Riccardo Colantonio

The Effect of Thrombectomy on Myocardial Blush in Primary Angioplasty: The Randomized Evaluation of Thrombus Aspiration by Two Thrombectomy Devices in Acute Myocardial Infarction (RETAMI) Trial

Background: In patients with ST‐segment elevation myocardial infarction (STEMI), primary percutaneous coronary intervention (PCI) may cause thrombus dislodgment leading to microvascular function impairment, which is a negative independent predictor of myocardial function recovery. Compared with conventional stenting, pretreatment with aspiration thrombectomy during primary PCI significantly improves coronary epicardial flow and myocardial tissue perfusion parameters. We sought to evaluate the angiographic findings of two different manual aspiration thrombectomy devices (Diver‐Invatec® (DI) and Export‐Medtronic®® (EM)) in STEMI patients undergoing primary angioplasty. Methods: We randomized 103 STEMI patients referred to our hospital to undergo primary PCI (<12 hr from symptoms onset) to DI (n = 52) and EM (n = 51) devices. The primary angiographic composite end‐points were the rates of post‐thrombectomy thrombus score (TS) ≤≤2, TIMI flow grade ≥≥2, and post‐stenting myocardial blush grade (MBG) ≥≥2 in the two groups. Results: Baseline, clinical, and angiographic preprocedural findings did not differ between the two groups. After aspiration thrombectomy, a TS ≤≤ 2 was more frequently present in EM group (92.3 vs. 69.3%, P = 0.0052). Also the rate of post‐thrombectomy TIMI ≥≥ 2 (69.3 vs. 92.2%, P = 0.0052) and post‐stenting MBG ≥≥2 (88.2 vs. 69.3%, P = 0.029) were significantly higher in EM group. No significative differences were observed in terms of clinical events at 1 and 12 months. Conclusions: In this single‐center, prospective, randomized study, a EM use before stenting in STEMI patients seems to remove more thrombotic burden compared with DI, providing a greater post‐thrombectomy epicardial flow and a better post‐stenting microvascular perfusion.

Incidence of contrast-induced acute kidney injury associated with diagnostic or interventional coronary angiography

BACKGROUND Contrast-induced acute kidney injury (CI-AKI) represents an important cause of hospital-acquired AKI. The aim of this study was to evaluate the incidence of CI-AKI after coronary angiography (CA) or percutaneous coronary intervention (PCI) and the role of patient-/procedure-related risk factors. METHODS For 11 months, patients undergoing CA or PCI were prospectively evaluated for CI-AKI, and factors possibly affecting CI-AKI were analyzed. Statistical analysis was completed using Students t-test, chi-square or Fisher exact test, and multivariate logistic regression. RESULTS Among 585 consecutive patients, incidence of CI-AKI was 5.1% (n=30) and renal replacement therapy was required in 10% of those (n=3). Incidence of CI-AKI was higher in patients with anemia or chronic kidney disease (CKD) associated with diabetes. Basal hemoglobin was significantly lower in CI-AKI patients while Mehran score, contrast medium (CM) volume, contrast ratio (CM volume / maximum contrast dose) and ratio glomerular filtration rate (CM volume / GFR) were significantly higher. Multivariate analysis selected a higher contrast ratio as a factor independently associated with a higher risk of CI-AKI which otherwise appeared to be lower with increasing basal hemoglobin. CONCLUSIONS The incidence of CI-AKI after CA or PCI was higher in patients with CKD associated with diabetes. Lower levels of basal hemoglobin appeared to be related to a higher risk of CI-AKI, and contrast media volume, especially if exceeding the dose adjusted for renal function, was a strong modifiable risk factor for CI-AKI.

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.

Comparison between balloon angioplasty and additional coronary stent implantation for the treatment of drug-eluting stent restenosis: 18-Month clinical outcomes

Objective To evaluate the long-term outcomes after different modalities of treatment of drug-eluting stent (DES) in-stent restenosis (ISR) in a ‘real world’ setting. Methods Actually, few and conflicting data are available about the management of in-stent restenosis (ISR) after DES implantation. In our ‘real world’ registry 1082 consecutive patients who received a DES implantation were included. At 9-month angiographic follow-up, 93 patients presented a DES ISR that was treated with ‘homo-DES’ (HMD) (N = 27), ‘hetero-DES’ (HTD) (N = 19) and conventional balloon angioplasty (POBA) (N = 47). We evaluated the clinical outcomes in terms of major adverse cardiac event (MACE) (death, myocardial infarction and target vessel revascularization) at 18 months. Results There was no difference for clinical and angiographic characteristics between the three groups, except for the presence of silent ischaemia as clinical presentation (7.7 HMD vs. 2.2% POBA; P = 0.0001). No late stent thrombosis was found. At 18-month clinical follow-up patients treated with HMD, HTD and POBA presented a rate of MACE of 10.2, 0 and 8.7%, respectively (P = NS). Kaplan–Meier survival probability showed that HTD and POBA treatment tended to have more favourable outcomes at 18 months than the HMD treatment. Conclusion In our registry, POBA seems to be as effective as other DES implantations in cases of DES ISR, especially in cases of focal type (Mehran classification IA, IC), in terms of long-term outcomes.

