Gregg W Stone

New York State, New York, New York, United States

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Publications (1000)9352.92 Total impact

  • Joseph F. Sabik, Gregg W. Stone
    Journal of the American College of Cardiology 05/2015; DOI:10.1016/j.jacc.2015.04.006 · 15.34 Impact Factor
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    ABSTRACT: Unprotected left main coronary artery (ULMCA) stenosis has relatively high prevalence and exposes patients to a high risk for adverse cardiovascular events. The optimal revascularisation strategy (coronary artery bypass surgery [CABG] or percutaneous coronary intervention [PCI]) for patients with complex coronary artery disease is a topic of continuing debate. The introduction of the newer-generation drug-eluting stents (DES) -with documented improvements in both safety and efficacy- has prompted the interventional community to design two new dedicated randomised trials comparing CABG and PCI: the NOBLE (Coronary Artery Bypass Grafting Vs Drug Eluting Stent Percutaneous Coronary Angioplasty in the Treatment of Unprotected Left Main Stenosis) and EXCEL (Evaluation of XIENCE Everolimus Eluting Stent Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trials. The aims of the present review are to describe the similarities and contrasts between these two trials as well to explore their future implications in ULMCA treatment.
    EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 05/2015; 11(V):V115-V119. DOI:10.4244/EIJV11SVA26 · 3.76 Impact Factor
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    ABSTRACT: A systematic review and a meta-analysis were performed to define better the role of statin use prior to angiography in preventing contrast-induced acute kidney injury (CI-AKI). MEDLINE, Embase, Cochrane Library, references from review articles, and conference proceedings were searched, with no language restriction, for randomised controlled trials (RCT) evaluating the use of statin therapy prior to angiography for the prevention of CI-AKI. Nineteen RCTs including 7,161 patients were identified. The pooled analysis demonstrated a significant reduction in the incidence of CI-AKI in patients treated with statin prior to invasive angiography when compared with control (RR 0.52; 95% CI: 0.40-0.67). Patients with chronic kidney disease stage 3 or worse were largely underrepresented in these trials, and statin therapy did not significantly reduce the risk of CI-AKI in the three studies which enrolled a patient population with a mean eGFR of <60 ml/min (RR 0.54; 95% CI: 0.2-1.42). This meta-analysis suggests a potential benefit for statin use prior to angiography to reduce the incidence of CI-AKI. Additional research is needed to define better the benefits of statin therapy prior to angiography to prevent CI-AKI, especially in high-risk patients with chronic kidney disease who were largely underrepresented in the available trials.
    EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 05/2015; 11(1). DOI:10.4244/EIJY15M05_03 · 3.76 Impact Factor
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    ABSTRACT: This study sought to determine whether pre-percutaneous coronary intervention (PCI) plaque characterization using near-infrared spectroscopy identifies lipid-rich plaques at risk of periprocedural myonecrosis and whether these events may be prevented by the use of a distal protection filter during PCI. Lipid-rich plaques may be prone to distal embolization and periprocedural myocardial infarction (MI) in patients undergoing PCI. Patients undergoing stent implantation of a single native coronary lesion were enrolled in a multicenter, prospective trial. Near-infrared spectroscopy and intravascular ultrasound were performed at baseline, and lesions with a maximal lipid core burden index over any 4-mm length (maxLCBI4mm) ≥600 were randomized to PCI with versus without a distal protection filter. The primary endpoint was periprocedural MI, defined as troponin or a creatine kinase-myocardial band increase to 3 or more times the upper limit of normal. Eighty-five patients were enrolled at 9 U.S. sites. The median (interquartile range) maxLCBI4mm was 448.4 (274.8 to 654.4) pre-PCI and decreased to 156.0 (75.6 to 312.6) post-PCI (p < 0.0001). Periprocedural MI developed in 21 patients (24.7%). The maxLCBI4mm was higher in patients with versus without MI (481.5 [425.6 to 679.6] vs. 371.5 [228.9 to 611.6], p = 0.05). Among 31 randomized lesions with maxLCBI4mm ≥600, there was no difference in the rates of periprocedural MI with versus without the use of a distal protection filter (35.7% vs. 23.5%, respectively; relative risk: 1.52; 95% confidence interval: 0.50 to 4.60, p = 0.69). Plaque characterization by near-infrared spectroscopy identifies lipid-rich lesions with an increased likelihood of periprocedural MI after stent implantation, presumably due to distal embolization. However, in this pilot randomized trial, the use of a distal protection filter did not prevent myonecrosis after PCI of lipid-rich plaques. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
