Abstract 5995: Efficacy Of The Everolimus-eluting Stent in Diabetic Patients: Comparison With The Paclitaxel-eluting Stent

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Hiromasa Otake ◽  
Junya Ako ◽  
Masao Yamasaki ◽  
Ichizo Tsujino ◽  
Takao Shimohama ◽  
...  
Keyword(s):  
De Novo ◽  
Neointimal Hyperplasia ◽  
Multicenter Trial ◽  
Volume Index ◽  
Diabetic Patients ◽  
Lumen Area ◽  
Post Intervention ◽  
Cross Sectional ◽  
Incomplete Stent Apposition

Background: In the diabetic subgroup of the Spirit III trial (randomized, multicenter trial comparing Everolimus-eluting XIENCE ™ V stent (EES) to Paclitaxel-eluting Taxus ™ stent (PES) in de novo native coronary artery lesions), PES showed a trend toward fewer major adverse cardiac event compared with EES during 1 year follow-up in patients with diabetes despite lower observed late loss with EES at 8 months. Methods: The Stanford University IVUS Core Laboratory database was queried to evaluate the efficacy of EES in diabetics compared with PES. A total of 113 lesions treated with EES (n=58) and PES (n=55) undergoing 8 or 9 months follow up 3-D intravascular ultrasound (IVUS) were enrolled. Volume index (volume/length) was calculated for vessel (VVI), peri-plaque (PVI), neointima (NIV), and lumen (LVI). %NIV was calculated as neointimal volume / stent volume × 100. Cross-sectional narrowing (CSN) was defined as neointimal area divided by stent area (%). Late lumen area loss was calculated as minimum lumen area (MLA) at post-intervention (Post) minus MLA at follow-up (FUP). Late incomplete stent apposition (LISA) was defined as separation of at least 1 strut from the vessel wall with blood speckle behind the strut, where Post IVUS revealed well apposition. Results: Average stent length was significantly longer in EES. EES showed less neointimal hyperplasia and smaller LVI loss than PES (Table ), whereas no statistical interactions were observed between EES and serial changes for VVI and PVI. PES showed a significant increase in PVI (Post: 7.6±3.1, FUP: 8.4±3.1; p=0.049) and a trend toward increase in VVI (Post: 14.8±5.5, FUP: 15.5±4.2; p=0.07) between Post and FUP. One case with LISA was observed in EES group. Conclusions: EES demonstrated significant suppression of neointimal hyperplasia in diabetic patients without vessel expansion compared with PES up to 8 months follow up. Figure 1 Intra Individual matched In-Stent Late Luminal Loss[mm]

Abstract 2771: Comparison of Everolimus-Eluting Stents with Paclitaxel-Eluting Stents in De Novo Native Coronary Artery Lesions: Intravascular Ultrasound Results From the SPIRIT III Trial

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Masao Yamasaki ◽  
Ichizo Tsujino ◽  
Ryota Sakurai ◽  
Katsuhisa Waseda ◽  
Takao Hasegawa ◽  
...  
Keyword(s):  
Coronary Artery ◽  
Intravascular Ultrasound ◽  
De Novo ◽  
Volume Index ◽  
Chromium Alloy ◽  
Lumen Area ◽  
Coronary Artery Lesions ◽  
Post Intervention ◽  
Native Coronary Artery

