A propensity score matched comparative study between paclitaxel-coated balloon and everolimus-eluting stents for the treatment of small coronary vessels.

OBJECTIVES: To compare the long-term clinical outcomes of paclitaxel drug-coated-balloons (DCB) and everolimus-eluting-stents (EES) following the treatment of de novo small vessel coronary artery disease. BACKGROUND: It is currently unclear whether treatment of de novo small vessel coronary disease with DCB is comparable to second generation drug-eluting stents, which are the current standard of care. METHODS: The present study enrolled 90 patients with small vessel coronary disease from the DCB treatment arm of the BELLO (Balloon Elution and Late Loss Optimization) trial and 2,000 patients treated with EES at the San Raffaele Scientific Institute. Propensity score matching was performed to adjust for differences in baseline clinical and angiographic characteristics, yielding a total of 181 patients: 90 patients with 94 lesions receiving DCB and 91 patients with 94 lesions receiving EES. Major adverse cardiac events (MACE) were defined as the composite of cardiac death, recurrent non-fatal myocardial infarction, and target vessel revascularization. RESULTS: After propensity score matching, baseline clinical and angiographic characteristics were similar between the two groups. The cumulative MACE rate at 1-year was 12.2% with DCB and 15.4% with EES (P = 0.538). Patients in the DCB group had similar TLR rates as compared to EES over the same interval (4.4% vs. 5.6%; P = 0.720). There were no cases of definite or probable stent or vessel thrombosis. CONCLUSIONS: The use of paclitaxel-DCB appears to be associated with similar clinical outcomes when compared to second-generation-EES in small coronary artery disease. The findings of this study should be confirmed with larger prospective randomized studies with longer follow-up. © 2017 Wiley Periodicals, Inc.

A multidisciplinary consensus document on follow-up strategies for patients treated with percutaneous coronary intervention.

The number of percutaneous coronary interventions (PCI) is increasing worldwide. Follow-up strategies after PCI are extremely heterogeneous and can greatly affect the cost of medical care. Of note, clinical evaluations and non-invasive exams are often performed to low risk patients. In the present consensus document, practical advises are provided with respect to a tailored follow-up strategy on the basis of patients' risk profile. Three strategies follow-up have been defined and types and timing of clinical and instrumental evaluations are reported. Clinical and interventional cardiologists, cardiac rehabilitators, and general practitioners, who are in charge to manage post-PCI patients, equally contributed to the creation of the present document.

Combination of Double Chimney Technique and Prosthesis Post-Dilation After Valve-in-Valve Implantation.

Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) is an effective treatment for aortic bioprosthetic valve degeneration. ViV-TAVI could lead to coronary occlusion. We describe the case of a patient treated with double chimney technique to protect coronary ostia followed by post-dilation for high residual transvalvular gradient using "three-kissing balloon" approach. (Level of Difficulty: Advanced.).

Safety and effectiveness of drug eluting stent in patients with ST elevation myocardial infarction undergoing primary angioplasty.

BACKGROUND: Drug eluting stents (DES) have recently been proven to further reduce restenosis and revascularization rate in comparison to bare metal stents in elective procedures. Most early DES trials did not include patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation MI, because these patients tend to have lower restenosis rates than other patient groups and delayed endothelization of these stents raises concern about a possible increase of thrombotic complications in the setting of STEMI. AIM: To confirm the safety and effectiveness of DES in patients with STEMI in a real-world scenario. METHODS: From January 2004 to December 2006, clinical and angiographic data of 370 patients with STEMI treated with primary PCI have been analyzed. Patients were retrospectively followed for the occurrence of major adverse cardiac events (MACE): death, reinfarction and target vessel revascularization (TVR). RESULTS: Overall, 120 patients received DES (32%, DES group) and 250 received bare metal stents (68%, BMS group) in the infarct related artery. Compared with the BMS group, DES patients were younger, (mean age 56 +/- 12 vs. 65 +/- 10; P < 0.001) had more often diabetes mellitus (47% vs. 14% P < 0.001), anterior localization (65% vs. 45%; P < 0.0011) and less cardiogenic shock at admission (4% vs. 7%; P < 0.001). The angiographic characteristics in the DES group showed longer lesions (23 mm vs. 19 mm) and smaller diameter of vessels (2.5 mm vs. 3.0 mm). After a median follow-up of 24 +/- 9 months, there was no significant difference in the rate of stent thrombosis (1.6% in the DES group vs. 1.2% in the BMS group, P = ns). The incidence of MACE was significantly lower in the DES group compared with the BMS group (HR 0.56 [95% CI: 0.3-0.8]; P = 0.01), principally due to the lower rate of TVR (HR 0.41 [95% CI: 0.2-0.85]; P = 0.01). CONCLUSIONS: Utilization of DES in the setting of primary PCI for STEMI, in our "real world," was safe and improved the 3-year clinical outcome compared with BMS reducing the need of TVR.

