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Kandzari D.E.,Piedmont Heart Institute | Barker C.S.,University of Houston | Leon M.B.,Columbia University | Mauri L.,Brigham and Womens Hospital | And 3 more authors.
JACC: Cardiovascular Interventions | Year: 2011

Objectives: We sought to evaluate differences in late safety outcomes relative to dual antiplatelet therapy (DAPT) duration in patients treated with zotarolimus-eluting stents (ZES). Background: Despite treatment recommendations for at least 12 months of DAPT following drug-eluting stent revascularization, device-specific outcomes relative to DAPT duration are absent. Methods: Among 2,032 patients undergoing percutaneous coronary revascularization with ZES in 5 trials, late safety events were compared relative to DAPT duration for patients with <6 months DAPT adherence and survival free of major ischemic and bleeding events. Results: A total of 1,414 event-free patients on DAPT at 6 months were identified. Patient group comparisons relative to DAPT included: 6 months versus <12 months, and 6 months versus ≥24 months. Through 3 years, risk-adjusted ischemic event rates did not significantly differ between groups: 6 versus ≥12 months: death (2.7% vs. 2.2%), myocardial infarction (MI, 0.3% vs. 1.1%), and definite/probable stent thrombosis (ST, 0.3% vs. 0%); 6 versus ≥24 months: death (1.6% vs. 1.6%), MI (0.4% vs. 1.2%), and definite/probable ST (0.1% vs. 0.2%). Composite events also did not statistically vary between DAPT durations. In multivariable analysis, 6-month versus longer DAPT duration was not associated with increased likelihood of thrombotic events at 3-year follow-up. Major bleeding was negligible across groups. Conclusions: Among patients treated with ZES, late-term events of death, MI, stroke, and ST do not significantly differ between patients taking 6 months DAPT compared with continuation beyond 1 year. These findings merit further study to identify the appropriate duration of DAPT according to specific drug-eluting stents. © 2011 American College of Cardiology Foundation. Source


Kandzari D.E.,Piedmont Heart Institute | Mauri L.,Harvard University | Popma J.J.,Beth Israel Deaconess Medical Center | Turco M.A.,Center for Cardiac and Vascular Research | And 3 more authors.
JACC: Cardiovascular Interventions | Year: 2011

Objectives: This study sought to compare late safety and efficacy outcomes following percutaneous coronary revascularization with zotarolimus-eluting stents (ZES) and sirolimus-eluting stents (SES). Background: Despite higher late lumen loss and binary restenosis with ZES compared with SES, it is uncertain whether differences in early angiographic measures translate into more disparate late clinical events. Methods: Clinical outcomes were prospectively evaluated through 5 years in the ENDEAVOR III (A Randomized Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Cypher Sirolimus-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions) that randomized 436 patients of relatively low anatomic and clinical risk to treatment with ZES (n = 323) or SES (n = 113) and evaluated a primary endpoint of 8-month angiographic late lumen loss. Results: At 5 years (completeness of follow-up: 95.2%), pre-specified endpoints of all-cause mortality (5.2% vs. 13.0%, p = 0.02), myocardial infarction (1.0% vs. 4.6%, p = 0.03), and the composite event rates of cardiac death/myocardial infarction (1.3% vs. 6.5%, p = 0.009) and major adverse cardiac events (14.0% vs. 22.2%, p = 0.05) were significantly lower among patients treated with ZES. Rates of target lesion (8.1% ZES vs. 6.5% SES, p = 0.68) and target vessel revascularization were similar between treatment groups. Stent thrombosis was infrequent and similar in both groups (0.7% ZES vs. 0.9% SES, p = 1.0). Between 9 months and 5 years, progression of major adverse cardiac events was significantly more common with SES than with ZES (16.7% vs. 7.8%, p = 0.015). Conclusions: Despite initially higher angiographic late lumen loss, rates of clinical restenosis beyond the protocol-specified angiographic follow-up period remain stable with ZES compared with the rates for SES, resulting in similar late-term efficacy. Over 5 years, significant differences in death, myocardial infarction, and composite endpoints favored treatment with ZES. (The Medtronic Endeavor III Drug Eluting Coronary Stent System Clinical Trial [ENDEAVOR III]; NCT00217256). © 2011 American College of Cardiology Foundation. Source


Kandzari D.E.,Piedmont Heart Institute | Leon M.B.,Columbia University Medical Center | Meredith I.,Monash University | Fajadet J.,Clinique Pasteur | And 2 more authors.
JACC: Cardiovascular Interventions | Year: 2013

