Predictors of thrombotic complications after placement of the flexible coil stent

doi:10.1016/0002-9149(94)90186-4

The American Journal of Cardiology

Volume 73, Issue 16, 15 June 1994, Pages 1216-1219

https://doi.org/10.1016/0002-9149(94)90186-4 Get rights and content

Abstract

The balloon-expandable, stainless steel, flexible coil stent is a useful device for managing acute or threatened closure after percutaneous transluminal coronary angioplasty.^1–5 Use of the device is associated with thrombosis of the stented vessel in a small but important group of patients.^3,6–10 The clinical, angiographic, and procedural factors associated with stent thrombosis with this device are still unknown. The objective of this study was to define predictors of stent thrombosis occurring within the ftrst month after stenting with this device.

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Cited by (85)

Long-term serial changes in platelet activation indices following sirolimus elution and bare metal stent implantation in patients with stable coronary artery disease
2017, Hellenic Journal of Cardiology
Citation Excerpt :
Consequently, the onset, development, and formation of the thrombus within the stent, which can also cause restenosis, are a complication in which various factors are involved, influencing platelet adhesion, endothelial function, coagulation, and fibrinolysis. Various conditions, such as incorrect stent deployment or a poor choice of size, a small stent, small vessel, bifurcation of the vessel, implantation of multiple stents, eccentric lesions, acute coronary syndrome, low ejection fraction, or subtherapeutic antiplatelet medication,9–12 are considered to be risk factors for thrombosis. However, there are some patients who show none of the above factors.
Platelet activation is crucial in the development of stent thrombosis following percutaneous coronary intervention (PCI). We carried out a long-term assessment of multiple factors implicated in the thrombotic process and monitored markers of platelet activation after the implantation of sirolimus-eluting stents (SES) in patients with stable coronary artery disease (CAD). Additionally, we compared these findings with those after bare-metal stent (BMS) implantation.
A cohort of 47 consecutive patients, aged <70 years, with severe stenosis (>70% narrowing of the lumen) of one major epicardial coronary artery and stable CAD underwent successful elective PCI. Patients were randomly allocated to SES (n = 25) or BMS (n = 22). Venous blood was obtained 24 hours before and 24 hours, 48 hours, 1 month, and 6 months after PCI for measurements of plasma levels of sP-selectin, von Willebrand Factor (vWF), fibrinogen, d-dimer, sCD40, factor VIII, b-thromboglobulin (b-TG) and platelet factor 4 (PF-4).
There were no significant differences between the two groups in levels of fibrinogen or d-dimers in peripheral blood. However, we observed a significant kinetic effect (p < 0.001) and stent-effect (p < 0.015) on vWF levels and a significant kinetic effect (p = 0.012) on factor VIII, sP-selectin (p = 0.04), b-TG (p < 0.001), and PF4 (p = 0.016). A trend towards a significant stent effect on sCD40 was also detected (p = 0.06).
SES and BMS did not show significant differences in relationship to markers of platelet activation and coagulation in patients with stable CAD. Although some markers showed an increase after stent implantation, they returned to the initial levels 6 months later.
Percutaneous coronary intervention in myocardial infarction. Current concepts
2005, Revista Espanola de Cardiologia
La reperfusión mecánica (percutánea) en el contexto del infarto agudo de miocardio con elevación del segmento ST ha demostrado ser la forma más eficaz para restaurar un flujo coronario temprano, completo y sostenible en la arteria causante. La angioplastia primaria con balón demostró superioridad clínica en los estudios aleatorizados que la comparaban con trombólisis.
El temor inicial a la utilización del stent en angioplastia primaria desapareció con los estudios aleatorizados en los que se demostraron mejores resultados con el stent, incluso al compararlo con el subgrupo de pacientes en los que la angioplastia con balón había sido óptima.
La necesidad de trasladar a los pacientes a centros con facilidades de intervencionismo coronario no disminuye la eficacia de la angioplastia primaria, que sigue siendo superior al tratamiento con trombólisis en el centro de ingreso.
La embolización distal interfiere con la adecuada reperfusion miocárdica. El correcto manejo del trombo se ha abordado de diferentes formas: implantación del stent sin predilatación previa con balón, trombectomía, dispositivos de protección distal e inhibidores de las glucoproteínas IIb/IIIa. Estos últimos administrados de forma temprana, el stent directo y la trombectomía con el sistema X-Sizer seguido de implantación de stent fueron las únicas estrategias eficaces en estudios aleatorizados.
