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Aim To assess the “real world” clinical outcome of patients with bifurcated lesions undergoing percutaneous coronary intervention with implantation of second and third generations of zotarolimus-eluting stent. Methods and Results Nine Italian centres participated in a prospective multicentre clinical project evaluating the outcome of patients receiving zotarolimus-eluting Resolute stent and Resolute Integrity stents. Patients with bifurcated lesions entered this evaluation. Clinical characteristics and angiographic and procedural details were prospectively recorded. Clinical outcome was prospectively assessed to evaluate the occurrence of major adverse cardiac events (MACE). A total of 577 patients were enrolled. The target lesion was distal left main in 11.1% and left anterior descending artery in 52.8%, and 30.3% of lesions were Medina 1,1,1. At a mean follow-up time of 27.0 ± 13.5 months, the survival free from MACE was 91.8%. Survival free from MACE was similar in patients grouped according to different bifurcated lesion complexity. On the contrary, patients receiving a single stent had better survival free from MACE as compared with those with double stent (P = 0.005). At multivariable analysis, double stenting (but not bifurcated lesion complexity) was found to be a significant predictor of MACE (hazard ratio, 2.52; 95% confidence interval, 1.28–4.94; P = 0.007). Of note, patients receiving the second stent as a bail-out had worse survival free from MACE compared with those who received it as a planned technique (P = 0.045). Conclusion The treatment of patients with bifurcated lesions with second and third generation zotarolimus-eluting stents is associated with good long-term clinical outcomes. Clinical outcome seems to be independent of lesion complexity, but may be influenced by the stenting technique (single or double stenting as well as elective or bail-out double stenting). © 2015 Wiley Periodicals, Inc.

Aims: Restenosis and bifurcated lesions represent technically challenging lesions for percutaneous coronary interventions (PCI). Data regarding procedural and clinical outcome of re-PCI for restenosis of stented bifurcated lesions are lacking. Our aims were to evaluate angiographic and procedural results and one-year clinical outcome of PCI for restenosis of stented bifurcated lesions. Methods and results: Consecutive patients undergoing PCI for restenosis of one bifurcated lesion previously treated by stent implantation at our centre entered the study. The primary endpoint was angiographic and procedural success, defined as final residual stenosis ≤30% in the main vessel with TIMI 3 flow in both MV and side branch, and stenosis ≤50% in the SB without death, myocardial infarction or target vessel revascularisation during hospitalisation. The secondary endpoint was the incidence of major adverse cardiac events at one-year clinical follow-up. The study population included 64 patients treated by PCI on a single restenotic bifurcated lesion. Angiographic and procedural success was achieved in 61 cases (95.3%) whereas the three cases of failure were due to SB residual stenosis >50%. At one year, MACE rate was 18.7% (12/64) with rates of cardiac death, MI and TVR of 1.6% (1/64), 6.2% (4/64) and 18.7% (12/64), respectively. No cases of stent thrombosis occurred. Patients treated by a single drug-eluting stent (DES) on main vessel (MV) had a significant lower rate of MACE at one year as compared to patients treated with balloon only PCI or by double-stenting technique or with a BMS, irrespective of the strategy adopted: 4/37 (10.8%) vs. 8/27 (29.6%); p=0.04. Conclusions: PCI in restenotic bifurcated lesions can be a good treatment option with high rates of angiographic and procedural success and an acceptable rate of long-term MACE. The use of a single DES implantation may be a promising strategy as it is associated with lower rates of MACE in the long term.

The glycoprotein (GP) IIb/IIIa receptor is critical to the process of platelet aggregation and thrombus formation as it serves as the final common pathway for platelet aggregation. For this reason, the development of GP IIb/IIIa inhibitors that block fibrinogen binding to the receptor has become an attractive strategy for antiplatelet therapy with an expected strong and specific effect. Presently, there are three commercially available GP IIb/IIIa inhibitors: abciximab, eptifibatide and tirofiban. All three drugs are commonly administered intravenously, and large-scale clinical trials have demonstrated a clear clinical benefit and good safety profile in patients at high risk, especially those undergoing percutaneous coronary interventions (PCI). Recently, several studies tested the intracoronary (IC) route for GP IIb/IIIa inhibitors in order to verify its safety and its possible superiority as compared to the intravenous (IV) route. The majority of the studies testing the IC route were conducted using abciximab and in patients with STEMI with better results in terms of myocardial reperfusion and infarct size and also promising results in terms of clinical outcome. On the IC administration of eptifibatide and tirofiban only some, even if promising, data are available. Larger and randomized studies are warranted to confirm the superiority of the IC route of administration of the GP IIb/IIIa inhibitors to the IV one in patients with coronary artery disease undergoing PCI.

OBJECTIVE: To determine the efficacy of a quality control strategy in cervical cytology in the detection of high-grade squamous intraepithelial lesions. METHODS: Forty-two patients were selected who underwent a Pap smear and cervical uterine biopsy between April 2008 and December 2009, with evidence of a high-grade squamous intraepithelial lesion in one or both tests. The statistical parameters of the smear test were calculated before and after systematic meetings for review of the archived test results (6 years), in which the following was done: interobserver diagnostic consensus; cytohistological correlation, with the latter as gold standard; and evaluation of the therapeutic status of each patient. RESULTS: Once these controls were applied, it was noted that sensitivity and positive likelihood ratio of the test for high-grade squamous intraepithelial lesion increased 9.5% (34.5 to 44%) and 0.45% (1.64 to 2.09%), respectively, while specificity remained at 79%. Reduction in interference of false-negative results associated with errors in the analytical phase of the cytological productive process gave an estimate of failures in collection of the specimens (pre-analytical phase). CONCLUSION: In addition to improving the performance of the cytological diagnosis of the high-grade squamous intraepithelial lesion, the proposed quality control strategy allows a reflection on the causes of incorrect or conflicting scrutiny. OBJETIVO: Determinar a eficácia de uma estratégia de controle de qualidade em colpocitologia na detecção da lesão intraepitelial escamosa de alto grau. MÉTODOS: Foram selecionadas 42 pacientes que realizaram Papanicolaou e biópsia cervicouterina entre abril de 2008 e dezembro de 2009, com evidência de lesão intraepitelial escamosa de alto grau em um ou em ambos os exames. Os parâmetros estatísticos do esfregaço foram calculados antes e após reuniões sistematizadas de revisão dos exames arquivados (6 anos), nas quais se procedeu a: consensualização diagnóstica interobservadores; correlação cito-histológica, sendo a última padrão-ouro; e avaliação do status terapêutico de cada paciente. RESULTADOS: Aplicados tais controles, observou-se que a sensibilidade e a likelihood ratio positiva do teste para lesão intraepitelial escamosa de alto grau aumentaram 9,5% (34,5 para 44%) e 0,45% (1,64 para 2,09%), respectivamente, enquanto sua especificidade se manteve em 79%. A redução da interferência dos falso-negativos associados a erros na fase analítica do processo produtivo citológico traz estimativa das falhas de coleta do material (fase pré-analítica). CONCLUSÃO: Além de melhorar o desempenho do diagnóstico colpocitológico de lesão intraepitelial escamosa de alto grau, a estratégia de controle de qualidade proposta permite refletir sobre as causas de escrutínio incorreto ou discordante.

