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Biomedical subjects

James Hermiller

Publications and source records attributed to James Hermiller.

14 recordsLinked to original sources
PubMed2006

Impact of routine angiographic follow-up on the clinical benefits of paclitaxel-eluting stents: results from the TAXUS-IV trial.

OBJECTIVES: The objectives of the study were to evaluate the effect of angiographic follow-up on revascularization rates in the TAXUS-IV trial and to determine whether the relative benefit of paclitaxel-eluting stent implantation compared with bare metal stent implantation was modified by angiographic follow-up. BACKGROUND: Although several clinical trials have demonstrated that drug-eluting stents (DES) reduce restenosis compared with bare-metal stents (BMS), virtually all of these studies have incorporated angiographic follow-up. METHODS: In the TAXUS-IV trial, 1,314 percutaneous coronary intervention patients were randomized to receive paclitaxel-eluting stents (PES) (n = 662) or identical-appearing BMS (n = 652). Clinical outcomes were compared, stratified by assignment to angiographic follow-up or clinical follow-up alone. RESULTS: Compared with clinical follow-up alone, angiographic follow-up patients had a significantly higher rate of target vessel revascularization (TVR) at 1 year (adjusted hazard ratio [HR] 1.46; p = 0.04), with similar relative increases in PES and BMS patients. Because PES reduced TVR by approximately 60% regardless of type of follow-up, assignment to angiographic follow-up tended to overestimate the absolute benefit of PES relative to clinical follow-up alone. In contrast, assessment of end points immediately before the time of follow-up angiography led to substantial underestimation of the absolute benefit of PES implantation. CONCLUSIONS: Performance of mandatory angiographic follow-up increases rates of TVR among patients receiving both BMS and PES and overestimates the absolute clinical benefits of PES relative to clinical follow-up alone. Nonetheless, PES substantially reduces TVR regardless of assignment to mandatory angiographic follow-up or not. Future studies designed to determine the true clinical benefits of DES should either forgo routine angiographic follow-up or separate the time of repeat angiography from the primary clinical end point by as long as possible.

Angioplasty, Balloon, Coronary↗
PubMed2006

Platelet glycoprotein IIb/IIIa receptor inhibition as adjunctive treatment during saphenous vein graft stenting: differential effects after randomization to occlusion or filter-based embolic protection.

AIMS: Although embolic protection devices reduce complications during saphenous vein graft (SVG) stenting, adverse events still occur in approximately 10% of patients. IIb/IIIa antagonists have not been proven effective during SVG intervention. We hypothesized that adjunctive use of these agents might enhance the efficacy of embolic protection devices. METHODS AND RESULTS: In the prospective, multicentre FilterWire EX Randomized Evaluation trial, 651 patients undergoing SVG stenting were randomized to either filter-based FilterWire EX or balloon occlusion/aspiration GuardWire embolic protection devices. IIb/IIIa inhibitor use was at the discretion of the investigator, with randomization stratified by intended use. Patients pre-selected for IIb/IIIa inhibitor use (n = 345) had higher baseline risk, with increased 30-day major adverse cardiac events (MACE, 13.0 vs. 8.0%, P = 0.03). GuardWire assigned patients treated with IIb/IIIa inhibitors had higher 30-day MACE compared with those not treated with IIb/IIIa inhibitors (16.0 vs. 6.3%, P = 0.007). In contrast, MACE in high-risk FilterWire patients treated with IIb/IIIa inhibitors were similar to their lower risk, untreated counterparts (9.9 vs. 9.5%, P = 0.89). Multivariable analysis detected a borderline significant (P = 0.056) interaction for lower MACE between FilterWire and IIb/IIIa inhibitor use. Adjustment by the propensity to use IIb/IIIa inhibitors resulted in a significant (P = 0.023) interaction for lower MACE rates. IIb/IIIa inhibition in conjunction with FilterWire was associated with less abrupt closure, no reflow, or distal embolization. CONCLUSION: IIb/IIIa antagonists may improve procedural outcome during SVG stenting in high risk patients, utilizing filter-based embolic protection devices.

