Luigi Politi

Radial Versus Femoral Randomized Investigation in ST-Segment Elevation Acute Coronary Syndrome The RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) Study

OBJECTIVES The purpose of this study was to assess whether transradial access for ST-segment elevation acute coronary syndrome undergoing early invasive treatment is associated with better outcome compared with conventional transfemoral access. BACKGROUND In patients with acute coronary syndrome, bleeding is a significant predictor of worse outcome. Access site complications represent a significant source of bleeding for those patients undergoing revascularization, especially when femoral access is used. METHODS The RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) was a multicenter, randomized, parallel-group study. Between January 2009 and July 2011, 1,001 acute ST-segment elevation acute coronary syndrome patients undergoing primary/rescue percutaneous coronary intervention were randomized to the radial (500) or femoral (501) approach at 4 high-volume centers. The primary endpoint was the 30-day rate of net adverse clinical events (NACEs), defined as a composite of cardiac death, stroke, myocardial infarction, target lesion revascularization, and bleeding). Individual components of NACEs and length of hospital stay were secondary endpoints. RESULTS The primary endpoint of 30-day NACEs occurred in 68 patients (13.6%) in the radial arm and 105 patients (21.0%) in the femoral arm (p = 0.003). In particular, compared with femoral, radial access was associated with significantly lower rates of cardiac mortality (5.2% vs. 9.2%, p = 0.020), bleeding (7.8% vs. 12.2%, p = 0.026), and shorter hospital stay (5 days first to third quartile range, 4 to 7 days] vs. 6 [range, 5 to 8 days]; p = 0.03). CONCLUSIONS Radial access in patients with ST-segment elevation acute coronary syndrome is associated with significant clinical benefits, in terms of both lower morbidity and cardiac mortality. Thus, it should become the recommended approach in these patients, provided adequate operator and center expertise is present. (Radial Versus Femoral Investigation in ST Elevation Acute Coronary Syndrome [RIFLE-STEACS]; NCT01420614).

Radial Versus Femoral Randomized Investigation in ST Elevation Acute Coronary Syndrome: the RIFLE STEACS Study

OBJECTIVES The purpose of this study was to assess whether transradial access for ST-segment elevation acute coronary syndrome undergoing early invasive treatment is associated with better outcome compared with conventional transfemoral access. BACKGROUND In patients with acute coronary syndrome, bleeding is a significant predictor of worse outcome. Access site complications represent a significant source of bleeding for those patients undergoing revascularization, especially when femoral access is used. METHODS The RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) was a multicenter, randomized, parallel-group study. Between January 2009 and July 2011, 1,001 acute ST-segment elevation acute coronary syndrome patients undergoing primary/rescue percutaneous coronary intervention were randomized to the radial (500) or femoral (501) approach at 4 high-volume centers. The primary endpoint was the 30-day rate of net adverse clinical events (NACEs), defined as a composite of cardiac death, stroke, myocardial infarction, target lesion revascularization, and bleeding). Individual components of NACEs and length of hospital stay were secondary endpoints. RESULTS The primary endpoint of 30-day NACEs occurred in 68 patients (13.6%) in the radial arm and 105 patients (21.0%) in the femoral arm (p = 0.003). In particular, compared with femoral, radial access was associated with significantly lower rates of cardiac mortality (5.2% vs. 9.2%, p = 0.020), bleeding (7.8% vs. 12.2%, p = 0.026), and shorter hospital stay (5 days first to third quartile range, 4 to 7 days] vs. 6 [range, 5 to 8 days]; p = 0.03). CONCLUSIONS Radial access in patients with ST-segment elevation acute coronary syndrome is associated with significant clinical benefits, in terms of both lower morbidity and cardiac mortality. Thus, it should become the recommended approach in these patients, provided adequate operator and center expertise is present. (Radial Versus Femoral Investigation in ST Elevation Acute Coronary Syndrome [RIFLE-STEACS]; NCT01420614).

A randomised trial of target-vessel versus multi-vessel revascularisation in ST-elevation myocardial infarction: major adverse cardiac events during long-term follow-up

Background Few reports described outcomes of complete compared with infarct-related artery (IRA)-only revascularisation in patients with ST-elevation myocardial infarction (STEMI) and multivessel coronary artery disease (CAD). Moreover, no studies have compared the simultaneous treatment of non-IRA with the IRA treatment followed by an elective procedure for the other lesions (staged revascularisation). Methods The outcomes of 214 consecutive patients with STEMI and multivessel CAD undergoing primary angioplasty were studied. Before the first angioplasty patients were randomly assigned to three different strategies: culprit vessel angioplasty-only (COR group); staged revascularisation (SR group) and simultaneous treatment of non-IRA (CR group). Results During a mean follow-up of 2.5 years, 42 (50.0%) patients in the COR group experienced at least one major adverse cardiac event (MACE), 13 (20.0%) in the SR group and 15 (23.1%) in the CR group, p<0.001. Inhospital death, repeat revascularisation and re-hospitalisation occurred more frequently in the COR group (all p<0.05), whereas there was no significant difference in re-infarction among the three groups. Survival free of MACE was significantly reduced in the COR group but was similar in the CR and SR groups. Conclusions Culprit vessel-only angioplasty was associated with the highest rate of long-term MACE compared with multivessel treatment. Patients scheduled for staged revascularisation experienced a similar rate of MACE to patients undergoing complete simultaneous treatment of non-IRA.

