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1.
Gesundheitswesen ; 77(2): e15-9, 2015 Feb.
Artículo en Alemán | MEDLINE | ID: mdl-25714193

RESUMEN

AIM OF THE STUDY: How can 2 pseudonymised data sets be linked? Using the example of data from the Berlin Myocardial Infarction Registry and from a German sickness fund (AOK Nordost) we will demonstrate how record linkage can be achieved without personal identifiers. METHODS: In different steps the method of deterministic record linkage with indirect identifiers: age, sex, hospital admission date and time, will be explained. RESULTS: We were able to show that 80.6% of the expected maximum number of patients were matched with our approach. As a result we had no duplicate matches in the linkage process, where one AOK patient was linked to 2 or more BMIR patients or vice versa. The matching variables produced enough uniqueness to be used as indirect patient identifiers. CONCLUSION: Deterministic record linkage with the following indirect indicators: age, sex, hospital admission date and time was possible in our study of patients with myocardial infarction in a circumscribed geographical region, which limited the number of cases and avoided mismatches.


Asunto(s)
Anonimización de la Información , Sistemas de Información en Hospital/estadística & datos numéricos , Registro Médico Coordinado/métodos , Infarto del Miocardio/epidemiología , Programas Nacionales de Salud/estadística & datos numéricos , Sistema de Registros/estadística & datos numéricos , Adulto , Exactitud de los Datos , Femenino , Alemania/epidemiología , Hospitalización/estadística & datos numéricos , Humanos , Almacenamiento y Recuperación de la Información/métodos , Almacenamiento y Recuperación de la Información/estadística & datos numéricos , Masculino , Uso Significativo/estadística & datos numéricos , Persona de Mediana Edad , Infarto del Miocardio/diagnóstico , Infarto del Miocardio/terapia
2.
Z Kardiol ; 94(4): 231-8, 2005 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-15803259

RESUMEN

The relationship between volume and outcome in medicine has been intensively investigated in the last few decades. The large amount of accumulated data demonstrates that for many surgical or non-surgical procedures and medical conditions, patients being treated in high-volume hospitals or by high-volume physicians have lower mortality rates and better quality of life compared to those treated by low-volume hospitals or by low-volume physicians. Although the degree of the relationship between high volume and better outcome varies, it is persistent across a wide range of procedures and conditions. Percutaneous coronary interventions (PCIs) have an important impact on public health, given the frequency of coronary heart disease for which these procedures are performed. Studies carried out before and after the advent of stents on the relationship between volume and outcome for PCIs have almost consistently reported that performance of PCIs in high-volume institutions or by high-volume operators is associated with improved outcomes for patients, regardless of the specific indication for PCI. For those procedures for which a relationship between high volume and better outcome has been clearly demonstrated, patients as well as their referring physicians should be informed that patients can benefit both in terms of reduced mortality and improved quality of life if they are treated by high-volume health care providers. Consequently, for these procedures, a health care policy aiming at their concentration in high-volume institutions should be strongly considered.


Asunto(s)
Angioplastia Coronaria con Balón/mortalidad , Angioplastia Coronaria con Balón/estadística & datos numéricos , Enfermedad de la Arteria Coronaria/mortalidad , Enfermedad de la Arteria Coronaria/cirugía , Hospitales/estadística & datos numéricos , Evaluación de Resultado en la Atención de Salud/métodos , Médicos/estadística & datos numéricos , Mortalidad Hospitalaria , Humanos , Evaluación de Resultado en la Atención de Salud/estadística & datos numéricos , Estadística como Asunto , Resultado del Tratamiento
3.
J Intern Med ; 256(5): 388-97, 2004 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-15485474