    JACC. Cardiovascular Interventions 05/2015; DOI:10.1016/j.jcin.2015.01.032 · 7.44 Impact Factor
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    ABSTRACT: Whether premature dual antiplatelet therapy (DAPT) interruption is safe in patients receiving cobalt chromium everolimus-eluting stents remains controversial. We sought to examine the relationship between DAPT discontinuation and stent thrombosis (ST) after cobalt chromium everolimus-eluting stents. Outcomes from 11 219 patients were pooled from 3 randomized trials and 4 registries with 2-year follow-up period after cobalt chromium everolimus-eluting stent implantation. Rates of definite/probable ST were analyzed according to DAPT discontinuation in the following time intervals: 0 to 30, 30 to 90, 90 to 180, 180 to 365, and 365 to 730 days. Eighty-five cases of ST (0.75%) occurred in 83 patients during 2 years, with 41 (48.2%) events occurring within 30 days. The 2-year ST rate in patients interrupting DAPT at any time was similar to that in patients never interrupting DAPT through 2 years (25/4067 [0.63%] versus 58/7152 [0.83%] respectively; P=0.27]. By propensity and DAPT usage-adjusted multivariable analysis, permanent DAPT discontinuation before 30 days was independently associated with the occurrence of ST (hazard ratio [95% confidence interval], 26.8 [8.4-85.4]; P<0.0001), whereas permanent DAPT discontinuation in any interval after 90 days was not associated with ST. Only 2 ST events occurred after DAPT discontinuation between 30 and 90 days (both between 30 and 60 days), and the association between permanent DAPT discontinuation and ST during this period is unclear (hazard ratio [95% confidence interval], 8.7 [2.0-37.3]; P=0.004 for adjusted analysis and 3.4 [0.8-13.8]; P=0.07 for the unadjusted analysis). In this large pooled experience, permanent DAPT discontinuation before 30 days after cobalt chromium everolimus-eluting stent implantation was strongly associated with ST, whereas DAPT discontinuation beyond 90 days appeared safe. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00180310, NCT00180479, NCT00307047, NCT00402272, NCT00496938, NCT00676520, and NCT00631228. © 2015 American Heart Association, Inc.
    Circulation Cardiovascular Interventions 05/2015; 8(5). DOI:10.1161/CIRCINTERVENTIONS.114.001362 · 6.98 Impact Factor
  • Gregg W Stone, Jagat Narula
    JACC. Cardiovascular imaging 05/2015; 8(5):623-5. DOI:10.1016/j.jcmg.2015.03.003 · 6.99 Impact Factor
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    ABSTRACT: Incomplete revascularization is common after percutaneous coronary intervention (PCI). Whether a "reasonable" degree of incomplete revascularization is associated with a similar favorable long-term prognosis compared with complete revascularization remains unknown. We sought to quantify the proportion of coronary artery disease burden treated by PCI and evaluate its impact on outcomes using a new prognostic instrument-the Synergy Between PCI with Taxus and Cardiac Surgery (SYNTAX) Revascularization Index (SRI). The baseline SYNTAX score (bSS), the residual SYNTAX score, and the delta SYNTAX score (ΔSS) were determined from 888 angiograms of patients enrolled in the prospective SYNTAX trial. The SRI was then calculated for each patient using the following formula: SRI = (ΔSS/bSS]) × 100. Outcomes were examined according to the proportion of revascularized myocardium (SRI = 100% [complete revascularization], 50% to <100%, and <50%). The Youden index for the SRI was computed to identify the best cutoff for 5-year all-cause mortality. The mean bSS was 28.4 ± 11.5, and after PCI, the mean ΔSS was 23.8 ± 10.9 and the mean residual SYNTAX score was 4.5 ± 6.9. The mean SRI was 85.3 ± 21.2% and was 100% in 385 patients (43.5%), <100% to 50% in 454 patients (51.1%), and <50% in 48 patients (5.4%). Five-year adverse outcomes, including death, were inversely proportional to the SRI. An SRI cutoff of <70% (present in 142 patients [16.0%] after PCI) had the best prognostic accuracy for prediction of death and, by multivariable analysis, was an independent predictor of 5-year mortality (hazard ratio [HR] 4.13, 95% confidence interval [CI] 2.79 to 6.11, p <0.0001). In conclusion, the SRI is a newly described method for quantifying the proportion of coronary artery disease burden treated by PCI. The SRI is a useful tool in assessing the degree of revascularization after PCI, with SRI ≥70% representing a "reasonable" goal for patients with complex coronary artery disease. Copyright © 2015 Elsevier Inc. All rights reserved.
