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Biomedical subjects

Wolfgang Rutsch

Publications and source records attributed to Wolfgang Rutsch.

At least 19 recordsLinked to original sources
PubMed2007

Coronary artery stenosis quantification using multislice computed tomography.

RATIONALE AND OBJECTIVES: Reliable noninvasive detection of stenoses with multislice computed tomography (MSCT) is feasible. This study's aim was to analyze the agreement, correlation, and reliability of MSCT with conventional coronary angiography as the reference standard for quantification of coronary artery stenoses. MATERIALS AND METHODS: A total of 118 significant (at least 50%) coronary artery stenoses with a reference vessel diameter of at least 1.5 mm in 62 patients were analyzed by MSCT using 16 detector rows (Aquilion, Toshiba, Otawara, Japan), multisegment reconstruction, and voxel sizes of 0.35x0.35x0.5 mm. The degree of stenosis on MSCT and quantitative coronary angiography (QCA) was measured by correlating the difference between the reference vessel diameter (average of 2 measurements directly proximal and distal to the stenosis) and the stenotic vessel diameter to the reference vessel diameter. RESULTS: Correlation between the percent diameter stenosis determined by MSCT (78.2+/-13.6%) and QCA (76.0+/-14.8%) was significant (P<0.001) but only moderately so (R=0.51). Bland-Altman analysis revealed no systematic under- or overestimation with MSCT but large limits of agreements (+/-27.6%). Also the limits of agreement for interobserver agreement (reliability) of MSCT data were considerably large (+/-24.8%). Among the 27 coronary artery stenoses with a reference diameter of at least 3.5 mm, there was improved correlation (R=0.80) and the limits of agreement between MSCT and QCA were significantly smaller (+/-17.3%, P<0.008). The agreement between MSCT and QCA was not significantly different for stenoses with no calcification or only calcium spots (+/-28.2%) as compared with those with moderate-or-severe calcifications (+/-27.3%; P=0.8). MSCT allowed correct classification of coronary stenoses into low-grade (below 75%) and high-grade stenoses (at least 75%), in 62% (73 of 118). CONCLUSIONS: The accuracy and reliability of coronary artery stenosis quantification with MSCT using isotropic voxel sizes and multisegment reconstruction is still too low to recommend routine clinical application because of rather low agreement, correlation, and reliability. Despite these limitations, the current results demonstrate the potential of MSCT for reliable and accurate quantification of coronary artery stenoses in the near future provided that further improvements in spatial and temporal resolution will be achieved.

Anatomy, Cross-Sectional↗
PubMed2006

Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter.

BACKGROUND: Treatment of coronary in-stent restenosis is hampered by a high incidence of recurrent in-stent restenosis. We assessed the efficacy and safety of a paclitaxel-coated balloon in this setting. METHODS: We enrolled 52 patients with in-stent restenosis in a randomized, double-blind, multicenter trial to compare the effects of a balloon catheter coated with paclitaxel (3 microg per square millimeter of balloon surface area) with those of an uncoated balloon catheter in coronary angioplasty. The primary end point was late luminal loss as seen on angiography. Secondary end points included the rates of restenosis (a binary variable) and major adverse cardiac events. RESULTS: Multivessel disease was present in 80% of patients in both groups. Quantitative coronary angiography revealed no significant differences in baseline measures. At 6 months, angiography showed that the mean (+/-SD) in-segment late luminal loss was 0.74+/-0.86 mm in the uncoated-balloon group versus 0.03+/-0.48 mm in the coated-balloon group (P=0.002). A total of 10 of 23 patients (43%) in the uncoated-balloon group had restenosis, as compared with 1 of 22 patients (5%) in the coated-balloon group (P=0.002). At 12 months, the rate of major adverse cardiac events was 31% in the uncoated-balloon group and 4% in the coated-balloon group (P=0.01). This difference was primarily due to the need for target-lesion revascularization in six patients in the uncoated-balloon group (P=0.02). CONCLUSIONS: Treatment of coronary in-stent restenosis with paclitaxel-coated balloon catheters significantly reduced the incidence of restenosis. These data suggest that the inhibition of restenosis by local drug delivery may not require stent implantation and sustained drug release at the site of injury. (ClinicalTrials.gov number, NCT00106587 [ClinicalTrials.gov].).