La prevención del daño por reperfusión no ha sido demostrada con ninguna de las estrategias probadas, aunque es difícil mejorar el buen resultado clínico obtenido en la mayoría de los pacientes con intervencionismo percutáneo.
La angioplastia de rescate está indicada en cualquier infarto con sospecha de fracaso de la trombólisis, especialmente si el centro dispone de facilidades para realizar la angioplastia o el paciente puede ser transferido precozmente a un centro con disponibilidad de angioplastia en casos de infartos extensos y/o inestabilidad hemodinámica.
El shock cardiogénico tiene mejor pronóstico con una estrategia invasiva.
Percutaneous mechanical reperfusion during acute myocardial infarction with ST-segment elevation has proved to be the most effective way of quickly restoring adequate flow in the affected coronary artery. Randomized clinical trials have shown that percutaneous coronary intervention (PCI) is superior to thrombolysis.
Initial fears about the use of stents in primary angioplasty vanished when clinical studies demonstrated that they gave better results than those obtained under optimal conditions with balloon angioplasty.
The need to transfer patients to a cardiac catheterization laboratory for primary PCI does not decrease the efficacy of this form of treatment, which remains superior to immediate thrombolysis at the admitting hospital.
Distal embolization can alter the situation by preventing myocardial reperfusion. Although there are many therapeutic strategies for managing thrombotic lesions, only early administration of glycoprotein IIb/IIIa inhibitors, direct stenting, and use of an X-Sizer device followed by stent implantation have been shown in randomized studies to lead to significant improvements in clinical or angiographic parameters.
No technique has been shown to prevent damage due to myocardial reperfusion. However, it would be difficult to improve upon the good results achieved with PCI in the majority of patients.
Rescue PCI is indicated when thrombolysis appears to have failed, especially when a catheterization laboratory is close by or when patients can be transferred early to a center with angioplasty facilities.
For most cases of cardiogenic shock, PCI is the only therapeutic modality currently recommended.
Interventional cardiology. Where are we and where are we going from here?
2005, Revista Espanola de Cardiologia
Este artículo tiene como objetivo resumir 2 décadas de intervencionismo coronario percutáneo. Durante este tiempo, esta modalidad terapéutica ha evolucionado más rápidamente que cualquier otra forma de tratamiento en el campo de las enfermedades cardiovasculares. Se describen los resultados del intervencionismo en la primera época, así como el incremento en la tasa de éxito primario y la reducción de complicaciones durante estos años, coincidiendo con la incorporación de los nuevos avances tecnológicos. La tasa de éxito primario al comienzo de la década de los noventa en el tratamiento percutáneo de las lesiones coronarias era del 86-88%, con una incidencia de reestenosis del 30-40%. En la actualidad, las cifras de éxito primario han aumentado a más de un 95% y la tasa de reestenosis se ha reducido a menos del 10%, incluidos muchos tipos de lesiones clásicamente consideradas complejas. La principal limitación del intervencionismo coronario actual son lesiones en las que resulta imposible acceder debido a una oclusión antigua o a tortuosidad o calcificación extrema de los segmentos proximales. Los avances tan rápidos de estos años han permitido ampliar las indicaciones de esta modalidad de revascularización y han obligado a revisar con frecuencia las guías de actuación clínica. Al mismo tiempo, resulta muy difícil analizar los estudios comparativos con otras modalidades de revascularización debido a que la metodología utilizada en estudios con 5-10 años de seguimiento ha quedado obsoleta hoy día.
This article summarizes 20 years of percutaneous interventional cardiology for coronary angioplasty. During this period, interventional cardiology has evolved faster than any other type of treatment in the field of cardiovascular diseases. We describe the early results of interventional cardiology, the increase in primary success rates and the reduction in complication rates for percutaneous techniques during this period, which coincided with the introduction of technological advances. In the early 1990s, primary success rates for the treatment of coronary lesions stood at 86%-88%, with a restenosis rate of 30%-40% at 6-month follow-up. Current primary success rates have risen to over 95% with a restenosis rate of under 10%, even for many types of lesions classically considered complex. Currently the main limitations in interventional cardiology remain coronary segments that cannot be accessed due to chronic total occlusion, or severe proximal tortuosity or calcification. Rapid improvements have led to broader clinical indications for percutaneous revascularization procedures, and have made frequent updates of clinical practice guidelines necessary. Meanwhile, comparative studies involving other modes of surgical revascularization have become extremely difficult because percutaneous methods used in long-term studies begun 5 to 10 years have become obsolete.
