ABSTRACT
OBJECTIVES: To examine the benefit of the Tryton dedicated side branch (SB) stent compared with provisional stenting in the treatment of complex bifurcation lesions involving large SBs. BACKGROUND: The TRYTON Trial was designed to evaluate the utility of a dedicated SB stent to treat true bifurcation lesions involving large (≥2.5 mm by visual estimation) SBs. Patient enrolled in the trial had smaller SB diameters than intended (59% SB ≤2.25 mm by Core Lab QCA). The TRYTON Trial did not meet its primary endpoint due to an increased rate of peri-procedural myocardial infarctions (MIs). METHODS: The TRYTON Trial randomized 704 patients to the Tryton SB stent with main vessel DES versus provisional SB treatment with main vessel DES. The rates of the primary end point of target vessel failure and the secondary powered end point of angiographic percent diameter stenosis in the SB at 9 months were assessed and compared between the two treatment strategies among patients with a SB ≥2.25 mm diameter at baseline determined by Core Lab QCA. RESULTS: Among the 704 patients enrolled in the TRYTON Trial, 289 patients (143 provisional and 146 Tryton stent; 41% of entire cohort) had a SB ≥2.25 mm. The primary end point of TVF was numerically lower in the Tryton group compared with the provisional group (11.3% vs. 15.6%, P = 0.38), and was within the non-inferiority margin. No difference among the rates of clinically driven target vessel revascularization (3.5% vs. 4.3% P = 0.77) or cardiac death (0% both groups) were seen. In-segment percent diameter stenosis of the SB was significantly lower in the Tryton group compared with the provisional group (30.4% vs. 40.6%, P = 0.004). CONCLUSIONS: Analysis of the TRYTON Trial cohort of SB ≥2.25 mm supports the safety and efficacy of the Tryton SB stent compared with a provisional stenting strategy in the treatment of bifurcation lesions involving large SBs. © 2015 Wiley Periodicals, Inc.
Subject(s)
Angioplasty, Balloon, Coronary/instrumentation , Coronary Artery Disease/therapy , Coronary Stenosis/therapy , Stents , Aged , Angioplasty, Balloon, Coronary/adverse effects , Angioplasty, Balloon, Coronary/mortality , Coronary Angiography , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/mortality , Coronary Stenosis/diagnostic imaging , Coronary Stenosis/mortality , Coronary Thrombosis/etiology , Female , Humans , Male , Middle Aged , Myocardial Infarction/etiology , Prospective Studies , Prosthesis Design , Risk Factors , Severity of Illness Index , Single-Blind Method , Time Factors , Treatment OutcomeABSTRACT
OBJECTIVES: To report 1- and 2-year clinical outcomes of patients receiving platinum chromium everolimus-eluting stents (PtCr-EES) in the prospective, single-arm PLATINUM small vessel (SV) and long lesion (LL) studies. BACKGROUND: Small vessel diameter and long lesion length are independently associated with increased risk of adverse cardiac events after drug-eluting stent implantation. METHODS: The PLATINUM SV study enrolled 94 patients with coronary artery lesions in vessels ≥2.25 mm to <2.50 mm in diameter and ≤28 mm in length. The PLATINUM LL study enrolled 102 patients with lesions >24 to ≤34 mm long in vessels ≥2.50 to ≤4.25 mm in diameter. The primary endpoint for both studies was target lesion failure (TLF) at 1 year compared to a prespecified performance goal based on outcomes with the TAXUS Express paclitaxel-eluting stent in small vessels and long lesions. RESULTS: One-year TLF rates with the PtCr-EES were significantly (P < 0.001) lower than the predetermined performance goals: 2.4% versus 21.1% in the SV cohort and 3.2% versus 19.4% in the LL cohort. Cumulative rates of TLF to 2 years were 4.7% in the SV cohort and 8.8% in the LL cohort. No myocardial infarction or ARC definite/probable stent thromboses occurred in either cohort through 2-year follow-up. CONCLUSIONS: The clinical efficacy and safety outcomes observed in these small vessel and long lesion cohorts support the use of the PtCr-EES in the treatment of small diameter vessels and long lesions.
