Direct stent implantation without predilatation using the multilink stent

doi:10.1016/S0002-9149(98)00683-3

The American Journal of Cardiology

Volume 82, Issue 12, 15 December 1998, Pages 1437-1440

https://doi.org/10.1016/S0002-9149(98)00683-3 Get rights and content

Abstract

The standard coronary stent implantation technique requires routine predilatation of the target lesion with a balloon catheter. In this study, we prospectively studied the feasibility and efficiency of elective coronary stent implantation without predilatation. In 94 patients who presented with various ischemic syndromes, direct implantation of 100 balloon expandable ACS MultiLink stents (7 over-the-wire, 93 rapid exchange) was attempted in 100 coronary lesions selected to have favorable characteristics. The stent crossed the lesion without predilatation in 97 cases (97%) and was successfully deployed in 93 (95.8%). In 4 patients, adjunctive high-pressure postdilatation was necessary to achieve optimal stent expansion. Reference vessel diameter was 3.12 ± 0.77 mm and lesion length 8.8 ± 2.7 mm. Minimal luminal diameter increased from 0.95 ± 0.38 mm to 2.98 ± 0.28 mm and diameter stenosis decreased from 71 ± 11% to 8 ± 11% after stenting. One occlusive dissection was treated by a second stent. There were no major in-hospital complications. At 1 month follow-up, 1 subacute thrombotic occlusion occurred. These results indicate that in a carefully selected coronary lesion subset, elective stent implantation without predilatation can be safely and effectively performed. The long-term results of this approach and possible advantages over the conventional implantation techniques remain unclear and need to be evaluated in further clinical studies.

Section snippets

Patient selection

Between November 1995 and October 1997, 2,067 patients underwent 2,441 percutaneous revascularization procedures in our center. In total, 1,987 stents were implanted. Our study cohort consists of 94 consecutive patients (100 narrowings) from this population who underwent implantation of 100 MultiLink stents without predilatation. Patients would be considered for the study if they fulfilled ≥1 of the following criteria: (1) they presented with unstable angina of recent onset (<1 month); (2) they

Results

In total, 94 patients (79% men) with 100 lesions were included in the study. Clinical presentation and other baseline characteristics are described in TABLE I, TABLE II . There were 92 (92%) primary and 8 (8%) restenotic lesions. Eccentricity (Figure 2) was present in 42 (42%), thrombus in 5 (5%), and a small side branch in 9 (9%). The lesions were ostial in 7 (7%), 11 (11%) were >10 mm, and 24 (24%) on a bend (<45°). TIMI flow grade 3 was present in 93 lesions (93%) and grade 2 was present in

Comparison with standard technique

Dissections that occur frequently during balloon angioplasty appear to be an integral element of the mechanism of lumen enlargement, predominantly achieved by expansion of the arterial wall and fissuring of the atherosclerotic plaque.7, 8 Lesion predilatation with a moderately undersized balloon may reduce the incidence of dissections, but increases procedure duration and cost. Furthermore, when a complex dissection occurs, collagen and tissue factors are exposed and the risk for thrombosis,

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Cited by (95)

