Gammaretrovirus-mediated correction of SCID-X1 is associated with skewed vector integration site distribution in vivo.

We treated 10 children with X-linked SCID (SCID-X1) using gammaretrovirus-mediated gene transfer. Those with sufficient follow-up were found to have recovered substantial immunity in the absence of any serious adverse events up to 5 years after treatment. To determine the influence of vector integration on lymphoid reconstitution, we compared retroviral integration sites (RISs) from peripheral blood CD3(+) T lymphocytes of 5 patients taken between 9 and 30 months after transplantation with transduced CD34(+) progenitor cells derived from 1 further patient and 1 healthy donor. Integration occurred preferentially in gene regions on either side of transcription start sites, was clustered, and correlated with the expression level in CD34(+) progenitors during transduction. In contrast to those in CD34(+) cells, RISs recovered from engrafted CD3(+) T cells were significantly overrepresented within or near genes encoding proteins with kinase or transferase activity or involved in phosphorus metabolism. Although gross patterns of gene expression were unchanged in transduced cells, the divergence of RIS target frequency between transduced progenitor cells and post-thymic T lymphocytes indicates that vector integration influences cell survival, engraftment, or proliferation.

The restenosis story: is intracoronary radiation therapy the solution?

Restenosis remains a major limitation of percutaneous transluminal coronary intervention. Stenting made an important contribution in restenosis reduction, but in-stent restenosis is becoming a growing problem. Although radiation therapy was traditionally used to kill relatively fast-growing tumor cells, it has also been used to clinically treat benign but problematic hyperplastic conditions. In addition, in vitro studies have shown that radiation inhibits serum-stimulated growth of arterial smooth muscle cells and fibroblasts, and decreases collagen synthesis by fibroblasts. The effects of radiation on neointimal inhibition after vascular injury were investigated in animal models using various catheter- and stent-based endovascular approaches (brachytherapy) as well as externally delivered x-irradiation. These studies have consistently shown that ionizing radiation delivered by the endoluminal approach results in remarkable suppression of neointima formation. However, animal studies also demonstrate altered vessel wall healing with increased thrombogenicity. The catheter-based approach with gamma- or beta-emitters showed feasibility and appears promising in early human clinical trials, whereas the strategy of using radiation stents is more problematic in the clinical arena. A number of randomized multicenter trials have been initiated and the results are eagerly awaited. More work needs to be done to define the optimal dosage, and to study the short- and long-term vascular biologic effects of brachytherapy. Additionally, if this form of therapy proves efficacious in the large, randomized, clinical trials, its cost-effectiveness will then need to be established. This review touches on some of the basic concepts involved in using the strategy of endovascular irradiation therapy for restenosis prevention after percutaneous coronary intervention and reviews the evidence of clinical efficacy and safety.

Trends in outcome and costs of coronary intervention in the 1990s.

Our objective was to examine trends in outcome and cost of percutaneous coronary intervention (PCI) between 1990 and 1999. PCI has become the most common form of myocardial revascularization in recent years, rivaling the more established coronary artery bypass surgery. There has been increasing interest in improving outcome of PCI while also seeking to minimize cost. A total of 21,755 patients undergoing PCI were evaluated. Clinical data were gathered from the Emory Cardiovascular Database and financial data from the UB92 formulation of the hospital bill. Charges were reduced to cost using departmental cost-to-charge ratios. Costs were inflated to 1999 dollars using medical care inflation rates. Mortality varied without a significant trend from 0.63% to 0.44% (p = 0.64). The Q-wave myocardial infarction rate decreased from 0.68% to 0.40% (p = 0.0003). Emergent coronary surgery decreased from 3.50% to 1.25% (p <0.0001). Mean hospital inflation-adjusted cost decreased from $10,478 to $8,367 (p <0.0001). Length of stay after the procedure decreased from 2.8 to 1.8 days (p <0.0001). Outcome of PCI continues to improve, with a decrease in coronary surgery and Q-wave myocardial infarction but with no significant change in mortality. This was accomplished while also decreasing costs and length of stay. Whether these favorable trends will continue remains to be seen.

Influence of age on outcome after percutaneous transluminal coronary angioplasty.

