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This study was performed to compare the safety and efficacy of sirolimus-eluting stents (SESs) and paclitaxel-eluting stents (PESs) on the outcomes of diabetic patients. Recent data with drug-eluting stents have shown improved clinical outcomes in diabetic patients. This study compared outcomes between the 2 available drug-eluting stents, SESs and PESs. From the prospective drug-eluting stent registries at the investigators' institution, 1,320 consecutive diabetic patients treated with SESs (n=873, 1,293 lesions) and PESs (n=447, 733 lesions) were identified and their in-hospital and 1- and 6-month clinical outcomes compared. Baseline characteristics showed more men, more patients with previous coronary bypass surgery, and smaller ejection fractions in the PES group and more obese patients in the SES group. Procedural characteristics were similar except for more left anterior descending artery and proximal lesions and the greater use of glycoprotein IIb/IIIa inhibitors in the SES group and more type C lesions, direct stenting, and stents per patient in the PES group. In-hospital complications were similar. Clinical follow-up at 1 month was also similar between the 2 groups, including subacute stent thrombosis. At 6 months, the 2 groups had similar mortality (7% vs 7%), myocardial infarctions (18% vs 21%), target lesion revascularization, target vessel revascularization, major adverse cardiac events (11% vs 12%), and late thrombosis (0.3% vs 0%). Subanalysis of insulin-treated diabetic patients showed no significant differences in outcomes in the 2 groups. No significant differences were found between SESs and PESs on Cox regression analysis for hazard ratios. In conclusion, SESs and PESs are associated with similar efficacy and safety with regard to repeat revascularization rates, major adverse cardiac events, and stent thrombosis up to 6 months for the treatment of coronary artery disease in patients with diabetes mellitus regardless of insulin therapy.

Background: Bivalirudin is replacing heparin as the anticoagulant agent of choice for elective percutaneous coronary intervention (PCI). This study aimed to assess the safety and clinical outcomes of bivalirudin versus unfractionated heparin (UFH) in patients undergoing PCI for acute myocardial infarction (AMI)., Methods: A cohort of 672 consecutive patients presenting with AMI without prior thrombolytic therapy were treated with either bivalirudin (216 patients) or UFH (456 patients). Platelet glycoprotein IIb/IIIa inhibitors were administered at the operator's discretion. The in-hospital, 30-day, and 6-month outcomes of the two groups were compared., Results: Baseline clinical and angiographic characteristics were similar between the groups. In-hospital complications were similar, although there was a trend of a less major hematocrit drop in the bivalirudin group (0.9% vs. 3.1%, P=.09). All clinical outcomes were similar between the groups at 30-day and 6-month follow-ups. There was no statistical significance for acute thrombosis and subacute thrombosis between the groups, and there was no late thrombosis from either group. The event-free survival rate was similar between the groups (P=.41)., Conclusion: The use of bivalirudin in patients undergoing PCI after AMI is safe and feasible. Bivalirudin should be considered as an alternative anticoagulant agent during PCI to treat patients presenting with AMI.

Objectives: We aimed to compare clinical outcomes of octogenarians > or =80 years of age after coronary drug-eluting stent (DES) implantation., Background: Although octogenarians constitute a fast-growing portion of cardiovascular patients, they are not adequately represented in current clinical revascularization trials., Methods: We analyzed the data of 3,166 consecutive patients who underwent percutaneous coronary intervention (PCI) and DES implantation since March 2003. Periprocedural events, 1- and 6-month clinical outcomes were compared between octogenarians (n = 339) and patients <80 years of age (n = 2,827)., Results: Baseline characteristics revealed a higher prevalence of females (P < 0.001), Caucasians (P = 0.004), chronic renal failure (P < 0.001), heart failure (P < 0.001), number of diseased vessels (P = 0.009), and lower ejection fraction (P = 0.03) in octogenarians. Patients <80 years showed more positive family history (P < 0.001), hyperlipidemia (P = 0.006), smoking (P < 0.001), and obesity (P < 0.001). Clinical presentation and procedural success were similar in both groups as were death, myocardial infarction (MI), and repeat revascularization in-hospital. At 6 months, restenosis rates were low and comparable. In the subgroup of octogenarians who presented with acute coronary syndrome, mortality (15% vs. 3%, P < 0.001) and Q-wave MI occurred more often. Multivariate analysis revealed age >80 (P = 0.008), cardiogenic shock (P < 0.001), Q-wave MI at presentation (P = 0.003), and length of hospital stay (P = 0.003) to be independent predictors of mortality., Conclusions: PCI with DES in octogenarians results in a similar reduction of restenosis rates when compared to patients <80 years. Yet in octogenarians who presented with acute coronary syndrome, incidence of mortality and Q-wave MI at 6 months was higher as compared to younger patients., (Copyright 2006 Wiley-Liss, Inc.)

Objectives: The purpose of this study was to examine the clinical outcomes of patients who underwent stenting with > or =3 sirolimus-eluting stents (SES) when compared with those treated with > or =3 paclitaxel-eluting stents (PES)., Background: Drug-eluting stent (DES) implantation for single coronary lesions is proven to be effective and durable., Methods: A total of 126 patients who received DES were identified, of which 66 patients received > or =3 SES (SES group) and 60 patients received > or =3 PES (PES group)., Results: The baseline clinical and angiographic characteristics were compatible between the two study groups. During the index hospitalization, all clinical outcomes were similar between the two groups. There were no deaths or Q-wave myocardial infarctions (MIs) in either group. At 30 days' and 6 months' follow-up, all clinical outcomes, including death, Q-wave MI, non-Q-wave MI, target lesion revascularization, target vascular revascularization, and major adverse cardiac events, were compatible between both groups. There were 2 patients (3.0%) with subacute thrombosis in the SES group and 1 patient (1.7%) in the PES group, but there was no statistical significance. There was no late thrombosis from either group. In addition, patients in the SES group had similar event-free survival rates as compared with those in the PES group (P = 0.56)., Conclusions: Patients who require > or =3 DES implantations experienced increased adverse clinical events as compared with historical single stent implantation. However, there were no differences in safety and efficacy among the patients treated with SES as compared with those treated with PES., (Copyright 2006 Wiley-Liss, Inc.)

