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Introduction Direct stenting (DS) is associated with improved markers of reperfusion during primary percutaneous coronary intervention (PPCI) for ST-elevation myocardial infarction (STEMI). However, data evaluating its impact in small vessel coronary artery disease (CAD) are lacking. Aim To compare DS and conventional stenting (CS) for small vessel CAD on clinical outcomes of patients with STEMI undergoing PPCI. Material and methods A cohort of 616 STEMI patients treated with DS (202 patients) or CS (414 patients) in small vessel (≤ 2.75 mm) lesions was retrospectively analyzed. The primary endpoint was to compare the occurrence of major adverse cardiac events (MACE) between groups during 2-year follow-up. The secondary end points included in-hospital target lesion revascularization (TLR) and in-hospital death. Results The primary end-point, MACEs, occurred in 9.2% in the DS group and 12.3% in the CS group (p > 0.05). The rates of TLR, myocardial infarction (MI) and target vessel revascularization (TVR) were not significantly different between groups (p > 0.05). The stent thrombosis (ST) rate was significantly lower in the DS group (1.0% vs. 4.2%, p = 0.04) at 2 years. However, DS was not found to be an independent predictor of ST in multivariate analysis. There were no significant differences in in-hospital rates of death and TLR. The DS compared to CS resulted in greater rates of postprocedural TIMI grade 3 flow, and lower risk of edge dissection. The procedure time, radiation exposure and contrast administration were found to be significantly lower in the DS group. Conclusions In selected patients with STEMI undergoing PPCI for small vessel CAD, DS is not only safe and feasible but also reduces ST rates, contrast load, and procedural and radiation exposure time.

Background: Direct stenting without pre-dilation or post-dilation has been advocated for saphenous vein graft percutaneous coronary intervention to decrease the incidence of distal embolization, periprocedural myocardial infarction, and target lesion revascularization. Methods: We performed a post hoc analysis of patients enrolled in the DIVA (Drug-Eluting Stents Versus Bare Metal Stents in Saphenous Vein Graft Angioplasty; NCT 01121224) prospective, double-blind, randomized controlled trial. Patients were stratified into stent-only and balloon-stent groups. Primary end point was 12-month incidence of target vessel failure (defined as the composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization). Secondary end points included all-cause death, stent thrombosis, myocardial infarction, and target lesion revascularization during follow-up. Results: Of the 575 patients included in this substudy, 185 (32%) patients underwent stent-only percutaneous coronary intervention. Patients in the stent-only versus balloon-stent group had similar baseline characteristics and similar incidence of target vessel failure at 12-months (15% versus 19%; hazard ratio, 1.34 [95% CI, 0.86–2.08]; P =0.19). During long-term follow-up (median of 2.7 years), the incidence of definite stent thrombosis (1% versus 5%; hazard ratio, 9.20 [95% CI, 1.23–68.92]; P =0.0085), the composite of definite or probable stent thrombosis (5% versus 11%; hazard ratio, 2.52 [95% CI, 1.23–5.18]; P =0.009), and target vessel myocardial infarction (8% versus 14%; hazard ratio, 1.92 [95% CI, 1.08–3.40]; P =0.023) was lower in the stent-only group. Multivariable analysis showed that a higher number of years since coronary artery bypass grafting and >1 target saphenous vein graft lesions were associated with increased target vessel failure during entire follow-up, while preintervention Thrombolysis in Myocardial Infarction-3 flow was protective. Conclusions: In patients undergoing percutaneous coronary intervention of de novo saphenous vein graft lesions, there was no difference in target vessel failure at 12 months and long-term follow-up in the stent-only versus the balloon-stent group; however, the incidence of stent thrombosis was lower in the stent-only group, as was target vessel myocardial infarction. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT 01121224.

A large thrombus burden is not uncommon in primary percutaneous coronary intervention, and is associated with more frequent complications. The role of intracoronary thrombolysis and glycoprotein IIb/IIIa inhibitors in the management of a large thrombus burden is discussed. The use of thromboaspiration must follow a particular logic and used with rigorous manipulations; the capacities of the protective filters are often exceeded. Stents dedicated to thrombus management can be used. Interest and limits of these stents are developed. Direct stenting should be encouraged, and delayed stenting probably considered for the most important thrombotic burden despite "negative" results in studies.

Introduction: The SLENDER Integrated Delivery System (IDS™) is an ‘all-in-one’ fixed-wire coronary stenting device designed for direct stenting, precluding the need for conventional guidewires and predilatation balloons. It achieves ultra-low profiles (crossing profiles as low as 0.031” / 0.79), enabling the downsizing of catheters to facilitate TRI across wider subsets of patients.Areas covered: This paper aims to evaluate the SLENDER IDS for the treatment of coronary artery disease.Expert commentary: The system represents the first advance in coronary stent delivery since the introduction of rapid-exchange stent delivery systems more than 20 years ago. SLENDER IDS has demonstrated non-inferiority compared with commercial DES, excellent long-term safety and a potentially more efficient approach to PCI where patient comfort is enhanced, procedures are streamlined and resource consumption is reduced.

Objective The aim of this study is to compare the procedure and treatment outcomes of using either direct stenting alone following pharmacomechanical thrombectomy or continued catheter-directed thrombolysis after stenting for treatment of acute left iliofemoral deep vein thrombosis while clot removal degree achieved grade III. Methods From March 2018 to May 2019, 82 patients who underwent iliac venous stenting for treatment of acute left iliofemoral deep vein thrombosis with iliac vein stenosis after pharmacomechanical thrombectomy therapy using the AngioJet system while Clot removal degree achieved grade III were divided into two groups: Direct stenting alone group ( n = 39) and continued catheter-directed thrombolysis after stenting group ( n = 43). Comparisons were made regarding the treatment outcomes, stent patency rate, and Villalta scale between these two groups. Results No serious perioperative complications occurred. The mean urokinase dose and hospitalization time in the stenting alone group and continued catheter-directed thrombolysis after the stenting group were 0.30 million U versus 1.76 ± 0.54 million U and 4.85 ± 0.93 days versus 6.33 ± 1.02 days, ( P Conclusion When the clot removal degree of pharmacomechanical thrombectomy thrombectomy reaches grade III, both stenting alone and continued catheter-directed thrombolysis after stenting are effective treatment modalities. For young patients with low bleeding risk, continued catheter-directed thrombolysis after stenting has a better patency rate and a lower 1-year post-thrombotic syndrome risk and does not increase major bleeding events. However, it may increase the time and costs of hospitalization accordingly.

