Acute Coronary Syndromes and SARS-CoV-2 Infection: Results From an Observational Multicenter Registry During the Second Pandemic Spread in Lombardy.

Background: COVID-19 had an adverse impact on the management and outcome of acute coronary syndromes (ACS), but most available data refer to March-April 2020. Aim: This study aims to investigate the clinical characteristics, time of treatment, and clinical outcome of patients at hospitals serving as macro-hubs during the second pandemic wave of SARS-CoV-2 (November 2020-January 2021). Methods and Results: Nine out of thirteen "macro-hubs" agreed to participate in the registry with a total of 941 patients included. The median age was 67 years (IQR 58-77) and ST-elevation myocardial infarction (STEMI) was the clinical presentation in 54% of cases. Almost all patients (97%) underwent coronary angiography, with more than 60% of patients transported to a macro-hub by the Emergency Medical Service (EMS). In the whole population of STEMI patients, the median time from symptom onset to First Medical Contact (FMC) was 64 min (IQR 30-180). The median time from FMC to CathLab was 69 min (IQR 39-105). A total of 59 patients (6.3%) presented a concomitant confirmed SARS-CoV-2 infection, and pneumonia was present in 42.4% of these cases. No significant differences were found between STEMI patients with and without SARS-CoV-2 infection in treatment time intervals. Patients with concomitant SARS-CoV-2 infection had a significantly higher in-hospital mortality compared to those without (16.9% vs. 3.6%, P < 0.0001). However, post-discharge mortality was similar to 6-month mortality (4.2% vs. 4.1%, P = 0.98). In the multivariate analysis, SARS-CoV-2 infection did not show an independent association with in-hospital mortality, whereas pneumonia had higher mortality (OR 5.65, P = 0.05). Conclusion: During the second wave of SARS-CoV-2 infection, almost all patients with ACS received coronary angiography for STEMI with an acceptable time delay. Patients with concomitant infection presented a lower in-hospital survival with no difference in post-discharge mortality; infection by itself was not an independent predictor of mortality but pneumonia was.

Polymer-Free Biolimus-Eluting Stents or Polymer-Based Zotarolimus-Eluting Stents for Coronary Bifurcation Lesions.

BACKGROUND: A polymer-free biolimus-eluting stent (PF-BES) and a zotarolimus-eluting stent (ZES) recently showed similar clinical profiles and appear to be competing options in specific clinical settings of patients undergoing percutaneous coronary intervention (PCI). Whether they perform similarly also in complex procedural settings as coronary bifurcation lesions remains unaddressed. METHODS: All consecutive patients undergoing coronary bifurcation PCI with PF-BES or the new iteration of the ZES from three large multicenter real-world registries were included. The primary outcome was major adverse cardiovascular events (MACE), a composite of all-cause death, myocardial infarction (MI), target lesion revascularization (TLR) and stent thrombosis (ST). Multiple analyses to adjust for baseline differences were carried out including propensity-score matching, propensity-score stratification and inverse-probability-weighting. Outcomes are reported according to Cox proportional hazard models censored at 400-day follow-up. RESULTS: 1169 patients treated with PF-BES (n = 440) or ZES (n = 729) on the main branch of a coronary bifurcation lesion were included (mean age 69 ± 11 years, 75.4% male, 53.8% acute coronary syndrome at presentation, 26.6% left main bifurcation, median dual antiplatelet therapy duration 12 [range 12-12] months). MACE, all-cause death, TLR and ST tended towards non-statistically higher rates with the PF-BES as compared to the ZES. Higher MI and target vessel revascularization occurrence was observed with PF-BES. CONCLUSIONS: In this large contemporary cohort of patients undergoing coronary bifurcation PCI, the occurrence of MACE was non-statistically different with the use of PF-BES and ZES devices. However, differences favoring the ZES device that may entail clinical relevance were observed. Further studies are needed to confirm these findings and explore whether they remain valid when a short dual antiplatelet therapy is adopted.

Impact of serum uric acid levels on cardiovascular events and quality of life in patients with chronic coronary syndromes: Insights from a contemporary, prospective, nationwide registry.