RESUMEN

OBJECTIVE: The objective of this randomized trial was to assess the antirestenotic effects of phosphorylcholine (PC)-coated stents as well as of abciximab in small coronary arteries when compared with percutaneous transluminal coronary angioplasty (PTCA) and placebo respectively. BACKGROUND: Stent coating with PC has been shown to reduce protein absorption and platelet activation which may reduce the risk of restenosis. Furthermore, on the basis of nondedicated studies abciximab is believed to reduce the risk of restenosis after coronary interventions. METHODS: A total of 502 patients with lesions situated in small coronary arteries (vessel diameter /=50% diameter stenosis) at follow-up; death or myocardial infarction, and target vessel revascularization (TVR), were assessed as secondary end-points. RESULTS: Angiographic restenosis did not differ between patients treated with PC-coated stents or with PTCA (39.0% vs. 34.2%; P = 0.30) and between patients receiving abciximab or placebo (39.3% vs. 34.3%; P = 0.29). Similarly, the need for TVR at 1-year follow-up did not differ between patients receiving PC-coated stents or PTCA (20.2% vs. 20.5%; P = 0.98) as well as between patients treated with abciximab or placebo (18.7% vs. 21.9%; P = 0.44). CONCLUSIONS: PC-coated stents and abciximab failed to reduce the incidence of angiographic restenosis after percutaneous coronary intervention of small coronary arteries. These data strengthen the belief that future studies on prevention of restenosis in small coronary arteries should focus on drug-eluting stents.


Asunto(s)
Angioplastia Coronaria con Balón/métodos , Anticuerpos Monoclonales/administración & dosificación , Anticoagulantes/administración & dosificación , Reestenosis Coronaria/prevención & control , Fragmentos Fab de Inmunoglobulinas/administración & dosificación , Fosforilcolina/administración & dosificación , Inhibidores de Agregación Plaquetaria/administración & dosificación , Stents , Abciximab , Anciano , Femenino , Estudios de Seguimiento , Humanos , Masculino , Resultado del Tratamiento
4.
Catheter Cardiovasc Interv ; 54(4): 414-9, 2001 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-11747172

RESUMEN

The objective of this multicenter randomized study was to compare the angiographic and clinical results achieved 1 year after coronary placement of two stent models: the hand-mounted JoStent and the premounted Multi-Link Duet stent. We included 505 patients who were randomly assigned to receive either the hand-mounted JoStent (n = 252) or the premounted Multi-Link Duet stent (n = 253). The primary endpoint of the study, late lumen loss, measured 1.12 mm in the JoStent group and 1.17 mm in the Multi-Link Duet group. These values were statistically equivalent (P = 0.02 from the equivalence test). No significant difference was observed in the incidence of restenosis, 24.2% in the JoStent and 25.2% in the Multi-Link Duet stent group, and target vessel revascularization, 13.9% in the JoStent and 15.4% in the Multi-Link Duet patients. In conclusion, the hand-mounted JoStent and the premounted Multi-Link Duet stent enable excellent procedural success rates and equally favorable 1-year angiographic and clinical outcomes.


Asunto(s)
Enfermedad de la Arteria Coronaria/cirugía , Stents , Anciano , Implantación de Prótesis Vascular/instrumentación , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/complicaciones , Enfermedad de la Arteria Coronaria/mortalidad , Determinación de Punto Final , Femenino , Estudios de Seguimiento , Oclusión de Injerto Vascular/epidemiología , Oclusión de Injerto Vascular/etiología , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Diseño de Prótesis , Análisis de Supervivencia , Factores de Tiempo , Resultado del Tratamiento
6.
Circulation ; 103(23): 2816-21, 2001 Jun 12.
Artículo en Inglés | MEDLINE | ID: mdl-11401938

RESUMEN

BACKGROUND: Increased thrombogenicity and smooth muscle cell proliferative response induced by the metal struts compromise the advantages of coronary stenting. The objective of this randomized, multicenter study was to assess whether a reduced strut thickness of coronary stents is associated with improved follow-up angiographic and clinical results. METHODS AND RESULTS: A total of 651 patients with coronary lesions situated in native vessels >2.8 mm in diameter were randomly assigned to receive 1 of 2 commercially available stents of comparable design but different thickness: 326 patients to the thin-strut stent (strut thickness of 50 microm) and 325 patients to the thick-strut stent (strut thickness of 140 microm). The primary end point was the angiographic restenosis (>/=50% diameter stenosis at follow-up angiography). Secondary end points were the incidence of reinterventions due to restenosis-induced ischemia and the combined rate of death and myocardial infarctions at 1 year. The incidence of angiographic restenosis was 15.0% in the thin-strut group and 25.8% in the thick-strut group (relative risk, 0.58; 95% CI, 0.39 to 0.87; P=0.003). Clinical restenosis was also significantly reduced, with a reintervention rate of 8.6% among thin-strut patients and 13.8% among thick-strut patients (relative risk, 0.62; 95% CI, 0.39 to 0.99; P=0.03). No difference was observed in the combined 1-year rate of death and myocardial infarction. CONCLUSIONS: The use of a thinner-strut device is associated with a significant reduction of angiographic and clinical restenosis after coronary artery stenting. These findings may have relevant implications for the currently most widely used percutaneous coronary intervention.