First Results of the DEB-AMI (Drug Eluting Balloon in Acute ST-Segment Elevation Myocardial Infarction) Trial A Multicenter Randomized Comparison of Drug-Eluting Balloon Plus Bare-Metal Stent Versus Bare-Metal Stent Versus Drug-Eluting Stent in Primary Percutaneous Coronary Intervention With 6-Month Angiographic, Intravascular, Functional, and Clinical Outcomes

OBJECTIVES The goal of this study was to compare angiographic, intravascular imaging, and functional parameters, as well as the clinical outcomes of patients treated with drug-eluting balloon (DEB) plus bare-metal stent (BMS) versus BMS versus drug-eluting stent (DES) for ST-segment elevated acute myocardial infarction (STEMI). BACKGROUND Concerns remain regarding the long-term safety of DES in STEMI. DEB could provide an attractive alternative in order to achieve potentially similar effectiveness but limiting the long-term hazards related to late-acquired stent malapposition and thus stent thrombosis. METHODS In this randomized, international, 2-center, single-blinded, 3-arm study, STEMI patients were randomly assigned to group A: BMS; group B: DEB plus BMS; or group C: DES after successful thrombus aspiration. The primary endpoint was 6-month angiographic in-stent late-luminal loss. Secondary endpoints were in-stent binary restenosis, major adverse cardiac events (MACE: cardiac death, myocardial infarction, target vessel revascularization). In a subgroup of patients, stent (mal)apposition (by optical coherence tomography) and endothelial function (by acetylcholine infusion) was assessed. RESULTS Overall, 150 patients were randomized. Procedural success was achieved in 96.7%. In groups A, B, and C, respectively, late-luminal loss was 0.74 ± 0.57 mm, 0.64 ± 0.56 mm, and 0.21 ± 0.32 mm (p < 0.01); binary restenosis was 26.2%, 28.6%, and 4.7% (p = 0.01); and MACE rates were 23.5%, 20.0%, and 4.1% (p = 0.02), respectively. The median percentage [25th to 75th interquartile range] of uncovered and malapposed stent struts per lesion was 0 [0 to 0.35], 2.84 [0 to 6.63], and 5.21 [3.25 to 14.5] (p < 0.01). Significant paradoxical vasoconstriction was seen in groups B and C. CONCLUSIONS In STEMI patients, DEB followed by BMS implantation failed to show angiographic superiority to BMS only. Angiographic results of DES were superior to both BMS and DEB. Moreover, DEB before implantation induced more uncovered and malapposed stent struts than BMS, but less than after DES. (Drug-Eluting Balloon in Acute Myocardial Infarction [DEB-AMI]; NCT00856765).

Reduction of scatter radiation during transradial percutaneous coronary angiography: A randomized trial using a lead-free radiation shield†

Background: Occupational radiation exposure is a growing problem due to the increasing number and complexity of interventional procedures performed. Radial artery access has reduced the number of complications at the price of longer procedure duration. Radpad® scatter protection is a sterile, disposable bismuth‐barium radiation shield drape that should be able to decrease the dose of operator radiation during diagnostic and interventional procedures. Such radiation shield has never been tested in a randomized study in humans.

Perioperative Red Blood Cell Transfusion and Outcome in Stable Patients after Elective Major Vascular Surgery

OBJECTIVES Definitive evidence that red blood cell transfusion improves outcome after vascular surgery is lacking. The aims of the study were to determine, among stable consecutive patients who underwent elective major vascular surgery, (1) the association between postoperative transfusion and 30-day death, myocardial infarction, and both, and (2) and if this association differs according to the presence of postoperative anaemia (haemoglobin value less than 9.0 g/dL within 7 days after surgery). METHODS A retrospective observational study was conducted on 359 patients prospectively screened according to the ACC/AHA guidelines for preoperative risk in non-cardiac surgery. Main outcome was 30-day death; secondary outcomes 30-day myocardial infarction, and composite of 30-day myocardial infarction or death. RESULTS Of the patients included, 95 (26.5%) received at least one unit of red blood cells. Patients who received transfusion had a significantly increased hazard of 30-day death (hazard ratio [HR] 11.72, 95% confidence interval [CI] 3.92-35.10; p<0.0001), myocardial infarction (HR 3.3, 95% CI 1.7-6.1; p=0.0003), and both (HR 4.0 95% CI 2.2-7.3; p<0.0001). Such associations held even after adjusting for baseline characteristics, surgical risk, bleeding, and propensity to receive transfusion. There was a significant interaction between transfusion and postoperative anaemia (p=0.012). In patients without anaemia, transfusion was associated with higher risk of 30-day death (HR 19.20, 95% CI 3.99-92.45; p=0.007), myocardial infarction (HR 5.05, 95% CI 2.23-11.44; p=0.0001), and both. Conversely, in patients with anaemia this association was not significant. CONCLUSIONS In patients who underwent elective major vascular surgery, perioperative transfusion was associated with a significantly increased risk of 30-day events which was more attributable to patients with lesser degree of anaemia. Our data caution against the use of liberal transfusion in stable vascular surgery patients.

