Biomedical subjects

Gregg W Stone

Publications and source records attributed to Gregg W Stone.

At least 73 records · Page 4Linked to original sources

PubMed2005

Impact and determinants of left ventricular function in patients undergoing primary percutaneous coronary intervention in acute myocardial infarction.

We evaluated the prognostic effect of baseline left ventricular function and the determinants of its recovery after acute myocardial infarction (AMI) treated by primary angioplasty. Left ventriculography was performed during the index procedure in 1,620 of 2,082 patients (78%) who underwent primary angioplasty for AMI in the CADILLAC trial. One-year survival rate was significantly lower in patients whose baseline left ventricular ejection fraction (LVEF) was <40% than in those whose LVEF was > or =40% (89.0% vs 97.2%, respectively, p <0.0001). The effect of baseline left ventricular dysfunction on mortality was confined to the first 3 months after AMI; thereafter, survival was independent of baseline LVEF. By multivariate analysis, baseline LVEF (hazard ratio 0.93, 95% confidence interval 0.90 to 0.97, p <0.001) and infarct zone regional wall motion (hazard ratio 2.67, 95% confidence interval 1.08 to 6.63, p = 0.03) were independent predictors of 1-year mortality. Seven-month convalescent LVEF was also directly related to baseline LVEF and inversely correlated with previous AMI, multivessel coronary disease, preprocedural Thrombolysis In Myocardial Infarction grade 0 to 2 flow, larger infarct artery diameter, and infarct artery restenosis at follow-up. In conclusion, baseline left ventricular function measured during the index procedure is a strong independent predictor of early and late survival after primary angioplasty. Simple clinical and angiographic features readily available at the time of primary angioplasty also predict convalescent LVEF and are thus of prognostic utility.

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PubMed2005

Intravascular ultrasound study of patterns of calcium in ruptured coronary plaques.

Coronary calcium is intimately associated with coronary atherosclerotic plaque development, although it is controversial as to whether coronary calcium is associated with plaque instability. We analyzed 101 IVUS-detected ruptured plaques and compared them with 101 computer-matched control plaques without evidence of plaque rupture. The arc of calcium was measured every 0.5 mm within 10-mm-long segments that spanned the minimum lumen cross-sectional area, and the number and length of calcium deposits were assessed. Ruptured plaques had a significantly larger number of individual calcium deposits than control plaques (3.5 +/- 1.7 vs 1.8 +/- 1.1, p <0.001). However, the arc of the largest calcium deposit was smaller and the length of the largest calcium deposit in each plaque was shorter in ruptured plaques compared with control plaques (67.3 degrees +/- 41.4 degrees vs 114.9 degrees +/- 77.4 degrees , p <0.001, and 1.6 +/- 1.3 vs 4.0 +/- 2.7 mm, p <0.001, respectively). There was no difference in the number of superficial calcium deposits between the 2 groups, although ruptured plaques had significantly smaller arcs of superficial calcium compared with control plaques (56.2 degrees +/- 35.5 degrees vs 95.8 degrees +/- 65.2 degrees , p <0.001). Conversely, the number of deep calcium deposits was significantly larger in ruptured plaques than in control plaques (1.8 +/- 1.4 vs 0.3 +/- 0.6, p <0.001), although the arc of deep calcium was similar in the 2 groups. Ruptured plaques had quantitatively less calcium, especially superficial calcium, but a larger number of small calcium deposits, especially deep calcium deposits. In conclusion, ruptured plaques are associated with a larger number of calcium deposits within an arc of <90 degrees , a larger number of deep calcium deposits, and a remodeling index.

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PubMed2005

Intravascular ultrasonic assessment of stent diameters derived from manufacturer's compliance charts.