Subject(s)
Cardiovascular Agents/administration & dosage , Chromium , Coronary Artery Disease/therapy , Drug-Eluting Stents , Percutaneous Coronary Intervention/instrumentation , Platinum , Sirolimus/analogs & derivatives , Aged , Coronary Artery Disease/diagnosis , Europe , Everolimus , Female , Humans , Japan , Male , Middle Aged , New Zealand , Percutaneous Coronary Intervention/adverse effects , Prospective Studies , Prosthesis Design , Sirolimus/administration & dosage , Time Factors , Treatment Outcome , United StatesABSTRACT
BACKGROUND: Continuous improvement in carotid artery stenting (CAS) outcomes, especially for periprocedural death and stroke in high-surgical-risk patients, have been seen in recent randomized trials of CAS versus carotid endarterectomy and CAS registries. However, these studies use stringent inclusion/exclusion criteria for patient, institution, and physician selection. The Carotid Stenting Boston Scientific Surveillance Program (CABANA) study was initiated to evaluate periprocedural outcomes with modern versions of the Carotid Wallstent and FilterWire EZ System for operators with a wide range of clinical specialties, CAS experience and training levels, in patients with a broad range of high-surgical-risk conditions and lesion types. METHODS: This prospective, single-arm study enrolled 1,097 subjects with 1,098 carotid artery lesions at 99 study centers. Investigators were grouped into one of three tiers according to whether they had a high, medium, or low level of previous CAS experience and were also categorized by their CAS-credential-based training requirements for the CABANA study. Follow-up at 30 days includes clinical evaluation and independent neurological and NIH stroke scale assessments. The primary endpoint rate of 30-day composite stroke, death, and MI, as well as the rates of these individual events, will be evaluated across the overall study, by physician experience tier, and by physician training tier. DISCUSSION: The evaluation of periprocedural CAS safety in a real-world environment with modern devices in high-surgical-risk patients treated by physicians with a broad range of training and experience will better inform treatment decisions in the future.
Subject(s)
Angioplasty/instrumentation , Carotid Stenosis/therapy , Embolic Protection Devices , Research Design , Stents , Angioplasty/adverse effects , Angioplasty/mortality , Carotid Stenosis/complications , Carotid Stenosis/mortality , Clinical Competence , Humans , Myocardial Infarction/etiology , Patient Safety , Product Surveillance, Postmarketing , Prospective Studies , Prosthesis Design , Registries , Risk Assessment , Risk Factors , Stroke/etiology , Time Factors , Treatment OutcomeABSTRACT
[Figure: see text].
Subject(s)
Atherosclerosis , Coronary Artery Disease , Drug-Eluting Stents , Percutaneous Coronary Intervention , Absorbable Implants , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/therapy , Everolimus , Humans , Percutaneous Coronary Intervention/adverse effects , Polymers , Prospective Studies , Sirolimus/adverse effects , Stents , Treatment OutcomeABSTRACT
OBJECTIVES: We sought to determine the economic value of early angiography and prophylactic angioplasty to prevent hemodialysis-access thrombosis. BACKGROUND: End stage renal disease consumes more than 6% of the Medicare budget. There is a need to understand the financial impact of each component of care. METHODS: We conducted an observational economic analysis of a closed cohort of 818 hemodialysis patients, of whom 560 were referred for 1437 consecutive radiographic procedures during an 8-year period. Patient-level, bottom-up microcosting methods provided supply and personnel costs before and after expansion of an angiographic referral program. RESULTS: The rate of referral for malfunctioning but nonthrombosed hemodialysis accesses increased from 18.8 +/- 8.8 to 48.3 +/- 11.9 angiographic procedures per 100 patient-years (P < 0.001), which was associated with a decline in access thrombosis from 27.6 to 22.0 events per 100 patient-years (P = 0.029) and a net cost of $34,586 per 100 patient-years. The incremental cost-effectiveness ratio for invasive surveillance was $6,177 per thrombosis event avoided. The angiographic program expanded at the same time that the proportion of autogenous fistulas increased from 28.3% +/- 11.3% to 59.7% +/- 10.7% of total referrals (P = 0.0001). On multivariable logistic regression analysis, the expanded angiography program (P = 0.001) and the proportion of autogenous fistulas (P = 0.0001) were both independently associated with the reduction in access thrombosis. CONCLUSIONS: Given the incremental costs and the relatively modest benefits in preventing access thrombosis, preemptive angiographic management may represent a less efficient use of healthcare resources than increasing the number of patients with autogenous fistulas. (c) 2009 Wiley-Liss, Inc.
