Clinical and economic impact of diabetes mellitus on percutaneous and surgical treatment of multivessel coronary disease patients: insights from the Arterial Revascularization Therapy Study (ARTS) trial.

BACKGROUND: Our aims were to compare coronary artery bypass grafting (CABG) and stenting for the treatment of diabetic patients with multivessel coronary disease enrolled in the Arterial Revascularization Therapy Study (ARTS) trial and to determine the costs of these 2 treatment strategies. METHODS AND RESULTS: Patients (n=1205) were randomly assigned to stent implantation (n=600; diabetic, 112) or CABG (n=605; diabetic, 96). Costs per patient were calculated as the product of each patient's use of resources and the corresponding unit costs. Baseline characteristics were similar between the groups. At 1 year, diabetic patients treated with stenting had the lowest event-free survival rate (63.4%) because of a higher incidence of repeat revascularization compared with both diabetic patients treated with CABG (84.4%, P<0.001) and nondiabetic patients treated with stents (76.2%, P=0.04). Conversely, diabetic and nondiabetic patients experienced similar 1-year event-free survival rates when treated with CABG (84.4% and 88.4%). The total 1-year costs for stenting and CABG in diabetic patients were $12 855 and $16 585 (P<0.001) and in the nondiabetic groups, $10 164 for stenting and $13 082 for surgery. CONCLUSIONS: Multivessel diabetic patients treated with stenting had a worse 1-year outcome than patients assigned to CABG or nondiabetics treated with stenting. The strategy of stenting was less costly than CABG, however, regardless of diabetic status.

[Coronary arteriography with a very low profile catheter: efficacy and safety of the procedure and of the 60 minute hospital discharge]. / Arteriografia coronária com cateter de muito baixo perfil. Eficácia e segurança do procedimento e da alta hospitalar aos 60 minutos.

PURPOSE: To evaluate the feasibility, efficacy and safety of the use of 4F Judkins catheters for coronary angiography. METHODS: From August/95 to January/96, 70 patients with suspected coronary artery disease underwent coronary cineangiography by the Judkins technique, with 4F catheters. Following puncture of the right femoral artery, 4F sheaths were introduced. At the end of the procedure, the sheath was removed and manual compression was applied for 15 min. Patients were oriented to walk under specialized supervision, 60 min after the procedure, and discharged after 4h. RESULTS: Thirty nine (56%) patients were male, the age ranged from 31 to 83 (mean 57) years and weight from 43 to 101 (mean 69) kg. Optimal quality images were obtained in 62 patients (88%). It was necessary to use larger caliber catheters (6 and 8F) in 8 patients, due to femoral tortuosity or inadequate opacification of coronary arteries. There were no vascular complications nor major bleedings. In only 2 cases (3%) there was a minor bleeding, treated by new local compression. Sixty (85%) patients walked after 60 +/- 5 min and were discharged after 4h. CONCLUSION: The use of 4F catheters for coronary angiography by femoral approach allowed early deambulation with no major bleeding. Image quality was good, with little contrast used and short hospital stay. This technique may lead to a simpler less traumatic and less invasive coronary angiography.

Safety and efficacy of coronary stent implantation. Acute and six month outcomes of 1,126 consecutive patients treated in 1996 and 1997.