Aged↗
PubMed2006

Evaluation of global and regional left ventricular function with 16-slice computed tomography, biplane cineventriculography, and two-dimensional transthoracic echocardiography: comparison with magnetic resonance imaging.

OBJECTIVES: We sought to compare left ventricular (LV) function assessed with multislice computed tomography (MSCT), biplane cineventriculography (CVG), and transthoracic echocardiography (Echo), with magnetic resonance imaging (MRI) as the reference standard. BACKGROUND: With the same data as acquired for noninvasive coronary angiography, MSCT enables registration of myocardial function. METHODS: A total of 88 patients (64 men and 24 women) underwent MSCT with 16 x 0.5 mm detector collimation, CVG, and MRI, whereas Echo was retrospectively analyzed in a subset of 30 patients. RESULTS: Regarding the ejection fraction, the agreement was significantly superior for MSCT than for CVG (+/- 10.2% vs. +/- 16.8%; p < 0.001) and Echo (+/- 11.0% vs. +/- 21.2%; p < 0.001). For the end-diastolic and end-systolic volumes, the limits of agreement with CVG (p < 0.001) and Echo (p < 0.001 and p < 0.02, respectively) were also significantly larger than with MSCT. In comparison with MSCT, CVG significantly overestimated the end-diastolic and end-systolic volumes (p < 0.001). Intraobserver analysis of MSCT yielded limits of agreement for ejection fraction (+/- 4.8%), end-diastolic volume (+/- 15.6 ml) and end-systolic volume (+/- 8.0 ml), and myocardial mass (+/- 18.2 g). The accuracy in identifying patients and myocardial segments with abnormal regional function was significantly higher with MSCT (84% and 95%) than with CVG (63% and 90%; p < 0.002 and p < 0.001), whereas MSCT and Echo were not significantly different in identifying patients with abnormal regional function. CONCLUSIONS: Our results indicate that the assessment of global and regional LV function with MSCT is more accurate than with CVG, whereas MSCT is superior to Echo for global function. This suggests that MSCT allows reliable evaluation of global and regional LV function.

Aged↗
PubMed2006

Noninvasive detection of coronary artery stenoses with multislice computed tomography or magnetic resonance imaging.

BACKGROUND: Multislice computed tomography (CT) and magnetic resonance imaging (MRI) are the main candidates for noninvasive coronary angiography; however, multislice CT, unlike MRI, exposes patients to radiation and an iodinated intravenous contrast agent. OBJECTIVE: To compare the diagnostic accuracy of multislice CT and MRI for noninvasive detection of clinically significant coronary stenoses (> or =50%). DESIGN: Prospective intention-to-diagnose study. SETTING: Single tertiary referral center, Berlin, Germany. PATIENTS: 129 consecutive patients with suspected coronary artery disease. INTERVENTIONS: Multislice CT and MRI were both performed within a median of 1 day before conventional coronary angiography, which served as the reference standard. MEASUREMENTS: Diagnostic performance of multislice CT and MRI. RESULTS: 129 patients completed the study. Altogether, 108 patients with 430 vessels could be examined with both multislice CT and MRI and were used for analysis. In the per-patient analysis, the sensitivity of multislice CT (92% [95% CI, 82% to 96%]) was significantly higher than that of MRI (74% [CI, 61% to 83%]; P = 0.013). The sensitivity for detecting clinically significant stenoses was 82% for multislice CT and 54% for MRI (P < 0.001). Specificity and negative predictive value of multislice CT and MRI in the per-vessel analysis were 90% versus 87% (P = 0.73) and 95% versus 90% (P = 0.032), respectively. The effective radiation dose used with multislice CT (mean, 12.3 mSv [SD, 1.4]) in a consecutive subgroup of 73 patients was not significantly different from that used with diagnostic cardiac catheterization (11.4 mSv [SD, 4.8]) (P = 0.169). Most patients (74%) indicated that they would prefer multislice CT for future diagnostic imaging (P < 0.001). LIMITATIONS: This was a single-center study with 129 patients. CONCLUSIONS: In patients referred for conventional coronary angiography, multislice CT compares favorably with MRI for noninvasive detection of coronary stenoses.