BACKGROUND AND AIMS: Hyperuricemia is a metabolic disorder that has been associated with adverse cardiovascular (CV) events. Using the data from a nationwide, prospective registry on patients with chronic coronary syndromes (CCS), we assessed the impact of serum uric acid (SUA) levels on quality of life (QoL) and major adverse CV events (MACE), a composite of CV death and hospitalization for myocardial infarction, heart failure (HF), angina or revascularization at 1-year. METHODS AND RESULTS: Among the 5070 consecutive CCS patients enrolled in the registry, levels of SUA were available for 2394 (47.2%). Patients with SUA levels available at baseline were grouped as low tertile (n = 860; 4.3 [3.7-4.7] mg/dL), middle tertile (n = 739; 5.6 [5.3-5.9] mg/dL) and high tertile (n = 795; 7.1 [6.7-7.9] mg/dL). At 1 year, the incidence of MACE was 3.7%, 4.1% and 6.8% for low, middle and high tertiles, respectively (p = 0.005 for low vs high tertile). Patients in the high tertile of SUA had a significantly higher rate of CV mortality (1.4% vs 0.4%; p = 0.05) and hospital admission for HF (2.8% vs 1.6%; p = 0.03) compared to the low tertile. However, hyperuricemia did not result as an independent predictor of MACE at multivariable analysis [hazard ratio: 1.27; 95% confidence intervals: 0.81-2.00; p = 0.3]. CONCLUSIONS: In this contemporary, large cohort of CCS, those in the high tertile of SUA had a greater burden of CV disease and worse QoL. However, SUA did not significantly influence the higher rate of CV mortality, hospitalization for HF and MACE observed in these patients during 1-year follow-up.

Management of acute coronary syndromes during the COVID-19 outbreak in Lombardy: The "macro-hub" experience.

BACKGROUND: During the COVID-19 outbreak, healthcare Authorities of Lombardy modified the regional network concerning time-dependent emergencies. Specifically, 13 Macro-Hubs were identified to deliver timely optimal care to patients with acute coronary syndromes (ACS). Aim of this paper is to present the results of this experience. METHODS AND RESULTS: This is a multicenter, observational study. A total of 953 patients were included, presenting with STEMI in 57.7% of the cases. About 98% of patients received coronary angiography with a median since first medical contact to angiography of 79 (IQR 45-124) minutes for STEMI and 1262 (IQR 643-2481) minutes for NSTEMI.A total of 107 patients (11.2%) had SARS-CoV2 infection, mostly with STEMI (74.8%). The time interval from first medical contact to cath-lab was significant shorter in patients with COVID-19, both in the overall population and in STEMI patients (87 (IQR 41-310) versus 160 (IQR 67-1220) minutes, P = 0.001, and 61 (IQR 23-98) versus 80 (IQR 47-126) minutes, P = 0.01, respectively). In-hospital mortality and cardiogenic shock rates were higher among patients with COVID-19 compared to patients without (32% vs 6%, P < 0.0001, and 16.8% vs 6.7%, P < 0.0003, respectively). CONCLUSIONS: During the COVID-19 outbreak in Lombardy, the redefinition of ACS network according to enlarged Macro-Hubs allowed to continue with timely ACS management, while reserving a high number of intensive care beds for the pandemic. Patients with ACS and COVID-19 presented a worst outcome, particularly in case of STEMI.

Real-world reasons and outcomes for 1-month versus longer dual antiplatelet therapy strategies with a polymer-free BIOLIMUS A9-coated stent.