    The American Journal of Cardiology 04/2015; DOI:10.1016/j.amjcard.2015.03.056 · 3.43 Impact Factor
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    ABSTRACT: Plaque ruptures and attenuated plaques are considered to be unstable and have been identified in both culprit and nonculprit lesions of patients with ST-segment elevation myocardial infarction (STEMI). However, there are limited data available on the natural evolution of these plaques and their long-term clinical outcome. We investigated the natural evolution and long-term impact of plaque ruptures and attenuated plaques in untreated segments of infarct-related arteries in patients with STEMI. In the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction trial, 389 patients with 429 lesions underwent intravascular ultrasound (IVUS) at baseline. Follow-up IVUS at 13 months was conducted in 245 patients. Three-year follow-up data were available for all patients. Segments not treated between baseline and follow-up were compared. Baseline IVUS identified 29 plaque ruptures in 27 patients (7%). Of 11 plaque ruptures with follow-up IVUS, four healed and seven persisted. Conversely, through follow-up IVUS, nine new plaque ruptures in nine patients (4%) were identified. Attenuated plaques were identified in 31 of 38 plaque ruptures (81.5%), of which 24 were in the same circumferential segment as the ruptured cavity and seven were within 5 mm proximal or distal to the plaque rupture. Morphologic changes during follow-up, including new plaque ruptures and changes in the attenuated plaque frequency and distribution, were not accompanied by either serious lumen compromise or clinical events. Serial IVUS analysis demonstrated that the morphology of unstable plaques within untreated segments in STEMI patients treated with optimal systemic therapies markedly changed during the 13-month follow-up period, without lumen compromise or clinical events at the 3-year follow-up.
    Coronary artery disease 04/2015; DOI:10.1097/MCA.0000000000000251 · 1.30 Impact Factor
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    ABSTRACT: Although platelet reactivity during P2Y12-inhibitors is associated with stent thrombosis (ST) and bleeding, standardized and clinically validated thresholds for accurate risk stratification after percutaneous coronary intervention (PCI) are lacking. We sought to determine the prognostic value of low platelet reactivity (LPR), optimal platelet reactivity (OPR), or high platelet reactivity (HPR) by applying uniform cut-off values for standardized devices. Authors of studies published before January 2015, reporting associations between platelet reactivity, ST, and major bleeding were contacted for a collaborative analysis using consensus-defined, uniform cut-offs for standardized platelet function assays. Based on best available evidence for each device (exploratory studies), LPR-OPR-HPR categories were defined as <95, 95-208, and >208 PRU for VerifyNow, <19, 19-46, and >46 U for the Multiplate analyser and <16, 16-50, and >50% for VASP assay. Seventeen studies including 20 839 patients were used for the analysis; 97% were treated with clopidogrel and 3% with prasugrel. Patients with HPR had significantly higher risk for ST [risk ratio (RR) and 95% CI: 2.73 (2.03-3.69), P < 0.00001], yet a slight reduction in bleeding [RR: 0.84 (0.71-0.99), P = 0.04] compared with those with OPR. In contrast, patients with LPR had a higher risk for bleeding [RR: 1.74 (1.47-2.06), P < 0.00001], without any further benefit in ST [RR: 1.06 (0.68-1.65), P = 0.78] in contrast to OPR. Mortality was significantly higher in patients with HPR compared with other categories (P < 0.05). Validation cohorts (n = 14) confirmed all results of exploratory studies (n = 3). Platelet reactivity assessment during thienopyridine-type P2Y12-inhibitors identifies PCI-treated patients at higher risk for mortality and ST (HPR) or at an elevated risk for bleeding (LPR). Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.
