Luigi Inglese

Randomized evaluation of polytetrafluoroethylene-covered stent in saphenous vein grafts: the Randomized Evaluation of polytetrafluoroethylene COVERed stent in Saphenous vein grafts (RECOVERS) Trial.

Background Treatment of lesions located in saphenous vein grafts (SVGs) is associated with increased procedural risk and a high rate of restenosis. Methods and Results We conducted a randomized, multicenter trial to evaluate the usefulness of a polytetrafluoroethylene (PTFE)‐covered stent compared with a bare stainless steel (SS) stent for prevention of restenosis and major adverse cardiac events (MACE) in patients undergoing SVG treatment. The primary end point was angiographic restenosis at 6 months. Secondary end points were 30‐day and 6‐month MACE rates, defined as the cumulative of death, myocardial infarction (MI), and target lesion revascularization. Between September 1999 and January 2002, 301 patients with SVG lesions were randomized to either the PTFE‐covered JoStent coronary stent graft (PTFE group, n=156) or the SS JoFlex stent (control group, n=145). Angiographic and procedural success rates were similar between the 2 groups (97.4% versus 97.9% and 87.3% versus 93.8%, respectively). The incidence of 30‐day MACE was higher in the PTFE group (10.9% versus 4.1%, P=0.047) and was mainly attributed to MI (10.3% versus 3.4%, P=0.037). The primary end point, the restenosis rate at 6‐month follow‐up, was similar between the 2 groups (24.2% versus 24.8%, P=0.237). Although the 6‐month non‐Q‐wave MI rate was higher in the PTFE group (12.8% versus 4.1%, P=0.013), the cumulative MACE rate was not different (23.1% versus 15.9%, P=0.153). Conclusions The study did not demonstrate a difference in restenosis rate and 6‐month clinical outcome between the PTFE‐covered stent and the SS stent for treatment of SVG lesions. However, a higher incidence of nonfatal myocardial infarctions was found in patients treated with the PTFE‐covered stent. (Circulation. 2003;108:37‐42.)

Ostial and midshaft lesions vs. bifurcation lesions in 1111 patients with unprotected left main coronary artery stenosis treated with drug-eluting stents: results of the survey from the Italian Society of Invasive Cardiology

AIMS In this study, we compared the cumulative risk of major adverse cardiac events (MACE) of patients with distal unprotected left main coronary artery (ULMCA) stenosis with those of patients with ostial and midshaft lesions treated with drug-eluting stent (DES). METHODS AND RESULTS The survey promoted by the Italian Society of Invasive Cardiology on ULMCA stenosis was an observational study involving 19 high-volume Italian centres. We enrolled 1111 patients with ULMCA stenosis treated with DES. Major adverse cardiac events were defined as death, myocardial infarction, and target lesion revascularization. Three hundred and thirty-four patients had ostial or midshaft lesions (group 1) and 777 bifurcations (group 2). The adjusted hazards ratio of the risk of 2 year MACE of patients in group 2 vs. patients in group 1 was 1.50 (P = 0.024). However, we observed that there was a significant difference between patients with bifurcations treated with two stents and those in group 1 (P = 0.001), but not between patients with bifurcations treated with one stent and those in group 1 (P = 0.38). CONCLUSION Patients with bifurcations have a worse outcome than patients with ostial and midshaft lesions. However, the technique used to treat bifurcations has a significant impact on clinical outcomes.

Impact of Bifurcation Technique on 2-Year Clinical Outcomes in 773 Patients With Distal Unprotected Left Main Coronary Artery Stenosis Treated With Drug-Eluting Stents

Background—Distal unprotected left main coronary artery (ULMCA) stenosis represents a technical challenge for interventional cardiologists. In this study, we compared 2-year clinical outcomes of different stenting strategies in patients with distal ULMCA stenosis treated with drug-eluting stents. Methods and Results—The survey promoted by the Italian Society of Invasive Cardiology on ULMCA stenosis was an observational study on patients with ULMCA stenosis treated with percutaneous coronary intervention. In this study, we selected patients with distal ULMCA stenosis treated with drug-eluting stents. Seven hundred seventy-three patients were eligible for this study: 456 were treated with 1 stent (group 1) and 317 with 2 stents (group 2). The primary end point of the study was the incidence of major adverse cardiac events (MACEs), defined as the occurrence of mortality, myocardial infarction, and target lesion revascularization. During a 2-year follow-up, risk-adjusted survival free from MACE was significantly higher in patients in group 1 than in patients in group 2. The propensity-adjusted hazard ratio for the risk of 2-year MACE in patients in group 1 versus group 2 was 0.53 (95% CI, 0.37 to 0.76). The propensity-adjusted hazard ratio for the risk of 2-year cardiac mortality and myocardial infarction in patients in group 1 versus group 2 was 0.38 (95% CI, 0.17 to 0.85). Conclusions—Compared with the 2-stent technique, the 1-stent technique is associated with a better 2-year MACE-free survival. The stenting strategy is a prognostic factor that should be taken into account when deciding the optimal revascularization treatment.