Background : SPIRIT III is a pivotal, multicenter, 2:1 randomized, controlled trial comparing Everolimus-eluting cobalt-chromium alloy XIENCE™ V stents (EES) to Paclitaxel-eluting Taxus ™ stents (PES) in de novo native coronary artery lesions. Intravascular ultrasound (IVUS) was performed in a subset of Spirit III to further investigate the safety and efficacy profiles of EES. Methods : The SPIRIT III IVUS study enrolled 305 patients who received 359 stents (244 EES in 205 patients; 115 PES in 100 patients). Serial IVUS imaging was performed post-intervention and at 8 months follow-up. Late lumen area loss was calculated as minimum lumen area (MLA) at post-intervention minus MLA at follow-up. Volume index, defined as volume data divided by stent length, was obtained for vessel (VVI), stent (SVI), lumen (LVI), plaque (PVI), and neointima (NVI). Results : At baseline, the incidence of tissue prolapse, edge dissections, and incomplete stent apposition (ISA) were not significantly different between EES and PES (15.6 vs 19.7%, 1.3 vs 2.8%, and 31.8 vs 28.2%, respectively). At follow-up, edge dissections and late-acquired ISA were not significantly different between EES and PES (1.4 vs 3.1%, 1.7 vs 4.1%, respectively). EES showed significantly less neointimal hyperplasia and a trend toward larger follow-up lumen than PES (Table ), whereas no statistical interactions were observed between EES and serial changes for VVI and PVI. PES showed a significant increase in VVI and PVI between post-intervention and follow-up. Reference segment analysis showed no unfavorable edge effect adjacent to either EES or PES. Conclusion : Detailed IVUS analysis confirmed significantly greater neointimal suppression with EES, with no apparent adverse vessel response, as compared to PES. Additional drug-eluting stent trials in more complex lesions are warranted to further validate the clinical utility of these new technologies.

Abstract 1717: Post-Procedural Incomplete Stent Apposition after Implantation of Everolimus-Eluting or Paclitaxel-Eluting Stents: Insights from the Randomized SPIRIT III Trial

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Masao Yamasaki ◽  
Junya Ako ◽  
Ichizo Tsujino ◽  
Ryota Sakurai ◽  
Katsuhisa Waseda ◽  
...  
Keyword(s):  
Vessel Wall ◽  
De Novo ◽  
Neointimal Hyperplasia ◽  
List Type ◽  
Chromium Alloy ◽  
Incomplete Stent Apposition ◽  
Longitudinal Length ◽  
Distal Edge ◽  
Stent Strut

Background : We investigated the morphometric changes of post-procedural incomplete stent apposition (ISA) after implantation of Everolimus-eluting cobalt-chromium alloy XIENCE™ V stents (EES) and Paclitaxel-eluting Taxus ™ stents (PES). Methods : Data were obtained from the SPIRIT III trial (2:1 randomized, multicenter trial comparing EES to PES in de novo native coronary artery lesions). Serial IVUS imaging was performed post-intervention and at 8 months follow-up. ISA was defined as separation of at least 1 stent strut from the vessel wall with evidence of blood speckle behind the strut. The following parameters were obtained from the IVUS analysis: ISA area at the maximum ISA (max ISA) site, ISA angle (angle of the ISA arc at the max ISA site), ISA depth (length between the stent strut and the vessel wall at the max ISA site), and ISA length (longitudinal length of the ISA); vessel, stent, lumen, peri-stent plaque, and neointimal hyperplasia area at the ISA site. Results : At baseline, there were 34 ISA sites in 29 EES (18 at the proximal edge, 9 at the distal edge, and 7 within the stent body), and 16 ISA sites in 11 PES (4 at the proximal edge, 5 at the distal edge, and 7 within the stent body). ISA area, angle, depth, and length decreased between post-procedure and follow-up period in both groups (Table ). Vessel and peri-stent plaque area increased in PES, whereas no changes were observed in EES. There was no difference in the incidence of either persistent or resolved ISA between the 2 groups (p=0.32). Neither stent thrombosis nor in-stent restenosis occurred in the patients with post-procedural ISA over a period of 12 months. Conclusion : This IVUS analysis suggests different vessel responses at the site of post-procedural ISA between EES and PES, but no clinical consequences. Longer term follow-up with larger cohorts is warranted to further validate the clinical implications of ISA with drug-eluting stents.

scholarly journals Treatment of de novo coronary artery lesions with paclitaxel drug coated balloons (DCB) in diabetic and non-diabetic patients

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K.M.Z Mohd Saad Jalaluddin
Keyword(s):  
Myocardial Infarction ◽  
Coronary Artery ◽  
De Novo ◽  
Target Lesion ◽  
Diabetic Group ◽  
Target Lesion Revascularization ◽  
Diabetic Patients ◽  
Coronary Artery Lesions ◽  
Artery Disease

