Dennis Zavalloni

The first report of late stent thrombosis leading to acute myocardial infarction in patient receiving the new endothelial progenitor cell capture stent

The endothelial progenitor cell (EPC) capture stent is a stainless steel coronary stent covered with antibodies specific to EPCs surface antigens, designed to promote the faster formation of a functional endothelial lining. This may prevent both stent thrombosis and restenosis as well as reduce the need of prolonged double antiplatelet therapy. Here we report a case of late (156 days after implantation) EPC capture stent thrombosis and re-stenosis of a second EPC capture stent occurring both in the same patient after withdrawal of clopidogrel. Intravascular ultrasound performed during his acute admission showed undersizing of the stent with thrombosis. The present case raises the question about the safety of the EPC capture stent and the need to prolong at least for 6 months double antiplatelet therapy also in patients receiving this new stent.

Immunosuppressive therapy with oral prednisone to prevent restenosis after PCI. A multicenter randomized trial

BACKGROUND Prednisone at immunosuppressive doses after stenting has shown remarkable efficacy in reducing ischemic recurrences in nondiabetic patients with high post-procedural levels of C-reactive protein; the study aim was to compare the clinical outcome obtained in a control group of patients treated with bare metal stents versus 2 other study groups--bare metal stent plus oral prednisone or drug eluting stents--assuming similar optimal adjunctive medical treatment. METHODS Five tertiary Italian hospitals enrolled 375 nondiabetic patients with coronary artery disease and no contraindications to dual antiplatelet treatment or corticosteroid therapy in a randomized, controlled study performed between 2007 and 2009. Patients were allocated into 3 study groups: bare metal stents (controls), bare metal stents followed by a 40-day prednisone treatment, or drug-eluting stents. The primary endpoint was the event-free survival of cardiovascular death, myocardial infarction, and recurrence of ischemia needing repeated target vessel revascularization at 1 year as adjudicated by an independent clinical events committee. RESULTS One-year follow-up was obtained in all patients. Patients receiving bare metal stents alone as compared to those treated with prednisone or drug-eluting stents had lower event-free survival; the primary endpoint was 80.8% in controls compared to 88.0% in the prednisone and 88.8% in the drug-eluting stent groups, respectively (P=.04 and .006). CONCLUSION Compared with bare metal stents alone, prednisone treatment after bare metal stents or drug-eluting stent implantation result in a better event-free survival at 1 year.

Randomized comparison of operator radiation exposure comparing transradial and transfemoral approach for percutaneous coronary procedures: rationale and design of the minimizing adverse haemorrhagic events by TRansradial access site and systemic implementation of angioX - RAdiation Dose study (RAD-MATRIX).

BACKGROUND Radiation absorbed by interventional cardiologists is a frequently under-evaluated important issue. Aim is to compare radiation dose absorbed by interventional cardiologists during percutaneous coronary procedures for acute coronary syndromes comparing transradial and transfemoral access. METHODS The randomized multicentre MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX) trial has been designed to compare the clinical outcome of patients with acute coronary syndromes treated invasively according to the access site (transfemoral vs. transradial) and to the anticoagulant therapy (bivalirudin vs. heparin). Selected experienced interventional cardiologists involved in this study have been equipped with dedicated thermoluminescent dosimeters to evaluate the radiation dose absorbed during transfemoral or right transradial or left transradial access. For each access we evaluate the radiation dose absorbed at wrist, at thorax and at eye level. Consequently the operator is equipped with three sets (transfemoral, right transradial or left transradial access) of three different dosimeters (wrist, thorax and eye dosimeter). Primary end-point of the study is the procedural radiation dose absorbed by operators at thorax. An important secondary end-point is the procedural radiation dose absorbed by operators comparing the right or left radial approach. Patient randomization is performed according to the MATRIX protocol for the femoral or radial approach. A further randomization for the radial approach is performed to compare right and left transradial access. CONCLUSIONS The RAD-MATRIX study will probably consent to clarify the radiation issue for interventional cardiologist comparing transradial and transfemoral access in the setting of acute coronary syndromes.

Inflammatory substrate with eosinophils may be present in bare-metal stent thrombosis.

Coronary stent thrombosis is a rare but life-threatening event after percutaneous revascularization. We report an in-vivo documentation of the pathologic process in the setting of a very late thrombosis within a bare-metal stent, showing eosinophil infiltrates. Interestingly, our case indicates that eosinophil infiltrates might not be a peculiarity of late drug-eluting stent thrombosis.