Relationship between early administration of abciximab and TIMI flow in STEMI patients undergoing primary angioplasty: findings from a large regional STEMI network.

AIMS: The aim of this study is to assess whether in S-T Elevation Myocardial Infarction (STEMI) a relationship between early administration of abciximab and Thrombolysis In Myocardial Infarction (TIMI) flow before and after primary percutaneous coronary intervention (PCI) in 960 consecutive patients exists. METHODS: From 1 February 2001 onward, in the Province of Mantua it has been operating a 'Cardiology Network for the Acute Infarction Care' having its Hub in the Central Coronary ICU/Cath Lab of Mantua Hospital and being its Spokes centers represented by the emergency rooms and Central Coronary ICUs of the four territorial hospitals. RESULTS: T1 (time from symptoms onset to first medical contact) and T2 (time from first medical contact to angioplasty) are shorter for patients rescued by first aid units rather than for those presented in emergency rooms as well as Ta (time from symptoms onset to abciximab administration). Furthermore, the patients that received abciximab before hospital arrival had less frequently a coronary occlusion [odds ratio = 0.74, 95% confidence interval (0.57-0.96), P = 0.013]. The patients with T1 less than 4 h are 753/960 (78.4%). For this type of patients, there was a significant Ta difference between the pre-PCI TIMI-flow classes (F = 4.467, df = 3, P = 0.04). Planned contrasts revealed that mean time of TIMI flow 0 (M = 104.2) is statistically different from mean time of TIMI flow 3 (M = 85.7), P = 0.013. CONCLUSION: Our results suggest that the use of abciximab, free from pharmacokinetic limits of oral P2Y12 inhibitors, should be considered in STEMI patients with early presentation before primary PCI.

[Transcatheter valve-in-valve implantation in a patient with a degenerative sutureless aortic bioprosthesis: case report and literature review]. / Impianto transcatetere di valvola aortica in paziente con bioprotesi aortica sutureless degenerata: descrizione di un caso e revisione della letteratura.

Sutureless aortic bioprostheses (SAB) provide shorter aortic cross-clamp time and cardiopulmonary bypass duration compared to conventional aortic valve replacement. Similarly to other bioprostheses, reintervention may become necessary in some cases because of long-term structural degeneration of the valve. Valve-in-valve (ViV) transcatheter aortic valve replacement may represent an effective and safe alternative to aortic valve replacement in patients with degenerated bioprostheses who carry a high risk for reintervention. We report the case of a self-expandable transcatheter ViV procedure in a degenerated SAB.

Comparison of paclitaxel drug-eluting balloon and paclitaxel-eluting stent in small coronary vessels in diabetic and nondiabetic patients - results from the BELLO (balloon elution and late loss optimization) trial.

OBJECTIVES: To evaluate the impact of diabetes on the efficacy of drug-eluting balloon (DEB) as compared to paclitaxel-eluting stent (PES) for the reduction of restenosis in small vessels according to the presence of diabetes in patients enrolled in the BELLO (Balloon Elution and Late Loss Optimization) trial. BACKGROUND: Small vessel disease is common in diabetic patients but currently there are no available data regarding DEB in these patients. METHODS: In the BELLO trial, 182 patients with lesions in small vessels were randomized 1:1 to receive DEB or PES. In the current sub analysis, patients were stratified according to the presence of diabetes. The diabetic group consisted of 74 patients (DEB=39, PES=35) and the nondiabetic group of 108 patients (DEB=51, PES=57). Angiographic endpoints examined were in-stent/in-balloon and in-segment late loss and binary restenosis at 6 months. Clinical endpoints were major adverse cardiac events (MACE; death, myocardial infarction, target vessel revascularization) at 1 year. RESULTS: In-stent/in-balloon late loss was significantly less with DEB as compared to PES in both diabetic (0.05±0.41 vs. 0.30±0.51mm, p=0.033) and nondiabetic patients (0.10±0.36 vs. 0.29±0.40mm, p=0.015). In patients with diabetes, angiographic restenosis and in-segment late loss were significantly lower with DEB as compared to PES (respectively, 6.3% vs. 25.0%; p=0.039 and -0.013±0.39 vs. 0.25±0.53; p=0.023), with no differences noted in nondiabetic patients. The cumulative MACE rate at 1 year was similar between DEB and PES in both the diabetic (13.2% vs. 25%, p=0.194) and nondiabetic groups (11.8% vs. 14.3%, p=0.699). CONCLUSIONS: Diabetes does not appear to have a negative impact on the efficacy of DEB in small vessels, which were associated with better angiographic outcomes at 6 months in this complex subgroup. Larger studies are needed to confirm these findings.