Subject(s)
Angiography/economics , Angioplasty, Balloon/economics , Arteriovenous Shunt, Surgical/economics , Blood Vessel Prosthesis Implantation/economics , Graft Occlusion, Vascular/prevention & control , Kidney Failure, Chronic/therapy , Renal Dialysis/economics , Thrombosis/prevention & control , Arteriovenous Shunt, Surgical/adverse effects , Blood Vessel Prosthesis Implantation/adverse effects , Cost Savings , Cost-Benefit Analysis , Graft Occlusion, Vascular/diagnostic imaging , Graft Occlusion, Vascular/economics , Graft Occlusion, Vascular/etiology , Health Care Costs , Health Care Rationing/economics , Humans , Kidney Failure, Chronic/economics , Logistic Models , Models, Economic , Practice Guidelines as Topic , Program Evaluation , Referral and Consultation/economics , Thrombosis/diagnostic imaging , Thrombosis/economics , Thrombosis/etiology , Time Factors , Treatment Outcome , Vascular PatencyABSTRACT
BACKGROUND: Endovascular repair of abdominal aortic aneurysms with the Endologix Powerlink System has been shown to be a safe and effective alternative to open surgery in patients having an aortic neck diameter of up to 26 mm. We report the mid-term outcomes of an endovascular repair approach wherein the infrarenal bifurcated stent graft was placed at the aortoiliac bifurcation, with concomitant placement of a proximal extension having suprarenal orientation for proximal sealing. METHODS: Between 2006 and 2008, eight US sites enrolled 44 consecutive eligible patients presenting with abdominal aortic aneurysm in a prospective, single arm pivotal trial approved by the Food and Drug Administration. Each patient received a Powerlink infrarenal bifurcated stent graft through anatomical fixation at the aortoiliac bifurcation and a suprarenal extension to achieve proximal sealing. Analysis of the primary endpoint (proximal type I endoleak) was evaluated using contrast-enhanced computed tomography scans at 30 days, with on-going long-term follow-up for safety and treatment effectiveness. RESULTS: Patients (89% male) presented at a mean age of 70 ± 10 years with mean maximal aneurysm sac diameter of 5.5 cm. Challenging infrarenal aortic neck anatomy was present in 93% of patients. Technical success was 100% over a mean procedure time of 129 minutes. No aneurysm-related deaths, conversions, ruptures, migrations, or type III or IV endoleaks have been observed. The majority of endoleaks (80%) observed to date are type II. Currently, the primary clinical success rate is 93%. Two endovascular secondary procedures have been performed for resolution of type IA or type IB endoleak, and one surgical intervention was performed for resolution of limb occlusion. Significant reduction in sac diameter is observed to up to 2 years. CONCLUSIONS: The combination of an anatomically-fixed Powerlink infrarenal bifurcated stent graft and a suprarenal proximal extension safely and effectively excludes aneurysms in eligible patients. Longer term follow-up will determine the durability of these findings.
Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortography/methods , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/instrumentation , Endoleak/etiology , Endovascular Procedures/adverse effects , Endovascular Procedures/instrumentation , Female , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Prospective Studies , Prosthesis Design , Risk Assessment , Risk Factors , Stents , Time Factors , Tomography, X-Ray Computed , Treatment Outcome , United StatesABSTRACT
BACKGROUND: Percutaneous coronary intervention of severely calcified lesions carries a high risk of adverse events despite the use of contemporary devices. The Classic Crown Orbital Atherectomy System (OAS) was safe and effective for severely calcified lesion preparation in the ORBIT II study (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) but was not optimized for tight lesions. COAST (Coronary Orbital Atherectomy System Study) evaluated the safety and efficacy of calcified lesion preparation before stent implantation with the Diamondback 360 Micro Crown Coronary OAS, designed for use in tighter lesions. METHODS: COAST was a prospective, multicenter, single-arm study that enrolled 100 patients with severely calcified de novo coronary lesions at 17 sites in the United States and Japan. The primary effectiveness end point was procedural success, defined as stent delivery with residual stenosis <50% without in-hospital major adverse cardiac events (MACE), and the primary safety end point was freedom from MACE (composite of cardiac death, myocardial infarction, or target vessel revascularization) at 30 days. RESULTS: The OAS Micro Crown was inserted in all patients. A stent was delivered with a residual stenosis <50% in all except one patient (99.0%). Procedural success was achieved in 85 (85.0%) subjects versus 391 (88.9%) in ORBIT II (P=0.30), and freedom from MACE at 30 days was achieved in 85.0% versus 89.6% in ORBIT II (P=0.21). Freedom from MACE was 77.8% at 1 year. CONCLUSIONS: Prestent preparation of severely calcified lesions using the novel Micro Crown OAS resulted in similar rates of procedural success and freedom from MACE compared with the Classic Crown OAS. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02132611.
Subject(s)
Atherectomy, Coronary , Coronary Artery Disease/therapy , Percutaneous Coronary Intervention , Vascular Calcification/therapy , Aged , Aged, 80 and over , Atherectomy, Coronary/adverse effects , Atherectomy, Coronary/mortality , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/mortality , Female , Humans , Japan , Male , Middle Aged , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/instrumentation , Percutaneous Coronary Intervention/mortality , Progression-Free Survival , Prospective Studies , Risk Assessment , Risk Factors , Severity of Illness Index , Stents , Time Factors , United States , Vascular Calcification/diagnostic imaging , Vascular Calcification/mortalityABSTRACT
OBJECTIVES: The aim of this study was to determine whether immature hemodialysis fistulas undergo flow-induced adaptive remodeling after successful percutaneous angioplasty. BACKGROUND: Approximately 50% of radiocephalic fistulas remain immature after surgery and cannot be used for hemodialysis. Small fistulas with anastomotic inflow stenoses may undergo salvage angioplasty, but the time course of outward remodeling after successful treatment has not been defined. METHODS: Thirty-two of 39 patients (82%) with inaccessible, hypoplastic radiocephalic fistulas underwent attempted salvage angioplasty of inflow stenoses involving the arteriovenous anastomoses. Twenty patients experienced salvage of their fistulas and successfully underwent hemodialysis (51%). RESULTS: Eleven patients had serial angiographic procedures, which allowed paired sequential quantitative angiographic measurements of the fistulas to be made during a median follow-up of 200 days (range 5-2,298 days). Fistula diameters increased from 4.5 +/- 1.3 mm to 8.0 +/- 2.5 mm (mean +/- S.D.). The mean growth of the fistulas was 1.0 +/- 0.9 mm per year. CONCLUSIONS: The mechanism of adaptive remodeling transforms nonmaturing hypoplastic autogenous fistulas into functioning accessible dialysis accesses after successful percutaneous transluminal angioplasty of inflow anastomotic stenoses.