BACKGROUND: A large trial established the favorable profile of a new polymer-free biolimus A9-eluting stent (PF-BES) with a 1-month dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients. This is the first study comparing outcomes for a 1-month versus longer DAPT strategies following PF-BES-percutaneous coronary intervention (PCI). METHODS: All patients undergoing PF-BES-PCI (January 2016 to July 2018) were included in the multicenter CHANCE registry. Patients were stratified according to DAPT strategy at discharge (planned 1-month vs. planned >1-month). Primary outcomes were the 390-day estimates of a patient-oriented and of a device-oriented composite endpoints (POCE: death, myocardial infarction [MI] or target vessel revascularization; DOCE: cardiac death, target vessel-MI or ischemia-driven target lesion revascularization). Landmark analyses from 1-month post-PCI were carried. RESULTS: Following PF-BES-PCI, 328(40.3%) and 485(59.6%) patients were discharged with 1-month and longer DAPT (12 months [6-12]), respectively. Patients with a previous or index MI were less likely to be discharged on 1-month DAPT. Patients prescribed with 1-month DAPT were more likely to be at HBR than those with longer DAPT (90.2% vs. 69.9%, p = .001). No between-groups differences in the primary outcomes (planned 1-month vs. planned >1-month DAPT: POCE 11.9% vs. 13.2%, p = .747; DOCE: 4.8% vs. 8.1%, p = .500) were observed, also after adjusting for confoundings (POCE: adjusted-hazard ratio [adj-HR] 1.26, 95%CI 0.74-2.13; DOCE: adj-HR 1.00, 95%CI 0.49-1.99). Landmark analyses showed similar results. CONCLUSIONS: In a large all-comers registry of PF-BES PCI, no interaction of planned DAPT strategy (1-month vs. >1-month) with outcomes was found. This observation warrants investigation in adequately powered randomized studies (ClinicalTrials.gov NCT03622203).

Safety and efficacy of polymer-free biolimus-eluting stents versus ultrathin stents in unprotected left main or coronary bifurcation: A propensity score analysis from the RAIN and CHANCE registries.

OBJECTIVES: Evaluate safety and efficacy of polymer-free biolimus-eluting stents (PF-BESs) versus ultrathin stents in unprotected left main (ULM) or bifurcation. BACKGROUND: PF-BESs due to reduced length of dual antiplatelet therapy (DAPT) are increasingly used. However, there are limited data about safety and efficacy for ULM or bifurcation. METHODS: We selected all-patients treated for ULM or bifurcation from two multicenter real life registries (RAIN [NCT03544294] evaluating ultrathin stents, CHANCE [NCT03622203] appraising PF-BES). After propensity score with matching, the primary endpoint was major adverse cardiac events (MACE; a composite of all-cause death, myocardial infarction, target lesion revascularization [TLR], and stent thrombosis [ST]), while its components along with target vessel revascularization (TVR) secondary endpoints. RESULTS: Three thousand and three patients treated with ultrathin stents and 446 with PF-BESs, resulting respectively in 562 and 281 after propensity score with matching (33 and 22%, respectively, with ULM disease). After 12 (8-20) months, rates of MACE were similar (9 vs. 8%, p = 0.56) without difference in TLR and ST (3.0 vs. 1.7%, p = .19 and 1.8 vs. 1.1%, p = .42). These results were consistent for ULM group (3 vs. 1.7% and 1.8 vs. 1.1%, p = .49 and .76), for non-ULM group (2.1 vs. 3.4%, p = .56 and 1.2 vs. 1.7%, p = .78) and for two-stent strategy (8.7 vs. 4.5% and 4.3 vs. 3.2%, p = .75 and .91). Among patients treated with 1 month of DAPT in both groups, those with ultrathin stents experienced higher rates of MACE related to all-cause death (22 vs. 12%, p = .04) with higher although not significant rates of ST (3 vs. 0%, p = .45). CONCLUSIONS: PF-BES implanted on ULM or BiF offered freedom from TLR and ST comparable to ultrathin stents. PF-BESs patients assuming DAPT for 1 month experienced a lower despite not significant incidence of ST.

Bridge therapy or standard treatment for urgent surgery after coronary stent implantation: Analysis of 314 patients.

Intravenous administration of a short acting glycoprotein IIb/IIIa inhibitor has been proposed as a bridge to surgery in patients on dual antiplatelet treatment, but data in comparison with other treatment options are not available. We conducted a retrospective analysis of consecutive patients who underwent un-deferrable, non-emergency surgery after coronary stenting. The bridge therapy was performed after discontinuation of the oral P2Y12 inhibitor by using i.v. tirofiban infusion. Net Adverse Clinical Events (NACE) was the primary outcome. We analyzed 314 consecutive patients: the bridge strategy was performed in 87 patients, whereas 227 were treated with other treatment options and represent the control group. Thirty-day NACE occurred in 8% of patients in the bridge group and in 22.5% in the control group (p < 0.01). Bridge therapy was associated with decreased 30-day NACE rate [Odds ratio (OR) 0.30; 95% confidence interval (CI) 0.13-0.39; p < 0.01], particularly when the time interval between stenting and surgery was ≤ 60 days (OR 0.09, 95% CI 0.01-0.72; p = 0.02). There were no cases of stent thrombosis in the bridge group and 3 (1.3%) in the control group. Bridge therapy was associated with decreased events rates as compared to both patients with and without P2Y12 inhibitors discontinuation in the control group. After adjustment for the most relevant covariates, the favorable effect of the bridge therapy was not materially modified. In conclusion, perioperative bridge therapy using tirofiban was associated with reduced 30-day NACE rate, particularly when surgery was performed within 60 days after stent implantation.