[Percutaneous coronary revascularization in patients over eighty: acute and long-term results]. / Rivascolarizzazione coronarica percutanea nei pazienti ultraottantenni: risultati immediati e a lungo termine.

BACKGROUND: As a consequence of prolonged life expectancy the number of older patients with symptomatic coronary artery disease is constantly increasing. The aim of the study was to evaluate procedural success, immediate and long-term outcomes and the predictive factors of prognosis in patients aged > 80 years with high-risk coronary artery disease treated with coronary angioplasty. METHODS: In this retrospective study, we report the diagnostic and therapeutic strategies adopted in patients aged > 80 years admitted to our institution for acute coronary syndrome with or without ST-segment elevation or disabling angina (CCS class 3-4) and the immediate and long-term results of patients treated with coronary angioplasty. RESULTS: A conservative approach was adopted in 180 patients (33%, group 1) out of the total number of 545 patients, while 365 patients (67%, group 2) underwent coronary angiography. Among these, 85% underwent revascularization. Relevant comorbidities were significantly higher in group 1 (59 vs 16%, p < 0.001) while a clinical presentation with ST-elevation myocardial infarction was prevalent in group 2 (15 vs 6%, p = 0.007). The in-hospital mortality was 19% in group 1 and 7.9% in group 2 (p = 0.001). Among 198 patients treated with angioplasty, procedural success was achieved in 93% of cases, with 8% in-hospital mortality. Periprocedural myocardial infarction occurred in 3.3% and major bleeding in 5.6% of patients. At multivariate analysis ST-elevation myocardial infarction and cardiogenic shock were significantly related to the in-hospital mortality. At follow-up (mean 25 +/- 13 months) 13 patients died, 9 from cardiac causes and 4 from noncardiac events. Recurrence of ischemia requiring revascularization occurred in 15.9% of cases. Cumulative survival at follow-up was respectively 86% at 1 year and 83% at 5 years, while the event-free survival at 5 years was 59% in the entire group, without any significant difference among patients with multivessel disease in whom a complete vs an incomplete revascularization was performed. The presence of severe comorbidities appeared to be the only predictive factor of unfavorable outcome at long-term follow-up at multivariate analysis. CONCLUSIONS: In patients aged > 80 years with symptomatic ischemic heart disease at high risk, the invasive approach was prevalent. Higher mortality rates were found in patients in whom coronary angiography was not performed. Comorbidities represent an important negative prognostic factor, impairing both the possibility of an invasive approach and conditioning an unfavorable outcome of revascularized patients. Coronary angioplasty can be successfully performed even in elderly patients. The in-hospital mortality turns out significantly higher in the setting of an acute ST-elevation myocardial infarction or in cardiogenic shock patients. For patients overcoming the acute phase, high survival rates can be expected at follow-up.

[The use of the Export Catheter device in a patient with acute myocardial infarction for thrombotic occlusion of the venous graft on the left anterior descending coronary artery: a case report]. / Utilizzo di Export Catheter in paziente con infarto miocardico acuto per occlusione trombotica del graft venoso su discendente anteriore: descrizione di un caso clinico.

