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Biomedical subjects

Gregg W Stone

Publications and source records attributed to Gregg W Stone.

At least 127 records · Page 7Linked to original sources
PubMed2004

Does beta-blocker therapy improve clinical outcomes of acute myocardial infarction after successful primary angioplasty?

OBJECTIVES: We sought to determine if beta-blocker therapy improves clinical outcomes of acute myocardial infarction (AMI) after successful primary percutaneous coronary intervention (PCI). BACKGROUND: We have shown that pre-treatment with beta-blockers has a beneficial effect on short-term clinical outcomes in patients undergoing primary PCI for AMI. It is unknown if beta-blocker therapy after successful primary PCI improves prognosis of AMI. METHODS: We analyzed clinical, angiographic, and outcomes data in 2442 patients who underwent successful primary PCI in the Primary Angioplasty in Acute Myocardial Infarction-2 (PAMI-2), PAMI No Surgery-on-Site (PAMI noSOS), Stent PAMI, and Air PAMI trials. We classified patients into beta group (those who received beta-blockers after successful PCI, n = 1661) and no-beta group (n = 781). We compared death and major adverse cardiac events (MACE) (death, reinfarction, and ischemia-driven target vessel revascularization) at six months between groups receiving and not receiving beta-blockers. RESULTS: At six months, beta patients were less likely to die (2.2% vs. 6.6%, p < 0.0001) or experience MACE (14 vs. 17%, p = 0.036). In multivariate analysis, beta-blockers were independently associated with lower six-month mortality (odds ratio [OR] 0.43, 95% confidence interval [CI] 0.26 to 0.73, p = 0.0016). Beta-blocker therapy was an independent predictor of lower six-month events in high-risk subgroups: ejection fraction <or=50% (death: OR 0.34, 95% CI 0.19 to 0.60, p = 0.0002) or multi-vessel coronary artery disease (CAD) (death: OR 0.26, 95% CI 0.14 to 0.48, p < 0.0001; MACE: OR 0.57, 95% CI 0.41 to 0.80, p = 0.0011). CONCLUSIONS: Treatment with beta-blockers after successful primary PCI is associated with reduced six-month mortality, with the greatest benefit in patients with a low ejection fraction or multi-vessel CAD.

Adrenergic beta-Antagonists↗
PubMed2004

Sustained ventricular tachycardia or fibrillation in the cardiac catheterization laboratory among patients receiving primary percutaneous coronary intervention: incidence, predictors, and outcomes.

OBJECTIVES: We sought to evaluate the incidence, predictors, and outcomes of ventricular tachycardia and/or ventricular fibrillation (VT/VF) in the cardiac catheterization laboratory among patients undergoing primary percutaneous coronary intervention (PCI). BACKGROUND: Although VT/VF has been known to occur during primary PCI, the current data do not identify patients at risk for these arrhythmias or the outcomes of such patients. METHODS: We evaluated 3065 patients enrolled in the Primary Angioplasty in Myocardial Infarction (PAMI) trials, who underwent primary PCI to evaluate the associations of VT/VF and the influence of these arrhythmias on in-hospital and one-year outcomes. RESULTS: In patients undergoing primary PCI, VT/VF occurred in 133 (4.3%). Multivariate analysis identified the following as independent correlates of VT/VF: smoking (odds ratio [OR] 1.95, 95% confidence interval [CI] 1.26 to 3.02), lack of preprocedural beta-blockers (OR 2.34, 95% CI 1.35 to 4.07), time from symptom onset to emergency room of <or=180 min (OR 2.63, 95% CI 1.42 to 4.89), initial Thrombolysis In Myocardial Infarction (TIMI) flow grade 0 (OR 2.06, 95% CI 1.23 to 3.47), and right coronary artery-related infarct (OR 1.93, 95% CI 1.25 to 2.99). Although patients with VT/VF had a higher incidence of bradyarrhythmias, hypotension, cardiopulmonary resuscitation, and endotracheal intubation in the catheterization laboratory, their in-hospital and one-year adverse outcomes were similar to those of the cohort without these arrhythmias. CONCLUSIONS: Our findings suggest that the incidence of VT/VF during primary PCI is low, indicating that these arrhythmias do not influence PCI success or in-hospital or one-year outcomes. Our data further help identify patients at risk of VT/VF during primary PCI and suggest that pretreatment with beta-blockers should be strongly considered to reduce these arrhythmias.

