Oral rapamycin after coronary bare-metal stent implantation to prevent restenosis: the Prospective, Randomized Oral Rapamycin in Argentina (ORAR II) Study.

OBJECTIVES: The purpose of this study was to assess the role of oral rapamycin in decreased restenosis after bare metal stent implantation. BACKGROUND: Small observational studies suggest that the administration of oral rapamycin reduces angiographic restenosis after bare metal stent implantation. METHODS: Between September 2003 and September 2004, 100 patients were randomized to either oral rapamycin (6-mg loading dose given 2.7 h before intervention followed by 3 mg/day for 14 days) plus diltiazem 180 mg/day or no therapy after the implantation of a coronary bare metal stent design. The primary study end point was incidence of angiographic binary restenosis and late loss at nine months. The secondary end points were target lesion revascularization, target vessel revascularization, and incidence of major adverse cardiovascular events at 1 year. RESULTS: Angiographic follow-up was completed in 87% of patients. In the rapamycin group, the drug was well tolerated (26% minor side effects) and was maintained in 96% of patients. At 9 months, the in-segment binary restenosis was reduced by 72% (11.6% rapamycin vs. 42.8% no-therapy group, p = 0.001) and the in-stent binary restenosis was reduced by 65% (12% rapamycin vs. 34.6% no-therapy group, p = 0.009). The in-segment late loss was also significantly reduced with oral therapy (0.66 vs. 1.13 mm, respectively; 43% reduction, p < 0.001). At 1 year, patients in the oral rapamycin group also showed a significantly lower incidence of target vessel revascularization (8.3% vs. 38%, respectively, p < 0.001), target lesion revascularization (7.6% vs. 37.2%, respectively, p < 0.001), and major adverse cardiovascular events (20% vs. 44%, respectively, p = 0.018). CONCLUSIONS: This randomized, controlled, and unblinded study showed that the administration of oral rapamycin during 14 days after stent implantation significantly reduces angiographic and clinical parameters of restenosis.

Revascularization strategies of coronary multiple vessel disease in the Drug Eluting Stent Era: one year follow-up results of the ERACI III Trial.

OBJECTIVE: To compare the incidence of major adverse cardiac and cerebrovascular events (MACCE) in patients with multiple vessel coronary artery disease treated with drug eluted stents (DES), bare metal stents, percutaneous coronary interventions (PCI) or bypass surgery (CABG). METHODS: In the Argentine Randomized Study Coronary Angioplasty versus Coronary Bypass Surgery in Multiple Vessel Disease (ERACI) III trial, 225 patients with multivessel disease who received DES met clinical and angiographic inclusion criteria for the ERACI II trial. This cohort (ERACI III-DES) was compared to both ERACI II treatment arms (ERACII-PCI and ERACI II-CABG). The primary end point was freedom from MACCE at one year. RESULTS: Comparison of baseline demographic and angiographic data, revealed that ERACI III-DES patients were older, smoked more, had more diabetes, hyperlipidaemia, hypertension, type C lesions and received more stents. At one year freedom from MACCE was significantly greater in ERACI III-DES cohort (88%) than ERACI II CABG (80.5% p=0.038) and ERACI II PCI (78% p=0.006) patients. The ERACI III-DES cohort had similar freedom from death and acute myocardial infarction (AMI) to ERACI II PCI patients but greater than ERACI II-CABG arm. Freedom from repeat revascularization was similar between ERACI III-DES to ERACI II-CABG (95.1% p=ns) patients, but both were significantly better than those in the ERACI II-PCI arm ( 91.2% and 83%p=0.002 and 0.02 respectively). CONCLUSION: Patients with multiple vessel disease treated with DES in ERACI III had better one year outcomes than those treated with PCI or CABG in ERACI II.

Latin American randomized trial of balloon angioplasty versus coronary stenting in diabetic patients with small vessel reference size (Latin American Small Vessel [LASMAL II] Trial): immediate and long-term results.