Blue Finger Syndrome is a manifestation of atheromatous embolization at the upper limb. It's a rare pathology, with risk of recurrence and tissue lose, which could be particular troublesome at the upper limb. The authors present a case of a Blue Finger Syndrome secondary to an atherosclerotic plaque in the right subclavian artery (which is an unusual location), corrected with a stent. The majority of authors consider that the embolization source should be corrected. If it is not corrected, there is a risk of re-embolization, which may threaten the limb viability. Endovascular treatment is safe and efficacious. Direct stenting, especially with closed stents design appear to be the safest technique to trap thrombi and prevent distal thrombus embolization.

DES implant in uncalcified CAD can occur with or without vessel prep. It remains unclear if vessel prep (vs. high-pressure direct stenting) and/or DES architecture impact stent expansion/strut apposition. We randomized 21 PCI pts with minimally calcified (ACC/AHA Type A/B1) lesions to 3 DES implant

Aims The multi-center SPEED registry evaluated the procedural success and in-hospital clinical outcomes of direct stenting with the Svelte ‘all-in-one’ coronary stent Integrated Delivery System (IDS) through diagnostic catheters to identify the clinical indications for which this approach is appropriately suited. Methods & results Forty-eight (48) patients with 54 lesions of lengths ≤20 mm and RVD 2.5–3.5 mm were targeted for direct stenting through diagnostic catheters (4–6F) via radial or femoral approach. Procedural characteristics early in an investigator's experience (28 lesions) were compared with outcomes following experience (26 lesions). Procedure, device and strategy success were realized in 54 (100%), 50 (93%) and 46 (85%) lesions, respectively, with strategy success significantly related to RVD (P = 0.05), lesion location (P = 0.01), and diagnostic catheter size (P = 0.05). Significant improvement in crossing and intervention time and trends toward improvement in device and strategy success, reductions in procedure and radiation time and contrast use were observed. Conclusions Direct stenting through diagnostic catheters via radial or femoral approach using the Svelte IDS is feasible and associated with good in-hospital outcomes. This approach offers the attractive option of assessing lesions via diagnostic catheter and, depending upon vessel anatomy and lesion morphology, continuing with ad-hoc interventional treatment using the same diagnostic catheter. Improvements in strategy success and procedural efficiencies, based on operator experience, facilitate catheter downsizing and reduce intervention time, ancillary product use and overall procedure costs. © 2014 Wiley Periodicals, Inc.

Primary percutaneous coronary interventions (PCIs) significantly reduce mortality in patients with ST-segment elevation myocardial infarction (STEMI). But the mortality rate in women remains higher than in men. Despite considerable improvements in STEMI mortality for women and men over the last 3

DES may be deployed with or without vessel prep in uncalcified CAD. It is unknown if vessel prep improves DES expansion/apposition vs. high-pressure direct stenting and if the architecture of individual DES platforms impacts expansion. High-resolution OCT is an ideal tool for measuring DES sizing/

Aims: Our aim was to demonstrate the safety and efficacy of the Svelte sirolimus-eluting coronary stenton-a-wire Integrated Delivery System (IDS) with bioresorbable drug coating compared to the Resolute Integrity zotarolimus-eluting stent with durable polymer in patients with de novo coronary artery lesions. Methods and results: Direct stenting, particularly in conjunction with transradial intervention (TRI), has been associated with reduced bleeding complications, procedure time, radiation exposure and contrast administration compared to conventional stenting with wiring and predilatation. The low-profile Svelte IDS is designed to facilitate TRI and direct stenting, reducing the number of procedural steps, time and cost associated with coronary stenting. DIRECT II was a prospective, multicentre trial which enrolled 159 patients to establish non-inferiority of the Svelte IDS versus Resolute Integrity using a 2:1 randomisation. The primary endpoint was angiographic in-stent late lumen loss (LLL) at six months. Target vessel failure (TVF), as well as secondary clinical endpoints, will be assessed annually up to five years. At six months, in-stent LLL was 0.09±0.31 mm in the Svelte IDS group compared to 0.13±0.27 mm in the Resolute Integrity group (p

The aim of the study is to assess serum Cardiac Troponin-I level in patients who have underdone Percutaneous coronary intervention (PCI) as an indication of myocardial injury and. Compare the troponin-I level in direct or conventional stetting in PCI and assess the superiorty of two methods of PCI, regarding myocardial injury and outcome. Cardiac Troponin-I (cTnI) is known to have the highest specificity & analytic sensitivity for detection of myocardial injury. This study was aimed to compare between conventional and direct stenting by assessing of serum cTnI. This observentional study was carried out in the Deparment of Biochemistry, Dhaka Medical College & Dept. of Cardiology, Ibrahim Cardiac Hospital and Research Institute during the period from July 2007 to June 2008. In this study we enrolled 60 diagnosed cases of coronary heart disease patients which were grouped as direct stenting (30 patients) and conventional stenting (30 patients) group. In this study, the age of the patients ranged from 42-72 years with a mean of 56.7 (±7.1) years. Male and female participants were 44 and 16 respectively. The mean left ventricular ejection fraction of them were 55.43 (±7.9) %. The difference of the mean troponin-I level before direct and conventional stenting was similar. Although the mean level of troponin-I after conventional stenting was higher (0.081± 0.042) than that of direct stenting (0.066±0.042), the difference of means was not statically significant (P> 0.05). Significant difference was observed between the mean before and after direct stenting as well as conventional stenting. From our observation we can conclude that serum cTnI level was higher after conventional stenting than that of direct stenting but the difference of means was not statically significant. It rises significantly after Percutaneous coronary intervention regardless of the type of procedure, whether direct or conventional stenting. Though the clinical outcome is reported to be similar in direct and conventional stenting, the direct stenting requires less procedural and equipment cost as well as less exposure time to radiation. DOI: http://dx.doi.org/10.3329/uhj.v7i1.10206 UHJ 2011; 7(1): 23-27

Compared to balloon predilation, direct stenting (DS) shortens procedural time and reduces radiation and contrast exposure. A meta-analysis that included 7 studies comparing these 2 strategies revealed lower adverse event rate with DS. Studies included in the present meta-analysis were mostly observational and utilized first generation drug-eluting stent. Patient and lesion selection may explain these positive results.