Aged↗
PubMed2004

Impact of intravenous beta-blockade before primary angioplasty on survival in patients undergoing mechanical reperfusion therapy for acute myocardial infarction.

OBJECTIVES: We sought to examine the effect of intravenous beta-blockers administered before primary percutaneous coronary intervention (PCI) on survival and myocardial recovery after acute myocardial infarction (AMI). BACKGROUND: Studies of primary PCI but not thrombolysis have suggested that beta-blocker administration before reperfusion may enhance survival. Whether oral beta-blocker use before admission modulates this effect is unknown. METHODS: The Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) trial randomized 2082 AMI patients to either stenting or balloon angioplasty, each +/- abciximab. In accordance with the protocol, intravenous beta-blockers were administered before PCI in the absence of contraindications. RESULTS: A total of 1136 patients (54.5%, BB+ group) received beta-blockers before PCI, whereas 946 (45.5%, BB- group) did not. The 30-day mortality was significantly lower in the BB+ group than in the BB- group (1.5% vs. 2.8%, p = 0.03), an effect entirely limited to patients who had not been receiving beta-blockers before admission (1.2% vs. 2.9%, p = 0.007). In contrast, no survival benefit with pre-procedural beta-blockers was observed in patients receiving beta-blockers at home (3.3% vs. 1.9%, respectively, p = 0.47). By multivariate analysis, pre-procedural beta-blocker use was an independent predictor of lower 30-day mortality among patients without previous beta-blocker therapy (relative risk = 0.38 [95% confidence interval 0.17 to 0.87], p = 0.02). The improvement in left ventricular ejection fraction from baseline to seven months was also greater after intravenous beta-blockers (3.8% vs. 1.3%, p = 0.01), an effect limited to patients not receiving oral beta-blockers before admission. CONCLUSIONS: In patients with AMI undergoing primary PCI, myocardial recovery is enhanced and 30-day mortality is reduced with pre-procedural intravenous beta-blockade, effects confined to patients untreated with oral beta-blocker medication before admission.

Adrenergic beta-Antagonists↗
PubMed2004

Short- and long-term results after multivessel stenting in diabetic patients.

OBJECTIVES: The present study evaluated clinical outcomes in diabetic patients after multivessel stenting. BACKGROUND: Multivessel angioplasty studies have reported decreased survival in diabetic patients undergoing conventional balloon angioplasty compared with coronary artery bypass graft surgery (CABG). However, several studies have demonstrated excellent procedural success and acceptable clinical outcomes after multivessel stenting. METHODS: Multivessel stenting was performed in 689 patients with 1,639 native coronary lesions. Patients were classified into three groups according to diabetes mellitus (DM) status: 1) no DM (501 patients/1,200 lesions); 2) DM treated with oral agents (102 patients/235 lesions); and 3) DM treated with insulin (86 patients/204 lesions). RESULTS: Procedural success was high overall. In-hospital CABG was higher in diabetics treated with insulin compared with the other two groups (3.5% vs. 0.4% vs. 1.0%, p = 0.02). There were no significant differences in the incidence of in-hospital cardiac death and myocardial infarction. Diabetic patients treated with oral agents or insulin had higher one-year target lesion revascularization rates than non-diabetic patients (25% vs. 35% vs. 16%, p < 0.001). Lower one-year survival was observed in diabetic patients treated with either oral agents or insulin, compared with non-diabetic patients (85% vs. 86% vs. 95%, p < 0.001). On multivariable analysis, DM was an independent predictor of one-year mortality, myocardial infarction, and target lesion revascularization after multivessel stenting. CONCLUSIONS: Despite a high technical success rate of multivessel stenting, diabetic patients, especially those treated with insulin, have higher in-hospital CABG, higher subsequent revascularization rates, and lower one-year survival than non-diabetic patients.