Objectives: The goal of this study was to use intravascular ultrasound (IVUS) to compare octogenarians versus patients <65 years of age with regard to culprit lesion morphology in acute myocardial infarction (MI)., Background: Although octogenarians represent the fastest-growing segment of our population and have a higher risk profile, they are underrepresented in therapeutic trials., Methods: Between 2002 and 2005, 42 octogenarians and 52 patients <65 years of age underwent pre-intervention IVUS within 2 days from onset of an MI. Qualitative and quantitative measurements were performed at the lesion site and at the proximal and distal references. Positive remodeling was defined as a remodeling index (lesion/mean reference arterial area) > or =1., Results: Elderly patients mostly (71%) presented with non-ST-segment elevation myocardial infarction (NSTEMI), whereas patients <65 years of age presented almost equally with ST-segment elevation myocardial infarction (STEMI) and NSTEMI (56% vs. 44%). The frequency of rupture/dissection was greater in the <65-year-old group (32% vs. 9%, p = 0.009), and culprit lesions contained more thrombus in this group (14% vs. 2%, p = 0.04). Conversely, in octogenarians, lesions were predominantly calcified (57% vs. 10%, p < 0.001) and longer (20.9 +/- 7.8 mm vs. 16.6 +/- 6.1 mm, p = 0.004) with less positive remodeling (19% vs. 56%, p < 0.001). On multivariant logistic regression analysis, age was the only independent predictor of calcified plaque (p = 0.02) and remodeling (p = 0.005)., Conclusions: Negative remodeling and calcified plaque with rare plaque ruptured were common in elderly people with acute MI. These findings may contribute to the difference in clinical presentation and may suggest a different pathophysiologic mechanism of MI in octogenarians.

Objectives: We aimed to compare the clinical outcomes of dialysis versus nondialysis patients after coronary drug-eluting stent (DES) implantation., Background: The revascularization of ischemic heart disease in dialysis patients has remained controversial due to consistent exclusion of this population from major trials, especially in the context of percutaneous coronary interventions (PCI) with DES., Methods: We analyzed the data on 3,442 consecutive patients who underwent PCI and DES implantation since March 2003. Periprocedural events, 1- and 6-month clinical outcomes were then compared between dialysis (n = 72) and nondialysis patients (n = 3,370)., Results: Baseline characteristics revealed a higher prevalence of female gender (p = 0.03), African Americans (p < 0.001), hypertension (p < 0.001), diabetes mellitus (p < 0.001), number of diseased vessels (p = 0.04), lower ejection fraction (p < 0.001), and a higher prevalence of acute myocardial infarction (MI) (p = 0.04) in dialysis patients. Nondialysis patients showed more history of smoking (p < 0.001) and obesity (p = 0.02). Procedural success was higher (p = 0.05), while there was a trend toward a lower mortality rate, in the nondialysis group during hospitalization. At 6 months, the restenosis rate was low and comparable, but mortality occurred more often (16% vs. 3.8%; p < 0.001) in dialysis patients. Multivariate analysis revealed cardiogenic shock (p = 0.04) to be an independent predictor of mortality., Conclusions: PCI with DES in dialysis patients is safe and feasible, with a similar reduction of repeat revascularization when compared with nondialysis patients. There was, however, a higher incidence of mortality in dialysis patients at 6 months, mostly influenced by contributing comorbidities and more severe conditions at presentation.

Salivary responses habituate to repeated presentations of food cues, and these responses recover when new food stimuli are presented. Research suggests that within-session changes in motivated responding for food may also habituate, and motivated responding may, therefore, recover when new foods are presented. The purpose of this study was to evaluate similarities in the pattern of salivation and motivated responding for a cheeseburger stimulus in children, followed by either a novel stimulus (French fries) or another cheeseburger trial. The order of the task (salivation or motivation) was counterbalanced over days. Salivation and motivated responding for cheeseburger were reliably reduced over seven trials, and responses recovered after presentation of French fries on trial 8. Random regression models showed a significant relationship between the rate of change in motivated responding and salivation. These results provide additional support for similarities in processes that regulate salivation and motivated responding for food and strengthen support for the hypothesis that changes in motivated responding can be understood by habituation theory.

There are treatment failures after de novo drug-eluting stent (DES) implantation and after treatment with DESs or vascular brachytherapy (VBT) of in-stent restenosis (ISR) lesions. We studied 38 patients who presented with DES failure (26 patients after de novo DES implantation and 12 patients after DES treatment of ISR) and 30 patients who presented with VBT failure (all after treatment of ISR). Standard clinical data were collected and volumetric intravascular ultrasound was measured. Patients who presented with DES failures were 58.8 +/- 9.6 years of age and those who presented with VBT failures were 59.8 +/- 8.7 years of age; 60.5% of DES and 58.6% of VBT failures were in men; 31.5% of DES failures and 46.6% of VBT failures occurred in diabetic patients; and times to presentation were 210 +/- 101 days in DES failures and 510 +/- 527 days in VBT failures (p = 0.001). Minimal stent area was significantly larger in VBT than in the 2 DES failure groups (de novo DES implantation and DES treatment of ISR, p <0.0001); this was associated with more neointimal hyperplasia in VBT failures (p <0.0001). After it was normalized to stent length, intimal hyperplasia was diffusely distributed in VBT failures; conversely, DES failures were associated with less intimal hyperplasia and the intimal hyperplasia was mostly focal, with greater accumulation in the proximal and mid segments. In conclusion, VBT failures were caused by significant, recurrent, and diffuse intimal hyperplasia in the setting of adequate stent expansion, whereas DES failures were caused by only modest, but focal, intimal hyperplasia in the setting of DES underexpansion.

We investigated the safety and efficacy of drug-eluting stents (DESs) for the treatment of patients who presented with in-stent restenosis (ISR) of saphenous vein grafts (SVGs) and compared the in-hospital and 6-month clinical outcomes of DESs with those of intravascular brachytherapy and balloon angioplasty alone. Records of 187 patients who presented with ISR of SVGs were analyzed. Of these, 34 consecutive patients were treated with DES implantation, 93 were treated with intravascular brachytherapy (n = 60 with gamma-radiation, n = 33 with beta-radiation), and 60 patients underwent conventional treatment with balloon angioplasty alone. Clinical and angiographic characteristics at baseline were comparable between groups. The DES group had less non-Q-wave myocardial infarction than did the intravascular brachytherapy and balloon angioplasty groups (0%, 20%, and 26%, p = 0.003 and <0.001, respectively). At 6 months, death occurred in 0% of the DES group, 2% of the intravascular brachytherapy group, and 5% of the balloon angioplasty group (p = 0.36 and <0.18, respectively). Target lesion revascularization/major adverse cardiac events were similar in the intravascular brachytherapy and DES groups (12% and 3%, p = 0.13) and significantly decreased compared with patients who were treated with balloon angioplasty alone (55%, p <0.001 for the 2 comparisons). The results of this retrospective analysis suggest that DES implantation is at least as effective and safe as intravascular brachytherapy for the treatment of SVG ISR and that these treatment modalities are superior to balloon angioplasty alone.