This study estimates the influence of age on outcomes (mainly survival) of 21,516 patients who underwent percutaneous transluminal coronary angioplasty (PTCA) between 1980 and 1996. We prospectively analyzed the patients in 5 age groups: <50, 50 to 59, 60 to 69, 70 to 79, and > or =80 years old. During the in-hospital period after PTCA, mortality increased from 0.28% in patients aged <50 to 3.45% in patients aged > or =80; Q-wave myocardial infarction was not significantly associated with age, and the 2 older groups were referred less often to coronary artery bypass graft surgery. During follow-up, lasting up to 10 years, the hazard of death was significantly influenced by age; Q-wave myocardial infarction was influenced by age, although the magnitude of the effect was relatively small and of questionable clinical significance; and coronary artery bypass graft surgery was performed less often in the 2 older age groups. Additional PTCA was similarly performed among the age groups. Age, diabetes mellitus, systemic hypertension, heart failure class, angioplasty in graft vessel, number of coronary vessels narrowed, and previous myocardial infarction were predictors of death over the 10-year follow-up. Age was the most important correlate of death after PTCA, with a 65% increase in the hazard of death for each 10-year increase in age. Age has an independent effect on early and late survival after PTCA.

Production and absorption of nitric oxide gas in the nose.

Some nitric oxide gas (NO) produced in the sinuses and nasal cavity is absorbed before leaving the nose. To measure production and absorption, we introduced NO at different concentrations into one nostril while sampling the NO leaving the opposite nostril with the soft palate closed. The quantity of NO gas produced in six normal subjects (amount leaving plus the amount absorbed) averaged 352 nl/min and was the same at gas flows ranging from 8 to 347 ml/min and at 10 l/min. An absorption coefficient A was calculated by dividing the amount of NO absorbed by the concentration leaving the nose. A ranged from 17 ml/min at a nasal gas flow of 8 ml/min to an A of 24 ml/min at a nasal gas flow of 347 ml/min. The calculated rates of production and absorption did not change when gas flow rate was increased, suggesting diffusion equilibrium. The amount of uptake of NO in the nasal mucosa can be explained by its solubility coupled with tissue and blood reactivity.

Usefulness of the substitution of nonangiographic end points (death, acute myocardial infarction, coronary bypass and/or repeat angioplasty) for follow-up coronary angiography in evaluating the success of coronary angioplasty in patients with angina pectoris.

Historically, restenosis after coronary angioplasty has been assessed angiographically at about 6 months. The desirability of avoiding routine follow-up angiography as well as the recognition that angiographic and clinical assessments are not necessarily the same has prompted greater interest in following patients clinically after angioplasty. Clinical restenosis has been defined as the composite of death, myocardial infarction, coronary surgery, or additional angioplasty within 6 months of the index procedure. Clinical restenosis was observed in 2,340 of 11,473 patients (20.4%). The mortality at 6 months was only 1%. Although there were somewhat more acute myocardial infarctions and coronary surgical procedures, the most frequent event was additional angioplasty. Angiographic restenosis was noted in 30% of patients without clinical restenosis and in 87% of patients with clinical restenosis (p < 0.0001). Patients with clinical restenosis were less likely to be women, had more systemic hypertension, diabetes mellitus, more severe angina originally, fewer prior myocardial infarctions, more multivessel and left anterior descending artery disease, more multisite procedures, more branch site procedures, and longer and tighter stenoses both before and after the procedure. The year of the procedure did not correlate with restenosis. Clinical restenosis is less common than angiographic restenosis and the most common event is additional angioplasty. Although clinical restenosis is rarely fatal, it does result in inconvenience and additional resource consumption.

Outcome of coronary bypass surgery versus coronary angioplasty in diabetic patients with multivessel coronary artery disease.