Aged↗
PubMed2004

Importance of mitral regurgitation inpatients undergoing percutaneous coronary intervention for acute myocardial infarction: the Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) trial.

OBJECTIVES: We sought to determine the prognostic importance of mitral regurgitation (MR) in patients undergoing percutaneous coronary intervention for acute myocardial infarction (AMI). BACKGROUND: Mitral regurgitation has been associated with a poor prognosis in patients treated with thrombolytic therapy for AMI. The prognostic significance of MR in patients undergoing mechanical reperfusion therapy for AMI is unknown. METHODS: Left ventriculography was performed during the index procedure in 1,976 (95%) of 2,082 non-shock patients enrolled in a prospective, multicenter, randomized trial of mechanical reperfusion strategies in AMI. The severity of operator-assessed MR was divided into four strata: none (n = 1,726), mild (n = 192), and moderate/severe (n = 58). RESULTS: Patients with progressively more severe MR were older (p < 0.0001), were more often women (p < 0.0001), and had higher Killip class (p = 0.0007). More severe grades of MR correlated with triple-vessel disease (p < 0.0001) and lower left ventricular ejection fraction (LVEF) as measured during the index procedure (p = 0.0004). Increasingly severe MR was strongly associated with a higher mortality at 30 days (1.4% vs. 3.7% vs. 8.6%, respectively; p < 0.0001) and at one year (2.9%, 8.5%, 20.8%, respectively; p < 0.0001). By multivariate analysis, the presence of even mild MR was an independent predictor of long-term mortality (mild MR, relative risk [RR] = 2.40, p = 0.005; moderate/severe MR, RR = 2.82, p = 0.006). CONCLUSIONS: Mitral regurgitation of any degree present on the baseline left ventriculogram during the index procedure is a powerful, independent predictor of mortality in patients undergoing mechanical reperfusion therapy for AMI. The presence of MR identifies high-risk patients in whom close out-patient follow-up is warranted, and who may benefit from aggressive adjunctive medical or surgical therapies.

Abciximab↗
PubMed2004

Minimally invasive coronary artery bypass grafting versus stenting for patients with proximal left anterior descending coronary artery disease.

The purpose of this study was to compare the clinical outcomes of stenting and minimally invasive coronary artery bypass grafting (MIDCAB) in patients with proximal left anterior descending (LAD) coronary artery disease. The Patency, Outcome, Economics of Minimally invasive direct coronary bypass (POEM) study demonstrated that MIDCAB had similar safety and long-term efficacy for LAD revascularization compared with conventional coronary artery bypass grafting. Although LAD stenting is superior to conventional balloon angioplasty, whether it is comparable to MIDCAB is not known. We identified a matched population of 429 consecutive patients with 1-vessel disease who underwent elective proximal LAD stenting and compared their clinical outcomes with those of the 152 patients in the MIDCAB group of the POEM study. The in-hospital event rate was similar in both groups, except for a shorter length of hospital stay with LAD stenting compared with MIDCAB (2.68 vs 4.07 days, p <0.0001). At 6-month follow-up, the incidence of death and Q-wave myocardial infarction or that of cerebrovascular accident was not significantly different between these 2 groups. However, target vessel revascularization was significantly higher with LAD stenting than MIDCAB (13.3% vs 6.6%, p = 0.045). In the subgroup of patients without diabetes, all clinical events were similar in both groups, and the benefit of a shorter hospital stay associated with stenting was maintained. Compared with MIDCAB, LAD stenting is associated with higher repeat revascularization rates but offers the advantage of shorter hospitalization. For nondiabetics with proximal LAD disease, stenting may be the revascularization strategy of choice.