Subject(s)
Angioplasty, Balloon , Arteriovenous Shunt, Surgical/adverse effects , Brachiocephalic Veins/surgery , Graft Occlusion, Vascular/therapy , Kidney Failure, Chronic/therapy , Radial Artery/surgery , Renal Dialysis , Adaptation, Physiological , Brachiocephalic Veins/diagnostic imaging , Brachiocephalic Veins/physiopathology , Constriction, Pathologic , Female , Graft Occlusion, Vascular/diagnostic imaging , Graft Occlusion, Vascular/etiology , Graft Occlusion, Vascular/physiopathology , Humans , Male , Radial Artery/diagnostic imaging , Radial Artery/physiopathology , Radiography , Regional Blood Flow , Salvage Therapy , Time Factors , Treatment Outcome , Vascular PatencyABSTRACT
OBJECTIVES: The aim of the present study was to quantify the probability of increased mortality with paclitaxel compared with control in a dataset of 28 randomized controlled trials. BACKGROUND: Analysis of data from 28 randomized controlled trials using conventional null-hypothesis statistical testing has produced the unexpected finding of a 68% increase in mortality at 2 years and a 93% increase at 3 to 5 years after using paclitaxel-eluting balloons and stents to treat femoropopliteal arterial disease, but no biologic explanation for increased mortality has been identified. METHODS: A Bayesian sequential model was developed to quantify the probability of increased mortality 1, 2, and 3 to 5 years after treatment, and p values were replaced with meta-analytic Bayes factors (BFs), which provide decisive evidence at values >100 and very strong evidence at values of 32 to 100. RESULTS: The evidence for increased mortality at 1 year (BF = 0.02), 2 years (BF = 8.5), and 3 to 5 years (BF = 14.6) was less than conclusive. All-cause mortality at 1 year was similar between the paclitaxel and control arms at 1 year (odds ratio: 0.92; 95% Bayesian credible interval: 0.53 to 1.53) and 2 years (odds ratio: 1.23; 95% Bayesian credible interval: 0.84 to 1.71) but was increased at 3 to 5 years (odds ratio: 1.43; 95% Bayesian credible interval: 1.01 to 1.90). CONCLUSIONS: This study finds some support for increased mortality after using paclitaxel-eluting devices in femoropopliteal arterial disease, but the evidence is not unequivocal and may not sway skeptical investigators concerned about causation, unreported studies, or the post hoc analysis of trials underpowered for mortality.
Subject(s)
Angioplasty, Balloon/instrumentation , Angioplasty, Balloon/mortality , Cardiovascular Agents/administration & dosage , Coated Materials, Biocompatible , Drug-Eluting Stents , Paclitaxel/administration & dosage , Peripheral Arterial Disease/therapy , Vascular Access Devices , Angioplasty, Balloon/adverse effects , Bayes Theorem , Cardiovascular Agents/adverse effects , Humans , Paclitaxel/adverse effects , Peripheral Arterial Disease/mortality , Prosthesis Design , Randomized Controlled Trials as Topic , Risk Assessment , Risk Factors , Time Factors , Treatment OutcomeABSTRACT
BACKGROUND: The thin-strut SYNERGY stent has an abluminal everolimus-eluting bioabsorbable polymer coating designed to facilitate vascular healing and reduce risk of stent thrombosis. In the multicenter, randomized EVOLVE II trial (The EVOLVE II Clinical Trial to Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion[s]), SYNERGY was noninferior to the durable polymer PROMUS Element Plus everolimus-eluting stent for the primary end point of 1-year target lesion failure. Longer-term clinical follow-up will support the relative efficacy and safety of SYNERGY. METHODS: Patients with ≤3 native coronary lesions (reference vessel diameter ≥2.25-≤4.00 mm; length ≤34 mm) in ≤2 major epicardial vessels were randomized 1:1 to SYNERGY (N=838) or PROMUS Element Plus (N=846). EVOLVE II included a Diabetes substudy which pooled patients with diabetes mellitus from the randomized controlled trial (n=263) and from a sequential, single-arm substudy (N=203). RESULTS: The 5-year target lesion failure rate was 14.3% for SYNERGY and 14.2% for PROMUS Element Plus (P=0.91). Landmark analysis demonstrated similar rates of target lesion failure from discharge to 1-year (P=0.90) and from 1 to 5 years (P=0.94). Definite/probable stent thrombosis was infrequent in both arms (SYNERGY 0.7% versus PROMUS Element Plus 0.9%; P=0.75). There were no significant differences in the rates of cardiac death, myocardial infarction, or revascularization. Among patients with diabetes mellitus, the target lesion failure rate to 1-year was noninferior to a prespecified performance goal and to 5 years was 17.0%. CONCLUSIONS: SYNERGY demonstrated comparable outcomes to PROMUS Element Plus, with low rates of stent thrombosis and adverse events through 5 years of follow-up. Five-year clinical outcomes were favorable in patients with diabetes mellitus. These data support the long-term safety and effectiveness of SYNERGY in a broad range of patients. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01665053.