Asunto(s)
Implantación de Prótesis Vascular/efectos adversos , Enfermedad Coronaria/diagnóstico por imagen , Enfermedad Coronaria/cirugía , Oclusión de Injerto Vascular/etiología , Stents/efectos adversos , Anciano , Angiografía Coronaria , Vasos Coronarios/patología , Vasos Coronarios/cirugía , Femenino , Estudios de Seguimiento , Oclusión de Injerto Vascular/diagnóstico , Oclusión de Injerto Vascular/prevención & control , Hemodinámica , Humanos , Incidencia , Modelos Logísticos , Masculino , Riesgo , Medición de Riesgo , Stents/normas , Tasa de Supervivencia , Resultado del Tratamiento
8.
J Am Coll Cardiol ; 37(8): 2066-73, 2001 Jun 15.
Artículo en Inglés | MEDLINE | ID: mdl-11419889

RESUMEN

OBJECTIVES: We attempted to make a comprehensive assessment of the risk of stent failure (death, myocardial infarction or angiographically documented occlusion), differentiating early (first and second weeks) and late (third and fourth weeks) events. BACKGROUND: The risk of stent failure decreases rapidly within the first week. It has been suggested that the risk rate for late events is close to 0% and that the thienopyridine regimen (ticlopidine or clopidogrel) could be safely reduced from four to two weeks, minimizing the risk of hematological complications. METHODS: We analyzed 5,678 patients with successful coronary stent placement and a four-week ticlopidine regimen. RESULTS: The rate of stent failure was 2.5% at four weeks, with 112 early (2.0%) and 30 late events (0.5%). Multivariate analysis identified different risk factors for early versus late events. While variables on stenosis severity and procedural results that can be influenced by the operator were identified as independent risk factors for early events (percent stenosis before and after the procedure, residual dissection, length of stented segment), more clinical variables were associated with late events (age, reduced left ventricular function, systemic hypertension as a protective factor). The late-event rate was <0.1% in the absence of these factors, but it was 2.5% with all three risk factors present. CONCLUSIONS: The risk of late stent failure is low with a four-week ticlopidine regimen. However, high-risk subgroups have a risk of 2.5%. As this rate is presumably higher if thienopyridines are discontinued after two weeks, these data suggest that a risk stratification to a two- or four-week regimen is preferable to a general reduction.


Asunto(s)
Enfermedad Coronaria/terapia , Inhibidores de Agregación Plaquetaria/uso terapéutico , Stents , Ticlopidina/uso terapéutico , Anciano , Enfermedad Coronaria/tratamiento farmacológico , Femenino , Humanos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Inhibidores de Agregación Plaquetaria/administración & dosificación , Falla de Prótesis , Estudios Retrospectivos , Factores de Riesgo , Ticlopidina/administración & dosificación , Factores de Tiempo
9.
Am J Cardiol ; 87(4): 397-400, 2001 Feb 15.
Artículo en Inglés | MEDLINE | ID: mdl-11179521

RESUMEN

Combined antiplatelet therapy after coronary stent placement is superior to anticoagulation with respect to early outcome. It is unclear if this benefit is maintained during long-term follow-up. This study reports on the 4-year clinical outcome of patients randomized in the Intracoronary Stenting and Antithrombotic Regimen trial. In the Intracoronary Stenting and Antithrombotic Regimen trial, 517 patients were randomized after successful placement of Palmaz-Schatz stents: 257 to aspirin and ticlopidine, and 260 to aspirin and phenprocoumon. Ticlopidine and phenprocoumon were given for 4 weeks. At 30 days, patients with ticlopidine had significantly fewer adverse cardiac events (1.6% vs 6.2%; p = 0.007), nonfatal myocardial infarction (0.8% vs 3.5%; p = 0.034), and target vessel revascularization procedures (1.2% vs 5.4%; p = 0.007). At 4 years, rates for any adverse cardiac events were 22.6% versus 28.5% (p = 0.078), for nonfatal myocardial infarction 0.9% versus 5.8% (p = 0.003), and for target vessel revascularization 18.3% versus 22.7% (p = 0.21). The absolute difference in event rates (4.6% after 30 days) was maintained after 4 years (5.9%). Event rates beyond day 30 were not significantly different (21.1% vs 22.5%; p = 0.78), nor were the rates beyond the first year, which were very low (5.2% vs 3.6%; p = 0.50). This study shows that the benefit of combined antiplatelet therapy evident after 30 days is maintained after 4 years. Independent of the initial regimen, rates of adverse cardiac events are low beyond the first year.