OBJECTIVES: This study sought to compare the outcome of percutaneous transluminal coronary angioplasty (PTCA) (n = 834) and coronary artery bypass graft surgery (CABG) (n = 1805) in diabetic patients with multivessel coronary disease from an observational database. BACKGROUND: There is concern about selection of revascularization in diabetic patients with multivessel coronary artery disease. METHODS: Data were collected prospectively and entered into a computerized database. Follow-up was by letter or telephone or additional events resulting in readmission. RESULTS: After CABG there were more in-hospital deaths (0.36% vs. 4.99%, p < 0.0001) and a trend toward more Q wave myocardial infarctions than after PTCA. Five- and 10-year survival rates were 78% and 45% after PTCA and 76% and 48% after CABG, respectively (p = 0.47). At 5 and 10 years, insulin-requiring patients had lower survival rates of 72% and 31% after PTCA and 70% and 48% after CABG, respectively (p = 0.54). Multivariate correlates of long-term mortality were older age, low left ventricular ejection fraction, heart failure and hypertension. In the total group, insulin requirement was a correlate of long-term mortality. For the total group, choice of therapy had a multivariate hazard ratio close to 1. In the insulin-requiring subgroup, the multivariate hazard ratio was 1.35 (95% confidence interval 1.01 to 1.79) for PTCA versus CABG. Corrected for baseline differences, 5- and 10-year survival rates were 68% and 36% after PTCA and 75% and 47% after CABG, respectively, in the insulin-requiring subgroup. Nonfatal events were more common after PTCA, especially additional revascularization. CONCLUSIONS: This study reveals a high incidence of events in diabetic patients and raises further questions about angioplasty in insulin-requiring diabetic patients with multivessel disease.

Directional coronary atherectomy (DCA): a report from the New Approaches to Coronary Intervention (NACI) registry.

Directional coronary atherectomy (DCA) with the Simpson coronary atherocath seeks to debulk rather than simply displace obstructive tissue and is a means of enlarging the stenotic coronary lumen. This report from the New Approaches to Coronary Intervention (NACI) registry describes the experience of 1,196 patients who underwent DCA as the sole treatment for either native vessel or vein graft lesions. Device success (post-DCA residual stenosis <50% and > or =20% improvement) was achieved in 87.8%, with a lesion success rate (postprocedural residual stenosis <50% and > or =20% improvement) of 94.0%. The mean resultant stenosis after all interventions (by core laboratory) was 19%. Significant in-hospital complications occurred in 2.8% of patients with DCA attempts, including death 0.6%, Q-wave myocardial infarction (MI) 1.5%, and emergent coronary artery bypass graft surgery (CABG) 2.8%. At 1-year follow-up, cumulative mortality was 3.6%, with repeat revascularization in 28% (repeat percutaneous transluminal coronary angioplasty, 20.1%; CABG, 10.6%). This reflected percutaneous or surgical revascularization of the original lesion (target lesion revascularization) in 22.6% of patients. Subgroup analysis showed a lower lesion success rate and an increased complication rate for unplanned use, vein graft treatment, and treatment of a de novo (vs a restenotic) lesion. Multivariate analysis shows that diabetes mellitus, unstable angina, treatment of a restenotic lesion, and greater residual stenosis after the initial procedure were independent predictors of the composite endpoint of death/Q-wave MI/target lesion revascularization by 1-year follow-up. Among these generally favorable acute and 1-year results, the NACI directional atherectomy data confirm the "bigger is better" hypothesis: that lesions with a lower residual stenosis after a successful procedure had significantly fewer target lesion revascularizations between 30 days and 1 year, with no increase in major adverse events.

Stent placement compared with balloon angioplasty for obstructed coronary bypass grafts. Saphenous Vein De Novo Trial Investigators.