Registro Absorb Italiano (BVS-RAI): an investigators-owned and -directed, open, prospective registry of consecutive patients treated with the Absorb™ BVS: study design.

BACKGROUND: The Absorb™ BVS is a bioresorbable, everolimus-eluting scaffold approved and marketed for coronary use. Published data on long-term results after treatment are limited to a small number of patients, most of them with elective PCI of simple lesions. The importance of scaffold resorption is variably appreciated among cardiologists, and indications for use from health technology assessment bodies or guidelines are missing. Instruments are needed to collect, share and assess the experience being accumulated with this new device in several centres. METHODS/DESIGN: The BVS-RAI Registry is a spontaneous initiative of a group of Italian interventional cardiologists in cooperation with Centro di Ricerche Farmacologiche e Biomediche "Mario Negri" Institute, and is not recipient of funding or benefits originating from the BVS manufacturer. It is a prospective registry with 5-year follow-up of all consecutive patients who have undergone successful implantation of 1 or more coronary BVS following the indications, techniques and protocols used in each of the participating institutions. Outcome measures are BVS target lesion failure within one year and device-oriented major adverse cardiac events within 5years. The registry started in October 2012 and will extend enrolment throughout 2015, with the aim to include about 1000 patients. ClinicalTrials.gov identifier is CT02298413. CONCLUSIONS: The BVS-RAI Registry will contribute observational knowledge on the long-term safety and efficacy of the Absorb™ BVS as used in a number of Italian interventional centres in a broad spectrum of settings. Unrewarded and undirected consecutive patient enrolments are key-features of this observation, which is therefore likely to reflect common clinical practice in those centres.

[Acute coronary syndrome and cancer: which therapeutic option first?]. / Sindrome coronarica acuta e neoplasia: quale iter scegliere?

Cardiovascular disease and cancer are the leading causes of mortality worldwide. We report our experience in a cancer patient with acute coronary syndrome successfully treated by hybrid revascularization, i.e. off-pump coronary artery bypass grafting, followed by surgical removal of the tumor and percutaneous coronary intervention. The concomitant presence of cancer and acute coronary syndrome is not rare, ranging from 1.9% to 4.2%. Usually, the most life-threatening disease should be treated first, more frequently coronary artery disease. There are several therapeutic approaches to patients with cancer and coronary artery disease and cancer, including percutaneous coronary intervention, surgical treatment of cancer, or coronary artery bypass grafting. Each of these options should consider the severity of cardiac disease, the stage of malignancy and the clinical conditions of the patient.

Bridge with intravenous antiplatelet therapy during temporary withdrawal of oral agents for surgical procedures: a systematic review.

Patients needing surgery within 1 year after drug-eluting cardiac stent implantation are challenging to manage because of an increased thrombotic and bleeding risk. A "bridge therapy" with short-acting antiplatelet agents in the perioperative period is an option. We assessed the outcome and safety of such a bridge therapy in cardiovascular and non-cardiovascular surgery. We performed a comprehensive search of MEDLINE, EMBASE, the Cochrane Library, and ongoing trial registers, irrespective of type of design. Our primary outcome was the success rate of bridge therapy in terms of freedom from cardiac ischaemic adverse events, whereas secondary outcome was freedom from bleeding/transfusion. We also performed combined success rate for each bridge therapy drug (tirofiban, eptifibatide, and cangrelor). We included eight case series and one randomised controlled trial. Among the 420 patients included, the technique was effective 96.2 % of the times [95 % confidence interval (CI) 94.4-98.0 %]. The success rate was 100 % for tirofiban (4 studies), 93.8 % for eptifibatide (4 studies), and 96.2 % for cangrelor (1 study). Freedom from bleeding/transfusion events was observed in 72.6 % of the times (95 % CI 68.4-76.9 %), and was higher with cangrelor (88.7 %; 95 % CI 82.7-94.7 %) than with other drugs (81.0 % for tirofiban and 58.6 % for eptifibatide). Evidence from case series and one randomised controlled trial suggests that, in patients with recent coronary stenting undergoing major surgery, perioperative bridge therapy with intravenous antiplatelet agents is an effective and safe treatment option to ensure low rate of ischaemic events.

