Coronary stenting in diabetics: immediate and mid-term clinical outcome.

Balloon angioplasty in diabetics is associated with acceptable immediate results but with high rates of restenosis, target vessel revascularization, and late mortality. The impact of coronary stenting on the outcome of these patients remains controversial. We reported the immediate and mid-term clinical outcome of 272 consecutive diabetic patients, representing 12.5% of the population undergoing coronary stenting between May 1995 and April 1997. Diabetes mellitus was insulin-requiring in 58 patients and non-insulin-requiring in 214. Stenting performed on large vessels (mean diameter >/=3 mm) was successful in 99.2% of nondiabetic patients and in all cases in diabetics. During in-hospital stay, the complications rate, including mortality, nonfatal myocardial infarction, emergency coronary bypass surgery, and stent subacute thrombosis, was similar in nondiabetic patients, insulin-requiring, and non-insulin-requiring diabetics (2.55%, 0%, and 2.0%, respectively). No complication occurred in the insulin-requiring group. One patient (0.5%) died from myocardial infarction and another (0.5%) presented a nonfatal myocardial infarction (subacute stent thrombosis) in the non-insulin-requiring group. The clinical follow-up (mean length 13 +/- 8 months) was obtained in 93% and 97% of the insulin-requiring and non-insulin-requiring diabetics, respectively. Overall mortality was significantly higher in insulin-requiring patients (9.3% vs. 2.4%). Nonfatal myocardial infarction and target lesion revascularization rates were similar in the two groups (0% vs. 0.5% and 8.2% vs. 10.5%). These results suggest that coronary stenting in diabetics could be performed with acceptable immediate and mid-term results. Cathet. Cardiovasc. Intervent. 47:279-284, 1999.     

评价冠状动脉内支架对冠状动脉闭塞的临床及血管造影的远期疗效

目的　研究对完全闭塞的血管成功ＰＴＣＡ术后,选择性置入支架的近期及远期临床疗效及血管造影结果。方法４９８例完全血管闭塞的病人中,能成功进行ＰＴＣＡ并置入支架,完成临床及血管造影随访的８４例病人,共放置９８个支架,观察其术后近期及远期临床事件发生率及血管造影的特点。结果　置入支架后,住院期间,５％的病人出现亚急性血管闭塞,无死亡,１例发生心肌梗塞,至半年随访终点时,共有３０％的病人出现再狭窄,血管闭塞率１３％,重施血管再通术２０％,半年后的无心脏事件率为６８％。结论对完全血管闭塞病人,选择性支架术明显降低再狭窄及血管闭塞率,减少临床心脏事件的发生率。     

Coronary artery stenting in the elderly: short-term outcome and long-term angiographic and clinical follow-up

Objectives. This study sought to compare the short- and long-term outcomes of elderly patients undergoing coronary artery stenting with those of younger patients and to determine the long-term clinical outcome and survival of elderly patients post stent implantation.Background. Elderly patients undergoing coronary revascularization are considered a high-risk group. Few data exist that relate the results of stenting in treating coronary artery disease in the elderly population.Methods. All elderly patients ≥75 years of age who underwent coronary artery stenting between March 1993 and July 1997 (n = 137) at our center were compared to the patients <75 who underwent coronary artery stenting during the same time period (n = 2,551). Long-term clinical follow-up and survival were determined for the elderly group.Results. Elderly patients presented with lower ejection fractions (54% vs. 58%, p = 0.0001), more unstable angina (47% vs. 28%, p = 0.0001), and more multivessel disease (78% vs. 62%, p = 0.0001) than younger patients. These older patients had higher rates of procedure related complications including procedural myocardial infarction (MI) (2.9% vs. 1.7%, p = 0.2), emergency CABG (3.7% vs. 1.4%, p = 0.04), and death (2.2% vs. 0.12%, p = 0.0001). Angiographic follow-up, obtained in both groups, demonstrated significantly higher restenosis rates in the elderly versus younger patients (47% vs. 28%, p = 0.0007). Longer term clinical follow-up, which was obtained only in the elderly group, showed that at a mean follow-up period of 12 months post coronary stenting, elderly survival free from death, MI, revascularization and angina was 54% and that their overall survival was 91%. Subanalysis of the elderly patients who died showed much higher incidence of combined unstable angina (80%), prior MI (60%), lower ejection fraction (46%), multivessel disease (100%) and complex lesions (100%) than the overall group.Conclusions. Elderly patients who undergo coronary artery stenting have significantly higher rates of procedural complications and worse six month outcomes than younger patients, especially those who present with combined unstable angina, history of MI, EF < 50%, multivessel disease and complex lesions. Overall survival in the elderly population at 12 months postcoronary artery stenting was 91% and event-free survival was 54%.     

