Probal Roy

Washington Hospital Center, Washington, D. C., DC, USA

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Publications (44)132.85 Total impact

  • Article: Decline in platelet count in patients treated by percutaneous coronary intervention: definition, incidence, prognostic importance, and predictive factors.
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    ABSTRACT: We investigated the incidence, predictors, and prognostic impact of a decline in platelet count (DPC) in patients treated by percutaneous coronary intervention (PCI). A total of 10 146 consecutive patients treated by PCI from 2003 to 2006 were included. According to the magnitude of the DPC, the population was divided into four groups: no DPC (<10%), minor DPC (10-24%), moderate DPC (25-49%), and severe DPC (>or=50%). The primary haemorrhagic endpoint was a composite of post-procedure surgical repair major bleeding. The primary ischaemic endpoint was 30-day all-cause mortality-non-fatal myocardial infarction. Among the total population, 36% had a DPC <10%, 47.7% had a DPC of 10-24%, 14% had a DPC of 25-49%, and 2.3% had a DPC >or=50%. On multivariate analysis, moderate and severe DPC were independent predictive factors of the ischaemic outcome. Two procedural practices were identified that, if modified, might reduce the incidence of acquired thrombocytopaenia. Both the intraprocedural use of heparin (as opposed to bivalirudin) and of low molecular weight contrast material were independently associated with severe acquired thrombocytopaenia. Moderate and severe DPC are independent predictors of adverse bleeding and ischaemic outcomes in PCI. Adoption of intraprocedural anticoagulant other than heparin and avoidance of a low molecular weight contrast agent could potentially decrease the occurrence of severe acquired thrombocytopaenia.
    European Heart Journal 05/2010; 31(9):1079-87. · 10.48 Impact Factor
  • Article: Relation of drug-eluting stent strut distribution to stent thrombosis in coronary arteries.
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    ABSTRACT: The distribution of stent struts is critical to drug deposition and, therefore, may affect the amount of neointima and the risk of thrombosis after drug-eluting stent (DES) implantation. The aim of our study was to evaluate stent strut distribution in the setting of a drug-eluting stent thrombosis (ST). We retrospectively analyzed postprocedural intravascular ultrasound (IVUS) images of 13 patients who subsequently developed ST (14 DES thrombotic lesions) and a control group of 27 patients (30 DES lesions) matched for stent type and presence of chronic renal failure. In addition to standard IVUS measurements, visible struts were counted and maximum interstrut angle was measured at 1-mm intervals. Early ST was defined as < or =30 days after DES deployment and late ST as >30 days after DES deployment. Compared with DES controls, the ST group had a larger maximum interstrut angle (60.8 +/- 8.3 degrees vs 55.7 +/- 4.8 degrees , p = 0.014) and a similar number of stent struts (8.4 +/- 0.6 vs 8.7 +/- 0.6, p = NS). Maximum interstrut angle tended to be larger in late ST than in early ST (66.1 +/- 10.8 degrees vs 57.8 +/- 5.0 degrees , p = 0.071). The incidence of maximum interstrut angles > or =90 degrees and > or =120 degrees observed continuously for > or =2 mm of stent length was higher in the ST group (p = 0.009 and p = 0.096, respectively). In conclusion, DES-treated lesions leading to ST had larger maximum interstrut gaps distributed circumferentially and longitudinally, but a similar number of struts at the time of DES implantation compared with DES controls.
    The American journal of cardiology 09/2009; 104(3):343-8. · 3.58 Impact Factor
  • Article: Prognostic value of procedure-related myocardial infarction according to the universal definition of myocardial infarction in saphenous vein graft interventions.