Percutaneous coronary interventions (PCIs) in diabetic patients with small reference diameter vessels remain an important challenge in interventional cardiology because it is associated with increased complications and restenosis rates. Plain old balloon angioplasty (POBA) has limited efficacy in patients with lesions in small vessels. Although coronary stenting (stent) has been demonstrated to improve both immediate and long-term results after coronary intervention, small reference diameter is a strong predictor of restenosis after stent implantation. Thus, the question of how to best treat diabetic patients with lesions in small reference diameter remains unanswered. The purpose of this international and multicenter study was to compare the incidence of angiographic restenosis between percutaneous transluminal coronary angioplasty (PTCA) and stent in diabetic patients undergoing PCI of small reference diameter vessels using a specially designed phosphoryl choline (PC)-coated stent for small vessels. The patient population comprised of 220 diabetic patients with lesions in small reference diameter (< 2.9 mm but > 2.0 mm) that were randomized into two different PCI strategies: PTCA with provisional stenting (n = 109) versus stent (n = 111). In the PTCA arm, 26 patients (24%) crossed over to stent during the initial procedure; glycoproteins IIb to IIIa was used in 40.5% of patients in both groups. During initial procedure and at 30 days, both strategies of revascularitation had similar clinical success and acute complications. During long-term follow-up, even though requirements of target vessel revascularization and incidence of major adverse cardiovascular event were similar with both techniques, angiographic binary restenosis (45% with PTCA and 28% with stents, P = .047), net gain (0.74 mm with POBA and 0.94 mm with stents, P = .008), and freedom from target vessel failure (66% with POBA and 81.2% with stents, P = .013) were significantly improved when diabetic patients were initially treated with stent therapy. In summary, in diabetic patients with small coronary arteries, the use of a coronary PC coated stent as a primary device during percutaneous interventions was associated with better angiographic and long-term outcome.

The impact of age in the immediate and long-term outcomes of percutaneous mitral balloon valvuloplasty.

BACKGROUND: Differences in age, clinical characteristics, and valve morphology may account for controversial results of percutaneous mitral balloon valvuloplasty (PMV). METHODS: We have previously reported the immediate and long-term clinical follow-up (50 +/- 45 months) of 879 patients who underwent PMV at the Massachusetts General Hospital. In the present study, we used this database to determine the impact of age in the immediate and long-term outcome of PMV. For purpose of analysis, these patients were divided into four age groups: group 1 (< or =35 years), group 2 (36-55 years), group 3 (56-75 years), and group 4 (>75 years). RESULTS: The incidence of atrial fibrillation, calcified valves under fluoroscopy, higher echocardiographic score, New York Heart Association (NYHA) class IV and pre-PMV mitral regurgitation (MR) increased with patient's age. As patients became older, a lower post-PMV mitral valve area (2.1 +/- 0.7, 2.0 +/- 0.6, 1.8 +/- 0.6, and 1.6 +/- 0.6; P < 0.0001) and progressive decrease in procedural success (81.4%, 80.5%, 65.3%, and 53%; P < 0.0001) were observed. Younger age was identified as an independent predictor of PMV success by multiple stepwise logistic regression (odds ratio [OR]: 3.33; confidence interval [CI]: 1.41-7.69, P = 0.006). Furthermore, age was identified as an independent predictor of long-term events by Cox regression analysis (risk ratio [RR]: 1.02; CI: 1.01-1.03, P < 0.00001). However, the effect of age seemed to be blunted by the morphology of the valve at follow-up, as patients with echocardiogram score >8 in groups 2, 3, and 4 presented similar combined event-free survival (death, mitral valve replacement, or redo PMV). CONCLUSION: Age is an important predictor of immediate and long-term outcomes after PMV, particularly in patients with optimal mitral valve morphology. (

Five-year follow-up of the Argentine randomized trial of coronary angioplasty with stenting versus coronary bypass surgery in patients with multiple vessel disease (ERACI II).