PURPOSE: The authors analyzed the 30-day and 6-month outcomes of 1,126 consecutive patients who underwent coronary stent implantation in 1996 and 1997. METHODS: The 30-day results and 6-month angiographic follow-up were analyzed in patients treated with coronary stents in 1996 and 1997. All patients underwent coronary stenting with high-pressure implantation (> 12 atm) and antiplatelet drug regimen (aspirin plus ticlopidine). RESULTS: During the study period, 1,390 coronary stents were implanted in 1,200 vessels of 1,126 patients; 477 patients were treated in the year 1996 and 649 in 1997. The number of percutaneous procedures performed using stents increased significantly in 1997 compared to 1996 (64% vs 48%, p = 0.0001). The 30-day results were similar in both years: the success and stent thrombosis rates were equal (97% and 0.8%, respectively). The occurrence of new Q wave MI (1.3% vs 1.1%, 1996 vs 1997, p = NS), emergency coronary bypass surgery (1% vs 0.6%, 1996 vs 1997, p = NS) and 30-day death rates (0.2% vs 0.5%, 1996 vs 1997, p = NS) were similar. The 6-month restenosis rate was 25% in 1996 and 27% in 1997 (p = NS); the target vessel revascularization rate was 15% in 1996 and 16% in 1997 (p = NS). CONCLUSIONS: Intracoronary stenting showed a high success rate and a low incidence of 30-day occurrence of new major coronary events in both periods, despite the greater angiographic complexity of the patients treated with in 1997. These adverse variables did not have a negative influence at the 6-month clinical and angiographic follow-up, with similar rates of restenosis and ischemia-driven target lesion revascularization rates.

[Coronary angioplasty using double balloon in artery of large calibre (hugging balloons)]. / Angioplastia coronária com uso de duplo balão em artéria de grande calibre (hugging balloons).

In this case report the transluminal coronary angioplasty was performed in a oversized right coronary artery with a severe lesion with thrombus inside, using the Hugging balloon technique (two dilatation balloon catheters used simultaneously). This technique achieved minimal residual lesion and had a favorable clinical outcome of the patient.

[Influence of the clinical presentation on immediate and long-term results after rotational atherectomy]. / Influência do quadro clínico nos resultados imediatos e tardios após aterectomia rotacional.

PURPOSE: To analyse the influence of unstable coronary syndromes (UCS) in the early and late prognosis after rotational atherectomy (RA). METHODS: We treated 236 patients with RA between Aug/1992 and May/1996. Patients were divided into two groups: A) stable coronary syndromes 120 (51%) patients; B) UCS: 116 (49%) patients. DEFINITIONS: 1) procedure success (PS)--lesion success in all locations were RA use was attempted, without a major complication; 2) late coronary events (LCE)--angina, MI, additional revascularization or death. RESULTS: There was a significant predominance of age > 70 (A = 14% x B = 24%, p = 0.03) in B and previous MI (A = 32% x B = 11%, p = 0.0001) in A. Other characteristics were similar in both groups, including complex lesions (type B2/C), which were observed in 77% A stenosis and 80% B lesions. PS was 95% in A and 92% in B (p = NS). In-hospital major complications were observed in 2.5% A and 4.3% B patients, (p = NS). One patient died in each group. A and B patients had similar time of follow-up. LCE occurred in 25% A and 39% B patients (p = 0.002). Recurrence of angina (36% x 23%; p = 0.01) and target lesion revascularization (29% x 18%; p = 0.03) were also more frequently required in B cases. CONCLUSION: This study suggests that UCS (group A) does not implicate in worse acute results after RA. However, UCS patients present greater incidence of late coronary events, particularly recurrence of angina and target-lesion revascularization.

[Heparin in coronary angioplasty. Randomized study in cases with low risk of acute occlusion]. / Heparina na angioplastia coronária. Estudo randomizado em casos com baixo risco para lclusão aguda.

