Self-reported syphilis and gonorrhoea testing among men who have sex with men: national HIV behavioural surveillance system, 2003-5.

OBJECTIVES: The Centers for Disease Control and Prevention provides guidance on sexually transmitted disease (STD) testing specifically for men who have sex with men (MSM) in STD treatment guidelines to address increasing rates of gonorrhoea and syphilis among MSM in the USA. The guidelines recommend at least annual syphilis, gonorrhoea and chlamydia testing for sexually active MSM. The implementation of these guidelines was evaluated. METHODS: Data from the 2003-5 MSM cycle of the National HIV Behavioural Surveillance System were used. The proportion of sexually active HIV-negative MSM reporting syphilis and gonorrhoea testing during the previous year was determined and multivariate logistic regression was used to identify factors associated with testing. RESULTS: Of 10 030 MSM, 39% and 36% reported having been tested for syphilis and gonorrhoea in the previous year, respectively. Four factors were associated with syphilis and gonorrhoea testing, respectively: age 18-24 years versus > or =45 years (odds ratio (OR) 2.2, 95% CI 1.8 to 2.5; OR 2.7, 95% CI 2.3 to 3.2), black versus white race (OR 1.3, 95% CI 1.1 to 1.4; OR 1.4, 95% CI 1.2 to 1.6), private insurance versus no insurance (OR 1.3, 95% CI 1.1 to 1.4; OR 1.3, 95% CI 1.1 to 1.4) and disclosing male-male sex to a healthcare provider (OR 2.2, 95% CI 2.0 to 2.5; OR 2.1, 95% CI 1.9 to 2.3). CONCLUSIONS: Syphilis and gonorrhoea testing among MSM was low, despite specific testing recommendations in the STD treatment guidelines. To increase STD testing among MSM, healthcare providers should assess the risks of STD for male patients through routine enquiries about sexual activity.

Behavioral and social sciences and public health at CDC.

Although the history of CDC spans 60 years, only during the last 2 decades of the 20th century did the agency come to recognize and better understand the importance of the behavioral and social sciences to its overall mission. This recognition was a consequence of several events, notably the growing public awareness of the many conditions and diseases linked to unhealthy behavior and the creation of three new organizational units at CDC--the National Center for Chronic Disease Prevention and Health Promotion in 1988, the National Center for Injury Prevention and Control in 1992, and the National Center for HIV, STD, and TB Prevention in 1993--that focused on conditions, diseases, and injuries with clear behavioral risks. Accordingly, the relatively small number of CDC behavioral and social scientists were initially concentrated in these three centers. In 1995, to raise awareness of behavioral and social sciences at CDC and to integrate these fields into CDC-conducted and -supported research and practice activities, the agency's behavioral and social scientists established the Behavioral and Social Sciences Working Group (BSSWG). The application of the behavioral and social science disciplines to public health attests to the success of the working group. Today, BSSWG continues as a formal organization sponsored by the Office of the Chief Science Officer within the CDC Office of the Director.

Myocardial first-pass perfusion magnetic resonance imaging: a multicenter dose-ranging study.

BACKGROUND: MRI can identify patients with obstructive coronary artery disease by imaging the left ventricular myocardium during a first-pass contrast bolus in the presence and absence of pharmacologically induced myocardial hyperemia. The purpose of this multicenter dose-ranging study was to determine the minimally efficacious dose of gadopentetate dimeglumine injection (Magnevist Injection; Berlex Laboratories) for detecting obstructive coronary artery disease. METHOD AND RESULTS: A total of 99 patients scheduled for coronary artery catheterization as part of their clinical evaluation were enrolled in this study. Patients were randomized to 1 of 3 doses of gadopentate dimeglumine: 0.05, 0.10, or 0.15 mmol/kg. First-pass perfusion imaging was performed during hyperemia (induced by a 4-minute infusion of adenosine at a rate of 140 microg x kg(-1) x min(-1)) and then again in the absence of adenosine with otherwise identical imaging parameters and the same contrast dose. Perfusion defects were evaluated subjectively by 4 blinded reviewers. Receiver-operating curve analysis showed that the areas under the receiver-operating curve were 0.90, 0.72, and 0.83 for the low-, medium-, and high-contrast doses, respectively, compared with quantitative coronary angiography (diameter stenosis > or =70%). For the low-dose group, mean sensitivity was 93+/-0%, mean specificity was 75+/-7%, and mean accuracy was 85+/-3%. CONCLUSIONS: First-pass perfusion MRI is a safe and accurate test for identifying patients with obstructive coronary artery disease. A low dose of 0.05 mmol/kg gadopentetate dimeglumine is at least as efficacious as higher doses.