Asunto(s)
Anticoagulantes/administración & dosificación , Enfermedad Coronaria/terapia , Inhibidores de Agregación Plaquetaria/administración & dosificación , Stents , Angioplastia de Balón , Aspirina/administración & dosificación , Angiografía Coronaria , Quimioterapia Combinada , Femenino , Humanos , Masculino , Persona de Mediana Edad , Fenprocumón/administración & dosificación , Recurrencia , Estadísticas no Paramétricas , Análisis de Supervivencia , Ticlopidina/administración & dosificación , Resultado del Tratamiento
10.
Am J Cardiol ; 87(4): 463-6, A7, 2001 Feb 15.
Artículo en Inglés | MEDLINE | ID: mdl-11179537

RESUMEN

The objective of this randomized pilot trial with 21 patients was to evaluate the effectiveness of a rhenium-188 liquid-filled balloon system to prevent recurrent restenosis after percutaneous transluminal coronary angioplasty for in-stent restenosis. A significant benefit from brachytherapy was seen at 6-month repeat angiography, as well as during the clinical follow-up of 12 months.


Asunto(s)
Angioplastia de Balón/métodos , Braquiterapia/métodos , Enfermedad Coronaria/radioterapia , Radioisótopos , Renio , Anciano , Angiografía Coronaria , Enfermedad Coronaria/patología , Enfermedad Coronaria/cirugía , Femenino , Humanos , Masculino , Proyectos Piloto , Recurrencia , Stents , Análisis de Supervivencia , Resultado del Tratamiento
11.
Am J Cardiol ; 87(1): 34-9, 2001 Jan 01.
Artículo en Inglés | MEDLINE | ID: mdl-11137830

RESUMEN

Coronary stent implantation is being performed in an increasing number of patients with a wide spectrum of clinical and lesion characteristics. A variety of stent designs are now available and continuous efforts are being made to improve the stent placement procedure. The objective of this study was to perform a comprehensive analysis of the relation between clinical, lesion, and procedural factors, and restenosis after intracoronary stenting in a large and unselected population of patients. A consecutive series of 4,510 patients with coronary stent placement was analyzed. Exclusion criteria were only a failed procedure and an adverse outcome within the first month after the intervention. Follow-up angiography was performed in 80% of patients at 6 months. Clinical, lesion, and procedural data from all 3,370 patients (4,229 stented lesions) with follow-up angiography were analyzed in a logistic regression model for restenosis (> or =50% diameter stenosis). Clinical factors contributed to the predictive power of the model much less than lesion and procedural factors. The strongest risk factor for restenosis was a small vessel size, with a 79% increase in the risk for a vessel of 2.7 mm versus a vessel of 3.4 mm in diameter. Stent design was the second strongest factor; the incidence of restenosis ranged from 20.0% to 50.3% depending on the stent type implanted. In conclusion, this study demonstrates the predominant role of lesion and procedural factors in determining the occurrence of restenosis after coronary stent placement. Among these factors, stent design appears to play a particularly important role in the hyperplastic response of the vessel wall.