Abstract Background Drug-coated balloon has been widely used to treat In-Stent Restenosis as recommended by ESC/EACT coronary intervention guideline. However, trials of effectiveness of DCB in treating de novo lesions in diabetic patients are limited. This study will highlight the impact of DCB in diabetic patients with only de novo lesions against non-diabetic patients. Aim To compare the outcomes of Paclitaxel Drug Coated Balloon (DCB) in Diabetic and non-diabetic patients with only de novo coronary artery disease. Methods A retrospective, single center study was conducted from January 2016 till December 2018. All diabetic and non-diabetic patients underwent angioplasty to only de novo coronary artery lesions were included in the study. Patients' baseline characteristic, angiographic data, post procedural and 12 months follow-up outcomes including major adverse coronary artery event (MACE), target lesion revascularization (TLR) and myocardial infarction (MI) are compared. Results A total of 1257 patients (726 diabetic and 531 non-diabetic patients) with total 1385 de novo coronary artery lesions (791 lesions in diabetic group and 594 lesions in non-diabetic group) were included in this study. Mean age for non-diabetic group was 57.6±10.6 years and diabetic group was 59.6±9.6 years with male predominance (91.1% in non-diabetic group, n=484 and 79.2% in diabetic group, n=575). Majority of diabetic group has hypertension (83.7%, n=608 vs 58.6%, n+311), chronic renal failure (10.3%, n=75 vs 1.9%, n=10), documented coronary artery disease (55.6%, n=404 vs 47.5%, n=252) and previous coronary angioplasty 39.5%, n=287 vs 28.8%, n=153). Adequate pre-dilatation was done in both groups (98.5%, n=585 in non-diabetic group and 99.4%, n=786 in diabetic group; p=0.000). Mean DCB diameter and length were almost similar in both groups. Mean residual stenosis after DCB was 11.15±16.9% in non-diabetic group and 13.13±13.4% in the diabetic group (p=0.008). 74.6% of non-diabetic group (n=396) and 77.1% of diabetic group (n=560) were on double antiplatelet therapy for 12 months. 86.8% (n=461) of non-diabetic and 88.4% (n=642) of diabetic patients were available for follow up. MACE events were significantly higher (p=0.000) in diabetic group (4.3%, n=31) as compare to non-diabetic group (0.6%, n=3). Target lesion revascularization (TLR) and myocardial infarction (MI) was also significantly higher in diabetic group (TLR 1.4%, N=10 vs 0.6%, n=3, p=0.049; MI 2.6%, n=19 vs 0.4%, n=2, p=0.002). Conclusion Treating de novo coronary lesions in diabetic patients with DCB associated with significantly higher MACE events, target lesion revascularization and myocardial infarction. Diabetic patients appear to have a greater volume of atherosclerotic plaque and increased propensity for atherosclerotic plaque rupture. Funding Acknowledgement Type of funding source: None

Abstract 3322: Chronic Vascular Responses To Sirolimus-eluting Stent Compared With Bare-metal Stent In Diabetic Patients: Evaluated By Optical Coherence Tomography.

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Takashi Kubo ◽  
Toshio Imanishi ◽  
Hiroki Matsumoto ◽  
Manabu Kashiwagi ◽  
Hiroto Tsujioka ◽  
...  
Keyword(s):  
Optical Coherence Tomography ◽  
Neointimal Hyperplasia ◽  
Bare Metal Stent ◽  
Diabetic Patients ◽  
Imaging Method ◽  
Bare Metal ◽  
Optical Coherence ◽  
Metal Stent ◽  
Cross Sectional ◽  
Sirolimus Eluting Stent