Coronary Artery Bypass↗
PubMed2004

Relation of final lumen dimensions in saphenous vein grafts after stent implantation to outcome.

Larger final lumen dimensions after percutaneous coronary interventions in native coronary arteries lead to lower restenosis rates. We sought to determine the impact of stent expansion, as assessed by intravascular ultrasound, on clinical results of stent implantation in saphenous vein grafts (SVGs). We identified 226 consecutive patients who underwent intravascular ultrasound-guided stenting of 234 de novo SVG lesions. Patients were divided into 2 groups based on the final stent cross-sectional area (CSA): group I (stent CSA <100% of the reference lumen CSA, n = 176 patients, 182 lesions) and group II (stent CSA >/=100% of the reference lumen CSA, n = 50 patients, 52 lesions). Baseline patient characteristics were similar between the 2 groups with the exception of smaller lesions in group II. More aggressive stent expansion (group II) was associated with (1) increased rates of in-hospital non-Q-wave myocardial infarction (29% vs 17%, p = 0.05), (2) any myocardial infarction (26% vs 8%, p = 0.003) at 1-year follow-up, and (3) no improvement in target vessel revascularization at 1 year (31% vs 26%, p = 0.3). Aggressive stent expansion in SVG lesions resulted in higher myocardial infarction rates and, unlike native arteries, no improvement in target vessel revascularization rate at 1 year. A less aggressive stent implantation strategy in SVGs than in native coronary lesions appears prudent.

Aged↗
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

Non-polymer-based paclitaxel-coated coronary stents for the treatment of patients with de novo coronary lesions: angiographic follow-up of the DELIVER clinical trial.

BACKGROUND: Paclitaxel, a microtubule-stabilizing compound with potent antitumor activity, has been shown to inhibit smooth muscle cell proliferation and migration. The DELIVER trial was a prospective, randomized, blinded, multicenter clinical evaluation of the non-polymer-based paclitaxel-coated ACHIEVE stent compared with the stainless steel Multi-Link (ML) PENTA stent. METHODS AND RESULTS: A total of 1043 patients with focal de novo coronary lesions, <25 mm in length, in 2.5- to 4.0-mm vessels were randomized (ACHIEVE n=524; ML PENTA n=519). Angiographic follow-up was performed in a subset of 442 patients (ACHIEVE n=228; ML PENTA n=214). Prespecified end points were a 40% reduction in target-vessel failure at 9 months (primary clinical end point) and a 50% reduction in binary restenosis at 8 months (major secondary end point). Baseline clinical characteristics were comparable between the groups. Patients in ACHIEVE had more type C lesions and a larger reference diameter. At follow-up, stent late loss was 0.81 versus 0.98 mm (P=0.003), stent binary restenosis was 14.9% versus 20.6% (P=0.076), and target-vessel failure was 11.9% versus 14.5% (P=0.12) for ACHIEVE and ML PENTA, respectively. CONCLUSIONS: The ACHIEVE paclitaxel-coated stent decreased neointimal proliferation compared with the bare-metal PENTA stent; however, this reduction was insufficient to meet the prespecified primary end point of target-vessel failure and the secondary end point of binary restenosis.

Combined Modality Therapy↗
PubMed2004

Contribution of stent underexpansion to recurrence after sirolimus-eluting stent implantation for in-stent restenosis.

BACKGROUND: We used intravascular ultrasound (IVUS) to evaluate recurrence after sirolimus-eluting stent (SES) implantation treatment of in-stent restenosis (ISR). METHODS AND RESULTS: Forty-eight ISR lesions (41 patients with objective evidence of ischemia) were treated with SES. Recurrent ISR was identified in 11 lesions (all focal); repeat revascularization was performed in 10. These were compared with 16 patients (19 lesions) without recurrence as documented by angiography. Nine of 11 recurrent lesions had a minimum stent area (MSA) <5.0 mm2 versus 5 of 19 nonrecurrent lesions (P=0.003); 7 of 11 recurrent lesions had an MSA <4.0 mm2 versus 4 of 19 nonrecurrent lesions (P=0.02); and 4 of 11 recurrent lesions had an MSA <3.0 mm2 versus 1 of 19 nonrecurrent lesions (P=0.03). A gap between SESs was identified in 3 of 11 recurrences versus 1 of 19 nonrecurrent lesions. CONCLUSIONS: Stent underexpansion is a significant cause of failure after SES implantation treatment of ISR.