Clinical impact of stent construction and design in percutaneous coronary intervention
2004, American Heart Journal
Citation Excerpt :
Although it is highly flexible and provides greater side-branch access, the coil or coil-related stent design, such as the Gianturco-Roubin Flex/GR-II (Cook), Wiktor stent (Medtronic, Minneapolis, Minn), and GFX (Applied Vascular Engineering, Santa Rosa, Calif), nonetheless suffers from a high degree of elastic recoil and tissue prolapse and has weak radial strength. These downside features are probably the reasons for its higher early complication rate, lower acute luminal gain, and higher late loss compared with the tubular and corrugated stents,15,16 as have been demonstrated in 3 recent randomized studies.17–19 In the trial by Lansky et al,17 the GR-II stent was found to be associated with a significantly higher subacute stent thrombosis rate (3.9% vs 0.3%, P < .001), a higher restenosis rate (47.3% vs 20.6%, P < .001), and a lower 12-month event-free survival (71.7% vs 83.9%, P < .001) compared with the Palmaz-Schatz stent.
Convincing end point data demonstrating the anatomic and clinical superiority of stent placement compared with balloon angioplasty together with significant improvement in stenting technique and poststent management have resulted in an explosion in stenting procedures and the emergence of more than 40 stent types with disparate designs and material composition in clinical use. Structural nuances in design, composition, and coating of different stent models, however, have been shown to have a major influence on the risk of stent thrombosis, the degree of vessel wall injury, and subsequent intimal proliferation in the experimental model. There is now substantial amount of evidence to indicate that the same relationship between stent structural characteristics and vessel wall outcome holds true in humans. This article provides an up-to-date overview of the clinical impact of stent construction and design, including the clinical performance of drug-eluting stents.
Comparison of immediate and one-year outcome after coronary angioplasty of narrowing <3 mm with those ≥3 mm (The National Heart, Lung, and Blood Institute Dynamic Registry)
2001, American Journal of Cardiology
Citation Excerpt :
There are limited data on the role of stent placement in the treatment of small coronary arteries (Table 7). 14–21 Earlier reports suggest a higher incidence of subacute thrombosis with the use of smaller sized stents and/or treatment of smaller coronary arteries with stents.22–24 Although this increased risk of thrombosis was not observed in other studies,15–21 a worse clinical outcome at follow-up was reported for patients with small vessels.14,17,18
Balloon angioplasty of small coronary artery lesions has been associated with lower success and higher complication rates than large coronary artery lesions. This study evaluates the in-hospital and 1-year outcome of the treatment of small coronary artery lesions in the modern era of interventional cardiology and compares it with the outcome of treating large coronary artery lesions. Of 1,658 patients with a single lesion treated from July 1997 to February 1998 in the National Heart, Lung, and Blood Institute (NHLBI) Dynamic Registry, there were 587 patients with small coronary artery lesions (<3 mm) and 1,071 patients with large coronary artery lesions (≥3 mm). Success, in-hospital, and 1-year outcomes between both groups were compared. Patients with lesions in small coronary arteries were more often women, insulin-treated diabetics, and had undergone more prior coronary bypass graft surgery. Conventional angioplasty alone was performed more often and angioplasty with stents was performed less often in the small coronary artery than in the large coronary artery group. Angiographic success was slightly lower in the small coronary artery group (94.2% vs 96.9%, p <0.05). Periprocedural and in-hospital complication rates were similar in both groups. Likewise, at 1-year follow-up, major adverse cardiac events including death, myocardial infarction, and coronary artery bypass graft surgery were relatively low and comparable between the 2 groups, although patients with small coronary arteries were more likely to undergo repeat revascularization (17.4% vs 13.6%, p <0.05). Treatment of lesions in small coronary arteries in the modern era is associated with high success and low complication rates, comparable to the treatment of large coronary artery lesions, although the incidence of repeat revascularization was significantly greater at follow-up even if stents were used.