Background Restoration of myocardial perfusion is the goal of percutaneous coronary intervention (PCI) in patients with ST elevation myocardial infarction. A major predictor of no-reflow is the increasing time to treatment (TTT). Thrombus aspiration (TA) is reported to improve myocardial reperfusion as compared with standard PCI (SP). Objective To investigate the influence of TTT on TA efficacy. Design Pooled analysis of individual patients' data of three prospective randomised trials comparing TA and SP. Patients A total of 299 patients (150 in TA group and 149 in SP group) entered the study. The study population was divided into three subgroups according to the TTT: ≤3 h (short TTT subgroup), >3 h to ≤6 h (intermediate TTT subgroup), >6 h to ≤12 h (long TTT subgroup). Main outcome measures The goal of the study was the comparison of optimal myocardial reperfusion, defined as the combination of myocardial blush grade 2 or 3 at post-PCI angiography and ST resolution more than 70% at post-PCI ECG, between SP and TA according to TTT. Results In the SP group, increasing TTT was associated with a decreased rate of optimal reperfusion (27.4% vs 17.9% vs 10%, p for trend=0.06), whereas in the TA group the same trend was not seen (40.9% vs 33.8% vs 50%, p for trend=0.93). In a multivariate logistic regression model, a significant interaction (p=0.04) between time to treatment and thrombus aspiration was observed. Conclusions TA limits the adverse effects of TTT prolongation on myocardial reperfusion.

The transfemoral approach is the standard approach for performing chronic total occlusion procedures. However, hemorrhagic and vascular entry site complications are known to be reduced by the adoption of the transradial approach. Thus, the transradial approach is gaining interest and, facilitated by the improvement of materials and techniques, will be applied in procedures previously considered possible only by femoral access. In this article, we review the data regarding the feasibility and safety of the transradial approach for chronic total occlusion percutaneous coronary interventions and provide an overview of the technical aspects useful for performing chronic total occlusion by radial access.

BACKGROUND Thrombus aspiration improves microvascular obstruction in patients with acute myocardial infarction treated by percutaneous coronary intervention. However, drugs such as nitroprusside and adenosine have not yet been tested as adjuncts to thrombus aspiration. Therefore, we designed a placebo-controlled, randomized, open-label, blind-examination, multicenter trial assessing the effects of intracoronary nitroprusside or adenosine on microvascular obstruction in patients undergoing primary or rescue percutaneous coronary intervention and thrombus aspiration. METHODS AND RESULTS Six hospitals in Italy participate in the REOPEN-AMI study. Two hundred and forty consecutive patients with acute myocardial infarction undergoing primary or rescue percutaneous coronary intervention and thrombus aspiration are randomly allocated 1: 1: 1 to receive either intracoronary nitroprusside, adenosine or placebo. The primary end-point is the incidence of ST resolution greater than 70% on surface ECG at 90 min after the procedure. Secondary end-points are: incidence of angiographic no-reflow (thrombolysis in myocardial infarction flow < or =2 or 3 with a myocardial blush grade

Introduccion y objetivos La clasificacion de Medina de las lesiones bifurcadas ha alcanzado gran difusion debido a su simplicidad. No hay datos sobre el uso de la clasificacion de Medina para orientar la tecnica de implantacion de stents que utilizar en las bifurcaciones. Metodos Se clasifico prospectivamente a pacientes consecutivos con lesiones bifurcadas (rama lateral ≥ 2,25 mm) utilizando la clasificacion de Medina. La estrategia estudiada consistio en implantar dos stents en las lesiones Medina 1,1,1 (grupo M3) e implantar un stent tan solo en el vaso principal en las lesiones con otras clasificaciones de Medina (grupo OM). Las variables de valoracion clinicas fueron los eventos cardiacos adversos mayores (MACE) y la revascularizacion de la lesion Diana (RLD) durante la hospitalizacion y en un seguimiento de 12 meses. Resultados Se incluyo en el estudio a un total de 120 pacientes. De ellos, 25 formaron el grupo M3 y 95 el grupo OM. Los dos grupos no diferian en lo relativo a las caracteristicas basales. La estrategia programada se aplico satisfactoriamente en el 97% de los casos del grupo OM, frente al 68% de los del grupo M3 (p Conclusiones Una estrategia intencionada de implantacion de un unico stent en pacientes con lesiones bifurcadas, sin lesiones de tipo Medina 1,1,1, se asocial a una tasa muy baja de necesidad de implantacion de un segundo stent. Ademas, la eleccion de un stent metalico sin recubrimiento predice la RLD y ello indica que deben emplearse de manera habitual stents liberadores de farmacos para tratar las lesiones bifurcadas, sea cual fuere su complejidad angiografica.

The Medina bifurcated lesion classification has been widely adopted because of its simplicity. However, no data are available on its use in helping select the best stenting technique for bifurcations.Consecutive patients with bifurcated lesions (side branchor=2.25 mm) were prospectively assessed using the Medina classification. The treatment strategy studied involved implanting two stents in lesions with a Medina classification of 1,1,1 (M3 group) and one stent in only the main vessel in lesions with other Medina classifications (OM group). Clinical endpoints were a major adverse cardiac event (MACE) and target lesion revascularization (TLR) during hospitalization and at 12-month follow-up.The study included 120 patients: 25 in the M3 group and 95 in the OM group. There was no difference in baseline characteristics between the groups. The treatment strategy was successfully implemented in 97% of the OM group and 68% of the M3 group (P.001). No death or TLR was recorded during hospitalization, though three myocardial infarctions occurred postoperatively (2.1% in the OM group vs 4.0% in the M3 group; P=.6). At 12 months, there was no difference in clinical outcome between the two groups (MACE: 12.6% in the OM group vs 8% in the M3 group; P=.4; TLR: 13.7% in the OM group vs 8% in the M3 group; P=.5). Multivariate analysis showed that bare metal stent implantation (only in patients receiving a single stent) was the only independent predictor of TLR.The planned treatment strategy of implanting a single stent in patients with bifurcated lesions not classified as Medina 1,1,1 lesions was associated with a very low rate of second stent implantation. Moreover, bare metal stent use was a predictor of TLR, suggesting that drug-eluting stents should be used routinely to treat bifurcated lesions regardless of their angiographic complexity.