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    ABSTRACT: In the recently published universal definition of myocardial infarction (MI), a troponin elevation above 3x above the 99th percentile of normal after percutaneous coronary intervention (PCI) is a procedure-related (type 4a) MI. Although troponin rise is common after saphenous vein graft (SVG) PCI, its prognostic value remains undetermined. We aimed to investigate the prognostic value of the universal definition of PCI-related MI in SVG interventions. A cohort of 589 unselected consecutives patients with normal preprocedural troponin Ic undergoing isolated SVG PCI with drug-eluting stent implantation was included. Patients were divided into 2 groups according to the peak troponin value post PCI: those with MI defined as a peak troponin value above 3x the 99th percentile of normal post-PCI (MI group, n = 166) and those without (no MI group, n = 423). The primary end point was the rate of major adverse cardiac events including death, MI, and target vessel revascularization at 1-year follow-up. Baseline characteristics were similar between the 2 groups. In the MI group, patients had more complex angiographic features (type C lesions: 44.7 vs 34.8%; P = .006). The rate of direct stenting and distal protection use were similar in the 2 groups (MI vs no MI: 29.2 vs 28.7%; P = .9 and 32 vs 37.5%; P = .24, respectively). Patients in the MI group had a worse inhospital course but a similar 1-year rate of major adverse cardiac events (22.3 vs 19.1%; P = .39). Procedure-related MI after PCI, as defined by the universal definition, is associated with an adverse inhospital course but may not predict long-term outcome in SVG PCI.
    American heart journal 06/2009; 157(5):894-8. · 4.65 Impact Factor
  • Article: Impact of thrombus aspiration use for the treatment of stent thrombosis on early patient outcomes.
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    ABSTRACT: Recent data suggest a clinical benefit with the systematic use of thrombus aspiration (TA) for the treatment of ST-elevation myocardial infarction (STEMI). Nevertheless, the impact of TA as a treatment strategy for stent thrombosis (ST) is unknown. This study aimed to analyze the impact of TA use for the treatment of ST on patient outcomes. From 2003 to 2008, 91 consecutive patients who presented with a definite ST were included in this analysis. We compared procedural success rates and the incidence of the composite criteria death-recurrent MI-recurrent ST at 30 days in patients who were treated with TA (TA group, n = 36) versus those who were not (No-TA group, n = 55). Baseline characteristics were similar between the two groups except for the body mass index: 26.2 +/- 5.4 vs. 29.3 +/- 6.2 in the TA and No- TA groups, respectively (p = 0.028). ST presented more likely as STEMI in the TA group: 86.1% vs. 67.3% (p = 0.043). Except for TA use, there was no difference in the treatment therapeutics between groups, including for glycoprotein IIb/IIIa inhibitors. The rate of procedural success was higher in the TA group than in the No-TA group: 88.9% vs. 70.9% (p = 0.043). The incidence of the endpoint of death-recurrent MI-recurrent ST was significantly lower in the TA group: 22.2% vs. 47.2% (p = 0.026). By multivariate analysis, TA use was independently associated with a decrease in the composite criteria (HR = 0.45, p = 0.039). This study suggests that TA use for ST treatment permits an improvement in patient outcomes at 30 days with a significant decrease in the incidence of the composite criteria death-recurrent MI-recurrent ST. Further prospective studies are needed, however, to definitively address the benefit of TA use in this particular setting.
    The Journal of invasive cardiology 06/2009; 21(5):210-4. · 1.84 Impact Factor
  • Article: Prognostic value of the Syntax score in patients undergoing coronary artery bypass grafting for three-vessel coronary artery disease.
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    ABSTRACT: The Syntax score prognostic value has recently been highlighted in patients undergoing percutaneous coronary intervention (PCI) for multivessel coronary artery disease (CAD), however its prognostic value in patients undergoing coronary artery bypass grafting (CABG) for multivessel CAD is still unknown. The aim of this study was to evaluate the prognostic value of the Syntax score in patients undergoing CABG for 3-vessel CAD. A cohort of 320 consecutive patients with multivessel (3-vessel) CAD who were subjected for CABG were included in this study and divided into tertiles according to the Syntax score (<24.5, 24.5-34, and >34). During the 1-year follow-up, cardiovascular events including death, myocardial infarction (MI), and stroke were systematically indexed. The primary end point was the composite criteria death/MI/stroke. The Syntax score ranged from 11-74 with a mean of 31.2 +/- 12.6 and a median of 28.5 [22-38]. Baseline clinical characteristics were similar among the tertiles. No statistical difference was found for the composite criteria death/MI/stroke: 9.4% versus 7.5% versus 10.4% in the groups with a Syntax score <24.5, 24.5-34, and >34, respectively (P = 0.754). Unlike for PCI, the Syntax score has a poor prognostic value for severe cardiovascular events in patients undergoing CABG for 3-vessel CAD. Other risk scores should be used to predict the outcome of this population.