We evaluated the effect of high versus low loading doses of clopidogrel in patients with stable angina pectoris who underwent percutaneous coronary intervention (PCI) on periprocedural events, in-hospital complications, and 30-day outcomes. The recommended loading dose of clopidogrel for patients with PCI is currently 300 mg. Recent studies have suggested that 600 mg may decrease periprocedural complications in patients with unstable angina. However, whether this holds for patients with stable angina pectoris is unknown. We reviewed records of 445 patients with stable angina pectoris who underwent PCI and were loaded with 300 mg (n = 126) or 600 mg (n = 319) of clopidogrel immediately before the procedure. Study end points were periprocedural ischemic events, bleeding complications, and a composite of major adverse cardiac events at 30 days. Baseline characteristics and procedural indexes were similar between groups. Major in-hospital complications were recorded in 2 patients in the 600-mg group and in no patient in the 300-mg group (p = 1.00). Postprocedural increase of cardiac enzymes (troponin I, p = 0.91; creatinine kinase-MB, p = 0.395) and major bleeding (0.6% vs 0%, p = 1.00) were comparable, as was 30-day major adverse cardiac events (1.2% vs 0%, p = 0.56). Multivariate analysis did not identify any risk decrease for periprocedural myocardial infarction with 600 mg of clopidogrel (odds ratio 2.68, 95% confidence interval 0.74 to 9.78, p = 0.135). In conclusion, in patients with stable angina pectoris, a 300-mg clopidogrel loading dose, when given immediately before PCI, is sufficient. Although 600 mg was clinically safe, it was not associated with fewer periprocedural events and improved 30-day outcomes compared with 300 mg.

Contrast-induced nephropathy (CIN) is a common complication of coronary angiography that is associated with significant morbidity and mortality. Preexisting renal dysfunction is the most important risk factor for the development of CIN. A novel strategy of infusing 1 L of 5% dextrose immediately before catheterization is associated with a lower rate of CIN in those at high risk (creatinine clearance < or = 60 ml/min). CIN occurred in 47 patients (5.7%) in the control group and 2 patients (1.4%) in the group treated with 5% dextrose. The relative risk decrease was 73% (p = 0.03). This is an effective, quick, and inexpensive method of improving outcomes in patients who undergo percutaneous coronary interventions.

Background: Saphenous vein graft (SVG) intervention is associated with a significantly increased rate of periprocedural complications and late clinical and angiographic restenosis. In the contemporary drug-eluting stent (DES) era, the comparison of the efficacy of sirolimus-eluting stents (SES) with paclitaxel-eluting stents (PES) in SVG interventions is currently unknown. We conducted this retrospective analysis to investigate this issue., Methods and Results: Forty-seven patients with 50 SVG lesions who underwent standard percutaneous coronary intervention (PCI) with SES (SES group) were compared with 42 patients with 45 SVG lesions with PES (PES group). All patients received distal protection devices (DPDs) during the interventions. The in-hospital, 30-day, and 6-month clinical outcomes in both groups were compared. Baseline clinical and procedural characteristics were balanced between both groups except for the proximal and mid lesions. There were no deaths or Q-wave myocardial infarctions (MIs) during the index hospitalization. Non-Q-wave MI was similar between the two groups (SES vs PES, 4.3% vs 7.1%, P=0.55). At 30-day and 6-month follow-ups, all the clinical outcomes were similar between the two groups. There was no subacute thrombosis (SAT) or late thrombosis in either group. The event-free survival at 6 months was also similar between both groups (P=0.75)., Conclusions: The use of DES in patients undergoing SVG intervention with a DPD is clinically safe and feasible. As compared to SES, PES have the same efficacy and clinical outcomes in SVG interventions up to 6 months.

Background: Sirolimus-eluting stent (SES) implantation for the treatment of single coronary lesions is proven to be effective and durable. However, the safety and efficacy of overlapping SES for the treatment of long lesions have not been well established., Objectives: We conducted a retrospective analysis to compare the clinical outcomes of overlapping versus nonoverlapping SES., Methods: Fifty-five patients who received overlapping SES were compared with 39 patients who received nonoverlapping SES., Results: The baseline clinical and angiographic characteristics were balanced between the two study groups. The in-hospital complications were similar between groups, except that non-Q-wave myocardial infarction was significantly higher in the Overlapping SES group when compared with the Nonoverlapping SES group (23.6% vs. 7.7%, P = 0.04). This higher rate of myonecrosis is due to periprocedural side branch compromises, including side branch narrowing, occlusion, and flow reduction. At 30 days and 6 months follow-up, all clinical outcomes were similar between the study groups. In addition, the event-free survival rate was similar between groups (P = 0.87)., Conclusions: The implantation of overlapping SES for the treatment of long, native coronary lesions is feasible and effective but is associated with an increased rate of periprocedural myonecrosis. This phenomenon is caused primarily by side branch compromises, but does not have any adverse impact on late clinical events.

Patients with chronic renal insufficiency (CRI) have higher rates of target vessel revascularization and mortality. The efficacy of sirolimus-eluting stents (SESs) to improve the clinical outcomes of these patients is unknown. We investigated the effect of SESs versus bare metal stents (BMSs) on outcomes of patients with CRI. Among the first 1,522 patients treated with SESs, 76 were identified with CRI and 1,446 without CRI. In-hospital and 1- and 6-month clinical outcomes were compared with 153 patients with CRI who were treated with BMSs. Patients with CRI were older, hypertensive, and diabetic and had more previous myocardial infarctions, revascularizations, and decreased left ventricular function (p <0.001). These patients had more saphenous vein graft lesions, were treated with more debulking devices (p <0.003), and had higher rates of in-hospital complications and mortality (p <0.001) compared with those without CRI. Among patients with CRI, treatment with SESs did not affect clinical outcomes at 1 month and was associated with lower incidences of target vessel revascularization (7.1% vs 22.1%, p = 0.02) at 6 months but did not affect other events, including mortality (16.7% vs 14.7% p = 0.89), compared with BMSs. However, treatment with SESs in patients without CRI was associated with significantly lower rates of major adverse cardiac events at 6 months (p <0.001). In conclusion, percutaneous coronary intervention with SESs in patients with CRI is associated with low rates of repeat revascularization compared with BMSs but has no effect on mortality at 6 months.

This retrospective analysis compared clinical outcomes of patients who underwent stenting with > or =3 sirolimus-eluting stents (SESs) with those who received a single SES. SES (Cypher) implantation for single vessels is proved to be effective and durable, but knowledge regarding the safety and effectiveness of multiple stenting with SESs is currently limited. In total, 929 consecutive patients who received SESs were identified; 63 received > or =3 SESs (multi group) and 866 received 1 SES (single group). The multi group had more non-Q-wave myocardial infarctions (MIs) during the index hospitalization (p = 0.02). At 30-day follow-up, death, Q-wave MI, subacute thrombosis, and major adverse cardiac events were higher in the multi group than in the single group. At 6 months, death, Q-wave MI, target lesion revascularization, and major adverse cardiac events continued to be higher in the multi group. Using multivariate analysis, > or =3 SES implantations, American College of Cardiology/American Heart Association type C lesions, and cardiogenic shock were identified as independent predictors for 6-month major adverse cardiac events. In addition, patients in the multi group had a significantly lower survival rate than patients in the single group (p <0.0001). Patients who required > or =3 SES implantations developed increased periprocedural non-Q-wave MI and worse adverse clinical outcomes at 30 days and 6 months compared with patients who required a single SES implantation. In conclusion, when patients present with multiple coronary lesions, percutaneous coronary intervention with multiple SESs should be undertaken with great caution.