Coronary Angiography↗
PubMed2006

Clinical and angiographic analysis with a cobalt alloy coronary stent (driver) in stable and unstable angina pectoris.

The Clinical and Angiographic analysis with a Cobalt Alloy Coronary Stent (Driver) (CLASS) study was a prospective, nonrandomized, multicenter study designed to assess the safety and efficacy of a cobalt-chromium alloy-based stent in patients with stable or unstable angina pectoris. A total of 203 lesions were treated in 202 enrolled patients. The percentage of major adverse cardiac event-free patients was 87.6% (177 of 202) at 6 months (primary safety end point; major adverse cardiac events were defined as death, myocardial infarction, emergency bypass surgery, or target lesion revascularization [percutaneous transluminal coronary angioplasty or coronary artery bypass grafting]). The angiographic success rate (primary efficacy end point) was 100%, and the procedural success rate was 98%. The binary in-stent restenosis rate at 6 months was 12.6%. Our results have demonstrated that the Driver cobalt-chromium alloy stent can be used with a low 6-month incidence of major adverse cardiac events, a low 6-month binary restenosis rate, and high angiographic and procedural success rates.

Aged↗
PubMed2006

Combination of free-breathing and breathhold steady-state free precession magnetic resonance angiography for detection of coronary artery stenoses.

PURPOSE: To analyze the incremental diagnostic value of a combination of two approaches (free-breathing and breathhold) vs. the sole free-breathing approach to coronary magnetic resonance angiography (CMRA) for detection of significant stenoses. MATERIALS AND METHODS: Thirty patients were consecutively included in this prospective trial. CMRA was performed on a 1.5-T MR scanner (Magnetom Sonata, Siemens) using a balanced steady-state free precession (SSFP) sequence during free-breathing (2.4 x 0.9 x 0.7 mm3). Breathholding acquisitions (3.0 x 1.5 x 0.7 mm3) were only performed in cases in which the quality of free-breathing CMRA precluded assessment. Patients with contraindications to CMRA, claustrophobia, or nonassessable images were not excluded from the assessment of diagnostic accuracy (intention-to-diagnose design). RESULTS: In 60% of all free-breathing coronary acquisitions the image quality was adequate for diagnostic assessment. For the remaining 40% of the cases, breathhold acquisitions were obtained. The sensitivity, specificity, nonassessable rate, and accuracy in identifying main coronary branches with significant stenoses using the combination of both breathing approaches and the free-breathing approach alone were 65% vs. 32%, 73% vs. 53%, 24% vs. 52%, and 71% vs. 46%, respectively (P < 0.001). CONCLUSION: In this consecutive cohort of patients, the combination of free-breathing and breathhold CMRA significantly improved diagnostic accuracy. Nevertheless, even this combination did not reach accuracies sufficient for routine clinical application.

Cohort Studies↗
PubMed2005

Long-term fluvastatin reduces the hazardous effect of renal impairment on four-year atherosclerotic outcomes (a LIPS substudy).

Mild renal impairment is an important risk factor for late cardiovascular complications. This substudy of the Lescol Intervention Prevention Study (LIPS) assessed the effect of fluvastatin on outcome of patients who had renal dysfunction and those who did not. Complete data for creatinine clearance calculation (Cockcroft-Gault formula) were available for 1,558 patients (92.9% of the LIPS population). Patients were randomized to fluvastatin or placebo after successful completion of a first percutaneous coronary intervention. Follow-up time was 3 to 4 years. The effect of baseline creatinine clearance on coronary atherosclerotic events (cardiac death, nonfatal myocardial infarction, and coronary reinterventions not related to restenosis) was evaluated. Baseline creatinine clearance (logarithmic transformation) was inversely associated with an incidence of adverse events among patients who received placebo (hazard ratio 0.99, 95% confidence interval 0.982 to 0.998, p = 0.01). However, no association was noted between creatinine clearance and the incidence of adverse events among patients who received fluvastatin (hazard ratio 1.0, 95% confidence interval 0.99 to 1.0, p = 0.63). No further deterioration in creatinine clearance was observed during follow-up, regardless of baseline renal function or allocated treatment. Occurrence of adverse events was not related to changes in renal function during follow-up. Fluvastatin therapy markedly decreased the risk of coronary atherosclerotic events after percutaneous intervention in patients who had lower values of creatinine clearance at baseline. The benefit of fluvastatin was unrelated to any effect on renal function.

