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Laura Mauri,
Elyse Foster,
Donald D Glower,
Patricia Apruzzese,
Joseph M Massaro,
Howard C Herrmann,
James Hermiller,
William Gray,
Andrew Wang,
Wesley R Pedersen,
Tanvir Bajwa,
John Lasala,
Reginald Low,
Paul Grayburn,
Ted Feldman
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ABSTRACT: OBJECTIVES: We sought to evaluate 4-year outcomes of percutaneous repair versus surgery for mitral regurgitation. BACKGROUND: Transcatheter therapies are being developed to treat valvular heart disease. In the EVEREST II Trial, treatment of mitral valve regurgitation (MR) with a novel percutaneous device was compared with surgery and showed superior safety, but less reduction in MR at one year overall. We report the four year outcomes from the EVEREST II Trial. METHODS: Patients with grade 3+ or 4+ MR were randomly assigned to percutaneous repair with the MitraClip device or conventional mitral valve surgery in a 2:1 ratio (184:95). Patients were prospectively consented for five years of follow-up. RESULTS: At four years, the rate of the composite endpoint of freedom from death, surgery, or 3+ or 4+ MR in the intention to treat population was 39.8% vs. 53.4% in the percutaneous repair group and surgical groups, respectively (p=0.070). Rates of death were 17.4% vs. 17.8% (p=0.914), and 3+ or 4+ MR was present in 21.7% vs. 24.7% (p=0.745) at 4 years of follow-up, respectively. Surgery for mitral valve dysfunction, however, occurred in 20.4% vs. 2.2% (p<0.001) at one year and 24.8% vs. 5.5% (p<0.001) at four years. CONCLUSIONS: Patients treated with percutaneous repair of the mitral valve more commonly required surgery to treat residual MR; however, after the first year of follow-up, there were few surgeries required after either percutaneous or surgical treatment and no difference in the prevalence of moderate-severe and severe MR or mortality at four years.
Journal of the American College of Cardiology 05/2013; · 14.16 Impact Factor
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ABSTRACT: 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.
04/2013; · 1.07 Impact Factor
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Alexandre Abizaid,
John A Ormiston,
Jean Fajadet, Laura Mauri,
Joachim Schofer,
Stefan Verheye,
Joseph Dens,
Leif Thuesen,
Nathalie Macours,
Ayesha C Qureshi,
Christian Spaulding
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ABSTRACT: Aims: To assess the two-year clinical follow-up of the NEVO RES-1 study, a randomised comparison between the NEVO™ sirolimus-eluting coronary stent system (NEVO SES) and the TAXUS Liberté™ paclitaxel-eluting stent (TAXUS PES). Methods and results: NEVO RES-I randomised 394 patients with single de novo lesions with a maximum length of 28 mm and diameter of 2.5-3.5 mm to NEVO SES (n=202) versus TAXUS PES (n=192). Six-month angiographic results demonstrated the superiority of the NEVO SES over the TAXUS PES for the primary endpoint, in-stent late loss. At one year, MACE (death, emergent CABG, TLR, and MI) in the NEVO SES group was 6.1% versus 10.6% in the TAXUS PES group (p=0.139). After two years, MACE was 7.2% in the NEVO SES group versus 13.0% in TAXUS PES group (p=0.086). Corresponding rates of TLR were 3.6% versus 7.6% (p=0.116). No ARC-defined definite or probable stent thromboses (ST) were reported with NEVO SES while two occurred with TAXUS PES. Conclusions: While not designed or powered for clinical endpoints, individual and composite clinical endpoints numerically favoured the NEVO SES over the TAXUS PES, with continued separation over time up to two years. No ARC-defined definite or probable ST was reported in the NEVO SES group at two years. Clinical trial identifier: NCT00606333 http://www.clinicaltrials.gov.
EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 03/2013; · 3.29 Impact Factor
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Ajay J Kirtane,
Martin B Leon,
Michael W Ball,
Harpaul S Bajwa,
Michael H Sketch,
Patrick S Coleman,
Robert C Stoler,
Stylianos Papadakos,
Donald E Cutlip, Laura Mauri,
David E Kandzari
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ABSTRACT: OBJECTIVES: This study sought to report the final 5-year outcomes of the ENDEAVOR IV (A Randomized, Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions) trial comparing the Endeavor zotarolimus-eluting stent (E-ZES) (Medtronic, Santa Rosa, CA) with the Taxus paclitaxel-eluting stent (PES) (Boston Scientific, Natick, Massachusetts) in patients with single de novo coronary lesions. BACKGROUND: Primary results of the ENDEAVOR IV trial demonstrated similar clinical outcomes with E-ZES and PES. Concerns with regard to late adverse clinical events with drug-eluting stents highlight the need for long-term follow-up with these devices. METHODS: Late outcomes after the use of E-ZES and PES were examined in the multicenter randomized ENDEAVOR IV trial in cumulative and landmark analyses. Assessed outcomes were related to device efficacy and patient safety. RESULTS: At 5 years, clinical data were available for 722 (93.4%) E-ZES patients and 718 (92.6%) PES patients. Overall rates of target lesion revascularization (7.7% vs. 8.6%, p = 0.70) and target vessel failure were similar (17.2% vs. 21.1%, p = 0.061) with E-ZES compared with PES. The incidence of cardiac death or myocardial infarction (MI) was lower with E-ZES (6.4% vs. 9.1%, p = 0.048), primarily driven by a lower rate of target vessel MI with E-ZES (2.6% vs. 6.0%, p = 0.002). Although overall definite/probable stent thrombosis rates were similar between stents (1.3% vs. 2%, p = 0.42), rates of very late stent thrombosis (0.4% vs. 1.8%, p = 0.012) and late MI events (1.3% vs. 3.5%, p = 0.008) were significantly lower with E-ZES compared with PES. CONCLUSIONS: These data demonstrate the durable efficacy and safety of E-ZES compared with PES for the treatment of de novo coronary lesions. Significant improvements in late safety outcomes were observed with E-ZES but should be considered hypothesis-generating, given the limited statistical power of the trial. (A Randomized, Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions; NCT00217269).
03/2013; · 1.07 Impact Factor
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Sigmund Silber,
Patrick W Serruys,
Martin B Leon,
Ian T Meredith,
Stephan Windecker,
Franz-Josef Neumann,
Jorge Belardi,
Petr Widimsky,
Joe Massaro,
Victor Novack,
Alan C Yeung,
Shigeru Saito, Laura Mauri
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ABSTRACT: OBJECTIVES: The aim of this study was to describe the process to obtain Food and Drug Administration (FDA) approval for the expanded indication for treatment with the Resolute zotarolimus-eluting stent (R-ZES) in patients with coronary artery disease and diabetes. BACKGROUND: The R-ZES is the first drug-eluting stent specifically indicated in the United States for percutaneous coronary intervention in patients with diabetes. METHODS: We pooled patient-level data for 5,130 patients from the RESOLUTE Global Clinical Program. A performance goal prospectively determined in conjunction with the FDA was established as a rate of target vessel failure at 12 months of 14.5%. In addition to the FDA pre-specified cohort of less complex patients with diabetes (n = 878), we evaluated outcomes of the R-ZES in all 1,535 patients with diabetes compared with all 3,595 patients without diabetes at 2 years. RESULTS: The 12-month rate of target vessel failure in the pre-specified diabetic cohort was 7.8% (upper 95% confidence interval: 9.51%), significantly lower than the performance goal of 14.5% (p < 0.001). After 2 years, the cumulative incidence of target lesion failure in patients with non-insulin-treated diabetes was comparable to that of patients without diabetes (8.0% vs. 7.1%). The higher risk insulin-treated population demonstrated a significantly higher target lesion failure rate (13.7%). In the whole population, including complex patients, rates of stent thrombosis were not significantly different between patients with and without diabetes (1.2% vs. 0.8%). CONCLUSIONS: The R-ZES is safe and effective in patients with diabetes. Long-term clinical data of patients with non-insulin-treated diabetes are equivalent to patients without diabetes. Patients with insulin-treated diabetes remain a higher risk subset. (The Clinical Response Evaluation of the Medtronic Endeavor CR ABT-578 Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions; NCT00248079; RESOLUTE All-comers Trial: A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention; NCT00617084; A Clinical Evaluation of the Medtronic Resolute Zotarolimus-Eluting Coronary Stent System in the Treatment of De Novo Lesions in Native Coronary Arteries With a Reference Vessel Diameter of 2.25 mm to 4.2 mm; NCT00726453; RESOLUTE International Registry: Evaluation of the Resolute Zotarolimus-Eluting Stent System in a 'Real-World' Patient Population; NCT00752128; The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent in De Novo Lesions in Native Coronary Arteries; NCT00927940).