    European Heart Journal 04/2015; DOI:10.1093/eurheartj/ehv104 · 14.72 Impact Factor
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    ABSTRACT: Rapid and consistent platelet inhibition represents the cornerstone of pharmacological treatment in the early hours of ST-segment elevation myocardial infarction (STEMI). Oral P2Y12 inhibitors are recommended to be administered as early as possible in STEMI patients undergoing primary percutaneous coronary intervention (PCI). However, a delay in the onset of antiplatelet agent effects has been recently described in the first several hours following oral administration of clopidogrel, prasugrel and ticagrelor. As a result, primary PCI is performed in most cases with P2Y12 inhibition that may be inadequate. Several strategies may be applied in order to ‘bridge the gap’ in platelet inhibition after oral P2Y12 inhibitors in STEMI, like upstream administration of P2Y12 inhibitors, loading dose modification, use of an intravenous P2Y12 inhibitor or Glycoprotein IIb/IIIa inhibitors’ administration. These strategies may further improve clinical outcomes in this high-risk ‘golden window’.
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    ABSTRACT: Transcatheter mitral interventions has been developed to address an unmet clinical need and may be an alternative therapeutic option to surgery with the intent to provide symptomatic and prognostic benefit. Beyond MitraClip therapy, alternative repair technologies are being developed to expand the transcatheter intervention armamentarium. Recently, the feasibility of transcatheter mitral valve implantation in native non-calcified valves has been reported in very high-risk patients. Acknowledging the lack of scientific evidence to date, it is difficult to predict what the ultimate future role of transcatheter mitral valve interventions will be. The purpose of the present report is to review the current state-of-the-art of mitral valve intervention, and to identify the potential future scenarios, which might benefit most from the transcatheter repair and replacement devices under development. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.
    European Heart Journal 04/2015; DOI:10.1093/eurheartj/ehv123 · 14.72 Impact Factor
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    ABSTRACT: Patients with ST-segment-elevation myocardial infarction are at increased risk of cerebrovascular events. We assessed the incidence, predictors, and implications of cerebrovascular events in patients with ST-segment-elevation myocardial infarction managed with a primary percutaneous coronary intervention strategy. In the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial, 72 of 3602 patients (2.0%) experienced at least 1 cerebrovascular event (stroke: 63 patients; transient ischemic attack: 12 patients) during the 3-year follow-up (40.3% within 30 days, 20.8% between 30 days and 1 year, and 38.9% between 1 and 3 years). Stroke was ischemic in 58 (92.1%) patients and hemorrhagic in 5 (7.9%) patients. More than half of all strokes (52.3%) were disabling. By principal management strategy, cerebrovascular events developed in 2.0%, 14.9%, and 1.9% of patients triaged to primary percutaneous coronary intervention, coronary artery bypass grafting, and medical therapy, respectively (P<0.0001). Cerebrovascular events were independently predicted by older age, creatinine clearance <60 mL/min, treatment with coronary artery bypass grafting, anemia, and diabetes mellitus. Cerebrovascular events were associated with significantly increased rates of 3-year mortality (20.5% versus 6.5%; P<0.0001), as well as reinfarction (14.3% versus 3.8%; P=0.0007), ischemia-driven target vessel revascularization (22.8% versus 13.0%; P=0.006), and major bleeding (23.5% versus 8.4%; P<0.0001). In HORIZONS-AMI, cerebrovascular events within 3 years after ST-segment-elevation myocardial infarction in patients undergoing a primary percutaneous coronary intervention management strategy occurred in 2.0% of patients and were most frequent after coronary artery bypass grafting. Cerebrovascular events were often disabling and were strongly associated with high rates of death, reinfarction, recurrent ischemia, and major bleeding. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00433966. © 2015 American Heart Association, Inc.
    Circulation Cardiovascular Interventions 04/2015; 8(4). DOI:10.1161/CIRCINTERVENTIONS.114.002283 · 6.98 Impact Factor
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    ABSTRACT: We sought to evaluate the relation between the extent of coronary artery disease (CAD) and bleeding risk in patients undergoing percutaneous coronary intervention (PCI) for non-ST segment elevation acute coronary syndrome (NSTEACS). Patients with severe CAD undergoing PCI for NSTEACS are at high risk for recurrent adverse events. Hemorrhagic events after PCI are associated with high rates of morbidity and mortality. Despite sharing many common risk factors, the relationship between the extent of CAD and bleeding after PCI remains understudied. The SYNTAX score (SS) was used to quantify the extent and severity of CAD. We stratified 2627 patients from the ACUITY PCI cohort into SS groups based on score tertiles from the ACUITY trial (<7, 7-12, and >12). Thirty-day major bleeding rates were determined for each group. When stratified by ACUITY tertiles, 30-day major bleeding rates were significantly greater in the highest SS tertile (>12) than in the intermediate and lowest tertiles (P<.01). By multivariable analysis, the SS (by augmentation of 1 point) remained independently associated with 30-day major bleeding (hazard ratio = 1.03; 95% confidence interval, 1.01-1.04; P<.01). The results of this large-scale study suggest that in addition to its previously described association with adverse ischemic events, the extent of CAD, as assessed by the SS, was independently associated with major bleeding after PCI for NSTEACS.