Aged↗
PubMed2006

Six-month outcomes after percutaneous intervention for lesions in aortocoronary saphenous vein grafts using distal protection devices: results from the FIRE trial.

BACKGROUND: The filter-based FilterWire EX (Boston Scientific, Natick, MA) embolic protection system and the GuardWire (Medtronic, Santa Rosa, CA) balloon occlusion and aspiration device have been previously shown to reduce periprocedural complication rates of percutaneous coronary intervention for saphenous vein graft (SVG) disease and are considered the standard of care in this setting. The late clinical course after treatment with these devices has not been reported. METHODS: In the FIRE trial, 651 patients undergoing SVG intervention were randomized to either the FilterWire EX or GuardWire. Six-month rates of the primary end point (composite major adverse cardiac events [MACE]) and its components (death, myocardial infarction [MI], or target vessel revascularization) were studied. RESULTS: MACE at 30 days occurred in 9.9% of patients randomized to the FilterWire EX compared with 11.6% with the GuardWire, P = .53. By 6 months, MACE had increased to 19.3% and 21.9% in FilterWire EX and GuardWire groups, respectively, (relative risk 0.88, 95% CI 0.65-1.19; P = .44). All-cause 6-month mortality in the entire population was 3.5% (3.0% with FilterWire EX vs 4.1% with GuardWire, P = .53, with all deaths occurring after hospital discharge). MI occurred in 12.0% of patients at 6 months (12.1% vs 11.9% with the FilterWire EX and GuardWire, respectively, P = .99), and target vessel revascularization was required in 9.1% (8.2% vs 10.0%, respectively, P = .42). CONCLUSIONS: SVG intervention with the FilterWire EX and GuardWire distal protection devices resulted in similar outcomes at 6 months, although the clinical course after hospital discharge was not benign, with significant rates of death, MI, and repeat intervention.

Aged↗
PubMed2005

Polymer-based paclitaxel-eluting stents reduce in-stent neointimal tissue proliferation: a serial volumetric intravascular ultrasound analysis from the TAXUS-IV trial.

OBJECTIVES: The aim of this study was to use serial volumetric intravascular ultrasound (IVUS) to evaluate the effects of polymer-based, paclitaxel-eluting stents on in-stent neointima formation and late incomplete stent apposition. BACKGROUND: The TAXUS-IV trial demonstrated that the slow-release, polymer-based, paclitaxel-eluting stent reduces angiographic restenosis and the need for repeat revascularization procedures. Serial IVUS studies reveal details of the pattern of vascular responses provoked by stent implantation that provide insight into device safety and efficacy. METHODS: In the TAXUS-IV trial, patients were randomized to the slow-release, polymer-based, paclitaxel-eluting TAXUS stent or a bare-metal EXPRESS stent (Boston Scientific Corp., Natick, Massachusetts). As part of a formal substudy, complete volumetric IVUS data were available in 170 patients, including 88 TAXUS patients and 82 controls, at implantation and at nine-month follow-up. RESULTS: No baseline differences were present in the clinical characteristics or IVUS parameters between the control and TAXUS groups. At nine-month follow-up, IVUS lumen volumes were larger in the TAXUS group (123 +/- 43 mm(3) vs. 104 +/- 44 mm(3), p = 0.005), due to a reduction in neointimal volume (18 +/- 18 mm(3) vs. 41 +/- 23 mm(3), p < 0.001). Millimeter-by-millimeter analysis within the stent demonstrated uniform suppression of neointimal growth along the entire stent length. Late lumen loss was similar at the proximal edge of the stent between the two groups, and reduced with the TAXUS stent at the distal edge (p = 0.004). Incomplete stent apposition at nine months was observed in only 3.0% of control and 4.0% of TAXUS stents (p = 0.12). CONCLUSIONS: Polymer-based, paclitaxel-eluting TAXUS stents are effective in inhibiting neointimal tissue proliferation, and do not result in late incomplete stent apposition.

Antineoplastic Agents↗
PubMed2005

Relationship between angiographic late loss and target lesion revascularization after coronary stent implantation: analysis from the TAXUS-IV trial.