Age Factors↗
PubMed2004

Lack of clopidogrel pretreatment effect on the relative efficacy of bivalirudin with provisional glycoprotein IIb/IIIa blockade compared to heparin with routine glycoprotein IIb/IIIa blockade: a REPLACE-2 substudy.

OBJECTIVES: The purpose of this study was to assess if clopidogrel pretreatment affects the relative efficacy of bivalirudin versus heparin with glycoprotein (GP) IIb/IIIa blockade for percutaneous coronary interventions (PCI). BACKGROUND: Although thienopyridine pretreatment may improve clinical outcomes with PCI, it is unknown if bivalirudin's efficacy compared with heparin is dependent upon such pretreatment. METHODS: The Randomized Evaluation in Percutaneous coronary intervention Linking Angiomax to reduced Clinical Events (REPLACE-2) trial was a double-blind, triple-dummy, randomized-controlled trial comparing heparin plus routine GP IIb/IIIa blockade (heparin group) with bivalirudin plus provisional GP IIb/IIIa blockade (bivalirudin group) during PCI. The primary end point was a composite of death, myocardial infarction (MI), urgent revascularization at 30 days, and major in-hospital bleeding. The secondary end point was a 30-day composite of death, MI, and urgent revascularization. Clopidogrel pretreatment was encouraged (300 mg loading, 75 mg/day). RESULTS: Of 6,010 patients enrolled, 5,893 received clopidogrel, with 85.8% in the bivalirudin and 84.6% in the heparin group receiving clopidogrel pretreatment. Bivalirudin (provisional GP IIb/IIIa blockade 7.2%) was noninferior to the heparin group for both primary and secondary end points. Clopidogrel pretreatment did not affect the relative efficacy of bivalirudin versus heparin with GP IIb/IIIa blockade, irrespective of pretreatment duration. Pretreatment was associated with significantly lower primary end point with bivalirudin (8.7% pretreatment vs. 12.9% no pretreatment, p = 0.007), and nonsignificantly with heparin (9.7% vs. 11.7%, respectively, p = 0.20). Multivariable models showed a trend toward lower primary and secondary end points with clopidogrel pretreatment. CONCLUSIONS: Clopidogrel pretreatment at the doses and time administered in this trial did not influence the relative efficacy of bivalirudin versus heparin plus GP IIb/IIIa blockade for PCI. However, pretreatment was associated with a trend towards lower clinical events after PCI.

Aged↗
PubMed2004

Atypical vessels as an early sign of intracardiac myxoma?

We report on a woman with previously unknown left atrial myxoma, who underwent percutaneous coronary intervention. 45 months after the initial coronary angiography, echocardiography demonstrated a large atrial myxoma, which was not seen echocardiographically before. The retrospective analysis of the pre-intervention coronary angiography revealed atypical vessels in the atrial septum, which are interpreted as early signs of myxoma.

Chest Pain↗
PubMed2004

Long-term efficacy of bivalirudin and provisional glycoprotein IIb/IIIa blockade vs heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary revascularization: REPLACE-2 randomized trial.