Objectives: The aim of this study was to determine whether rheolytic thrombectomy (RT) before direct infarct artery stenting as compared with direct stenting (DS) alone results in improved myocardi...

Preliminary studies suggest that direct stenting (DS) during percutaneous coronary intervention (PCI) may reduce microvascular obstruction and improve clinical outcome. Thrombus aspiration may facilitate direct stenting. We assessed the impact of DS on myocardial reperfusion and clinical outcome and

INTRODUÇÃO: Existem poucos estudos contemporâneos avaliando o implante de stent direto em pacientes com infarto agudo do miocárdio com supradesnivelamento do segmento ST (IAM). MÉTODO: Estudo de coorte prospectivo com pacientes consecutivamente atendidos com IAM em um centro de referência em cardiologia entre dezembro de 2009 e janeiro de 2010. Dados clínicos e laboratoriais, características angiográficas e evolução hospitalar foram avaliados. Foram excluídos pacientes com mais de 12 horas de evolução, com menos de 18 anos de idade ou por recusa em participar do estudo. Os pacientes submetidos a implante de stent direto foram comparados àqueles tratados com pré-dilatação. Os dados foram armazenados em banco de dados dedicado e analisados com SPSS 17.0. RESULTADOS: No período do estudo, 98 pacientes foram submetidos a angioplastia primária, dos quais em 33 (34,7%) foi implantado stent direto e em 65 (65,3%) foi realizada pré-dilatação. A média de idade dos 98 pacientes foi de 58,6 ± 10,6 anos e 63% eram do sexo masculino. Os procedimentos com stent direto foram menos frequentes em lesões calcificadas (9% vs. 30%; P = 0,02) e mais frequentes naqueles com TIMI 3 pré-procedimento (41% vs. 18%; P = 0,06), sendo a tromboaspiração mais frequentemente utilizada nestes casos (41% vs. 14%; P = 0,003). Não houve diferença estatisticamente significante em relação aos desfechos clínicos nos dois grupos de pacientes. CONCLUSÃO: A técnica de stent direto foi mais frequentemente utilizada em pacientes com fluxo normal antes do procedimento e em conjunto com tromboaspiração, e menos usada em lesões calcificadas. O implante de stent direto não foi associado a diferenças significativas nas taxas de desfechos clínicos. BACKGROUND: There are few contemporary studies assessing direct stenting in patients with acute ST-segment elevation myocardial infarction (AMI). METHOD: Prospective cohort study in consecutive patients with AMI seen at a reference cardiology center from December 2009 to January 2010. Clinical and laboratory data, angiographic characteristics and hospital outcomes were evaluated. Patients with over 12 hours of symptom onset, with less than 18 years of age and those who denied participating in the study were excluded. Patients undergoing direct stenting were compared to those treated with stent with balloon pre-dilatation. Data were entered in a dedicated database and analyzed by SPSS 17.0. RESULTS: During the study period, 98 patients were submitted to primary angioplasty, of which 33 (34.7%) received direct stenting and 65 (65.3%) underwent stent with balloon pre-dilatation. Mean age was 58.6 ± 10.6 years and 63% were men. Direct stenting was less frequent in calcified lesions (9% vs. 30%; P = 0.02) and more frequent in those with TIMI 3 before the procedure (41% vs. 18%; P = 0.06) and thrombus aspiration was more frequently used in these cases (41% vs. 14%; P = 0.003). There was no statistically significant difference for the clinical outcome in both groups of patients. CONCLUSION: Direct stenting was more frequently used in patients with normal flow prior the procedure and in combination with thrombus aspiration and less used in calcified lesions. It was not associated to significant differences in clinical outcome rates.

To develop and prospectively evaluate the safety and efficacy of an algorithm for tailoring neuroprotection devices (NPD) and stent types to the patient/lesion in carotid artery stenting (CAS).From November 2002 to October 2007, 499 patients (360 men; mean age 65.2+/-8.4 years, range 36-88) were prospectively enrolled in a safety and efficacy study of tailored CAS using proximal (flow blockade or reversal) or distal (filters or occlusion) NPDs and closed- or open-cell self-expanding stents. Of the 535 lesions treated in the study, 175 (32.7%) were "high risk" by morphology. Half (50.1%) the patients were symptomatic.A quarter (137, 25.6%) of the procedures were performed under proximal protection and the remainder (398, 74.4%) with distal NPDs; the direct stenting rate was 66.9%. High-risk lesions were treated predominantly with a proximal NPD and closed-cell stent (77.1% and 82.9%, respectively) and less frequently by direct stenting (37.1%, p0.0001 versus non-high-risk lesions). The in-hospital death/stroke rate was 2.0% (95% CI 0.85% to 3.23%), and the death/major stroke rate was 0.7% (95% CI 0.02% to 1.48%). There were no myocardial infarctions, but there was 1 (0.2%) further death within 30 days. With the tailored approach, symptom status and high-risk lesion morphology were not risk factors for an adverse outcome after CAS; only age75 years (p0.001) was a predictor of short-term death. Long-term survival (95.4% at 1 and 88.3% at 5 years) was similar for symptomatic versus asymptomatic patients, direct stenting versus predilation, and closed- vs. open-cell stent design; only coronary artery disease adversely impacted survival (p = 0.04). The rates of freedom from death/ipsilateral stroke were 94.9% at 1 year and 85.9% at 5 years.Tailored CAS is associated with a low complication rate and high long-term efficacy. CAS operators should have a practical knowledge of different NPDs, including at least one proximal type.