We used intravascular ultrasound (IVUS) to assess the accuracy of manufacturers' stent balloon compliance charts. Many interventional cardiologists rely on manufacturers' compliance charts to select stent size and optimize stent diameters according to inflation pressures during percutaneous procedures. We randomly selected 212 patients who had de novo coronary lesions that had been treated with a single, bare metal, > or =3.0-mm stent (Bx velocity, NIR, TETRA/PENTA, S660/S670/S7) under IVUS guidance. Cases of stent overlap and postdilatation with another balloon were excluded. Predicted stent diameters were derived from each manufacturer's compliance charts, and stent size and final maximal deployment pressures were derived from each physician's report. IVUS-measured minimum stent diameters (range 1.4 to 4.0 mm, mean 2.79 +/- 0.48) were smaller than predicted diameters (range 3.1 to 4.57 mm, mean 3.79 +/- 0.44). The ratio of IVUS to predicted diameters ranged from 44% to 97% (mean 74 +/- 10%). This finding was common to all 3 stent sizes: 74 +/- 12% for 3.0 mm, 73 +/- 9% for 3.5 mm, and 74 +/- 9% for 4.0-mm stents (p = 0.9). This finding was also common to all 4 stent manufacturers, 72 +/- 8% for Boston Scientific, 76 +/- 11% for Guidant, 73 +/- 9% for Cordis, and 74 +/- 11% for Medtronic (p = 0.13), and to different stent lengths. Only 3.8% of the stents achieved 90% of the predicted minimum stent diameters, and only 24.6% achieved 80% of the predicted minimum stent diameters. In conclusion, in human coronary arteries, minimal stent diameter measured by IVUS is significantly smaller than that predicted by in vitro compliance charts. These differences are independent of stent manufacturer, length, diameter, and deployment pressure.

Aged↗

PubMed2005

A randomized, double-blinded, placebo-controlled multicenter trial of adenosine as an adjunct to reperfusion in the treatment of acute myocardial infarction (AMISTAD-II).

OBJECTIVES: The purpose of this research was to determine the effect of intravenous adenosine on clinical outcomes and infarct size in ST-segment elevation myocardial infarction (STEMI) patients undergoing reperfusion therapy. BACKGROUND: Previous small studies suggest that adenosine may reduce the size of an evolving infarction. METHODS: Patients (n = 2,118) with evolving anterior STEMI receiving thrombolysis or primary angioplasty were randomized to a 3-h infusion of either adenosine 50 or 70 microg/kg/min or of placebo. The primary end point was new congestive heart failure (CHF) beginning >24 h after randomization, or the first re-hospitalization for CHF, or death from any cause within six months. Infarct size was measured in a subset of 243 patients by technetium-99m sestamibi tomography. RESULTS: There was no difference in the primary end point between placebo (17.9%) and either the pooled adenosine dose groups (16.3%) or, separately, the 50-microg/kg/min dose and 70-microg/kg/min groups (16.5% vs. 16.1%, respectively, p = 0.43). The pooled adenosine group trended toward a smaller median infarct size compared with the placebo group, 17% versus 27% (p = 0.074). A dose-response relationship with final median infarct size was seen: 11% at the high dose (p = 0.023 vs. placebo) and 23% at the low dose (p = NS vs. placebo). Infarct size and occurrence of a primary end point were significantly related (p < 0.001). CONCLUSIONS: Clinical outcomes in patients with STEMI undergoing reperfusion therapy were not significantly improved with adenosine, although infarct size was reduced with the 70-microg/kg/min adenosine infusion, a finding that correlated with fewer adverse clinical events. A larger study limited to the 70-microg/kg/min dose is, therefore, warranted.

Adenosine↗

PubMed2005

Prediction of mortality after primary percutaneous coronary intervention for acute myocardial infarction: the CADILLAC risk score.