Effect of Coronary Percutaneous Revascularization on Interferon-γ and Interleukin-10 Producing CD4+ T Cells during Acute Myocardial Infarction:

T lymphocytes play an important role in the induction and progression of acute coronary syndromes (ACS). To gain insight into how different T cell subsets can influence ACS, we analyzed the frequencies of circulating CD4+T cells producing either pro-inflammatory interferon(IFN)-γ or anti-inflammatory interleukin (IL)-10 in subjects presenting with ST-elevation myocardial infarction (STEMI). The effect of coronary bare metal (BS) and paclitaxel-eluting stent (PES) on the balance between CD4+IFN-γ+ and CD4+IL-10+ lymphocytes was also investigated. Peripheral blood mononuclear cells (PBMC) were isolated from 38 consecutive patients with STEMI before and 48 hrs or 6 days after implantation of either BS or PES. Twenty patients with no history of coronary artery disease were included as basal controls. PBMC were stimulated in vitro with anti-CD3/anti-CD28 monoclonal antibodies, and CD4+IFN-γ+ or CD4+IL-10+ T cells were detected by flow cytometry intracellular staining. The frequency of peripheral CD4+IL-10+ T cells was significantly higher in STEMI patients as compared with controls. Conversely, the frequency of CD4+IFN-γ+ T lymphocytes did not differ between STEMI and subjects without history of coronary artery disease. Six days after the revascularization procedure, the percentage of CD4+IL-10+ T cells was significantly decreased in BS but not in the PES group, whereas the relative percentage of CD4+IFN-γ+ T lymphocytes were diminished in both groups as compared with baseline levels. Our data indicate that STEMI is associated with a peripheral expansion of CD4+IL-10+T lymphocytes, and that primary coronary revascularization with implantation of either BS or PES is followed by a reduction in circulating CD4+IFN-γ+ T lymphocytes. PES implantation, however, appears to inhibit the relative decrease of the IL-10 producing lymphocyte as observed in BS implanted patients, shifting the balance between pro-inflammatory and anti-inflammatory T cell populations in favor of the latter.

Midterm and one-year outcome of amphilimus polymer free drug eluting stent in patients needing short dual antiplatelet therapy. Insight from the ASTUTE registry (AmphilimuS iTalian mUlticenTer rEgistry)

BACKGROUND To assess clinical outcomes of patients needing short dual antiplatelet therapy (S-DAPT) after PCI with Cre8 polymer-free amphilimus eluting-stent (AES). The Cre8-AES with pure i-Carbofilm coating was supposed to induce faster stent endothelialization and reduce device thrombogenicity. METHODS We performed a sub-analysis of unrestricted consecutive patients treated with Cre8-AES between August 2011 and January 2015. Two groups were formed: 1) patients discharged with S-DAPT (≤3-month), because of high bleeding risk or attending urgent non-cardiac surgery; and 2) patients discharged with Recommended DAPT duration (R-DAPT; ≥6-month). The primary ischemic- and bleeding-safety endpoints were Target Vessel Failure (TVF, composite endpoint of cardiac-death, target vessel-myocardial infarction and target vessel-revascularization), and major-bleeding (BARC ≥type-3a) at 6-month and 1-year. RESULTS 106 patients (8.7%) were discharged with ≤3-month DAPT (83±19days; S-DAPT group) and 1102 patients (90.6%) with ≥6-month DAPT (342±62days; R-DAPT group). Between S-DAPT and R-DAPT groups no significant differences were observed in TVF at 1-year (5.7% vs 5.1%); 1-year BARC major bleeding rate was higher in S-DAPT group (3.4% vs 0.2%, p=0.007) with all bleeding events occurred within 3months. The landmark analysis (started at 90days, ended at 1year) showed no differences in BARC major bleedings between groups (0% vs. 0.3%). CONCLUSIONS The results of this multicenter registry show that the use of Cre8 AES in patients needing short DAPT (≤3-month) was safe regarding ischemic events and could favor a reduction of bleeding events related to the recommended DAPT. A large randomized trial is necessary to support these preliminary findings.