CONTEXT: In the Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)-2 trial, bivalirudin with provisional glycoprotein IIb/IIIa (Gp IIb/IIIa) inhibition was found to be noninferior to heparin plus planned Gp IIb/IIIa blockade in the prevention of acute ischemic end points and was associated with significantly less bleeding by 30 days after percutaneous coronary intervention (PCI). OBJECTIVE: To determine whether the efficacy of bivalirudin remains comparable with that of heparin plus Gp IIb/IIIa blockade over 6 months and 1 year. DESIGN, SETTING, AND PARTICIPANTS: Follow-up study to 1 year of a randomized, double-blind trial conducted among 6010 patients undergoing urgent or elective PCI at 233 community or referral hospitals in 9 countries from October 2001 through August 2002. INTERVENTIONS: Patients were randomly assigned to receive intravenously bivalirudin (0.75 mg/kg bolus, 1.75 mg/kg per hour for the duration of PCI), with provisional Gp IIb/IIIa inhibition, or to receive heparin (65 U/kg bolus), with planned Gp IIb/IIIa inhibition (abciximab or eptifibatide). Both groups received daily aspirin and a thienopyridine for at least 30 days after PCI. MAIN OUTCOME MEASURES: Incidence of death, myocardial infarction, or repeat revascularization by 6 months and death by 12 months after enrollment. RESULTS: At 6 months, death occurred in 1.4% of patients in the heparin plus Gp IIb/IIIa group and in 1.0% of patients in the bivalirudin group (hazard ratio [HR], 0.70; 95% confidence interval [CI], 0.43-1.14; P =.15). Myocardial infarction occurred in 7.4% and 8.2% of patients, respectively (HR, 1.12; 95% CI, 0.93-1.34; P =.24), and repeat revascularization was required in 11.4% and 12.1% of patients, respectively (HR, 1.06; 95% CI, 0.91-1.23; P =.45). By 1 year, death occurred in 2.46% of patients treated with heparin plus Gp IIb/IIIa blockade and in 1.89% of patients treated with bivalirudin (HR, 0.78; 95% CI, 0.55-1.11; P =.16). Nonsignificant trends toward lower 1-year mortality with bivalirudin were present in all patient subgroups analyzed and were of greatest magnitude among high-risk patients. CONCLUSION: Long-term clinical outcome with bivalirudin and provisional Gp IIb/IIIa blockade is comparable with that of heparin plus planned Gp IIb/IIIa inhibition during contemporary PCI.

Abciximab↗
PubMed2004

Direct stenting versus direct stenting followed by centered beta-radiation with intravascular ultrasound-guided dosimetry and long-term anti-platelet treatment: results of a randomized trial: Beta-Radiation Investigation with Direct Stenting and Galileo in Europe (BRIDGE).

OBJECTIVES: We sought to assess the efficacy of vascular brachytherapy (VBT) combined with stenting for the primary prevention of restenosis. BACKGROUND: Intravascular brachytherapy after stent implantation for de novo lesions has been abandoned for the present. We revisited this procedure by optimizing all procedural steps-the use of glycoprotein IIb/IIa blockers, direct stenting, adequate radiation coverage, avoidance of edge damage, source centering, intravascular ultrasound-guided dosimetry, and continuation of a dual anti-platelet regimen for one year. METHODS: The Beta-Radiation Investigation with Direct stenting and Galileo in Europe (BRIDGE) study is a multicenter, randomized controlled trial evaluating the long-term efficacy of VBT with P-32 (20 Gy at 1 mm in the coronary wall) after direct stenting. The primary end point was angiographic intra-stent late loss; secondary end points were six months binary restenosis and neo-intimal hyperplasia. Patients (n = 112) with de novo lesions (2.5 to 4.0 mm in diameter up to 15 mm long) were randomized to either VBT or no-VBT. RESULTS: At six months, intra-stent loss was 0.43 and 0.84 mm (p < 0.001) in the irradiated and control groups, respectively. Intra-stent neo-intimal volume was reduced from 36 mm3 to 10 mm3. However, in the irradiated group there were six late occlusions as well as eight restenoses outside the stented and peri-stented area at the fall-off dose edges of the irradiated area. Accordingly, the target vessel revascularization and major adverse cardiac and cerebrovascular events rates at one year in the VBT group (20.4% and 25.9%, respectively) were higher than in the control group (12.1% and 17.2%, respectively). CONCLUSIONS: Despite the optimization of pre-, peri-, and post-procedural factors and despite the relative efficacy of the brachytherapy for the prevention of the intra-stent neo-intimal hyperplasia, the clinical outcome of the irradiated group was less favorable than that of the control group.