Background: Metabolic syndrome (MS), the combination of hypertension, obesity, dyslipidemia, and insulin resistance, is a precursor of diabetes mellitus (DM) and highly prevalent among patients with acute myocardial infarction (AMI). Diabetes mellitus is associated with larger infarct size and worse outcomes after AMI. This study examined infarct size and short-term outcomes among nondiabetic patients with MS following contemporary treatment of AMI., Methods: Four hundred five consecutive patients with AMI treated with primary percutaneous coronary intervention were evaluated. Patients with diabetes (n=105) were excluded. Those with MS (n=167) included patients with three or more of the following criteria: hypertension, elevated fasting blood glucose, hypertriglyceridemia, low high-density lipoprotein, and obesity [body mass index (BMI)> or =30]. The control group (n=133) included patients without MS or DM., Results: Baseline characteristics were similar except for hypertension, BMI, and dyslipidemia, which by study design were higher in the MS group. The MS group had larger infarct size as determined by peak creatine kinase-MB (79.8+/-133.8 vs. 30.84+/-51.5, P<.001). Overall in-hospital complications were higher in patients with MS (21.1% vs. 9.2%, P=.003). Metabolic syndrome is associated with a 10-fold increased risk of acute renal failure after myocardial infarction (7.9% vs. 0.8%, P=.007)., Conclusion: Metabolic syndrome in nondiabetic patients with AMI is associated with larger infarct size, more in-hospital complications, and a marked increase of acute renal failure. Awareness of MS and preventative measures is crucial in this population to minimize infarct size and decrease morbidity after AMI.

The long-term outcome of patients who present with an identified plaque rupture in a nonflow-limiting lesion is not well known. We retrospectively studied 17 consecutive patients in whom intravascular ultrasound identified plaque rupture in nonflow-limiting lesions (minimum lumen area >4.0 mm2) that were not treated with coronary intervention. After a mean follow-up of 43 +/- 25 months, events related to those lesions were 1 death (6%) of undetermined cause (6%) that occurred after 69 months, no myocardial infarction, and 2 revascularizations (12%) that occurred at 3 and 67 months. Overall, the cumulative rate of cardiac events was 18%.

Recurrent in-stent restenosis (ISR) following intracoronary radiation therapy (IRT) continues to be a therapeutic challenge. The present study aims to evaluate the clinical outcomes of patients who were treated with drug-eluting stent (DES) implantation versus repeat IRT for recurrent ISR after brachytherapy failure. A cohort of 88 patients who were previously treated with brachytherapy for ISR and presented with angina and recurrence of angiographic restenosis were evaluated for treatment with either DES [sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES); n = 34] or percutaneous coronary intervention (PCI) and repeat radiation (gamma or beta radiation; n = 54). The two groups had similar baseline clinical and angiographic characteristics. The in-hospital outcomes were similar between both groups. At long-term follow-up of 9.7 +/- 4.1 months for the DES group and 10.3 +/- 3.5 months for the repeat IRT group, there were no deaths or myocardial infarctions (MI). There was a trend toward more target vessel revascularization-major adverse cardiac events (TVR-MACE) in the DES group (p = 0.09). In addition, the patients in the DES group had a significantly lower survival rate compared to those in the repeat IRT group (p = 0.018). For patients who had recurrent ISR following IRT, either DES implantation or repeat radiation is safe and is associated with excellent immediate outcomes. Yet, at long-term follow-up, repeat IRT was associated with less recurrences and need for repeat revascularization when compared to DES implantation. Therefore, repeat IRT should be considered as an option for this difficult patient subset.

Patients with diabetes mellitus are at increased risk for repeat interventions and mortality after coronary angioplasty and stenting. The efficacy of sirolimus-eluting stents (SESs) to improve the outcomes of these patients is a focus of interest. In the first 1,407 patients treated with SESs at our institution, 492 were diabetic (insulin dependent diabetes mellitus [IDDM], n = 160 and non-insulin-dependent DM [NIDDM], n = 332). The in-hospital and 1- and 6-month clinical outcomes were compared with those of 915 patients without DM (non-DM). The baseline characteristics were similar, except for more women, obesity, previous myocardial infarction, coronary artery bypass grafting, and renal insufficiency in the DM group (p <0.001). Compared with non-DM patients, DM patients had higher in-hospital (p <0.05) and 1-month mortality (p = 0.02). IDDM patients had more in-hospital renal failure (p = 0.04) and Q-wave myocardial infarctions (1.6% vs 0%, p = 0.04) compared with NIDDM patients, and higher mortality (3.1% vs 0.8%, p = 0.04) and subacute stent thromboses (2.3% vs 0.5%, p = 0.07) than non-DM patients at 30 days. At 6 months, DM patients had a higher incidence of Q-wave myocardial infarction, target lesion revascularization-major adverse cardiac events, and composite of death and Q-wave myocardial infarction than non-DM patients (6.0% vs 2.7%, p = 0.01). Late outcomes between the IDDM and NIDDM groups were similar. Multivariate analysis showed diabetes and acute renal failure as independent predictors of target lesion revascularization-major adverse cardiac events. In conclusion, our data showed that, despite a reduction in repeat revascularization, coronary intervention with SESs in diabetic patients is limited by higher mortality at 1 month and a higher incidence of Q-wave myocardial infarction and target lesion revascularization-major adverse cardiac events at 6 months compared with non-DM patients. Careful surveillance is required in IDDM patients undergoing SES implantation.

