Clinical Comparison With Short-Term Follow-Up of Bioresorbable Vascular Scaffold Versus Everolimus-Eluting Stent in Primary Percutaneous Coronary Interventions.

Objective of this study was to assess the clinical performance of bioresorbable vascular scaffold (BVS) compared to everolimus-eluting stent (EES) in subjects with ST-segment elevation myocardial infarction (STEMI). We included all consecutive patients with STEMI who underwent percutaneous coronary intervention (PCI) with BVS implantation in centers participating to the Italian ABSORB Prospective Registry (BVS-RAI) and PCI with EES in the same centers during the same period. The 2 groups were compared. The primary end point was patient-oriented composite end point (POCE) including cardiac death, myocardial infarction, and target lesion revascularization (TLR) at the longest available follow-up. BVS or EES thrombosis at follow-up was also evaluated. Of the 563 patients with STEMI included, 122 received BVS and 441 EES. Procedural success was obtained in 549 (97.5%) cases without significant differences between the 2 groups (BVS 99.3% vs EES 97.0%, p = 0.2). At a median of 220-day (interquartile range 178 to 369) follow-up, no significant differences were observed in terms of POCE (BVS 4.9% vs EES 7.0%, p = 0.4); death (BVS 0.8%, EES 2.0%, p = 0.4), MI (BVS 4.1%, EES 2.0%, p = 0.2), TLR (BVS 4.1%, EES 4.5%, p = 0.8), device thrombosis (BVS 2.5%, EES 1.4%, p = 0.4). All TLR cases were successfully managed with re-PCI in both groups. A propensity matching of the study populations showed no significant differences regarding POCE at the longest available follow-up (odds ratio 0.53, 0.1 to 4.3). In conclusion, in this direct prospective comparison, BVS was associated with similar clinical results compared to EES in the STEMI setting. Larger and adequately powered randomized trials are needed to fully assess the potential clinical benefit of BVS versus the current standard of care in patients with STEMI.

Early aggressive versus initially conservative treatment in elderly patients with non-ST-segment elevation acute coronary syndrome: a randomized controlled trial.

OBJECTIVES: This study sought to determine the risk versus benefit ratio of an early aggressive (EA) approach in elderly patients with non-ST-segment elevation acute coronary syndromes (NSTEACS). BACKGROUND: Elderly patients have been scarcely represented in trials comparing treatment strategies in NSTEACS. METHODS: A total of 313 patients ≥ 75 years of age (mean 82 years) with NSTEACS within 48 h from qualifying symptoms were randomly allocated to an EA strategy (coronary angiography and, when indicated, revascularization within 72 h) or an initially conservative (IC) strategy (angiography and revascularization only for recurrent ischemia). The primary endpoint was the composite of death, myocardial infarction, disabling stroke, and repeat hospital stay for cardiovascular causes or severe bleeding within 1 year. RESULTS: During admission, 88% of the patients in the EA group underwent angiography (55% revascularization), compared with 29% (23% revascularization) in the IC group. The primary outcome occurred in 43 patients (27.9%) in the EA group and 55 (34.6%) in the IC group (hazard ratio [HR]: 0.80; 95% confidence interval [CI]: 0.53 to 1.19; p = 0.26). The rates of mortality (HR: 0.87; 95% CI: 0.49 to 1.56), myocardial infarction (HR: 0.67; 95% CI: 0.33 to 1.36), and repeat hospital stay (HR: 0.81; 95% CI: 0.45 to 1.46) did not differ between groups. The primary endpoint was significantly reduced in patients with elevated troponin on admission (HR: 0.43; 95% CI: 0.23 to 0.80), but not in those with normal troponin (HR: 1.67; 95% CI: 0.75 to 3.70; p for interaction = 0.03). CONCLUSIONS: The present study does not allow a definite conclusion about the benefit of an EA approach when applied systematically among elderly patients with NSTEACS. The finding of a significant interaction for the treatment effect according to troponin status at baseline should be confirmed in a larger size trial. (Italian Elderly ACS Study; NCT00510185).

[Transcatheter aortic valve implantation in bicuspid aortic valve: never say never]. / Valvola bicuspide e impianto di valvola aortica transcatetere: mai dire mai.