03/2013; · 1.07 Impact Factor
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ABSTRACT: Background Emergency surgery has become a rare event after percutaneous coronary intervention (PCI). Whether having cardiac-surgery services available on-site is essential for ensuring the best possible outcomes during and after PCI remains uncertain. Methods We enrolled patients with indications for nonemergency PCI who presented at hospitals in Massachusetts without on-site cardiac surgery and randomly assigned these patients, in a 3:1 ratio, to undergo PCI at that hospital or at a partner hospital that had cardiac surgery services available. A total of 10 hospitals without on-site cardiac surgery and 7 with on-site cardiac surgery participated. The coprimary end points were the rates of major adverse cardiac events - a composite of death, myocardial infarction, repeat revascularization, or stroke - at 30 days (safety end point) and at 12 months (effectiveness end point). The primary end points were analyzed according to the intention-to-treat principle and were tested with the use of multiplicative noninferiority margins of 1.5 (for safety) and 1.3 (for effectiveness). Results A total of 3691 patients were randomly assigned to undergo PCI at a hospital without on-site cardiac surgery (2774 patients) or at a hospital with on-site cardiac surgery (917 patients). The rates of major adverse cardiac events were 9.5% in hospitals without on-site cardiac surgery and 9.4% in hospitals with on-site cardiac surgery at 30 days (relative risk, 1.00; 95% one-sided upper confidence limit, 1.22; P<0.001 for noninferiority) and 17.3% and 17.8%, respectively, at 12 months (relative risk, 0.98; 95% one-sided upper confidence limit, 1.13; P<0.001 for noninferiority). The rates of death, myocardial infarction, repeat revascularization, and stroke (the components of the primary end point) did not differ significantly between the groups at either time point. Conclusions Nonemergency PCI procedures performed at hospitals in Massachusetts without on-site surgical services were noninferior to procedures performed at hospitals with on-site surgical services with respect to the 30-day and 1-year rates of clinical events. (Funded by the participating hospitals without on-site cardiac surgery; MASS COM ClinicalTrials.gov number, NCT01116882 .).
New England Journal of Medicine 03/2013; · 53.30 Impact Factor
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Vasim Farooq,
Pascal Vranckx, Laura Mauri,
Donald E Cutlip,
Jorge Belardi,
Sigmund Silber,
Petr Widimsky,
Martin Leon,
Stephan Windecker,
Ian Meredith,
Manuela Negoita,
Frank van Leeuwen,
Franz-Joseph Neumann,
Alan C Yeung,
Hector M Garcia-Garcia,
Patrick W Serruys
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ABSTRACT: BACKGROUND: Overlapping first generation sirolimus- and paclitaxel-eluting stents are associated with persistent inflammation, fibrin deposition and delayed endothelialisation in preclinical models, and adverse angiographic and clinical outcomes-including death and myocardial infarction (MI)-in clinical studies. OBJECTIVES: To establish as to whether there are any safety concerns with newer generation drug-eluting stents (DES). DESIGN: Propensity score adjustment of baseline anatomical and clinical characteristics were used to compare clinical outcomes (Kaplan-Meier estimates) between patients implanted with overlapping DES (Resolute zotarolimus-eluting stent (R-ZES) or R-ZES/other DES) against no overlapping DES. Additionally, angiographic outcomes for overlapping R-ZES and everolimus-eluting stents were evaluated in the randomised RESOLUTE All-Comers Trial. SETTING: Patient level data from five controlled studies of the RESOLUTE Global Clinical Program evaluating the R-ZES were pooled. Enrolment criteria were generally unrestrictive. PATIENTS: 5130 patients. MAIN OUTCOME MEASURES: 2-year clinical outcomes and 13-month angiographic outcomes. RESULTS: 644 of 5130 patients (12.6%) in the RESOLUTE Global Clinical Program underwent overlapping DES implantation. Implantation of overlapping DES was associated with an increased frequency of MI and more complex/calcified lesion types at baseline. Adjusted in-hospital, 30-day and 2-year clinical outcomes indicated comparable cardiac death (2-year overlap vs non-overlap: 3.0% vs 2.1%, p=0.36), major adverse cardiac events (13.3% vs 10.7%, p=0.19), target-vessel MI (3.9% vs 3.4%, p=0.40), clinically driven target vessel revascularisation (7.7% vs 6.5%, p=0.32), and definite/probable stent thrombosis (1.4% vs 0.9%, p=0.28). 13-month adjusted angiographic outcomes were comparable between overlapping and non-overlapping DES. CONCLUSIONS: Overlapping newer generation DES are safe and effective, with comparable angiographic and clinical outcomes-including repeat revascularisation-to non-overlapping DES. CLINICALTRIALS.GOV IDENTIFIERS: NCT00248079; NCT00617084; NCT00726453; NCT00752128; NCT00927940.