PURPOSE: To assess the efficacy of heparin in preventing the abrupt closure after coronary angioplasty in low risk patients for this phenomenon. METHODS: In the last 4 years, 525 patients successfully dilated were randomized to receive intravenous heparin (n = 264) or not (n = 261) after the angioplasty. The excluding criteria were contraindications for heparin and risk for abrupt closure (refractory unstable angina, primary coronary angioplasty in acute myocardial infarction, evidence of intracoronary thrombus, intimal tear after the procedure and cases of chronic total occlusions). Both heparin and non heparin groups were similar in respect to female sex (15% x 17%; p = NS), age over 70 years old (7% x 9%; p = NS), previous myocardial infarction (26% x 24%; p = NS), multi-vessel procedures (4% x 7%; p = NS, stable angina (40% x 46%; p = NS), unstable angina (52% x 48%; p = NS) and angioplasty after thrombolytic therapy (8% x 6%; p = NS). RESULTS: The overall incidence of abrupt closure was 2/525 (0.4%), with one case (0.4%) in each group. The in-hospital mortality was 1/525 (0.2%), which occurred in a non-heparin patient, due to a anterior myocardial infarction. Major complications occurred similarly in heparin and non-heparin groups (0.4%). Bleeding complications were observed more frequently in the heparin group (7% x 2%; p = 0.002). All of them were in the catheterization site and none required blood transfusion. Severe systemic bleeding were not observed. CONCLUSION: In patients regarded as low risk for abrupt closure, the incidence of this complication was really low (0.4%) and heparin probably do not prevent it.

[Outpatient heart catheterization. An analysis of experience accumulated over 10 months]. / Cateterismo cardíaco ambulatorial. Análise da experiência acumulada em 10 meses.

PURPOSE: To identify patients suitable for outpatient cardiac catheterization strategy, based on social aspects, risks and complications, for a 24 hour period. METHODS: In a series of 2.126 cases submitted to cardiac catheterization at the Instituto Dante Pazzanese de Cardiologia, between September 1990 and June 1991, were excluded: a) those over 75 years of age; b) the acute ischemic syndromes; c) those in NYHA functional class IV; d) patients who used 7 or 8 French femoral angiographic catheters; e) patients who had undergone general anesthesia, electrophysiological study or endomyocardial biopsy. After the procedure, the patients were observed for a 3 hour period and in the absence of any complication, they were discharged from the hospital, returning the next day for clinical evaluation. If any complication occurred it was registered. RESULTS: In a cohort of 719 eligible patients, 68% were male, with a mean age of 55.3 years. Sixty one per cent were in NYHA functional class I and most of them (80.8%) were studied by the brachial approach. Eighty-three per cent of the patients were submitted to coronary angiography, with 52% of them having coronary artery disease. Four hundred and fourteen patients were not discharged on the same day: 217 did not have their procedures finish after 6 p.m., 111 for social-economical reasons, 23 because of their physician's refuse, 8 because of left main coronary disease, 55 because of any kind of complication. All the 305 patients who were discharged on the same day, did not have shown any complication in the next day evaluation. CONCLUSION: Outpatient cardiac catheterization is a safe technique in selected patients, making possible the accomplishment of a greater number of procedures improving bed utilization and decreasing hospital costs.

[Inefficacy of diltiazem in restenosis prevention after coronary angioplasty]. / Ineficácia do diltiazem na prevenção da reestenose após angioplastia coronária.

PURPOSE: To evaluate the efficacy of diltiazem in preventing restenosis after balloon angioplasty (PTCA). METHODS: Eighty-nine patients who were undergone to successful PTCA, were divided them in 2 groups (G): A) 44 patients (50%) who received diltiazem (180 mg tid) immediately after PTCA and were kept on it for 6 months); B) 45 patients (50%) who received placebo. Fifty two lesions were dilated in GA and 54 in GB. Patients were excluded from analysis for several reasons, including: necessity of diltiazem or others calcium channel blockers use; heart failure, bradicardia, AV block of any degree, PTCA to chronic total occlusion, ostial lesions and AMI less than 30 days prior to PTCA. Patients were randomized to either the active drug or placebo in a double blind fashion. Restenosis was defined as a 50% lesion. Patients underwent late angiography either at 6 months or sooner if clinically indicated. RESULTS: Both G were similar to age > 70 years (A = 7% vs B = 4%-p = NS), sex (A = 13% vs B = 11%-p = NS), stable angina (A = 43% vs B = 51%), unstable angina (A = 57% vs B = 49%-p = NS) and single vessel (A = 91% vs B = 87%-p = NS) or multivessel (A = 9% vs B = 13%-p = NS) PTCA. We studied 39/44 (89%) patients in GA and 43/45 (96%) in GB (p = NS). We observed restenosis in 17/39 (43%) in GA and 16/43 (37%) in GB (p = NS). The restenosis rate per lesion was 39% in GA and 31% in GB (p = NS). CONCLUSION: Diltiazem was ineffective in the prevention of restenosis following PTCA.