OBJECTIVES: We sought to evaluate the relationship between angiographic late loss and clinical outcomes in the drug-eluting stent era. BACKGROUND: The interrelationship between angiographic late loss, binary restenosis, and clinical recurrence (target lesion revascularization [TLR]) after coronary stent implantation has been incompletely evaluated. METHODS: Using the angiographic substudy of the TAXUS-IV trial, in which 1,314 patients with de novo coronary lesions were randomized to either the paclitaxel-eluting TAXUS stent or to its bare-metal equivalent, we defined the relationship between in-stent and analysis segment late loss, the shape of the late loss histogram (variance and skewedness), and nine-month TLR. RESULTS: Late loss by several measures was closely related to TLR (area under the receiver-operator curve >0.90). For individual vessels of the size in this study (2.8 +/- 0.5 mm), the likelihood of TLR did not exceed 5% until analysis segment late loss was >0.5 mm, and did not exceed 10% until late loss was >0.65 mm. At greater late losses, the late loss TLR relationship was steep and nearly linear. For the overall patient cohort, the rate of TLR was related, however, not only to median late loss, but also to measures of its statistical distribution (TLR increased with lack of homogeneous biologic response [greater variance and greater right skewedness]). Similar relationships held for late loss measured within the confines of the stent itself. CONCLUSIONS: Coronary stents result in large lumens with "room" to accommodate up to approximately 0.5 to 0.65 mm of tissue (angiographic analysis segment late loss) before the likelihood of clinical restenosis (TLR) exceeds 5% to 10%. These data have important implications toward understanding the absolute and relative efficacy of drug-eluting stents.

Angina Pectoris↗
PubMed2005

Influence of vessel diameter on the efficacy of distal protection devices during saphenous vein graft intervention.

We sought to determine the influence of vessel diameter on the efficacy of distal protection devices during saphenous vein graft intervention. From the Filterwire EX Randomized Evaluation trial, in which patients who underwent saphenous vein graft stenting were randomized to distal protection with the GuardWire or FilterWire EX, outcomes in 572 patients were examined in vessel size tertiles. The 30-day composite incidence of major adverse cardiac events (MACEs) increased with vessel size and was 6.9%, 9.7%, and 14.9% in the smallest, middle, and largest tertiles, respectively (p = 0.04). MACE rates were relatively vessel size independent for the GuardWire but increased steadily with vessel size with the FilterWire EX. In the smallest tertile, MACEs were reduced by 71% with the FilterWire EX compared with the GuardWire (p = 0.05), with the devices showing similar event rates in the other tertiles.

Aged↗
PubMed2005

Clinical experience with a circumferential clip-based vascular closure device in diagnostic catheterization.

BACKGROUND: The StarClose Vascular Closure System (Abbott Vascular Devices, Redwood City, California) utilizes a small, flexible nitinol clip to complete a circumferential, extravascular closure of the femoral arteriotomy site. The StarClose is an investigational device in the United States, limited by Federal law to investigational use. The StarClose is CE Mark approved. METHODS: The CLIP study was a prospective, randomized, multicenter trial utilizing a noninferiority design to compare the rate of major vascular complications and time-to-hemostasis using the StarClose system versus manual compression. A total of 596 subjects were enrolled, 208 of whom underwent diagnostic angiography. This diagnostic subset is the focus of this report. The primary safety endpoint was major vascular complications and the primary efficacy endpoint was time-to-hemostasis. All patients were followed at 30 days with a clinical exam. RESULTS: Subjects were randomized 2:1 to the StarClose (n = 136) or manual compression (n = 72). There were no major vascular complications in either group. Minor vascular complications occurred in 3 StarClose patients (2.2%), and 1 manual compression patient (1.4%) (p = 1.00). Use of the StarClose device reduced mean time-to-hemostasis from 15.47 +/- 11.4 to 1.46 +/- 4.5 minutes (p < 0.001) when compared to manual compression, and reduced the average time-to-ambulation from 269 +/- 135 to 163 +/- 105 minutes (p < or = 0.001). Device success was 94.1% (127/135), and procedural success was 100% (136/136). CONCLUSION: The clinical results of this study concluded that the StarClose Vascular Closure System is noninferior to standard compression with respect to the the primary safety endpoint of closing arteriotomies in patients who undergo percutaneous diagnostic procedures.