    Catheterization and Cardiovascular Interventions 05/2009; 73(5):612-7. · 2.29 Impact Factor
  • Article: Requirement for emergent coronary artery bypass surgery following percutaneous coronary intervention in the stent era.
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    ABSTRACT: Performance of percutaneous coronary intervention (PCI) at centers without cardiothoracic surgery is a contentious issue. Although this practice allows greater access to care, there are safety concerns. The aim was to assess the requirement for emergent coronary artery bypass grafting (CABG) after PCI and characterize patients at highest risk using independent predictors. The study population consisted of 21,957 unselected patients who underwent PCI from August 1994 (Food and Drug Administration stent approval) to January 2008 at a single medical center. Patients requiring emergent CABG (defined as within 24 hours of the index procedure) were identified. Logistic regression analysis was performed to assess for independent correlates of emergent CABG. Emergent CABG was required in 90 patients (cumulative incidence 0.41%). Indications for CABG included triple-vessel disease, dissection, acute closure, perforation, and failure to cross. These patients had significantly higher in-hospital cardiac death rates (7.8% vs 0.7%; p <0.01) and higher rates of Q-wave myocardial infarction, neurologic events, and renal insufficiency. Independent correlates of emergent CABG after PCI were acute ST-segment elevation myocardial infarction presentation, cardiogenic shock, triple-vessel disease, and type C lesion. Risk assessment based on these predictors identified 0.3% of the patient population to have a 9.3% cumulative incidence of emergent CABG. In conclusion, the need for emergent CABG after PCI in the stent era was low and was associated with poor in-hospital outcomes. Risk was nonuniform, with 0.3% of the study population, characterized by acute presentation and complex coronary disease, at heightened risk of emergent surgery.
    The American journal of cardiology 05/2009; 103(7):950-3. · 3.58 Impact Factor
  • Article: Outcome differences with the use of drug-eluting stents for the treatment of in-stent restenosis of bare-metal stents versus drug-eluting stents.
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    ABSTRACT: Drug-eluting stent (DES) implantation is the standard treatment for patients with bare-metal stent (BMS) in-stent restenosis (ISR) and is associated with low rates of target-vessel revascularization. Outcomes in patients with DES ISR treated using repeated DES placement are less certain. A total of 119 patients who presented with BMS ISR and 119 patients with DES ISR matched for baseline characteristics were evaluated. Both groups of patients were treated using DESs and compared with regard to major adverse cardiac events, including death, myocardial infarction, and target-vessel revascularization, at 1 year. Baseline characteristics were similar between groups. Compared with patients with BMS ISR, those with DES ISR had similar 1-year rates of death (5.1% BMS ISR vs 3.5% DES ISR; p = 0.75) and myocardial infarction (2.6% BMS ISR vs 3.5% DES ISR; p = 0.72) when treated using DESs. However, at 1 year, patients with DES ISR experienced significantly higher rates of target-vessel revascularization (10.3% BMS ISR vs 22.2% DES ISR; p = 0.01), with a trend toward increased overall major adverse cardiac events, including death, myocardial infarction, and target-vessel revascularization (16.0% BMS ISR vs 25.2% DES ISR; p = 0.08). Stent thrombosis occurred with similar frequency in both groups (2.5% BMS ISR vs 0.8% DES ISR; p = 0.62). In conclusion, DES ISR continues to be a therapeutic challenge because patients with DES ISR treated using DESs experience higher rates of recurrence compared with patients with BMS ISR treated using DESs. The optimal treatment of patients with DES restenosis remains to be defined.
    The American journal of cardiology 03/2009; 103(4):491-5. · 3.58 Impact Factor
  • Article: Emergence of the concept of platelet reactivity monitoring of response to thienopyridines.
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    ABSTRACT: Clinical trials have demonstrated the beneficial impact of clopidogrel in preventing major adverse cardiovascular events (MACE), particularly in patients undergoing percutaneous coronary intervention (PCI). The concept of biological clopidogrel resistance emerged with the finding of persistent platelet activation despite clopidogrel therapy in some patients. Further, a link between biological clopidogrel resistance and thrombotic recurrence after PCI was observed and a threshold of platelet reactivity (PR) for thrombotic events was suggested. Consistently, in recent trials, enhanced PR inhibition translated into a reduction in the rate of MACE after PCI. This review aims to present the emergence of the concept of PR monitoring in patients undergoing PCI following recent advances in this field.