Continuous venovenous hemofiltration after coronary procedures for the prevention of contrast-induced acute kidney injury in patients with severe chronic renal failure.

Continuous venovenous hemofiltration (CVVH) is a renal replacement therapy that has been successfully used in patients with severe chronic renal failure to prevent contrast-induced acute kidney injury (CI-AKI). In this study, we present a consecutive experience using a new CVVH protocol that has also been applied to patients with acute coronary syndrome (ACS). CVVH was performed in consecutive patients with estimated glomerular filtration rate <30 ml/min/1.73 m(2) (mean ± SD, 21.1 ± 7.3 ml/min/1.73 m(2)) undergoing diagnostic or interventional coronary procedures starting after the angiographic procedures. Iopamidol was used as a contrast agent. In the first 6 patients, iopamidol removal by the CVVH hemofilter and kidney was calculated by measuring iopamidol concentrations in the blood, urine, and ultrafiltrate collected during the 6-hour CVVH session. In the second phase, the protocol was applied to 47 additional patients meeting the inclusion criteria. Six-hour CVVH resulted in iopamidol removal comparable with that of 12-hour diuresis (43 ± 12% vs 42 ± 15% of administered, p = NS). CI-AKI occurred in 7.5% of patients in the whole population and no patients had acute pulmonary edema, need for dialysis, or any major bleeding. In conclusion, in a population including patients with ACS with severe chronic renal failure undergoing coronary angiographic procedures, 6-hour CVVH performed only after contrast medium exposure was able to remove an amount of contrast medium similar to that removed by the kidneys in 12 hours and resulted in a low rate of CI-AKI.

The bivalirudin paradox: high evidence, low use.

A series of trials have shown that bivalirudin, a direct thrombin inhibitor that does not require the cofactor antithrombin III to be effective, is a reasonable alternative to unfractionated heparin (UFH) alone or associated with glycoprotein IIb/IIIa antagonists (GPI) in patients undergoing percutaneous coronary interventions (PCI). Particularly in patients with acute coronary syndromes (ACS), the effects of bivalirudin are striking. In the HORIZONS-AMI trial, patients with persistent ST-segment elevation (STEMI) had lower 30-day rates of net adverse clinical events and major bleeding, largely due to the significantly lower 30-day rate of non-coronary artery bypass grafting major bleeding. Bivalirudin also resulted in significantly lower rates of all-cause mortality and cardiac mortality, a benefit that extended up to 3-year follow-up. The beneficial effects of bivalirudin as compared to UFH associated with abciximab were also observed in 1721 non-ST elevation myocardial infarction (NSTEMI) patients undergoing PCI in the ISAR REACT 4 study. Although no difference was found between the two treatment strategies in the 30-day primary endpoint, bivalirudin use resulted in a lower rate of major bleeding. Despite the abundant evidence of benefit provided by bivalirudin in the treatment of ACS and the high level of recommendation received by the most recent Guidelines, its use is still low. The reasons for this underuse are multifactorial, the most likely being the preference of operators for the use of a low-cost agent, like UFH, that can be associated with a GPI. Countering platelet hyperreactivity is still the main goal of interventional cardiologists treating ACS patients invasively, apparently downplaying the pathogenetic role of thrombin in this clinical condition.

How to reduce mortality in ST-elevation myocardial infarction patients treated with primary percutaneous coronary interventions: cut the bleeding.