Transcatheter aortic valve implantation (TAVI) is an emerging alternative technique that has shown promise in the treatment of severe aortic stenosis in patient populations at high risk with conventional surgery. The presence of a bicuspid aortic valve (BAV) has been considered an exclusion criterion for TAVI, because of the presumed risk for poor seating or paravalvular regurgitation due to severe distortion of the native valve leaflets. For this reason, BAV disease has generally been an exclusion criterion in major trials of TAVI and there is little clinical experience available. We report a case of transcatheter valve replacement in a poor surgical candidate with BAV stenosis using a new 29 mm Edwards Sapien prosthesis.

[Risk factors, life habits and personal beliefs of nurses and nurse-students about cardiovascular prevention]. / Fattori di rischio, abitudini di vita, convinzioni personali di infermieri e studenti-infermieri in materia di prevenzione cardiovascolare.

BACKGROUND: The contribution of conventional factors (hypertension, dyslipidemia, diabetes mellitus and smoke) to the risk of development of atherosclerotic cardiovascular disease is known. Nurses have a strong role in helping patients improve their risk profile, and change their lifestyle. Behaviors and beliefs of the nurses (and physicians as well) are relevant to their "reliability" as models and educators. METHODS: A questionnaire was administered to a cohort of 98 students attending the last course-year in a school of nursing, and to a cohort of 84 nurses working in a cardiovascular department, to investigate their awareness of their own risk factors, their lifestyle, and their attitudes as to the primary prevention of cardiovascular disease. RESULTS: Among heritable risk factors, hypertension ranked first in the awareness of both students and nurses, but the risk inherent in a family history of sudden death and early myocardial infarction was recognized only by 36% of subjects. Smokers were more frequent among students than among nurses (40 vs 25%); in both cohorts the misconception was common among smokers, that "light" cigarettes or smoking "no more than 5-10 cigarettes per day" is not harmful (15 and 30% of responders, respectively). The knowledge of upper normal limits for blood pressure, plasma cholesterol and triglycerides was often poor in both cohorts. CONCLUSIONS: The knowledge and awareness of risk factors and harmful life habits should be improved by stressing their importance to the nurse students with a high priority during the school, and to the practicing nurses during postgraduate courses. This may be especially important for smoking. On the whole, however, our data suggest that the majority of the interviewed subjects, especially among the nurses, have a lifestyle that is a credible model for our patients.

Half-dose thrombolysis to begin with, when immediate coronary angioplasty in acute myocardial infarction is not possible.

BACKGROUND: Low-dose lytic drugs are sometimes administered to patients with ST-elevation acute myocardial infarction (AMI) as a bridge to coronary angioplasty (facilitated PTCA). Reports are scarce. The characteristics and outcomes of a recent series of consecutive patients treated in our Center are presented. METHODS: In August 2000 facilitated PTCA with half-dose reteplase was started in our Center in all cases when the cath lab was not immediately (< 30 min) available, or the patient had to be transferred to us. Since August 2000, 153 patients were admitted to our cath lab to undergo facilitated (n = 80) or primary (n = 73) PTCA. The data of all patients were prospectively collected, and were analyzed on an "intention-to-treat" basis. RESULTS: No significant differences were found between facilitated and primary PTCA patients with regard to: gender, diabetes, hypertension, previous PTCA/bypass surgery, heart rate at admission, systolic blood pressure, anterior AMI, number of leads with ST-segment elevation, total ST-segment deviation, collateral flow to the infarct-related artery, and three-vessel disease. In our series, facilitated vs primary PTCA patients had a better risk profile: they were younger (61 +/- 13 vs 66 +/- 11 years, p = 0.016), less frequently had a previous AMI (7 vs 24%, p = 0.01), had a shorter time from pain onset to first emergency room admission (122 +/- 104 vs 168 +/- 162 min, p = 0.045), and a trend to a shorter total time to the cath lab (209 +/- 121 vs 255 +/- 183 min, p = 0.073) despite a similar emergency room-to-cath lab component (89 +/- 50 vs 98 +/- 92 min, median 74 vs 65 min, p = NS). Moreover, they presented with a lower Killip class on admission (1.1 +/- 0.4 vs 1.5 +/- 0.98, p = 0.01), with more patients in Killip class 1 (95 vs 74%, p = 0.001). One vs 8% of patients were in shock. Facilitated vs primary PTCA patients had an initial TIMI 2-3 flow in 42 vs 25% of cases (p = 0.031), a final TIMI 3 flow in 82 vs 71% (p = NS), > or = 50% ST-segment resolution in 73 vs 58% (p = NS), and both of the latter in 62 vs 45% (p = 0.099); distal coronary embolization occurred in 9 vs 14% of cases (p = NS); intra-aortic balloon counterpulsation was used in 5 vs 12% and glycoprotein IIb/IIIa inhibitors in 10% of the whole population. The overall in-hospital mortality was 3.7 vs 9.6% (p = NS), and 2.5 vs 4.5% (p = NS) when patients in shock at admission were not considered. Reinfarction occurred in 2 patients submitted to facilitated PTCA (who had had no immediate PTCA, due to full reperfusion) and in none of the patients submitted to primary PTCA; no patient presented with stroke or major bleeding. CONCLUSIONS: Pre-treatment with thrombolysis often provides a patent vessel before PTCA, appears to be safe, and may improve reperfusion after PTCA. In this setting, the additional use of glycoprotein IIb/IIIa inhibitors before PTCA only in non-reperfused patients may be significantly risk- and cost-effective.