Heart (British Cardiac Society) 03/2013; · 4.22 Impact Factor
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ABSTRACT: BACKGROUND AND PURPOSE: The goal of carotid artery stenting is to decrease the risk of stroke or other adverse events from carotid artery disease. Choosing a treatment strategy requires patient-specific information regarding periprocedural risk of adverse neurologic events. The aim of this study was to predict individual patient risk after carotid artery stenting in patients at higher risk for carotid endarterectomy. METHODS: Subjects enrolled in the Stenting and Angioplasty with Protection in Patients at High-Risk for Endarterectomy (SAPPHIRE) worldwide study underwent carotid artery stenting with distal protection. Only patients with at least 1 anatomic or comorbid factor associated with elevated surgical risk were included. Preprocedural factors were used to develop a model and integer-based risk score predicting stroke or death within 30 days. The model was calibrated and internally validated using bootstrap resampling. RESULTS: Ten thousand one hundred eighty-six patients were included in the analysis. The overall rate of stroke or death was 3.6% at 30 days after carotid artery stenting. Independent predictors of adverse outcomes were increased age (P=0.006), history of stroke (P<0.001), history of transient ischemic attack presentation (P=0.001), recent (<4 weeks) myocardial infarction (P=0.006), dialysis treatment (P=0.007), need for cardiac surgery in addition to carotid revascularization (P=0.005), a right-sided carotid stenosis (P=0.006), a longer carotid plaque (P=0.012), the presence of a Type II or III aortic arch (P=0.035), and a tortuous carotid arterial system (P=0.004). The optimism-adjusted C-statistic was 0.691. CONCLUSIONS: Commonly collected clinical and anatomic variables can identify patients at high and low risk for stroke or death after carotid artery stenting.
Stroke 11/2012; · 5.73 Impact Factor
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ABSTRACT: BACKGROUND: ALTHOUGH DRUG-ELUTING STENTS AND INTENSIVE SECONDARY PREVENTION HAVE CONTRIBUTED TO IMPROVED OUTCOMES AFTER PERCUTANEOUS CORONARY INTERVENTION (PCI), REPEAT REVASCULARIZATION REMAINS RELATIVELY COMMON IN CONTEMPORARY PRACTICE. WE USED DATA FROM THE MULTICENTER EVALUATION OF DRUG-ELUTING STENTS AND ISCHEMIC EVENTS REGISTRY TO EVALUATE THE RELATIVE FREQUENCY AND TIMING OF STAGED REVASCULARIZATION, TARGET LESION REVASCULARIZATION (TLR), AND OTHER NONTARGET REVASCULARIZATION DURING THE FIRST YEAR AFTER CONTEMPORARY PCI.METHODS AND RESULTS: PATIENTS WITH STAGED REVASCULARIZATION, TLR, AND OTHER UNPLANNED PROCEDURES (ELSEWHERE IN THE TARGET VESSEL OR IN OTHER CORONARY ARTERIES) WERE EVALUATED IN TIME-DEPENDENT MODELS USING KAPLAN-MEIER LIFE-TABLE ESTIMATION. PREDICTORS OF TLR AND UNPLANNED REVASCULARIZATION AT NONTARGET SITES WERE IDENTIFIED USING LOGISTIC REGRESSION. BETWEEN JULY 2004 TO JUNE 2007, 10 144 PATIENTS UNDERGOING PCI WERE ENROLLED AT 55 US HOSPITALS, OF WHOM 86% WERE TREATED WITH AT LEAST 1 DRUG-ELUTING STENT. TWELVE PERCENT REQUIRED REPEAT REVASCULARIZATION WITHIN THE FIRST YEAR (3% STAGED; 9% UNPLANNED). MORE THAN 75% OF STAGED REVASCULARIZATIONS WERE PERFORMED 30 DAYS AFTER INDEX PCI, ALTHOUGH THERE WAS SIGNIFICANT VARIATION IN THIS PRACTICE ACROSS HOSPITALS (RANGE, 0%54%). TLR OCCURRED IN 4.5% OF PATIENTS, WITH HIGHER HAZARD RATES BETWEEN 2 TO 9 MONTHS AFTER PCI, WHEREAS THE RISK OF UNPLANNED NON-TLR (4.4% CUMULATIVE INCIDENCE) WAS CONSTANT OVER TIME.CONCLUSIONS: Among unselected patients undergoing PCI in the drug-eluting stent era, the incidence of repeat revascularization at 1 year is ≈12%. Among unplanned procedures, only half are performed for TLR. To achieve further improvements in PCI outcomes, future efforts should concentrate as much on identifying ischemia-producing lesions and intensifying secondary prevention therapies as on the prevention of restenosis.
Circulation Cardiovascular Interventions 10/2012; · 6.06 Impact Factor
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ABSTRACT: BACKGROUND: Individuals with chronic kidney disease (CKD) have high rates of myocardial infarction (MI), but whether the nature of coronary lesions susceptible to plaque rupture is altered and whether the high rate of MI is related to a greater burden of atherosclerotic lesions in individuals with CKD is uncertain. METHODS: We used quantitative coronary angiography to assess atherosclerotic plaque location and characteristics at baseline and at the time of MI in 62 patients with and without CKD. Univariate and multivariable conditional logistic regression models were used to assess whether the association between pre-MI angiographic findings and MI differs in individuals with and without CKD. RESULTS: The risk of MI rose as the distance from the coronary ostium decreased both in patients with CKD (odds ratio per 10 mm 0.92 [95 % CI 0.87-0.99]) and in those without CKD (odds ratio 0.83 [95 % CI 0.75-0.93]). Although tighter degrees of coronary stenosis were associated with increased risks of MI in patients with and without CKD, the majority of MIs (70.9 % in patients with CKD and 89.5 % in those without CKD) occurred in segments with <50 % diameter stenosis at baseline. CONCLUSIONS: The characteristics of lesions progressing to MI are similar in individuals with and without CKD and the majority of events occur in areas with <50 % stenosis at baseline. Given the high burden of non-stenotic lesions in patients with CKD, an interventional strategy aimed solely at sites with high-grade stenosis is unlikely to markedly reduce the risk of MI in patients with CKD.