Objectives: The aim of this study was to evaluate late safety and efficacy outcomes among patients enrolled in clinical trials comparing Endeavor zotarolimus-eluting stents (E-ZES) (Medtronic, Inc., Santa Rosa, California) with first-generation drug-eluting stents (DES) and bare-metal stents (BMS). Background: Despite demonstration of higher angiographic luminal loss and restenosis with E-ZES compared with alternative DES, whether differences in these early angiographic measures translate into more disparate late clinical events is uncertain. Methods: Among 3,616 patients undergoing percutaneous coronary revascularization in 5 registration trials, late safety and efficacy events were compared between E-ZES (n = 2,132) versus sirolimus- or paclitaxel-eluting stents (n = 888) or BMS (n = 596). Results: Compared with a parallel cohort of patients treated with first-generation DES and BMS, 5-year rates of cardiac death/myocardial infarction (MI) (5.8% vs. 8.8% DES, p = 0.003; vs. 8.4% BMS, p = 0.02) and major adverse cardiac events (16.1% vs. 20.6% DES, p = 0.009; vs. 24.6% BMS, p < 0.001) were significantly lower with E-ZES. The E-ZES was associated with significantly lower target lesion revascularization (TLR) compared with BMS (7.4% vs. 16.3%, p < 0.001) but similar to comparator DES (7.4% vs. 8.1%, p = 0.63). Despite higher TLR in the first year with E-ZES compared with DES, between 1- and 5-year follow-up, rates of cardiac death/MI, TLR, and definite/probable stent thrombosis were significantly lower with E-ZES. Conclusions: Over 5 years, significant differences in cardiac death/MI and composite endpoints favored treatment with E-ZES over comparator BMS and DES. Rates of clinical restenosis and safety events, including stent thrombosis beyond the first year of revascularization, remain stable with E-ZES, leading to significant differences compared with first-generation DES. © 2013 American College of Cardiology Foundation. Source


Garbi M.,Kings College | Chambers J.,Cardiothoracic Center | Vannan M.A.,Piedmont Heart Institute | Lancellotti P.,University of Liege | Lancellotti P.,GVM Care and Research
JACC: Cardiovascular Imaging | Year: 2015

Valve stress echocardiography (VSE) is increasingly used both within specialist valve clinics and within dedicated VSE services, mandating practical guidance for referral, procedure, reporting, and clinical implementation of results. Therefore, a didactic VSE guide was compiled based on current European Society of Cardiology and American College of Cardiology/American Heart Association valve disease management guidelines, review of existing evidence, and the authors' extensive experience with VSE. The VSE indications were grouped into 3 categories: symptoms despite nonsevere valve disease, asymptomatic severe valve disease, and valve disease with reduced left ventricular systolic function. The aim of the test, the type of stress to be used, the sequence of image acquisition, the information to be included in the report, and the implication of the VSE results for clinical management were described for every indication and summarized in user-friendly tables. © 2015 American College of Cardiology Foundation. Source


Bhatt D.L.,Harvard University | Kandzari D.E.,Piedmont Heart Institute | O'Neill W.W.,Ford Motor Company | D'Agostino R.,Boston University | And 13 more authors.
New England Journal of Medicine | Year: 2014

BACKGROUND: Prior unblinded studies have suggested that catheter-based renal-artery denervation reduces blood pressure in patients with resistant hypertension. METHODS: We designed a prospective, single-blind, randomized, sham-controlled trial. Patients with severe resistant hypertension were randomly assigned in a 2:1 ratio to undergo renal denervation or a sham procedure. Before randomization, patients were receiving a stable antihypertensive regimen involving maximally tolerated doses of at least three drugs, including a diuretic. The primary efficacy end point was the change in office systolic blood pressure at 6 months; a secondary efficacy end point was the change in mean 24-hour ambulatory systolic blood pressure. The primary safety end point was a composite of death, end-stage renal disease, embolic events resulting in end-organ damage, renovascular complications, or hypertensive crisis at 1 month or new renal-artery stenosis of more than 70% at 6 months. RESULTS: A total of 535 patients underwent randomization. The mean (±SD) change in systolic blood pressure at 6 months was -14.13±23.93 mm Hg in the denervation group as compared with -11.74±25.94 mm Hg in the sham-procedure group (P<0.001 for both comparisons of the change from baseline), for a difference of -2.39 mm Hg (95% confidence interval [CI], -6.89 to 2.12; P = 0.26 for superiority with a margin of 5 mm Hg). The change in 24-hour ambulatory systolic blood pressure was -6.75±15.11 mm Hg in the denervation group and -4.79±17.25 mm Hg in the sham-procedure group, for a difference of -1.96 mm Hg (95% CI, -4.97 to 1.06; P = 0.98 for superiority with a margin of 2 mm Hg). There were no significant differences in safety between the two groups. CONCLUSIONS: This blinded trial did not show a significant reduction of systolic blood pressure in patients with resistant hypertension 6 months after renal-artery denervation as compared with a sham control. Copyright © 2014 Massachusetts Medical Society. Source

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