Combined Abciximab REteplase Stent Study in acute myocardial infarction (CARESS in AMI).

BACKGROUND: Most patients with acute myocardial infarction (AMI) are admitted to hospitals without percutaneous transluminal coronary angioplasty (PTCA) facilities or are initially managed in a prehospital mobile unit. Thrombolysis remains the most readily available reperfusion treatment in those settings, but the optimal subsequent strategy in those patients is unclear. If a mechanical recanalization is likely to be performed in an emergency, it is probably desirable that the patient receives abciximab, the glycoprotein IIb/IIIa antagonist with the strongest evidence of benefit for angioplasty in AMI. OBJECTIVE: The aim of this trial is to compare the effects on clinical outcome and cost-effectiveness of 2 strategies after immediate treatment with abciximab and half-dose reteplase for ST-elevation AMI: to manage the patients conservatively (referring them for rescue PTCA only if needed) or to immediately send all patients for emergency coronary angioplasty. METHODS: The Combined Abciximab RE-teplase Stent Study in Acute Myocardial Infarction (CARESS in AMI) is an open, prospective, randomized, multicenter clinical trial conducted in patients with high-risk ST-segment elevation AMI treated within 12 hours from symptom onset in hospitals without PTCA facilities or in a prehospital mobile intensive care unit. Apart from contraindications to thrombolysis, the main exclusion criteria are age > or =75 years and a past history of CABG surgery or a percutaneous coronary intervention procedure involving the infarct-related artery. Enrollment will be performed in hospitals without PTCA facilities or directly in the ambulance if a dedicated system is in place for prehospital diagnosis and treatment of AMI. Patients will receive half-dose reteplase and full-dose abciximab and will subsequently be randomized to conventional medical therapy (with referral for emergency rescue PTCA allowed in selected cases) or emergency angioplasty. The primary end point is the 30-day combined incidence of mortality, reinfarction, and refractory ischemia. In order to obtain a 95% power (2-sided) to detect a 42% reduction in the primary end point, 900 patients are required in each arm of the study. Secondary end points include the 1-year composite end point of mortality, reinfarction, refractory ischemia, and hospital readmission because of heart failure; resource use at 30 days and 1 year; and the incidence of inhospital stroke and bleeding complications in the 2 groups. RESULTS: Seventy-four patients have been randomized (as of March 10, 2004); results are expected in June 2005. CONCLUSION: This study will establish whether angioplasty must be started as soon as possible in all patients who receive combined pharmacologic reperfusion with the glycoprotein IIb/IIIa inhibitor abciximab and half-dose thrombolysis or whether it can be postponed or skipped in patients with signs of successful reperfusion, with obvious organizational advantages.

Management and outcomes of patients transferred for rescue coronary angioplasty in acute myocardial infarction.

