Giulia Conti

Thrombus Aspiration During Primary Percutaneous Coronary Intervention Improves Myocardial Reperfusion and Reduces Infarct Size. The EXPIRA (Thrombectomy With Export Catheter in Infarct-Related Artery During Primary Percutaneous Coronary Intervention) Prospective, Randomized Trial

OBJECTIVES The purpose of this study was to evaluate the impact on myocardial perfusion and infarct size as assessed by contrast-enhanced magnetic resonance imaging (CE-MRI) of a manual thrombectomy device, Export Medtronic (EM) (Medtronic Inc., Minneapolis, Minnesota), as adjunctive therapy in primary percutaneous coronary intervention (PPCI) in a subset of patients with anterior ST-segment elevation myocardial infarction (STEMI). BACKGROUND PPCI may cause thrombus dislodgment, leading to microvascular damage. METHODS One hundred seventy-five STEMI patients were randomly assigned to standard percutaneous coronary intervention (PCI) (n = 87) or EM-PCI (n = 88). The primary end points were the occurrence of myocardial blush grade > or =2 and the rate of 90-min ST-segment resolution >70%. The CE-MRI substudy was performed in 75 patients with anterior STEMI to assess microvascular obstruction and infarct size. RESULTS Myocardial blush grade > or =2 and ST-segment resolution occurred more frequently in the EM-PCI group (88% vs. 60%, p = 0.001; and 64% vs. 39%, p = 0.001). In the acute phase, microvascular obstruction extent was significantly lower in the EM-PCI group and at 3 months, infarct size was significantly reduced only in the EM-PCI group. A lower incidence of cardiac death in the EM-PCI group (4.6% vs. 0%, log-rank test p = 0.02) was observed at 9 months. CONCLUSIONS Thrombectomy prevents thrombus embolization and preserves microvascular integrity reducing infarct size, and it therefore represents an useful adjunctive therapy in PPCI.

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.

Comparison of high reloading ROsuvastatin and Atorvastatin pretreatment in patients undergoing elective PCI to reduce the incidence of MyocArdial periprocedural necrosis. the ROMA II trial

OBJECTIVES The objective of this study is to compare a reloading dose of Rosuvastatin and Atorvastatin administered within 24 h before coronary angioplasty (PCI) in reducing the rate of periprocedural myonecrosis and major cardiac and cerebrovascular events (MACCE) in patients on chronic statin treatment undergoing elective PCI. BACKGROUND Elective PCI may be complicated with elevation of cardiac biomarkers. Several studies suggested that pretreatment with statins may be associated with a reduction in periprocedural myocardial necrosis. METHODS Three hundred and fifty patients with stable angina who underwent elective PCI were randomly assigned to receive a pre-procedural reloading dose of Rosuvastatin (40 mg) (Rosuvastatin Group-RG n=175) or Atorvastatin (80 mg) (Atorvastatin Group-AG n=175) and a control group on chronic statin therapy without reloading (Control-Group-CG). The primary end-point was periprocedural myocardial necrosis and the occurrence of MACCE at 30-day,6-12 month follow-up. Also we evaluate the rise of periprocedural Troponin T serum levels >3× the upper limit of normal. RESULTS Twelve and 24-hour post-PCI Creatine Kinase Muscle and Brain (CK-MB) elevation >3× occurred more frequently in the CG than in the RG and in the AG (at 24-h: 25.0 vs 7.1; p=0.003 and 25.0 vs 6.1; p=0.001). At 30-day, 6-and 12-month follow-up the incidence of cumulative MACCE was higher in CG than in the RG or AG (at 12-month: 41.0% vs 11.4% vs 12.0%; p=0.001). There was no difference between the RG and AG in terms of myocardial post-procedural necrosis and MACCE occurrence at follow-up. CONCLUSIONS High-dose statin reloading improves procedural and long term clinical outcomes in stable patients on chronic statin therapy. Both Rosuvastatin and Atorvastatin showed similar beneficial effects on procedural and long-term outcomes.

Rosuvastatin pretreatment in patients undergoing elective PCI to reduce the incidence of myocardial periprocedural necrosis: The ROMA trial

The aim of this study is to assess the efficacy of the high‐dose rosuvastatin preadministration in reducing periprocedural myocardial necrosis and major adverse cardiovascular and cerebrovascular events (MACCE) in patients undergoing elective percutaneous coronary intervention (PCI).

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.