Subject(s)
Absorbable Implants , Cardiovascular Agents/administration & dosage , Coronary Artery Disease/therapy , Diabetes Mellitus/therapy , Drug-Eluting Stents , Everolimus/administration & dosage , Percutaneous Coronary Intervention/instrumentation , Polymers , Aged , Cardiovascular Agents/adverse effects , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/mortality , Diabetes Mellitus/diagnosis , Diabetes Mellitus/mortality , Everolimus/adverse effects , Female , Humans , Male , Middle Aged , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/mortality , Prosthesis Design , Risk Factors , Time Factors , Treatment OutcomeABSTRACT
Several sub-Saharan militaries have large percentages of troops with human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome. With the arrival of avian influenza in Africa, the potential exists that some of those soldiers might also become infected with H5N1, the virus responsible for the disease. Two possible scenarios have been postulated regarding how such a coinfection of HIV and H5N1 might present. (1) Soldiers already weakened by HIV/acquired immunodeficiency syndrome rapidly succumb to H5N1. The cause of death is a "cytokine storm," essentially a runaway inflammatory response. (2) The weakened immune system prevents the cytokine storm from occurring; however, H5N1 is still present, replicating, and being shed, leading to the infection of others. A cytokine storm is particularly dangerous for individuals of military age, as evidenced by the large number of soldiers who died during the 1918 influenza epidemic. If large numbers of sub-Saharan soldiers suffer a similar fate from avian influenza, then military and political instability could develop.
Subject(s)
Disease Outbreaks , HIV Infections/epidemiology , Influenza A Virus, H5N1 Subtype , Influenza in Birds/transmission , Military Medicine , Military Personnel , Africa South of the Sahara/epidemiology , Animals , Birds , Geography , HIV Infections/immunology , HIV Infections/transmission , Humans , Influenza in Birds/epidemiology , United StatesABSTRACT
OBJECTIVES: The authors sought to evaluate the final 5-year safety and effectiveness of the platinum-chromium everolimus-eluting stent (PtCr-EES) in the randomized trial, as well as in 2 single-arm substudies that evaluated PtCr-EES in small vessels (diameter <2.5 mm; n = 94) and long lesions (24 to 34 mm; n = 102). BACKGROUND: In the multicenter, randomized PLATINUM (PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions), the PtCr-EES was noninferior to the cobalt-chromium everolimus-eluting stent (CoCr-EES) at 1 year in 1,530 patients undergoing percutaneous coronary intervention. METHODS: Patients with 1 or 2 de novo coronary artery lesions (reference vessel diameter 2.50 to 4.25 mm, length ≤24 mm) were randomized 1:1 to PtCr-EES versus CoCr-EES. All patients in the substudies received PtCr-EES. The primary endpoint was target lesion failure (TLF), a composite of target vessel-related cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization. RESULTS: In the randomized trial, the 5-year TLF rate was 9.1% for PtCr-EES and 9.3% for CoCr-EES (hazard ratio [HR]: 0.97; p = 0.87). Landmark analysis demonstrated similar TLF rates from discharge to 1 year (HR: 1.12; p = 0.70) and from 1 to 5 years (HR: 0.90; p = 0.63). There were no significant differences in the rates of cardiac death, myocardial infarction, target lesion or vessel revascularization, or stent thrombosis. PtCr-EES had 5-year TLF rates of 7.0% in small vessels and 13.6% in long lesions. CONCLUSIONS: PtCr-EES demonstrated comparable safety and effectiveness to CoCr-EES through 5 years of follow-up, with low rates of stent thrombosis and other adverse events. The 5-year event rates were also acceptable in patients with small vessels and long lesions treated with PtCr-EES. (The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions [PLATINUM]; NCT00823212; The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions in Small Vessels [PLATINUM SV]; NCT01498692; The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of Long De Novo Coronary Artery Lesions [PLATINUM LL]; NCT01500434).