Asunto(s)
Enfermedad Coronaria/cirugía , Stents , Análisis de Varianza , Angiografía Coronaria , Enfermedad Coronaria/patología , Diseño de Equipo , Femenino , Humanos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Recurrencia , Factores de Riesgo
12.
Catheter Cardiovasc Interv ; 50(3): 290-7, 2000 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-10878624

RESUMEN

The objective of this randomized trial was to assess whether differences in stent design are translated in different clinical outcomes in patients undergoing coronary stent placement. This multicenter randomized trial included 1,147 patients who were randomly assigned to receive one of five types of stainless steel stents: Inflow, MULTI-LINK, NIR, Palmaz-Schatz, and PURA-A stent. Primary endpoint of the study was event-free survival at 1 year. Event-free survival at 1 year was significantly different between the groups (P = 0.014), ranging from 69.4% to 82.4%. Similarly, freedom from myocardial infarction was also significantly different (P = 0.022), with values between 88.2% and 95.2%. Diameter stenosis at 6 months varied from 38.1% +/- 25.0% to 45.6% +/- 27.7% (P = 0. 046), late lumen loss ranged from 1.01 +/- 0.70 mm to 1.20 +/- 0.82 mm (P = 0.085), and the incidence of restenosis varied between 25.3% and 35.9% (P = 0.145). Thus, stent design has a significant impact on the long-term results after coronary stent placement.


Asunto(s)
Enfermedad Coronaria/terapia , Stents , Anciano , Angiografía Coronaria , Enfermedad Coronaria/diagnóstico por imagen , Enfermedad Coronaria/mortalidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Diseño de Prótesis , Recurrencia , Análisis de Supervivencia , Resultado del Tratamiento
13.
Circulation ; 101(21): 2478-83, 2000 May 30.
Artículo en Inglés | MEDLINE | ID: mdl-10831521

RESUMEN

BACKGROUND: Gold is a highly biocompatible material. Experimental evidence suggests that coating the stent with a gold layer may have a beneficial influence. In this randomized trial, we assessed whether gold-coated stents were associated with a better clinical and angiographic outcome after coronary placement. METHODS AND RESULTS: Patients with symptomatic coronary artery disease were randomly assigned to receive either a gold-coated Inflow stent (n = 367) or an uncoated Inflow stainless steel stent (n = 364) of identical design. Follow-up angiography was routinely performed at 6 months. The primary end point of the study was the occurrence of any adverse clinical event (death, myocardial infarction, or target-vessel revascularization) during the first year after stenting. At 30 days, there was no significant difference in the combined incidence of adverse events, with 7.9% in the gold-stent group versus 5.8% in the steel-stent group (P = 0.25). The incidence of angiographic restenosis (> or =50% diameter stenosis) was 49.7% in the gold-stent group and 38.1% in the steel-stent group (P = 0.003). One-year survival free of myocardial infarction was 88.6% in the gold-stent group and 91.8% in the steel-stent group (P = 0.14). One-year event-free survival was significantly less favorable in the gold-stent group (62.9% versus 73.9% in the steel-stent group; P = 0.001). CONCLUSIONS: Coating steel stents with gold had no significant influence on the thrombotic events observed during the first 30 days after the intervention. However, gold-coated stents were associated with a considerable increase in the risk of restenosis over the first year after stenting.


Asunto(s)
Enfermedad Coronaria/terapia , Oro , Stents , Anciano , Materiales Biocompatibles , Angiografía Coronaria , Supervivencia sin Enfermedad , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Recurrencia , Acero
14.
Circulation ; 100(12): 1285-90, 1999 Sep 21.
Artículo en Inglés | MEDLINE | ID: mdl-10491372

RESUMEN

Background-The modified American College of Cardiology/American Heart Association (ACC/AHA) lesion morphology criteria are predictive of early outcome after various coronary catheter interventions. Their potential prognostic value after stent implantation and, in particular, for restenosis and long-term clinical outcome has not been studied. We assessed the prognostic value of the modified ACC/AHA criteria for the long-term angiographic and clinical outcome of patients after coronary stenting. Methods and Results-This study includes 2944 consecutive patients with symptomatic coronary artery disease treated with coronary stent placement. Modified ACC/AHA lesion morphology criteria were used to qualitatively assess the angiograms; type A and B1 lesions were categorized as simple, and type B2 and C lesions were designated complex. Primary end points were angiographic restenosis and 1-year event-free survival. Restenosis rate was 33.2% in complex lesions and 24.9% in simple lesions (P<0.001). It was 21. 7% for type A, 26.3% for type B1, 33.7% for type B2, and 32.6% for type C lesions. One-year event-free survival was 75.6% for patients with complex lesions and 81.1% for patients with simple lesions (P<0. 001). It was 85.2% for patients with type A, 79.4% for type B1, 75. 9% for type B2, and 75.2% type C lesions. The higher risk for restenosis and an adverse outcome associated with complex lesions was also maintained after multivariate adjustment for other clinical and angiographic characteristics. Conclusions-The modified ACC/AHA lesion morphology scheme has significant prognostic value for the outcome of patients after coronary stent placement. Lesion morphology is able to influence the restenosis process and thus the entire 1-year clinical course of these patients.