OBJECTIVE: An optical coherence tomography (OCT) study was performed to compre the vascular response to sirolimus-eluting stent (SES) with bare-metal stent (BMS) in patients with diabetic mellitus (DM). BACKGROUND: Despite advances in the medical treatment and revascularization procedures, coronary artery disease remains a leading cause of morbidity and mortality in patients with DM. Few retrospective subgroup analyses of pivotal clinical trials have suggested that SES may be effective for reduction of restenosis in diabetic patients. OCT is a new intravascular imaging method with a high resolution of approximately 10 micrometer and allows us to evaluate instent neointimal hyperplasia (NIH) in vivo. METHODS and RESULTS: Serial OCT analyses were performed in 60 lesions (SES in DM patients=19; SES in non-DM patients=14; BMS in DM patients=10; BMS in non-DM patients=17) at 9-month follow-up. A total of 6920 stent struts were visualized by OCT and NIH thickness inside each strut and incidence of exposed stnet struts were evaluated in cross-sectional image. The NIH thickness was significantly different among 4 groups (97 +/− 100 vs. 43 +/− 61 vs. 425 +/− 206 vs. 209 +/− 138 micrometer, respectively). The NIH thickness of SES in DM was significantly thicker than that of SES in non-DM (p<0.001), although it was significantly thinner than that of BMS in DM (p<0.001) or BMS in non-DM (p<0.001). All struts of BMS were covered by neointima, but 14% of struts of SES were exposed. The incidence of exposed struts and exposed struts with inadequate apposition in DES were significantly lower in DM compared with those in non-DM (5% vs. 34%, p<0.0001; 2% vs. 5%, p <0.001, respectively). Moreover, the frequency of DES with partially exposed strut was significantly lower in DM than non-DM (32% vs. 71%, p<0.027). CONCLUSION: The present OCT study revealed that DES inhibited the NIH effectively with low incidence of exposed stent strut in DM patients at 9-month after implantation.

scholarly journals Reversal of Prediabetes in Saudi Adults: Results from an 18 Month Lifestyle Intervention

Nutrients ◽  
2020 ◽  
Vol 12 (3) ◽  
pp. 804 ◽  
Author(s):  
Osama E. Amer ◽  
Shaun Sabico ◽  
Hanan A. Alfawaz ◽  
Naji Aljohani ◽  
Syed Danish Hussain ◽  
...  
Keyword(s):  
Lifestyle Intervention ◽  
Lifestyle Modification ◽  
Multicenter Trial ◽  
Lifestyle Changes ◽  
Control Group ◽  
Post Intervention ◽  
Exercise Behaviors ◽  
Diet And Exercise ◽  
To Receive

Aim: This 18 month intervention study aims to determine the efficacy of a lifestyle modification program on prediabetes reversal among Saudi adults. Methods: An 18 month randomized, multicenter trial was conducted among Saudis with prediabetes aged 25–60 recruited from King Salman Hospital and primary care centers in Riyadh, Saudi Arabia. A total of 180 consenting individuals were randomized (1:1) to receive either intensive lifestyle intervention (ILIG) or guidance (control group, CG). ILIG was provided with a personalized lifestyle counseling by nutritionists every 3 months to improve diet and exercise behaviors. CG was given booklets containing information on prediabetes and its prevention. Data from lifestyle assessments and laboratory measurements were analyzed at baseline and every 6 months. The primary outcome was the reversal rate of prediabetes. Results: 158 participants were analyzed (CG:85, ILIG:73) at the 12 month follow-up and 28 participants (CG:11 and ILIG:17) completed the entire 18 month study. Post-intervention, the cumulative incidence of prediabetes reversal in the ILIG was 38 participants (52.1%) which was significantly higher than CG with 26 participants (30.6%) (p = 0.02). Conclusion: A tailored lifestyle intervention is effective in reversing prediabetes, at least for a year, among Arab adults with prediabetes. The challenge of sustaining interest in adopting lifestyle changes for a longer duration should be addressed in this population.

scholarly journals Long-Term Follow-Up of Incomplete Stent Apposition in Patients Who Received Sirolimus-Eluting Stent for De Novo Coronary Lesions