Coronary angioplasty, eventually followed by stent implantation, represents the gold standard of acute myocardial infarction (AMI) treatment. Optimal reperfusion implies both patency of the infarct-related artery and a good myocardial microrevascularization with normal tissue reperfusion. The so called no-reflow phenomenon mainly occurs in the presence of highly thrombotic lesions, especially during primary angioplasty and it represents a negative prognostic factor of the outcome of AMI patients treated with angioplasty. A 77-year-old high-risk male patient, previous coronary artery bypass graft with the saphenous vein graft to the left anterior descending coronary artery for post-AMI angina in 1984, aided by 118 ambulance for anterior AMI was admitted to our cath-lab for primary coronary angioplasty. During the transport he was given aspirin i.v. 300 mg, heparin 5000 IU and abciximab (9.4 ml bolus plus infusion for 12 hours). The time of treatment (from symptom onset to first inflation) was about 90 min. Coronary angiography showed a massive thrombus occlusion of the vein graft with TIMI 0 distal flow. We employed the Export Catheter for mechanical aspiration of the occluding thrombus. The procedure was completed with direct stent implantation with good angiographic outcome. The use of thrombus aspiration and protection devices (filters or occlusive balloons) associated or not with the use of glycoprotein IIb/IIIa receptor blockers, has reduced the risk of distal embolization and of no-reflow phenomenon.

[Telecardiology in the management of acute myocardial infarction: the experience of the provincial network of Mantova]. / La telecardiologia nella gestione dell'infarto miocardico acuto: l'esperienza della rete provinciale di Mantova.

BACKGROUND: Since June 2001 we activated a program for the treatment of acute myocardial infarction, based on the early assessment of the patient's risk profile, on telematic connection among care centers and optimization of critical pathways for access to care. The aim of this work was to assess the effectiveness of telemedicine in the reduction of time to treatment. METHODS: Mantova, a province of eastern Lombardy (northern Italy) is provided with one single sanitary district with one (tertiary hospital) referring hospital equipped with a cath lab on call 24/24 hours for primary coronary angioplasty (PTCA) and cardiac surgery and 6 community hospitals: 2 with coronary care units, 2 with a cardiology section, and 2 rehabilitation hospitals. The emergency medical system transport, activated 24/24 hours, consists of 6 advanced life support (ALS) ambulances and 11 basic life support (BLS) ambulances (2 with trained nurse staff). Each ALS ambulance is equipped with a semiautomatic defibrillator LIFEPACK 12 coupled with cellular telephone GSM transmission of the 12-lead ECG. RESULTS: In the first 3-year activity of the project 340 patients with acute myocardial infarction underwent primary PTCA: 248 (73%) referred to first aid of the nearest hospital reached either by BLS ambulance or by their own means of transport and were hence transferred to the referring hospital for primary PTCA (group A), while 92 patients (27%) were aided at their own house by ALS ambulances and, after transmission of the 12-lead ECG to the referring coronary care unit, were directly transferred to the cath lab (group B). Decisional delay was 144 +/- 65 min in group A while 74 +/- 37 min in group B. Mean door-to-balloon time was 76 +/- 26 min in group A and 47 +/- 21 min in group B. High incidence of post-procedural TIMI 3 flow was achieved in both groups. In-hospital mortality was 6.8% in group A e 5.4% in group B. CONCLUSIONS: Our data show that patients referring directly to ALS ambulances had a lower decisional delay. Transmission of the patient's ECG and clinical parameters allows an early and accurate diagnosis and assessment of the individual risk profile with a consistent reduction in time to treatment and positive effects on the mortality rate.

A 2-year follow-up of a randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels the BELLO study.

BACKGROUND/OBJECTIVES: A prospective, multi-center, randomized trial, BELLO (Balloon Elution and Late Loss Optimization), showed that the primary endpoint of in-stent (in-balloon) late loss was significantly less with drug-eluting balloons (DEB) as compared with paclitaxel-eluting stents (PES). At 6 months, DEB and PES were associated with similar rates of angiographic restenosis, target lesion revascularization (TLR), and major adverse cardiac events (MACE) defined as death, myocardial infarction and target vessel revascularization. The aim of this study was to report 2-year clinical outcomes after treatment of de novo small vessel disease with DEB as compared with PES. METHODS: A total of 182 patients were enrolled and randomized to treatment with DEB (n=90) in 94 lesions or PES (n=92) in 98 lesions. The study endpoint was the incidence of MACE at 2-year follow-up. RESULTS: Two-year follow-up was achieved in almost all cases (97.8% in DEB group vs. 98.9% in PES group). There was a trend towards a lower incidence of MACE in the DEB group as compared with the PES group (14.8% vs. 25.3%; p=0.08). TLR rates in the DEB group were acceptable at 6 months, 1 year and 2 years and did not differ significantly from the PES group (4.4% vs. 7.6%, p=0.37; 6.7% vs. 12.1%, p=0.23; 6.8% vs. 12.1%, p=0.25, respectively). CONCLUSIONS: Our results suggest that treatment of small vessel disease with a paclitaxel DEB is associated with a trend for improved clinical outcomes as compared with PES up to 2 years. Late catch-up phenomenon requiring repeat intervention after treatment with DEB was not evident in this study.