The aim of the present study was to use intravascular ultrasonography (IVUS) to assess plaque morphology and morphometry in patients with varying degrees of chronic renal insufficiency, including end-stage renal disease (ESRD) on dialysis replacement. Cardiovascular disease is the main cause of death for patients with chronic renal insufficiency, particularly in patients with ESRD. The impact of several degrees of renal insufficiency (including ESRD) on coronary plaque characteristics has not been determined. A total of 142 patients who underwent IVUS imaging of a de novo native coronary artery stenosis before percutaneous intervention were matched for age, gender, and diabetes and were grouped according to calculated creatinine clearance (CrCl): CrCl >70 ml/min (n = 39); CrCl 50 to 69 ml/min (n = 41); CrCl <50 ml/min, (n = 37), and ESRD (n = 25). Standard clinical, angiographic, and IVUS parameters were measured. The ESRD group had more African-American (p = 0.002) and hypertensive (p = 0.002) patients. No significant difference was found in any of the IVUS measurements among patients with CrCl >70, 50 to 69, and <50 ml/min: reference and lesion site arterial, lumen, and plaque areas and volumes, and arterial calcium (p = NS for all comparisons). Conversely, patients with ESRD had larger reference segment arterial and lumen areas and volumes; larger lesion site arterial, lumen, and plaque areas; and larger arcs of calcium (p <0.05 for all post hoc comparisons between patients with ESRD and patients with CrCl >70, 50 to 69, and <50 ml/min). Thus, chronic renal insufficiency in the absence of dialysis is not associated with increased reference segment or lesion site plaque burden and calcium. However, the transition to the need for dialysis is associated with progressive calcific atherosclerosis (larger lesion plaque area and calcium).

Background: Bivalirudin is replacing heparin in percutaneous coronary interventions (PCIs), including vascular brachytherapy (VBT). The aim of the study was to compare bivalirudin with eptifibatide in patients with in-stent restenosis (ISR) undergoing PCI and VBT., Methods: One hundred forty-four patients treated with bivalirudin as a single antithrombotic agent were compared with 150 patients treated with eptifibatide. Bivalirudin as a bolus of 0.75 mg/kg followed by 1.75 mg/kg/h infusion until the end of the procedure, and eptifibatide as a double bolus of 180 microg/kg followed by 2 microg/kg/min infusion for 18 h after the procedure were used. The main outcome measures were in-hospital events and 30-day clinical outcomes., Results: Baseline clinical characteristics were similar except that patients in the eptifibatide group were younger (P=.02) and had more saphenous vein graft lesions (P<.001). Patients in the bivalirudin group had a higher number of lesions in the right coronary artery (P<.001) and a higher number of vessels treated (P<.001). Postprocedure creatinine phosphokinase (CPK)-MB levels were significantly lower in the bivalirudin group (P<.03). In-hospital events showed significantly less minor bleeding (P=.01) and a trend toward lower major bleeding and major adverse cardiac events (MACE) in the bivalirudin group (P=.06). Thirty-day outcomes showed a significantly lower incidence of non-Q-wave myocardial infarction (MI) in the bivalirudin group (P=.004)., Conclusion: Bivalirudin, as a single antithrombotic agent during PCI and VBT, is associated with significantly lower postprocedural CPK-MB elevation, minor bleeding complications, 30-day non-Q-wave MI rates, and a trend toward lower major bleeding and in-hospital MACE when compared with eptifibatide.

Background: Bivalirudin is shown to be a competent substitute for heparin in percutaneous coronary intervention (PCI). The safety and efficacy of bivalirudin in patients undergoing PCI and vascular brachytherapy (VBT) are not known. This study aimed to assess the safety and efficacy of bivalirudin as a single antithrombotic agent in patients undergoing PCI and VBT., Methods: A total of 152 patients enrolled in the Brachytherapy and Bivalirudin Evaluation Study underwent PCI and VBT with either gamma (n = 8) or beta radiation (n = 144). The main outcome measures were in-hospital events and 30-day clinical outcomes. All patients were treated with bivalirudin (0.75 mg/kg bolus and 1.75 mg/kg per hour infusion for beta radiation, 1 mg/kg bolus and 2.5 mg/kg per hour infusion for gamma radiation) as a single antithrombotic agent during the entire procedure., Results: Baseline clinical and angiographic characteristics were similar between the 2 groups. More than 90% of the patients received beta radiation. In-hospital events showed a higher prevalence of acute procedural intracoronary thrombosis in patients treated with gamma- vs beta radiation (25% vs. 0.7%, P < .001). Thirty-day outcomes including death, Q-wave, and non-Q-wave myocardial infarctions, subacute stent thromboses, and repeat revascularizations were similar in both groups., Conclusion: Bivalirudin, as a single antithrombotic agent during PCI and VBT with beta emitters, may be used safely, but its use in the setting of PCI and gamma radiation may not be acceptable due to an increased incidence of acute procedural intracoronary thrombosis.

The aim of this study was to compare intimal hyperplasia (IH) growth at 6 months in patients with de novo lesions treated with stents versus IH regrowth in patients with treated in-stent restenosis. Intravascular ultrasound was performed after intervention and at the 6-month follow-up visit as part of a standardized protocol across several clinical trials. At 6 months, the lumen was larger in the de novo group (mean lumen cross-sectional area [CSA] 6.31 +/- 2.2 vs 4.48 +/- 1.9 mm(2), p = 0.0001; minimum lumen CSA 4.2 +/- 1.8 vs 2.59 +/- 1.5 mm(2), p = 0.0001). However, the total increase in the mean IH CSA volume was the similar in the de novo and ISR groups (2.89 +/- 1.6 vs 2.64 +/- 1.94 mm(2), respectively; p = 0.11). We found that IH regrowth in restented in-stent restenosis lesions was similar to that in de novo stent implantation and that the final lumen CSA was an important component of in-stent restenosis recurrence.

Sirolimus-eluting stents (SESs) are currently being used in patients undergoing percutaneous coronary intervention (PCI). SESs have not been evaluated in the treatment of acute myocardial infarction by primary angioplasty. We report our initial experience with SESs implanted during primary angioplasty. One hundred and three patients were treated within 12 hr after onset of acute myocardial infarction (AMI) with primary angioplasty and SES implantation. Those patients were compared to 504 patients treated with bare metal stents (BMSs). Angiographic success (TIMI flow grade 3 and residual stenosis < 50%) was completed in 98% of patients with SESs and no subacute stent thrombosis was reported. In-hospital outcomes were similar in the SES and BMS groups. At 6 months, major cardiac events were less frequent in the SES group than in the BMS group (9% vs. 24%, respectively; P < 0.001), driven by a lesser need for repeat revascularization with SESs (1% vs. 10.3% with BMSs; P = 0.014). Mortality at 6 months was 7% with SESs and 11% with BMSs (P = 0.14). SESs are safe and effective for the treatment of AMI by primary angioplasty. As compared to BMSs, SESs improve long-term outcome after AMI, mainly by reducing the need for repeat revascularization.

Sirolimus-eluting stents (SESs; Cypher) have demonstrated a significant reduction in restenosis rates when compared to bare metal stents (BMSs). The purpose of this study was to evaluate the strategy of exclusive use of two SESs versus the combination of one BMS and one SES for two-vessel coronary artery disease (CAD). It was found that the selective use of one SES combined with one BMS in patients undergoing percutaneous coronary intervention that requires more than one stent is safe, feasible, and associated with favorable procedural, 30-day, and 6-month clinical outcomes when compared to the exclusive use of SESs.