    Heart (British Cardiac Society) 03/2009; 95(15):1214-9. · 4.22 Impact Factor
  • Article: Temporal relation between Clopidogrel cessation and stent thrombosis after drug-eluting stent implantation.
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    ABSTRACT: The risk of late thrombotic events and the need for prolonged dual antiplatelet therapy detract from the clinical advantage offered by drug-eluting stents (DESs). Short-term studies have shown premature clopidogrel cessation to be a strong predictor of stent thrombosis (ST) after DES implantation. Data pertaining to the utility of clopidogrel therapy and its optimal duration to prevent late ST remain limited. The study population consisted of 2,889 patients who underwent unrestricted intracoronary DES implantation from April 2003 to January 2007 for whom clopidogrel compliance data were available. Definite ST proved by angiography or autopsy within 12 months of the index procedure occurred in 61 patients. Comparisons of clinical and procedural characteristics in addition to outcomes (death and Q-wave myocardial infarction) were made between the ST and no-ST (2,828 patients) groups. Clopidogrel compliance was assessed at all follow-up time points. For patients in the ST group, clopidogrel compliance status for the remaining study period was defined as that at the time of ST. Logistic regression analysis was performed at 30 days, 6 months, and 12 months to identify independent predictors of cumulative ST. Patients with ST were more likely to have previous congestive heart failure and worse left ventricular ejection fraction. ST was associated with significantly higher mortality at 12 months (23.5% vs 3.2%, p <0.001). Clopidogrel compliance was 80.2% in the overall population and 73.8% in patients presenting with ST (82.6% in patients presenting with early ST and 43.8% in those with late ST). By logistic regression analysis, clopidogrel cessation was an independent predictor of cumulative ST at 30 days and 6 months but not at 12 months. In conclusion, high rates of clopidogrel compliance can be achieved in contemporary practice. Clopidogrel cessation by 12 months is no longer predictive of ST, thus suggesting the optimal duration of therapy for the prevention of ST to be 6 to 12 months.
    The American journal of cardiology 03/2009; 103(6):801-5. · 3.58 Impact Factor
  • Article: Intravascular ultrasound-guided percutaneous coronary interventions in contemporary practice.
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    ABSTRACT: Intravascular ultrasound imaging has been pivotal in the understanding of coronary artery disease and the development of percutaneous coronary intervention. The ability to analyse vessel walls and measure atherosclerotic lesions more accurately has enabled the field of invasive cardiology to overcome the limits of angiography. In fact, intravascular ultrasound measurements correlate with functional measurement of coronary blood flow, as a result interest in their use for the diagnosis of lesion severity in ambiguous lesions and for left main trunk analysis has grown. On the interventional side, intravascular ultrasound is used to determine the major predictors of restenosis and stent thrombosis, which are the main pitfalls of percutaneous coronary intervention. In the bare-metal stent era, intravascular ultrasound-guided percutaneous coronary intervention was associated with a reduction in restenosis rates because it enabled identification and treatment of the risk factors for complications. Although drug-eluting stents have provided a great technological advance in percutaneous coronary intervention, further reducing the rate of in-stent restenosis, they have not abolished restenosis completely; intravascular ultrasound has also been used in this setting to identify the mechanisms responsible for drug-eluting stent restenosis. As in the bare-metal stent era, identification of the predictors of restenosis and stent thrombosis and their subsequent treatment may offer the promise of improved outcome in the drug-eluting stent era. This review focuses on the potential benefit of intravascular ultrasound-guided percutaneous coronary intervention with regard to restenosis and stent thrombosis in the bare-metal stent and drug-eluting stent eras.
    Archives of Cardiovascular Diseases 03/2009; 102(2):143-51. · 1.51 Impact Factor
  • Article: Clinical presentation and outcome of patients hospitalized for symptomatic in-stent restenosis treated by percutaneous coronary intervention: comparison between drug-eluting stents and bare-metal stents.