Clinical outcomes of compromised side branch (stent jail) after coronary stenting with the NIR stent.

Acute side-branch (SB) compromise or occlusion stent jail after native coronary stenting is a matter of concern. Attempts at maintaining SB patency can be a technical challenge. The purpose of this study was to determine the clinical impact of SB compromise or occlusion in patients undergoing stenting of parent vessel lesions. We evaluated in-hospital and long-term clinical outcomes (death, Q-wave myocardial infarction, and repeat revascularization rates at 6 months) in 318 consecutive patients undergoing NIR stent implantation across an SB. Based on independent angiographic analysis, 218 (68.6%) patients had no poststent SB compromise, 85 (26.7%) patients had narrowed SB (> 70% narrowing, without total occlusion), and 15 (4.7%) patients had an occluded SB after stent implantation. The baseline patient and lesion characteristics were similar between the groups. Procedural success was 100%. Patients with SB occlusion had a higher stents/lesion ratio (P < 0.006). Side-branch occlusion was associated with higher in-hospital ischemic complications (Q-wave myocardial infarction, 7%; non-Q-wave myocardial infarction, 20%; P < 0.05) compared to patients with SB compromise or normal SB. At 6-month follow-up, there was a trend for more myocardial infarctions in the group with SB occlusion during the index procedure (Q-wave myocardial infarction, 7% vs. 1% in the narrowed and 0% in normal SB; P = 0.09). However, late target lesion revascularization and mortality were similar in the three groups (P = 0.91). SB occlusion after parent vessel stenting is associated with more frequent in-hospital Q-wave and non-Q-wave myocardial infarctions. However, with the NIR stent, side-branch compromise or occlusion does not influence late (6 month) major adverse events, including death, myocardial infarction, or need for repeat revascularization.

Importance of time to reperfusion on outcomes with primary coronary angioplasty for acute myocardial infarction (results from the Stent Primary Angioplasty in Myocardial Infarction Trial).

The mortality benefit of thrombolytic therapy for acute myocardial infarction (AMI) is strongly dependent on time to treatment. Recent observations suggest that time to treatment may be less important with primary percutaneous transluminal coronary angioplasty (PTCA). Patients with AMI of <12 hours duration, without cardiogenic shock, who were treated with primary PTCA from the Stent PAMI Trial (n = 1,232) were evaluated to assess the effect of time to reperfusion on outcomes. Thrombolysis In Myocardial Infarction grade 3 flow was achieved in a high proportion of patients regardless of time to treatment. Improvement in ejection fraction from baseline to 6 months was substantial with reperfusion at <2 hours but was modest and relatively independent of time to reperfusion after 2 hours (<2 hours, 12.3% vs > or =2 hours, 4.2%, p = 0.004). There were no differences in 1- or 6-month mortality by time to reperfusion (6-month mortality: <2 hours [5.5%], 2 to <4 hours [4.6%], 4 to <6 hours [4.5%], >6 hours [4.2%], p = 0.97). There were also no differences in other clinical outcomes by time to reperfusion, except that reinfarction and infarct artery reocclusion at 6 months were more frequent with later reperfusion. The lack of correlation between time to treatment and mortality in patients without cardiogenic shock suggests that the survival benefit of primary PTCA may be related principally to factors other than myocardial salvage. These data may also have implications regarding the triage of patients with AMI for primary PTCA.

HIV-related behaviors and perceptions among adults in 25 states: 1997 Behavioral Risk Factor Surveillance System.