OBJECTIVES: The purpose of the present study is to report the five-year follow-up results of the ERACI II trial. BACKGROUND: Immediate and one-year follow-up results of the ERACI II study showed a prognosis advantage of percutaneous coronary intervention (PCI) with stents over coronary artery bypass grafting (CABG). METHODS: A total of 450 patients were randomly assigned to undergo either PCI (n = 225); or CABG (n = 225). Only patients with multi-vessel disease were enrolled. Clinical follow-up during five years was obtained in 92% of the total population after hospital discharge. The primary end point of the study was to compare freedom from major adverse cardiovascular events (MACE) at 30 days, 1 year, 3 years, and 5 years of follow-up. RESULTS: At five years of follow-up, patients initially treated with PCI had similar survival and freedom from non-fatal acute myocardial infarction than those initially treated with CABG (92.8% vs. 88.4% and 97.3% vs. 94% respectively, p = 0.16). Freedom from repeat revascularization procedures (PCI/CABG) was significantly lower with PCI compared with CABG (71.5% vs. 92.4%, p = 0.0002). Freedom from MACE was also significantly lower with PCI compared with CABG (65.3% vs. 76.4%; p = 0.013). At five years similar numbers of patients randomized to each revascularization procedure were asymptomatic or with class I angina. CONCLUSIONS: At five years of follow-up, in the ERACI II study, there were no survival benefits from any revascularization procedure; however patients initially treated with CABG had better freedom from repeat revascularization procedures and from MACE.

Latin American randomized trial of balloon angioplasty vs coronary stenting for small vessels (LASMAL): immediate and long-term results.

PURPOSE: To assess the potential role of coronary stent to improved acute success and reduce late restenosis in lesions with reference diameter <2.9 mm using a bare metal stent specifically designed for small coronary vessels. There is controversy on the results among previous studies comparing bare metal stent implantation with conventional balloon percutaneous transluminal coronary angioplasty (PTCA). Differences in baseline characteristics, inclusion and exclusion criteria, and stent design may account for these discrepancies. METHODS: The population of this multicenter, multinational randomized study (LASMAL) consisted of 246 patients undergoing percutaneous coronary intervention of small vessel reference diameter. They were randomized into 2 strategies of percutaneous revascularization: elective primary stent (n = 124) or conventional balloon PTCA with provisional stenting (n = 122) in the presence of acute, threatened closure or flow-limiting dissections. RESULTS: The clinical success rate was significantly better for the stent group (98.3% vs 91.8%; P = 0.038). At 30 days follow-up, requirements of target vessel revascularization (TVR) (6.6% vs 0.8%; P = 0.018) and incidence of major adverse cardiac and cerebrovascular events (MACCE) (9.8% vs 2.4%; P = 0.01) was significantly lower in the stent strategy. Postpercutaneous coronary intervention minimal luminal diameter (MLD) was significantly larger in the stent group (2.3 +/- 0.2 mm vs 2.2 +/- 0.2 mm; P = 0.003). At follow-up, MLD in the stent group was larger than with PTCA (1.7 +/- 0.7 mm vs 1.5 +/- 0.7 mm, respectively; P = 0.035). Net gain was also significantly better with stent strategy (1.1 +/- 0.7 mm vs 0.8 +/- 0.7 mm, respectively; P = 0.002). Stenting resulted in a significant lower angiographic binary restenosis (20% vs 31%; P = 0.02) than PTCA. Furthermore, patients treated with stent were more frequently free from MACCE at 9-month follow-up (death, acute myocardial infarction [AMI], stroke, repeat revascularization procedures) than those treated initially with PTCA (82.2% vs 72% of PTCA, P = 0.046). CONCLUSIONS: The use of a specifically designed bare metal coronary phosphoril choline-coated stent as primary device during percutaneous interventions in small coronary arteries was associated with high procedural success and low in-hospital and 30-day follow-up complications. At long-term follow-up, patients initially treated with stents had lower angiographic restenosis rate and were more frequently free from major adverse cardiac events.