Combined Modality Therapy↗
PubMed2004

Comparison of frequency of hemorrhagic stroke in patients <75 years versus > or =75 years of age among patients receiving glycoprotein IIb/IIIa inhibitors during percutaneous coronary interventions.

We identified 1,369 consecutive patients who received glycoprotein IIb/IIIa inhibitors during 1,461 stenting procedures (2,382 lesions); of these, 240 (17.5%) were aged > or =75 years (253 procedures, 430 lesions). Very elderly patients (> or =75 years) had similar in-hospital outcomes but a higher hemorrhagic stroke rate than patients aged <75 years.

Age Factors↗
PubMed2004

Relation between late patency of the infarct-related artery, left ventricular function, and clinical outcomes after primary percutaneous intervention for acute myocardial infarction (CADILLAC trial).

The importance of sustained patency of the infarct-related artery after primary percutaneous coronary intervention for acute myocardial infarction is controversial. We examined serial measures of left ventricular function and clinical outcomes in 280 patients with an initially occluded infarct artery in whom Thrombolysis In Myocardial Infarction trial grade 3 flow was achieved and routine follow-up angiography was performed 7 months after percutaneous coronary intervention. Reocclusion of the infarct artery was associated with decreased event-free survival, and the degree of restenosis was an independent predictor of the lack in improvement in left ventricular ejection fraction over time.

Aged↗
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↗
PubMed2004

Reduced vascular complications after percutaneous coronary interventions with a nonmechanical suture device: results from the randomized RACE study.

The objective of this study was to evaluate the safety and efficacy of a novel nonmechanical percutaneous suture device, X-Press, after diagnostic catheterization and percutaneous coronary interventions (PCIs) in the setting of glycoprotein IIb/IIIa inhibitor usage. Current percutaneous vascular suture devices remain mechanically complex and expensive and have not been shown to reduce major vascular complications. Using a 2:1 randomization scheme (2:1 ratio, device vs. compression), 393 patients undergoing diagnostic catheterization (n = 133) or PCI (n = 260) were randomized in the prospective Rapid Ambulation After Closure (RACE) study and evaluated for time to ambulation, time to hemostasis, treatment success, and incidence of major vascular complications. Glycoprotein IIb/IIIa inhibitors were used in 52% of PCI patients. There was a significant reduction in the primary efficacy endpoint of median time to ambulation for device compared to control with both diagnostic (2.2 vs. 6.2 hr; P = 0.0001) and PCI patients (4.1 vs. 14.7 hr; P = 0.0001). Device malfunction occurred in 3.1% patients without clinical sequalae. Equivalence in the primary safety endpoint, the incidence of major complications (vascular repair, ultrasound-guided compression, transfusion, or infection) at 14 days, was observed with the X-Press device (1/261; 0.4%) compared to control (3/132; 2.3%; P = 0.11). In PCI patients, half of whom received glycoprotein IIb/IIIa inhibitors, there was a significant reduction in the incidence of vascular complications in patients using the device (0/172; 0%) compared to control (3/88; 3.4%; P = 0.037). In diagnostic catheterization and PCI, a novel nonmechanical suture device reduced the time to ambulation and demonstrated equivalence in major complications compared to conventional compression techniques. The incidence of major complications after PCI was reduced with the device.

Blood Vessels↗
PubMed2004

Gamma radiation for in-stent restenosis: effect of lesion length on angiographic and clinical outcomes.