Percutaneous treatment of a popliteal bifurcation--the value of coronary devices and strategies.

In this case report, we describe the use of coronary techniques and devices in the treatment of a complex popliteal artery bifurcation. In particular, we demonstrate that the Venture™ wire control catheter is a useful tool not only in coronary lesions but also in wiring angulated peripheral lesions.

Prasugrel or Ticagrelor in ST-Segment–Elevation Myocardial Infarction Patients With Diabetes Mellitus

Prasugrel or ticagrelor is recommended in patients with ST-segment–elevation myocardial infarction (STEMI). Patients with diabetes mellitus are characterized by enhanced platelet reactivity (PR) and a reduced response to oral antiplatelet agents.1 The RESET 2D trial (Prasugrel vs Ticagrelor in ST-Elevation Myocardial Infarction Patients With Diabetes Mellitus) was a prospective, randomized, pharmacodynamic study evaluating platelet inhibition by loading dose (LD) of ticagrelor or prasugrel in P2Y12-naive patients with diabetes mellitus presenting with STEMI. The local ethics committee approved the study (ClinicalTrials.gov NCT01531114). All consecutive patients with STEMI with diabetes mellitus undergoing primary percutaneous coronary intervention who were P2Y12 naive were considered for PR assessment. Major exclusion criteria were bleeding diathesis, periprocedural glycoprotein IIb/IIIa receptor inhibitor use, morphine administration, previous ischemic/hemorrhagic stroke, and any contraindication to antiplatelet therapy. Eligible patients were randomized 1:1 to receive ticagrelor 180-mg LD or prasugrel 60-mg LD at the time of percutaneous coronary intervention. All patients received oral aspirin 325 mg and intravenous unfractionated heparin (70 U/kg). Platelet function testing was performed with VerifyNow (Accumetrics, San Diego, CA) at baseline and …

Percutaneous intervention therapy for vascular erectile dysfunction

Erectile dysfunction (ED) is defined as the inability to get and maintain a sufficient erection to ensure an acceptable sexual activity for the subject and the partner. Although ED does not represent per se a serious disease, it carries a notable and severe influence on quality of life, with significant implications on familiar and social relationship; DE may cause depression, shame, impairment of personal esteem and relational problems. Among many possible etiologies of ED, atherosclerotic disease of penile arteries represents one of the most frequent causes, so it should always be looked for in patients with multiple risk factors for cardiovascular disease or an established coronary or peripheral artery disease. Up to 75% of patients with ED have a stenosis of the iliac-pudendus-penile artery system, deputy to perfusion of male genital organ. Recently the potential treatment of this pathologic condition by percutaneous approach has emerged with valid angiographic results and with a significant improvement in symptoms and quality of life. This review focuses on the normal anatomy and physiology of erection, the pathophysiology of ED, the common points between ED and ischemic cardiomyopathy and, lastly, the new chance of endovascular intervention for ED, to give our cardiologist colleagues the opportunity to screen and adequately treat patients with vascular ED.

Benefits on coronary restenosis from elective paclitaxel-eluting stent implantation in patients aged 75 years and older

Objective Elderly patients are increasingly referred for revascularisation yet have been underrepresented in some large clinical trials. Although the advent of drug-eluting stents has dramatically reduced clinical events related to restenosis, older age remains one of the most important correlates of adverse outcome, even after an elective percutaneous coronary intervention (PCI). We sought to evaluate the impact of paclitaxel-eluting stents on coronary restenosis in elderly patients undergoing elective PCI. Methods Patients undergoing successful elective PCI with stenting of de novo coronary artery lesions were identified and screened for participation in this study. All patients included in our analysis were divided into two cohort groups: patients aged <75 years (younger cohort) and patients aged ≥75 years (elderly cohort). We evaluated the six-month incidence of target lesion revascularisation (TLR) and major adverse cardiac events, which included TLR, death and myocardial infarction. Results A total of 171 (58 aged ≥75 years) consecutive patients were enrolled in the study. At six months, TLR rate was similar in both groups [1.77 vs. 1.72%, odds ratio (OR) 0.97, 95% confidence interval (CI) 0.08–10.9, P = 0.98, in the younger and elderly group, respectively]. Even the rate of major adverse cardiac events was comparable between the two groups (7.96 vs. 8.62%, OR 1.09, 95% CI 0.34–3.41, P = 0.88, in the younger and elderly group, respectively). Also the angiographic restenosis rates were comparable between patients <75 or ≥75 years (4.42 vs. 3.46%, P = 0.76). Conclusions After elective paclitaxel-eluting stent implantation, there is no difference in coronary restenosis in younger and elderly patients, suggesting an age-independent efficacy.