Transthoracic left ventricular puncture for the assessment of patients with aortic and mitral valve prostheses: the Massachusetts General Hospital experience, 1989-2000.

Accurate assessment of suspected prosthetic valve dysfunction is critically important as reoperation carries high risk. Noninvasive methods of hemodynamic assessment of patients with both aortic and mitral mechanical valves continue to be frustrated by the interference created by prosthetic material and direct left ventricular puncture may be required for definitive hemodynamic assessment. We report the hemodynamic and angiographic results and outcomes of 38 consecutive patients with double valve replacement who underwent left ventricular puncture as part of evaluation of possible prosthetic dysfunction. These results were compared with those obtained by noninvasive testing. We found noninvasive assessment alone to be unsatisfactory as measurements of regurgitation and stenosis correlated poorly with those obtained by direct left ventricular puncture. Important information that altered patient management was obtained from invasive assessment in 68% of cases with an acceptable rate of complications. Therefore, hemodynamic and angiographic assessment using transthoracic left ventricular puncture should be entertained in patients with mitral and aortic valve replacement presenting with congestive heart failure and suspected prosthesis dysfunction.

Directional coronary atherectomy vs. rotational atherectomy for the treatment of in-stent restenosis of native coronary arteries.

Management of in-stent restenosis has become a significant challenge in interventional cardiology. Since the mechanism of in-stent restenosis is predominantly intimal hyperplasia, debulking techniques have been used to treat this condition. This study is a nonrandomized comparison of the immediate and long-term results of directional coronary atherectomy (DCA; n = 58) vs. high-speed rotational atherectomy (ROTA; n = 61) for the treatment of in-stent restenosis of native coronary arteries. There were no in-hospital deaths, Q-wave myocardial infarctions, or emergency coronary artery bypass surgery in either group. DCA resulted in a larger postprocedural minimal luminal diameter of (2.57 +/- 0.51 vs. 2.14 +/- 0.37 mm; P < 0.0001) and a larger acute gain (1.83 +/- 0.52 vs. 1.42 +/- 0.48 mm; P < 0.0001). Furthermore, 12-month clinically indicated target lesion revascularization (39% vs. 21%; P = 0.02) and long-term follow-up MACE (44% vs. 28%; P = 0.03) was greater in the ROTA group. The present study suggests that DCA appears to be superior to ROTA for the treatment of in-stent restenosis of native coronary arteries. Compared to ROTA, the debulking effect of DCA leads to a larger postprocedure minimal luminal diameter, and a lower incidence of subsequent target lesion revascularization and MACE.

Angioplastia coronaria en lesiones no protegidas de tronco de arteria coronaria izquierda: resultados intrahospitalarios y al seguimiento en la era del stent / Unprotected left main angioplasty in Stent Era: in hospital and long term outcome

A cuarenta y dos pacientes con lesión no protegida de tronco de coronaria izquierda se les realizó angioplastia coronaria con implante de 45 stents. El 95 por ciento de los pacientes tenía, al momento del tratamiento, angina inestable y/o infarto de miocardio. Los resultados intrahospitalarios mostraron éxito técnico-clínico en el 100 por ciento de los casos. En la evolución alejada (13,6 meses) la sobrevida fue del 88 por ciento y la necesidad de nuevos procedimientos de revascularización del 19 por ciento. La mortalidad alejada no estuvo asociada a reestenosis silente del stent y/o oclusión subaguda del mismo

Angioplastia coronaria en lesiones no protegidas de tronco de arteria coronaria izquierda: resultados intrahospitalarios y al seguimiento en la era del stent / Unprotected left main angioplasty in Stent Era: in hospital and long term outcome