Coronary atherosclerosis in Type II diabetes: angiographic findings and clinical outcome

Aims/hypothesis. Prevalence and incidence of coronary heart disease (CHD) are increased in patients with Type II (non-insulin-dependent) diabetes mellitus; whether this is entirely due to more extensive coronary atherosclerosis is, however, controversial. Methods. We analysed the clinical, angiographic and follow-up data of 2253 consecutive patients undergoing coronary angiography over the decade 1983–1992. Results. Abnormal coronary arteries (≥ 50 % stenosis) were found more frequently in diabetic than in non-diabetic subjects (85 vs 67 %, p < 0.0001), the excess being explained by a higher prevalence of three-vessel disease (36 vs 17 %, p < 0.0001). The sum of all angiographically detectable lumen stenoses (atherosclerosis score, ATS) was higher in diabetic than in non-diabetic subjects (352 ± 232 vs 211 ± 201 units, p < 0.0001). After adjusting for measured cardiovascular risk factors, diabetes was still associated with an excess ATS (114 units in men and 187 units in women, p < 0.0001 for both, p < 0.03 for the interaction ATS x sex). Within the diabetic group, the only variable that was independently (of sex and age) associated with ATS was serum cholesterol, whereas plasma glucose concentration, disease duration and type of treatment were not correlated with the severity of coronary atherosclerosis. In contrast, clinical grade proteinuria was not associated with a more diffuse coronary atherosclerosis either in diabetic (366 ± 243 vs 354 ± 233 units) or non-diabetic subjects (231 ± 201 vs 207 ± 197 units). Over a mean follow-up period of 88 months, 19 % of diabetic patients compared with 10 % of non-diabetic patients died of a cardiac cause (age and sex-adjusted odds ratio OR = 1.34 [1.14–1.57]). In a Cox model adjusting for age, sex and all major risk factors, diabetes was still associated with a significant excess risk of dying of a cardiac cause (OR = 1.37 [1.14–1.60]); this excess was similar to, and independent of, that carried by the presence of prior myocardial infarction in the whole population (OR = 1.42 [1.25–1.62]). Proteinuria was associated with a higher risk of cardiac death, particularly in diabetic patients, independently of coronary atherosclerosis (adjusted OR = 1.46 [1.03–1.99]). Conclusion/interpretation. In patients undergoing angiography, diabetes, especially in women, is associated with more severe and diffuse coronary atherosclerosis which is not explained by either the traditional risk factors or the presence of proteinuria. On follow-up, these patients experience an excess of cardiac deaths, to which coronary atherosclerosis and proteinuria make independent, quantitative contributions. [Diabetologia (2000) 43: 632–641] Received: 13 December 1999 and in revised form: 7 March 2000     

Initial results and long-term clinical and angiographic outcome of coronary stenting in women

To assess whether gender influences the results of coronary stenting, 158 consecutive women undergoing coronary stenting were compared with 823 consecutive men. Women had more adverse baseline characteristics, a higher hospital mortality, and were independently associated with procedural failure/complications (relative risk 2.4, 95% confidence interval 1.2 to 4.8); however, the long-term event-free survival and the restenosis rate were not influenced by gender.     