    The Journal of invasive cardiology 04/2015; 27(4):203-11. · 0.82 Impact Factor
  • Anita W. Asgar, Michael J. Mack, Gregg W. Stone
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    ABSTRACT: The development of secondary mitral regurgitation (MR) due to left ventricular dysfunction, also known as functional MR, is strongly associated with a poor prognosis in patients with heart failure. The mechanisms underlying secondary MR are multifactorial; accurate imaging assessment of secondary MR may be challenging and nuanced; and the appropriate roles of medical, surgical, and interventional therapies for management of secondary MR are controversial and evolving. In this review, the pathophysiology, evaluation, and prognosis of secondary MR in patients with heart failure are discussed, and we evaluate in detail the evidence for the various therapeutic approaches for secondary MR, including guideline-directed medication for left ventricular dysfunction, cardiac resynchronization therapy and revascularization when appropriate, and mitral valve surgery and transcatheter interventions. The role of a multidisciplinary heart team in determining the optimal management strategy for secondary MR is also discussed.
    Journal of the American College of Cardiology 03/2015; 65(12). DOI:10.1016/j.jacc.2015.02.009 · 15.34 Impact Factor
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    ABSTRACT: Pressure-controlled intermittent coronary sinus occlusion (PICSO) may improve myocardial perfusion after pPCI. We evaluated the safety and feasibility of PICSO after pPCI for STEMI, and explored its effects on infarct size and myocardial function. Thirty patients were enrolled following successful pPCI of a left anterior descending coronary artery culprit lesion for anterior STEMI, in whom PICSO for 90 minutes was attempted. Infarct size and myocardial function were assessed by cardiovascular magnetic resonance (CMR) at two to five days and four months post pPCI. An independent core laboratory selected matched historical control patients with CMR data for comparison. PICSO was initiated in 19 patients (63%), and could be maintained for 90 (±2) minutes in 12 patients (40%). Major adverse safety events occurred in one patient (3%). Comparing all PICSO-treated patients to matched controls demonstrated no significant differences in infarct size or myocardial recovery. However, infarct size reduction from two to five days to four months was greater for patients successfully treated with PICSO compared with matched controls (41.6±8.2% vs. 27.7±9.9%, respectively; p=0.04). PICSO is safe in the setting of STEMI, although feasibility was limited. Administration of sufficient PICSO therapy may be associated with enhanced myocardial recovery during follow-up, warranting further evaluation of this novel therapy.
    EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 03/2015; 10(11). DOI:10.4244/EIJY15M03_10 · 3.76 Impact Factor
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    ABSTRACT: We sought to compare the outcomes of fractional flow reserve (FFR)-guided and angiography (Angio)-guided provisional side-branch (SB) stenting for true coronary bifurcation lesions. Angio-guided provisional SB stenting after stenting of the main vessel provides favorable outcomes for the majority of coronary bifurcation lesions. Whether an FFR-guided provisional stenting approach is superior has not been studied. A total of 320 patients with single Medina 1,1,1 and 0,1,1 coronary bifurcation lesions undergoing stenting with a provisional SB approach were randomly assigned 1:1 to Angio-guided and FFR-guided groups. SB stenting was performed for Thrombolysis In Myocardial Infarction flow <3, ostial SB stenosis greater than 70%, or greater than type A dissection after main vessel stenting in the Angio-guided group and for SB-FFR <0.80 in the FFR-guided group. The primary endpoint was the 1-year composite rate of major adverse cardiac events (cardiac death, myocardial infarction, and clinically driven target vessel revascularization). Comparing the Angio-guided and FFR-guided groups, treatment of the SB (balloon or stenting) was performed in 63.1% and 56.3% of lesions respectively (p = 0.07); stenting of the SB was attempted in 38.1% and 25.9%, respectively (p = 0.01); and, when attempted, stenting was successful in 83.6% and 73.3% of SBs, respectively (p = 0.01). The 1-year composite major adverse cardiac event rate was 18.1% in both groups (hazard ratio: 0.91, 95% confidence interval: 0.48 to 1.88, p = 1.0). The 1-year target vessel revascularization and stent thrombosis rates were 6.9% and 5.6% (p = 0.82) and 1.3% and 0.6% (p = 0.56) in the Angio-guided and FFR-guided groups, respectively. In this multicenter, randomized trial, angiographic and FFR guidance of provisional SB stenting of true coronary bifurcation lesions provided similar 1-year clinical outcomes. (Randomized Study on DK Crush Technique Versus Provisional Stenting Technique for Coronary Artery Bifurcation Lesions; ChicTR-TRC-00000015). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