The OPTIMIZE randomized trial to assess safety and efficacy of the Svelte IDS and RX Sirolimus-eluting coronary stent Systems for the Treatment of atherosclerotic lesions: Trial design and rationale
2019, American Heart Journal
Coronary stenting without angioplasty pretreatment (direct stenting) may simplify procedures in appropriate lesions. Direct stenting is facilitated by smaller profile coronary stent platforms. The present study was designed for regulatory approval of a novel drug-eluting coronary stent and incorporates both randomized comparison for non-inferiority to an approved predicate device as well as a nested evaluation of subjects eligible for direct stenting.
Prospective, single-blind, randomized, active-control, multi-center study designed to assess the safety and efficacy of the novel Svelte sirolimus-eluting stent (SES) systems. A total of 1630 subjects with up to 3 target lesions will be randomized 1:1 to the Svelte SES versus either the Xience or Promus everolimus-eluting stents (control). Randomization will be stratified by whether or not a direct stenting strategy is planned by the investigator. The primary endpoint is target lesion failure (TLF) at 12 months post index procedure, defined as cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization, and the primary analysis is a non-inferiority test with a non-inferiority margin of 3.58%. Secondary clinical endpoints include individual components of TLF, stent thrombosis and measures of procedural resource utilization including contrast administration, fluoroscopy exposure and procedural resource utilization as well as costs.
The OPTMIZE Trial will evaluate the safety, efficacy and clinical value of the novel Svelte SES in subjects with up to 3 lesions, and will provide a comparison of direct stenting between randomized devices.
Characterization of primary percutaneous coronary intervention requiring predilation
2016, Revista Brasileira de Cardiologia Invasiva
Citation Excerpt :
However, balloon insufflation may cause barotrauma in the fragile vessel, leading to immediate complications, such as dissection, thrombosis, and microvascular obstruction; it can also influence late results, such as increased risk of target vessel failure.3,4 Thus, direct stent implantation is recommended in selected cases, with potential improvement in the final epicardial flow, reduction in procedure duration and costs, reduced radiation exposure, and benefits regarding adverse clinical outcomes.5–8 The patient's emergency condition in the presence of an acute myocardial infarction (AMI) makes this an essential subject; however, there are few conclusive data available in the literature.
Although predilation during primary percutaneous coronary intervention offers greater predictability for stent implantation, it is associated with complications that may negatively influence immediate and late outcomes. The objective of this study was to characterize procedures requiring predilation, comparing them to those performed by direct stent implantation.
Primary percutaneous coronary interventions registered at the Central Nacional de Intervenções Cardiovasculares (CENIC) from 2006 to 2016 were analyzed. The clinical and angiographic profiles of the procedures performed with or without predilation, hospital outcome measures, and predictors of mortality were characterized.
The sample consisted of 17,515 patients. Those who underwent predilation differed from the direct stent implantation group regarding clinical characteristics, with a higher prevalence of elderly, women, and associated comorbidities. In the first group, the rates of calcified lesions, bifurcations, occlusions, and multivessel coronary disease were higher. Intervention failure rates were also higher in patients undergoing predilation, as well as the rates of major adverse cardiac events. In the multiple logistic regression model, the need for predilation was correlated with the occurrence of hospital death.
Primary percutaneous coronary intervention requiring predilation was characterized by a higher prevalence of clinical comorbidities and by angiographic and technical complexity of the procedures. Predilation is an independent predictor of hospital mortality in this clinical setting.
Embora a pré-dilatação durante a intervenção coronária percutânea primária confira maior previsibilidade ao implante do stent, ela associa-se a complicações que podem influenciar negativamente em seus resultados imediatos e tardios. O objetivo deste estudo foi caracterizar os procedimentos com necessidade de pré-dilatação, comparando-os àqueles realizados pelo implante direto de stent.