Direct stenting without predilatation is a well-defined, feasible method with bare metal stents. Direct stenting has also been shown to be safe and feasible with drug-eluting stents, however, there is much less evidence with this type of device when compared with bare metal stents. Three hundred and sixty-four coronary lesions in 257 consecutive patients (mean age, 57.4 +/- 9.8 years; 63 women) who had undergone elective stenting either with or without predilatation via a paclitaxel-eluting stent between March 2003 and March 2006 were retrospectively analyzed. Quantitative coronary angiography analysis was compared between the two groups of procedures; stenting with predilatation and direct stenting. All procedures were uneventful. No deaths occurred during the follow-up period. Direct stenting when compared with the predilatation technique, significantly decreased both procedure time (32.1 +/- 17.9 minute versus 41.2 +/- 18.6 minute, P < 0.0001) and fluoroscopy time (10.6 +/- 7.8 minute versus 15.5 +/- 7.6 minute, P < 0.0001). There was no difference in quantitative analysis parameters of coronary angiography during follow-up or the rates of stent thrombosis and restenosis. Direct stenting seems to be as feasible and safe as conventional predilatation and stenting in selected cases. Direct stenting seems to decrease procedural time and radiation exposure without any negative effect on quantitative analysis parameters of coronary angiography with approximately a one-year follow-up period.

We present a case of a bifurcation lesion treated with two dedicated sirolimus eluting bifurcation stents, BiOSS Lim in the setting of non-ST elevation myocardial infarction and poor left ventricular function. We demonstrate the feasibility of a new technique, a "simplified" culotte technique. The key differences of this new technique compared with conventional culotte are: better sizing of the stent due to the specific design of the stent with a larger proximal diameter and smaller distal diameter, direct stenting of the second stent without predilatation of the stent struts of the first deployed stent, and possibility to perform post-dilatation directly with properly sized balloons without additional predilatation.

To report a case of incomplete expansion, fracture, and thrombosis of a stent in the renal artery.A 47-year-old man with right renal artery occlusion underwent direct stenting of the left renal artery using a balloon-expandable stent. Completion angiography showed satisfactory patency of the vessel although the stent was not fully expanded in its central segment. The patient received 5000 units of heparin during the procedure, but no additional anticoagulant or antiplatelet therapy in the peri/postinterventional period. Twenty-five days later, he presented with acute renal insufficiency and uncontrolled hypertension. Angiography revealed in-stent thrombosis and collateral flow in the distal segment of the left renal artery. He underwent an aortorenal bypass, which salvaged the kidney. The stent, after removal from the vessel, was fractured and not completely expanded.Incomplete expansion and fracture of the stent associated with insufficient antiplatelet therapy produced in-stent thrombosis. Collateral flow prevented kidney necrosis.

The sirolimus-eluting stent has been studied extensively in randomized controlled trials of patients with native de novo coronary lesions. Lesion predilation before stent placement has been the predominant implantation strategy in these trials. Direct implantation of the sirolimus-eluting stent without lesion predilation has been undertaken at the investigators' discretion in certain trials as well as in patients enrolled in a post-marketing surveillance registry, and was the intended implantation strategy in the DIRECT trial. Comparisons with patients receiving sirolimus-eluting stents after lesion predilation in the trials and the registry were all confounded by imbalances in patient, lesion, and/or procedural characteristics and point to the highly selective nature of the direct-stenting strategy. At present, direct implantation of the sirolimus-eluting stent appears to be safe and as effective as conventional (predilated) stenting, provided that the targeted coronary lesion is amenable to the direct approach. Since a randomized trial of implantation strategies is lacking, there is no conclusive evidence as to the hypothesized superiority of direct over predilated stenting in suitable coronary lesions.

Objectives We sought to assess the impact of direct stenting (DS) using the sirolimus-eluting stent (SES) on angiographic and clinical outcomes. Background The SES is superior to bare-metal stents in the treatment of native de novo coronary artery lesions in randomized, controlled trials. Methods A post hoc analysis was performed on 225 patients (158 men; 62 ± 11 years old) who received SES in the pooled cohorts of the European and Canadian Sirolimus-Eluting Stent in Coronary Lesions (E-SIRIUS and C-SIRIUS, respectively) trials. Of these patients, 57 (25%) had undergone DS at the investigator's discretion. Lesion predilation preceded SES implantation in the remaining 168 patients. Results Patient and lesion characteristics were no different between the two subgroups, except for a lower prevalence of moderate to severe lesion calcification (5% vs. predilation 19%, p = 0.017) and a lower baseline diameter stenosis (61.6% vs. predilation 68.1%, p Conclusions Direct SES deployment performed at the investigator's discretion was as safe and efficacious at mid-term follow-up as stenting preceded by lesion predilation.

Stenting is a potential alternative treatment for carotid artery stenosis. Direct stenting may, theoretically, reduce the risk of embolism by minimizing plaque manipulation before tissue scaffolding is achieved. The results of direct carotid stenting are reported and compared with those of stenting with predilatation. One hundred and seventy-four carotid artery stenoses were treated from July 1998 to February 2002, with 84 lesions directly stented (Group 1) and the other 90 lesions stented after predilatation (Group 2). The criteria for direct stenting were minimal luminal diameter (MLD) > 1 mm and no visible thrombus angiographically. Technical success rates of the two groups were both 100%, without any cross-over. Reference vessel diameter and lesion length did not differ between the two groups. In Group 1, diameter stenosis was lower (79 ± 8 vs 92 ± 7%, P