OBJECTIVES: To assess the level of HIV-related risk behavior among the general US adult population, we analyzed data from the first sexual behavior questions available for states to use with the Behavioral Risk Factor Surveillance System. METHODS: The Behavioral Risk Factor Surveillance System is a state-specific, population-based, random telephone survey. In 1997, 25 states collected sexual behavior data. Annual prevalence estimates for selected behaviors were calculated and examined by sociodemographic characteristics. The correlation between actual and perceived HIV risk also was determined. RESULTS: Most (77.1%) of the respondents reported just 1 sexual partner in the past year; 26.0% reported using a condom at last intercourse. Males, persons who were younger, and Blacks were more likely to report 2 or more partners but also more likely to report using a condom at last intercourse. Only 4.1% of the respondents reported a risk factor for HIV infection; 7.7% reported that they were at medium or high risk for HIV. Actual and perceived HIV risk were positively associated. CONCLUSIONS: Most US adults do not engage in HIV-related risk behavior; those that do are more likely to report protective behavior.

Effect of gender on the outcomes of contemporary percutaneous coronary intervention.

Limited information exists regarding the outcomes of newer percutaneous coronary intervention (PCI) technologies in women. This study sought to determine whether female gender is an independent risk factor for PCI mortality and/or complications in contemporary practice. Using information from the National Cardiovascular Network (NCN) Database on 109,708 (33% women) PCI cases from 22 hospitals between January 1994 and January 1998, we examined the association of gender with unadjusted and risk-adjusted procedural outcomes. Women undergoing PCI were older, smaller, and had more comorbid illness than men, but less extensive coronary disease. Temporal trends in PCI device selection were similar in men and women. Compared with men, women had higher unadjusted procedural mortality rates (1.8% vs 1.0%, p <0.001), more strokes (0.4% vs 0.2%, p <0.001), and higher vascular complication rates (5.4% vs 2.7%, p <0.001). However, after adjusting for baseline clinical risk factors, and importantly, body surface area, women and men had similar PCI mortality risks (adjusted odds ratio 1.07, 95% confidence interval 0.92 to 1.24). Gender was not an independent risk factor for mortality among subgroups receiving coronary stent or atherectomy devices after risk adjustment. However, women undergoing PCI remained at higher risk for stroke, vascular complications, and repeat in-hospital revascularization than men, even after risk adjustment. We conclude that in contemporary practice, a patient's body size rather than gender, conveys independent risk for mortality after PCI.

Modeling and reinforcement to combat HIV: the MARCH approach to behavior change.

Theory and research suggest that behavioral interventions to prevent HIV/AIDS may be most effective when they are personalized and affectively compelling, when they provide models of desired behaviors, and when they are linked to social and cultural narratives. Effective strategies must also take into account the opportunities and obstacles present in the local environment. The Modeling and Reinforcement to Combat HIV (MARCH) projects combine key aspects of individual behavior change with efforts to change social norms. There are 2 main components to the program: entertainment as a vehicle for education (longrunning serialized dramas on radio or television portray role models evolving toward the adoption of positive behaviors) and interpersonal reinforcement at the community level (support from friends, family members, and others can help people initiate behavior changes; support through changes in social norms is necessary for behavioral effects to be sustained over time). Both media and interpersonal intervention activities should be linked to existing resources in the community and, wherever possible, provide increased access to preventive services, supplies, and other supporting elements.

Acute and 6-month clinical and angiographic outcome after implantation of the ACS Duet stent for single-vessel coronary artery disease: final results of the European and US ACS Multi-link Duet Registry.

The aim of the study was to determine the safety and efficacy of the second-generation ACS Multi-Link Duet coronary stent system for the treatment of single, symptomatic, de novo, native coronary artery lesions. Between February and June 1998, 427 patients (69.3% male, 51.5% class 3 or 4 angina, 20.1% diabetic, 43.6% hyperlipidemia) were included at 38 centers in this prospective observational study. All patients received ticlopidine 500 mg/day for 1 month and aspirin > or =100 mg/day. The Duet stent was available in 8, 18, and 28 mm length and 3.0, 3.5, and 4.0 mm diameter. After adequate predilatation, stents were successfully implanted, at up to 16 atm, in 99.3% of patients. Mean vessel diameter by core laboratory quantitative coronary angiography was 3.0 +/- 0.53 mm and postprocedural minimum luminal diameter was 2.79 +/- 0.43 mm (12% +/- 9.3% diameter stenosis). At 30 days, 96.7% of patients were event-free and at 6 months 88.1% remained free of major adverse cardiac events. The restenosis rate was 18.1%. The ACS Duet stent was safely implanted in >99% of target lesions by a diverse group of international investigators. With late outcomes at least comparable to the best published results, this stent platform provides safe and effective percutaneous treatment of obstructive coronary artery disease. Cathet Cardiovasc Intervent 2001;54:25-33.