Bivalirudin (Angiomax) is increasingly used as a substitute for heparin in a variety of percutaneous coronary interventions, and data on its usage in saphenous vein graft interventions are limited. This retrospective, observational study evaluated the efficacy and safety of bivalirudin compared with heparin as an antithrombotic regimen in patients who underwent saphenous vein graft intervention with distal protection devices. We found that bivalirudin use is clinically safe and feasible, with fewer vascular and ischemic complications compared with heparin.

Background: The efficacy of intracoronary gamma radiation (IRT-gamma) in reducing recurrent in-stent restenosis (ISR) is well established using doses of 14-18 Gy. We sought to examine whether an escalation in dose to 21 Gy is safe and confers additional benefit in reducing repeat revascularization and major adverse cardiac events (MACE) in patients with diffuse ISR., Methods: Forty-seven patients with diffuse ISR (lesion length 20-80 mm) in native coronary arteries (n=25) and saphenous vein grafts (n=22) underwent percutaneous transluminal coronary angioplasty and/or additional stents followed by IRT-gamma using the Checkmate system (Cordis) with a dose of 21 Gy. All patients were discharged with clopidogrel for 12 months and aspirin indefinitely. Six-month angiographic and 12-month clinical outcomes of these patients were compared to 120 patients treated with 18 Gy using the same system., Results: At baseline, patients in the 21-Gy group had more multivessel, vein graft disease and history of prior myocardial infarctions and coronary artery bypass grafts (P<.001). The use of debulking devices and stents was less in this group (P<.001). Procedural and in-hospital complications were similar. Follow-up at 6 months revealed nonsignificant but lower late loss (in-stent, 0.33+/-0.7 mm; in-lesion, 0.41+/-0.6 mm) in the 21-Gy group compared to the 18-Gy group; follow-up at 12 months revealed a trend toward less overall myocardial infarction, although repeat revascularization and MACE rates were similar., Conclusions: IRT-gamma therapy for diffuse ISR lesions with a 21-Gy dose is clinically safe and feasible with marked reduction in late loss but does not confer additional benefit with regard to repeat revascularization and MACE when compared to a dose of 18 Gy.

We aimed to assess the incidence of underexpansion and the relationship between delivery pressure and expansion with sirolimus-eluting stents. Adequate stent expansion contributes to early and late improved outcomes. In 51 patients (53 lesions) with native coronary artery narrowing, balloon-expandable sirolimus-eluting stents (Cypher) were serially expanded with gradual balloon inflations [14 atm, 20 atm, and in case of minimal stent cross-sectional area (CSA)/reference lumen CSA < 50% at 20 atm, postdilatation with 0.5 mm larger balloon]. Intravascular ultrasound (IVUS) imaging was performed before intervention and after each gradual balloon inflation. Stent expansion (minimal stent CSA/reference lumen CSA) was measured. Stent expansion was 72% +/- 16% after 14 atm balloon inflation, 90% +/- 18% after 20 atm balloon inflation (P < 0.001 vs. 14 atm), and 90% +/- 18% at the end of the procedure (including optional postdilatations with 0.5 mm larger balloon; P = NS vs. 20 atm). Stent expansion addressed by MUSIC criteria (all struts apposed, no tissue protrusion, and final lumen CSA > 80% of the reference or > 90% if minimal lumen CSA was < 9 mm2) was adequate in 15% of the cases after 14 atm balloon inflation, in 60% after 20 atm balloon inflation (P < 0.001 vs. 14 atm), and in 60% at the end of the procedure (P = NS vs. 20 atm). Sirolimus-eluting stent underexpansion is common when deployed at conventional pressures. Increasing balloon delivery pressure or assessing stent expansion with IVUS seems warranted in order to ensure adequate sirolimus-eluting stent deployment., (Copyright 2005 Wiley-Liss, Inc)

The Washington Radiation for In-Stent Restenosis Trial in Saphenous Vein Grafts (SVG WRIST) demonstrated safety and efficacy of intravascular radiation therapy (IRT) for the treatment of in-stent restenosis (ISR) in SVG at 12 months. In this study, we aimed to examine whether the safety and efficacy of IRT is durable up to 36 months. One hundred twenty patients with diffuse ISR in SVG underwent balloon angioplasty, laser or atherectomy ablation, and/or additional stenting. After successful intervention, patients were randomly assigned in a double-blind fashion to intravascular treatment with a ribbon containing either iridium (Ir)-192 (n = 60) or nonradioactive seeds (n = 60). The prescribed dose at 2 mm from the source was either 14 or 15 Gy in vessels 2.5-4.0 mm or 18 Gy in vessels > 4.0 mm in diameter. At 36 months, target lesion revascularization (TLR; 43% vs. 66%; P = 0.02) and target lesion revascularization-major adverse cardiac event (TLR-MACE; 49% vs. 71%; P = 0.02) rates continued to be lower in the IRT group, but both target vessel revascularization (TVR; 59% vs. 71%; P = 0.17) and TVR-MACE (63% vs. 77%; P = 0.11) rates were not. In SVG WRIST, patients with ISR treated with IRT had a marked reduction in the need for repeat TLR at 36 months, with sustained clinical benefit at 3 years despite late recurrences, which were more pronounced in the radiation group., (Copyright 2005 Wiley-Liss, Inc)

Background: Intracoronary beta-radiation therapy reduces in-stent restenosis (ISR). We aimed to determine the safety and feasibility of intracoronary radiation therapy (IRT) utilizing tungsten (188W), a beta emitter., Methods: A total of 30 patients with angiographic evidence of ISR in a previously treated native coronary artery underwent percutaneous coronary intervention (PCI; balloon angioplasty, ablation by atherectomy, or laser angioplasty). After the intervention, a noncentered delivery catheter with a side guide 0.014-in. wire carrying a tungsten (188W) coil, with an active length of 33 mm, was inserted. Patients were randomized to a radiation dose of 18, 22, or 25 Gy at 2 mm from the center of the source. Aspirin and Plavix, at 300 mg loading dose, were administered prior to intervention. Plavix 75 mg/day was prescribed for 6 months after the procedure., Results: At 6 months follow-up, the overall binary angiographic restenosis rate was 18.8%. Target vessel revascularization (TVR) was 23% and target lesion revascularization related major adverse cardiac events (TLR-MACE) was 13.3%, without any intergroup differences. A comparison with the original Washington Radiation for In-stent restenosis Trial (WRIST) radiation cohort utilizing an 192Iridium source (prescription dose 15 Gy at 2 mm from the source) showed similar TVR and TLR-MACE rates of 30% and 18%, respectively. The TVR and TLR-MACE rates in the WRIST placebo cohort were 70% and 66%, respectively., Conclusions: Vascular brachytherapy with tungsten (188W) is feasible and safe. The 6-month clinical outcomes are similar to the original WRIST radiation group.