Coronary stenting without predilatation in a broad spectrum of clinical and angiographic situations

BACKGROUND: Direct coronary stenting without balloon predilatation has the potential benefits of a reduced risk of extended dissections, reduced fluoroscopy exposure, reduced procedural time, and potential cost savings. With the availability of superior stents and delivery systems, we review our experience with direct stent deployments in a large selected patient cohort. METHODS: We prospectively studied 158 consecutive cases of attempted coronary stenting without balloon predilatation over a 1-year period. RESULTS: Indications for the procedure included unstable angina (71%), stable angina (24%) and acute myocardial infarction (5%). Target vessels were the anterior descending artery (56%), right coronary artery (30%), circumflex artery (8%), and vein grafts (6%). Pre-procedural TIMI flows were grade 3 (91.7%), grade 2 (5.8%), grade 1 (1.3%) and 0 (1.3%). Lesion types were graded A (27%), B (61%), and C (12%). Stent types included NIR Primo (80.4%), ACS Multi-Link RX Duet (10.1%), NIR (5.1%), and others (4.4%). Stents ranged from 3.0Eth 4.0 mm in diameter (median = 3 mm) and 8Eth 32 mm in length (median = 16 mm). Stents were successfully deployed in 155 cases (98.1%); 2 (1.3%) required predilatation and 1 (0.6%) deployed stent could not be expanded and was opened by rotablation. All except the rotablator case achieved final TIMI grade 3 flow, and 66% did not require further balloon dilatation. There were no deaths or cases of urgent bypass surgery. Case duration and radiation exposure in direct stenting (32.8 +/- 18.9 minutes and 6.7 +/- 6.2 minutes, respectively) compared favorably to those in a matched group of patients in conventional stenting (47 +/- 18 minutes and 11 +/- 7 minutes) and coronary angioplasty (40 +/- 12 minutes and 10 +/- 6 minutes) for single-lesion cases (p < 0.005). Creatine kinase elevation related to the procedure was observed in 5 patients. Subacute stent thrombosis occurred in 2 (1.3%) cases. CONCLUSION: Direct coronary stenting was successfully and safely accomplished in a variety of clinical situations in selected patients.     

Coronary angioplasty: clinical and angiographic follow-up

To evaluate the clinical status and restenosis rate after percutaneous transluminal coronary angiography (PTCA), 251 consecutive patients who had undergone a successful procedure from February 1979 to May 1983 were studied. Angiography was done routinely in 92 of the initial 100 consecutive patients in whom the procedure was successful (group I), 1 to 11 months (mean 6) after PTCA. Restenosis occurred in 37 of 92 patients (40%); all but 2 (who had collateral flow to the restenosed vessel) had symptoms. Conversely, 44 of 46 asymptomatic patients had no restenosis. The other 159 patients (group II) were followed up clinically, with angiography performed only if signs or symptoms of ischemia recurred. Restenosis suspected clinically and confirmed angiographically occurred in 35 of 92 patients (38%) in group I and 36 of 154 patients (23%) in group II. Of 251 patients with follow-up of at least 6 months, 109 patients (43%) became symptomatic. Of 109 symptomatic patients, 104 consented to coronary angiography; restenosis was found in 67%, progression of narrowing in other arteries occurred in 13%, and the remaining patients were presumed to have large or small vessel vasospasm. The mortality rate for the entire group was 0.8%. When repeat angioplasty was applied to patients with restenosis, over 80% of the group improved at an average follow-up time of 21 months. Symptomatic restenosis may occur less often when higher balloon inflation pressures are used during PTCA.     

Coronary stenting for unstable angina: predictors of 30-day and long-term clinical outcome