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    ABSTRACT: In-stent restenosis remains the major limitation of percutaneous coronary intervention (PCI), particularly after bare-metal stent (BMS) implantation. Drug-eluting stents (DES) decrease in-stent restenosis, which is thought to have minimal clinical consequences, but may increase the risk of stent thrombosis and its attendant high mortality rate. To assess the clinical consequences of in-stent restenosis, including severity of associated illness and acute and 1-year outcomes and to compare DES and BMS in-stent restenosis. Using our prospective PCI registry, we compared data from 1958 consecutive patients hospitalized with BMS in-stent restenosis between January 2000 and April 2003 and all 190 patients with DES in-stent restenosis admitted between April 2003 and September 2006. Risk-adjusted outcomes were calculated using propensity-score matching. An unstable presentation was noted in 78.1% of 2148 patients. Patients with DES in-stent restenosis presented more often with acute myocardial infarction (4.3% versus 1.6%, p<0.001). At 1 year, mortality for all patients was 5.7% and target-vessel revascularization was 21.5%. After risk adjustment, target-vessel revascularization and target-vessel revascularization-major adverse cardiac events were greater in patients with DES in-stent restenosis (respectively, 27.8% versus 19.7%, p=0.05; 32.5% versus 24.3%, p=0.06). In-stent restenosis is associated with unstable presentation and a higher 1-year adverse events rate than expected in patients undergoing elective PCI. For an identical level of cardiac risk, it seems that DES in-stent restenosis outcomes are slightly worse than BMS in-stent restenosis outcomes.
    Archives of Cardiovascular Diseases 03/2009; 102(3):209-17. · 1.51 Impact Factor
  • Article: Comparison of outcomes of drug-eluting stents versus bare-metal stents in nonostial proximal left anterior descending coronary arteries.
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    ABSTRACT: Drug-eluting stents (DES) have reduced the rate of in-stent restenosis compared with bare-metal stents, but are associated with an increased risk of late stent thrombosis. The proximal left anterior descending artery (LAD) is a large vessel and is considered to be at increased risk of both restenosis and stent thrombosis. The risk-benefit ratio of each type of stent therefore is of great clinical interest in this location. The aim was to compare 1-year outcomes of DESs and bare-metal stents in nonostial proximal LADs. Historic cohorts of patients who underwent percutaneous coronary intervention of nonostial proximal LAD lesions were compared. A total of 137 patients in the bare-metal stent group and 350 patients in the DES group were compared. The primary and secondary end points were target-lesion revascularization (TLR) rate and major adverse cardiac event rate, including death, myocardial infarction and TLR at 1-year follow-up. Patients in both groups had similar baseline characteristics. Intravascular ultrasound guidance was used in most percutaneous coronary intervention (bare-metal stents vs DESs 72.4% vs 74.5%; p = 0.6). Stent diameter was large in both groups (3.2 +/- 0.5 vs 3.2 +/- 0.3 mm; p = 0.6). Patients in the DES group had longer stents implanted (15 +/- 7 vs 17 +/- 7 mm; p <0.01). Major adverse cardiac event and TLR rates were not different (bare-metal stents vs DESs 16.4% vs 14.7%; p = 0.7 and 4.5% vs 5.2%; p = 0.8). In multivariate analysis, the TLR rate was independent of type of stent used. In conclusion, DESs carry no clinical benefit over bare-metal stents for nonostial proximal LAD lesions. Bare-metal stents therefore could be a cost-effective alternative in this location.
    The American journal of cardiology 02/2009; 103(4):496-500. · 3.58 Impact Factor
  • Article: Clinical outcomes after implantation of small diameter (=2.5 mm) sirolimus- versus paclitaxel-eluting stents.
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    ABSTRACT: Small vessel and stent size continue to be strong predictors of restenosis in the drug-eluting stent (DES) era. Data comparing the efficacy and safety of small diameter sirolimus-eluting stents (SES) to paclitaxel-eluting stents (PES) are conflicting and confounded by the use of angiographic follow-up and the melding of various stent diameters. In this retrospective study we compared the clinical outcomes at 1 year of 571 patients after implantation of either a 2.5-mm diameter SES or PES in a real world population. Baseline characteristics including clinical presentation and cardiovascular risk factors were similar between the 2 groups. Mean length of stent implanted per patient was 19.5+/-5.8 mm (SES) vs 17+/-5 mm (PES) (p<0.001). In-hospital, 6-month, and 1-year outcomes were similar. The unadjusted hazard ratio (HR) for major adverse cardiac events according to stent type was 1.1 (95% CI, 0.6-2.2, p=0.68) with an adjusted HR of 0.8 (95% CI, 0.5-1.5, p=0.56). The cumulative rate of stent thrombosis at 1 year was 0.7% for SES vs.1.2% for PES (p=0.64). In conclusion, the rates of repeat revascularization are low with DES use in small vessels (=2.5 mm), with no clinical differences between SES and PES in a real world population.