OBJECTIVES: We sought to develop a simple risk score for predicting mortality after primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI). BACKGROUND: Accurate risk stratification after primary PCI is important. Previous risk scores after reperfusion therapy have incorporated clinical +/- angiographic variables but have not considered baseline left ventricular function. Moreover, prior studies have not been validated against independent databases or studies. METHODS: The databases from the two largest multicenter, randomized AMI trials of primary PCI were utilized for score derivation (the Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications [CADILLAC] trial, n = 2,082) and subsequent validation (the Stent-Primary Angioplasty in Myocardial Infarction [Stent-PAMI] trial, n = 900). Logistic regression and the jackknife procedure were used to select correlates of one-year mortality that were subsequently weighted and integrated into an integer scoring system. RESULTS: Seven variables selected from the initial multivariate model were weighted proportionally to their respective odds ratio for one-year mortality (age >65 years [2 points], Killip class 2/3 [3 points], baseline left ventricular ejection fraction <40% [4 points], anemia [2 points], renal insufficiency [3 points], triple-vessel disease [2 points], and post-procedural Thrombolysis In Myocardial Infarction flow grade [2 points]). Three strata of risk were defined (low risk, score 0 to 2; intermediate risk, score 3 to 5; and high risk, score >/=6) with excellent prognostic accuracy for survival in the derivation and validation sets (c statistics = 0.83 and 0.81 for 30-day mortality and 0.79 and 0.78 for 1-year mortality, respectively). CONCLUSIONS: In AMI patients treated with primary PCI, seven risk factors readily available at the time of intervention accurately predict short- and long-term mortality. Of note, measurement of baseline left ventricular function is the single most powerful predictor of survival and should be incorporated into risk score models.

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PubMed2005

Influence of stent length to lesion length ratio on angiographic and clinical outcomes after implantation of bare metal and drug-eluting stents (the TAXUS-IV Study).

Longer bare metal stent lengths have been associated with greater restenosis. However, the effect of the ratio of stent length to lesion length on clinical and angiographic restenosis after implantation of bare metal and drug-eluting stents has not been clearly defined. Patients in the TAXUS-IV study who underwent single-study stent placement were categorized into tertiles based on ratios of stent length to lesion length. Clinical results at 1 year and angiographic outcomes at 9 months were compared across the 3 groups. The median ratios of stent length to lesion length were 1.20, 1.58, and 2.27 in the 3 tertiles. Analysis segment restenosis rates at 9 months were similar across the 3 tertiles with bare metal stents (24.7% vs 26.7% vs 23.8%, respectively, p = 0.90 for trend) and paclitaxel-eluting stents (11.7% vs 6.5% vs 5.4%, respectively, p = 0.24). Similarly, there were no differences in 1-year rates of target lesion revascularization across the 3 tertiles for bare metal stents (14.6% vs 14.8% vs 13.7%, respectively, p = 0.91) or paclitaxel-eluting stents (6.1% vs 3.6% vs 4.0%, respectively, p = 0.38). By multivariate analysis, the ratio of stent length to lesion length was an independent predictor of neither 9-month angiographic restenosis nor 1-year target lesion revascularization in the bare metal stent arm (odds ratio 1.21, p = 0.36, and hazard ratio 0.80, p = 0.31, respectively) or in the paclitaxel-eluting stent arm (odds ratio 0.86, p = 0.76, and hazard ratio 0.58, p = 0.21, respectively). These data do not support the arbitrary use of larger ratios of stent length to lesion length in patients who undergo implantation of drug-eluting stents.

Angioplasty, Balloon, Coronary↗

PubMed2005

Outcomes with the paclitaxel-eluting stent in patients with acute coronary syndromes: analysis from the TAXUS-IV trial.

OBJECTIVES: We sought to investigate the outcomes of paclitaxel-eluting stent implantation in patients with unstable angina or non-ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention (PCI). BACKGROUND: Whether the paclitaxel-eluting stent is safe and effective in patients with acute coronary syndromes (ACS) is unknown. METHODS: In the TAXUS-IV trial, 1,314 patients with stable or unstable ischemic syndromes undergoing PCI were randomized to treatment with either the slow-release, polymer-based, paclitaxel-eluting TAXUS stent or a bare-metal EXPRESS stent (Boston Scientific Corp., Natick, Massachusetts). The results were stratified by the acuity of the presenting clinical syndrome. RESULTS: Acute coronary syndromes were present in 450 patients (34.2%), 237 of whom were assigned to paclitaxel-eluting stents and 213 to bare-metal stents. The baseline and procedural characteristics were well matched between the groups. Clinical outcomes at 30 days were similar with both stents. At one-year follow-up, patients with ACS assigned to the paclitaxel-eluting stent compared to the control stent had strikingly lower rates of target lesion revascularization (TLR) (3.9% vs. 16.0%, p < 0.0001) and major adverse cardiac events (11.1 vs. 21.7%, p = 0.002). By multivariate analysis, ACS was an independent predictor of in-stent restenosis in the cohort treated with bare-metal stents (hazard ratio [HR] = 2.03 [95% confidence interval (CI) 1.05 to 3.92], p = 0.035), while among patients randomized to the paclitaxel-eluting stents, ACS was an independent predictor of freedom from restenosis (HR = 0.27 [95% CI 0.08 to 0.97], p = 0.04). CONCLUSIONS: The use of the paclitaxel-eluting TAXUS stent was safe in patients with unstable ischemic syndromes, and was associated with marked reduction of ischemia-driven TLR and adverse cardiac events at one year.