Two-Year Clinical Outcome With Drug-Eluting Stents Versus Bare-Metal Stents in a Real-World Registry of Unprotected Left Main Coronary Artery Stenosis from the Italian Society of Invasive Cardiology

Data are limited about the relative efficacy of drug-eluting stents (DESs) versus bare-metal stents (BMSs) for the treatment of unprotected left main coronary artery (ULMCA) stenosis. The survey promoted by the Italian Society of Invasive Cardiology on ULMCA stenosis was an observational study involving 19 high-volume Italian centers of patients with ULMCA stenosis treated using percutaneous coronary intervention (PCI). From January 2002 to December 2006, of 1,453 patients identified with ULMCA stenosis treated with PCI, 1,111 were treated with DESs and 342 were treated with BMSs. During a 2-year follow-up, risk-adjusted survival free from cardiac death was significantly higher in patients treated with DESs than in those treated with BMSs. The propensity-adjusted hazard ratio for risk of 2-year cardiac mortality after DES versus BMS implantation was 0.49 (95% confidence interval 0.32 to 0.77). The benefit of DESs in reducing cardiac mortality was obtained in the period from 3 to 6 months and maintained up to 2 years. In conclusion, for patients with ULMCA stenosis undergoing PCI, DES implantation was associated with higher adjusted rates of 2-year survival free from cardiac death. The benefit of DESs in reducing cardiac mortality was obtained in the period in which clinical manifestations of restenosis usually peak.

Are drug-eluting stents superior to bare-metal stents in patients with unprotected non- bifurcational left main disease? Insights from a multicentre registry

AIMS To compare long-term clinical outcome following drug-eluting stents (DES) or bare-metal stents (BMS) implantation on lesions located at the ostium or the shaft of the left main in a large real-world population. The advent of DES decreased the risk of unprotected left main coronary artery (ULMCA) restenosis when compared with BMS, but it is unclear if this advantage continues when non-bifurcational lesions are considered. METHODS AND RESULTS The GISE-SICI registry is a retrospective, observational multicentre registry promoted by the Italian Society of Invasive Cardiology in which 19 high-volume participating centres enrolled 1453 consecutive patients who underwent percutaneous coronary intervention on ULMCA between January 2002 and December 2006. From the registry, a total of 479 consecutive patients with ostial and shaft lesions who underwent DES (n = 334) or BMS (n = 145) implantation were analysed with extensive multivariable and propensity score adjustments. At 3-year follow-up, risk-adjusted survival rates were higher in patients treated with DES than in those treated with BMS. The adjusted hazard ratio (HR) for the risk of mortality after DES implantation relative to BMS implantation was 0.37 (95% CI: 0.15-0.96, P = 0.04). The adjusted HR for the risk of cardiac mortality was 0.31 (95% CI: 0.09-1.04, P = 0.06). The adjusted 3-year rates of target lesion revascularization (TLR) were not significantly lower in the DES group than in the BMS group (P = 0.60). CONCLUSION In a large population of patients with lesions located at the ostium or the shaft of the left main in a real-world setting, DES were associated with favourable clinical outcomes when compared with BMS, although there was no evidence of a significant reduction in TLR with DES vs. BMS.