Foram analisadas as intervenções coronárias percutâneas primárias cadastradas na Central Nacional de Intervenções Cardiovasculares (CENIC) durante o período de 2006 a 2016, tendo sido caracterizados os perfis clínico e angiográfico dos procedimentos efetivados com ou sem pré-dilatação, aferição de desfechos hospitalares e preditores de mortalidade.
A amostra foi composta por 17.515 pacientes. Aqueles submetidos à pré-dilatação diferiram do grupo stent direto, quanto às características clínicas, com maior prevalência de idosos, mulheres e comorbidades associadas. No primeiro, as taxas de lesões calcificadas, bifurcações, oclusões e coronariopatia multiarterial foram maiores. Também foram maiores as taxas de insucesso da intervenção entre pacientes submetidos à pré-dilatação e de eventos cardíacos adversos maiores. No modelo de regressão logística múltipla, a necessidade de pré-dilatação correlacionou-se com a ocorrência de óbito hospitalar.
A intervenção coronária percutânea primária com necessidade de pré-dilatação caracterizou-se pela maior prevalência de comorbidades clínicas entre os pacientes e pela complexidade angiográfica e técnica dos procedimentos. A pré-dilatação constituiu-se em variável preditora independente de mortalidade hospitalar neste cenário clínico.
Effectiveness of "direct" stenting without balloon predilatation (from the multilink Tetra Randomised European Direct Stent Study [TRENDS])
2006, American Journal of Cardiology
The purpose of the TRENDS trial was to assess the safety, efficacy, and cost effectiveness of a no-predilatation (“direct”) stenting strategy in the treatment of de novo native coronary artery lesions using the Multilink Tetra stent system. In this multicenter, prospective clinical trial, 1,000 patients were randomized (1:1) to receive a Multilink Tetra stent with or without balloon predilatation. The primary outcome measurement was major adverse cardiac events (MACEs) at 30 days; secondary end points included resource utilization (including procedural duration, equipment use, and length of hospital stay), MACEs, and angiographic binary restenosis at 180 days. In the predilatation group, 587 stents were implanted in 499 patients; in the direct group, 579 stents were implanted in 501 patients. In the direct group, stents in 31 lesions (5.7%) required predilatation and multivariate analysis identified calcification (odds ratio 5.81), angulation (odds ratio 5.34), and preprocedural minimal lumen diameter (odds ratio 0.09) as direct stenting failure. MACEs at 30 days were similar in the 2 groups, with 19 (3.8%) in the predilatation group and 13 (2.6%) in the direct group (p = NS). Resource utilization favored the direct strategy, with decreases in balloon use, contrast media, and procedure time, but a larger number of guiding catheters was used. The 180-day MACE rate of 9.8% in the direct group was not significantly less than the rate of 10.8% in the predilatation group (p = NS). Quantitative angiographic follow-up at 6 months demonstrated in-stent binary restenotic rates of 11.4% in the predilatation group (late loss 0.88 ± 0.53 mm) and 12.3% in the direct group (late loss 0.82 ± 0.51 mm, p = NS) and in-segment restenosis rates of 12.2% and 13.4%, respectively (p = NS). In conclusion, a direct stenting strategy with the Multilink Tetra stent was feasible and safe in 94% of lesions and associated with lower resource utilization compared with a predilatation approach. Direct stenting was not associated with significantly lower MACE and target lesion revascularization rates and had no effect on late angiographic follow-up, with similar late loss reflecting an identical biologic response to bare metal stent placement.
Early results of direct coronary stenting in consecutive patients when multivessel, complex, long lesions, and small vessels are included
2005, International Journal of Cardiology
Direct coronary stenting is the dominant technique for coronary stent implantation, but previous randomized studies have strongly selected lesions to treat. To evaluate whether the results can be generalized to routine clinical practice, all consecutive patients with direct stenting in 15 hospitals were entered into a prospective registry. Single vessels and simple lesions, but also multivessel, complex and long lesions, and small vessels size (≤2.5 mm) were included. Immediately results as well as clinical events within 30 days after the procedure were evaluated.