Objectives: To investigate the outcome of patients undergoing percutaneous coronary interventions (PCI) with implantation of a new thin-strut cobalt-chromium bare-metal-stent (BMS) in the drug-eluting-stent (DES) era. Background: Despite the contemporary penetration of DES in the clinical practice, a relevant percentage of patients are still treated by BMS. Data on clinical outcome of novel BMSs are lacking. Methods: This is a single-centre-registry enrolling patients treated by Skylor™ stent implantation. During the study, the criteria for BMS selection adopted at our institution (“internal” criteria) were as follows: (1) limited compliance to prolonged double antiplatelet therapy, (2) ST-elevation myocardial infarction (STEMI) or saphenous vein grafts (SVG) interventions, and (3) in the absence of these conditions, noncomplex (no bifurcations, no chronic total occlusions) lesions considered at low restenosis risk on the basis of arbitrary angiographic criteria (short lesions, large vessels). Primary and secondary end-points were respectively major adverse cardiovascular events (MACE) and target vessel failure (TVF) up to 9-month. Results: A total of 150 patients were treated with Skylor™ stent on 169 lesions. At 9-month follow-up, MACE occurred in 12 patients (8.0%) and TVF in 21 lesions (12.4%). By multivariable analysis, the predictors of MACE were Euroscore≥9 and ejection fraction < 30% while the predictors of TVF were the absence of the angiographic criteria of low restenosis risk and ejection fraction < 30%. Conclusions: In the DES era, the use of a last-generation BMS in patients with limited compliance to double antiplatelet therapy, STEMI or SVG interventions, and noncomplex angiographic lesions may be associated with acceptable clinical outcome. © 2009 Wiley-Liss, Inc.

Objectives The aim of this study was to evaluate the use of a new manual thrombus-aspirating device in unselected patients with ST-segment elevation acute myocardial infarction (STEMI) undergoing urgent percutaneous coronary intervention (PCI). Background Failure to achieve myocardial reperfusion often occurs during PCI in patients with STEMI. The use of thrombus-aspirating devices might improve myocardial reperfusion by reducing distal embolization. Methods We prospectively randomized before coronary angiography 100 consecutive patients with STEMI to either standard PCI or PCI with manual thrombus-aspiration. Primary end points of the study were post-procedural rates of myocardial blush grade (MBG) ≥2 and ST-segment resolution (STR) ≥70%. Analyses were planned by intention to treat. Results Ninety-nine patients entered the analyses. The rates of post-procedural MBG ≥2 and STR ≥70% were, respectively, 68.0% and 44.9% in the thrombus-aspiration group compared with 58.0% and 36.7% in the standard PCI group: odds ratio (OR) 2.6 (95% confidence interval [CI] 1.2 to 5.9), p = 0.020, and 2.4 (95% CI 1.1 to 5.3), p = 0.034, respectively. Moreover, the rate of patients achieving both the angiographic and electrocardiographic (ECG) criteria of optimal reperfusion was significantly higher in the thrombus-aspiration group compared with standard PCI: 46.0% versus 24.5%, OR 2.6 (95% CI 1.1 to 6.2), p = 0.025. In multivariate analysis, randomization to thrombus-aspiration was a significant independent predictor of achievement of MBG ≥2 and STR ≥70% (p = 0.013). Conclusions This prospective randomized study shows that manual thrombus-aspiration in unselected patients with STEMI undergoing primary or rescue PCI is clinically feasible and results in better angiographic and ECG myocardial reperfusion rates compared with those achieved by standard PCI.

We report a rare case of neuroendocrine tumor of the anal canal and its poor prognosis, plus discuss the need of immunohistochemical for an acurate diagnosis and to guide treatment.

The role of intraaortic balloon pump (IABP) during percutaneous coronary intervention (PCI) in high-risk acute patients remains debated. Device-related complications and the more complex patient management could explain such lack of clinical benefit. We aimed to assess the impact of transradial versus transfemoral access for PCI requiring IABP support on vascular complications and clinical outcome.We retrospectively analyzed 321 consecutive patients receiving IABP support during transfemoral (n = 209) or transradial (n = 112) PCI. Thirty-day net adverse clinical events (NACEs) (composite of postprocedural bleeding, cardiac death, myocardial infarction, target lesion revascularization, and stroke) were the primary end point, with access-related bleeding and hospital stay as secondary end points.Cardiogenic shock and hemodynamic instability were the most common indications for IABP support. Cumulative 30-day NACE rate was 50.2%, whereas an access site-related bleeding occurred in 14.3%. Patients undergoing transfemoral PCI had a higher unadjusted rate of NACEs when compared with the transradial group (57.4% vs 36.6%, P.01), mainly due more access-related bleedings (18.7% vs 6.3%, P.01). Such increased risk of NACEs was confirmed after propensity score adjustment (hazard ratio 0.57 [0.4-0.9], P = .007), whereas hospital stay appeared comparable in the 2 groups.In this observational registry, high-risk patients undergoing PCI and requiring IABP support appeared to have fewer NACEs if transradial access was used instead of transfemoral, mainly due to fewer access-related bleedings. Given the inherent limitations of this retrospective work, including the inability to adjust for unknown confounders, further controlled studies are warranted to confirm or refute these findings.

Percutaneous coronary intervention (PCI) of coronary chronic total occlusions (CTO) has historically been limited by technical success rates of 50–70%, despite being performed in highly selected cases. Currently, however, operators and programs with greater experience of CTO interventions and modern techniques and technologies can consistently achieve technical success rates of >80% in a more unselected and complex population of CTO patients [1–3]. The transfemoral approach (TFA) represents the most extensively used access route for CTO treatment. However, recently there has been growing interest in using the transradial approach (TRA) to perform PCI for CTO [4,5]. In this editorial, we analyze the pros and cons of selecting the TFA or TRA when approaching a CTO.