    International journal of cardiology 02/2009; 144(1):105-7. · 7.08 Impact Factor
  • Article: Impact of bivalirudin use on outcomes in nonagenarians undergoing percutaneous coronary intervention.
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    ABSTRACT: With an aging population, nonagenarians constitute an increasing percentage of patients with coronary artery disease. The aim of this study was to determine the predictors and outcome of nonagenarians undergoing percutaneous coronary intervention (PCI) for symptomatic coronary artery disease. From 2002 to 2007, a cohort of 171 consecutive nonagenarians underwent PCI and stent implantation in our center. Patients given bivalirudin (n = 79) during the procedure were compared to those given heparin (n = 92). In-hospital and 6-month rates of major adverse cardiovascular events (MACE) including death, myocardial infarction (MI), and target lesion revascularization were indexed. In-hospital bleedings were also indexed. The mean age was 92.5 +/- 2.5 years. The population was 52% female. Nearly 30% of patients had diabetes mellitus and >25% had renal failure. The mean left ventricular ejection fraction was 45%+/- 14%. The clinical presentation was an acute MI in 59% of the cases. The in-hospital rates of death and bleedings were 4.1% and 17.5%, respectively. Clinical presentations as MI or cardiogenic shock were associated with high rates of in-hospital death: 19.3% and 30%, respectively. Bivalirudin use was associated with a 41.5% decrease in in-hospital bleedings. The 6-month incidence of MACE was 13.6% and was driven by death. Predictors of 6-month outcomes were clinical presentations as MI or cardiogenic shock, renal failure, and total stent length. Nonagenarians represent a particular population with a high percentage of females and a high incidence of comorbidities. In this study, we highlighted that nonagenarians have logically a worse prognosis than is reported in younger patients, with especially high rates of in-hospital bleedings. Bivalirudin use was associated with an important decrease in in-hospital bleedings; thus, it should be systematically considered in such patients to improve early outcome.
    Journal of Interventional Cardiology 02/2009; 22(1):61-7. · 1.18 Impact Factor
  • Article: Vascular brachytherapy for patients with drug-eluting stent restenosis.
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    ABSTRACT: The rate of drug-eluting stent (DES) in-stent restenosis (ISR) exceeds 10% in complex subsets of patients and lesions. The optimal management of DES ISR remains undetermined. Vascular brachytherapy (VBT) is proven to be effective for the treatment of bare metal stent ISR but its outcome for DES ISR has not been established. Ninety-nine consecutive patients who presented with ISR following DES implantation in 122 lesions were subjected to conventional percutaneous coronary intervention with adjunct VBT using either beta radiation (Beta Rail in 74 patients [82.2%] and the Galileo system in 13 patients [14.4%]) or gamma radiation (Checkmate system in 3 patients [3.3%]). Patients were followed clinically for major adverse cardiac events (MACE) during 1-year follow-up. A high proportion of patients in this cohort presented with complex ISR; 31.1% had recurrences of ISR to the same site, 55% had diffuse or proliferate pattern of restenosis, and 23 lesions (18.9%) were located in a saphenous vein graft. Procedural success and uneventful in-hospital course were documented in all patients post VBT. At 12 months' follow-up, the target lesion revascularization (TLR) rate was 11% and the overall MACE rate was 26%. Patients with multiple episodes of ISR to the same site had a TLR of 16% and MACE rate of 35.5%. VBT for the treatment of DES ISR was found to be effective and safe and should be considered for the treatment of DES ISR, in particular in complex patients with multiple recurrences.
    Journal of Interventional Cardiology 01/2009; 21(6):528-34. · 1.18 Impact Factor
  • Article: Impact of "nuisance" bleeding on clopidogrel compliance in patients undergoing intracoronary drug-eluting stent implantation.