Acute myocardial infarction in progressively elderly patients. A comparative analysis of immediate results in patients who underwent primary percutaneous coronary intervention.

OBJECTIVE: Analysis of the in-hospital results, in progressively elderly patients who undergo primary percutaneous coronary intervention (PCI) in the first 24 hours of AMI. METHODS: The patients were divided into three different age groups (60/69, 70/79, and > or =80 years) and were treated from 7/95 until 12/99. The primary success rate and the occurrence of major clinical events were analyzed at the end of the in-hospital phase. Coronary stent implantation and abciximab use were employed at the interventionist discretion. RESULTS: We analyzed 201 patients with age ranging from 60 to 93 years, who underwent primary PCI. Patients with ages above 70 were more often female (p=.015). Those with ages above 80 were treated later with PCI (p=.054), and all of them presented with total occlusion of the infarct-related artery. Coronary stents were implanted in 30% of the patients. Procedural success was lower in > or =80 year old patients (p=.022), and the death rate was higher in > or =70 years olds (p=.019). Reinfarction and coronary bypass surgery were uncommon events. A trend occurred toward a higher combined incidence of major in-hospital events according to increased age (p=.064). CONCLUSION: Elderly patients (> or =70 years) presented with adverse clinical and angiographic profiles and patients > or =80 years of age obtained reduced TIMI 3 flow success rates after primary PTCA, and those > or =70 years had a higher death rate.

[Efficacy of repeat coronary dilatation in patients with restenosis of the anterior descending artery]. / Eficácia da redilatação coronária em portadores de reestenose da artéria descendente anterior.

PURPOSE: To analyze the clinical characteristics, acute and long term results of repeat percutaneous transluminal coronary angioplasty (PTCA) for restenosis of the proximal left anterior descending coronary artery (LDA) METHODS: We studied 113 patients, 79% male, mean age 59 years, 49.5% had stable angina, with single vessel proximal LDA disease undergoing repeat PTCA for a first restenosis from January/88 to December/92. We examined the in hospital outcome (success rate and complications) and long term follow up (angina status, occurrence of myocardial infarction (MI), death and need for repeat PTCA or coronary artery bypass graft (CABG) of this subgroup. RESULTS: Primary success was 96%. Complications included: 1% MI, 1% emergency CABG and 1% procedural death. Follow up data (mean 42 months) was available in 102 (94%) out of 109 patients with successful repeat PTCA: 64 (63%) patients were asymptomatic, 5 (5%) had a MI and 28 (27%) required repeat PTCA or CABG. Actuarial 5 year freedom from death was 94%, freedom from death and MI was 91% and freedom from death, MI and repeat PTCA or CABG was 52%. CONCLUSION: Repeat PTCA is an effective treatment for proximal LAD restenosis with a high success rate, low incidence of procedural complications and provides excellent long term cardiac survival, however repeat revascularization is frequently required.

[Coronary angioplasty in patients with restenosis. Characterization of clinical and angiographic profiles, hospital clinical course, and implications for the selection of patients]. / Angioplastia coronária em pacientes com lesões reestenóticas. Caracterização do perfil clínico e angiográfico, evolução hospitalar e implicações para seleção de pacientes.