Intravascular radiation therapy after balloon angioplasty of narrowed femoropopliteal arteries to prevent restenosis: results of the PARIS feasibility clinical trial.

PURPOSE: To conduct a feasibility study to assess the feasibility, safety, and outcome of endoluminal gamma radiation therapy after balloon angioplasty of superficial femoral artery (SFA) lesions. MATERIALS AND METHODS: Forty patients with claudication were enrolled in the study and underwent percutaneous transluminal angioplasty (PTA) of SFA lesions with a mean lesion length of 9.8 cm +/- 3.0 and a mean reference vessel diameter of 5.2 mm +/- 3.1. After successful PTA, a segmented centering balloon catheter was positioned to cover the PTA site. The patients were then transported to the radiation oncology suite and treated with a microSelectron HDR afterloader with use of an Ir-192 source with a prescribed dose of 14 Gy, 2 mm into the vessel wall. Ankle-brachial index (ABI) and Rutherford score were evaluated at 1, 6, and 12 months after the procedure and angiographic follow-up was conducted at 6 months. RESULTS: Radiation was delivered successfully to 35 of 40 patients. There were no procedural complications. Exercise and rest ABI were higher at 1 year (0.72 +/- 0.26 and 0.89 +/- 0.18, respectively) compared to baseline (0.51 +/- 0.25 and 0.67 +/- 0.17, respectively). Maximum walking time on a treadmill increased from 3.41 min +/- 2.41 to 4.43 min +/- 2.49 at 30 days and was 4.04 min +/- 2.8 at 12 months. The angiographic binary restenosis rate at 6 months was 17.2% and the clinical restenosis rate at 12 months was 13.3%. There were no angiographic or clinical adverse events related to the radiation therapy. CONCLUSIONS: Intraarterial radiation after PTA of SFA lesions with use of high-dose rate gamma radiation is feasible and safe. The angiographic and clinical improvements are sustainable at 1 year and represent a potent antirestenotic therapy for the treatment of narrowed peripheral arteries.

Normal flow (TIMI-3) before mechanical reperfusion therapy is an independent determinant of survival in acute myocardial infarction: analysis from the primary angioplasty in myocardial infarction trials.

BACKGROUND: Whereas survival after lytic therapy for myocardial infarction is strongly dependent on early administration, it is unknown whether the otherwise excellent outcomes in patients undergoing primary PTCA for acute myocardial infarction, in whom TIMI-3 flow rates of >90% may be achieved, can be further improved by early reperfusion. METHODS AND RESULTS: Among 2507 patients enrolled in 4 PAMI trials undergoing primary PTCA, spontaneous reperfusion (TIMI-3 flow) was present in 16% at initial angiography. Compared with patients without TIMI-3 flow, those with TIMI-3 flow before PTCA had greater left ventricular ejection fraction (57+/-10% versus 53+/-11%, P=0.003) and were less likely to present in heart failure (7.0% versus 11.6%, P=0.009). Patients with initial TIMI-3 flow had significantly lower in-hospital rates of mortality, new-onset heart failure, and hypotension and had a shorter hospital stay. Cumulative 6-month mortality was 0.5% in patients with initial TIMI-3 flow, 2.8% with TIMI-2 flow, and 4.4% with initial TIMI-0/1 flow (P=0.009). By multivariate analysis, TIMI-3 flow before PTCA was an independent determinant of survival (odds ratio 2.1, P=0.04), even when corrected for by postprocedural TIMI-3 flow. CONCLUSIONS: Patients undergoing primary PTCA in whom TIMI-3 flow is present before angioplasty present with greater clinical and angiographic evidence of myocardial salvage, are less likely to develop complications related to left ventricular failure, and have improved early and late survival. These data warrant prospective randomized trials of pharmacological strategies to promote early reperfusion before definitive mechanical intervention in acute myocardial infarction.

Differential impact on survival of electrocardiographic Q-wave versus enzymatic myocardial infarction after percutaneous intervention: a device-specific analysis of 7147 patients.