BACKGROUND: Treatment of stenosis in saphenous-vein grafts after coronary-artery bypass surgery is a difficult challenge. The purpose of this study was to compare the effects of stent placement with those of balloon angioplasty on clinical and angiographic outcomes in patients with obstructive disease of saphenous-vein grafts. METHODS: A total of 220 patients with new lesions in aortocoronary-venous bypass grafts were randomly assigned to placement of Palmaz-Schatz stents or standard balloon angioplasty. Coronary angiography was performed during the index procedure and six months later. RESULTS: As compared with the patients assigned to angioplasty, those assigned to stenting had a higher rate of procedural efficacy, defined as a reduction in stenosis to less than 50 percent of the vessel diameter without a major cardiac complication (92 percent vs. 69 percent, P<0.001), but they had more frequent hemorrhagic complications (17 percent vs. 5 percent, P<0.01). Patients in the stent group had a larger mean (+/-SD) increase in luminal diameter immediately after the procedure (1.92+/-0.30 mm, as compared with 1.21+/-0.37 mm in the angioplasty group; P<0.001) and a greater mean net gain in luminal diameter at six months (0.85+/-0.96 vs. 0.54+/-0.91 mm, P=0.002). Restenosis occurred in 37 percent of the patients in the stent group and in 46 percent of the patients in the angioplasty group (P=0.24). The outcome in terms of freedom from death, myocardial infarction, repeated bypass surgery, or revascularization of the target lesion was significantly better in the stent group (73 percent vs. 58 percent, P = 0.03). CONCLUSIONS: As compared with balloon angioplasty, stenting of selected venous bypass-graft lesions resulted in superior procedural outcomes, a larger gain in luminal diameter, and a reduction in major cardiac events. However, there was no significant benefit in the rate of angiographic restenosis, which was the primary end point of the study.

Short- and long-term outcome of narrowed saphenous vein bypass graft: a comparison of Palmaz-Schatz stent, directional coronary atherectomy, and balloon angioplasty.

Percutaneous treatment of saphenous vein graft (SVG) stenosis has been established as an alternative to repeat coronary artery bypass grafting. Intracoronary Palmaz-Schatz stent (PSS) and directional coronary atherectomy (DCA) have been suggested to provide better short- and long-term results than balloon angioplasty. Records of 840 patients with 931 SVG lesions treated with PSS (121 patients, 132 lesions), DCA (103 patients, 107 lesions), and balloon angioplasty (616 patients, 692 lesions) were reviewed. Inhospital and long-term outcome were compared among treated groups. The groups had similar clinical and angiographic baseline characteristics except for higher previously dilated grafts in the stent group and graft location among devices. Stent placement was angiographically successful in 99%, DCA in 95%, and balloon angioplasty in 93% of the lesions (p = 0.03). Quantitative angiography revealed a larger lumen diameter after procedure after PSS (3.2 mm) and DCA (3.1 mm) compared with 2.4 mm after balloon angioplasty (p = 0.0001). Angiographic complications (abrupt closure, severe dissections, or distal embolization) were evident in eight (6.1%) lesions after PSS placement, in 17 (15.9%) after DCA, and in 61 (8.8%) after balloon angioplasty. Serious in-hospital clinical complications (death, emergency coronary artery bypass grafting, or Q-wave myocardial infarction) were similar among devices. Survival rates were similar among the groups (p = 0.15). Repeat revascularization at follow-up was reported in 58 (60.4%) of patients after PSS, in 48 (51.1%) after DCA, and in 280 (49.4%) after balloon angioplasty. Correlates of additional revascularization at follow-up were older grafts, calcific lesions, previously dilated grafts, longer lesions, and patients with lower ejection fractions (odds ratio 1.06, 1.34, 1.43, 1.04, and 1.01, respectively). Correlates of mortality rate at follow-up were older patients, patients with lower ejection fractions, and distal embolization (odds ratio 1.04, 1.04, and 1.92, respectively). These data suggest that in patents with SVG stenosis the initial success and morbidity rates are similar when comparing PSS and DCA with balloon angioplasty. Although a larger lumen is obtained with PSS and DCA, patients who underwent balloon angioplasty had similar rates of cardiac events and requirements for additional procedures at follow-up.

Maturational changes in Na(+)-K+ pump activity in guinea pig airway smooth muscle.