ObjectivesThis study sought to assess whether intracoronary adenosine or nitroprusside following thrombus aspiration (TA) is superior to TA alone for the prevention of microvascular obstruction (MVO) in ST-segment elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention (PCI).BackgroundMVO, due to its multifactorial pathogenesis, still occurs after TA in a sizeable portion of patients.MethodsWe performed a placebo-controlled, randomized, open-label, blind-examination, multicenter trial. A total of 240 STEMI patients with Thrombolysis In Myocardial Infarction (TIMI) flow grade 0/1 were randomly allocated 1:1:1 to receive adenosine (n = 80), nitroprusside (n = 80), or saline (n = 80) given distal to the occluded site after TA. The primary endpoint was the incidence of ST-segment resolution (STR) >70% on surface electrocardiogram at 90 min after PCI. Secondary endpoints were angiographic MVO incidence (TIMI flow grade ≤2 or 3 with a myocardial blush grade 70% occurred in in 71% of adenosine-treated patients, in 54% of nitroprusside-treated patients, and in 51% of saline-treated patients (p = 0.009 and p = 0.75, respectively, vs. saline). Angiographic MVO occurred in 18% of adenosine-treated patients, in 24% of nitroprusside-treated patients, and in 30% of saline-treated patients (p = 0.06 and p = 0.37, respectively, vs. saline). MACE occurred in 10%, 14%, and 20% of patients, respectively (p = 0.08 and p = 0.29 vs. saline).ConclusionsIn STEMI patients treated by PCI and TA, the additional intracoronary administration of adenosine, but not that of nitroprusside, results in a significant improvement of MVO, as assessed by STR.

We report a rare case of neuroendocrine tumor of the anal canal and its poor prognosis, plus discuss the need of immunohistochemical for an acurate diagnosis and to guide treatment. Relatamos um caso raro de tumor neuroendócrino do canal anal e seu mau prognóstico, bem como a necessidade de imuno-histoquímica para o diagnóstico correto e para orientar o tratamento.

Background Randomized trials have shown that transradial approach, compared with transfemoral, reduces vascular complications (VCs) of coronary procedures in selected patients. Yet, radial approach is associated to a variety of access-site VC as well as to a higher failure rate compared with femoral access. Methods At our institution, from May 2005 to May 2010, we prospectively assessed the occurrence and outcome of VC in consecutive patients undergoing transradial percutaneous coronary procedures performed by trained radial operators. The need of access crossover to complete the procedure was also prospectively investigated. Vascular complications were classified as "radial related" or "nonradial related" (in the case of access crossover). Vascular complications were also classified "major" if requiring surgery and/or blood transfusions or causing hemoglobin drop >3 g/dL. Results Ten thousand six hundred seventy-six procedures were performed using a right radial (87.5%), left radial (12.4%), or ulnar (0.1%) artery as primary access. A total of 53 VCs (0.5%) were observed: 44 (83%) radial related and 9 (17%) nonradial related. Major VCs occurred in 16 patients only (0.2%) and were radial related in 10 (62.5%) and nonradial related in 6 (37.5%) patients. Vascular complications rate was stable during the study and independent of operator's experience. Access crossover rate was 4.9%, differed according to the operator radial experience and significantly decreased over time. Conclusions The present study, conducted in a center with high volume of radial procedures, shows that transradial approach is associated with a very low rate of VC, which is stable over time. On the contrary, access crossover rate decreased over time and differed according to operator (radial) experience.

Safe guidewire placement in the main vessel (MV) and in the side branch (SB) does represent the key point for successful percutaneous coronary interventions (PCI) in bifurcated lesions. During bifurcation PCI, SB wiring is systematically performed as a first step and is often repeated ("rewiring") during the procedure in order to treat the SB after MV stenting. Wiring and rewiring are crucial phases of bifurcation PCI which require, in the most complex cases, specific operator experience. In the present paper, the classic SB wiring techniques necessary for routine bifurcation interventions (antegrade and pullback wiring technique) as well as "advanced" wiring techniques ("reverse wire" technique, Venture-facilitate wiring, MV balloon predilation or debulking) are described. Moreover, the rewiring technique is discussed in detail, with particular attention on the tips and tricks which may facilitate the achievement of optimal result with provisional stenting (pullback rewiring) and help manage bail out situations like acute SB flow impairment after MV stenting.

As data on the use of the latest-generation drugeluting stents (DES) in bifurcation interventions are lacking, we realized a multicenter registry to assess the procedural and clinical results obtained in patients with unselected bifurcated lesions treated with the novel zotarolimus-eluting Resolute stent (ZRS).Three Italian centers participated in the study. Consecutive patients with significant stenosis of bifurcated lesions undergoing DES implantation were treated with ZRS. The recommended technique was the "provisional TAP approach" [main-vessel (MV) stent implantation eventually followed by kissing balloon and sidebranch (SB) stenting according to TAP technique]. Clinical characteristics, procedural details and clinical follow-up data were prospectively recorded. Procedural success was defined as post-percutaneous coronary intervention visual stenosis20% on MV and TIMI 3 flow on both MV and SB. Primary endpoint was major adverse coronary events (cardiac death, myocardial infarction and target vessel revascularization) at 9-month follow up. A total of 180 patients were enrolled. The target lesion was located in the distal left main in 16% and in the left anterior descending artery in 52%. All but 3 cases were treated according to the provisional TAP approach (kissing balloon rate, 69%; overall SB stenting rate, 10.6%). Procedural success was obtained in 98.3% (3 failures due to final SB TIMI flow3). At 9-month follow up, the survival free from MACE was 97.8% (1 cardiac death and 3 repeat revascularizations).The use of the latest-generation ZRS in unselected bifurcated lesions treated by a provisional approach is associated with excellent procedural results and with promising clinical outcomes.

Transradial approach is known to reduce access-site complications of coronary procedures. However, the diffusion of transradial approach in the interventional cardiology community is limited by its higher failure rate compared to transfemoral. Transradial approach failures are mainly caused by a series of anatomic variants which may be encountered in the upper limb arteries. Such anatomic variants have been variously classified based on postmortem studies or systematic angiographic studies. We propose a simplified "operative" classification of anatomic vascular variants and physiopathologic conditions of the arterial axis, from radial to aortic root, possibly affecting transradial cardiovascular procedures.