Antineoplastic Agents↗

PubMed2005

Outcomes with the polymer-based paclitaxel-eluting TAXUS stent in patients with diabetes mellitus: the TAXUS-IV trial.

OBJECTIVES: We sought to determine the safety and efficacy of polymer-regulated site-specific delivery of paclitaxel in patients with diabetes mellitus undergoing stent implantation. BACKGROUND: Percutaneous coronary intervention in patients with diabetes is associated with high rates of restenosis and repeat revascularization due to excessive neointimal proliferation, a process that may be blunted with the site-specific delivery of paclitaxel. METHODS: In the TAXUS-IV trial, 1,314 patients were prospectively randomized to the slow rate-release polymer-based paclitaxel-eluting TAXUS stent or the bare-metal EXPRESS stent (Boston Scientific Corp., Natick, Massachusetts). Medically treated diabetes was present in 318 patients (24%), 105 of whom required insulin. RESULTS: Among patients with diabetes, the TAXUS stent, compared to the bare-metal stent, reduced the rate of 9-month binary angiographic restenosis by 81% (6.4% vs. 34.5%, p < 0.0001), and reduced the 12-month rates of target lesion revascularization by 65% (7.4% vs. 20.9%, p = 0.0008), target vessel revascularization by 53% (11.3% vs. 24%, p < 0.004), and composite major adverse cardiac events by 44% (15.6% vs. 27.7%, p = 0.01). The one-year rates of cardiac death (1.9% vs. 2.5%), myocardial infarction (3.2% vs. 6.4%), and subacute thrombosis (0.6% vs. 1.2%) were comparable between the paclitaxel-eluting and control stents, respectively. In the insulin-requiring subgroup, the TAXUS stent reduced angiographic restenosis by 82% (7.7% vs. 42.9%, p = 0.0065), and reduced the one-year rate of target lesion revascularization by 68% (6.2% vs. 19.4%, p = 0.07), a relative reduction similar to patients without diabetes. CONCLUSIONS: The site-specific delivery of paclitaxel after coronary stent implantation is highly effective in reducing clinical and angiographic restenosis in patients with diabetes mellitus.

Antineoplastic Agents↗

PubMed2005

Gender-based outcomes after paclitaxel-eluting stent implantation in patients with coronary artery disease.

OBJECTIVES: We sought to determine whether gender influences the results of paclitaxel-eluting stent implantation. BACKGROUND: The TAXUS-IV trial demonstrated the safety and effectiveness of the slow-release, polymer-based, paclitaxel-eluting TAXUS stent compared to bare-metal stents in patients undergoing elective coronary intervention. Whether these results are generalizable to women is not known. METHODS: A total of 1,314 patients with coronary lesions 10- to 28-mm long in 2.5- to 3.75-mm vessels were randomized to TAXUS stent versus bare-metal EXPRESS stents (Boston Scientific Corp., Natick, Massachusetts). Outcomes examined were stratified by gender. RESULTS: A total of 662 patients (including 187 women) were assigned to the TAXUS stent, and 652 (180 women) received the control stent. Women were older than men, and had more hypertension, diabetes, renal insufficiency, unstable angina, and heart failure, but less smoking. Among patients receiving the TAXUS stent, women compared with men had higher unadjusted one-year rates of target lesion revascularization (TLR) (7.6% vs. 3.2%, p = 0.03), though female gender was not an independent predictor of TLR (odds ratio [OR] = 1.72 [95% confidence interval (CI) 0.68 to 4.37], p = 0.25). Moreover, restenosis rates were similar in men and women treated with the TAXUS stent (8.6% vs. 7.6%, respectively, p = 0.80), as was late loss (0.22 vs. 0.23 mm, p = 0.90). Compared to control stents, treatment with the TAXUS stent in women resulted in a significant reduction in nine-month restenosis (8.6% vs. 29.2%, p = 0.0001) and one-year TLR (7.6% vs. 14.9%, p = 0.02). The only independent predictor of freedom from restenosis in women was randomization to the TAXUS stent (OR = 0.28 [95% CI 0.11 to 0.74], p = 0.01). CONCLUSIONS: The benefits of the paclitaxel-eluting stent in reducing clinical and angiographic restenosis are generalizable to women.