BACKGROUND: The relative prognostic importance of ECG myocardial infarction (MI) after intervention compared with varying degrees of enzymatic elevation has not been characterized, and the device-specific implications of periprocedural MI are also unknown. METHODS AND RESULTS: Serial creatine phosphokinase (CPK)-MB levels were determined after elective percutaneous intervention of 12 098 lesions in 7147 consecutive patients at a tertiary referral center. Procedural, in-hospital, and follow-up data were collected by independent research nurses, and clinical and ECG events were adjudicated by a separate committee. Stents were implanted in 50.6% of lesions, atheroablation was performed in 54.8%, and PTCA alone was performed in 9.8%. The peak periprocedural CPK-MB level was >3x the upper limit of normal (ULN) in 17.9% of patients, and Q-wave MI developed in 0.6%. By multivariate analysis, the periprocedural development of new Q waves was the most powerful independent determinant of death (2-year mortality rate, 38.3%; hazard ratio, 9.9; P<0.0001). Non-Q-wave MI with CPK-MB >8x ULN was also a strong predictor of death (2-year mortality rate, 16.3%; hazard ratio, 2.2; P<0.0001); survival was unaffected by lesser degrees of CPK-MB elevation. Though CPK-MB elevation was more common after atheroablation and stenting than PTCA, the rates of Q-wave MI and survival were device-independent. CONCLUSIONS: Myonecrosis after percutaneous intervention is common in a high-risk referral population dominated by atheroablation and stent use. Large periprocedural infarctions (signified by new Q waves and CPK-MB >8xULN) are powerful determinants of death, whereas lesser degrees of CPK-MB release and specific device use do not adversely affect survival.

Trends in HIV testing among pregnant women: United States, 1994-1999.

OBJECTIVES: This study evaluated 1995 guidelines for HIV testing of pregnant women. METHODS: Analysis focused on Behavioral Risk Factor Surveillance System data for the years 1994 through 1999. Data were aggregated across states. RESULTS: Percentages of pregnant women tested for HIV increased from 1995 to 1996 (from 41% to 53%) and again from 1997 (52%) to 1998 (60%). CONCLUSIONS: After implementation of the guidelines, the percentage of pregnant women tested for HIV increased, although nearly half had not been tested. More efforts are needed to encourage women to undergo testing for HIV during pregnancy, thus maximizing opportunities for offering antiretroviral therapy.

Intravascular ultrasound-guided renal artery stenting.

PURPOSE: To evaluate the clinical outcomes of patients undergoing renal artery stenting with intravascular ultrasound (IVUS) guidance and compare measurements between IVUS and angiography. METHODS: One hundred thirty-one patients (71 women; mean age 71 +/- 8 years) underwent IVUS-guided Palmaz stent implantation in 153 stenotic renal arteries at a single center. The indications for stenting were uncontrolled hypertension (102, 77.9%), renal insufficiency (10, 7.6%), and both conditions (19, 14.5%). The majority of lesions were ostial (114, 74.5%); the remainder occupied the proximal renal artery (39, 25.5%). The mean lesion length and diameter stenosis were 6.5 +/- 3.0 mm and 74% +/- 10%, respectively, as measured by angiography. Data were recorded in a prespecified database; angiographic and IVUS images were analyzed at dedicated core laboratories and compared. RESULTS: Angiographic success was achieved in all patients, but IVUS indicated the need for additional intervention in 36 (23.5%) cases. There was strong correlation between the angiographic and IVUS measurements of lesion length (r = 0.60, p < 0.0001) and pre-/postprocedural minimal luminal diameter (r = 0.72 and 0.63, respectively; p < 0.0001). The mean contrast volume was 74 +/- 18 mL per case. In-hospital renal failure occurred in 8 (6.1%) patients; 2 (1.5%) required transient hemodialysis. At a mean 15-month follow-up, patients were treated with fewer antihypertensive medications (p = 0.05), and systolic and diastolic arterial blood pressures had decreased (p = 0.001); no significant change was noted in serum creatinine. CONCLUSIONS: IVUS-guided stenting facilitates safe renal artery revascularization. IVUS imaging may complement angiography in certain cases, which should be studied further in prospective studies with iodinated or noniodinated contrast agents.

Vascular complications after percutaneous coronary interventions following hemostasis with manual compression versus arteriotomy closure devices.