Background: The best timing for coronary angiography (immediate vs early) in patients with acute non–ST-elevation myocardial infarction (NSTEMI) is controversial. Hypothesis: Evaluate in NSTEMI patients the effects of an immediate compared to an early invasive strategy on microvascular damage, myocardial perfusion, and infarct size. Methods: We randomized 54 consecutive patients with first episode of NSTEMI: 27 patients (22 males, age 58.8 ± 9.4 years, group A) underwent immediate (≤6 hours) percutaneous coronary intervention (PCI) with a double bolus of eptifibatide, and 27 patients (24 males, age 59.7 ± 9.8 years, P = 0.72, group B) underwent early (7–72 hours) PCI with upstream eptifibatide. Microvascular damage was evaluated at predischarge by myocardial contrast echocardiography, and the contrast defect length was calculated. Results: There were no significant differences in pre-PCI myocardial blush grade (MBG) (41% MBG 0 or 1 in group A vs 37% MBG 0 or 1 in group B, P = 0.78), in post-PCI MBG (7.4% MBG 0 or 1 in both groups, P = 1.00), and in contrast defect length (4.5% in group A vs 2.8% in group B, P = 0.56). However, group A showed a significant reduction in creatine kinase myocardial band isoenzyme peak (26 ± 26 ng/mL in group A vs 69 ± 79 ng/mL in group B, P = 0.01) and in troponin T peak (0.84 ± 1.2 ng/mL in group A vs 1.8 ± 2.1 ng/mL in group B, P = 0.048). Conclusions: In patients with NSTEMI treated with eptifibatide, immediate PCI is associated with less increase in myonecrosis markers compared with PCI within 72 hours. There were no significant differences in myocardial perfusion between the 2 strategies. Copyright © 2010 Wiley Periodicals, Inc. The authors have no funding, financial relationships, or conflicts of interest to disclose.

Background Subgroup analyses of trials enrolling acute coronary syndrome patients suggest that inhibition of glycoprotein IIb/IIIa can improve the outcome of diabetic patients undergoing percutaneous coronary interventions (PCIs), possibly by improving microvascular perfusion. However, the efficacy of small-molecule IIb/IIIa receptor inhibitors to improve microvascular perfusion in stable diabetic patients undergoing elective PCI has not been specifically investigated. Methods We randomized consecutive stable diabetic patients, undergoing elective PCI, to tirofiban or placebo groups along with double antiplatelet therapy. High-dose bolus (25 microg/kg per 3 min) of tirofiban was administered immediately before PCI followed by 8 h continuous infusion (0.15 microg/kg per min). Postprocedural myonecrosis was assessed prospectively by measurement of cardiac troponin T (cTnT) at 6 and 24 h after PCI. The primary end-points were post-PCI coronary flow estimated by corrected thrombolysis in myocardial infarction frame count and post-PCI myocardial infarction. Platelet aggregation was measured by platelet function analyser-100 values. Results Forty-six patients entered the study (22 randomized to placebo and 24 randomized to tirofiban). The study drug was associated with a significant increase of platelet function analyser-100 values that peaked immediately after PCI and was maintained at 6 h (pre-PCI: 131 +/- 65 s; post-PCI: 222 +/- 49 s; after 6 h: 219 +/- 55 s).Post-PCI corrected thrombolysis in myocardial infarction frame count was similar in tirofiban and in placebo groups (10.2 +/- 3.6 vs. 12.0 +/- 7.6, P = 0.30, respectively). The prevalence of raised cTnT levels was similar in the two groups (25 vs. 30%, P = 0.56, respectively). At multivariate analysis, direct stenting (associated with reduced myonecrosis) and postdilatation (associated with increased myonecrosis) predicted cTnT elevation. Conclusion A high-dose bolus of tirofiban in stable diabetic patients undergoing elective PCI, along with double antiplatelet therapy, was associated with a significant further inhibition of platelet aggregation which, however, did not translate in a lower incidence of post-PCI distal embolization.

Udgivelsesdato: 2009-Sep AIMS: Thrombectomy in patients with ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI) is associated to better myocardial reperfusion. However, no single trial was adequately powered to asses the impact of thrombectomy on long-term clinical outcome and to identify patients at higher benefit. Thus, we sought to assess these issues in a collaborative individual patient-data pooled analysis of randomized studies (study acronym: ATTEMPT, number of registration: NCT00766740). METHODS AND RESULTS: Individual data of 2686 patients enrolled in 11 trials entered the pooled analysis. Primary endpoint of the study was all-cause mortality. Major adverse cardiac events (MACE) were considered as the occurrence of all-cause death and/or target lesion/vessel revascularization and/or myocardial infarction (MI). Subgroups analysis was planned according to type of thrombectomy device (manual or non-manual), diabetic status, IIb/IIIa-inhibitor therapy, ischaemic time, infarct-related artery, pre-PCI TIMI flow. Clinical follow-up was available in 2674 (99.6%) patients at a median of 365 days. Kaplan-Meier analysis showed that allocation to thrombectomy was associated with significantly lower all-cause mortality (P = 0.049). Thrombectomy was also associated with significantly reduced MACE (P = 0.011) and death + MI rate during the follow-up (P = 0.015). Subgroups analysis showed that thrombectomy is associated to improved survival in patients treated with IIb/IIIa-inhibitors (P = 0.045) and that the survival benefit is confined to patients treated in manual thrombectomy trials (P = 0.011). CONCLUSION: The present large pooled analysis of randomized trials suggests that thrombectomy (in particular manual thrombectomy) significantly improves the clinical outcome in patients with STEMI undergoing mechanical reperfusion and that its effect may be additional to that of IIb/IIIa-inhibitors.

The purpose of this study was to assess the influence of cleaning pits and fissures with an aluminum oxide air abrasion system on the detection of occlusal caries in primary teeth using loser fluorescence (LF) and visual examination.The sample comprised 65 pit and fissure sites on extracted primary teeth suspected to be carious. The sites were submitted to 2 visual examinations (examiner JAR) and 2 LF readings (examiner TMV). Next, the occlusal surfaces were air-abraded and re-examined thereafter using both methods. The teeth were sectioned, and the histological analysis of the sites with a stereoscopic magnifying lens at X32 magnification was used as the gold standard.Cohen's kappa statistic for LF and visual examination were, respectively, 0.282/0.884 before and 0.896/0.905 after air abrasion. LF showed a sensitivity of 0.28 increasing to 0.49 and a specificity of 0.50 increasing to 0.92. Visual examination showed sensitivity of 0.78 and specificity of 0.73. Both increased after air abrasion.The findings suggest that cleaning pits and fissures with aluminum oxide air abrasion increased the accuracy of LF and visual examination for detection of occlusal caries in primary teeth.