[Network for the treatment of acute myocardial infarction in the province of Mantova: results after 2 years of work]. / Rete provinciale per la terapia deII'infarto miocardico acuto a Mantova: risultati di due anni di attività.

BACKGROUND: Since June 2001, in the province of Mantova, we have been carrying out a program for the management of acute myocardial infarction based on early assessment of the patients' risk profile, on telematic connection among care centers and on optimization of in- and out-of-hospital critical pathways for the access to care. METHODS: Our network provides connection among the following centers: advanced life support ambulances, 7 hospitals, 3 coronary care units, 1 cath lab on call 24 hours a day for primary angioplasty, 1 thoracic surgery division. This program, through its strong telematic platform, allows early assessment of myocardial infarction, and provides primary angioplasty to all high-risk patients, being fibrinolytic treatment reserved only to the low-risk patients admitted in peripheral hospitals. RESULTS: Two hundred and twenty patients with acute myocardial infarction were treated with angioplasty; 179 (81%) patients underwent primary angioplasty, 26 (12%) patients facilitated angioplasty and 15 patients (7%) rescue angioplasty; 121 patients (55%) were first admitted in the Mantova hospital, 65 patients (30%) were referred to Mantova from peripheral hospitals and 34 patients (15%) were directly transported to the cath lab by advanced life support ambulances. Procedural success was obtained in 98% of cases, with 05% intraprocedural mortality. In-hospital mortality was 55%, while mortality of cardiogenic shock patients was 36%. Recurrence of acute myocardial infarction occurred in 1% and major bleeding in 2.2% of patients. One patient with cardiogenic shock died during transport. Mean door-to-balloon time was 73 min with 39% reduction in the second period of recruitment after telematic connection. CONCLUSIONS: This program, developed in the setting of a provincial network for the management of acute myocardial infarction, provided primary angioplasty to all high-risk patients, with a high procedural success rate. Within a few months, time to treatment was minimized by the employment of telematic facilities.

Perioperative management of antiplatelet therapy in patients with coronary stents undergoing cardiac and non-cardiac surgery: a consensus document from Italian cardiological, surgical and anaesthesiological societies.

Optimal perioperative antiplatelet therapy in patients with coronary stents undergoing surgery still remains poorly defined and a matter of debate among cardiologists, surgeons and anaesthesiologists. Surgery represents one of the most common reasons for premature antiplatelet therapy discontinuation, which is associated with a significant increase in mortality and major adverse cardiac events, in particular stent thrombosis. Clinical practice guidelines provide little support with regard to managing antiplatelet therapy in the perioperative phase in the case of patients with non-deferrable surgical interventions and/or high haemorrhagic risk. Moreover, a standard definition of ischaemic and haemorrhagic risk has never been determined. Finally, recommendations shared by cardiologists, surgeons and anaesthesiologists are lacking. The present consensus document provides practical recommendations on the perioperative management of antiplatelet therapy in patients with coronary stents undergoing surgery. Cardiologists, surgeons and anaesthesiologists have contributed equally to its creation. On the basis of clinical and angiographic data, the individual thrombotic risk has been defined. All surgical interventions have been classified according to their inherent haemorrhagic risk. A consensus on the optimal antiplatelet regimen in the perioperative phase has been reached on the basis of the ischaemic and haemorrhagic risk. Aspirin should be continued perioperatively in the majority of surgical operations, whereas dual antiplatelet therapy should not be withdrawn for surgery in the case of low bleeding risk. In selected patients at high risk for both bleeding and ischaemic events, when oral antiplatelet therapy withdrawal is required, perioperative treatment with short-acting intravenous glycoprotein IIb/IIIa inhibitors (tirofiban or eptifibatide) should be taken into consideration.