Asunto(s)
Angiografía Coronaria , Enfermedad Coronaria/diagnóstico por imagen , Enfermedad Coronaria/terapia , Stents , Supervivencia sin Enfermedad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Pronóstico , Recurrencia , Resultado del Tratamiento
15.
Circulation ; 100(9): 918-23, 1999 Aug 31.
Artículo en Inglés | MEDLINE | ID: mdl-10468521

RESUMEN

BACKGROUND: High-pressure dilatation is considered a better stent placement strategy, but this has not yet been proved by appropriately designed studies. The objective of this randomized trial was to assess the role of high-pressure dilatation in the early and late outcome of patients undergoing coronary stent placement. METHODS AND RESULTS: Consecutive patients with coronary stent placement were randomly assigned to high- (15 to 20 atm, 468 patients) or low- (8 to 13 atm, 466 patients) balloon-pressure dilatation. The primary end point of the study was the event-free survival at 1 year. Secondary end points were the incidence of stent thrombosis at 30 days and angiographic restenosis (>/=50% diameter stenosis) at 6 months. The incidence of stent thrombosis was 1.7% in the high-pressure and 1.9% in the low-pressure group (relative risk 0.89; 95% CI 0.30 to 2.56). During the first 30 days, although there was no significant difference in the incidence of Q-wave myocardial infarction, the incidence of non-Q-wave infarction was 6.4% in the high-pressure and 3.4% in the low-pressure group (relative risk 1. 87; 95% CI 1.02 to 3.42). The restenosis rate was 30.4% in the high-pressure and 31.4% in the low-pressure group (relative risk 0. 97; 95% CI 0.75 to 1.26). Event-free survival at 1 year was not significantly different between the groups, with 78.8% in high-pressure patients and 75.5% in patients assigned to low-pressure dilatation (hazard ratio 0.85; 95% CI 0.65 to 1.11). CONCLUSIONS: The systematic use of high-balloon-pressure inflation (15 to 20 atm) during coronary stent placement is not associated with any significant influence on the 1-year outcome of patients undergoing this intervention.


Asunto(s)
Cateterismo/métodos , Angiografía Coronaria , Enfermedad Coronaria/terapia , Stents , Anciano , Factores de Confusión Epidemiológicos , Enfermedad Coronaria/diagnóstico por imagen , Supervivencia sin Enfermedad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Presión , Recurrencia , Factores de Tiempo , Resultado del Tratamiento
16.
Am J Cardiol ; 82(6): 803-6, A9, 1998 Sep 15.
Artículo en Inglés | MEDLINE | ID: mdl-9761095

RESUMEN

A consecutive series of 132 patients with total chronic coronary occlusions were compared with 1,966 patients with stenotic lesions in terms of angiographic and clinical outcome. We concluded that patients with chronically occluded coronary lesions present a higher rate of target lesion revascularizations and angiographic restenosis than patients with stenotic lesions.


Asunto(s)
Angiografía Coronaria , Enfermedad Coronaria/cirugía , Stents , Implantación de Prótesis Vascular , Enfermedad Crónica , Enfermedad Coronaria/diagnóstico por imagen , Supervivencia sin Enfermedad , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Recurrencia , Estudios Retrospectivos , Resultado del Tratamiento
17.
Circulation ; 98(2): 104-11, 1998 Jul 14.
Artículo en Inglés | MEDLINE | ID: mdl-9679715