Stent thrombosis (ST) is a recognized complication of percutaneous coronary interventions (PCI). Due to the high thrombus burden present in ST, the use of thrombus aspiration (TA) may enhance the angiographic results by limiting distal embolization.Consecutive patients undergoing urgent PCI due to ST were studied, consisting of two groups according to the type of intervention (standard PCI [SP] or TA). TIMI flow, corrected TIMI frame count (cTFC), myocardial blush grade (MBG), thrombus score (TS), Yip's adverse thrombus burden features, occurrence of angiographically evident distal embolization (DE) were evaluated offline. In-hospital outcomes were also recorded.Twenty-eight patients entered the study. Baseline clinical and angiographic features were similar between patients treated by SP (n = 12) and those treated by TA (n = 16). After PCI, a trend in favor of TA as compared to SP was observed for post-PCI TIMI 3 flow rate (67% vs. 89%; p = 0.10), final cTFC (31 +/- 35 vs. 17 +/- 21; p = 0.10) and MBG 2-3 rate (40% vs. 67%; p = 0.12). Accordingly, the rate of adverse angiographic outcome (post-PCI TIMI 0-1 flow and/or DE) was significantly lower in the TA as compared to SP: 5% (1 out of 18) vs. 33% (5 out of 15) respectively (p = 0.04). Throughout hospitalization, major adverse events occurred in 6% of TA patients vs. 33% of SP patients (p = 0.08).TA in patients with ST is safe and is associated with better angiographic outcomes compared to standard PCI. Larger studies are warranted to confirm these early observations.

To overview and summarize the results emerging from the studies on adjunctive devices (AD) with theoretical anti-embolic properties in patients with ST-elevation acute myocardial infarction (STEMI) undergoing percutaneous coronary interventions (PCI).A series of small-to-medium size randomized studies have compared different AD with standard PCI (SP) in the setting of STEMI. The reported results are conflicting.Eighteen prospective randomized studies on 3180 STEMI patients comparing AD with SP were identified and entered the meta-analysis. Pre-specified angiographic, electrocardiographic (absence of ST-segment resolution, STR) and early (up to 30 days) clinical end-points were assessed.AD were associated with lower rates of angiographically evident distal embolization: OR (95% CI): 0.54 (0.37-0.81). Analyses of angiographic and electrocardiographic reperfusion showed striking heterogeneity among studies and an overall trend toward better results with AD: OR (95% CI) 0.76 (95% CI 0.51-1.12) for TIMI3, 0.53 (0.37-0.76) for myocardial blush grade (MBG)3, 0.60 (0.45-0.78) for absence of STR. Subgroup analysis according to the type of AD for the end-point of no STR showed concordant absence of benefit in studies testing distal protection devices, positive results being confined to the studies using thrombectomy devices (OR 0.46, 95% CI 0.32-0.66). However, the possibility of a "small study" bias within thrombectomy studies cannot be discharged (significant heterogeneity and positive Egger's test). Early major adverse cardiac events were not different between AD and SP.AD use may be associated with reduced rate of angiographic distal embolization, and improved MBG 3 and STR rates. However, efficacy might vary with the type of device employed. Moreover, early clinical outcome is not modified suggesting that further, larger, studies are needed to assess the clinical impact of AD.We conducted a meta-analysis of 18 prospective randomized trials comparing adjunctive devices (AD) with standard PCI in the setting of STEMI. The use of AD was associated with lower rates of (angiographically evident) distal embolization. Analyses of angiographic and electrocardiographic reperfusion showed striking heterogeneity and an overall trend toward better results with AD. Subgroup analysis suggested that different types of device may have different effects. Early major adverse cardiac events were similar between AD and SP.

A series of thrombectomy and distal filter devices have been developed to limit distal embolization during percutaneous coronary interventions (PCI).To evaluate the feasibility of the combined use of thrombus-aspirating catheters and distal filter devices in patients at high risk of no-reflow.Thrombus aspiration (TA) and distal filter protection (DFP) were sequentially used in a series of patients undergoing urgent PCI within 48 hours of acute myocardial infarction (MI). Inclusion criteria were: (1) occlusion of the infarct-related artery; (2) at least 2 out of the 6 Yip's classification features of high thrombus burden. Coronary angiograms were evaluated off-line to assess thrombus score, coronary flow and distal embolization in different phases of the procedure.TA followed by DFP prior to balloon dilatation or stent implantation was successfully performed in 20 patients with acute MI due to occlusion of de novo lesions (80%) or in-stent thrombosis (20%) located in a native coronary artery (90%) or a saphenous vein graft (10%). TA was associated with a significant acute reduction of TS and improvement of coronary flow (TIMI grade from 0.7 +/- 0.8 to 1.6 +/- 1.1; p = 0.004 and CTFC from 83 +/- 29 to 52 +/- 36; p = 0.006). This facilitated the deployment of DFP, which did not induce significant flow modification (TIMI grade: 2.3 +/- 0.9 pre-DFP placement vs. 2.2 +/- 1.0 post-DFP placement; p = 0.20; CTFC: 32 +/- 28 pre-DFP placement vs. 35 +/- 28 post-DFP placement; p = 0.47). Post-PCI angiography revealed a 90% TIMI 3 flow rate and 47% MBG 3 rate with only 1 case of angiographically evident distal embolization.Sequential use of TA and DFP may be successfully used during PCI in patients at very high risk of distal embolization. However, the possible benefits of such an approach should be weighted with the increased complexity of the procedure. Further evaluations of the clinical efficacy of this approach are needed.

Background: In patients with acute coronary syndromes (ACS), distal embolization of thrombotic material is more likely to play a key role in the pathogenesis of myocardial no-reflow during percutaneous coronary intervention (PCI). Thus, interventional techniques able to reduce thrombus burden at the culprit vessel might improve final myocardial reperfusion. Objective: To evaluate a new rapid-exchange thrombus-aspirating catheter, the Diver C.E., in patients with thrombotic coronary lesions undergoing PCI. Methods: Fifty patients with acute myocardial infarction (n = 44) or with non-ST-elevation ACS and angiographic evidence of coronary thrombus (n = 6) undergoing urgent PCI were prospectively enrolled. The Diver C.E. was used to aspirate coronary thrombus from the culprit lesion after placement of the guidewire. Adjunctive balloon inflations and stent implantation were used to achieve good angiographic result. Angiographic coronary flow (by means of TIMI score and corrected TIMI frame count, cTFC), thrombus score (TS), and myocardial perfusion (by means of postintervention myocardial blush grade, MBG) were assessed in all patients. Results: The device could be successfully employed in 96% of the cases (48/50) and yielded significant (P < 0.0001) acute reduction in thrombus burden (TS: predevice 3.5 ± 0.8, postdevice 2.5 ± 0.9) and improvement in coronary flow (TIMI grade: predevice 1.0 ± 0.9, postdevice 2.0 ± 0.9; CTFC predevice 71 ± 31, postdevice 39 ± 26). Final TIMI grade 0–1 was observed in one patient only (2%). A significant (P = 0.02) correlation was found between preintervention TS and efficacy of thrombus aspiration. A more pronounced acute reduction of thrombus burden after thrombus aspiration (TS reduction ≥2) was associated with a better postintervention angiographic myocardial perfusion (MBG 2.3 ± 0.9 vs 1.7 ± 0.8; P = 0.05). Conclusions: This new, easy-to-use, device is able to reduce thrombus burden and to improve coronary flow in patients with thrombus-containing lesions. The improvement in myocardial perfusion associated to greater thrombus removal highlights the importance of thrombus aspiration in the management of thrombus-burdened coronary lesions. © 2006 Wiley-Liss, Inc.