Efficient and effective communication of specific patient information between referring and consulting physicians has become increasingly important with the need to evaluate a variety of treatment strategies, including coronary bypass surgery, coronary intervention, and medical therapy, without prolonging hospital stay. Until recently, the options available were either slow (mail or courier) or costly and cumbersome (hardware-based digital solutions). eMedcon, a new, easy-to-install Internet-based software solution described in this article, offers a quick and inexpensive solution to image digital cine transfer. eMedcon was tested at our institution, Washington Hospital Center, and was found to transmit images effectively and rapidly between physicians at any Internet-accessible site and Washington Hospital Center. Our data indicate that use of eMedcon led to an increase in repeat referrals and an increase in the number of physicians choosing to refer their patients to our institution., (2005 Wiley-Liss, Inc.)

Intracoronary radiation therapy (IRT) is well established in clinical practice as an effective treatment for in-stent restenosis. We aimed to determine if the 6-month clinical outcome of patients treated postapproval for marketing [commercial radiation (CR)] is equivalent to those patients enrolled in the Washington Radiation for In-Stent Restenosis Trials [Gamma WRIST and Beta WRIST; investigational radiation (IR)]. The 6-month clinical outcome of 110 consecutive patients with 125 lesions who received IRT (gamma, (192)Ir, 15-18 Gy, n = 6; or beta, (32)P, 20 Gy, n = 20; or (90)Sr/Y, 18.4-23.0 Gy, n = 99) in CR was compared with the 6-month clinical outcome of 117 patients with 117 lesions who received IRT ((192)Ir, 15 Gy, n = 65, in Gamma WRIST; and (90)Y, 20.6 Gy, n = 52, in Beta WRIST) in IR. Patients in CR were treated with wider radiation margins. The CR received antiplatelet therapy for at least 6 months and the IR for 1 month. The baseline characteristics of both groups were similar. Use of atheroablation devices was less in CR than IR (15.2% vs. 32.8%, respectively; P = 0.001). The overall major adverse cardiac events (death, Q-wave myocardial infarction, and target vessel revascularization; 18.2% vs. 29.1% in IR; P = 0.05) were significantly lower in the CR when compared with patients in the IR. The real-world clinical practice of IRT demonstrates lower events and better clinical outcomes. This is most likely a result of implementation of the lessons learned from the clinical trials such as optimizing the dosimetry by using a higher dose, treating wider margins to minimize edge effect, and administering prolonged antiplatelet therapy to abolish late thrombosis.

Pre-treatment of patients with clopidogrel prior to coronary angiography (CAG) and possible percutaneous coronary intervention (PCI) is a standard practice. Candidates for coronary artery bypass surgery (CABG) are discharged or remain in the hospital until CABG after clopidogrel is discontinued. We investigated whether any differences exist in the rates of surgical complications and outcomes between these two groups of patients. We conclude that continued hospitalization of clopidogrel pre-treated patients does not confer any safety benefit with regard to post-operative complications and 30-day mortality. Discharging these patients after CAG may reduce hospitalization costs.

This study aimed to compare the outcomes of patients with late total occlusion (LTO) versus patients with recurrence in the absence of LTO after intracoronary radiation therapy for in-stent restenosis. LTO, especially in the context of acute myocardial infarction, after intracoronary radiation therapy for in-stent restenosis, is associated with negative clinical outcomes after 6 and 12 months compared with in-stent restenosis without LTO.

Whether percutaneous coronary intervention (PCI) alone is safe in patients with moderate or severe aortic stenosis (AS) and coexisting coronary artery disease (CAD), and whether aortic valve replacement (AVR) can be deferred in patients with moderate AS by undergoing PCI alone is not known. We conducted a retrospective study of surgically inoperable patients with AS who underwent PCI (moderate AS, n = 28; and severe AS, n = 28) and compared to those with AVR (n = 55). The clinical characteristics, procedural complications, in-hospital and long-term clinical outcomes of PCI were compared. Baseline and procedural characteristics were similar except that lower age, hypertension, and renal impairment were seen in the AVR group. In-hospital complications were comparable among the 3 groups. Six-month and 1-year rates of myocardial infarction (MI), non-Q-wave MI, death and out-of-hospital death were similar between AVR and moderate AS patients (p = NS) and significantly high (p < 0.04) in patients with severe AS. On multivariate analysis, severe AS was the only significant predictor of 6-month and 1-year mortality. Our study suggests that PCI is safe in patients with moderate AS and coexisting CAD but is associated with poor outcomes in patients with severe AS.

Bivalirudin (Angiomax) is increasingly used as a substitute for heparin in a variety of percutaneous coronary interventions. This retrospective, observational study aimed to evaluate the efficacy and safety of bivalirudin compared with heparin as an antithrombotic regimen in patients treated with sirolimus-eluting stents (Cypher) and found that bivalirudin is clinically safe and feasible, with fewer vascular and ischemic complications compared with heparin.

Drug-eluting stents, since their approval in the United States, have become the treatment of choice for de novo coronary artery narrowing due to their ability to reduce restenosis and the need for repeat revascularization. We present two patients who underwent percutaneous coronary intervention for the treatment of multivessel coronary artery disease; both patients were treated with sirolimus-eluting stents (SES) and bare metal stents (BMS).

Anticoagulation during percutaneous coronary intervention (PCI) requires the monitoring of activated clotting time (ACT) to protect from periprocedural ischemic and bleeding complications; however, the optimal ACT values have not been established when PCI is performed with bivalirudin. After 495 consecutive patients treated for coronary artery disease with PCI received bivalirudin as a single anticoagulation agent, it was found that ACT is reproducible when bivalirudin is used during PCI and does not correlate with clinical events.

To determine the safety and efficacy, including the impact, on the late recurrence rate of an incremental gamma-radiation dose from 15 to 18 Gy, we report the 3-year clinical outcome of Washington Radiation for In-Stent Restenosis Trial for Long Lesions (Long WRIST). One hundred eighty patients with recurrent in-stent restenosis (ISR) were enrolled in the Long WRIST series and treated with (192)Ir with 1 month of antiplatelet therapy. Between 6 months and 3 years, the need for repeat revascularization was low and similar among the three groups. At 3 years, target lesion revascularization (TLR) and major adverse cardiac events (MACE) were less frequent in the 18 Gy group than in the 15 Gy group (P = 0.12 for TLR, P < 0.05 for MACE) and less frequent in the 15 Gy group as compared to the placebo group (P < 0.05 for TLR and MACE). At 3 years, a higher dose of 18 Gy with (192)Ir continues to improve the outcome of patients treated for ISR when compared to patients treated with 15 Gy or placebo., (Copyright 2004 Wiley-Liss, Inc.)