RESUMEN

BACKGROUND: Our rationale for this study was to analyze the risk for procedural failure of attempted stenting and the risk for major adverse cardiac events (MACE) after success and to develop a risk stratification protocol for successful procedures. METHODS AND RESULTS: Stenting was attempted in 2894 procedures during the 5-year study period (success in 98.3% of 3815 lesions). After failure, the MACE rate was 42.6%. The risk for failure was higher for lesions in the left circumflex coronary artery or in venous bypass grafts and after an acute occlusion before stenting; it increased with stenosis length or grade and decreased with vessel size and growing institutional experience in stenting. After success, death occurred in 0.8%, death or myocardial infarction in 2.0%, and any MACE in 3.6%. Independent risk factors for MACE were older age, diabetes, acute myocardial infarction, unstable angina, impaired left ventricular function, residual dissections, stent overlap, longer stented segments, and a postprocedural regimen without ticlopidine. Procedural factors were substantially stronger predictors than operator-independent variables available before procedures. Overall, the risk declined after the first 3 days. Two major factors exhibited time-dependent variations of their influence: while residual dissections were the dominant risk factor within the first 3 days with a reduction after that, no protective effect of ticlopidine could be identified before day 3. From these results, we derived a risk stratification protocol for individual procedures. CONCLUSIONS: These results underscore the importance of optimal angiographic results and the need for antiplatelet regimens with immediate onset. Our risk stratification protocol may guide individual postprocedural care and allow us to compare risk profiles of different study populations and to devise quality control programs for stenting.


Asunto(s)
Angioplastia Coronaria con Balón , Vasos Coronarios , Cardiopatías/etiología , Stents , Anciano , Vasos Coronarios/fisiopatología , Humanos , Masculino , Persona de Mediana Edad , Periodo Posoperatorio , Factores de Riesgo , Factores de Tiempo , Insuficiencia del Tratamiento
18.
Circulation ; 97(24): 2396-401, 1998 Jun 23.
Artículo en Inglés | MEDLINE | ID: mdl-9641690

RESUMEN

BACKGROUND: Little is known about the behavior with regard to restenosis of multiple lesions within the same patient treated with intracoronary stenting. Our objective was to test the hypothesis that there is an intrapatient dependence of restenosis between lesions. METHODS AND RESULTS: Quantitative analysis was carried out on angiograms obtained before, immediately after, and at 6 months after coronary stent placement in 1734 lesions in 1244 patients. We used a specialized logistic regression that not only accounts for intraclass correlation but also quantifies it in the form of odds ratio (OR) as the change in risk of a lesion to develop restenosis if another companion lesion had restenosis. The model was based on 23 patient- and lesion-related variables with binary restenosis (diameter stenosis > or =50%) as end point. The overall restenosis rate was 27.5%: 24.4% for single-lesion, 28.6% for double-lesion, and 33.8% for > or =3-lesion interventions. After adjustment for the influence of significant factors (hypercholesterolemia, systemic arterial hypertension, diabetes mellitus, previous PTCA, ostial lesion, location in left anterior descending coronary artery, number of stents placed, vessel size, stenosis severity, balloon-to-vessel ratio, and final result), the analysis found a significant intrapatient correlation, OR 2.5 (1.8 to 3.6). This means that in patients with multilesion interventions, the risk of a lesion to develop restenosis is 2.5 times higher if a companion lesion has restenosis, independently of the presence or absence of analyzed patient risk factors (eg, diabetes). CONCLUSIONS: This study demonstrates that there is a dependence of restenosis between coronary lesions in patients who undergo a multilesion intervention. The likelihood of restenosis for a lesion is higher when another companion lesion has also developed restenosis. Other, as yet unidentified patient factors may be the source of this intrapatient correlation of restenosis.


Asunto(s)
Enfermedad Coronaria/terapia , Stents , Anciano , Angiografía Coronaria , Enfermedad Coronaria/diagnóstico por imagen , Enfermedad Coronaria/patología , Femenino , Estudios de Seguimiento , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Oportunidad Relativa , Recurrencia , Factores de Riesgo , Grado de Desobstrucción Vascular
19.
Circulation ; 96(11): 3880-7, 1997 Dec 02.
Artículo en Inglés | MEDLINE | ID: mdl-9403611