[Coronary stenting and surgery: perioperative management of antiplatelet therapy in patients undergoing surgery after coronary stent implantation]. / Stent coronarico e chirurgia: la gestione perioperatoria della terapia antiaggregante nel paziente portatore di stent coronarico candidato a intervento chirurgico.

The management of antiplatelet therapy in patients with coronary stents undergoing surgery is a growing clinical problem and often represents a matter of debate between cardiologists and surgeons. It has been estimated that about 4-8% of patients undergoing coronary stenting need to undergo surgery within the next year. Surgery represents one of the most common reasons for premature antiplatelet therapy discontinuation, which is associated with a significant increase in mortality and major adverse cardiac events, in particular stent thrombosis. In addition, surgery confers an additional risk of perioperative cardiac ischemic events, being high in these patients because of the pro-inflammatory and pro-thrombotic effects of surgery. Current international guidelines recommend to postpone non-urgent surgery for at least 6 weeks after bare metal stent implantation and for 6-12 months after drug-eluting stent implantation. However, these recommendations provide little support with regard to managing antiplatelet therapy in the perioperative phase in case of urgent operations and/or high hemorrhagic risk. Furthermore, ischemic and hemorrhagic risk is not defined in detail on the basis of clinical and procedural characteristics. Finally, guidelines shared with cardiologists and surgeons are lacking. The present consensus document provides practical recommendations on the management of antiplatelet therapy in the perioperative period in patients with coronary stents undergoing surgery. Cardiologists and surgeons contributed equally to its creation. An ischemic risk stratification has been provided on the basis of clinical and procedural data. All surgical interventions have been defined on the basis of the hemorrhagic risk. A consensus on the most appropriate antiplatelet regimen in the perioperative phase has been reached on the basis of the ischemic and hemorrhagic risk. Dual antiplatelet therapy should not be withdrawn for surgery at low bleeding risk, whereas aspirin should be continued perioperatively in the majority of surgical operations. In the event of interventions at high risk for both bleeding and ischemic events, when oral antiplatelet therapy withdrawal is required, perioperative treatment with short-acting intravenous glycoprotein IIb/IIIa inhibitors (tirofiban or eptifibatide) should be considered.

A randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels: the BELLO (Balloon Elution and Late Loss Optimization) study.

OBJECTIVES: The aim of this study was to evaluate the efficacy of drug-eluting balloons (DEB) compared with paclitaxel-eluting stents (PES) for the reduction of restenosis in small vessels. BACKGROUND: DEB have been shown to be effective in the treatment of coronary in-stent restenosis, but data are limited regarding their efficacy in de novo disease. METHODS: BELLO (Balloon Elution and Late Loss Optimization) is a prospective, multicenter trial that randomized 182 patients with lesions located in small vessels (reference diameter <2.8 mm) to treatment with paclitaxel DEB and provisional bare-metal stenting (n = 90) or PES implantation (n = 92). The primary endpoint was noninferiority of angiographic in-stent (in-balloon) late loss with a delta of 0.25 mm. Secondary endpoints were angiographic restenosis, target lesion revascularization, and major adverse cardiac events (MACE; death, myocardial infarction, target vessel revascularization) at 6 months. RESULTS: Baseline characteristics were well matched, except for a smaller vessel size in the DEB group (2.15 ± 0.27 mm vs. 2.25 ± 0.24 mm; p = 0.003). The majority (89%) of lesions involved vessels with a diameter <2.5 mm. Bailout stenting was required in 20% of lesions in the DEB group. The primary endpoint of in-stent (in-balloon) late loss was significantly less with DEB compared with PES (0.08 ± 0.38 mm vs. 0.29 ± 0.44 mm; difference -0.21; 95% CI: -0.34 to -0.09; p(noninferiority) < 0.001; p(superiority) = 0.001). At 6 months, DEB and PES were associated with similar rates of angiographic restenosis (10% vs. 14.6%; p = 0.35), [corrected] target lesion revascularization (4.4% vs. 7.6%; p = 0.37), and MACE (10% vs. 16.3%; p = 0.21). [corrected]. CONCLUSIONS: Treatment of small-vessel disease with a paclitaxel DEB was associated with less angiographic late loss and similar rates of restenosis and revascularization as a PES. (Balloon Elution and Late Loss Optimization [BELLO]; Study NCT01086579).