Clinical and Experimental Nephrology 08/2012; · 1.37 Impact Factor
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Edoardo Camenzind,
William Wijns, Laura Mauri,
Volkhard Kurowski,
Keyur Parikh,
Runlin Gao,
Christoph Bode,
John P Greenwood,
Eric Boersma,
Pascal Vranckx,
Eugene McFadden,
Patrick W Serruys,
William W O'Neil,
Brenda Jorissen,
Frank Van Leeuwen,
Ph Gabriel Steg
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ABSTRACT: We sought to compare the long-term safety of two devices with different antiproliferative properties: the Endeavor zotarolimus-eluting stent (E-ZES; Medtronic, Inc) and the Cypher sirolimus-eluting stent (C-SES; Cordis, Johnson & Johnson) in a broad group of patients and lesions.
Between May 21, 2007 and Dec 22, 2008, we recruited 8791 patients from 36 recruiting countries to participate in this open-label, multicentre, randomised, superiority trial. Eligible patients were those aged 18 years or older undergoing elective, unplanned, or emergency procedures in native coronary arteries. Patients were randomly assigned to either receive E-ZES and C-SES (ratio 1:1). Randomisation was stratified per centre with varying block sizes of four, six, or eight patients, and concealed with a central telephone-based or web-based allocation service. The primary outcome was definite or probable stent thrombosis at 3 years and was analysed by intention to treat. Patients and investigators were aware of treatment assignment. This trial is registered with ClinicalTrials.gov, number NCT00476957.
PROTECT randomised 8791 patients, of whom 8709 provided consent to participate and were eligible: 4357 were allocated to the E-ZES group and 4352 patients to the C-SES group. At 3 years, rates of definite or probable stent thrombosis did not differ between groups (1·4% for E-ZES [predicted: 1·5%] vs 1·8% [predicted: 2·5%] for C-SES; hazard ratio [HR] 0·81, 95% CI 0·58-1·14, p=0·22). Dual antiplatelet therapy was used in 8402 (96%) patients at discharge, 7456 (88%) at 1 year, 3041 (37%) at 2 years, and 2364 (30%) at 3 years.
No evidence of superiority of E-ZES compared with C-SES in definite or probable stent thrombosis rates was noted at 3 years. Time analysis suggests a difference in definite or probable stent thrombosis between groups is emerging over time, and a longer follow-up is therefore needed given the clinical relevance of stent thrombosis.
Medtronic, Inc.
The Lancet 08/2012; 380(9851):1396-405. · 38.28 Impact Factor
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Amit P Amin,
John A Spertus,
David J Cohen,
Adnan Chhatriwalla,
Kevin F Kennedy,
Katherine Vilain,
Adam C Salisbury,
Lakshmi Venkitachalam,
Sue Min Lai, Laura Mauri,
Sharon-Lise T Normand,
John S Rumsfeld,
John C Messenger,
Robert W Yeh
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ABSTRACT: Benefits of drug-eluting stents (DES) in percutaneous coronary intervention (PCI) are greatest in those at the highest risk of target-vessel revascularization (TVR). Drug-eluting stents cost more than bare-metal stents (BMS) and necessitate prolonged dual antiplatelet therapy (DAPT), which increases costs, bleeding risk, and risk of complications if DAPT is prematurely discontinued. Our objective was to assess whether DES are preferentially used in patients with higher predicted TVR risk and to estimate if lower use of DES in low-TVR-risk patients would be more cost-effective than the existing DES use pattern.
We analyzed more than 1.5 million PCI procedures in the National Cardiovascular Data Registry (NCDR) CathPCI registry from 2004 through 2010 and estimated 1-year TVR risk with BMS using a validated model. We examined the association between TVR risk and DES use and the cost-effectiveness of lower DES use in low-TVR-risk patients (50% less DES use among patients with <10% TVR risk) compared with existing DES use.
There was marked variation in physicians' use of DES (range 2%-100%). Use of DES was high across all predicted TVR risk categories (73.9% in TVR risk <10%; 78.0% in TVR risk 10%-20%; and 83.2% in TVR risk >20%), with a modest relationship between TVR risk and DES use (relative risk, 1.005 per 1% increase in TVR risk [95% CI, 1.005-1.006]). Reducing DES use by 50% in low-TVR-risk patients was projected to lower US health care costs by $205 million per year while increasing the overall TVR event rate by 0.5% (95% CI, 0.49%-0.51%) in absolute terms.