Between April and November 2002, direct coronary stenting was performed in 452 consecutive patients (559 lesions) at 15 sites. Stents edge-protected by “sleeves” (SOX™ technology, NIR Stent, Boston Scientific) or with short transitional edge protection (STEP™ technology, Multilink Stents, Guidant) were selected to minimize vessel injury outside the stent edges during balloon inflation/deployment.
Stents were successfully implanted in 96% of lesions. Lesions were multivessel in 27%, type B2-C in 40%, very angulated in 28%, calcified in 18%, and longer than 20 mm in 10% of patients. Vessels were smaller than ≤2.5 mm in 27% of patients. Direct coronary stenting was unsuccessful in 25 lesions (24 patients) characterized by more unstable angina (p=0.07), more treated lesions (p<0.01), and more distal locations (p=0.001). Dissection occurred in 6% of patients, and one stent embolised. The 30-day follow-up period included 1 death (due to subacute occlusion), 11 (2.4%) acute myocardial infarctions (8 non-Q wave), and one stroke (following carotid surgery).
Direct coronary stenting yielded excellent results at 30 days although some expanded indications will be included.
Neointimal tissue proliferation after coronary stent implantation without predilatation
2005, Revista Espanola de Cardiologia
En la implantación de stent con predilatación la ecografía intracoronaria ha demostrado que la reducción luminal tardía se debe a la proliferación neointimal. En la presente serie analizamos el grado y la distribución de la proliferación neointimal intra-stent después de la implantación sin predilatación, así como las variables implicadas en esta respuesta proliferativa.
Se analizó a 45 pacientes después de la implantación exitosa de un stent sin predilatación y 23 pacientes con lesiones de características clínicas y angiográficas similares después de la implantación de un stent con predilatación. La ecografía intracoronaria en el seguimiento se realizó a los 7,85 ± 2,81 meses. Se midieron las áreas transversales (AT) en 5 segmentos predeterminados del segmento con stent. En el grupo de stent directo se empleó una presión de hinchado mayor que en el grupo con predilatación (13 ± 3 atm frente a 10 ± 2 atm; p = 0,005).
Los AT luminal y del stent fueron mayores en el grupo sin predilatación que en el grupo con predilatación. La proliferación neointimal en los 5 segmentos a lo largo del eje axial del stent fue similar en los dos grupos. Se observó una ligera relación lineal entre la placa fuera del stent y la proliferación neointimal en el grupo con predilatación (r = 0,37; p = 0,005) y sin predilatación (r = 0,33; p = 0,005).
De forma similar a la angioplastia convencional, en el stent directo la respuesta neointimal presenta un patrón difuso y homogéneo a lo largo del eje longitudinal del stent. Esta respuesta proliferativa se correlacionó ligeramente con la placa excluida por el stent.
Intravascular ultrasound (IVUS) studies in conventional stent angioplasty with predilatation have demonstrated that late luminal narrowing is caused by neointimal proliferation. In the present study, we analyzed the degree and distribution of in-stent neointimal proliferation after direct stent implantation and aimed to identify variables that predict a proliferative response.
We studied 45 patients who underwent successful stent implantation without predilatation and 23 patients with similar clinical and angiographic characteristics who underwent conventional stent angioplasty with predilatation. IVUS imaging was performed at 7.85±2.81 months. The cross-sectional area was measured at five predetermined points in the stented coronary segment. The inflation pressure used in patients who underwent direct stent implantation was higher than that employed in those who underwent conventional angioplasty with predilatation (13±3 atm vs 10±2 atm; P=.005).
Luminal and stent cross-sectional areas were greater in the group that did not undergo predilatation than in the group that did. Neointimal proliferation in the 5 sections analyzed along the axis of the stent was similar in the 2 groups. There was a weak linear relationship between the amount of plaque outside the stent and neointimal proliferation in both the group that underwent predilatation (r=0.37; P=.005) and the group that did not (r=0.33; P=.005).
As with conventional angioplasty, the neointimal proliferation that occurred after direct stent implantation showed a diffuse homogeneous pattern along the length of the stent. There was a weak correlation between this proliferative response and the amount of plaque outside the stent.
Direct stenting in saphenous vein grafts. Immediate and long-term results
2005, Revista Espanola de Cardiologia