OBJECTIVES: We evaluated the vascular complications after hemostasis with arteriotomy closure devices (ACD) versus manual compression after percutaneous coronary interventions (PCI). BACKGROUND: Previous clinical studies have indicated that ACD can be used for achievement of hemostasis and early ambulation after PCI. This study investigated the safety of ACD in achieving hemostasis after PCI compared with manual compression in a large cohort of consecutive patients. METHODS: A total of 5,093 patients were followed after PCI was performed with the transfemoral approach. Univariate and multivariate analysis were used to identify the predictors of vascular complications with ACD (n = 516) or with manual compression (n = 5,892) as a hemostasis option after sheath removal. RESULTS: The use of ACD was associated with a more frequent occurrence of hematoma compared with manual compression (9.3 vs. 5.1%, p < 0.001). There was also a higher rate of significant hematocrit drop (>15%) with ACD versus manual compression (5.2% vs. 2.5%, p < 0.001). Similar rates of pseudoaneurysm and arteriovenous fistulae were noted with either hemostasis technique. Vascular surgical repair at the access site was required more often with ACD versus manual compression (2.5 vs. 1.5%, p = 0.03). CONCLUSIONS: In this early experience with ACD after PCI, their use was associated with higher vascular complication rates than hemostasis with manual compression.

Are we making progress with percutaneous saphenous vein graft treatment? A comparison of 1990 to 1994 and 1995 to 1998 results.

OBJECTIVES: We sought to determine whether strategies to reduce procedural distal embolization and late repeat revascularization have resulted in more favorable outcomes after saphenous vein graft (SVG) angioplasty. BACKGROUND: Angioplasty of SVG lesions has been associated with frequent procedural and late cardiac events. Therefore, evolving strategies have been attempted to improve outcomes after SVG angioplasty. METHODS: We compared our earlier experience (1990 to 1994) of 1,055 patients with 1,412 SVG lesions with a recent group (1995 to 1998) of 964 patients with 1,315 lesions. RESULTS: Baseline characteristics were similar between the groups. However, there were significantly more unfavorable lesion characteristics (older, longer and significantly more degenerated SVGs) in the recent series. Between the two periods, there was decreased use ofatheroablative devices, whereas stent use increased. The procedural success rates (96.6% vs. 96.1%) were similar. However, one-year outcome (event-free survival) was significantly improved in the more recent experience (70.7% vs. 59.1%, p < 0.0001), especially late mortality (6.1% vs. 11.3%, p < 0.0001). Multivariate analysis showed stent use to be the only protective variable for both periods. CONCLUSIONS: This study shows that despite higher risk lesions, strategies to reduce distal embolization have maintained high procedural success. Late cardiac events, including mortality, have also been substantially reduced.

Developing standards in behavioral surveillance for HIV/STD prevention.

HIV/STD prevention programs are increasingly guided by behavioral rather than by disease indicators. Relevant HIV/STD-related behavioral information is currently available from a variety of surveys and surveillance systems at three levels: general population, infected populations, and high-risk populations. However, the utility of these systems for local program development is limited due to lack of standardization. In 1997 a Centers for Disease Control and Prevention working group was formed to develop a core set of items for HIV/STD behavioral surveillance for use across surveys. Core items were chosen on the basis of existing surveys and surveillance systems, relevant literature, testing in a cognitive laboratory, and field pilot-testing. A draft of the core set of sexual behavior questions is available on the web at http://www.cdc.gov/nchstp/od/core-workgroup for review and feedback. Questions on drug use, including drug injection practices, as well as questions on HIV testing and sexually transmitted diseases are in preparation and will also be posted on the web site for review.

Comparison of self-expanding and balloon-expandable stents for the reduction of restenosis.

To compare the efficacy of self-expanding (SE) and balloon-expandable (BE) stents in native coronary arteries, we randomly assigned 1,096 patients with new and restenotic lesions to receive either device. Baseline demographics and coronary angiographic characteristics were similar in the 2 groups. The incidence of major adverse cardiac events including death, myocardial infarction, bypass surgery, and repeat intervention was similar for both groups at 1 month (2.9% vs 3.1% for SE vs BE, respectively) and at 9 months (19.3% vs 20.1%, SE vs BE respectively). In a subgroup of patients who underwent follow-up angiography (n = 250), the binary restenosis rates (24.2% vs 18.7%, p = 0.30), late loss (0.98 vs 94 mm, p = 0.60), and loss index (0.55 vs 55, p = 0.95) were not significantly different for both groups. In 62 patients who underwent intravascular ultrasound examination (IVUS), there was a trend toward a lower incidence of edge tears in the SE group (6% vs 23%, p = 0.06). Follow-up IVUS analysis showed that the minimum stent area of the SE stent increased by 33% at 6 months, whereas no change occurred in the BE stents; this was accompanied by a greater degree of intimal proliferation in the SE stents compared with BE stents (3.1 +/- 2.0 vs 1.7 +/- 1.7 mm(2)). Thus, the SE stents had similar clinical and angiographic outcomes in patients with lesions in native coronary arteries.