Use of DES in the United States varies widely among physicians, with only a modest correlation to patients' risk of restenosis. Less DES use among patients with low risk of restenosis has the potential for significant cost savings for the US health care system while minimally increasing restenosis events.
Archives of internal medicine 07/2012; 172(15):1145-52. · 11.46 Impact Factor
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ABSTRACT: CKD patients have high mortality risk after myocardial infarction (MI). An adequate supply of coronary collaterals to the culprit vessel responsible for MI is associated with reduced risks of death and complications. Whether a diminished supply of collaterals contributes to the high risk in CKD patients is uncertain.
Quantitative coronary angiography was performed in a consecutive series of individuals with (n=58) and without (n=165) CKD (estimated GFR <60 ml/min per 1.73 m(2)) who underwent coronary angiography at the time of MI. Collateral supply was analyzed and candidate predictors were assessed in patient-level and individual artery-level models using logistic regression and ordered categorical regression, respectively.
There were no significant differences in collateral supply among 58 CKD patients and 165 individuals with preserved renal function. Culprit artery collaterals were present in 25.0% of CKD patients compared with 27.2% of individuals with preserved renal function (P=0.76). The odds of having an adequate supply of culprit vessel collaterals were also not significantly different in individuals with and without CKD, respectively. CKD patients were 2.22-fold more likely to have visible collaterals to the nonculprit vessels in unadjusted analyses. The difference was not significant after correction for percent stenosis and comorbid factors.
Our results do not support an independent association between CKD and diminished collateral supply to either the culprit or nonculprit vessels in MI. Additional studies are warranted to better define associations between myocardial capillary supply, collateral supply, and the full range of human CKD.
Clinical Journal of the American Society of Nephrology 04/2012; 7(7):1079-86. · 5.23 Impact Factor
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Howard C Herrmann,
Zachary M Gertz,
Frank E Silvestry,
Susan E Wiegers,
Y Joseph Woo,
James Hermiller,
Douglas Segar,
David Heimansohn,
William Gray,
Shunichi Homma,
Michael Argenziano,
Andrew Wang,
James Jollis,
Mark B Lampert,
John Alexander, Laura Mauri,
Elyse Foster,
Donald Glower,
Ted Feldman
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ABSTRACT: The purpose of this study was to characterize patients with mitral regurgitation (MR) and atrial fibrillation (AF) treated percutaneously using the MitraClip device (Abbott Vascular, Abbott Park, Illinois) and compare the results with surgery in this population.
The EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) randomized controlled trial compared a less invasive catheter-based treatment for MR with surgery, providing an opportunity to assess the impact of AF on the outcomes of both the MitraClip procedure and surgical repair.
The study population included 264 patients with moderately severe or severe MR assessed by an independent echocardiographic core laboratory. Comparison of safety and effectiveness study endpoints at 30 days and 1 year were made using both intention-to-treat and per-protocol (cohort of patients with MR ≤2+ at discharge) analyses.
Pre-existing AF was present in 27% of patients. These patients were older, had more advanced disease, and were more likely to have a functional etiology. Similar reduction of MR to ≤2+ before discharge was achieved in patients with AF (83%) and in patients without AF (75%, p = 0.3). Freedom from death, mitral valve surgery for valve dysfunction, and MR >2+ was similar at 12 months for AF patients (64%) and for no-AF patients (61%, p = 0.3). At 12 months, MR reduction to <2+ was greater with surgery than with MitraClip, but there was no interaction between rhythm and MR reduction, and no difference in all-cause mortality between patients with and patients without AF.
Atrial fibrillation is associated with more advanced valvular disease and noncardiac comorbidities. However, acute procedural success, safety, and 1-year efficacy with MitraClip therapy is similar for patients with AF and without AF.
Journal of the American College of Cardiology 04/2012; 59(14):1312-9. · 14.16 Impact Factor
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Donald Glower,
Gorav Ailawadi,
Michael Argenziano,
Michael Mack,
Alfredo Trento,
Andrew Wang,
D Scott Lim,
William Gray,
Paul Grayburn,
John Dent,
Linda Gillam,
Barathi Sethuraman,
Ted Feldman,
Elyse Foster, Laura Mauri,
Irving Kron
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ABSTRACT: The Endovascular Valve Edge-to-Edge Repair Study (EVEREST II) is a prospective, multicenter, randomized controlled trial comparing percutaneous repair with the MitraClip device to mitral valve (MV) surgery in the treatment of mitral regurgitation. The present study analyzed the patient characteristics and treatment effects on mitral repair versus replacement.