Alloys↗
PubMed2004

One-year clinical results with the slow-release, polymer-based, paclitaxel-eluting TAXUS stent: the TAXUS-IV trial.

BACKGROUND: The safety and efficacy of the slow-release, polymer-based, paclitaxel-eluting stent after implantation in a broad cross section of de novo coronary lesions at 1 year are unknown. METHODS AND RESULTS: In the TAXUS-IV trial, 1314 patients with single de novo coronary lesions 10 to 28 mm in length, with reference-vessel diameter 2.5 to 3.75 mm, coverable by a single study stent, were prospectively randomized to the slow-release, polymer-based, paclitaxel-eluting TAXUS stent or an identical-appearing bare-metal EXPRESS stent. By actuarial analysis, the TAXUS stent compared with the bare-metal stent reduced the 12-month rates of target-lesion revascularization by 73% (4.4% versus 15.1%, P<0.0001), target-vessel revascularization by 62% (7.1% versus 17.1%, P<0.0001), target-vessel failure by 52% (10.0% versus 19.4%, P<0.0001), and composite major adverse cardiac events by 49% (10.8% versus 20.0%, P<0.0001). The 1-year rates of cardiac death (1.4% versus 1.3%), myocardial infarction (3.5% versus 4.7%), and subacute thrombosis (0.6% versus 0.8%) were similar between the paclitaxel-eluting and control stents, respectively. Between 9 and 12 months, there were significantly fewer myocardial infarctions (0% versus 1.1%, P=0.007), target-vessel revascularizations (2.4% versus 5.8%, P=0.002), and major adverse cardiac events (2.4% versus 6.3%, P=0.0009) in the paclitaxel-eluting stent than in the control stent group, respectively. CONCLUSIONS: The relative efficacy reported at 9 months for the polymer-based, paclitaxel-eluting TAXUS stent compared with the EXPRESS stent is preserved and continues to increase at 1 year, with no safety concerns apparent.

Combined Modality Therapy↗
PubMed2004

A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease.

BACKGROUND: Restenosis after coronary stenting necessitates repeated percutaneous or surgical revascularization procedures. The delivery of paclitaxel to the site of vascular injury may reduce the incidence of neointimal hyperplasia and restenosis. METHODS: At 73 U.S. centers, we enrolled 1314 patients who were receiving a stent in a single, previously untreated coronary-artery stenosis (vessel diameter, 2.5 to 3.75 mm; lesion length, 10 to 28 mm) in a prospective, randomized, double-blind study. A total of 652 patients were randomly assigned to receive a bare-metal stent, and 662 to receive an identical-appearing, slow-release, polymer-based, paclitaxel-eluting stent. Angiographic follow-up was prespecified at nine months in 732 patients. RESULTS: In terms of base-line characteristics, the two groups were well matched. Diabetes mellitus was present in 24.2 percent of patients; the mean reference-vessel diameter was 2.75 mm, and the mean lesion length was 13.4 mm. A mean of 1.08 stents (length, 21.8 mm) were implanted per patient. The rate of ischemia-driven target-vessel revascularization at nine months was reduced from 12.0 percent with the implantation of a bare-metal stent to 4.7 percent with the implantation of a paclitaxel-eluting stent (relative risk, 0.39; 95 percent confidence interval, 0.26 to 0.59; P<0.001). Target-lesion revascularization was required in 3.0 percent of the group that received a paclitaxel-eluting stent, as compared with 11.3 percent of the group that received a bare-metal stent (relative risk, 0.27; 95 percent confidence interval, 0.16 to 0.43; P<0.001). The rate of angiographic restenosis was reduced from 26.6 percent to 7.9 percent with the paclitaxel-eluting stent (relative risk, 0.30; 95 percent confidence interval, 0.19 to 0.46; P<0.001). The nine-month composite rates of death from cardiac causes or myocardial infarction (4.7 percent and 4.3 percent, respectively) and stent thrombosis (0.6 percent and 0.8 percent, respectively) were similar in the group that received a paclitaxel-eluting stent and the group that received a bare-metal stent. CONCLUSIONS: As compared with bare-metal stents, the slow-release, polymer-based, paclitaxel-eluting stent is safe and markedly reduces the rates of clinical and angiographic restenosis at nine months.