PURPOSE: To define the clinical and angiographic profile of patients undergoing to a 2nd or a 3rd coronary angioplaty (PTCA) for the treatment of restenosis, and assess the safety and efficacy of redilatation. METHODS: Patients submitted to PTCA for a 1st (1stRE) or a 2nd (2ndRE) restenosis, from Jan/1980 through Dec/1993, were retrospectively identified, and compared to those undergoing to PTCA for de novo lesions (DN). RESULTS: A total of 5,736 underwent to dilatation of primary lesions, 610 of a 1stRE, and 64 of a 2ndRE. Patients with restenotic lesions had a higher prevalence of diabetes, smoking, history of prior infarction (1stRE e 2ndRE) and hyperlipidemia (2ndRE) as compared with primary lesions (p < 0.05). Besides patients with a 2ndRE had a higher incidence of left ventricular dysfunction, as compared to those with DN or a 1stRE (31.3% with EF < 45% in group 2ndRE, vs 19.8% and 23.1% in groups 1stRE and DN, respectively, p < 0.05). Primary success, infarct rate and mortality were similar in all groups, but emergency bypass surgery was significantly higher in the DN (2.1% vs 0.8% in 1stRE and 0% in 2ndRE, p < 0.05). CONCLUSION: Restenosis can be effectively treated by redilatation. Patients with clinical and angiographic features predisposing to further recurrence can be better treated with other interventions (i.e., coronary stents, bypass surgery).

Percutaneous handling of coronary lesions >20mm through stents. Is there a first choice strategy?

OBJECTIVE - This study compared the early and late results of the use of one single stent with those of the use of multiple stents in patients with lesions longer than 20mm. METHODS - Prospective assessment of patients electively treated with stents, with optimal stent deployment and followed-up for more than 3 months. From February '94 to January '98, 215 patients with lesions >20mm were treated. These patients were divided into 2 groups as follows: Group A - 105 patients (49%) with one stent implanted; Group B - 110 patients (51%) with multiple stents implanted. RESULTS - The mean length of the lesions was 26mm in group A (21-48mm) versus 29mm in group B (21-52mm) (p=0.01). Major complications occurred in one patient (0.9%) in group A (subacute thrombosis, myocardial infarctionand death) and in 2 patients (1.8%) in group B (one emergency surgery and one myocardial infarction) (p=NS). The results of the late follow-up period (>6 months) were similar for both groups (group A = 82% vs group B = 76%; p=NS), and we observed an event-free survical in 89% of the patients in group A and in 91% of the patients in group B (p=NS). Angina (group A = 11% vs group B = 7%) and lesion revascularization (group A = 5% vs group B = 6%; p=NS) also occurred in a similar percentage. No infarction or death was observed in the late follow-up period; restenosis was identified in 33% and 29% of the patients in groups A and B, respectively (p=NS). CONCLUSION - The results obtained using one stent and using multiple stents were similar; the greater cost-effectiveness of one stent implantation, however, seems to make this strategy the first choice.

Arteriografia coronária com cateter de muito baixo perfil. Eficácia e segurança do procedimento e da alta hospitalar aos 60 minutos / Coronary arteriography with a very low profile catheter. Efficacy and safety of the procedure and of the 60 minute hospital

OBJETIVO - Avaliar a eficiência, a segurança e a praticidade de angiografia coronária com cateteres 4 French (F), pela técnica de Judkins. MÉtodos - De agosto/95 a janeiro/96, 70 pacientes com suspeita de insuficiência coronária submeteram-se à cinecoronariografia, utilizando introdutores e cateteres 4F. Após o exame, realizava-se compressäo local por 15 min e , 6§ min após, os pacientes eram orientados a caminhar, sob vigilância, sendo dada a alta hospitalar após 4h. RESULTADOS - A idade variou de 31 a 83 (m=57) anos, sendo 39 (56 por cento) homens, com peso entre 43 a 101 (m=69) kg. Obteve-se ótima qualidade de imagem em 62 casos (88 por cento), havendo a necessidade de substituiçäo por cateteres de maior calibre (6 a 8F) em 8 (12 por cento) pacientes. Näo ocorreram complicaçöes vasculares ou sangramentos maiores. Em apenas 2 (3 por cento) casos, houve discreto sangramento, resolvido com nova compressäo local. Sessenta pacientes (85 por cento) deambularam aos 60ñ5 min e tiveram alta hospitalar com 4h, em média