BACKGROUND: Rescue coronary angioplasty (PTCA), though recommended by the guidelines, is not regularly performed after failed lysis in patients with ST-elevation acute myocardial infarction (AMI), and data from large contemporary studies are not available. The outcomes of a recent series of consecutive patients in our Center are presented. METHODS: Between August 2000 and November 2003, 270 patients with AMI < 12 hours were referred to our cath lab for emergency PTCA: 117 (43%) for rescue PTCA after failed lysis, and 153 for primary or facilitated PTCA. The baseline, procedural and outcome data of all patients were prospectively collected, analyzed on an "intention-to-treat" basis and compared. Cineangiographic data were reviewed by three angiographers who were unaware of the clinical data. RESULTS: No significant differences were found between rescue PTCA and primary/facilitated PTCA patients as to: age, female gender, diabetes, hypertension, previous AMI, time from pain onset to the first emergency room admission, heart rate at admission, systolic blood pressure, number of leads with ST-segment elevation, total ST-segment deviation, collateral flow to the infarct-related artery, initial TIMI 2-3 flow, and three-vessel disease. Patients with rescue PTCA, as compared to primary/facilitated PTCA, had a longer time from pain onset to the cath lab (336 +/- 196 vs 229 +/- 155 min, p = 0.0001) and more frequently had an anterior AMI (52 vs 38%, p = 0.027), a higher Killip class (1.5 +/- 0.98 vs 1.26 +/- 0.7, p = 0.02), shock (11 vs 5%, p = 0.073), and intra-aortic balloon pump use (17 vs 8%, p = 0.048); fewer patients were in Killip class 1 (74 vs 85%, p = 0.043). PTCA was performed immediately in 78 vs 95% of patients (p = 0.0001); 8 vs 3 patients had PTCA of the infarct-related artery and 8 vs 1 had bypass surgery later during hospitalization. Patients with rescue PTCA, as compared to primary/facilitated PTCA, had a final TIMI 3 flow in 62 vs 76% of cases (p = 0.017), > or = 70% ST-segment resolution in 36 vs 50% (p = 0.086), and both of the latter in 24 vs 45% (p = 0.006); the overall hospital mortality was 12 vs 6.5%, and 5.8 vs 3.4% when patients in shock on admission were not considered; reinfarction and stroke occurred in 0.9 vs 1.3% and in 2.6 vs 0% of the patients respectively. CONCLUSIONS: Due to referral, rescue PTCA patients were admitted to the cath lab later after the onset of infarction, and had a higher risk profile, as compared to primary/facilitated PTCA patients; both recanalization and reperfusion were less satisfactory, as were the outcomes. Thrombolysis is often ineffective but, as long as it remains a widespread treatment, efforts should be made to improve reperfusion and survival in these patients, possibly by an earlier referral for rescue PTCA.

Nurses' observational study on the practice of secondary prevention in a cardiovascular department.

BACKGROUND: Although interventional studies have established the prognostic importance of the control of risk factors in patients with cardiovascular disease, reviews invariably show that the implementation of secondary prevention in patients with cardiovascular disease during hospitalization for acute manifestations or interventions is unsatisfactory. The aim of this study was to observe secondary prevention practice in a cardiovascular department, as part of a quality assurance program. METHODS: Two hundred and twenty patients discharged from the intensive coronary care unit, cardiac surgery unit and vascular surgery unit were prospectively included. Data were extracted from medical records and discharge documents. One hundred and eleven patients with at least one modifiable risk factor which was previously not corrected, were interviewed at discharge and were reassessed 3 months later. RESULTS: Written prescriptions about smoking cessation and weight reduction were given to 7 and 3% of smokers and overweight patients respectively. In 17% of patients no lipid measurement was reported, and in 49% of patients with low-density lipoprotein (LDL) cholesterol levels > 129 mg/dl statins were not prescribed. In patients with a history of infarction, aspirin and beta-blockers were prescribed in 90 and 64% respectively. In diabetics, statins were prescribed to 48% and angiotensin-converting enzyme inhibitors to 31%. Less than 40% of patients were able to refer appropriate levels for their blood pressure, weight, and cholesterol, and 30% fully comprehended the importance of smoking cessation. At the 3-month follow-up visit, 37% of patients had LDL cholesterol levels > 129 mg/dl--in half of these patients despite statins. In 61% of diabetics glycemic control was poor, and one third of smokers had not stopped smoking. CONCLUSIONS: These observations by the nurses have shown pitfalls in the implementation of guidelines, due to incomplete risk assessment, insufficient drug treatment and ineffective patient education. These data are the starting point for upcoming actions of quality improvement in the cardiovascular department of our hospital.

[Coronary angioplasty in diabetic patients]. / L'angioplastica coronarica nei diabetici.

Increased thrombogenicity, endothelial dysfunction, proliferation of both the cells and the matrix in the vessel walls, dislipidemia and insulin-resistance are the main metabolic alterations in the diabetic scenario, with possible implications in terms of vessel restenosis after coronary angioplasty. The outcome of balloon coronary angioplasty in diabetics is poor. This is due to both increased restenosis and a high incidence of medium/long-term cardiac events; the use of stents in these patients has substantially improved the results, but the recurrence rate has not been abated to the level observed in the general population. Abciximab may be a helpful adjunct to coronary angioplasty in these patients, while coronary artery bypass grafting may still be preferable--as at present--in case of multivessel coronary artery disease. This viewpoint is likely to be substantially modified in the near future, if the promise of "zero restenosis" devices is kept.