Aged↗
PubMed2003

Prospective, randomized evaluation of thrombectomy prior to percutaneous intervention in diseased saphenous vein grafts and thrombus-containing coronary arteries.

OBJECTIVES: We sought to determine whether routine thrombectomy prior to stent implantation in diseased saphenous vein grafts (SVGs) and thrombus-containing native coronary arteries would reduce peri-procedural myonecrosis and subsequently enhance event-free survival. BACKGROUND: Percutaneous coronary intervention in diseased SVGs and thrombotic native coronary arteries is complicated by a high rate of peri-procedural myocardial infarction (MI). Thrombectomy prior to intervention may enhance the safety of intervention and improve early and late outcomes in these high-risk patients. METHODS: At 60 centers in the U.S. and Canada, 797 patients with 839 diseased SVGs or thrombus-containing native coronary arteries were prospectively randomized to stent implantation with versus without prior thrombectomy with the X-SIZER device (ev3, Plymouth, Minnesota). RESULTS: Peri-procedural MI occurred in 15.8% of patients assigned to the X-SIZER device compared with 16.6% of control patients (p = 0.77), although the rate of large MI (pre-specified as the development of new pathologic Q waves or creatine phosphokinase-MB isoenzyme elevation >8 x upper limits of normal) was reduced with X-SIZER device use from 9.6% to 5.5% (multivariate risk ratio 0.35 [95% confidence interval 0.18 to 0.66], p = 0.002). Major adverse cardiac events (cardiac death, MI, or repeat target vessel revascularization) occurred in 16.8% of X-SIZER patients versus 17.1% of control patients at 30 days (p = 0.92), and in 31.3% of X-SIZER patients versus 28.2% of control patients at 1 year (p = 0.35). CONCLUSIONS: Thrombectomy with the X-SIZER device prior to stent implantation in high-risk diseased SVGs and thrombus-containing native coronary arteries may reduce the extent, but not the occurrence, of myonecrosis. Early and late event-free survival, however, were not improved by routine thrombectomy with this device.

Adult↗
PubMed2003

Randomized comparison of distal protection with a filter-based catheter and a balloon occlusion and aspiration system during percutaneous intervention of diseased saphenous vein aorto-coronary bypass grafts.

BACKGROUND: The high rate of periprocedural complications resulting from atherothrombotic embolization after percutaneous intervention in diseased saphenous vein grafts is reduced by distal microcirculatory protection using a balloon occlusion and aspiration system. Whether filter-based catheters, which offer the inherent advantages of maintained perfusion and ease of use, are as effective for this purpose has not been established. METHODS AND RESULTS: A total of 651 patients undergoing percutaneous intervention of 682 saphenous vein graft lesions were prospectively randomized to distal protection with the filter-based FilterWire EX versus the GuardWire balloon occlusion and aspiration system. Device success was 95.5% and 97.2% with the FilterWire EX and GuardWire, respectively (P=0.25). Postprocedural measures of epicardial flow and angiographic complications were similar between the 2 groups, although bailout IIb/IIIa inhibitors were required slightly less frequently in the FilterWire EX group (0% versus 1.5%, P=0.03). The primary end point, the composite incidence of death, myocardial infarction, or target vessel revascularization at 30 days, occurred in 9.9% of FilterWire EX patients and 11.6% of GuardWire patients (difference [95% CI]=-1.7% [-6.4%, 3.1%]; P for superiority=0.53, P for noninferiority=0.0008). CONCLUSIONS: Distal protection with the FilterWire EX may be safely used as an adjunct to percutaneous intervention of diseased saphenous vein grafts and, compared with distal protection with the GuardWire balloon occlusion and aspiration system, results in similar rates of major adverse cardiac events at 30 days.

Aged↗