The no-reflow phenomenon in acute myocardial infarction after primary angioplasty: incidence, predictive factors, and long-term outcomes.

OBJECTIVE: We evaluated the incidence and predictive factors of impaired microcirculation, defined as myocardial blush grade (MBG) 0, in patients undergoing primary angioplasty for ST-elevation myocardial infarction. METHODS: Since 2001, in our province a network has been operating for the treatment of ST-elevation myocardial infarction based on the use of primary angioplasty in all high-risk patients and, up to December 2005, 530 patients were treated. Core angiographic analysis was performed, and images were technically adequate to assess epicardial and myocardial perfusion rates in 530 patients. Outcomes were examined according to postprocedural myocardial blush. RESULTS: Patients with MBG 0-1 had more diabetes and previous anterior myocardial infarction, longer delay to mechanical reperfusion, higher baseline mean leukocyte count, higher baseline C-reactive protein level as well as higher in-hospital mortality. The correlation between MBG, Thrombolysis in Myocardial Infarction (TIMI) flow grade and ST-segment resolution suggests that MBG is an optimal marker of reperfusion. CONCLUSIONS: Our results indicate that a fair percentage of patients with TIMI 3 flow after primary angioplasty do not show signs of effective reperfusion (MBG 0) and have a higher in-hospital mortality rate. Myocardial reperfusion after primary angioplasty, as assessed by MBG, strongly correlates with other markers of reperfusion success, including ST-segment resolution.

Impact of prehospital diagnosis in the management of ST elevation myocardial infarction in the era of primary percutaneous coronary intervention: reduction of treatment delay and mortality.

OBJECTIVES: The aim of the study is to assess, as primary endpoints, in-hospital mortality and percutaneous coronary intervention (PCI) mortality and to compare the outcome in ST elevation myocardial infarction (STEMI) patients with different pathways to a catheterization laboratory in the context of an area with 24 h availability of catheter facilities. METHODS: Three hundred and ninety-nine STEMI patients, referred to an interventional centre for primary PCI, were divided into two groups according to the different pathways to the catheterization laboratory. Group A had 263 patients diagnosed following admission to First Aid. Group B had 136 patients diagnosed in a prehospital setting with telemedicine equipment and transferred directly to the interventional centre by advanced life support (ALS) ambulance. RESULTS: Significantly shorter treatment delay was observed in group B patients than in group A (262 +/- 112 vs. 148 +/- 81 min in group A vs. B, P < 0.001). A significant reduction in total mortality was observed in group B compared with group A (8.7 vs. 3% in group A vs. B, P < 0.05). After multivariate analysis, predictors of in-hospital mortality are age and Killip class (P < 0.01), different pathways to catheterization laboratory, pre-PCI TIMI flow and onset-to-balloon time (P < 0.05). CONCLUSION: The present study shows a reduction in treatment delay and in-hospital mortality by prehospital ECG and direct referral to catheterization laboratory.

Is heparin still necessary after primary angioplasty in the era of platelet glycoprotein IIb/IIIa receptor inhibitors? A review of the literature.

While there is clear evidence for administering unfractionated heparin after systemic thrombolysis, there are not randomised trials supporting the usefulness of postprocedural heparin in the setting of primary angioplasty, especially in the era of glycoprotein IIb/IIIa inhibitors, and this issue is still a matter of debate. In this review we analysed the 30-day cardiac events of patients treated with primary angioplasty and abciximab, with or without postprocedural unfractionated heparin. We conducted a Medline search and eight studies were selected: in four of them heparin was continued for at least 12 h after the procedure (group 1), in the others heparin was used only during the procedure (group 2). The composite incidence of 30-day major adverse cardiac events was similar in the two groups (5.1 vs. 5.1%; 95% confidence interval 0.66-1.45; P = 0.91), whereas total bleeding occurred in 5.5% of group 1 compared with 3% of group 2 (relative risk 1.82; 95% confidence interval 1.19-2.80; P = 0.005). In conclusion, this review suggests that in the setting of primary angioplasty with concomitant glycoprotein IIb/IIIa inhibitors, postprocedural heparin does not appear to favourably affect cardiac and systemic ischaemic events and turns out to be associated with an increase in haemorrhagic complications.