BACKGROUND: In-hospital mortality for ST-elevation myocardial infarction (STEMI) has declined thanks to a greater use of primary percutaneous coronary interventions (PCI) associated with more effective antiplatelet and anticoagulant drugs. In this regard, bivalirudin has been shown to decrease total and cardiac mortality as compared to unfractionated heparin (UFH). OBJECTIVE: The primary purpose of this analysis is to evaluate the hypothesis that the reduction of in-hospital bleeding is the most plausible explanation for the improved survival of STEMI patients treated with bivalirudin during primary PCI. The secondary objective is to reconsider the prognostic significance of the radial access alone or in association with bivalirudin on the basis of the published data. METHODS: We have done a comprehensive evaluation of the main and related publications of the HORIZONS-AMI trial in addition to an extensive research by Medline of randomized trials evaluating the prognostic impact of radial access as compared with the femoral one in primary PCI. RESULTS: In the HORIZONS-AMI trial bivalirudin resulted in significantly lower rates of the 30 day primary endpoint (defined as major adverse ischemic outcomes plus major bleeding) over UFH plus GPI, largely due to the significantly lower rate of the protocol-defined major bleeding. All-cause and cardiac mortality were also reduced in the bivalirudin arm at 3 year follow-up. Recent studies have also shown that the use of the radial instead of the femoral approach for primary PCI is associated with reduced bleeding as well as reduced mortality. CONCLUSIONS: Our research suggests that decreasing bleeding by either a pharmacologic strategy (use of bivalirudin) or a technical approach (the transradial access) improves survival in STEMI patients undergoing primary PCI. The validity of this hypothesis should be confirmed by specific randomized trials.

Defining high-risk patients with ST-segment elevation acute myocardial infarction undergoing primary percutaneous coronary intervention: a comparison among different scoring systems and clinical definitions.

BACKGROUND: Identification of high-risk patients with ST-segment elevation acute myocardial infarction (STEMI) is of the utmost importance for adequate patient stratification and evaluation of additive treatments. However, there is no consensus on the optimal definition of high-risk patients. METHODS: We therefore compared 5 scoring systems in the assessment of the risk of 30-day mortality in 3214 patients with STEMI treated with primary percutaneous coronary intervention (PCI). RESULTS: Clinical scores showed a large variability in risk stratifying patients. Identification of high-risk patients ranged from 15% (PAMI score ≥ 9) to 66% (McNamara definition). McNamara, Antoniucci and Brodie definitions had the best sensitivity (0.87-0.88 and 95% confidence intervals (CI) ranging from 0.82-0.93) while PAMI ≥ 9 had the best specificity (0.87 with 95% CI of 0.86-0.88), while its sensitivity was quite low (0.42). In a sample size simulation of a trial aimed at demonstrating a 33% difference in 30-day mortality between two hypothetical treatments, the number of STEMI patients needed to be screened varied from 4712 for the Brodie definition to 9038 for the PAMI ≥ 9 score. CONCLUSIONS: There is a large variability in risk stratification, sensitivity, specificity and predictive values among different scoring systems. These considerations should be taken into account when designing randomised trials.

Treating acute coronary syndromes with new antiplatelet drugs: the mortality issue with prasugrel and ticagrelor.

Acute coronary syndromes (ACS) are the leading cause of mortality in Western countries. Until a few years ago, the antiplatelet drug to be administered in association with aspirin was indisputably clopidogrel. Recent data from randomized trials conducted in ACS patients have shown that the new oral antiplatelet regimens, prasugrel and ticagrelor, are associated with a significant reduction in cardiovascular events, as compared to clopidogrel. Moreover ticagrelor reduced both all-cause and cardiovascular mortality as compared to clopidogrel in the PLATO trial. However, there are intrinsic differences between the trials design and among the enrolled ACS populations, that make complex the generalization of the mortality results in the whole spectrum of ACS patients. We aimed to provide further insights into the unresolved mortality issues raised in the PLATO and TRITON-TIMI 38 trials, by analysing the effects of ticagrelor and prasugrel in the ACS populations included in the respective trials.

Impact of primary PCI volume on hospital mortality in STEMI patients: does time-to-presentation matter?