    JACC. Cardiovascular Interventions 03/2015; 8(4). DOI:10.1016/j.jcin.2014.12.221 · 7.44 Impact Factor
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    ABSTRACT: Randomized controlled trials comparing short- (≤6 months) with long-term (≥1 year) dual antiplatelet therapy (DAPT) after drug-eluting stent(s) (DES) placement have been insufficiently powered to detect significant differences in the risk of major adverse cardiac events (MACE). This study sought to compare clinical outcomes between short- (≤6 months) and long-term (1 year) DAPT and among 3 months, 6 months, and 1 year of DAPT post-DES placement by performing an individual patient data pairwise and network meta-analysis. Randomized controlled trials comparing DAPT durations after DES placement were searched through the MEDLINE, EMBASE, and Cochrane databases and in international meeting proceedings. The primary study outcome was 1-year risk of MACE (cardiac death, myocardial infarction, or definite/probable stent thrombosis). Four trials including 8,180 randomized patients were identified. At 1-year follow-up, short-term DAPT was associated with similar rates of MACE (hazard ratio [HR]: 1.11; 95% confidence interval [CI]: 0.86 to 1.43; p = 0.44), but significantly lower rates of bleeding (HR: 0.66; 95% CI: 0.46 to 0.94; p = 0.03) versus prolonged DAPT. Comparable results were apparent in the landmark period between DAPT discontinuation and 1-year follow-up (for MACE: HR: 1.20; 95% CI: 0.77 to 1.89; p = 0.42) (for bleeding: HR: 0.44; 95% CI: 0.21 to 0.91; p = 0.03). There were no significant differences in 1-year rates of MACE among 3-month versus 1-year DAPT, 6-month versus 1-year DAPT, or 3-month versus 6-month DAPT. Compared with prolonged DAPT, short-term DAPT is associated with similar rates of MACE but lower rates of bleeding after DES placement. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
    Journal of the American College of Cardiology 03/2015; 65(11). DOI:10.1016/j.jacc.2014.12.046 · 15.34 Impact Factor
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    ABSTRACT: Percutaneous coronary intervention of severely calcified lesions has historically been associated with major adverse cardiac event (MACE) rates as high as 30%. In the ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial, treatment of de novo severely calcified lesions with the Diamondback 360° Coronary Orbital Atherectomy System (OAS) resulted in low rates of procedural and 30-day adverse ischemic events. The long-term results from this trial have not been reported. We sought to determine the 1-year outcomes after orbital atherectomy of severely calcified coronary lesions. ORBIT II was a single-arm trial enrolling 443 subjects at 49 US sites with severely calcified lesions usually excluded from randomized trials. OAS utilizes a centrifugal differential sanding mechanism of action for plaque modification prior to stent implantation. After OAS drug-eluting stents were implanted in 88.2% of the patients. The primary safety end point was 30-day MACE, the composite of cardiac death, myocardial infarction, or target vessel revascularization [TVR]. The present analysis reports the 1-year follow-up results from ORBIT II. One-year data were available in 433 of 443 patients (97.7%), with median follow-up time of 16.7 months. The 1-year MACE rate was 16.4%, including cardiac death (3.0%), myocardial infarction (9.7%), and target vessel revascularization (5.9%). The 1-year target lesion revascularization rate was 4.7%, and stent thrombosis occurred in 1 patient (0.2%). Independent predictors of 1-year MACE and target vessel revascularization were diameter stenosis at baseline and the use of bare-metal stents. In patients with severely calcified lesions who underwent percutaneous coronary intervention, the use of OAS was associated with low rates of 1-year adverse ischemic events compared with historical controls. This finding has important clinical implications for the selection of optimum treatment strategies for patients with severely calcified lesions. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.