RESUMEN

BACKGROUND: Restenosis has been perceived as the tail end of a normal distribution of the response of the vessel to the intervention. However, recent studies have described a bimodal distribution for de novo lesions after percutaneous transluminal coronary angioplasty. This finding suggests that some lesions may be more susceptible for restenosis. Whether this holds true for a wider spectrum of lesions undergoing stent placement is not yet known. The present study analyzes the frequency distribution of angiographic indexes of restenosis 6 months after coronary stent implantation. METHODS AND RESULTS: Quantitative angiographic evaluation was performed in 1084 lesions of 1084 patients before, immediately after, and 6 months after successful Palmaz-Schatz stent placement; this represented 80.4% of patients eligible for follow-up angiography. Principal end points of the analysis were angiographic indexes of restenosis at 6 months. Twenty-two lesions that became totally occluded at follow-up were excluded from most parts of the analysis. Diameter stenosis, minimal luminal diameter (MLD), and lumen loss at 6 months did not follow a normal pattern; the bimodal pattern was demonstrated through deconvolution that yielded two separate normal components delineating two lesion populations, which developed distinctively different degrees of lumen renarrowing. The first and larger subgroup of lesions, which was less prone to restenosis, was centered around a mean value of 27% for diameter stenosis and 2.19 mm for MLD, whereas the second subgroup, with a greater tendency for restenosis, was situated around a mean value of 68% for diameter stenosis and 0.76 mm for MLD. The intersection point between the two theoretical normal distribution components was 53.5% for diameter stenosis and 1.09 mm for MLD at follow-up. CONCLUSIONS: Frequency-distribution curves of angiographic indexes of restenosis after coronary stent placement have a bimodal pattern, suggesting the existence of two distinct populations with different propensity to restenosis. These findings may encourage future efforts for the timely identification of the subset with a higher risk as the target of specific antirestenotic strategies.


Asunto(s)
Angiografía Coronaria , Enfermedad Coronaria/diagnóstico por imagen , Enfermedad Coronaria/cirugía , Stents , Anciano , Enfermedad Coronaria/patología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Recurrencia , Resultado del Tratamiento
20.
J Am Coll Cardiol ; 30(6): 1428-36, 1997 Nov 15.
Artículo en Inglés | MEDLINE | ID: mdl-9362398

RESUMEN

OBJECTIVES: The objective of this study was to identify clinical, lesional and procedural factors that can predict restenosis after coronary stent placement. BACKGROUND: Coronary stent placement reduces the restenosis rate compared with that after percutaneous transluminal coronary angioplasty (PTCA). However, restenosis remains an unresolved issue, and identification of its predictive factors may allow further insight into the underlying process. METHODS: All patients with successful coronary stent placement were eligible for this study unless they had had a major adverse cardiac event during the 1st 30 days after the procedure. Of the 1,349 eligible patients (1,753 lesions), follow-up angiography at 6 months was performed in 80.4% (1,084 patients, 1,399 lesions). Demographic, clinical, lesional and procedural data were prospectively recorded and analyzed for any predictive power for the occurrence of late restenosis after stenting. Restenosis was evaluated by using three outcomes at follow-up: binary restenosis as a diameter stenosis > or =50%, late lumen loss as lumen diameter reduction and target lesion revascularization (TLR) as any repeat PTCA or coronary artery bypass surgery involving the stented lesion. RESULTS: Multivariate analysis demonstrated that diabetes mellitus, placement of multiple stents and minimal lumen diameter (MLD) immediately after stenting were the strongest predictors of restenosis. Diabetes increased the risk of binary restenosis with an odds ratio (OR) [95% confidence interval] of 1.86 [1.56 to 2.16] and the risk of TLR with an OR of 1.45 [1.11 to 1.80]. Multiple stents increased the risk of binary restenosis with an OR of 1.81 [1.55 to 2.06] and that of TLR with an OR of 1.94 [1.66 to 2.22]. An MLD <3 mm at the end of the procedure augmented the risk of binary restenosis with an OR of 1.81 [1.55 to 2.06] and that of TLR with an OR of 2.05 [1.77 to 2.34]. Classification and regression tree analysis demonstrated that the incidence of restenosis may be as low as 16% for a lesion without any of these risk factors and as high as 59% for a lesion with a combination of these risk factors. CONCLUSIONS: Diabetes, multiple stents and smaller final MLD are strong predictors of restenosis after coronary stent placement. Achieving an optimal result with a minimal number of stents during the procedure may significantly reduce this risk even in patients with adverse clinical characteristics such as diabetes.


Asunto(s)
Enfermedad Coronaria/terapia , Stents , Anciano , Análisis de Varianza , Angioplastia Coronaria con Balón , Angiografía Coronaria , Enfermedad Coronaria/complicaciones , Enfermedad Coronaria/patología , Complicaciones de la Diabetes , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Recurrencia , Análisis de Regresión , Factores de Riesgo
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