Aged↗
PubMed2004

Vascular responses at proximal and distal edges of paclitaxel-eluting stents: serial intravascular ultrasound analysis from the TAXUS II trial.

BACKGROUND: On the basis of brachytherapy experience, edge stenosis has been raised as a potential limitation for drug-eluting stents. We used serial intravascular ultrasound (IVUS) to prospectively analyze vessel responses in adjacent reference segments after implantation of polymer-controlled paclitaxel-eluting stents. METHODS AND RESULTS: TAXUS II was a randomized, double-blind trial with 2 consecutive patient cohorts that compared slow-release (SR) and moderate-release (MR) paclitaxel-eluting stents with control bare metal stents (BMS). By protocol, all patients had postprocedure and 6-month follow-up IVUS. Quantitative IVUS analysis was performed by an independent core laboratory, blinded to treatment allocation, in 5-mm vessel segments immediately proximal and distal to the stent. Serial IVUS was available for 106 SR, 107 MR, and 214 BMS patients. For all 3 groups, a significant decrease in proximal-edge lumen area was observed at 6 months. The decrease was comparable (by ANOVA, P=0.194) for patients in the SR (-0.54+/-2.1 mm2) and MR (-0.88+/-1.9 mm2) groups compared with the BMS (-1.02+/-1.9 mm2) group. For the distal edge, a significant decrease in lumen area was only observed with BMS (-0.91+/-2.0 mm2, P<0.0001); this decrease was significantly attenuated with SR (0.08+/-2.0 mm2) and MR (-0.19+/-1.7 mm2) stents (P<0.0001 by ANOVA). Negative vessel remodeling was observed at the proximal (-0.48+/-2.2 mm2, P=0.011) but not the distal edges of BMS and at neither edge of SR or MR stents. CONCLUSIONS: The marked reduction in in-stent restenosis with SR or MR stents is not associated with increased edge stenosis at 6-month follow-up IVUS. In fact, compared with BMS, there is instead a significant reduction in late lumen loss at the distal edge with TAXUS stents.

Coronary Restenosis↗
PubMed2004

Direct stenting with TAXUS stents seems to be as safe and effective as with predilatation. A post hoc analysis of TAXUS II.

BACKGROUND AND METHOD: Although direct coronary stenting does not improve angiographic outcome, it makes sense by reducing procedure times, radiation exposure and costs. Other potential advantages of direct stenting may be a reduction of myocardial ischemia time, which could be clinically relevant in high-risk patients. With the introduction of drug-eluting stents, however, concern arose that direct stenting would possibly damage the polymer coating and change or diminish the efficacy of the programmed drug release. Also, concerns about safety by preventing optimal apposition of single stent struts developed. It is the purpose of this paper to retrospectively analyze the data from the TAXUS-II Trial (536 patients) regarding patients with and without direct stenting. While predilatation was recommended per protocol, direct stenting was not forbidden: thus, direct stenting was performed in 49 patients (TAXUS n = 23, control n = 26). RESULTS: In the TAXUS groups, there was no significant difference regarding major adverse cardiac events (MACE; 7.5% vs. 4.3%), angiographic restenosis in the analysis segment (4.8% vs. 4.3%), late loss (0.28 +/- 0.36 vs. 0.33 +/- 0.30 mm) or intravascular ultrasound-(IVUS-)measured volume obstruction (7.95 +/- 9.84% vs. 5.61 +/- 7.91%) at six months between the predilated and directly stented patients. The same was true for the patients receiving the control stent. Compared with the directly stented control group, the statistically significant positive effects of TAXUS direct stenting were maintained, regarding angiographic restenosis in the analysis segment (4.3% vs. 30.8%), late loss (0.33 +/- 0.30 vs. 0.80 +/- 0.62 mm) or IVUS-measured volume obstruction (5.61 +/- 7.91% vs. 22.50 +/- 21.62%) at six months. MACE was reduced from 19.2% to 4.3%; due to the small number of patients this trend did not reach statistical significance. After predilatation, all parameters were significantly improved by the TAXUS stent. CONCLUSION: Comparison of patients receiving TAXUS stents with or without predilatation revealed no differences in clinical, angiographic or IVUS parameters at six months. This suggests that direct stenting with the polymer-based paclitaxel-eluting TAXUS stent is feasible, safe and equally effective. Randomized trials comparing stenting after predilatation versus direct stenting with drug-eluting stents are warranted.