    The American Journal of Cardiology 03/2015; 63. DOI:10.1016/j.amjcard.2015.03.009 · 3.43 Impact Factor
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    ABSTRACT: Despite considerable improvements in the medical management of patients with myocardial infarction (MI), patients with large MI still have substantial risk to develop heart failure. In the early post MI setting, implantable cardioverter defibrillators have reduced arrhythmic deaths but have no impact on overall mortality. Hence, additional interventions are required to further reduce the overall morbidity and mortality of patients with large MI. The pacing remodeling prevention therapy (PRomPT) trial is designed to study the effects of peri-infarct pacing in preventing adverse post-MI remodeling. Up to 250 subjects with a peak creatine phosphokinase (CPK) > 3000 U/L (or a troponin T (TnT) > 10 mcg/L) at time of MI will be randomized to either dual-site or single-site biventricular pacing with the LV lead implanted in a peri-infarct region or a non-implanted control. Those randomized to a device will be blinded to the pacing mode, however randomization to a device or control cannot be blinded. Subjects randomized to pacing will have the device implanted within 10 days of MI. The primary objective is to assess the change in left ventricular end diastolic volume (LVEDV) from baseline to 18 months. Secondary objectives are to assess changes in clinical and mechanistic parameters between the groups, including rates of hospitalization for heart failure and cardiovascular events, the incidence of sudden cardiac death and all-cause mortality, NYHA functional class, 6 minute walking distance, and quality of life CONCLUSIONS: The PRomPT trial will provide important evidence regarding the potential of peri-infarct pacing to interrupt adverse remodeling in patients with large MI. Copyright © 2015 Elsevier Inc. All rights reserved.
    Journal of cardiac failure 03/2015; DOI:10.1016/j.cardfail.2015.03.005 · 3.07 Impact Factor
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    ABSTRACT: The safety and efficacy of bivalirudin compared with heparin with or without glycoprotein IIb/IIIa inhibitors in patients with acute myocardial infarction (AMI) undergoing primary percutaneous coronary intervention (PCI) are uncertain. To determine if bivalirudin is superior to heparin alone and to heparin plus tirofiban during primary PCI. Multicenter, open-label trial involving 2194 patients with AMI undergoing primary PCI at 82 centers in China between August 2012 and June 2013. Patients were randomly assigned to receive bivalirudin with a post-PCI infusion (n = 735), heparin alone (n = 729), or heparin plus tirofiban with a post-PCI infusion (n = 730). Among patients treated with bivalirudin, a postprocedure 1.75 mg/kg/h infusion was administered for a median of 180 minutes (IQR, 148-240 minutes). The primary end point was 30-day net adverse clinical events, a composite of major adverse cardiac or cerebral events (all-cause death, reinfarction, ischemia-driven target vessel revascularization, or stroke) or bleeding. Additional prespecified safety end points included the rates of acquired thrombocytopenia at 30 days, and stent thrombosis at 30 days and 1 year. Net adverse clinical events at 30 days occurred in 65 patients (8.8%) of 735 who were treated with bivalirudin compared with 96 patients (13.2%) of 729 treated with heparin (relative risk [RR], 0.67; 95% CI, 0.50-0.90; difference, -4.3%, 95% CI, -7.5% to -1.1%; P = .008); and 124 patients (17.0%) of 730 treated with heparin plus tirofiban (RR for bivalirudin vs heparin plus tirofiban, 0.52; 95% CI, 0.39-0.69; difference, -8.1%, 95% CI, -11.6% to -4.7%; P < .001). The 30-day bleeding rate was 4.1% for bivalirudin, 7.5% for heparin, and 12.3% for heparin plus tirofiban (P < .001). There were no statistically significant differences between treatments in the 30-day rates of major adverse cardiac or cerebral events (5.0% for bivalirudin, 5.8% for heparin, and 4.9% for heparin plus tirofiban, P = .74), stent thrombosis (0.6% vs 0.9% vs 0.7%, respectively, P = .77), acquired thrombocytopenia (0.1% vs 0.7% vs 1.1%; P = .07), or in acute (<24-hour) stent thrombosis (0.3% in each group). At the 1-year follow-up, the results remained similar. Among patients with AMI undergoing primary PCI, the use of bivalirudin with a median 3-hour postprocedure PCI-dose infusion resulted in a decrease in net adverse clinical events compared with both heparin alone and heparin plus tirofiban. This finding was primarily due to a reduction in bleeding events with bivalirudin, without significant differences in major adverse cardiac or cerebral events or stent thrombosis. clinicaltrials.gov Identifier: NCT01696110.