Coronary stenting in small vessels: Short-term and long-term clinical outcome
2000, Revista Espanola de Cardiologia
Determinar los resultados clínicos de la revascularización con stents intracoronarios en vasos menores de 3 mm.
El tamaño del vaso se evaluó como menor o mayor o igual de 3 mm en el momento del procedimiento y fue medido en el diámetro máximo. Estudiamos a un total de 234 pacientes consecutivos (300 stents en 279 lesiones), con un seguimiento clínico de 17,6 ± 10 meses, comprendiendo 84 stents implantados en 79 lesiones localizadas en vasos pequeños (< 3 mm). Se usó dilatación del stent a altas presiones (15,8 ± 2,2 atm) y tratamiento con aspirina y ticlopidina durante un mes.
La tasa de éxito del implante, sin eventos clínicos hospitalarios, fue del 93,7% en los vasos < 3 mm y del 93,5% en los ³ 3 mm (p = NS). La trombosis subaguda del stent ocurrió en tres vasos < 3 mm, frente a ninguna oclusión trombótica en vasos ³ 3 mm (el 3,8 frente al 0%; p = 0,006). A los dos años, la supervivencia libre de revascularización de la lesión diana fue inferior en vasos pequeños (el 73,6 frente al 90,3%; p < 0,001). En el análisis multivariado, un vaso < 3 mm fue predictor independiente de revascularización de la lesión diana a largo plazo (p = 0,001). A los dos años, la supervivencia libre de cualquier acontecimiento (muerte [el 4,6 frente al 3,8%; p = 0,7], infarto de miocardio [el 2,9 frente al 1,1%; p = 0,3] y revascularización de la lesión diana) para pacientes con implantes en vasos < 3 mm fue del 69,1, frente al 86,6% para implantes en vasos ³ 3 mm (p < 0,001).
El implante de stents en coronarias < 3 mm puede realizarse con éxito inicial similar al de los vasos mayores; sin embargo, se asocia a una mayor incidencia, tanto de trombosis subaguda como de reestenosis clínica (revascularización de la lesión diana) a largo plazo.
To assess the clinical outcome of coronary stenting in small vessels (< 3 mm), using high pressure balloon inflation and antithrombotic therapy. Patients and methods. Vessel size was evaluated as < or ³ 3 mm at the time of procedure and measured at a level of maximum diameter. We studied 234 consecutive patients with placement of 300 stents in 279 lesions, comprising 84 stents implanted in 79 lesions located at small vessels (< 3 mm). The standard technique included high pressure balloon inflation (15.8 ± 2.2 atm) and post-stenting therapy with ticlopidine and aspirin for one month. Mean clinical follow-up was 17.6 ± 10 months.
Procedural success without in-hospital major events was similar between small and large vessels (93.7 in vessels of < 3 mm vs 93.5% in vessels of ³ 3 mm; p = NS). Three small vessels presented subacute stent thrombosis, whereas no thrombotic occlusion occurred in large vessels (3.8 vs 0%; p = 0.006). At two years, small vessels had a lower target lesion revascularization free survival (73.6 vs 90.3%; p < 0.001). After adjustement for variables previously described as predictors of stent reestenosis, in multivariate analysis, a small vessel of < 3 mm was an independent predictor of target lesion revascularization (p = 0.001). Although patients with stenting in small vessels did not differ significantly in terms of any cause death (4.6 vs 3.8%; p = 0.7) nor acute myocardial infarction (2.9 vs 1.1%; p = 0.3), event-free survival was significantly lower after two years (69.1 vs 86.6%; p < 0.001).
As compared to large vessels, coronary stenting in small vessels was performed with similar rates of initial success, however they had a significantly worse clinical long-term outcome in terms of subacute stent thrombosis and target lesion revascularization at follow-up.

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^☆: This work was supported in part by funding from Cook, Inc., Bloomington, Indiana. Dr. Roubin's address is: 310 Lyons-Harrison Research Building, 1919 Seventh Avenue South, Birmingham, Alabama 35294-0007.

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Brief reportPredictors of thrombotic complications after placement of the flexible coil stent☆

Abstract

Am Heart J

Am J Cardiol

J Am Coll Cardiol

Am J Cardiol

Int J Cardiol

J Am Coll Cardiol

J Am Coll Cardiol

Intracoronary stenting for acute and threatened closure complicating percutaneous transluminal coronary angioplasty

Circulation

Brief report
Predictors of thrombotic complications after placement of the flexible coil stent☆