A cuarenta y dos pacientes con lesión no protegida de tronco de coronaria izquierda se les realizó angioplastia coronaria con implante de 45 stents. El 95 por ciento de los pacientes tenía, al momento del tratamiento, angina inestable y/o infarto de miocardio. Los resultados intrahospitalarios mostraron éxito técnico-clínico en el 100 por ciento de los casos. En la evolución alejada (13,6 meses) la sobrevida fue del 88 por ciento y la necesidad de nuevos procedimientos de revascularización del 19 por ciento. La mortalidad alejada no estuvo asociada a reestenosis silente del stent y/o oclusión subaguda del mismo (AU)

Angioplastia de emergencia en pacientes con infarto agudo de miocardio de alto riesgo: resultados y predictores de mortalidad hospitalaria y alejada / Primary angioplasty in high risk patients with acute myocardial infarction: long term follow-up and predictors of in-hospital mortality

A pesar de los promisorios resultados de la angioplastia en el infarto agudo de miocardio, aún son pocos los pacientes tratados con esta técnica en relación con los evaluados con trombolíticos. Más limitada aún es la información respecto de los subgrupos de pacientes, como por ejemplo los de alto riesgo. En ese sentido, el propósito del presente trabajo es analizar la experiencia en pacientes con infarto agudo de miocardio de alto riesgo sometidos a una angioplastia de emergencia dentro de las primeras 24 horas en nuestra institución y las variables predictoras de mortalidad hospitalaria alejada

Angioplastia de emergencia en pacientes con infarto agudo de miocardio de alto riesgo: resultados y predictores de mortalidad hospitalaria y alejada / Primary angioplasty in high risk patients with acute myocardial infarction: long term follow-up and predictors of in-hospital mortality

A pesar de los promisorios resultados de la angioplastia en el infarto agudo de miocardio, aún son pocos los pacientes tratados con esta técnica en relación con los evaluados con trombolíticos. Más limitada aún es la información respecto de los subgrupos de pacientes, como por ejemplo los de alto riesgo. En ese sentido, el propósito del presente trabajo es analizar la experiencia en pacientes con infarto agudo de miocardio de alto riesgo sometidos a una angioplastia de emergencia dentro de las primeras 24 horas en nuestra institución y las variables predictoras de mortalidad hospitalaria alejada (AU)

Estudio randomizado argentino, angioplastia coronaria con stent versus cirugía convencional en pacientes con obstrucciones coronarias de múltiples vasos (ERACI II): sobrevida y sobrevida libre de eventos a tres años de seguimiento / Argentine randomized study, coronary angioplasty with stent versus conventional surgery in patients with coronary obstructions of multiple vessels (ERACI II): survival and free events survival to three years of follow-up

Objetivo: el propósito de este trabajo fue comparar angioplastía coronaria (ATC) con Stent y cirugía de revascularización coronaria (CRM), en pacientes sintomáticos para angina y enfermedad coronaria de multiples vasos. Antecedentes: estudios randomizados previos que compararon ATC con balón versus CRM han demostrado resultados similares. Sin embargo CRM presento, en forma significativa, menor procedimientos de revascularización (ATC/CRM) en el seguimiento a largo plazo. Métodos: de 2759 pacientes con enfermedad coronaria fueron seleccionados, en siete centros, 450 pacientes fueron randomizados para este trabajo, 225 pacientes para ATC y 225 pacientes para CRM. Se incluyeron pacientes con enfermedad coronaria de múltiples vasos con indicación de revascularización. Resultados: ambos grupos tuvieron similares resultados clínicos y demográficos: angina inestable en el 92 por ciento, mayores de 65 años en el 38 por ciento y el 23 por ciento presentó enfermedad vascular periférica. A los 30 días del seguimiento el grupo ATC presento un bajo índice de complicaciones mayores (muerte infarto agudo miocardio, nuevos procedimientos de revascularización, y stroke) en comparación al grupo CRM (3.6 por ciento vs. 12.3 por ciento, p:0.002). La mortalidad en el grupo ATC fue de 0.9 por ciento vs. el 5.7 por ciento en el grupo CRM, <0.013, infarto agudo miocardio tipo Q (IAM) fue del 0.6 por ciento en el grupo ATC vs. 5.7 por ciento en el grupo CRM, p<0.013. En el seguimiento alejado (media 41ñ6.4 meses) la sobrevida fue 94.3 por ciento en el grupo ATC vs. 92.5 por ciento en el grupo CRM, p<0.031 (log rang test). La ausencia de IAM fue también mejor en el grupo ATC en comparación al del CRM (97.7 por ciento vs. 93.4 por ciento, p<0.017). Nuevos procedimientos de revascularización fueron más frecuentes en el grupo ATC que en el grupo CRM (22.7 por ciento vs. 5.3 por ciento, p<0.001). Conclusiones: este estudio multicéntrico y randomizado demostró que los pacientes con enfermedad coronaria de múltiples vasos tiene menor riesgo de muerte e infarto a 30 días cuando son tratados con stent en comparación a la cirugía coronaria convencional. Estas ventajas iniciales se mantuvieron a 3 años de seguimiento. Los requerimientos de nuevos procedimientos de revascularización fueron más elevados en el grupo stent.