The effect of maturation on the Na(+)-K+ pump of airway smooth muscle (ASM) was studied. Na(+)-K+ pump activity of tracheal smooth muscle from immature (1- to 2-week-old) and mature (10- to 12-week-old) guinea pigs was measured as the ouabain-sensitive component of the resting membrane potential and as ouabain-sensitive 86Rb+ uptake (using 86Rb+ as a marker for K+). Maturation resulted in decreases in both the contribution of the Na(+)-K+ pump of the resting membrane potential and in ouabain-sensitive 86Rb+ uptake. 86Rb+ efflux from tracheal smooth muscle was similar in tissues from immature and mature guinea pigs, suggesting that maturation has no effect on K+ (or at least 86Rb+) permeability. Na+ and K+ contents of tracheal smooth muscle were estimated from the uptakes of 24Na+ and 86Rb+ at equilibrium. Maturation resulted in a decrease in Na+ content but had no effect on K+ content. Since intracellular Na+ is one of the principal determinants of Na(+)-K+ pump activity, these results suggest that maturation results in a decrease in Na(+)-K+ pump activity in ASM, which may be due to a decrease in Na+ content.

Angioplasty or surgery for multivessel coronary artery disease: comparison of eligible registry and randomized patients in the EAST trial and influence of treatment selection on outcomes. Emory Angioplasty versus Surgery Trial Investigators.

The Emory Angioplasty versus Surgery Trial (EAST) showed that multivessel patients eligible for both percutaneous transluminal coronary angioplasty (PTCA) and coronary bypass surgery (CABG) had equivalent 3-year outcomes regarding survival, myocardial infarction, and major myocardial ischemia. Patients eligible for the trial who were not randomized because of physician or patient refusal were followed in a registry. This study compares the outcomes of the randomized and registry patients. Of the 842 eligible patients, 450 did not enter the trial. Their baseline features closely resembled those of the randomized patients and follow up was performed using the same methods. In the registry there was a bias toward selecting CABG in patients with 3-vessel disease (84%) and PTCA in patients with 2-vessel disease (54%). Three-year survival for the registry patients was 96.4%, which was better than the randomized patients, 93.4% (p = 0.044). Angina relief in the registry was equal for CABG and PTCA patients and was better for the PTCA registry (12.4%) than PTCA randomized patients (19.6%) (p = 0.079). Thus, the registry confirms that EAST is representative of all eligible patients and does not represent a low-risk subgroup. Since baseline differences were small, improved survival in the registry may be due to treatment selection. Physician judgment, even in patients judged appropriate for clinical trials, remains a potentially important predictor of outcomes.

H+-K+ ATPase inhibitors cause relaxation of guinea pig and human airway smooth muscle in vitro.

The effect of H+-K+ ATPase inhibitors on airway smooth muscle tone was investigated in vitro. Four H+-K+ ATPase inhibitors, SCH 28080 (2-methyl-8-(phenylmethoxy)-imidazo[1,2-a] pyridine-3-acetonitrile), SK&F 96067 (3-butyryl-4-(2-methylphenylamino)-8-methoxy-quinoline), omaprezole (5-methoxy-2-(((4-methoxy-3,5-dimethyl-2-pyridinyl)-methyl)-sulfinyl)-1H -benzimidazole) and NC-1300-B (2-(2-dimethylaminobenzylsulfiny)-5-methoxybenzimidazole), induced concentration-dependent relaxation of guinea pig trachea with spontaneous tone, with IC50 values of 5.9, 7.1, 155 and 79 microM, respectively, SCH 28080 and omeprazole also relaxed airways precontracted with carbachol or histamine in the presence of indomethacin. Relaxation was similar in intact and epithelium-denuded tracheal preparations, suggesting that the airway epithelium neither mediates or modulates relaxation induced by H+-K+ ATPase inhibitors. SCH 28080-induced relaxation was not influenced by tetrodotoxin, suggesting that it is not neurogenically mediated. Bafilomycin A1 and concanamycin A had no effect on guinea pig tracheal spontaneous tone, suggesting that relaxation induced by H+-K+ ATPase inhibitors is not due to an interaction with a vacuolar H+ ATPase. SCH 28080 also induced concentration-dependent relaxation of human bronchi precontracted with histamine. These results demonstrate that several structurally and/or mechanistically distinct H+-K+ ATPase inhibitors cause relaxation of airway smooth muscle in vitro, and suggest that a H+-K+ ATPase or similar pathway may play a role in the maintenance of airway smooth muscle tone.

"Bailout" coronary stenting in patients with a recent myocardial infarction.