Impact of Female Sex on Long-Term Outcomes in Patients With ST-Elevation Myocardial Infarction Treated by Primary Percutaneous Coronary Intervention

BACKGROUND Conflicting information exists about whether sex differences affect long-term outcomes in patients undergoing primary percutaneous coronary intervention (PCI). METHODS This retrospective study enrolled consecutive patients with ST-elevation myocardial infarction undergoing primary PCI within 24 hours from symptom onset. Hazard ratios (HRs) of events with 95% confidence interval (CI) were calculated in the overall population and in a propensity score matched cohort of women and men. RESULTS Among 481 patients, median age 66 years old, 138 (28.7%) were women. Women were older than men (72 vs 63 years, P<0.001), had a higher prevalence of hypertension (68% vs 54%, P=0.006), diabetes (27% vs 19%, P=0.04), and Killip class≥3 at admission (19% vs 10%, P=0.007). After a median follow-up of 1041 days women experienced a significant higher incidence of the composite of death, nonfatal myocardial infarction, and hospitalization for heart failure (31.9% vs 18.4%, unadjusted HR 1.86; 95% CI, 1.26-2.74; P=0.002), driven mainly by heart failure (unadjusted HR 2.47; 95% CI, 1.12-5.41; P=0.024), without significant differences in death (unadjusted HR 1.49; 95% CI, 0.88-2.53; P=0.13), or nonfatal myocardial infarction (unadjusted HR 1.59; 95% CI, 0.78-3.27; P=0.19) and no increase in target lesion revascularization (9.4% vs 12.5%, unadjusted HR 0.77; 95% CI, 0.42-1.44; P=0.42). After propensity score matching the hazard of the composite endpoint was largely attenuated (HR 1.32; 95% CI, 0.84-2.06; P=0.23). CONCLUSIONS Women undergoing primary PCI experience worse long-term outcomes than men, but this difference is largely explained by their more adverse baseline cardiovascular profile.

Drug-eluting stents for the percutaneous treatment of the anastomosis of the left internal mammary graft to left anterior descending artery.

BackgroundData on the treatment of left internal mammary to left anterior descending artery (LIMA-to-LAD) anastomotic disease are scarce and not homogeneous. Both surgery and percutaneous interventions (PCI) have been attempted, but the most effective treatment has not yet been established. In particular, should PCI be performed, the role of stenting seems to be limited by less favorable results than in other subsets of lesions. ObjectiveTo assess the clinical impact of drug-eluting stent (DES) use in this particular subset of lesions. MethodsWe describe a cohort of patients treated with PCI on LIMA-to-LAD anastomoses, reporting acute 1-year clinical and angiographic outcomes. The clinical impact of DES use was evaluated as the requirement for target lesion revascularizations (TLR). ResultsFifty-six consecutive patients were evaluated. Acute procedural success was achieved in 52 patients (92.8%). Plain balloon angioplasty allowed acute procedural success in 15 patients (28.8%), whereas stenting was required in 37 patients (71.2%) with suboptimal results or to treat complications. Bare-metal stents (BMS) were used in 17 and DES in 20 patients, without differences in acute results. One-year clinical follow-up was available in 96.1% of patients. TLR were needed in 17.3% of patients. No significant differences were detected in TLR rates after treatment with BMS and DES (26.6% vs. 25%; P=0.99). Two late stent thromboses were observed after DES deployment. ConclusionPCI of the stenoses of LIMA-to-LAD anastomoses with DES did not provide any clinical improvement over BMS use in long-term outcomes; DES use was associated with some cases of late thrombosis.

Platypnoea-orthodeoxia syndrome secondary to patent foramen ovale (PFO): a challenging subset for PFO percutaneous closure.

BACKGROUND Platypnoea-Orthodeoxia Syndrome (P-OS) is a rare disease characterised by arterial desaturation exacerbated by the upright position and relieved by recumbency. Patent foramen ovale (PFO) may lead to a P-OS causing a right-to-left shunt in the course of particular diseases that induce atrial deformation. Percutaneous closure of the defect usually allows prompt improvement of the clinical status. METHODS A series of patients with P-OS was treated with percutaneous PFO closure, according to standard clinical practice. Procedural monitoring was performed by transoesophageal two-dimensional-echocardiography (2D-echo). RESULTS PFO percutaneous closure was initially effective in only half of the patients because of high rates of acute residual shunt. This unexpected result was related to the very complex anatomy evaluation with 2D-echo, mainly due to a peculiar atrial deformation occurring in P-OS. A second device delivery allowed it to achieve complete defect closure in the remaining patients. Technical issues arising during the procedures are widely discussed. CONCLUSIONS Percutaneous closure of PFO in patients with P-OS is feasible but some technical issues should be considered when PFO anatomy is not clear with traditional imaging techniques.