AIMS: No-reflow after a primary percutaneous coronary intervention (PCI) is associated with a high incidence of left ventricular (LV) failure and a poor prognosis. Endothelin-1 (ET-1) is a potent endothelium-derived vasoconstrictor peptide and an important modulator of neutrophil function. Elevated systemic ET-1 levels have recently been reported to predict a poor prognosis in patients with acute myocardial infarction (AMI) treated by primary PCI. We aimed to investigate the relationship between systemic ET-1 plasma levels and no-reflow in a group of AMI patients treated by primary PCI. METHODS AND RESULTS: A group of 51 patients (age 59+/-9.9 years, 44 males) with a first AMI, undergoing successful primary or rescue PCI, were included in the study. Angiographic no-reflow was defined as coronary TIMI flow grade < or =2 or TIMI flow 3 with a final myocardial blush grade < or =2. Blood samples were obtained from all patients on admission for ET-1 levels measurement. No reflow was observed in 31 patients (61%). Variables associated with no-reflow at univariate analysis included culprit lesion of the left anterior coronary descending artery (LAD) (67 vs. 29%, P=0.006) and ET-1 plasma levels (3.95+/-0.7 vs. 3.3+/-0.8 pg/mL, P=0.004). At multivariable logistic regression analysis, ET-1 was the only significant predictor of no-reflow (P=0.03) together with LAD as the culprit vessel (P=0.04). CONCLUSION: ET-1 plasma levels predict angiographic no-reflow after successful primary or rescue PCI. These findings suggest that ET-1 antagonists might be beneficial in the management of no-reflow.

Platelets play a pivotal role in thrombus formation in patients with coronary artery disease (CAD), since the high shear generated in the presence of severe coronary stenoses can increase platelet reactivity (PR) and trigger thrombogenesis. Several reports have suggested a functional effect of human platelet antigen (HPA)-1 and HPA-2 gene polymorphisms on PR. However, the true determinants of high-shear PR in CAD patients taking their usual medications are still incompletely understood. In 104 patients with stable CAD we analyzed the possible clinical, biochemical and genetic factors affecting high-shear PR, measured by the ex vivo platelet function analyzer (PFA-100) collagen-adenosine diphosphate method. In univariate analysis, a lower PR was associated with decreased plasma von Willebrand factor-ristocetin cofactor activity, increased blood levels of triglycerides, female sex, use of thienopyridines, lower platelet count, and HPA-1b carriership. All variables, except HPA-1b, remained associated with lower PR in multivariate analysis. However, the introduction in the model of the HPA-1 and HPA-2 genotypes as interaction terms led to a significant improvement in the prediction of PR, although the quantitative effect was small (about 3% improvement, P=0.046).Thus, in CAD patients, there seems to be only a mild effect of the platelet glycoprotein HPA-1 and HPA-2 polymorphisms on collagen-adenosine diphosphate-stimulated PR after the effect of well-established clinical and biochemical determinants are considered.

The aim of this study was to evaluate the use of a new manual thrombus-aspirating device in unselected patients with ST-segment elevation acute myocardial infarction (STEMI) undergoing urgent percutaneous coronary intervention (PCI).Failure to achieve myocardial reperfusion often occurs during PCI in patients with STEMI. The use of thrombus-aspirating devices might improve myocardial reperfusion by reducing distal embolization.We prospectively randomized before coronary angiography 100 consecutive patients with STEMI to either standard PCI or PCI with manual thrombus-aspiration. Primary end points of the study were post-procedural rates of myocardial blush grade (MBG)or =2 and ST-segment resolution (STR)or =70%. Analyses were planned by intention to treat.Ninety-nine patients entered the analyses. The rates of post-procedural MBGor =2 and STRor =70% were, respectively, 68.0% and 44.9% in the thrombus-aspiration group compared with 58.0% and 36.7% in the standard PCI group: odds ratio (OR) 2.6 (95% confidence interval [CI] 1.2 to 5.9), p = 0.020, and 2.4 (95% CI 1.1 to 5.3), p = 0.034, respectively. Moreover, the rate of patients achieving both the angiographic and electrocardiographic (ECG) criteria of optimal reperfusion was significantly higher in the thrombus-aspiration group compared with standard PCI: 46.0% versus 24.5%, OR 2.6 (95% CI 1.1 to 6.2), p = 0.025. In multivariate analysis, randomization to thrombus-aspiration was a significant independent predictor of achievement of MBGor =2 and STRor =70% (p = 0.013).This prospective randomized study shows that manual thrombus-aspiration in unselected patients with STEMI undergoing primary or rescue PCI is clinically feasible and results in better angiographic and ECG myocardial reperfusion rates compared with those achieved by standard PCI.

Platelets play a pivotal role in thrombus formation in patients with coronary artery disease (CAD), since the high shear generated in the presence of severe coronary stenoses can increase platelet reactivity (PR) and trigger thrombogenesis. Several reports have suggested a functional effect of human platelet antigen (HPA)-1 and HPA-2 gene polymorphisms on PR. However, the true determinants of high-shear PR in CAD patients taking their usual medications are still incompletely understood. In 104 patients with stable CAD we analyzed the possible clinical, biochemical and genetic factors affecting high-shear PR, measured by the ex vivo platelet function analyzer (PFA-100) collagen–adenosine diphosphate method. In univariate analysis, a lower PR was associated with decreased plasma von Willebrand factor–ristocetin cofactor activity, increased blood levels of triglycerides, female sex, use of thienopyridines, lower platelet count, and HPA-1b carriership. All variables, except HPA-1b, remained associated with lower PR in multivariate analysis. However, the introduction in the model of the HPA-1 and HPA-2 genotypes as interaction terms led to a significant improvement in the prediction of PR, although the quantitative effect was small (about 3% improvement, P = 0.046). Thus, in CAD patients, there seems to be only a mild effect of the platelet glycoprotein HPA-1 and HPA-2 polymorphisms on collagen–adenosine diphosphate-stimulated PR after the effect of well-established clinical and biochemical determinants are considered.