Patients who underwent bailout intracoronary stenting within 7 days of a myocardial infarction had lower clinical and angiographic success rates and a higher incidence of emergent coronary artery bypass graft surgery than patients who underwent bailout stenting without a history of a recent myocardial infarction. In addition, there was a trend toward more cardiac events after discharge in patients who received stents after a recent myocardial infarction.

Percutaneous transluminal coronary angioplasty as a first revascularization procedure in single-, double- and triple-vessel coronary artery disease.

OBJECTIVES: We sought to compare in-hospital and long-term outcome after angioplasty in patients with single-, double- and triple-vessel disease. BACKGROUND: Coronary angioplasty is increasingly used in patients with multivessel disease. METHODS: The source of data was the clinical data base at Emory University. Patients who had previous coronary revascularization or who underwent angioplasty in the setting of acute myocardial infarction were excluded. RESULTS: Of 10,783 patients, 71% had one-vessel, 24% two-vessel and 5% three-vessel disease. Age, male gender, diabetes, hypertension, history of previous myocardial infarction, Canadian Cardiovascular Society class III or IV angina and congestive failure all increased with severity of disease. Complete revascularization was achieved in most patients with one-vessel disease, in a minority with two-vessel disease and rarely in those with three-vessel disease. Emergency coronary bypass surgery increased from 1.7% with one-vessel disease to 3.2% with three-vessel disease. Q wave myocardial infarctions could not be shown to vary significantly with severity of disease. The mortality rate increased from 0.2% with one-vessel disease to 1.2% with three-vessel disease. The number of vessels diseased was a multivariate correlate of in-hospital and long-term mortality. The 1-, 5- and 10-year survival was 0.99, 0.93 and 0.86 for one-vessel disease and 0.97, 0.89 and 0.76 for two-vessel disease, respectively. The 1-, 5- and 9-year survival was 0.95, 0.85 and 0.70 in three-vessel disease, respectively. Freedom from myocardial infarction, coronary bypass surgery and repeat angioplasty was also lower with more severe disease. CONCLUSIONS: Patients have increasing in-hospital and long-term mortality as the severity of disease increases. There is also an increased incidence of myocardial infarction and revascularization procedures with more severe disease.

Predictors of groin complications after balloon and new-device coronary intervention.

We reviewed the clinical course of 5,042 patients who underwent percutaneous transluminal coronary angioplasty (PTCA) using balloons or new devices: (stent, laser, directional and rotational atherectomy). A vascular complication was defined as the formation of a groin hematoma, bleeding, pseudoaneurysm, fistula, or the need for surgical repair. Vascular complications occurred in 309 (6.1%) patients, and 117 (2.3%) required vascular repair; among these patients, surgery was performed for correction of an an arteriovenous fistula in 12%, repair of pseudoaneurysm in 72%, repair for expanding hematoma and femoral artery lacerations in 10%, and retroperitoneal bleeding in 6%. The correlates of vascular complications were older age (66.8 vs 62.1 years; p < 0.0001), female gender (43% vs 26%; p < 0.0001), increased weight (82.1 +/- 16.46 vs 78.0 +/- 16.6 kg; p < 0.001), higher systolic blood pressure (140 +/- 25 vs 134 +/- 20 mm Hg; p < 0.001), increased heparin dose during the procedure (14,352 +/- 3,879 vs 13,599 +/- 3,508 IU; p = 0.001), administration of heparin after the procedure (232 vs 2,985 patients; p < 0.0001) and intracoronary stenting (14.9% vs 3.5%; p < 0.0001). Fifteen patients of 214 (7.0%) who underwent stent implantation had surgical repair. Vascular complications were not related to the size of the arterial sheath (8.11 +/- 0.8 vs 8.8 +/- 0.7Fr; p = 0.11) and the use of devices other than stents (laser, atherectomy) did not increase the rate of vascular complications.

Bioactivation of 5-hydroxymethyl-2-furaldehyde to an electrophilic and mutagenic allylic sulfuric acid ester.