Angioplasty, Balloon, Coronary↗
PubMed2004

Multisegment and halfscan reconstruction of 16-slice computed tomography for detection of coronary artery stenoses.

RATIONALE AND OBJECTIVES: To compare the diagnostic accuracy and image quality of 2 reconstruction algorithms (multisegment and halfscan) for computed tomography (CT) coronary angiography in patients without beta-blocker medication. MATERIALS AND METHODS: Thirty-four patients with 42 significant coronary stenoses in 136 main coronary branches were examined using a 16-slice CT scanner (Aquilion, Toshiba, Otawara, Japan). Twenty-seven patients (79%) had heart rates above 65 beats/min. RESULTS: Without exclusion of branches the sensitivity, specificity, accuracy, and rate of nonassessable segments with multisegment versus halfscan reconstruction were 88 versus 74%, 91 versus 71%, 90 versus 72%, and 2 versus 21% (P < 0.01), respectively. Multisegment reconstruction improved the average vessel length free of motion artifacts by 56% compared with halfscan reconstruction (P < 0.01). Image quality in terms of vessel continuity and visibility of side branches (P < 0.005) was significantly better using multisegment reconstruction. CONCLUSIONS: Multisegment reconstruction has superior diagnostic accuracy and image quality compared with halfscan reconstruction in patients with normal heart rates.

Adult↗
PubMed2003

Bivalirudin and provisional glycoprotein IIb/IIIa blockade compared with heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary intervention: REPLACE-2 randomized trial.

CONTEXT: The direct thrombin inhibitor bivalirudin has been associated with better efficacy and less bleeding than heparin during coronary balloon angioplasty but has not been widely tested during contemporary percutaneous coronary intervention (PCI). OBJECTIVE: To determine the efficacy of bivalirudin, with glycoprotein IIb/IIIa (Gp IIb/IIIa) inhibition on a provisional basis for complications during PCI, compared with heparin plus planned Gp IIb/IIIa blockade with regard to protection from periprocedural ischemic and hemorrhagic complications. DESIGN, SETTING, AND PARTICIPANTS: The Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)-2 trial, a randomized, double-blind, active-controlled trial conducted among 6010 patients undergoing urgent or elective PCI at 233 community or referral hospitals in 9 countries from October 2001 through August 2002. INTERVENTIONS: Patients were randomly assigned to receive intravenous bivalirudin (0.75-mg/kg bolus plus 1.75 mg/kg per hour for the duration of PCI), with provisional Gp IIb/IIIa inhibition (n = 2999), or heparin (65-U/kg bolus) with planned Gp IIb/IIIa inhibition (abciximab or eptifibatide) (n = 3011). Both groups received daily aspirin and a thienopyridine for at least 30 days after PCI. MAIN OUTCOME MEASURES: The primary composite end point was 30-day incidence of death, myocardial infarction, urgent repeat revascularization, or in-hospital major bleeding; the secondary composite end point was 30-day incidence of death, myocardial infarction, or urgent repeat revascularization. RESULTS: Provisional Gp IIb/IIIa blockade was administered to 7.2% of patients in the bivalirudin group. By 30 days, the primary composite end point had occurred among 9.2% of patients in the bivalirudin group vs 10.0% of patients in the heparin-plus-Gp IIb/IIIa group (odds ratio, 0.92; 95% confidence interval, 0.77-1.09; P =.32). The secondary composite end point occurred in 7.6% of patients in the bivalirudin vs 7.1% of patients in the heparin-plus-Gp IIb/IIIa groups (odds ratio, 1.09; 95% confidence interval 0.90-1.32; P =.40). Prespecified statistical criteria for noninferiority to heparin plus Gp IIb/IIIa were satisfied for both end points. In-hospital major bleeding rates were significantly reduced by bivalirudin (2.4% vs 4.1%; P<.001). CONCLUSIONS: Bivalirudin with provisional Gp IIb/IIIa blockade is statistically not inferior to heparin plus planned Gp IIb/IIIa blockade during contemporary PCI with regard to suppression of acute ischemic end points and is associated with less bleeding.