Of 279 patients enrolled, 80 surgical patients underwent 82 MV operations and 178 underwent an initial MitraClip procedure, of whom 37 underwent a subsequent MV operation within 1 year of their index the MitraClip procedure. A logistic regression model was used to predict MV replacement according to valve pathology, etiology of mitral regurgitation, age, previous cardiac surgery, and treatment group.
The rate of percutaneous or surgical MV repair at 1 year was 89% (158/178) in patients initially receiving the MitraClip device versus 84% (67/80) in the surgical patients (P = .36). Surgical repair was performed after the MitraClip procedure in 20 (54%) of 37 patients (P < .001 vs surgery). In both the MitraClip device and surgery groups, MV replacement was significantly associated with anterior leaflet pathology (P = .035). Logistic regression analysis showed that anterior leaflet pathology predicted MV replacement. In 5 (13.5%) of 37 patients undergoing surgery after MitraClip therapy, replacement was performed in part because of MV injury associated with the MitraClip procedure.
These data suggest that anterior leaflet pathology is strongly associated with MV replacement in patients undergoing either de novo MV surgery or surgery after MitraClip therapy. MitraClip therapy has a repair rate similar to surgery through 1 year but also imparts a risk of replacement of a potentially repairable valve.
The Journal of thoracic and cardiovascular surgery 04/2012; 143(4 Suppl):S60-3. · 3.41 Impact Factor
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ABSTRACT: Risk-standardized all-cause 30-day readmission rates (RSRRs) after percutaneous coronary intervention (PCI) have been endorsed as a national measure of hospital quality. Little is known about variation in the performance of hospitals on this measure, and whether high hospital rates of readmission after PCI are due to modifiable deficiencies in quality of care has not been assessed.
We estimated 30-day, all-cause RSRRs for all nonfederal PCI-performing hospitals in Massachusetts, adjusted for clinical and angiographic variables, between 2005 and 2008. We assessed if differences in race, insurance type, and PCI and post-PCI characteristics, including procedural complications and discharge characteristics, could explain variation between hospitals using nested hierarchical logistic regression models. Of 36 060 patients undergoing PCI at 24 hospitals and surviving to discharge, 4469 (12.4%) were readmitted within 30 days of discharge. Hospital RSRRs ranged from 9.5% to 17.9%, with 8 of 24 hospitals being identified as outliers (4 lower than expected and 4 higher than expected). Differences in race, insurance, PCI, and post-PCI factors accounted for 10.4% of the between-hospital variance in RSRRs.
We observed wide variation in hospital 30-day all-cause RSRRs after PCI, most of which could not be explained by identifiable differences in procedural and postprocedural factors. A better understanding of etiologies of hospital variation is necessary to determine whether this measure is an actionable assessment of hospital quality, and, if so, how hospitals might improve their performance.
Circulation Cardiovascular Interventions 03/2012; 5(2):227-36. · 6.06 Impact Factor
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Anthony J Furlan,
Mark Reisman,
Joseph Massaro, Laura Mauri,
Harold Adams,
Gregory W Albers,
Robert Felberg,
Howard Herrmann,
Saibal Kar,
Michael Landzberg,
Albert Raizner,
Lawrence Wechsler
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ABSTRACT: The prevalence of patent foramen ovale among patients with cryptogenic stroke is higher than that in the general population. Closure with a percutaneous device is often recommended in such patients, but it is not known whether this intervention reduces the risk of recurrent stroke.
We conducted a multicenter, randomized, open-label trial of closure with a percutaneous device, as compared with medical therapy alone, in patients between 18 and 60 years of age who presented with a cryptogenic stroke or transient ischemic attack (TIA) and had a patent foramen ovale. The primary end point was a composite of stroke or transient ischemic attack during 2 years of follow-up, death from any cause during the first 30 days, or death from neurologic causes between 31 days and 2 years.
A total of 909 patients were enrolled in the trial. The cumulative incidence (Kaplan-Meier estimate) of the primary end point was 5.5% in the closure group (447 patients) as compared with 6.8% in the medical-therapy group (462 patients) (adjusted hazard ratio, 0.78; 95% confidence interval, 0.45 to 1.35; P=0.37). The respective rates were 2.9% and 3.1% for stroke (P=0.79) and 3.1% and 4.1% for TIA (P=0.44). No deaths occurred by 30 days in either group, and there were no deaths from neurologic causes during the 2-year follow-up period. A cause other than paradoxical embolism was usually apparent in patients with recurrent neurologic events.
In patients with cryptogenic stroke or TIA who had a patent foramen ovale, closure with a device did not offer a greater benefit than medical therapy alone for the prevention of recurrent stroke or TIA. (Funded by NMT Medical; ClinicalTrials.gov number, NCT00201461.).
New England Journal of Medicine 03/2012; 366(11):991-9. · 53.30 Impact Factor
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ABSTRACT: The aim of this study was to evaluate the 5-year clinical safety and efficacy outcomes of patients treated for in-stent restenosis of bare-metal stents (BMSs).