Inhibitors of Platelets Glycoprotein IIb / IIIa (GP IIb / IIIa) Receptor: Rationale for their Use in Clinical Cardiology

The glycoprotein IIb/IIIa (GP IIb/IIIa) receptor is the most important receptor involved in platelet aggregation. A stable GP IIb/IIIa inhibition is required when a massive platelet activation triggers thrombosis. Three GP IIb/IIIa inhibitors are currently approved for clinical use: abciximab, tirofiban and integrilin. Their different pharmacodynamic and pharmacokinetic properties reflect a different efficacy in platelet inhibition.

Gender paradox in outcome after percutaneous coronary intervention with paclitaxel eluting stents.

AIMS To evaluate in-hospital and long-term outcome of women undergoing percutaneous coronary intervention (PCI) with paclitaxel-eluting stents (PES) as compared to men and historic controls treated with bare metal stents. METHODS AND RESULTS Eight-hundred and ten (810) consecutive patients (642 men and 168 women) with PES were analysed and also compared with 3,515 patients (2,811 men and 704 women) with at least one bare metal stent in the three years previous. In the PES group, women were significantly older than men (mean age of 68+/-10 vs. 63+/-10 years, p<0.001), with more diabetes (39.9 vs. 29.7%, p<0.05), smaller treated vessels (<2.5 mm in 34.9 vs. 24.8%, p=0.003), more left-anterior descending lesions (56.6 vs. 43.2%, p<0.001). More men had multivessel disease (78.8 vs. 62.5%, p<0,001), dyslipidaemia (73.2 versus 65.4%, p<0.05), smoking habit (74.3 versus 34.5%, p<0.001) or prior revascularisation (49.7 versus 36.1%, p<0.05). Compared to bare metal stents, similar higher risk features were recorded in women over time. No gender specific differences in in-hospital outcome were observed. At 12 months the rates of cardiac death, acute myocardial infarction (AMI) and late thrombosis were respectively 2.0%, 3.7% and 0% in women and 2.1%, 3.2%, and 1.2% in men (all p=NS). CONCLUSIONS Albeit with worse baseline clinical and angiographic characteristics in women, very high immediate success rates and a positive outcome can be achieved in both sexes after PES.

Immediate removal of femoral-sheath following protamine administration in patients undergoing intracoronary paclitaxel-eluting-stent implantation

Background: Immediate sheath-removal using post-procedural reversal of heparin with protamine reduces groin complications, shortens bed rest and hospital stay after percutaneous coronary intervention (PCI) with bare-metal stents. No data are available with newer and possibly more thrombogenic paclitaxel-eluting stents (PES). Aim: We assessed the safety and efficacy of post-procedural protamine administration after successful coronary PES implantation in elective PCI and in patients with acute coronary syndromes (ACS). Methods: A consecutive series of 291 patients received 0.5 mg of protamine per 100 units of heparin whenever the post-procedural ACT was > 180 seconds, followed by immediate removal of the sheath (protamine group). Outcomes were compared to a historic control group comprising 291 consecutive patients, who also underwent PCI with PES, but without reversal of anticoagulation by protamine (non protamine group). The incidence of post-procedural vascular complications and bleeding complications, as well as hospital stay, were compared; as were the incidence of major cardiac events at 24 h, 30 days and 6 months. Results: The post-procedural bleeding complications were significantly higher in the non-protamine group. Vascular complications were also more frequent in patients who were not treated with protamine. Hospitalisation length was significantly lower in the protamine group than in the non-protamine group (13.6 ± 7 h versus 20.41 ± 3.9 h; p < 0.001). The protamine-group patients also had a significantly reduced bed rest (10.3 h ± 5.6 h versus 18 h ± 3.5 h; p < 0.001). During hospitalisation, after PES implantation, no deaths or acute stent thrombosis were observed in either group. The overall incidence of thrombosis and major adverse cardiac events at follow-up were similar in the two groups. Conclusions: Immediate heparin neutralisation by protamine after successful PES implantation appears to be safe and feasible, also in patients with ACS. Use of protamine and early sheath removal after PCI confers early deambulation and may significantly limit healthcare cost, reduce vascular complications, bedrest, delayed discharge and patient discomfort.