Background Recent data suggest that the intracoronary (IC) administration of a systemic bolus dose of abciximab during PCI may increase the efficacy of this antiplatelet drug. However, the effect of IC abciximab on coronary angiographic flow has been not clarified. Methods We studied 37 consecutive patients with acute coronary syndromes (ACS) who underwent successful urgent PCI on the target vessel and were treated by an IC abciximab bolus (0.25 mg/kg) prior to the first balloon inflation (Group IC), and 37 matched controls who were treated by intravenous (IV) abciximab bolus at the same dose (Group IV). Corrected TIMI frame count (CTFC) in the culprit and in a non-culprit coronary artery branch was assessed before treatment, immediately after intracoronary administration of abciximab bolus and at the end of the procedure. Results After administration of abciximab, CTFC significantly decreased from 48+37 to 33+30 ( P =0.001) in the culprit vessel while in the non-culprit vessel it remained unchanged (16+7 pre-treatment and 16+7 post-treatment, P =0.68). Final CTFC was 12+4 in Group IC and 14+5 in Group IV ( P =0.069). Post-treatment mean peak of the cardiac enzymes showed a trend toward reduction in Group IC compared with Group IV. Conclusions The IC administration of abciximab bolus acutely decreases CTFC through culprit vessels of patients with ACS undergoing urgent PCI. Further studies evaluating the potential clinical benefits associated with IC abciximab administration are warranted.

Diabetes mellitus remains a significant predictor of adverse clinical outcomes after percutaneous coronary intervention (PCI). Outcomes after 2nd generation drug-eluting stent (DES) implantation in diabetics remains ill-defined. Aim of this study was to compare the clinical outcomes of the Resolute

Percutaneous intervention of thrombus containing lesion carries a high risk of periprocedural complications [1]. If the culprit lesion is a saphenous vein graft, thrombus burden is usually large [2]. Optimal treatment strategy for such situation is still not well-defined. We describe a staged approach with intravenous tirofiban infusion prior to stent implantation for the management of a large thrombus in a stenosed old vein graft. A 66-year-old man with a history of previous inferior MI, was admitted to our hospital because of recurrent episodes of chest pain at rest. Risk factors were hypertension, non-insulin-dependent diabetes and smoking. Eight years earlier he underwent a coronary angiography that revealed severe three-vessels disease. Coronary artery bypass graft was performed with a sequential saphenous vein graft to first diagonal and first marginal branch and a left internal mammary artery to left anterior descending coronary artery; the right coronary artery of small caliber, was not grafted. After four years the patient had a non ST-elevation myocardial infarction and underwent stenting of the circumflex artery. He remained asymptomatic for four years under medical therapy up to the current admission. On admission the ECG showed T wave inversion in lateral leads. There was a mild increase in total creatine kinase up to 270 IU/l. At coronary angiography the left internal mammary artery graft was patent with diffuse disease in the distal left anterior descending, the right coronary artery was occluded proximally with moderate in-stent restenosis of the

Adjunctive therapy with abciximab during primary percutaneous coronary intervention (PPCI) in patients with ST-elevation myocardial infarction (STEMI) determines a better short-term outcome compared to placebo. Tirofiban and eptifibatide represent a valid option with lower cost, but these have been less studied. The aim of the present study was to combine all randomized trials and registries to demonstrate the noninferiority of tirofiban and eptifibatide compared to abciximab in patients with STEMI treated with PPCI. We identified 6 randomized trials and 4 registries. Overall, 4,653 received small molecules and 2,696 abciximab, and the rate of combined death and nonfatal reinfarction did not differ (4.6% vs 4.5%, odds ratio 0.99, 95% confidence interval [CI] 0.78 to 1.27, p = 0.95) up to 30 days of follow-up, with an absolute difference of 0.1% (95% CI -1.06 to 0.8). Because the noninferiority limit was set at +1.5%, and because the upper point estimate (0.8%) of the 95% CI did not cross the prespecified limit, the noninferiority of the small molecules was documented. In-hospital major bleeding was also similar (8.8% vs 6.1%, odds ratio 0.92, 95% CI 0.75 to 1.13, p = 0.43). Sensitivity analysis comparing randomized trials to registries and tirofiban or eptifibatide to abciximab did not show any significant differences. In conclusion, our results documented noninferiority of "small molecules" compared to abciximab and, therefore, support their alternative use as adjunctive therapy during PPCI for patients with STEMI.

Maria De Vita1, Francesco Burzotta1, Giuseppe GL Biondi-Zoccai2, Thierry Lefevre3, Dariusz Dudek4, et al1Cardiology Institute, Catholic University of Sacred Heart, Rome, Italy; 2Interventional Cardiology, University of Turin, Italy; 3ICPS, Massy, France; 4Department of Cardiology, Jagiellonian University, Kracow, Poland, et alBackground: Available data from randomized trials on thrombectomy in patients with ST-elevation myocardial infarction (STEMI) have shown favorable trends in myocardial reperfusion. However, few data are available on the effect of thrombectomy on clinical outcome. Thus we have designed a collaborative individual patient-data meta-analysis which aimed to assess the long-term clinical outcome in STEMI patients randomized to percutaneous coronary intervention (PCI) with or without thrombectomy.Method: After a thorough database search, the principal investigators of randomized trials comparing thrombectomy with standard PCI in patients with STEMI were contacted. Principal investigators as authors of 11 randomized studies agreed to participate and were asked to complete a structured database by providing a series of key pre-PCI clinical and angiographic data as well as the longest available clinical outcome of the patients enrolled in the corresponding trial. The primary end-point of this pooled analysis is the comparison of overall survival rates between patients randomized to PCI with thrombectomy or PCI without thrombectomy. The secondary end-points are survival free from myocardial infarction (MI), target lesion revascularization (TLR), major adverse coronary events (MACE: death + MI + TLR) and death + MI between patients randomized to PCI with thrombectomy or PCI without thrombectomy. A pre-defined subgroup analysis is planned considering the following variables: type of thrombectomy device used, diabetes, rescue PCI, IIb/IIIa-inhibitors use, time-to-reperfusion, infarct-related artery, and pre-PCI TIMI flow.Implications: This study will provide useful data on the effect of the reported improved myocardial perfusion associated with thrombectomy on the long-term clinical outcome in patients with STEMI.Keywords: ST elevation myocardial infarction, thrombectomy, primary PCI&nbsp

Peri-procedural bleeding complications have been associated with a worse outcome in patients undergoing percutaneous coronary intervention (PCI), especially in the context of acute coronary syndromes (ACSs). This study aims to assess if the selection of transradial approach to perform PCI still