Circulation ◽  
2003 ◽  
Vol 108 (22) ◽  
pp. 2747-2750 ◽  
Author(s):  
Muzaffer Degertekin ◽  
Patrick W. Serruys ◽  
Kengo Tanabe ◽  
Chi Hang Lee ◽  
J. Edouardo Sousa ◽  
...  
Keyword(s):  
De Novo ◽  
Incomplete Stent Apposition ◽  
Long Term Follow Up ◽  
Coronary Lesions ◽  
Sirolimus Eluting Stent

Direct Financial Cost of Diabetes Mellitus among Adult Sudanese Patients in Khartoum State 2016-2017

2019 ◽  
pp. 1-8
Author(s):  
Mahmoud Elnil ◽  
Zeinab Swaraldahab ◽  
Sulaf Ibrahim Abdelaziz
Keyword(s):  
Diabetes Mellitus ◽  
Annual Cost ◽  
Health Care Services ◽  
Sampling Technique ◽  
Tight Glycemic Control ◽  
Cross Sectional Study ◽  
Total Annual Cost ◽  
Diabetic Patients ◽  
Cross Sectional

Background: Diabetes mellitus is a chronic disease with devastating short and long-term complications that affect productivity. The corner stone for diabetes care is tight glycemic control with regular follow up. To achieve this care, medications and other health care services must be available and affordable. Objective: To estimate the direct cost of diabetes mellitus care among adult patients in Khartoum state. Methods: Cross-sectional study using multi-stage sampling technique to select the facilities proportional to population size. Patients were interviewed using questionnaire. Results: The total annual cost of Diabetes was estimated to be 3820 Sudanese pound (SDG) per person. Hospitalizations fees accounted for the major portion of the cost. Forty-seven percent of the patients were admitted with diabetes related problems during the previous year. One in four of the diabetic patients had no sufficient supply of medications. Conclusion: The total annual cost was significantly lower among those with regular follow up visits than those with irregular visits (P < 0.03). Emphasis should be put on providing affordable and available health services and medication especially at PHC level.

scholarly journals Evaluation of Cognitive Functions of Individuals Older Than 65 With Diagnosis of Diabetes

2018 ◽  
Vol 34 (3) ◽  
pp. 171-175
Author(s):  
Serap Gokce ◽  
Canan Demir Barutcu
Keyword(s):  
Risk Factor ◽  
Cognitive Function ◽  
Cognitive Functions ◽  
Health Professionals ◽  
Cognitive Assessment ◽  
University Hospital ◽  
Average Score ◽  
Diabetic Patients ◽  
Cross Sectional

This study was conducted in order to examine the level of cognitive function of individuals ≥65 years of age with diabetes. The cross-sectional descriptive design was used. The research was carried out in the diabetes polyclinic of a university hospital between June 2016 and January 2018. The study sample consisted of 91 patients. Data were collected with the scale of Montreal Cognitive Assessment (MoCA). The average score of the patients in the MoCA Scale was found to be 19.61 ± 1.70 (min: 15, max: 26). Diabetes is a risk factor for cognitive dysfunction for individuals above 65 years of age. Health professionals regularly monitor the cognitive functions of diabetic patients and use the MoCA scale in these follow-up and plan training and counseling initiatives according to their needs.

scholarly journals Prevalence of Diabetic Foot Ulcer and Associated Factors among Adult Diabetic Patients on Follow-Up Clinic at Jimma Medical Center, Southwest Ethiopia, 2019: An Institutional-Based Cross-Sectional Study

2020 ◽  
Vol 2020 ◽  
pp. 1-6 ◽  
Author(s):  
Daba Abdissa ◽  
Tesfaye Adugna ◽  
Urge Gerema ◽  
Diriba Dereje
Keyword(s):  
Peripheral Neuropathy ◽  
Diabetic Foot ◽  
Medical Center ◽  
Previous History ◽  
Foot Ulcer ◽  
Diabetic Foot Ulcer ◽  
Diabetic Patients ◽  
Cross Sectional ◽  
History Of