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    ABSTRACT: Premature cessation of clopidogrel is a strong risk factor for drug-eluting stent thrombosis in patients undergoing percutaneous coronary intervention. The impact that superficial or "nuisance" bleeding may have on clopidogrel compliance has not been described. The study population consisted of 2,360 unselected patients undergoing successful drug-eluting stent implantation. Nuisance bleeding, defined as easy bruising, bleeding from small cuts, petechia, and ecchymosis, was assessed during routine clinical follow-up. Internal and alarming bleeding was recorded. Cessation of clopidogrel as a consequence of such bleeding was then assessed. Study population characteristics were 66.1% men, mean age 64.5 +/- 11.8 years, diabetes mellitus in 31.1%, smoking in 18.5%, systemic hypertension in 81.8%, dyslipidemia in 87.9%, history of coronary artery disease in 49.1%, chronic renal insufficiency in 8.7%, and acute myocardial infarction in 10.8%. A total of 837 patients reported bleeding events (incidence 32.4%) of which 85.7% were nuisance, 13.6% were internal, and 0.7% were alarming. Rate of clopidogrel discontinuation as a result of bleeding in the nuisance bleeding group was 11.1%. In conclusion, superficial or nuisance bleeding is common in patients taking dual antiplatelet therapy after percutaneous coronary intervention. Overall, 11.1% of patients with nuisance bleeding discontinued clopidogrel. Greater education and follow-up in this patient subset may lead to improved compliance with clopidogrel therapy.
    The American journal of cardiology 01/2009; 102(12):1614-7. · 3.58 Impact Factor
  • Article: Can direct stenting in selected saphenous vein graft lesions be considered an alternative to percutaneous intervention with a distal protection device?
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    ABSTRACT: Distal embolization during percutaneous coronary intervention (PCI) of saphenous vein graft (SVG) lesions is associated with a high rate of myonecrosis. Although direct stenting (DS) is feasible with less catheter manipulations, its ability to prevent distal embolization in SVG lesions compared with distal protection devices (DPD) is unknown. The study included 188 SVG lesions subjected to PCI, 101 patients with 101 lesions treated with DPD, and 87 patients with 87 lesions by DS without DPD. Major adverse cardiovascular events (MACE) in-hospital and at 30 days were compared. Baseline characteristics were comparable, except for higher frequencies of unstable angina (53% vs. 67%, P = 0.045) and prior myocardial infarction (38% vs. 53%, P = 0.07) in the DS group. There was no difference in lesion type aside from more restenotic lesions in the DS group (7% vs. 16%, P = 0.047). Drug-eluting stent deployment was similar. Stent length in the DPD group (22.8 +/- 7.2 mm) was significantly longer than that in the DS group (17.6 +/- 8.0 mm, P < 0.001). Although maximum creatine kinase (CK)-MB value in the DPD group (2.5 +/- 5.8 ng/ml) was significantly larger than in the DS group (1.3 +/- 1.5 ng/ml, P = 0.039), the frequency of CK-MB rise >2 times the upper limit of normal did not differ (11% vs. 6%, P = 0.2). There were no differences in MACE rates in-hospital and at 30 days. By multivariate analysis, neither DPD nor DS was a significant predictor for maximum CK-MB value. DS should be considered an alternative treatment to PCI with DPD for selected SVG lesions.
    Catheterization and Cardiovascular Interventions 12/2008; 72(6):799-803. · 2.29 Impact Factor
  • Article: Prognosis of patients suffering an acute coronary syndrome while already under chronic clopidogrel therapy.
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    ABSTRACT: To assess the prognosis of patients presenting with an acute coronary syndrome (ACS) despite chronic clopidogrel therapy (CCT). CCT has been shown to be beneficial in decreasing the frequency of major adverse cardiovascular events (MACE) in patients after an ACS or drug-eluting stent (DES) implantation. Some patients, however, still suffer thrombotic events while on CCT. The outcome of this particular subgroup of patients is unknown. A cohort of 1,281 patients undergoing percutaneous coronary intervention (PCI) for an ACS was studied. They were divided according to their treatment prior to the ACS. The CCT group was composed of all patients who had been taking clopidogrel for >or=30 days before the onset of the ACS (n = 175) and the no CCT group of all patients not on clopidogrel before the ACS (n = 1,106). Rates of cardiovascular death and myocardial infarction at 6 months' follow-up were compared. Patients in the CCT group were older (66 +/- 11 vs. 63 +/- 13; P< 0.001), and more often diabetic (46.8 vs. 31.9%; P < 0.01). In-hospital outcomes were similar, including the rate of death and myocardial infarction (no CCT vs. CCT group: 4.2 vs. 2.3%; P = 0.2). At 6 months, patients already taking clopidogrel before the ACS had a higher rate of MACE than patients who were not (18.3 vs. 11.8%; P = 0.02). In multivariate analysis, CCT before the ACS was associated with a hazard ratio of 1.7 for MACE. This study suggests that patients suffering an ACS while under on CCT have a poor long-term prognosis, which could be linked to clopidogrel low-response.