Side branch occlusion is 1 mechanism for the increase of creatine phosphokinase-MB after percutaneous coronary intervention and is associated with long-term adverse events. We studied 248 patients who underwent brachytherapy for in-stent restenosis with and without side branches, compared levels of creatine phosphokinase-MB with procedural, in-hospital, and long-term clinical outcomes, and found that patients with side branches have increased levels of creatine phosphokinase-MB after percutaneous coronary intervention and higher rates of restenosis, target vessel, and target lesion revascularization at 6-month follow-up.

The Integrilin Washington Radiation for In-Stent Restenosis Trial (WRIST) aimed to study the impact of IIb/IIIa inhibitors as adjunct therapy to intracoronary radiation therapy (IRT) for patients with in-stent restenosis (ISR). The impact of GP IIb/IIIa inhibitor (eptifibatide) as adjunct therapy to vascular brachytherapy using (192)Ir emitter was examined in patients with in-stent restenosis. In the study, 150 patients were assigned to eptifibatide (Integrilin) and 150 patients to heparin only. Clinical composite endpoints at 30 days were similar between the patients treated with and without eptifibatide (4.7% vs. 4.0%; P = 0.78). There was a similarity in the non-Q-wave myocardial infarction (MI) rates between the eptifibatide and the control group. Major bleeding was similar in patients treated with and without eptifibatide. Overall, the use of eptifibatide as adjunct therapy for patients with ISR that are treated with IRT did not impact the clinical outcome at 30 days., (Copyright 2004 Wiley-Liss, Inc.)

We aimed to study the consequences and late outcomes of patients who experienced peripheral vascular complications (PVCs) following percutaneous coronary interventions (PCI). A retrospective analysis of the medical records of 10,669 patients who underwent PCI and experienced PVC between 1995 and 2002 was conducted. One thousand ninety-six patients (10.27% of the study cohort) had PVC post-PCI. After PCI, patients with PVC had higher rates of in-hospital complications (P < 0.001) when compared to patients without PVC, including Q-wave myocardial infarction (MI; 1.2% vs. 0.3%), coronary artery bypass grafting (CABG; 3.8% vs. 0.6%), and death (4.0% vs. 1.0%). At 1-year follow-up, late complications of MI (37.4% vs. 25.4%), non-Q-wave MI (34.9% vs. 22.7%), death (12.9% vs. 5.9%), and CABG (5.7% vs. 4.5%) were higher (< 0.001) in patients with PVC compared to those without. Multivariate analysis identified PVC as a significant predictor of 1-year mortality (P = 0.045). This study underscores the need to make diligent efforts to minimize PVC and follow up these patients for future coronary events., (Copyright 2004 Wiley-Liss, Inc.)

Background: Nonionic radiographic contrast media (CM) is reported to be thrombogenic while performing diagnostic or interventional procedures. To avoid thrombosis, heparin is often added to the CM. Bivalirudin, used to replace heparin during percutaneous coronary intervention (PCI), is reported to be associated with reduced bleeding complications. We aimed to evaluate the impact of adding heparin to the CM during PCI in patients (pts) who underwent sirolimus-eluting stent (SES) implantation when bivalirudin was utilized as the sole antithrombotic agent., Methods: A total of 664 pts with 756 lesions underwent standard PCI with SES for various coronary artery lesions. Pts were treated with either bivalirudin only (the bivalirudin group; 0.75 mg/kg bolus and 1.75 mg/kg/h infusion, n = 323 pts) or bivalirudin (same dose) plus low-dose heparin added to the CM (the heparin mix group; mean dose = 2101.8+/-882.5 U, n = 341 pts) during PCI. The periprocedural, in-hospital, and 30-day clinical outcomes were compared., Results: Baseline clinical and angiographic parameters were similar between both groups. Periprocedural, in-hospital, and 1-month clinical outcomes, including thrombotic complications, were similar between the two groups. There was no difference in the periprocedural thrombosis rate between the groups. In the heparin mix group, the overall incidence of hematoma was significantly higher (3.8% vs. 8.5%, P = .01), there was a trend toward higher rates of blood transfusion (2.6% vs. 6.6%, P = .06) and overall vascular complications (0.01% vs. 5.3%, P <.001), including pseudoaneurysm (PSA; 0.0% vs. 2.6%, P = .004), and pts who required surgical repair (0.3% vs. 1.8%, P = .07)., Conclusions: The routine addition of low-dose heparin to CM during contemporary PCI does not add any protection value and is associated with higher rates of bleeding and vascular complications.

The aim of this study was to evaluate the effect of gamma radiation on the noninjured, unprotected left main coronary artery. Noninjured vessel segments are often radiated during treatment of in-stent restenosis with PCI and gamma radiation. Angiographic analysis using QCA methods was performed on 55 left main arteries of patients (32 with radiation of the left main compared to 23 controls) who participated in the Washington Radiation for In-Stent Restenosis Trials (WRIST). Baseline demographics and follow-up were comparable between the two groups, concluding that gamma radiation with long radiation safety margins is feasible and safe. Gamma radiation of noninjured irradiated left main vessels when used to facilitate wide radiation margins for proximal irradiated injured LAD and LCx is safe and does not compromise the vessel integrity and its lumen., (Copyright 2004 Wiley-Liss, Inc.)

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., (Copyright 2004 Wiley-Liss, Inc.)

We aimed to analyze periprocedural creatinine phosphokinase (CPK)-MB elevation in patients treated with intracoronary radiation therapy (IRT) for in-stent restenosis (ISR) to risk stratify these patients. The clinical significance of periprocedural CPK-MB elevation after IRT for ISR is unknown. An elevated CPK-MB has been associated with increased mortality after conventional angioplasty. We evaluated 1,326 patients who were enrolled in radiation trials for ISR at the Washington Hospital Center using gamma- and beta-emitters. Patients were analyzed according to degree of CPK-MB increase within 24 hours of the index IRT procedure (normal CPK-MB, CPK-MB 1 to 3 times the upper limit of normal, or CPK-MB >3 times the upper limit of normal). Patients with CPK-MB >3 times the upper limit of normal were older (64 +/- 12 years, p = 0.04), more likely to be smokers (64%, p = 0.04), hypertensive (85%, p <0.01), and diabetic (49%, p = 0.04). The cohort with the highest CPK-MB release (CPK-MB >3 times the upper limit of normal) had significantly higher rates of adverse clinical events at 12 months (major adverse cardiac events 40%, p <0.01), including death (9.3%, p <0.01) and late thrombosis (6.3%, p <0.01). Periprocedural CPK-MB elevation is of prognostic importance in patients treated with IRT for ISR, and its analysis appears to be mandatory to risk stratify these patients. The impact of glycoprotein IIb/IIIa antagonists in reducing periprocedural CPK-MB release awaits evaluation.