Age Factors↗

PubMed2005

Outcomes of paclitaxel-eluting stent implantation in patients with stenosis of the left anterior descending coronary artery.

OBJECTIVES: We sought to examine the efficacy of paclitaxel-eluting stent implantation in the left anterior descending coronary artery (LAD). BACKGROUND: Restenosis and recurrent cardiac events after percutaneous intervention are more common for lesions in the LAD than other native coronary arteries, and often necessitate bypass surgery. Drug-eluting stents may improve the long-term prognosis of this high-risk group. METHODS: In the TAXUS-IV trial, 1,314 patients with single de novo coronary lesions were assigned to implantation of the slow-release, polymer-based, paclitaxel-eluting TAXUS stent or an identical bare-metal stent; 536 (41%) randomized patients had LAD lesions. RESULTS: Baseline characteristics of patients with LAD lesions were well-matched between the randomized groups. Late lumen loss at nine months after paclitaxel-eluting and control stent implantation were 0.28 +/- 0.51 mm and 0.54 +/- 0.57 mm, respectively (p = 0.0004), and binary restenosis rates were 11.3% and 26.9%, respectively (p = 0.004). At one year, major adverse cardiac events (MACE) occurred in 13.5% of TAXUS-treated patients versus 21.2% treated with the control stent (p = 0.01). The need for bypass surgery at one year was reduced among patients randomized to the TAXUS stent (2.6% vs. 6.3%, p = 0.02). In the proximal LAD subgroup (n = 126), the one-year target vessel revascularization rate was 7.9% with the TAXUS stent and 18.6% with the bare-metal stent (p = 0.009). CONCLUSIONS: Compared to bare-metal stents, implantation of polymer-based, paclitaxel-eluting stents in LAD lesions is safe, and reduces angiographic restenosis and MACE one year. Notably, the need for bypass graft surgery due to restenosis is reduced after TAXUS stent implantation in LAD lesions.

Antineoplastic Agents↗

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

Abciximab as adjunctive therapy to reperfusion in acute ST-segment elevation myocardial infarction: a meta-analysis of randomized trials.