Las intervenciones percutáneas en los injertos de vena safena se asocian con peores resultados que las efectuadas en los vasos nativos, fundamentalmente por el riesgo de embolización. El stenting directo puede disminuir la agresión sobre el vaso. Se estudian los resultados del stenting directo en las safenas.
Se comparan 2 cohortes de pacientes consecutivos con implante de stent en las safenas mediante técnica directa (SD) y predilatación (PD) realizado entre septiembre de 1998 y marzo de 2003. Se analizan los resultados intrahospitalarios y a largo plazo y los predictores de mortalidad.
Se utilizó la SD en 71 pacientes con 83 lesiones y la PD en 46 pacientes con 54 lesiones. No hubo diferencias en cuanto a la edad, los factores de riesgo, la edad del injerto, la fracción de eyección, la longitud del stent, la situación posdilatación y número de stents por lesión, aunque sí en las mujeres (SD en el 38% y PD en el 17%; p = 0,02) y el diámetro del stent (SD, 3,59 ± 0,59 mm; y PD, 3,21 ± 0,59 mm; p = 0,001). Se observó una elevación del doble de los valores normales de la creatincinasa en el 10% de los pacientes (el 7% en el grupo SD y el 16% en el grupo PD; p = 0,1). Se produjo un caso de mortalidad intrahospitalaria. La mediana de seguimiento fue de 36,1 meses. La supervivencia global de la serie a los 12, 24, 36, 48 y 60 meses fue del 94 ± 2, el 87 ± 3, el 82 ± 17, el 67 ± 8 y el 58 ± 7%, respectivamente. La tasa de revascularización de la lesión tratada fue del 14% y la del vaso tratado del 20,5%, sin diferencias entre los grupos en la mortalidad y la revascularización. Los predictores de mortalidad fueron la fracción de eyección y el tabaquismo.
La supervivencia después de implante de un stent en injertos de safena es similar con SD y PD, aunque se observa una menor tendencia hacia la incidencia de infarto con la primera. Aunque los resultados intrahospitalarios son favorables, la supervivencia a largo plazo es menos favorable con ambas técnicas.
Percutaneous interventions on saphenous vein grafts are associated with a worse outcome than in native vessels, mainly because of the risk of embolization. Direct stenting may diminish aggression to the vessel. This study reports the results of direct stenting in saphenous vein grafts.
We compared 2 cohorts of consecutive patients treated with direct stenting (DS) and stenting with predilatation (PD) in saphenous vein grafts between September 1998 and March 2003. In-hospital and long-term results and predictors of mortality were analyzed.
The DS group contained 71 patients with 83 lesions, and the PD group contained 46 patients with 54 lesions. There were no differences in age, risk factors, age of the graft, ejection fraction, stent length, need for postdilatation or number of stents per lesion, although the DS group contained more women (DS=38%, PD=17%, P=.02), and stent diameter was larger (DS=3.59 [0.59] mm, PD=3.21 [0.59] mm, P=.001) in the DS group. Creatine phosphokinase elevation was ≥ 2-fold in 10% (DS= 7%, PD=16%, P=.1). One patient died in the hospital. Median follow-up time was 36.1 months. Survival was 94± 2% at 12 months, 87±3% at 24 months, 82±17% at 36 months, 67±8% at 48 months and 58±7% at 60 months. Revascularization rate was 14% for the target lesion and 20.5% for the target vessel, with no differences between groups in mortality or revascularization success rate. Predictors of mortality were ejection fraction and smoking habit.
Survival after stenting in saphenous vein grafts is similar with direct and conventional techniques, although there was a tendency toward a lower incidence of myocardial infarction with the former. Although the inhospital results were favorable, long-term survival was less favorable with both techniques.

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Coronary Artery DiseaseDirect stent implantation without predilatation using the multilink stent

Abstract

Section snippets

Patient selection

Results

Comparison with standard technique

J Am Coll Cardiol

J Am Coll Cardiol

J Am Coll Cardiol

Am J Cardiol

J Am Coll Cardiol

A randomized comparison of coronary stent placement and balloon angioplasty in the treatment of coronary artery disease

N Engl J Med

A comparison of balloon-expandable stent implantation with balloon angioplasty in patients with coronary artery disease

N Engl J Med

Experimental validation of geometric and densitometric coronary measurements on the new generation Cardiovascular Angiography Analysis System (CAAS II)

Cathet Cardiovasc Diagn

Coronary Artery Disease
Direct stent implantation without predilatation using the multilink stent