Nonbiodegradable Expanded Polytetrafluoroethylene-Covered Stent Implantation in Porcine Peripheral Arteries: Histologic Evaluation of Vascular Wall Response Compared with Uncoated Stents

AbstractPurpose: To test the vascular wall response to an expanded polytetrafluoroethylene-covered stent, compared with conventional stenting, up to 6 months after deployment in the vascular district of a swine model. Methods: Fourteen minipigs underwent implantation of expanded polytetrafluoroethylene-covered stents (CS) and bare stents (BS) in five peripheral arteries. Animals were killed at different time points (from 1 to 180 days). Histopathologic assessment by morphologic and morphometric analysis and by scanning electron microscopy (SEM) were used to assess the incorporation characteristics and re-endothelialization extent of the two types of stents. Results: A total of 70 stents (14 CS and 14 BS in the renal arteries; 28 CS in the iliac arteries, and 14 CS in the aorta) were implanted. Microscopic examination confirmed the absence of occlusive thrombi in both the CS and BS groups. Microthrombi were observed in 10 of 13 CS (77% of cases) and in four of four BS (100% of cases, p < 0.05). Inflammation was mild in 69% of segments in which a CS was implanted and in 74% of segments in which a BS was implanted (p= NS), while a severe inflammatory reaction was observed in 6% of CS segments and in 8% of BS segments (p= NS). No differences were detected at the long-term analysis between neointimal thickness in CS compared with BS segments (0.46 ± 0.18 mm vs 0.42 ± 0.26 mm at 90 days and 0.36 ± 0.08 mm vs 0.35 ± 0.04 mm at 180 days; p= NS, respectively). At SEM analysis, re-endothelization was evident 15 days after the implant in both CS and BS starting from the stent edges. Conclusion: CS implantation did not elicit a more severe thrombotic deposition compared with that of BS. A similar inflammatory reaction of the arterial wall was present in the two stent groups 3 and 6 months following the implant. In addition, CS implantation did not stimulate excessive neointimal formation when compared with BS.

Dobutamine stress echocardiography for the identification of multivessel coronary artery disease after uncomplicated myocardial infarction: the importance of test end-point

Our aim was to verify whether the sensitivity of pharmachological stress echocardiography for multivessel disease after acute myocardial infarction may be improved by a more aggressive protocol, i.e. not considering the appearance of the first wall motion abnormality as the absolute end-point if it occurs in the infarcted area without clinical or instrumental markers of extensive ischemia or left ventricular dysfunction. One-hundred twenty-one consecutive patients (age 32-71 years) prospectively underwent dobutamine-atropine stress echo (dobutamine infusion up to 40 micrograms/kg/min with additional atropine 1 mg) 11.8 +/- 4.8 days after uncomplicated myocardial infarction and coronary angiography within 6 weeks. Criteria for stopping the test were: significant ST depression or elevation, typical chest pain, major arrhythmias and left ventricular dysfunction. The test was considered as positive if a deterioration of basal wall motion pattern was observed: it was defined homozonally positive (the deterioration occurred in the myocardial area fed by the culprit vessel) or heterozonally positive (the deterioration occurred in a different vascular area). A coronary stenosis > 70% of vessel lumen was defined as critical. Thirty-four patients showed a negative test result. Among the 87 patients with positive test, 65 had no further wall motion deterioration from the first-induced wall motion abnormality (WMA) to peak test (Group A), whereas nine patients showed further homozonal (Group B) and 13 further heterozonal (Group C) asynergies. Sensitivity, specificity and accuracy of dobutamine stress echocardiography for multivessel disease were, respectively, 63%, 96% and 82% using the first-induced wall motion abnormality as test end-point, whilst they were 84% (P < 0.01), 93% and 89% according to the aggressive approach previously described. Dobutamine stress time of patients with multivessel disease was higher in Groups B and C (13.1 +/- 3.6 min) than in Group A (9.8 +/- 3.7 min, P < 0.01) and, finally, the mean obstruction of non-culprit vessel was higher in Group A (62.2%) than in Group C (47.4%, P < 0.05). No major complications were found. We conclude that the sensitivity of dobutamine stress echocardiography for multivessel disease following recent myocardial infarction is critically dependent on the test end-point. It may be improved by a more aggressive approach capable to identify less severe heterozonal coronary lesions.

Endovascular abdominal aneurysm repair and impact of systematic preoperative embolization of collateral arteries: endoleak analysis and long-term follow-up.