Background. Diabetic foot ulceration is a devastating complication of diabetes mellitus and is a major source of morbidity and mortality. So far, there are few published data on diabetic foot ulcers and its determinants among diabetic patients on follow-up at Jimma Medical Center. Hence, the aim of this study was to assess the prevalence of diabetic foot ulcer and its determinants among patients with diabetes mellitus at Jimma Medical Center. Methods. A hospital-based cross-sectional study was conducted from June 1 to August 30, 2019, and systematic random sampling technique was applied. The total number of study subjects who participated in the study was 277. Data were collected using an interview-administered structured questionnaire. Data were entered into EpiData version 3.1 and exported to SPSS version 20 software for analysis. Analysis was done using descriptive statistics and logistic regression. A variable having a p value of <0.25 in the bivariate model was subjected to multivariate analysis to avoid confounding the variable’s effect. Adjusted odds ratios (AOR) were calculated at 95% confidence interval and considered significant with a p value of ≤0.05. Result. The mean of age of participants was 50.1±14.19 years. More than three-fourths of participants (82.7%) were type 2 DM. The mean duration of diabetic patients was 6.00±5.07 years. The prevalence of diabetic foot ulcer was 11.6% among study participants. According to multivariate logistic regression analysis, previous history of ulceration (AOR=5.77; 95% CI: 2.37, 14.0) and peripheral neuropathy (AOR=11.2; 95% CI: 2.8, 44.4) were independent predictors of diabetic foot ulcer. Conclusion. The prevalence of diabetic foot ulcer was 11.6%. Previous history of ulceration and peripheral neuropathy were associated with diabetic foot ulcer. The health care providers are recommended to thoroughly give emphasis during follow-up of patients who had previous history of ulceration and peripheral neuropathy in order to decrease the occurrence of diabetic foot ulcer.

Abstract 2557: The Appraisal-Trial: Evaluating RESTEN-MPTM in Patients with Bare Metal Stent de novo Native Coronary Artery Lesions

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Sebastian Philipp ◽  
Dirk Böse ◽  
Igor Kordish ◽  
Johannes Brachmann ◽  
Klinikum Coburg ◽  
...  
Keyword(s):  
Coronary Artery ◽  
Intravascular Ultrasound ◽  
De Novo ◽  
Neointimal Hyperplasia ◽  
Bare Metal Stent ◽  
Coronary Artery Lesions ◽  
Cardiac Events ◽  
Late Lumen Loss ◽  
Vessel Lumen

Background: Although the use of drug-eluting stents has been shown to limit neointimal hyperplasia, currently available DES may adversely affect re-endothelialization, possibly precipitating late cardiac events. The aim of this study was to evaluate the efficacy and safety of a microbubble delivery of c-myc antisense peptide in preventing restenosis after coronary stenting in de novo stenosis with intravascular ultrasound. Methods: A BMS was implanted in de novo coronary artery lesions (RD ≥ 2.5- ≤4.0mm; TL ≥ 15- ≤ 30mm in length). Serial intravascular ultrasound analysis were performed in 25 lesions. A dose of 16mg RESTEN-MPTM (AVI BioPharma/Global Therapeutics LLC) was intravenously administered after stenting and again 24 hours later. Results: A total of 50 patients were enrolled, 34 in Essen, 13 in Coburg and 3 in Heidelberg. Before stenting, the MLD and length of stenosis was determined by QCA. 18 Patients had a LAD lesion, 21 LCX, 12 RCA. 84% (43/51) of the lesions were either Type B2 or C lesions. At six month follow-up, angiography with a QCA was performed. Generally the neointimal proliferation was minor and open vessel lumen could be demonstrated during follow-up. Of the 30 patients currently studied at six-months in the IVUS sub-study, six patients required TLR. Late lumen loss by QCA was 0.47±0.09mm. Volume stenosis by IVUS was 26 ± 4 %. Generally the neointima proliferation was minor and open vessel lumen could be demonstrated during follow-up. Summary: Microbubble delivery of c-myc antisense seems to be effective in reducing neointimal tissue proliferation without the problem of late stent thrombosis, because the proliferation seems to be attenuated but not fully blocked.

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