The SISR trial is a prospective, randomized trial that compared the safety and efficacy of sirolimus-eluting stent (SES) vs vascular brachytherapy (VBT) for the treatment of BMS in-stent restenosis.
A total of 384 patients with BMS in-stent restenosis were randomized to treatment with SES (n = 259) or VBT (n = 125) and were followed for 5 years.
At 5 years, the rates of target lesion revascularization (TLR) had narrowed and were nonsignificant between the SES and VBT groups, with TLR rates of 24.7% and 31.2% (95% CI -16.3% to 2.8%, P = .179) respectively. Target vessel failure was 33.6% vs 36.8% (95% CI -13.5% to 6.7% P = .568) for SES compared with VBT. The rate of major adverse cardiac event at 5 years was 34.0% vs 36.8% (95% CI -13.1% to7.1%, P = .648) for the SES compared with VBT. There were no differences between SES and VBT in terms of survival free from TLR (72.9% vs 66.4%, log-rank P = .08) or from target vessel failure (64.4% vs 61.3%, log-rank P = .349). There were no significant differences in the rates of definite/probable stent thrombosis (5.9% vs 2.5%, 95% CI -7.9% to 1.3%, P = .182) between the 2 groups.
At a 5-year follow-up, no differences in safety or efficacy outcomes were observed for treatment of BMS restenosis with SES vs VBT. There were no significant differences in survival free from TLR, target vessel revascularization, or major adverse cardiac events between the 2 groups at 5 years. Sirolimus-eluting stent is a viable treatment option compared with VBT for BMS restenosis.
American heart journal 03/2012; 163(3):438-45. · 4.65 Impact Factor
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Patrick L Whitlow,
Ted Feldman,
Wes R Pedersen,
D Scott Lim,
Robert Kipperman,
Richard Smalling,
Tanvir Bajwa,
Howard C Herrmann,
John Lasala,
James T Maddux,
Murat Tuzcu,
Samir Kapadia,
Alfredo Trento,
Robert J Siegel,
Elyse Foster,
Donald Glower, Laura Mauri,
Saibal Kar
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ABSTRACT: The EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study (HRS) assessed the safety and effectiveness of the MitraClip device (Abbott Vascular, Santa Clara, California) in patients with significant mitral regurgitation (MR) at high risk of surgical mortality rate.
Patients with severe MR (3 to 4+) at high risk of surgery may benefit from percutaneous mitral leaflet repair, a potentially safer approach to reduce MR.
Patients with severe symptomatic MR and an estimated surgical mortality rate of ≥12% were enrolled. A comparator group of patients screened concurrently but not enrolled were identified retrospectively and consented to compare survival in patients treated by standard care.
Seventy-eight patients underwent the MitraClip procedure. Their mean age was 77 years, >50% had previous cardiac surgery, and 46 had functional MR and 32 degenerative MR. MitraClip devices were successfully placed in 96% of patients. Protocol-predicted surgical mortality rate in the HRS and concurrent comparator group was 18.2% and 17.4%, respectively, and Society of Thoracic Surgeons calculator estimated mortality rate was 14.2% and 14.9%, respectively. The 30-day procedure-related mortality rate was 7.7% in the HRS and 8.3% in the comparator group (p = NS). The 12-month survival rate was 76% in the HRS and 55% in the concurrent comparator group (p = 0.047). In surviving patients with matched baseline and 12-month data, 78% had an MR grade of ≤2+. Left ventricular end-diastolic volume improved from 172 ml to 140 ml and end-systolic volume improved from 82 ml to 73 ml (both p = 0.001). New York Heart Association functional class improved from III/IV at baseline in 89% to class I/II in 74% (p < 0.0001). Quality of life was improved (Short Form-36 physical component score increased from 32.1 to 36.1 [p = 0.014] and the mental component score from 45.5 to 48.7 [p = 0.065]) at 12 months. The annual rate of hospitalization for congestive heart failure in surviving patients with matched data decreased from 0.59 to 0.32 (p = 0.034).
The MitraClip device reduced MR in a majority of patients deemed at high risk of surgery, resulting in improvement in clinical symptoms and significant left ventricular reverse remodeling over 12 months. (Pivotal Study of a Percutaneous Mitral Valve Repair System [EVEREST II]; NCT00209274).
Journal of the American College of Cardiology 01/2012; 59(2):130-9. · 14.16 Impact Factor
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Michael S Lee,
Seung-Jung Park,
David E Kandzari,
Ajay J Kirtane,
William F Fearon,
Emmanouil S Brilakis,
Paul Vermeersch,
Young-Hak Kim,
Ron Waksman,
Julinda Mehilli, Laura Mauri,
Gregg W Stone
11/2011; 4(11):1250-1. · 1.07 Impact Factor