Subject(s)
Cardiovascular Agents/administration & dosage , Chromium Alloys , Coronary Artery Disease/therapy , Drug-Eluting Stents , Everolimus/administration & dosage , Percutaneous Coronary Intervention/instrumentation , Platinum , Aged , Asia , Cardiovascular Agents/adverse effects , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/mortality , Coronary Thrombosis/etiology , Europe , Everolimus/adverse effects , Female , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Myocardial Infarction/etiology , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/mortality , Proportional Hazards Models , Prosthesis Design , Risk Factors , Time Factors , Treatment Outcome , United StatesABSTRACT
Glycoprotein (GP) IIb/IIIa inhibitors are often used as a rescue or bailout therapy to manage complications arising during percutaneous coronary intervention, rather than as prophylactic treatment. We sought to identify the characteristics and outcomes of patients requiring bailout treatment. The ESPRIT trial randomized 2,064 patients to receive eptifibatide or placebo starting immediately before percutaneous coronary intervention (PCI). Bailout therapy was used in 77 patients: 43 (4.2%) randomized to placebo and 34 (3.3%) to eptifibatide (p = 0.3). Bailout therapy for thrombosis was used more often in the placebo group (2.1% versus 1.0%; p = 0.03). Multivariable predictors of bailout included a greater than or equal to 90% stenosis, or visible thrombus on the baseline angiogram, and no aspirin pre-treatment before PCI. However, overall the model predicted bailout poorly (c-index = 0.64). The need for bailout cannot be reliably predicted using baseline characteristics. Patients experiencing complications have poor clinical outcomes despite bailout use of GP IIb/IIIa inhibitors.
Subject(s)
Cardiac Catheterization/adverse effects , Coronary Artery Disease/therapy , Peptides/therapeutic use , Platelet Glycoprotein GPIIb-IIIa Complex/antagonists & inhibitors , Stents , Aged , Angioplasty, Balloon, Coronary/adverse effects , Eptifibatide , Female , Humans , Male , Middle Aged , PlacebosABSTRACT
BACKGROUND: Drug eluting stents with durable polymers may be associated with hypersensitivity, delayed healing, and incomplete endothelialization, which may contribute to late/very late stent thrombosis and the need for prolonged dual antiplatelet therapy. Bioabsorbable polymers may facilitate stent healing, thus enhancing clinical safety. The SYNERGY stent is a thin-strut, platinum chromium metal alloy platform with an ultrathin bioabsorbable Poly(D,L-lactide-co-glycolide) abluminal everolimus-eluting polymer. We performed a multicenter, randomized controlled trial for regulatory approval to determine noninferiority of the SYNERGY stent to the durable polymer PROMUS Element Plus everolimus-eluting stent. METHODS AND RESULTS: Patients (n=1684) scheduled to undergo percutaneous coronary intervention for non-ST-segment-elevation acute coronary syndrome or stable coronary artery disease were randomized to receive either the SYNERGY stent or the PROMUS Element Plus stent. The primary end point of 12-month target lesion failure was observed in 6.7% of SYNERGY and 6.5% PROMUS Element Plus treated subjects by intention-to-treat (P=0.83 for difference; P=0.0005 for noninferiority), and 6.4% in both the groups by per-protocol analysis (P=0.0003 for noninferiority). Clinically indicated revascularization of the target lesion or definite/probable stent thrombosis were observed in 2.6% versus 1.7% (P=0.21) and 0.4% versus 0.6% (P=0.50) of SYNERGY versus PROMUS Element Plus-treated subjects, respectively. CONCLUSIONS: In this randomized trial, the SYNERGY bioabsorbable polymer everolimus-eluting stent was noninferior to the PROMUS Element Plus everolimus-eluting stent with respect to 1-year target lesion failure. These data support the relative safety and efficacy of SYNERGY in a broad range of patients undergoing percutaneous coronary intervention. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01665053.
Subject(s)
Absorbable Implants/statistics & numerical data , Acute Coronary Syndrome/surgery , Biocompatible Materials/administration & dosage , Blood Vessel Prosthesis Implantation , Coronary Artery Disease/surgery , Everolimus/administration & dosage , Percutaneous Coronary Intervention , Absorbable Implants/adverse effects , Aged , Biocompatible Materials/adverse effects , Biocompatible Materials/chemistry , Dioxanes , Drug-Eluting Stents/statistics & numerical data , Everolimus/adverse effects , Female , Follow-Up Studies , Humans , Male , Middle Aged , Platinum Compounds , Polymers/administration & dosage , Polymers/adverse effects , Treatment OutcomeABSTRACT
BACKGROUND: Bifurcation lesions are frequent among patients with symptomatic coronary disease treated by percutaneous coronary intervention. Current evidence recommends a conservative (provisional) approach when treating the side branch (SB). OBJECTIVES: The TRYTON (Prospective, Single Blind, Randomized Controlled Study to Evaluate the Safety & Effectiveness of the Tryton Side Branch Stent Used With DES in Treatment of de Novo Bifurcation Lesions in the Main Branch & Side Branch in Native Coronaries) bifurcation trial sought to compare treatment of de novo true bifurcation lesions using a dedicated bifurcation stent or SB balloon angioplasty. METHODS: We randomly assigned patients with true bifurcation lesions to a main vessel stent plus provisional stenting or the bifurcation stent. The primary endpoint (powered for noninferiority) was target vessel failure (TVF) (cardiac death, target vessel myocardial infarction, and target vessel revascularization). The secondary angiographic endpoint (powered for superiority) was in-segment percent diameter stenosis of the SB at 9 months. RESULTS: We randomized 704 patients with bifurcation coronary lesions at 58 centers (30 from Europe and 28 from the United States). At 