The exact relationship between primary percutaneous coronary intervention (PCI) volume and mortality remains unclear. No data are available on how this relationship could be affected by time-to-presentation. The primary aim of this study was to evaluate the impact of hospital primary PCI volume on in-hospital mortality in ST-elevation myocardial infarction (STEMI) patients depending on time-to-presentation. The impact of primary PCI volume on in-hospital mortality was investigated in a prospective registry of the Lombardy region in Northern Italy, deriving data on mortality rates and number of primary PCIs from a cohort of 2,558 patients. We also explored this relationship at different times-to-presentation (≤90 min, >90 min-180 min, >180 min) and risk profiles assessed with the TIMI Risk Index. A strong inverse relationship was found between primary PCI hospital volume and risk-adjusted mortality (r = -0.9; P < 0.001). High primary PCI volumes best predicted the improvement of survival when the time-to-presentation was ≤90 min (area under the curve = 0.73, P < 0.0001). At this time, the best primary PCI threshold to provide benefit was >66 primary PCIs/year (OR = 0.21 [95% CI 0.10-0.47], P < 0.001) and those with high TIMI Risk Index achieved the greatest benefit (P < 0.001). At >90 min-180 min, the model was less significant (P = 0.02) with a higher threshold of procedures (>145 primary PCIs/year) required to provide benefits. The model was not predictive of survival for time-to-presentation >180 min (P = 0.30). The reduction of mortality of STEMI patients treated at high-volume primary PCI centers is time-dependent and affected by risk profile. The greatest benefit was observed in high-risk patients presenting within 90 min from symptoms onset.

Importance and limits of pre-hospital electrocardiogram in patients with ST elevation myocardial infarction undergoing percutaneous coronary angioplasty.

BACKGROUND: The purpose of this study is to present data on the effects of pre-hospital electrocardiogram (PH-ECG) on the outcome of ST elevation myocardial infarction (STEMI) patients treated with percutaneous coronary angioplasty (PCI) included in a registry undertaken in the Italian region of Lombardy. Pre-hospital 12-lead electrocardiogram is recommended by current guidelines in order to achieve faster times to reperfusion in patients with STEMI. METHODS: The registry includes 3901 STEMI patients who underwent primary PCI over an 18-month period. RESULTS: Mean age was 63 ± 12 years. Admission through the emergency medical system (EMS) occurred in 1603 patients (40%): they were older, more frequently had previous MI, TIMI flow = 0 at entry and were more frequently in Killip class >1 than patients who were not admitted through the EMS. Among the patients admitted through the EMS, PH-ECG was obtained in 475 patients (12%). These patients had less frequently an anterior MI, but more frequently had absence of TIMI flow at entry than patients whose ECG was not teletransmitted. Moreover, they had a significantly shorter first medical contact-to-balloon time and a trend toward a lower 30-day death rate (5.3% vs 7.9 %, p = 0.06). However, only patients in Killip class 2-3 had a significantly lower mortality when the diagnostic ECG was transmitted, whereas no difference was found in Killip class 1 or Killip class 4 patients. CONCLUSIONS: In this registry, PH-ECG significantly decreased first medical contact-to-balloon time. Attempts to achieve faster reperfusion times should be undertaken, as this may result in improved outcome, particularly in patients with mild to moderate symptoms of heart failure.

LombardIMA: a regional registry for coronary angioplasty in ST-elevation myocardial infarction.

BACKGROUND: Percutaneous coronary intervention (PCI) has been shown to be the best reperfusion therapy for acute myocardial infarction with ST-elevation (STEMI), but data from registries show differences in patient populations and outcomes between randomized trials and real life. OBJECTIVES: We sought to provide information about the current status of this treatment with a registry collecting data in Lombardy, the most densely populated region in Italy, with widespread availability of cathlabs and a well-established network for the treatment of STEMI. METHODS AND RESULTS: Patient enrollment was performed by 32 hub centres recruiting 3901 STEMI patients who underwent PCI procedures within 12 h of the onset of symptoms, of whom 3317 patients underwent primary PCI, 376 'facilitated' PCI, and 208 rescue PCI in cathlabs located, in 77% of cases, in the same hospital of admission. In-hospital and 30-day total death were 4.4 and 6.6%, respectively. At multivariate analysis independent negative predictors of 30-day mortality were Killip class 3-4, number of involved ECG leads, chronic renal failure and age, whereas positive predictors were ST resolution more than 50% and postprocedural grade 3 thrombolysis in myocardial infarction flow. CONCLUSIONS: LombardIMA PCI registry enrolled STEMI patients representing a real-world population treated with PCI. Findings presented in this study may provide a benchmark for similar registries undertaken in other Italian regions and may be helpful to assess future possible developments of care for STEMI patients.