Intracoronary radiation with gamma wire inhibits recurrent in-stent restenosis.

To study the safety and efficacy of intracoronary gamma radiation delivered via a new high-activity (192)Ir source wire for the treatment of in-stent restenosis. In-stent restenosis results from neointimal tissue proliferation especially in its diffused form and presents a therapeutic challenge. Gamma radiation has been shown to decrease neointima formation within stents in animal models and in initial clinical trials. A total of 26 patients with in-stent restenosis underwent successful intervention and was treated with open-label (192)Ir using a high-activity line source. The specific activity of the source wire was 372+/-51 mCi, and the dwell time was 10.8+/-1.9 min. Primary endpoints were freedom from death, myocardial infraction (MI), and repeat target lesion revascularization (TLR) at 6 months. Secondary endpoints included angiographic restenosis and intravascular ultrasound (IVUS) neointimal hyperplasia. Procedural success was high (96.2%), and in-hospital and 30-day complications were low with no deaths, MI, or requirement for repeat revascularization. At 6 months, event-free survival was 85%: one patient required repeat PTCA, one underwent bypass surgery, and two had an MI. Baseline lesion length measured 15.77 mm. Follow-up angiography was available in 21/25 (84%) patients. The binary restenosis rates were 19.0% (4/21) in-stent and 23.8% (5/21) in-lesion. Follow-up IVUS was available in 20/25 patients. There was no increase in intimal hyperplasia from postintervention to follow-up (3.11.8 vs. 3.41.8 mm(2); P=.32). Eight patients had a reduction of neointimal intimal tissue at follow-up. These results indicate that intracoronary gamma radiation with the Angiorad source wire is safe and effective in preventing in-stent restenosis.

Serial intravascular ultrasound analysis of edge recurrence after intracoronary gamma radiation treatment of native artery in-stent restenosis lesions.

In the Washington Radiation for In-Stent restenosis Trial (WRIST), patients were first treated with conventional techniques and then randomized to either gamma-irradiation ((192)Ir) or placebo (dummy seeds). In the (192)Ir group with native coronary in-stent restenosis, we identified 8 patients with edge recurrence and compared them with 21 patients with no recurrence. Serial (postirradiation and follow-up) intravascular ultrasound analysis was performed according to conventional methods. When compared with nonrecurring lesions, lesions with distal edge recurrence had (1) greater decrease in mean distal lumen cross-sectional area (-3.0 +/- 1.2 vs -0.7 +/- 1.0 mm(2), p = 0.0002), (2) no change in mean distal external elastic membrane cross-sectional area versus an increase in mean distal cross-sectional area of 1.0 +/- 0.9 mm(2) in nonrecurring lesions (p = 0.0047), and (3) a greater increase in mean distal plaque + media cross-sectional area (2.9 +/- 1.2 mm vs 1.7 +/- 0.6 mm(2), p = 0.0103). Within the stented segment, the nonrecurring lesions had no decrease in mean lumen and no increase in mean intimal hyperplasia cross-sectional area. Conversely, lesions with distal edge recurrence had a significant decrease in mean intrastent lumen cross-sectional area (-1.7 +/- 1.7 mm(2)) and a significant increase in mean intrastent intimal hyperplasia cross-sectional area (1.6 +/- 1.6 mm(2)). Lesions with distal edge recurrence also had a greater decrease in mean proximal lumen cross-sectional area (-1.7 +/- 1.3 vs -0.3 +/- 0.8 mm(2), p = 0.0213), with a trend toward a greater increase in mean proximal plaque + media cross-sectional area. Thus, edge recurrence after (192)Ir treatment of in-stent restenosis is the result of neointimal hyperplasia (part of generalized treatment failure) and the absence of radiation-induced positive remodeling.