BACKGROUND: Unstable angina is usually caused by acute thrombosis superimposed on a fissured plaque. Coronary artery stenting has been shown to improve short- and long-term results of coronary angioplasty in mainly stable patients with one-vessel disease, but it is uncertain whether its use in an unstable clinical setting can be safe and useful. This study sought to evaluate the results of coronary stenting in unstable angina and to determine patient, lesion and procedure-related predictors of 30-day and long-term ischemic events. METHODS: We studied 266 consecutive patients (mean age 62 +/- 9 years) with unstable angina who underwent coronary artery stenting. The procedure was performed electively in 24%, in bailout situations in 11% and for a suboptimal result of conventional angioplasty in 65%. After stent implantation, patients were treated with anticoagulation (61) on combined antiplatelet therapy (200). Multivariate logistic regression analyses were performed to determine 30-day and long-term predictive factors of ischemic complications. RESULTS: Procedural success was obtained in 261 patients (98.1%). During the first 30 days after stenting, one patient died from cardiogenic shock (0.3%) and six (22%) suffered a non-fatal Q-wave myocardial infarction. Patients with combined antiplatelet therapy had a significantly lower stent thrombosis rate (1.5% versus 11.4%, P = 0.002) than those treated with anticoagulant regimen. At long-term follow-up (17.7 +/- 9.4 months) cardiac mortality myocardial infarction and target-vessel revascularization rates were 0.4%, 1.5% and 9.3%, respectively. In multivessel and diabetic patients, a worse long-term event-free survival was observed. Logistic multivariate analysis revealed bailout stenting, anticoagulant therapy, implantation of stents longer than 15 mm as predictors of 30-day ischemic events. In addition, multivessel coronary artery disease and stent application with balloon size of less than 3 mm were predictive of long-term ischemic events. CONCLUSIONS: This study demonstrates that, either electively or after failure of conventional angioplasty, coronary stenting represents an effective therapy for patients with unstable angina. In the same clinical setting, combined antiplatelet therapy is associated with a lower 30-day stent thrombosis rate than anticoagulant therapy. Bailout stenting, anticoagulant therapy, implantation of stents longer than 15 mm were shown to be predictors of 30-day ischemic events, whereas multivessel coronary artery disease and stent application with small balloon size were predictive of long-term ischemic events.     

慢性冠状动脉闭塞置入支架术与球囊扩张术的比较

目的为了解冠状动脉内支架及经皮冠状动脉腔内成形术（ＰＴＣＡ）治疗完全闭塞性冠状动脉血管的临床及冠状动脉造影效果。方法９５例完全冠状动脉闭塞的病人随机分成为：置入支架组（Ａ组４８例）;单纯ＰＴＣＡ组（Ｂ组４７例）,观察二组病人发生临床事件及６个月后的冠状动脉造影效果。结果６个月后两组病人完成临床及冠状动脉造影随访的共８５例,随访率为８９％,Ａ组４２例,Ｂ组４３例。Ａ组：１例于术后１０天内出现心肌梗塞,无１例死亡,其再狭窄率为２８．５％,血管再闭塞率为１１９％,最终重复血管重建术为１９％。Ｂ组：１例死亡,２例发生急性心肌梗塞,再狭窄率为５８％,血管再闭塞率为２２％,最终重复血管重建术达４５％。两组之间临床疗效差异均有显著性（Ｐ＜０．００１）。结论冠状动脉慢性闭塞的病人ＰＴＣＡ成功后选择性置入支架比单纯ＰＴＣＡ的近期及远期临床疗效预后要好（发生临床事件及重复血管重建术明显下降）。     

Long-term outcome of patients with silent versus symptomatic ischemia six months after percutaneous coronary intervention and stenting

OBJECTIVES: We sought to evaluate the incidence of silent ischemia versus symptomatic ischemia six months after percutaneous coronary intervention (PCI) and its impact on prognosis and to test the utility of myocardial perfusion single-photon emission computed tomography (SPECT), or MPS, for risk stratification in these patients. BACKGROUND: Silent ischemia is frequent after PCI. However, little is known about silent ischemia and long-term outcome after PCI and stenting. METHODS: In 356 consecutive patients with successful PCI and stenting and follow-up MPS after six months, long-term follow-up (4.1 +/- 0.3 years) was performed. The MPS images were interpreted by defining summed stress, rest, and difference scores (summed difference score [SDS] = extent of ischemia) and related to symptoms and outcome. Critical events included cardiac death, myocardial infarction, and target vessel revascularization. RESULTS: Eighty-one patients (23%) had evidence of target vessel ischemia, which was silent in 62%. The only independent predictor of silent ischemia was SDS (odds ratio 0.64, p = 0.001). During follow-up, 67 critical events occurred. For patients with an SDS of 0, 1-4, and >4, the critical event rates were 17%, 29%, and 69%, respectively. Similarly, patients without ischemia, silent ischemia, and symptomatic ischemia had 17%, 32%, and 52% of critical events, respectively. Diabetes (relative risk 1.98, p = 0.03) and SDS (relative risk 1.2, p < 0.001) were independent predictors of critical events. The MPS image added incremental information for the prediction of critical events. CONCLUSIONS: Six months after PCI and stenting, 23% of patients had target vessel ischemia, which was silent in 62%. Silent ischemia predicted a worse outcome than did no ischemia and tended to have a better outcome than symptomatic ischemia. This was closely related to the extent of ischemia. The SDS added incremental value to pre-scan findings with respect to diagnosis and prognosis, indicating the utility of MPS for risk stratification after PCI and stenting.     