    Catheterization and Cardiovascular Interventions 12/2008; 73(7):866-70. · 2.29 Impact Factor
  • Article: Impact of a 600-mg loading dose of clopidogrel on 30-day outcome in unselected patients undergoing percutaneous coronary intervention.
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    ABSTRACT: On the basis of biologic studies of platelet reactivity, the recent American College of Cardiology and American Heart Association guidelines recommend a 600-mg loading dose (LD) of clopidogrel in patients who undergo percutaneous coronary intervention (PCI). There is, however, a lack of studies addressing the clinical impact of such a clopidogrel LD. The aim of this study was to compare the clinical efficacy and safety of a 600-mg LD of clopidogrel with that of a 300-mg LD in an unselected cohort of patients who underwent PCI. A cohort of 4,105 unselected patients who underwent PCI were included in the study and divided according to the LD used: the high-LD group (600 mg) included 3,146 patients, and the low-LD group (300 mg) included 959. The primary end point was the rate of major adverse cardiovascular events (MACEs) at 1 month. Patients in the low-LD group more often had diabetes mellitus and histories of myocardial infarction (36.8% vs 31.9%, p = 0.01). Left ventricular ejection fractions were similar (0.49 +/- 0.14 vs 0.48 +/- 0.14, p = 0.25). Angiographic and procedural characteristics were identical between the 2 groups. Patients in the high-LD group had fewer MACEs after 1 month (2.9% vs 5.2%, p <0.001). In multivariate analysis, an LD of 600 mg was significantly associated with MACEs at 1-month follow-up, with an odds ratio of 0.62 (95% confidence interval 0.41 to 0.95, p = 0.03). In conclusion, a 600-mg LD was associated with a significant decrease in the rate of post-PCI MACEs at 1 month, without any in-hospital increase in bleeding complications. The results of this study therefore support the current guidelines of a 600-mg LD of clopidogrel in patients who undergo PCI.
    The American journal of cardiology 11/2008; 102(10):1318-22. · 3.58 Impact Factor
  • Article: Comparison of safety, efficacy, and outcome of successful versus unsuccessful percutaneous coronary intervention in "true" chronic total occlusions.
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    ABSTRACT: Despite improving techniques for opening chronic total occlusions (CTOs), the benefit of successful recanalization of the artery remains unclear. The aims of this study were to investigate the safety and efficacy of percutaneous coronary intervention for "true" CTO, defined by Thrombolysis In Myocardial Infarction (TIMI) flow grade 0 and duration > or =3 months, and to compare the outcome of successful versus failed procedures. A cohort of 172 consecutive patients with de novo CTOs of native vessels confirmed by angiographic review in which percutaneous coronary interventions were attempted was studied. End points included angiographic success, in-hospital complications, and long-term major adverse cardiac events. Technical success was obtained in 73.8% of CTO lesions (127 of 172). No deaths or nonfatal Q-wave myocardial infarctions occurred in the hospital. Repeat percutaneous coronary interventions in the hospital were required in 1.6% of patients (2 of 127) in whom the CTOs were initially opened. Perforation during the initial failed attempts occurred in 6.7% of patients (3 of 45). One patient required operative repair. After an average follow-up period of 2 years, patients with successful procedures experienced similar incidences of cardiac death and nonfatal Q-wave myocardial infarctions as did patients with failed procedures (5.3% and 4.9%, respectively, p = 0.3). Patients with successfully opened arteries required target vessel revascularization more frequently, but this did not reach statistical significance (18.8% vs 0%, p = 0.06). In conclusion, attempts to open CTOs with the devices available at the time of this registry were accompanied by a significant risk for perforation. Furthermore, successful recanalization did not translate into a reduction in 2-year mortality or nonfatal Q-wave myocardial infarctions compared with patients with failed procedures.
    The American journal of cardiology 11/2008; 102(9):1175-81. · 3.58 Impact Factor