CONTEXT: The benefits of abciximab in patients with ST-segment elevation myocardial infarction (STEMI) are still a matter of debate. OBJECTIVE: To combine data from all randomized trials conducted with abciximab in STEMI. DATA SOURCES: Formal searches of electronic databases (MEDLINE, PubMed) from from January 1990 to December 2004. STUDY SELECTION: We examined all completed, published, randomized trials of abciximab in STEMI. The following key words were used for study selection: randomized trial, myocardial infarction, reperfusion, primary angioplasty, facilitated angioplasty, stenting, fibrinolysis, IIb-IIIa inhibitors, and abciximab. DATA EXTRACTION: Information on study design, type and dosage of drugs, inclusion and exclusion criteria, number of patients, and clinical outcome was extracted by 2 investigators. Disagreements were resolved by consensus. DATA SYNTHESIS: Eleven trials were analyzed, involving 27115 patients (12,602 [46.5%] in the abciximab group, 14,513 [53.5%] in the control group). When compared with the control group, abciximab was associated with a significant reduction in short-term (30 days) mortality (2.4% vs 3.4%, P = .047) and long-term (6-12 months) mortality (4.4% vs 6.2%, P = .01) in patients undergoing primary angioplasty but not in those treated with fibrinolysis or in all trials combined. Abciximab was associated with a significant reduction in 30-day reinfarction, both in all trials combined (2.1% vs 3.3%, P<.001), in primary angioplasty (1.0% vs 1.9%, P = .03), and in fibrinolysis trials (2.3% vs 3.6%, P<.001). Abciximab did not result in an increased risk of intracranial bleeding (0.61% vs 0.62%, P = .62) but was associated with an increased risk of major bleeding complications when combined with fibrinolysis (5.2% vs 3.1%, P<.001) but not with primary angioplasty (4.7% vs 4.1%, P = .36). CONCLUSIONS: This meta-analysis shows that, when compared with the control group, adjunctive abciximab for STEMI is associated with a significant reduction in 30-day and long-term mortality in patients treated with primary angioplasty but not in those receiving fibrinolysis. The 30-day reinfarction rate is significantly reduced in patients treated with either fibrinolysis or primary angioplasty. A higher risk of major bleeding complications is observed with abciximab in association with fibrinolysis.

Abciximab↗

PubMed2005

Stent underexpansion and residual reference segment stenosis are related to stent thrombosis after sirolimus-eluting stent implantation: an intravascular ultrasound study.

OBJECTIVES: We sought to determine the predictors of stent thrombosis after sirolimus-eluting stent (SES) implantation. BACKGROUND: A number of cases of stent thrombosis have been reported after commercial release of the SES in the "real world," such that the U.S. Food and Drug Administration issued a warning. METHODS: Fifteen patients who developed stent thrombosis after successful SES implantation were analyzed and compared with 45 matched control patients who had no evidence of stent thrombosis. RESULTS: Minimum stent cross-sectional area (MSA) (4.3 +/- 1.6 mm(2) vs. 6.2 +/- 1.9 mm(2), p < 0.001) and stent expansion (0.65 +/- 0.18 vs. 0.85 +/- 0.14, p < 0.001) were significantly smaller in the stent thrombosis group than in the matched control patients. There was no significant difference in the rate of SES malapposition between the groups. However, the presence of a significant residual reference segment stenosis was more common in the stent thrombosis group compared with the matched control group (67% vs. 9%, p < 0.001). Independent predictors of stent thrombosis were stent underexpansion (p = 0.03) and a significant residual reference segment stenosis (p = 0.02). CONCLUSIONS: Stent underexpansion and residual reference segment stenosis are associated with stent thrombosis after successful SES implantation.

Aged↗

PubMed2005

Gender differences in outcomes after primary angioplasty versus primary stenting with and without abciximab for acute myocardial infarction: results of the Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) trial.

BACKGROUND: Women with acute myocardial infarction (AMI) undergoing primary angioplasty have higher rates of morbidity and mortality than do men. Whether contemporary interventional treatment strategies have improved outcomes for women compared with men is unknown. METHODS AND RESULTS: In the CADILLAC trial, 2082 patients (27% women) with AMI within 12 hours of symptom onset were randomized to balloon angioplasty (PTCA; n=518), PTCA+abciximab (n=528), stenting (n=512), and stenting+abciximab (n=524). As compared with men, women had a lower body surface area; had a greater prevalence of diabetes, hypertension, and hyperlipidemia; experienced significant delays to treatment; and had better baseline and final TIMI grade 3 flows. Unadjusted 1-year event rates were higher for women, including death (7.6% versus 3.0%, P<0.001), ischemic target-vessel revascularization (TVR; 16.7% versus 12.1%, P=0.006), and major adverse cardiac events (MACE; 23.9% versus 15.3%, P<0.001). Female gender was an independent predictor of MACE and bleeding complications, although comorbid risk factors and body surface area but not gender predicted 1-year death. For women, primary stenting resulted in a reduction in 1-year MACE from 28.1% to 19.1% (P=0.01) and in ischemic TVR from 20.4% to 10.8% (P=0.002) compared with PTCA. The addition of abciximab to primary stenting significantly reduced the 30-day ischemic TVR without increasing bleeding or stroke rates. CONCLUSIONS: The higher mortality rate in women compared with men after interventional treatment for AMI may be explained by differences in body size and clinical risk factors, although female gender remains an important independent determinant of overall adverse outcomes. For women in the CADILLAC trial, the addition of abciximab reduced 30-day TVR without increasing bleeding risk, and primary stenting reduced 1-year TVR and MACE rates compared with PTCA.

