%–30%), no or little inhibition of platelet aggregation is achieved with the

currently used dosing regimens. Some authors suggest that the antiplateleteffect achieved with the currently recommended maintenance dose can beaugmented. In fact, administration of a 150-mg daily maintenance dose isnow broadly discussed and occasionally used in clinical practice.Methods and results: Sixty-two patients after pretreatment with 600-mgloading dose of Plavix and after successful elective PCI were included in thetrial. They were allocated to receive one of two clopidogrel dailymaintenance doses (75 or 150 mg) for 30 days in a nonrandomized manner.Platelet function was evaluated 30 days after the intervention with the impactR device that measures the surface coverage (SC%) and average particle size(AS Um2) as reflection of platelet adhesion and aggregation. SC% after30 days was 2.4±0.52 and AS was 23.9±3.5 in pts treated with 150 mg/day,whereas it was 3.6±0.88 and AS was 33.8+4.2 in pts treated with 75 mg/day,with P values of SC=.02 and AS=.7.Conclusion: The main message of our study was to demonstrate thatdoubling of the conventional maintenance dose of clopidogrel may be anoption to improve platelet inhibition that might lead to decreased thromboticcomplication after PCI. This study shows that administration of 150-mgdaily maintenance dose of clopidogrel results in more intense inhibition ofplatelet function when compared with administration of the currentlyrecommended daily maintenance dose of 75 mg. The intensified clopidogreleffect of the high oral maintenance dose used in this trial has the potential tofurther reduce the incidence of ischemic events after PCI. Recently, it wasshown that the 150-mg daily maintenance dose is also more effective thanthe 75-mg daily maintenance dose in diabetic patients with a suboptimalresponse to clopidogrel.

doi:10.1016/j.carrev.2011.04.308

Safety of bivalirudin in primary percutaneous coronary interventionfollowing thrombolytic therapyGabriel L. Sardi, Michael A. Gaglia Jr., Manuel A. Gonzalez,Gabriel Maluenda, Ana Laynez-Carnicero, Rafael Romaguera,Michael Mahmoudi, Kohei Wakabayashi, Itsik Ben-Dor, Rebecca Torguson,William O. Suddath, Augusto D. Pichard, Lowell F. Satler, Ron WaksmanWashington Hospital Center, Washington, DC, USA

Background: Thrombolytic therapy is still used for patients presenting withST-elevation myocardial infarction. The safety and efficacy of bivalirudin(BIV) for primary percutaneous coronary intervention (PCI) in these patientshave not been established. This study aimed to compare the safety of BIV vs.unfractionated heparin (UFH) in patients undergoing primary PCI followinginitial management with thrombolytic therapy.Methods: A series of 104 consecutive patients treated with primary PCI, whoreceived full-dose thrombolytic therapy within 6 h prior to the intervention,was identified and retrospectively analyzed. The use of intraprocedural UFHand BIV was compared for in-hospital bleeding and ischemic events.Results: This series includes 47 patients (45%) treated with BIV and57 patients (55%) treated with UFH. The baseline characteristics were