Retrograde popliteal access as bail-out strategy for challenging occlusions of the superficial femoral artery: A multicenter registry

Background: The concomitant use of femoral and popliteal accesses has been recommended for challenging superficial femoral artery (SFA) occlusions, but no comprehensive comparison of this approach to a strategy of femoral access only is available. We thus aimed to appraise the risk‐benefit balance of retrograde popliteal access as bail‐out strategy for SFA occlusions. Methods: Consecutive patients with symptomatic SFA occlusion and undergoing percutaneous revascularization were enrolled. We distinguished patients in whom retrograde popliteal access was required as bail‐out strategy versus those not requiring such access. The primary end‐point was procedural success. Results: A total of 130 patients (152 limbs) were included, with 23 patients (25 limbs) requiring retrograde popliteal access. Occlusion length was 20.6 ± 8.8 cm in those requiring popliteal access versus 18.5 ± 8.5 cm in those without popliteal access, with TASC C/D lesions in 23 (92%) versus 106 (83%). Procedural success was achieved in 92 out of 107 patients (86.0%) treated with a standard approach and 22 out of 23 patients (95.7%) treated with retrograde popliteal access (total 114 out of 130 [87.7%]) and 112 out of 127 limbs (88.2%) and 24 out of 25 limbs (96.0%), respectively (total 136 out of 152 [89.5%]). No significant increase in early or long‐term adverse events was associated with retrograde popliteal access. Conclusions: Whenever standard access sites do not enable successful recanalization of SFA occlusions, retrograde popliteal access can be safely and effectively envisioned as bail‐out strategy.

A multicenter randomized study to evaluate intracoronary abciximab with the ClearWay catheter to improve outcomes with Lysis (IC ClearLy): trial study design and rationale.

Background Percutaneous coronary intervention (PCI) is a highly effective therapy for acute ST-elevation myocardial infarction. Adjunctive therapy with platelet glycoprotein (GP) IIb/IIIa inhibitor can result in increased vessel patency and improved outcomes in ST-elevation myocardial infarction patients undergoing PCI. The investigation of novel dosing and delivery strategies of this therapy may help to further improve outcomes. Methods IC-Clearly is a randomized, open-label, multicenter trial, with the purpose of evaluating the effectiveness of an intracoronary bolus dose of abciximab delivered using the ClearWay RX catheter vs. an intravenous bolus of abciximab for ST-elevation myocardial infarction with angiographically visible thrombus (thrombus grade ≥2). A total of 150 patients will be randomized 1: 1 to treatment of the culprit artery with intracoronary abciximab (75 patients) or intravenous abciximab (75 patients) in addition to a maintenance infusion regimen of abciximab administered intravenously for 12 h after PCI. The number of patients included in this study is based on the estimation of sample size needed to identify a statistically significant difference in the primary endpoints between the two groups. The primary endpoint chosen to evaluate this hypothesis is infarct size assessed by cardiac magnetic resonance. Clinical outcomes will be assessed for each patient through hospital discharge and at 30-day follow-up. Conclusion The purpose of this study is to evaluate whether an intracoronary bolus of abciximab delivered with the ClearWay RX catheter prior to the 12 h post-PCI intravenous infusion regimen of abciximab will result in significant additional clot resolution in vivo and improved myocardial perfusion when compared with an intravenous bolus of abciximab on top of the 12 h post-PCI intravenous infusion regimen of abciximab as per standard practice. The primary endpoint chosen to evaluate this hypothesis is infarct size as assessed by cardiac magnetic resonance.

ST-segment elevation myocardial infarction with concomitant multiple coronary arteries thromboses in a young patient with hyperhomocysteinaemia

A previously healthy 35-year-old Caucasian man presented to the emergency department with sudden onset of retrosternal chest pain at rest. Initially his haemodynamics were stable and cardiovascular examination was normal. His resting 12-lead electrocardiogram showed ST-segment elevation in the anterolateral leads and a transthoracic echocardiogram showed apical segments akinesia with …

COMPARISON OF RENALGUARD SYSTEM, CONTINUOUS VENOVENOUS HEMOFILTRATION AND HYDRATION IN HIGH-RISK PATIENTS FOR CONTRAST-INDUCED NEPHROPATHY

Contrast–induced nephropathy (CIN) is a relatively frequent complication of percutaneous coronary and peripheral artery interventions and is associated with significant in–hospital and long term morbidity and mortality. We aim to compare the impact on major events of RenalGuard system (