Impact of cilostazol on clinical and angiographic outcome after primary stenting for acute myocardial infarction

Cilostazol, an antiplatelet drug that also may inhibit smooth muscle proliferation, was given together with aspirin after primary stenting to treat patients with acute myocardial infarction. In a randomized controlled trials of 50 patients, clinical and angiographic outcome at 6 months was significantly improved with cilostazol, depicting a significantly smaller late loss and/or loss index.     

Coronary angiographic findings do not predict clinical outcome in patients with unstable angina

Objectives. The presence of thrombus formation and type of coronary artery lesion were determined in patients with unstable angina and correlated with the angiographic findings and clinical outcome.Background. Some previous studies have suggested that thrombus formation and lesions are predictive of the angiographic and clinical findings. This was evaluated in a retrospective analysis of 159 patients participating in the placebo-controlled Unstable Angina Study Using Eminase (UNASEM) trial on the effect of thrombolysis in unstable angina.Methods. Patients without a previous myocardial infarction who presented with a typical history of unstable angina in the presence or abnormal findings on the electrocardiogram indicative of ischemia were included in the study. After baseline angiography, study medication (anistreplasc or placebo) was given to 126 of 159 patients. Thirty-three patients did not receive medication because of significant main stem disease or normal coronary arteries or for other reasons. Angiography was repeated after 12 to 28 h.Results. Quantitative angiography showed a significant decrease in diameter stenosis in the anistreplase-treated group compared with the placebo-treated group (decrease 11% vs. 3%, p = 0.008). No differences in clinical outcome were found when thrombolytic treatment was compared with placebo (p = 0.98). Neither the presence nor absence of thrombus formation (p = 0.98) nor the type of lesion (p = 0.96) was related to the changes in diameter stenosis or to clinical outcome (p = 0.90 and p = 0.77, respectively). The power of these analyses to detect a 20% difference varied between 56% and 74%.Conclusions. In this selected group of patterns with unstable angina, type of coronary artery lesion and the presence or absence of thrombus formation does not predict clinical outcome.     

One-year clinical and angiographic follow-up after primary stenting

INTRODUCTION AND OBJECTIVES: The late reocclusion or restenosis rate of the infarct related artery is frequent after primary angioplasty. An implanted stent may be able to improve the coronary angioplasty results and long-term outcome of these patients. We present the clinical and angiographic outcome of a cohort of patients treated with primary stenting. PATIENTS AND METHODS: A group of 74 consecutive patients with acute myocardial infarction treated with primary angioplasty and stenting were followed for one year. An angiographic control was performed at the 6th month of follow-up in 91% of patients to assess the restenosis and reocclusion rates of the infarct-related artery. RESULTS: There were eight in-hospital deaths and three during follow-up (mortality rate 14.8%) and one non-fatal reinfarction (1.5%). The cumulative rate of recurrent ischemia was 6% at 3 months and 15% at 6 months, without any further increment at one-year follow-up. A new angioplasty was performed in 7 patients and three patients underwent surgical revascularization. Thus 80% of patients after discharge were free of events. The angiographic control showed only one reocclusion of the infarct related artery and a restenosis rate of 27%. CONCLUSIONS: These results show that primary stenting is an effective procedure in treating non-selected patients with acute myocardial infarction with a low long-term incidence of adverse events and a low restenosis rate.     