The relation between lesion length and effectiveness of gamma radiation treatment (gamma-RT) has not been well described. We evaluated the acute and long-term outcome according to baseline lesion length in 130 patients treated with (192)Ir in the Washington Radiation for In-Stent Restenosis Trial; 44 (35.5%) had baseline short in-stent restenosis (ISR) lesions (length < 15 mm) and 80 (64.5%) long ISR lesions (length > or = 15 mm). At 6-month follow-up after gamma-RT, the short ISR group had larger lumen dimensions and lower late loss than the long ISR group. Restenosis rate was significantly higher in patients with long ISR for both the placebo (74% vs. 39%; P = 0.01) and the gamma-RT arm (31% vs. 5.3%; P = 0.04). gamma-RT significantly improved the angiographic outcome in the short-lesion groups but had the more pronounced effect on the reduction of clinical events after treatment of long ISR group. Lesion length remains a powerful predictor of recurrent ISR and clinical events after treatment of ISR even with gamma-RT.

Brachytherapy↗
PubMed2004

Advanced c-myc antisense (AVI-4126)-eluting phosphorylcholine-coated stent implantation is associated with complete vascular healing and reduced neointimal formation in the porcine coronary restenosis model.

An advanced six-ring morpholino backbone c-myc antisense (AVI-4126) was shown to inhibit c-myc expression and intimal hyperplasia after local catheter delivery in a porcine balloon injury model. The purpose of this study was to investigate the effects of an AVI-4126-eluting phosphorylcholine-coated (PC) stent on c-myc expression restenosis and vascular healing after stent implantation in porcine coronary arteries. PC stents were loaded with AVI-4126 using soak trap. Nine pigs underwent AVI-4126 PC coronary stent implantation (two stents/animal). Two to six hours postprocedure, three pigs were sacrificed and stented segments were analyzed by Western blot for c-myc expression. In chronic experiments, six pigs (12 stent sites) were sacrificed at 28 days following intervention and vessels were perfusion-fixed. High-performance liquid chromatography analysis of plasma samples showed minimal presence of the antisense. Western blot analysis of the stented vessels demonstrated inhibition of c-myc expression at 2 and 6 hr after procedure. Quantitative histologic morphometry showed that the neointimal area was significantly reduced (by 40%) in the antisense-coated group compared with control (2.3 +/- 0.7 vs. 3.9 +/- 0.8 mm(2), respectively; P = 0.0077). Immunostaining and electron microscopy demonstrated complete endothelialization, without fibrin deposition, thrombosis, or necrosis in all implanted stents. In the porcine coronary model, an advanced c-myc-eluting PC stent blocked c-myc expression and significantly inhibited myointimal hyperplasia and allowed complete reendothelialization and healing response.

Animals↗
PubMed2004

Drug-eluting stent task force: final report and recommendations of the working committees on cost-effectiveness/economics, access to care, and medicolegal issues.

Coronary artery disease remains a major health problem worldwide. Since introduction of percutaneous transluminal coronary angioplasty and stents, much progress has been made. Percutaneous coronary intervention, however, has been limited by restenosis (repeat obstruction of arteries that have been previously treated. Introduction of drug-eluting stents (DESs) in April 2003 was a major breakthrough in preventing restenosis. In March 2003, The Society for Cardiovascular Angiography and Interventions (SCAI) published a position statement on the clinical implications of DESs, recommending an evidence-based adoption strategy. Subsequently, in May 2003, SCAI formed a multidisciplinary Drug Eluting Stent (DES) Task Force to address the significant nonclinical ramifications posed by DESs: medicolegal, financial, and access to care. The Task Force included representatives from physician societies, industry, academia, the reimbursement community, and health policy organizations. The resultant report presents analyses, options, and recommendations regarding those nonclinical issues based on the collective experience and knowledge of the Task Force members. The Task Force trusts that this report will be of value to the diverse constituencies involved with introduction of this important new technology.

Advisory Committees↗