Purpose To report our results of endovascular aneurysm repair (EVAR) over a 10-year period using systematic preoperative collateral artery embolization. Methods From 1999 until 2009, 124 patients (117 men; mean age 70.8 years) with abdominal aortic aneurysm (AAA) underwent embolization of patent lumbar and/or inferior mesenteric arteries prior to elective EVAR procedures. Embolization was systematically attempted and, whenever possible, performed using microcoils and a coaxial technique. Follow-up included computed tomography and/or magnetic resonance imaging and abdominal radiography. Results The technical success for EVAR was 96% (119/124), with 4 patients dying within 30 days (3.2% perioperative mortality) and 1 type III endoleak accounting for the failures. Collateral arteries were occluded spontaneously or by embolization in 60 (48%) of 124 patients. The endoleak rate was 50.9% (74 in 61 patients), most of which were type II (19%). Over a mean clinical follow-up of 60.5±34.1 months (range 1–144), aneurysm sac dimensions decreased in 66 patients, increased in 19 patients, and were stable in 35. The endoleak rate was significantly higher in the patients with increasing sac diameter (p<0.001). Among the patients with patent collateral arteries, 38/64 (59.3%) developed 46 leaks, while 28 leaks appeared in 23 (41%) of 56 patients with collateral artery occlusion (p=0.069). The type II endoleak rate significantly differed between these two groups (47.8% vs. 3.6%, p<0.001). Conclusion Preoperative collateral embolization seems to be a valid method of reducing the incidence of type II endoleak, improving the long-term outcome.

The Virtual histology In CaroTids Observational RegistrY (VICTORY) study: A European prospective registry to assess the feasibility and safety of intravascular ultrasound and virtual histology during carotid interventions☆

BACKGROUND Carotid occlusive disease is the most common determinant of thromboembolic stroke. However, limited insights in vivo into the pathophysiology and pathology of carotid plaques are available. We designed a prospective multicenter registry to appraise the safety and feasibility of intravascular ultrasound (IVUS) and IVUS-virtual histology (IVUS-VH) imaging before and immediately after carotid stenting. METHODS Symptomatic and asymptomatic patients scheduled for carotid stenting were included. IVUS-VH pullbacks were performed before and after stenting. Angiographic, IVUS and IVUS-VH analyses were performed. The primary objective was to appraise feasibility and safety of IVUS-VH, and secondary objectives were to correlate plaque composition and plaque type derived from IVUS-VH with acute and 30-day complications. RESULTS A total of 119 patients were enrolled. IVUS-VH could be performed in all cases (100%), with additional runs after completion of the stenting procedure in 85%. Most plaques were stable by IVUS-VH, with vulnerable ones at minimum lumen area in 7%. Conversely, vulnerable plaques were significantly more common elsewhere in the internal carotid artery (ICA, 24% of patients, p<0.001). Acute and 30-day adverse events were uncommon (2 strokes, 1 transient ischemic attack), with no significant association between these and IVUS-VH features. CONCLUSIONS IVUS and IVUS-VH examinations during carotid interventions are feasible and safe, and provide important insights on qualitative and quantitative compositions of carotid plaques. Whether carotid IVUS-VH can predict clinical events remains uncertain, awaiting long-term follow-up of the VICTORY study and additional clinical trials.

Temporal pattern of ischemic events in relation to dual antiplatelet therapy in patients with unprotected left main coronary artery stenosis undergoing percutaneous coronary intervention.

OBJECTIVES The aim of this study was to investigate whether there is a temporal pattern of ischemic events in relation to dual antiplatelet therapy in patients with unprotected left main coronary artery (ULMCA) stenosis treated with percutaneous coronary intervention (PCI). BACKGROUND Identifying which periods during follow-up of patients with ULMCA stenosis treated with PCI are associated with higher risk of clinical events might help to improve therapeutic strategies. METHODS We analyzed data from 15 centers involved in an observational study conducted by the Italian Society of Invasive Cardiology on patients with ULMCA stenosis treated with PCI. Eight hundred ninety-four patients were enrolled. RESULTS At 30-day follow-up, the rate of cardiac mortality and myocardial infarction (MI) was 5.4%. In patients still taking dual antiplatelet therapy, the adjusted incidence rate ratio/10,000 patient-days of the combination of cardiac mortality and MI in the 31- to 180-day interval compared with the 181- to 360-day interval after PCI was 3.64 (p = 0.035). This risk was particularly high in patients with acute coronary syndromes. After stopping clopidogrel, the adjusted incidence rate ratio of cardiac mortality and MI in the 0- to 90-day interval compared with the 91- to 180-day interval was 4.20 (p = 0.009). CONCLUSIONS In patients with ULMCA stenosis taking dual antiplatelet therapy there is an increased hazard of cardiac mortality and MI between 31 and 180 days compared with 181 to 360 days. Furthermore, there is an increased hazard of cardiac mortality and MI in the first 90 days after stopping clopidogrel.