9 months, TVF was 17.4% in the bifurcation stent group compared with 12.8% in the provisional group (p=0.11), mainly because of a higher periprocedural myocardial infarction rate (13.6% vs. 10.1%, p=0.19). The TVF difference of +4.6% (2-sided 95% confidence interval: -1.0 to 10.3; upper limit of the 1-sided 95% confidence interval: 10.3) was not within the pre-specified noninferiority margin of 5.5% (p=0.42 for noninferiority). The SB in-segment diameter stenosis among the angiographic cohort was lower in the bifurcation stent group compared with the provisional group (31.6% vs. 38.6%, p=0.002 for superiority), with no difference in binary restenosis rates (diameter stenosis≥50%) at 9 months follow-up (22.6% vs. 26.8%, p=0.44). CONCLUSIONS: Provisional stenting should remain the preferred strategy for treatment of non-left main true coronary bifurcation lesions. (Prospective, Single Blind, Randomized Controlled Study to Evaluate the Safety & Effectiveness of the Tryton Side Branch Stent Used With DES in Treatment of de Novo Bifurcation Lesions in the Main Branch & Side Branch in Native Coronaries [TRYTON]; NCT01258972).
Subject(s)
Angioplasty, Balloon, Coronary/methods , Coronary Stenosis/surgery , Coronary Vessels/surgery , Drug-Eluting Stents , Coronary Angiography , Coronary Stenosis/diagnostic imaging , Europe , Female , Follow-Up Studies , Humans , Male , Middle Aged , Prospective Studies , Prosthesis Design , Single-Blind Method , Time Factors , Treatment Outcome , United StatesABSTRACT
OBJECTIVES: The ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial evaluated the safety and efficacy of the coronary Orbital Atherectomy System (OAS) to prepare de novo, severely calcified coronary lesions for stent placement. BACKGROUND: Despite advances in interventional techniques, treatment of calcified coronary lesions remains a challenge. Stent placement in these lesions may result in stent underexpansion, malapposition, and procedural complications. METHODS: ORBIT II is a prospective, multicenter, nonblinded clinical trial that enrolled 443 consecutive patients with severely calcified coronary lesions at 49 U.S. sites from May 25, 2010, to November 26, 2012. Investigators used the centrifugal action of the OAS diamond-coated crown to modify calcified lesions prior to stent placement. RESULTS: The pre-procedure mean minimal lumen diameter of 0.5 mm increased to 2.9 mm after the procedure. The primary safety endpoint was 89.6% freedom from 30-day major adverse cardiac events compared with the performance goal of 83%. The primary efficacy endpoint (residual stenosis <50% post-stent without in-hospital major adverse cardiac events) was 88.9% compared with the performance goal of 82%. Stent delivery occurred successfully in 97.7% of cases with <50% stenosis in 98.6% of subjects. Low rates of in-hospital Q-wave myocardial infarction (0.7%), cardiac death (0.2%), and target vessel revascularization (0.7%) were reported. CONCLUSIONS: The ORBIT II coronary OAS trial met both the primary safety and efficacy endpoints by significant margins. Preparation of severely calcified plaque with the OAS not only helped facilitate stent delivery, but improved both acute and 30-day clinical outcomes compared with the outcomes of historic control subjects in this difficult-to-treat patient population. (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions [ORBIT II]; NCT01092416).
Subject(s)
Atherectomy, Coronary/instrumentation , Coronary Stenosis/therapy , Vascular Calcification/therapy , Aged , Atherectomy, Coronary/adverse effects , Coronary Stenosis/diagnosis , Coronary Stenosis/mortality , Equipment Design , Female , Humans , Male , Myocardial Infarction/etiology , Myocardial Infarction/mortality , Percutaneous Coronary Intervention/instrumentation , Prospective Studies , Severity of Illness Index , Stents , Time Factors , Treatment Outcome , United States , Vascular Calcification/diagnosis , Vascular Calcification/mortalityABSTRACT
OBJECTIVES: We sought to evaluate the clinical outcomes with a novel platinum chromium everolimus-eluting stent (PtCr-EES) compared with a predicate cobalt chromium everolimus-eluting stent (CoCr-EES) in patients undergoing percutaneous coronary intervention (PCI). BACKGROUND: Randomized trials have demonstrated an excellent safety and efficacy profile for the CoCr-EES. The PtCr-EES uses the identical antiproliferative agent and polymer but with a novel platinum chromium scaffold designed for enhanced deliverability, vessel conformability, side-branch access, radiopacity, radial strength, and fracture resistance. METHODS: A total of 1,530 patients undergoing PCI of 1 or 2 de novo native lesions were randomized at 132 worldwide sites to CoCr-EES (n = 762) or PtCr-EES (n = 768). The primary endpoint was the 12-month rate of target lesion failure (TLF), the composite of target vessel-related cardiac death, target vessel-related myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR) in the per-protocol population (patients who received ≥1 assigned study stent), powered for noninferiority. RESULTS: The 12-month rate of TLF in the per-protocol population occurred in 2.9% versus 3.4% of patients assigned to CoCr-EES versus PtCr-EES, respectively (difference: 0.5%, 95% confidence interval: -1.3% to 2.3%, p(noninferiority) = 0.001, p(superiority) = 0.60). By intention-to-treat, there were no significant differences between CoCr-EES and PtCr-EES in the 12-month rates of TLF (3.2% vs. 3.5%, p = 0.72), cardiac death or MI (2.5% vs. 2.0%, p = 0.56), TLR (1.9% vs. 1.9%, p = 0.96), or Academic Research Consortium definite or probable stent thrombosis (0.4% vs. 0.4%, p = 1.00). CONCLUSIONS: In this large-scale, prospective, single-blind randomized trial, a novel PtCr-EES was noninferior to the predicate CoCr-EES for TLF, with nonsignificant differences in measures of safety and efficacy through 12-month follow-up after PCI.