Abciximab↗
PubMed2003

Apical tissue tracking echocardiography for characterization of regional left ventricular function: comparison with magnetic resonance imaging in patients after myocardial infarction.

OBJECTIVE: The purpose of this study was to characterize the normal pattern of apical tracking and to investigate whether tissue tracking imaging is more useful for evaluation of regional left-ventricular function than noncontrast harmonic echocardiography in patients after myocardial infarction. BACKGROUND: Left ventricular longitudinal shortening plays an important role in cardiac contraction, and can be evaluated online by a new Doppler tissue imaging method. METHODS: We included 40 healthy participants and 40 patients after myocardial infarction. They underwent tissue tracking imaging and noncontrast harmonic imaging by an experienced and an inexperienced observer. Diagnostic accuracy of semiquantitative evaluation of left ventricular function was compared using magnetic resonance imaging as reference method. RESULTS: Velocity-time integrals decreased from basal to apical segments in healthy participants. Tissue tracking imaging has a higher diagnostic sensitivity than noncontrast imaging for the diagnosis of regional wall-motion abnormalities (expert, 78% vs 97%, P <.01; beginner, 63% vs 91%, P <.001), whereas specificity remained unchanged (expert, 99% vs 97%, not significant; beginner, 91% vs 92%, not significant). CONCLUSIONS: Tissue tracking imaging is feasible and evaluates regional systolic myocardial function quantitatively with high diagnostic accuracy compared with magnetic resonance imaging in patients after myocardial infarction, and is more accurate than noncontrast harmonic echocardiography.

Aged↗
PubMed2002

A randomized comparison of the value of additional stenting after optimal balloon angioplasty for long coronary lesions: final results of the additional value of NIR stents for treatment of long coronary lesions (ADVANCE) study.

OBJECTIVES: We sought to investigate the clinical benefit of additional stent implantation after achieving an optimal result of balloon angioplasty (BA) in long coronary lesions (>20 mm). BACKGROUND: Long coronary lesions are associated with increased early complications and late restenosis after BA. Stenting improves the early outcome, but stent restenosis is also related to both lesion length and stent length. METHODS: A total of 437 patients with a single native lesion 20 to 50 mm in length were included and underwent BA, using long balloons matched to lesion length and vessel diameter (balloon/artery ratio 1.1) to achieve a diameter stenosis (DS) <30% by on-line quantitative coronary angiography (QCA). "Bail-out stenting" was performed for flow-limiting dissections or >50% DS. Patients in whom an optimal BA result was achieved were randomized to additional stenting (using NIR stents) or no stenting. The primary end point was freedom from major adverse cardiac events (MACE) at nine months, and core laboratory QCA was performed on serial angiograms. RESULTS: Bailout stenting was necessary in 149 patients (34%) and was associated with a significantly increased risk of peri-procedural infarction (p < 0.02). Among the 288 randomized patients, the mean lesion length was 27+/-9 mm, and the vessel diameter was 2.78+/-0.52 mm. The procedural success rate was 90% for the 143 patients assigned to BA alone (control group), as compared with 93% in the 145 patients assigned to additional stenting (stent group), which resulted in a superior early minimal lumen diameter (0.54 mm, p < 0.001) and led to reduced angiographic restenosis (27% vs. 42%, p = 0.022). Freedom from MACE at nine months was 77% in both groups. CONCLUSIONS: A strategy of provisional stenting for long coronary lesions led to bailout stenting in one-third of patients, with a threefold increase in peri-procedural infarction. Additional stenting yielded a lower angiographic restenosis rate, but no reduction in MACE at nine months.

Aged↗