Although direct coronary stenting does not improve angiographic outcome, it makes sense by reducing procedure times, radiation exposure and costs. Other potential advantages of direct stenting may be a reduction of myocardial ischemia time, which could be clinically relevant in high-risk patients. With the introduction of drug-eluting stents, however, concern arose that direct stenting would possibly damage the polymer coating and change or diminish the efficacy of the programmed drug release. Also, concerns about safety by preventing optimal apposition of single stent struts developed. It is the purpose of this paper to retrospectively analyze the data from the TAXUS-II Trial (536 patients) regarding patients with and without direct stenting. While predilatation was recommended per protocol, direct stenting was not forbidden: thus, direct stenting was performed in 49 patients (TAXUS n = 23, control n = 26). In the TAXUS groups, there was no significant difference regarding major adverse cardiac events (MACE; 7.5% vs. 4.3%), angiographic restenosis in the analysis segment (4.8% vs. 4.3%), late loss (0.28 ± 0.36 vs. 0.33 ± 0.30 mm) or intravas- cular ultrasound-(IVUS-)measured volume obstruction (7.95 ± 9.84% vs. 5.61 ± 7.91%) at six months between the predilated and directly stented patients. The same was true for the patients receiving the control stent. Compared with the directly stented control group, the statistically significant positive effects of TAXUS direct stenting were maintained, regarding angiographic restenosis in the analysis segment (4.3% vs. 30.8%), late loss (0.33 ± 0.30 vs. 0.80 ± 0.62 mm) or IVUS-measured volume obstruction (5.61 ± 7.91% vs. 22.50 ± 21.62%) at six months. MACE was reduced from 19.2% to 4.3%; due to the small number of patients this trend did not reach statistical significance. After predilatation, all parameters were significantly improved by the TAXUS stent. Comparison of patients receiving TAXUS stents with or without predilatation revealed no differences in clinical, angiographic or IVUS parameters at six months. This suggests that direct stenting with the polymer-based paclitaxeleluting TAXUS stent is feasible, safe and equally effective. Randomized trials comparing stenting after predilatation versus direct stenting with drug-eluting stents are warranted.

The influence of stent diameter in a direct stenting technique was analyzed. We retrospectively identified 987 consecutive lesions in 773 patients in whom direct stenting was attempted. Lesions were divided into two groups: group 1, nominal stent diameter 2.5 mm (237 lesions) and group 2, > or =2.75 mm (n=750). Differences between groups were found in age (64.4 [10.4] vs 62.3 [11] P=.009), female sex (33.2% vs 17%; P

To determine the impact of operator experience on procedural, clinical and angiographic outcome after (direct) coronary stent implantation.Although for other forms of percutaneous coronary interventions an inverse relationship between operator volume and patient outcomes has been shown, the impact of operator volume on outcome after direct stenting has never been investigated.A retrospective analysis was performed on data from a prospective randomized trial comparing direct stenting with that after predilatation. The trial consisted of 400 patients with stable and unstable angina pectoris and/or myocardial ischemia due to a coronary stenosis of a single native vessel eligible in 1999-2001 for direct stenting. For a single-center high-volume clinic (1500 cases/year), the authors compared the most experienced operators (case load:4000) with well trained practitioners (case load: 175). One hundred and fifteen patients were identified who were treated by high-volume and 180 who were treated by medium-volume operators.Baseline patient characteristics were evenly distributed among groups. High-volume, compared with medium-volume operators, were faster (30.8 versus 42.2 minutes, p0.001), needed less frequent postdilatation (15% versus 24%, p = 0.06) and had lower fluoroscopy times (7.5 versus 11.2 minutes, p0.001), lower contrast usage (180 versus 228 ml, p0.001), lower procedural costs (euro1982 versus euro2164, p = 0.05) and reduced rates of major adverse cardiac and cerebral event (MACCE) at six months (12.2 versus 21.1%, p = 0.03). The medium-volume operator group experienced higher angiographic binary restenosis rates after direct stenting compared with stenting after predilatation (31.5 versus 14.9%, p = 0.005).Stenting performed by high-volume operators resulted in a 50% reduction in MACCE as compared with medium-volume physicians, which also had twice as much restenosis when using direct stenting. Hence, the more demanding technique of direct stenting should not be performed by unsupervised operators who have not yet completed their training. Furthermore, prolonged training periods and even more intensive supervision by experienced operators seems mandatory.

IVUS is considered as the most accurate tool for the assessment of optimal stent deployment. Direct stenting has shown to be a safe, efficient, and resource-saving procedure in selected patients. In a prospective 1-month feasibility trial, a new combined IVUS-coronary stent delivery platform (Josonics Flex, Jomed, Helsingborn, Sweden) was evaluated during direct stenting in consecutive patients considered eligible for direct stenting. The feasibility endpoint was successful stent deployment without any clinical adverse event, while the efficacy endpoint was strategic adaptation according to standard IVUS criteria for optimal stent deployment at the intermediate phase (after a result considered angiographically optimal) and at the end of the intervention (after optimization according to IVUS standards). A total of 16 patients were successfully treated with this device without any major clinical complication. At the intermediate phase, optimal stent deployment was achieved in four patients only, while at the end only one patient had nonoptimal IVUS stent deployment. In particular, the minimal in-stent cross-section area increased from 6.3 +/- 1.2 to 8.3 +/- 2.5 mm(2). These preliminary data demonstrate the feasibility of direct stenting with a combined IVUS-stent catheter in selected patients and confirm the results from larger randomized trials on the impact of IVUS on strategic adaptations during coronary stent placement.

With conventional stenting, predilatation frequently induces dissections that require deploying stents longer than originally planned. To assess whether direct stenting is safe and may prevent dissections and reduce the length of stents implanted, we conducted a randomized study comparing direct (n = 73) and conventional (n = 78) stenting. Direct stenting was successful in 89% of cases, 11% crossed over to predilation without complications. Dissections occurred more frequently in conventional stenting group (10.3% vs. 1.4%; P = 0.034), but did not translate to a significant stent length difference (16.31 ± 7.6 vs. 15.31 ± 5.5; P = NS). Periprocedure creatine kinase elevation and number of balloons utilized were lower with direct stenting. Cathet Cardiovasc Intervent 2003;58:434–440. © 2003 Wiley-Liss, Inc.