Subject(s)
Coronary Artery Disease/drug therapy , Drug-Eluting Stents/trends , Sirolimus/analogs & derivatives , Aged , Coronary Artery Disease/physiopathology , Coronary Artery Disease/surgery , Drug-Eluting Stents/standards , Everolimus , Female , Follow-Up Studies , Humans , Male , Middle Aged , Prospective Studies , Single-Blind Method , Sirolimus/administration & dosage , Treatment OutcomeABSTRACT
OBJECTIVES: The aim of this study was to evaluate the safety and efficacy of the novel platinum chromium TAXUS Element paclitaxel-eluting stent (PES) compared with the TAXUS Express PES (Boston Scientific, Natick, Massachusetts) in treating coronary artery stenoses. BACKGROUND: The TAXUS Element is a novel thin-strut (81 microm), platinum chromium alloy PES designed to improve radial strength, radiopacity, and deliverability, while safely providing comparable restenosis benefit compared with a previous-generation PES. METHODS: The PERSEUS (Prospective Evaluation in a Randomized Trial of the Safety and Efficacy of the Use of the TAXUS Element Paclitaxel-Eluting Coronary Stent System) Workhorse (WH) trial is a prospective, randomized (3:1), controlled, multicenter study of the TAXUS Element (vs. TAXUS Express) PES for the treatment of de novo coronary atherosclerotic lesionsSubject(s)
Chromium Alloys/administration & dosage
, Coronary Angiography/standards
, Coronary Stenosis/diagnostic imaging
, Coronary Stenosis/drug therapy
, Drug-Eluting Stents/standards
, Paclitaxel/administration & dosage
, Aged
, Chromium/administration & dosage
, Chromium/adverse effects
, Chromium Alloys/adverse effects
, Drug-Eluting Stents/adverse effects
, Female
, Follow-Up Studies
, Humans
, Male
, Middle Aged
, Paclitaxel/adverse effects
, Platinum/administration & dosage
, Platinum/adverse effects
, Prospective Studies
, Single-Blind Method
, Treatment Outcome
ABSTRACT
OBJECTIVES: We sought to evaluate the relative safety and efficacy of the novel Interceptor PLUS Coronary Filter System (Medtronic Vascular, Santa Rosa, California) compared with approved embolic-protection devices (e.g., GuardWire, Medtronic Vascular/FilterWire EZ, Boston Scientific, Natick, Massachusetts) during percutaneous coronary intervention (PCI) of degenerative saphenous vein grafts (SVG). BACKGROUND: Percutaneous coronary intervention of degenerative SVG is associated with embolization of atherothrombotic debris and subsequent myocardial infarction in a significant portion of patients. The use of distal embolic-protection devices has previously been demonstrated to reduce major adverse cardiovascular events associated with PCI in these patients. METHODS: In this multicenter, randomized noninferiority trial, 797 patients undergoing PCI with stenting of SVG stenoses (de novo or restenotic) with reference vessel diameter 2.5 mm to 5.25 mm were randomly assigned 2:1 to either the Interceptor PLUS (n = 533) or control distal-protection devices (GuardWire [n = 191], FilterWire EZ [n = 73]) at the physician's discretion. RESULTS: The trial primary clinical end point (composite occurrence of death, myocardial infarction, or urgent repeat revascularization through 30 days) was observed in 8% and 7.3% of Interceptor and control-treated patients, respectively (p = 0.025 for noninferiority; p = 0.77 for difference). Key secondary end points for device and procedural success were similar between randomly assigned treatment strategies. CONCLUSIONS: The Interceptor PLUS Coronary Filter System is noninferior in safety and efficacy to 30 days when compared with the GuardWire and FilterWire EZ distal embolic protection devices.