Beneficial impact of prolonged dual antiplatelet therapy after drug-eluting stent implantation

BACKGROUND  Twelve-month dual antiplatelet therapy (DAT) with aspirin and clopidogrel after drug-eluting stent (DES) implantation is routinely recommended. It is unclear if prolonged (>12-month) DAT is also favorable. We compared the outcome of patients discontinuing DAT 12 months after off-label DES implantation versus those with DAT for >12 months. METHODS  Baseline, treatment, and outcome data of patients undergoing off-label DES implantation and free from events 11.5 months after index procedure were retrospectively retrieved. Those discontinuing DAT between 11.5 and 12.5 months (12-month DAT group) were compared to those discontinuing DAT after 12.5 months (>12-month DAT group). The primary end-point was the long-term (>24-month) rate of major adverse cerebro-cardiovascular events (MACCE). RESULTS Two hundred seventy-two patients met study inclusion criteria: 133 (48.9%) in the 12-month DAT group and 139 (51.1%) in the >12-month DAT group (who were on DAT for an average of 24 months). After an average of 36 months after DES implantation, 14 patients (5.1%) developed MACCE, with 6 (3.5%) cardiac deaths, 7 (2.2%) myocardial infarctions, no stroke, and 5 (1.8%) repeat revascularizations. The >12-month DAT group had a significantly lower risk of MACCE (1 [0.7%] vs. 13 [9.8%] in the 12-month DAT group, P < 0.001) and myocardial infarction (0 vs. 7 [5.3%], P = 0.006), with such differences confirmed at multivariable propensity-adjusted analyses. No significant differences in terms of minor or major bleedings occurred. CONCLUSIONS In this retrospective registry, patients with off-label DES implantation receiving prolonged (>12 months) DAT presented with lower rates of MACCE and myocardial infarction.

Evidence from the Resorbable-polymer stent versus Unresorbable-polymer stent Deployment for coronary Intervention: (RUDI-2) registry

Evidence from the Resorbable-polymer stent versus Unresorbable-polymer stent Deployment for coronary Intervention: (RUDI-2) registry Gennaro Sardella , Carlo Briguori , Roberto Garbo , Enrico Romagnoli , Mauro Pennacchi ⁎, Michael Donahue , Giacomo Boccuzzi , Francesco Summaria , Giulia Conti , Emanuele Canali , Filippo Placentino , Rocco Stio , Luigi Lucisano , Giuseppe Biondi-Zoccai , Massimo Mancone , Francesco Fedele a a Policlinico Umberto I, Sapienza University of Rome, Rome, Italy b Clinica Mediterranea, Naples, Italy c San Giovanni Bosco Hospital, Turin, Italy d Policlinico Casilino, Rome, Italy e Aurelia Hospital, Rome, Italy f Department of Medico-Surgical Science and Biotechnologies, Sapienza University of Rome, Latina, Italy

Long-term outcome after drug-eluting stent implantation in unselected population: ROME and UDINE experience (the RUDI registry).

Objectives: The aim of our study is to evaluate the safety and efficacy of DES implantation in an unselected, “real world,” high‐risk population. Background: Several clinical trials showed that drug‐eluting stents (DESs) implantation is safe and effective in selected population. In spite of these encouraging results, there are some concerns about “real world” utilization of these stents. Methods: One thousand four hundred and fifty‐five off‐label patients have been included in our registry. Primary end‐points were: long‐term clinical incidence of major adverse cardiac and cerebrovascular events (MACCE) and thrombosis (ST). We detected the difference between uniDES vs. multiDES implantation in terms of MACCE, death, nonfatal‐MI, the composite of death/nonfatal‐MI and target lesion revascularization (TLR) and the difference between DES type in term of MACCE. Results: At 36 months follow‐up we found: cardiac death occurred in 20 patients (1.6%); 33 patients (2.6%) had a nonfatal MI and 81 patients (6.3%) had a TLR. We observed one (0.1%) acute, 9 subacute (0.6%), 6 late (0.6%), and 1 (0.5%) very late definite ST. No difference were found in terms of overall MACCE, MI, death and composite of death/nonfatal‐MI between uni‐ and multiDES implantation but multiDES group had a higher incidence of TLR. No difference between DES type in term of MACCE was detected. Conclusions: DES utilization shows their safety and efficacy in off‐label patients with complex clinical and angiographic profile in terms of long‐term incidence of MACCE. MultiDES implantation is associated with a higher risk of long‐term TLR. No difference between DES type was found.

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.

Rheumatic Heart Disease Predisposing to Embolic Myocardial Infarction: A Multimodality Imaging Approach.

We report a clinical case of a 45-year-old male with a diagnosis of inferior myocardial infarction and previous history of rheumatic fever during his childhood. Coronary angiography demonstrated normal coronary arteries. Transthoracic echocardiogram showed hypokinetic left ventricular inferolateral wall and mitral stenosis; furthermore, speckle tracking analysis revealed reduction of global longitudinal strain involving the inferior wall. A three-dimensional transesophaegeal echocardiography, performed to better characterize the anatomy of the valve and to find possible source of embolic infarct in an enlarged left atrium, showed rheumatic valvular involvement. Cardiac magnetic resonance confirmed the ischemic damage and also provided prognostic information. A multimodality imaging approach should be mandatory in patients with acute myocardial infarction and normal coronary angiography, to define possible sources of embolic infarction and to quantify myocardial damage.