Abciximab↗

PubMed2005

Impact of obesity on revascularization and restenosis rates after bare-metal and drug-eluting stent implantation (from the TAXUS-IV trial).

The effect of obesity on repeat coronary revascularization and restenosis in patients who undergo stent implantation has not been reported. We therefore examined the database from the multicenter randomized TAXUS-IV trial to determine the effect of body mass index (BMI) on outcomes after bare-metal and drug-eluting stent implantation. In TAXUS-IV, patients were randomized to receive a slow-release, polymer-based, paclitaxel-eluting stent or a bare-metal stent. Outcomes were stratified by baseline BMI. Of the 1,307 randomized patients who had documented BMI, 233 (17.8%) had normal weight (BMI <25 kg/m2), 531 (40.6%) were overweight (BMI < or =25 to 30 kg/m2), and 543 (41.5%) were obese (BMI > or =30 kg/m2). Patients who had been assigned to receive bare-metal stents and were overweight and obese compared with those who had normal weight had higher rates of 9-month binary restenosis (29.2% and 30.5% vs 9.3%, respectively; p = 0.01) and 1-year major adverse cardiac events (20.8% and 23.2% vs 11.1%, respectively; p = 0.02), whereas rates of these events did not differ significantly among those who received a paclitaxel-eluting stent (7.6% and 9.3% vs 4.9%, respectively for binary restenosis; p = 0.65; 11.3% and 10.4% vs 10.1%, respectively; p = 0.82 for major adverse cardiac events). By multivariate analysis, BMI > or =30.0 kg/m2 independently predicted binary restenosis (hazard ratio 4.26, p = 0.005), 1-year target vessel revascularization (hazard ratio 1.95, p = 0.04), and major adverse cardiac events (hazard ratio 1.95, p = 0.004) in patients who received bare-metal stents but not paclitaxel-eluting stents. In conclusion, obesity is an important risk factor for clinical and angiographic restenosis and for composite major adverse cardiac events in patients who receive bare-metal stents. Paclitaxel-eluting stents attenuate the increased risk associated with obesity, such that the intermediate-term prognosis after percutaneous coronary intervention is independent of weight.

Aged↗

PubMed2005

Guidelines for percutaneous coronary interventions. The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology.