In order to reduce vascular complications, the authors assessed safety and feasability of a new percutaneous transluminal coronary angioplasty (PTCA) strategy consisting of direct stenting with 3000 i.u. heparin and immediate sheath removal. Predicting factors of vascular complications during PTCA include heparin dosages, sheath dwell time and use of anti-glycoprotein (GP) IIb/IIIa. A simplified PTCA with direct stenting technique may allow the use of very low doses of heparin without anti-GPIIb/IIIa in selected cases. From April 1999 to April 2000 all patients who underwent PTCA in the authors' center were screened. Exclusion criteria comprised a contraindication for direct stenting, primary PTCA for acute myocardial infarction (MI) and a TIMI (thrombolysis in myocardial infarction) grade zero flow. All other patients were included. They received 3000 i.u. heparin before direct stenting whatever their current anticoagulation and their weight. The sheath was immediately removed using manual compression. Out of 716 consecutive PTCA patients, 171 (24%) were enrolled in the study (198 sites). Complete protocol was achieved in 150 patients (88%). Activated clotting time during the procedure was 179 +/- 32 seconds. No subacute thrombosis or creatine kinase elevation was observed before discharge. Only two uncomplicated groin hematomas and two false aneurysms (one surgical repair) were noted. This study shows that direct stenting with 3000 iu heparin is safe. Immediate sheath removal can be performed with a low rate of major vascular complications.

A patient with postinfarction angina was referred for coronary angiography. In addition to severe atherosclerotic coronary disease, which was responsible for clinical presentation, a single coronary artery arising from the left sinus of Valsalva was found. The authors report the use of direct coronary stent deployment without predilation to treat disease in this rare anomaly.

Direct stenting could potentially lead to a reduction in dissections, time, and restenosis at 6-month follow-up. Using the premounted Palmaz-Schatz Crown stent elective stenting was performed without predilatation in 61 consecutive patients who were compared with a control group of provisional stenting. All patients underwent clinical and angiographic follow-up at 6 months. Direct stenting was successful in 81% of patients. In 16% of the patients predilatation was needed. In 3% the stent could not be implanted despite predilatation. Stent dislodgment occurred in 2% of patients, without embolization. Six-month angiographic follow-up was performed in 51 (84%) of 61 patients. In the direct stenting group the mean preprocedural minimal luminal diameter (MLD) increased from 0.96 +/- 0.47 to 3.09 +/- 0.54 mm directly after the procedure. At 6-month follow-up the MLD measured 2.32 +/- 0.79 mm. In the provisional stenting group the mean MLD increased from 0.92 +/- 0.51 to 2.44 +/- 0.58 mm and was 1.84 +/- 0.70 mm at 6-month follow-up. Restenosis, defined as a diameter stenosis > 50%, occurred in 8% of the direct stenting group compared with 28% in the provisional stenting group (P < 0.001). Direct coronary stent implantation can be attempted safely and efficaciously. The risk of stent loss is low. The initial and long-term angiographic results are significantly better as compared with provisional stenting. The risk of restenosis is significantly lower.

A thorough understanding of the diseased tissue state is necessary for the successful treatment of a blocked arterial vessel using stent angioplasty. The constitutive representation of atherosclerotic tissue is of great interest to researchers and engineers using computational models to analyse stents, as it is this in silico environment that allows extensive exploration of tissue response to device implantation. This paper presents an in silico evaluation of the effects of variation of atherosclerotic tissue constitutive representation on tissue mechanical response during stent implantation. The motivation behind this work is to investigate the level of detail that is required when modelling atherosclerotic tissue in a stenting simulation, and to give recommendations to the FDA for their guideline document on coronary stent evaluation, and specifically the current requirements for computational stress analyses. This paper explores the effects of variation of the material model for the atherosclerotic tissue matrix, the effects of inclusion of calcifications and a lipid pool, and finally the effects of inclusion of the Mullins effect in the atherosclerotic tissue matrix, on tissue response in stenting simulations. Results indicate that the inclusion of the Mullins effect in a direct stenting simulation does not have a significant effect on the deformed shape of the tissue or the stress state of the tissue. The inclusion of a lipid pool induces a local redistribution of lesion deformation for a soft surrounding matrix and the inclusion of a small volume of calcifications dramatically alters the local results for a soft surrounding matrix. One of the key findings from this work is that the underlying constitutive model (elasticity model) used for the atherosclerotic tissue is the dominant feature of the tissue representation in predicting tissue response in a stenting simulation.

Randomised trials have shown that direct stenting (DS) is associated with improved markers of reperfusion during primary percutaneous coronary intervention (PPCI) for ST elevation myocardial infarction (STEMI). However, data evaluating its impact on long-term clinical outcomes are lacking. We set out to evaluate the effect of DS on mortality in a contemporary population of patients undergoing PPCI for STEMI.Consecutive patients undergoing PPCI for STEMI at two high-volume UK heart attack centres between September 2008- December 2010 (n=1562) were included in the analysis. Local databases were analysed for patient demographics, as well as details on PPCI strategy, including use of DS versus predilatation (PD) followed by stenting, manual thrombus aspiration (MT) and glycoprotein IIb/IIIa inhibitors (GPIs). National databases were interrogated for in-hospital, 30-day and one-year mortality. To determine the impact of PPCI strategy on one-year survival, multivariate logistic analysis was performed.Altogether 489 patients underwent DS (31.3%) and 1073 (68.7%) received PD prior to stenting. Patients receiving DS had reduced mortality at 30 days (2.04 versus 4.66%, p=0.01) and one year (3.27 versus 8.48%, p=0.0001). After multivariate adjustment, PD remained an independent predictor of one-year mortality (odds ratio 2.42, 95% confidence interval 1.08-5.45, p=0.032) along with age, cardiogenic shock, number of diseased vessels, and left main or proximal left anterior descending artery intervention. However, neither GPI use nor MT improved survival in either univariate or multivariate analyses.In a contemporary, unselected population of patients undergoing PPCI for STEMI, DS - when compared with stenting after PD - is independently predictive of improved 30-day and one-year survival.