Estudio randomizado argentino, angioplastia coronaria con stent versus cirugía convencional en pacientes con obstrucciones coronarias de múltiples vasos (ERACI II): sobrevida y sobrevida libre de eventos a tres años de seguimiento / Argentine randomized study, coronary angioplasty with stent versus conventional surgery in patients with coronary obstructions of multiple vessels (ERACI II): survival and free events survival to three years of follow-up

Objetivo: el propósito de este trabajo fue comparar angioplastía coronaria (ATC) con Stent y cirugía de revascularización coronaria (CRM), en pacientes sintomáticos para angina y enfermedad coronaria de multiples vasos. Antecedentes: estudios randomizados previos que compararon ATC con balón versus CRM han demostrado resultados similares. Sin embargo CRM presento, en forma significativa, menor procedimientos de revascularización (ATC/CRM) en el seguimiento a largo plazo. Métodos: de 2759 pacientes con enfermedad coronaria fueron seleccionados, en siete centros, 450 pacientes fueron randomizados para este trabajo, 225 pacientes para ATC y 225 pacientes para CRM. Se incluyeron pacientes con enfermedad coronaria de múltiples vasos con indicación de revascularización. Resultados: ambos grupos tuvieron similares resultados clínicos y demográficos: angina inestable en el 92 por ciento, mayores de 65 años en el 38 por ciento y el 23 por ciento presentó enfermedad vascular periférica. A los 30 días del seguimiento el grupo ATC presento un bajo índice de complicaciones mayores (muerte infarto agudo miocardio, nuevos procedimientos de revascularización, y stroke) en comparación al grupo CRM (3.6 por ciento vs. 12.3 por ciento, p:0.002). La mortalidad en el grupo ATC fue de 0.9 por ciento vs. el 5.7 por ciento en el grupo CRM, <0.013, infarto agudo miocardio tipo Q (IAM) fue del 0.6 por ciento en el grupo ATC vs. 5.7 por ciento en el grupo CRM, p<0.013. En el seguimiento alejado (media 41ñ6.4 meses) la sobrevida fue 94.3 por ciento en el grupo ATC vs. 92.5 por ciento en el grupo CRM, p<0.031 (log rang test). La ausencia de IAM fue también mejor en el grupo ATC en comparación al del CRM (97.7 por ciento vs. 93.4 por ciento, p<0.017). Nuevos procedimientos de revascularización fueron más frecuentes en el grupo ATC que en el grupo CRM (22.7 por ciento vs. 5.3 por ciento, p<0.001). Conclusiones: este estudio multicéntrico y randomizado demostró que los pacientes con enfermedad coronaria de múltiples vasos tiene menor riesgo de muerte e infarto a 30 días cuando son tratados con stent en comparación a la cirugía coronaria convencional. Estas ventajas iniciales se mantuvieron a 3 años de seguimiento. Los requerimientos de nuevos procedimientos de revascularización fueron más elevados en el grupo stent. (AU)