In patients with stable CAD, PCI can be considered a valuable initial mode of revascularization in all patients with objective large ischaemia in the presence of almost every lesion subset, with only one exception: chronic total occlusions that cannot be crossed. In early studies, there was a small survival advantage with CABG surgery compared with PCI without stenting. The addition of stents and newer adjunctive medications improved the outcome for PCI. The decision to recommend PCI or CABG surgery will be guided by technical improvements in cardiology or surgery, local expertise, and patients' preference. However, until proved otherwise, PCI should be used only with reservation in diabetics with multi-vessel disease and in patients with unprotected left main stenosis. The use of drug-eluting stents might change this situation. Patients presenting with NSTE-ACS (UA or NSTEMI) have to be stratified first for their risk of acute thrombotic complications. A clear benefit from early angiography (<48 h) and, when needed, PCI or CABG surgery has been reported only in the high-risk groups. Deferral of intervention does not improve outcome. Routine stenting is recommended on the basis of the predictability of the result and its immediate safety. In patients with STEMI, primary PCI should be the treatment of choice in patients presenting in a hospital with PCI facility and an experienced team. Patients with contra-indications to thrombolysis should be immediately transferred for primary PCI, because this might be their only chance for quickly opening the coronary artery. In cardiogenic shock, emergency PCI for complete revascularization may be life-saving and should be considered at an early stage. Compared with thrombolysis, randomized trials that transferred the patients for primary PCI to a 'heart attack centre' observed a better clinical outcome, despite transport times leading to a significantly longer delay between randomization and start of the treatment. The superiority of primary PCI over thrombolysis seems to be especially clinically relevant for the time interval between 3 and 12 h after onset of chest pain or other symptoms on the basis of its superior preservation of myocardium. Furthermore, with increasing time to presentation, major-adverse-cardiac-event rates increase after thrombolysis, but appear to remain relatively stable after primary PCI. Within the first 3 h after onset of chest pain or other symptoms, both reperfusion strategies seem equally effective in reducing infarct size and mortality. Therefore, thrombolysis is still a viable alternative to primary PCI, if it can be delivered within 3 h after onset of chest pain or other symptoms. Primary PCI compared with thrombolysis significantly reduced stroke. Overall, we prefer primary PCI over thrombolysis in the first 3 h of chest pain to prevent stroke, and in patients presenting 3-12 h after the onset of chest pain, to salvage myocardium and also to prevent stroke. At the moment, there is no evidence to recommend facilitated PCI. Rescue PCI is recommended, if thrombolysis failed within 45-60 min after starting the administration. After successful thrombolysis, the use of routine coronary angiography within 24 h and PCI, if applicable, is recommended even in asymptomatic patients without demonstrable ischaemia to improve patients' outcome. If a PCI centre is not available within 24 h, patients who have received successful thrombolysis with evidence of spontaneous or inducible ischaemia before discharge should be referred to coronary angiography and revascularized accordingly--independent of 'maximal' medical therapy.

Angioplasty, Balloon, Coronary↗

PubMed2005

Distal microcirculatory protection during percutaneous coronary intervention in acute ST-segment elevation myocardial infarction: a randomized controlled trial.

CONTEXT: Atheromatous and thrombotic embolization during percutaneous coronary intervention (PCI) in acute myocardial infarction is common and may result in microcirculatory dysfunction, the prevention of which may improve reperfusion success, reduce infarct size, and enhance event-free survival. OBJECTIVE: To determine whether protection of the distal microcirculation from thromboembolic debris liberated during primary PCI results in improved reperfusion and decreased infarct size. DESIGN, SETTING, AND PATIENTS: Prospective randomized controlled trial at 38 academic and community-based institutions in 7 countries enrolling 501 patients aged 18 years or older with ST-segment elevation myocardial infarction (STEMI) presenting within 6 hours of symptom onset and undergoing primary PCI or rescue intervention after failed thrombolysis. INTERVENTIONS: Patients were randomized between May 20, 2002, and November 21, 2003, to receive PCI with a balloon occlusion and aspiration distal microcirculatory protection system vs angioplasty without distal protection. MAIN OUTCOME MEASURES: Coprimary end points were ST-segment resolution (STR) measured 30 minutes after PCI by continuous Holter monitoring and infarct size measured by technetium Tc 99m sestamibi imaging between days 5 and 14. Secondary end points included major adverse cardiac events. RESULTS: Among 252 patients assigned to distal protection, aspiration was performed in 97% (242/251), all angioplasty balloon inflations were fully protected in 79% (193/245), and visible debris was retrieved from 73% (182/250). Complete STR was achieved in a similar proportion reperfused with vs without distal protection (63.3% [152/240] vs 61.9% [148/239], respectively; absolute difference, 1.4% [95% confidence interval, -7.7% to 10.5%; P = .78]), and left ventricular infarct size was similar in both groups (median, 12.0% [n = 229] vs 9.5% [n = 208], respectively; P = .15). Major adverse cardiac events at 6 months occurred with similar frequency in the distal protection and control groups (10.0% vs 11.0%, respectively; P = .66). CONCLUSIONS: A distal balloon occlusion and aspiration system effectively retrieves embolic debris in most patients with acute STEMI undergoing emergent PCI. Nonetheless, distal embolic protection did not result in improved microvascular flow, greater reperfusion success, reduced infarct size, or enhanced event-free survival.

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