5-Hydroxymethyl-2-furaldehyde (HMF), a ubiquitous food contaminant, has been proposed to be metabolically activated through sulfonation of its allylic hydroxyl functional group. In support of this idea, we have found the strong direct mutagenicity of chemically synthesized sulfuric acid ester, 5-sulfooxymethylfurfural (SMF), in Salmonella typhimurium TA104. The intrinsic mutagenicity of this reactive ester was significantly inhibited by glutathione and glutathione S-transferase activity in dialyzed rat liver cytosol. The metabolic formation of SMF was elucidated by enhanced mutagenicity of HMF in the presence of rat hepatic cytosol enriched with the sulfo-group donor, 3'-phosphoadenosine-5'-phosphosulfate (PAPS). The PAPS- and cytosol-dependent mutagenicity of HMF was markedly lessened by sulfotransferase inhibitors such as 2,6-dichloro-4-nitrophenol and dehydroepiandrosterone. These results suggest that HMF can be metabolically activated to an allylic sulfuric acid ester which may play a role as an ultimate electrophilic metabolite in toxification of the parent compound in vivo.

Influence of diabetes mellitus on early and late outcome after percutaneous transluminal coronary angioplasty.

BACKGROUND: Although patients with diabetes mellitus constitute an important segment of the population undergoing coronary angioplasty, the outcome of these patients has not been well characterized. METHODS AND RESULTS: Data for 1133 diabetic and 9300 nondiabetic patients undergoing elective angioplasty from 1980 to 1990 were analyzed. Diabetics were older and had more cardiovascular comorbidity. Insulin-requiring (IR) diabetics had diabetes for a longer duration and worse renal and ventricular functions compared with non-IR subjects. Angiographic and clinical successes after angioplasty were high and similar in diabetics and nondiabetics. In-hospital major complications were infrequent (3%), with a trend toward higher death or myocardial infarction in IR diabetics. Five-year survival (89% versus 93%) and freedom from infarction (81% versus 89%) were lower, and bypass surgery and additional angioplasty were required more often in diabetics. In diabetics, only 36% survived free of infarction or additional revascularization compared with 53% of nondiabetics, with a marked attrition in the first year after angioplasty, when restenosis is most common. Multivariate correlates of decreased 5-year survival were older age, reduced ejection fraction, history of heart failure, multivessel disease, and diabetes. IR diabetics had worse long-term survival and infarction-free survival than non-IR diabetics. CONCLUSIONS: Coronary angioplasty in diabetics is associated with high success and low complication rates. Although long-term survival is acceptable, diabetics have a higher rate of infarction and a greater need for additional revascularization procedures, probably because of early restenosis and late progression of coronary disease. The most appropriate treatment for these patients remains to be determined.

Efficacy and safety of using perfusion dilatation catheter as initial balloon in coronary angioplasty.

The efficacy and safety in using a new low-profile perfusion balloon catheter (PBC) as the initial balloon in percutaneous coronary angioplasty (PTCA) was assessed retrospectively in 61 patients: 43 males, mean age 62 +/- 12 years. Thirty-three patients (54%) had unstable angina. PTCA was performed using an improved PBC in the following vessels: LAD 40%; CX 21%; RCA 24%. Lesion morphology was: Type A 21%; Type B1 18%; Type B2 40%; Type C 21%. Mean artery size was 3.01 +/- 0.53 mm. Mean PBC size was 3.14 +/- 0.45 mm. The mean number of inflations used was 2.85 +/- 2.0. The mean longest inflation was 415 +/- 213 sec and the total inflation time was 663 +/- 342 sec to a mean maximum pressure atmosphere of 7.85 +/- 2.0 bars. The number of balloons used per procedure was 1.2 +/- 0.44. In 50 patients (82%) only one balloon was used during the PTCA. PTCA was successful (< 50% diameter stenosis without major complications) in 60 patients (98.4%). Mean diameter stenosis at baseline was 82 +/- 9.5% and post-angioplasty 13 +/- 10.6%. A mild intimal tear occurred in 6 patients (9.8%). A stent was implanted in 3 patients (4.9%) due to severe dissection. In hospital reocclusion occurred in one patient (1.6%). There were no deaths or emergency bypass surgery. A low profile PBC is safe and effective as an initial balloon in PTCA. It may reduce the number of balloons used and inflations per procedure.