Immediate and six months clinical and angiographic results of intracoronary Ephesos stent implantation: the "Ephesos-1" study

BACKGROUND: This study was conducted to evaluate the clinical and angiographic results of the Ephesos stent implantation in patients with symptomatic coronary artery disease. The Ephesos stent is a new balloon-expandable, stainless steel, tubular stent with multicellular design. METHODS: One hundred ten patients with native coronary artery disease were included in the study. The Ephesos stents were implanted in 163 de novo lesions detected in these patients. Immediate and long-term clinical and angiographic follow-up results were evaluated. RESULTS: Most of the patients had unstable angina 63.6%, and 36.7% of the lesions were type B and C. Mean lesion length was 12.7 +/- 4.7. In 62% of the patients the reference lumen diameter was < 3 mm. One Q-wave and one non-Q-wave myocardial infarction (MI) occurred due to acute thrombotic occlusion during hospital stay. The 6-month event-free survival rate was 77.3%. No patients died in the six-month follow-up period, but 2 patients had non-Q wave MI and 1 patient experienced Q-wave MI within this period. Control angiographic data was collected from 110 patients (100% of patients and a total of 163 lesions). Angiographic restenosis rate was 18.1%. Twenty-two patients with restenosis had repeated target lesion balloon dilatation. CONCLUSION: The results of the present study showed that the Ephesos stent is a safe and effective choice with a low incidence of major adverse cardiac events and restenosis rate within six months of follow-up.     

Clinical and angiographic outcome after coronary arterial stenting with the carbostent

The Carbostent is a new balloon-expandable, stainless steel, tubular stent with innovative multicellular design and unique turbastratic carbon coating (Carbofilm). This open nonrandomized 2-center study assesses the immediate and long-term clinical and angiographic outcomes after Carbostent implantation in patients with native coronary artery disease. The Carbostent was implanted in 112 patients with 132 de novo lesions. Most patients (55%) had unstable angina, and 38% of lesions were type B2-C. The mean lesion length was 12.5 +/- 7.0 mm, and 29% of lesions were > 15 mm in length. No stent deployment failure occurred, as well as acute or sub-acute stent thrombosis. The 6-month event-free survival was 84 +/- 4%. One patient with a stented right coronary artery and no restenosis at the angiographic follow-up died after 6 months of fatal infarction due to abrupt closure of a nontarget vessel. In-hospital non-Q-wave myocardial infarction occurred in 1 patient, and 11 patients had repeat target lesion revascularization (target lesion revascularization rate 10%). The 6-month angiographic follow-up was obtained in 108 patients (96%) (127 lesions). Angiographic restenosis rate was 11%. The loss index was 0.29 +/- 0.28. The results of this study indicate a potential benefit of Carbostent for the prevention of stent thrombosis and restenosis in these relatively high-risk patients. A larger trial is being planned to confirm these promising results.     

Coronary ectasia: prevalence,and clinical and angiographic characteristics

INTRODUCTION AND OBJECTIVES: Coronary ectasia is characterized by the presence of diffuse dilation of the coronary vessels and is detected in 0.3-5.3% of angiographic studies. Our objective was to evaluate the prevalence of this condition, to analyze its clinical and angiographic characteristics, and to compare patients with ectasia and patients without it. PATIENTS AND METHOD: Coronary angiography was performed in 4.332 patients from October 1998 to June 2001. This population was divided in two groups, patients with and patients without ectasia and patients without ectasia. Angiographic and clinical variables were compared in these groups. RESULTS: The prevalence of ectasia was 3.39%. Most patients with ectasia (77.6%) had coronary stenosis. Ectasia affected a single vessel in 49.7%, most frequently the right coronary artery (132 patients), which also showed the greatest dilation. Most patients with ectasia were men (91.2%), smokers (56.5%), and younger than patients without ectasia (60.8 11.7 vs. 63.3 10.7 years; p = 0.01). They also had a lower prevalence of diabetes (22.4%) and previous revascularization procedures (8.2% angioplasty and 1.4% surgical revascularization).Logistical regression analysis showed that only male sex was associated to the presence of ectasia (OR = 3.33; 95% CI, 1.81-6.13) and that only diabetes was independently associated with absence of ectasia (OR = 0.65; 95% CI, 0.43-0.98). CONCLUSIONS: The prevalence of coronary ectasia in patients who underwent angiography was 3.4%. Coronary ectasia was prevalent in males and associated to the classic cardiovascular risk factors, except diabetes, a pathology that was less frequent than usual.