    JAMA The Journal of the American Medical Association 03/2015; 313(13). DOI:10.1001/jama.2015.2323 · 30.39 Impact Factor

Publication Stats

36k Citations
9,352.92 Total Impact Points

Institutions

  • 2015
    • New York State
      New York, New York, United States
  • 2006–2015
    • New York Presbyterian Hospital
      • Department of Cardiology
      New York, New York, United States
    • University of Southampton
      Southampton, England, United Kingdom
    • Mid-Columbia Medical Center
      DLS, Oregon, United States
  • 2005–2015
    • CUNY Graduate Center
      New York, New York, United States
    • Isala Klinieken
      Zwolle, Overijssel, Netherlands
    • Chiba University
      Tiba, Chiba, Japan
    • Boston Scientific
      Boston, Massachusetts, United States
  • 2004–2015
    • Columbia University
      • Division of Cardiology
      New York, New York, United States
    • Brigham and Women's Hospital
      Boston, Massachusetts, United States
  • 2000–2015
    • Cardiovascular Research Foundation
      New York City, New York, United States
    • Cornell University
      Итак, New York, United States
  • 2014
    • University of Toronto
      Toronto, Ontario, Canada
  • 2013
    • The Christ Hospital
      Cincinnati, Ohio, United States
    • Hôpital du Sacré-Coeur de Montréal
      Montréal, Quebec, Canada
    • Florida Hospital
      Florida, United States
  • 2012–2013
    • Amedeo Avogadro University of Eastern Piedmont
      Novara, Piedmont, Italy
    • Icahn School of Medicine at Mount Sinai
      • Division of Cardiology
      Manhattan, New York, United States
  • 2010–2013
    • Yale-New Haven Hospital
      New Haven, Connecticut, United States
    • Lehigh Valley Health Network
      Allentown, Pennsylvania, United States
    • Fortis Escorts Heart Institute
      New Dilli, NCT, India
    • Kaiser Permanente
      • Department of Cardiology
      Oakland, CA, United States
    • Mayo Clinic - Rochester
      • Department of Cardiovascular Diseases
      Рочестер, Minnesota, United States
    • University of Catania
      • Department of Surgery (CHIR)
      Catania, Sicily, Italy
  • 2006–2013
    • Gracie Square Hospital, New York, NY
      New York City, New York, United States
  • 2011–2012
    • Mount Sinai Medical Center
      New York City, New York, United States
    • University of California, Los Angeles
      Los Ángeles, California, United States
    • Methodist Hospitals
      Gary, Indiana, United States
    • Saint Luke's Health System (KS, USA)
      Kansas City, Kansas, United States
    • Auckland City Hospital
      Окленд, Auckland, New Zealand
  • 2009
    • Harvard University
      Cambridge, Massachusetts, United States
    • Duke University Medical Center
      • Duke Clinical Research Institute
      Durham, NC, United States
    • Centre Hospitalier Universitaire de Caen
      Caen, Lower Normandy, France
  • 2000–2008
    • Lenox Hill Hospital
      New York, New York, United States
  • 2007
    • Rambam Medical Center
      • Department of Cardiology
      H̱efa, Haifa District, Israel
    • University of Hamburg
      Hamburg, Hamburg, Germany
  • 2002–2005
    • Hospital General Universitario Gregorio Marañón
      Madrid, Madrid, Spain
  • 1999–2004
    • Washington Hospital Center
      Washington, Washington, D.C., United States
  • 2003
    • Duke University
      Durham, North Carolina, United States
    • Baylor College of Medicine
      Houston, Texas, United States
  • 1995–2003
    • William Beaumont Army Medical Center
      El Paso, Texas, United States
    • Beaumont Hospital
      Dublin, Leinster, Ireland
  • 1995–1999
    • El Camino Hospital
      Mountain View, California, United States
  • 1989–1996
    • St. Luke's Hospital
      Cedar Rapids, Iowa, United States
  • 1990
    • University of Missouri - Kansas City
      Kansas City, Missouri, United States