Direct stenting (DS) was attempted in 99 coronary lesions in 94 patients while standard stenting (SS) was attempted in 113 lesions in 103 patients matched for clinical characteristics, stenosis type, and location and stent type. The angiographic result was also evaluated according to TIMI frame count method (TFC) before and after procedure. A clinical follow-up was performed 1 year after the procedure. Before the procedure, TIMI grade 3 flow was detected in 42 cases (42.4%), grade 2 in 40 cases (40.4%), grade 1 in 5 cases (5.1%), and grade 0 in 12 cases (12.1%) in the DS group; these data were similar in SS group. After the procedure, TIMI grade flow was 3 in 90 cases (92.8%) in DS group and in 87 (77.0%) in SS group (P < 0.005); grade 2 was observed in 7 case (7.2%) in DS group and in 25 (22.1%) in SS group (P < 0.005). Major adverse cardiac events during hospitalization and at follow-up were similar in two groups. Radiation exposure time and procedure costs per lesion were significantly reduced in DS group compared to SS group (10.1 ± 8 min vs. 13.9 ± 4.7 min, P < 0.001; and 1901 ± 687 Euro vs. 2352 ± 743 Euro, P < 0.001, respectively). This study confirms that, in selected patients, direct stenting is a safe and successful procedure, allowing a significant reduction in radiation exposure time and procedural costs compared to standard stenting technique. The angiographic success is confirmed by the improvement in TFC in all cases. Cathet Cardiovasc Intervent 2001;53:464–473. © 2001 Wiley-Liss, Inc.

BACKGROUND: Implantation of coronary stents after predilatation is a standard approach in the treatment of most coronary lesions. Stenting without predilatation could be a possible alternative way of treating a certain subset of patients. OBJECTIVE: To identify a group of patients suitable for this optional method, to evaluate their immediate clinical and angiographic outcomes and to test the feasibility and safety of this new therapeutic concept. METHODS: Ninety selected patients with 91 lesions were treated by implantation of coronary stents without predilatation. RESULTS: The mean duration of this procedure was 12.3 +/- 9.1 min and the fluoroscopic time was 3.6 +/- 2.9 min. The stenoses before and after this procedure were 77 +/- 10 and 5 +/- 9%, respectively. Predilatation, postdilatation or implantation of an additional stent was necessary for seven patients. Primary success rate was 92% with an excellent immediate clinical and angiographic outcome. No major complications occurred during direct stenting. CONCLUSION: Direct stenting is feasible using commercially available stents and could be performed for about 20% of patients for whom coronary intervention is indicated. The proper selection of lesions is of crucial importance. Lesions eligible for direct stenting should be without visible calcifications and on vessels without proximal tortuosity. This procedure proved to be safe and successful in this series of coronary interventions.

To evaluate the feasibility of stenting without predilatation, we registered all interventional procedures over a 6-month period. Six hundred patients were registered, and 684 lesions were treated. Interventions were divided into four groups: stenting without predilatation (SWOP), 221 lesions (32.4%); primary stenting with predilatation (PDS), 161 lesions (23.5%); provisional stenting (PRS), 131 lesions (19.2%); and plain-old balloon angioplasty (POBA), 171 lesions (25%). Interventional strategy was at the discretion of the operator based on few simple angiographic criteria and his clinical judgment. Procedural success was similar in all stent groups. We conclude that when primary stenting is planned, about 60% of lesions can be treated by SWOP effectively with excellent procedural results and considerable cost saving.

This randomized trial compared a strategy of direct stenting without predilatation (n = 39) with conventional stenting with predilatation (n = 42) in patients with suitable lesions in native vessels > or = 2. 5-mm diameter to be covered by either a 9- or 16-mm-length NIR Primo stent. Equipment cost [mean (median) +/- SD] was less in those with direct stenting [$1,199 (979) +/- 526] than in those with predilatation [$1,455 (1,285) +/- 401, P < 0.001]. There was no significant difference in contrast use or fluoroscopy time. Procedural time was shorter in the direct stenting group. The clinical outcome at 1 month was satisfactory in both groups. In selected patients, a strategy of direct stenting is feasible, costs less, and is quicker to perform than the conventional strategy of stenting following predilatation.

Recently studies with routine thrombus aspiration (TA) showed negative results in patients with ST-elevation myocardial infarction (STEMI). The aim of the present study was to assess impact of selective TA followed by direct stenting during primary percutaneous coronary intervention (PPCI). Between

INTRODUÇÃO: Os benefícios da utilização de cateteres de aspiração de trombos durante intervenção coronária percutânea (ICP) primária, com obtenção de melhor fluxo coronário e perfusão miocárdica e redução da mortalidade tardia, já estão estabelecidos na literatura. No entanto, seu uso na prática clínica parece não estar aplicado a todos os pacientes. Procuramos saber quais variáveis clínicas e angiográficas têm norteado a indicação desses dispositivos na ICP primária em nosso meio. MÉTODOS: No período de agosto de 2006 a novembro de 2010, 558 pacientes foram submetidos consecutivamente a ICP primária. Em 79 pacientes foram utilizados cateteres de aspiração de trombos (grupo 1), comparativamente a 479 pacientes nos quais esses dispositivos não foram aplicados (grupo 2). RESULTADOS: O grupo 1 apresentou predomínio de sexo masculino, tabagistas, infarto agudo do miocárdio (IAM) de maior extensão e lesões trombóticas. O uso de inibidores da glicoproteína IIb/IIIa, da técnica de stent direto e de stents de maior diâmetro e a ocorrência de distúrbios de fluxo coronário transitórios também foram mais frequentes no grupo 1. A taxa de sucesso do procedimento foi alta (93,7% vs. 92,3%; P = 0,4) e similar entre os grupos. Na alta hospitalar, a incidência de eventos cardíacos e cerebrovasculares adversos maiores (6,3% vs. 6,5%; P = 0,6), óbito (5,1% vs. 3,8%; P = 0,58), acidente vascular cerebral (1,3% vs. 0,4%; P = 0,09) e reinfarto (0 vs. 2,3%; P = 0,17) não mostrou diferenças entre os grupos. CONCLUSÕES: Cateteres de aspiração de trombos têm sido utilizados em 15% das ICPs primárias, geralmente nos IAM de maior extensão e com maior carga trombótica. Apesar da maior gravidade clínico-angiográfica desses pacientes, o sucesso do procedimento é alto e semelhante ao dos demais pacientes de menor risco. BACKGROUND: The benefits of using thrombus aspiration catheters during primary percutaneous coronary intervention (PCI), to obtain better coronary flow and myocardial perfusion and reducing late mortality are established in the literature. However, in the clinical practice it does not seem to be used for all patients. We tried to determine what clinical and angiographic variables have led to the indication of these devices in primary PCI at our institution. METHODS: From August 2006 to November 2010, 558 patients were consecutively submitted to primary PCI. Thrombus aspiration catheters were used in 79 patients (group 1), who were compared to 479 patients who did not use these devices (group 2). RESULTS: Group 1 showed a prevalence of males, smokers, large acute myocardial infarctions (AMI) and thrombotic lesions. The use of glycoprotein IIb/IIIa inhibitors, direct stenting and larger diameter stents and the presence of transient coronary flow disturbances were also more frequent in group 1. Procedure success rate was high (93.7% vs. 92.3%; P = 0.4) and it was similar between groups. At hospital discharge, the incidence of major adverse cardiac and cerebrovascular events (6.3% vs. 6.5%; P = 0.6), death (5.1% vs. 3.8%; P = 0.58), stroke (1.3% vs. 0.4%; P = 0.09), reinfarction (0 vs. 2.3%; P = 0.17) was not different between groups. CONCLUSIONS: Thrombus aspiration catheters have been used in 15% of primary PCIs, usually in AMIs with greater extension and thrombotic burden. Despite the more severe clinical-angiographic profile of these patients the success rate is high and similar to that of low-risk patients.

There is conflicting evidence as to whether direct stenting (DS) is superior to balloon angioplasty with subsequent stenting (conventional stenting, CS) in patients presenting with ST-elevation myocardial infarction (STEMI). This study aimed at comparing DS and CS in STEMI using a systematic review

Stents are the most remarkable advance to occur in coronary artery disease management in the last 28 years. Stent re-engineering transformed early hand-crimped, bulky systems into safer, balloon-crimped devices, substantially reducing strut thickness while maintaining radial strength. This made

The authors report on the use of 5 French diagnostic catheters to deliver a stent-on-a-wire system during a double vessel coronary intervention.

This study was conducted to determine the influence of lesion preparation using the AngioSculpt balloon on final stent expansion. Stent expansion remains an important predictor of restenosis and subacute thrombosis, even in the drug-eluting stent (DES) era. In these patients, the role of different predilation strategies has yet to be established. Two hundred ninety-nine consecutive de novo lesions treated with 1 >2.5-mm DES (Cypher or Taxus) under intravascular ultrasound guidance without postdilation, using 3 implantation strategies, were studied: (1) direct stenting without predilation (n = 145), (2) predilation with a conventional semi-compliant balloon (n = 117), and (3) predilation with the AngioSculpt balloon (n = 37). Stent expansion was defined as the ratio of intravascular ultrasound-measured minimum stent diameter and minimum stent area to the manufacturer's predicted stent diameter and area. These ratios were larger after AngioSculpt predilation, and a greater percentage of stents had final minimum stent areas >5.0 mm(2) (another commonly accepted criterion of adequate DES expansion). Lesion morphology, stent and lesion length, and reference vessel size did not affect DES expansion. In conclusion, in this observational, nonrandomized study, pretreatment with the AngioSculpt balloon enhanced stent expansion and minimized the difference between predicted and achieved stent dimensions.

WOS: 000248794000005 PubMed: 17294139 Background No-reflow developed after coronary revascularization is an independent predictor of in-hospital mortality and poor clinical outcome. In this study, we investigated the difference between direct stenting and stenting with predilation, regarding to development of no-reflow in patients with acute coronary syndromes (ACS) and the role of fibrinolytic system in that phenomenon. Methods Fifty eight patients with the diagnosis of ACS in whom percutaneous coronary intervention (PCI) was applied were included in study. Patients were divided into two groups according to stent application with and without predilation. Pre- and post-intervention corrected TIMI frame counts (cTFC) were calculated. Post-PCI plasminogen activator inhibitor-1 (PAI-1), tissue plasminogen activator (tPA), plasminogen and D-Dimer levels were measured. Results Pre-intervention cTFC values were similar between stenting with and without predilation groups (P > 0.05). There was a significant decrease in post-intervention cTFC values in both groups (P < 0.002 and P < 0.05, respectively). But, there was no significant difference between post-intervention cTFC values of the groups, regardless to stent implantation techniques. (P > 0.05). In patients having high cTFC values compared with having low cTFC values; PAI-1 (P = 0.002), tPA (P = 0.015), plasminogen (P = 0.040) and D-dimer (P = 0.049) levels were significantly higher. Also, significant relationship was determined between cTFC and PAI-1, tPA, plasminogen, D-dimer levels (P values 0.003

The DES era has increased the demand on PCI-based revascularization and lesion complexity. One of the technical problems still limiting success rates in complex PCI is limited device deliverability. This work describes a new technique to improve deliverability.When deliverability was limited during PCI, a second 0.014-inch guide wire was inserted into the non-target artery. Then, another attempt was made to deliver the device to the target lesion.The technique was attempted in 13 consecutive cases with difficulties in delivering a device; five of CTO (38.5%), five of diffuse calcifications (38.5%), two of direct stenting (15.3%) and one case (7.7%) of dilated aortic root. The anchor wire technique was the only maneuver needed in eight (61.5%) cases. Additional technique was needed in four (30.7%) cases. In four out of five (80%) CTO cases, the anchor wire technique allowed successful PCI and to deliver a balloon across a CTO. Final procedural success was achieved in 12 (92.3%) cases.The anchor wire technique can be very useful in increasing success rates in CTOs and various complex PCI's and has the advantage of being simple to use, without a need to re-cross the target lesion or to exchange PCI system.