Complete or Culprit-Only PCI in Older Patients with Myocardial Infarction.

BACKGROUND: The benefit of complete revascularization in older patients (≥75 years of age) with myocardial infarction and multivessel disease remains unclear. METHODS: In this multicenter, randomized trial, we assigned older patients with myocardial infarction and multivessel disease who were undergoing percutaneous coronary intervention (PCI) of the culprit lesion to receive either physiology-guided complete revascularization of nonculprit lesions or to receive no further revascularization. Functionally significant nonculprit lesions were identified either by pressure wire or angiography. The primary outcome was a composite of death, myocardial infarction, stroke, or any revascularization at 1 year. The key secondary outcome was a composite of cardiovascular death or myocardial infarction. Safety was assessed as a composite of contrast-associated acute kidney injury, stroke, or bleeding. RESULTS: A total of 1445 patients underwent randomization (720 to receive complete revascularization and 725 to receive culprit-only revascularization). The median age of the patients was 80 years (interquartile range, 77 to 84); 528 patients (36.5%) were women, and 509 (35.2%) were admitted for ST-segment elevation myocardial infarction. A primary-outcome event occurred in 113 patients (15.7%) in the complete-revascularization group and in 152 patients (21.0%) in the culprit-only group (hazard ratio, 0.73; 95% confidence interval [CI], 0.57 to 0.93; P = 0.01). Cardiovascular death or myocardial infarction occurred in 64 patients (8.9%) in the complete-revascularization group and in 98 patients (13.5%) in the culprit-only group (hazard ratio, 0.64; 95% CI, 0.47 to 0.88). The safety outcome did not appear to differ between the groups (22.5% vs. 20.4%; P = 0.37). CONCLUSIONS: Among patients who were 75 years of age or older with myocardial infarction and multivessel disease, those who underwent physiology-guided complete revascularization had a lower risk of a composite of death, myocardial infarction, stroke, or ischemia-driven revascularization at 1 year than those who received culprit-lesion-only PCI. (Funded by Consorzio Futuro in Ricerca and others; FIRE ClinicalTrials.gov number, NCT03772743.).

Complete versus culprit-only strategy in older MI patients with multivessel disease.

AIMS: The revascularization strategy to pursue in older myocardial infarction (MI) patients with multivessel disease (MVD) is currently unknown. For this reason, while waiting for the results of dedicated trials, we sought to compare a complete versus a culprit-only strategy in older MI patients by merging data from four registries. METHODS AND RESULTS: The inclusion criteria for the target population of the present study were (i) age ≥ 75 years; (ii) MI (STE or NSTE); (iii) MVD; (iv) successful treatment of culprit lesion. Propensity scores (PS) were derived using logistic regression (backward stepwise selection, p < 0.2). The primary outcome was all-cause mortality. Secondary outcomes were cardiovascular (CV) death, MI, and major bleeding. Multivariable adjustment included the PS and inverse probability of treatment weighting (IPTW). The Kaplan-Meier plots were weighted for IPT. Among 2087 patients included, 1362 (65%) received culprit-only treatment whereas 725 (35%) complete revascularization. The mean age was 81.5 years, while the mean follow-up was 419 ± 284 days. Seventy-four patients (10%) died in the complete group and 223 in the culprit-only one (16%). The adjusted cumulative 1-year mortality was 9.7% in the complete and 12.9% in the culprit-only group (adjusted HR: 0.67, 95% CI: 0.50-0.89). Complete revascularization was associated with lower incidence of CV death (adjusted HR: 0.68, 95% CI: 0.48-0.95) and MI (adjusted HR 0.67, 95% CI: 0.48-0.95). CONCLUSIONS: Culprit-only is the default strategy in older MI patients with MVD. In our analysis, complete revascularization was associated with lower all-cause and CV mortality and with a lower MI rate.

Acute coronary syndromes with high thrombotic burden: therapeutic innovations.

Antiplatelet agents represent one of the cornerstones of drug therapy for acute coronary syndromes (ACS). In the last decade, the arrival of prasugrel and ticagrelor, faster and more powerful oral platelet receptor P2Y12 inhibitors compared to clopidogrel, significantly improved platelet inhibition in patients with ACS. However, the reduction of thrombotic risk came at the cost of increased bleeding risk. Despite having similar indications, prasugrel and ticagrelor have different characteristics and methods of use, essentially due to a different design of the trials in which they have been studied. The optimal use of these antiplatelets in clinical practice should therefore be tailored in individual patients. In the acute phase of ACS with high thrombotic burden, all oral P2Y12 inhibitors have limitations, mainly due to the delay of onset of action related to oral administration. In this scenario, parenteral antiplatelet agents (glycoprotein inhibitors IIb/IIIa and cangrelor) may play a key role in case of percutaneous coronary interventions of high thrombotic coronary lesions and in the prevention of early thrombotic complications. Cangrelor, an intravenous inhibitor of the P2Y2 receptor, has peculiar pharmacokinetic and pharmacodynamic characteristics that make it particularly suitable to be used as an antiplatelet during coronary angioplasty as it achieves a rapid and powerful antiplatelet effect in patients not pretreated with oral medications, and has a favourable safety profile in relation to the bleeding risk.

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.

Relationship between Serum Inflammatory Biomarkers and Thrombus Characteristics in Patients with ST Segment Elevation Myocardial Infarction.

OBJECTIVES: To compare angiographic and optical coherence tomography (OCT) data pertinent to thrombi, along with the histologic characteristics of aspirated thrombi in patients presenting with ST elevation myocardial infarction (STEMI) with or without inflammation, as assessed by C-reactive protein (CRP) and myeloperoxidase (MPO). METHODS: In the OCTAVIA (Optical Coherence Tomography Assessment of Gender Diversity in Primary Angioplasty) study, 140 patients with STEMI referred for primary percutaneous intervention were enrolled. The patients underwent OCT assessment of the culprit vessel, along with blood sampling of CRP and MPO, and histologic analysis of the thrombus. RESULTS: Biomarkers were available for 129 patients, and histology and immunohistochemistry of the thrombi were available for 78 patients. Comparisons were made using the median thresholds of CRP and MPO (2.08 mg/L and 604.124 ng/mL, respectively). There was no correlation between CRP and MPO levels in the whole population (p = 0.685). Patients with high CRP levels had higher thrombus grades and more frequent TIMI flow 0/1 compared with those with low CRP levels (5 [1st quartile 3; 3rd quartile 5] vs. 3.5 mg/L [1; 5], p = 0.007, and 69.3 vs. 48.5%, p = 0.04, respectively). Patients with high MPO levels more commonly had early thrombi than had those with low MPO levels (42.5 vs. 20.0%, p = 0.04). CONCLUSIONS: CRP and MPO were not correlated in STEMI patients, possibly reflecting different pathogenic mechanisms, with CRP more related to thrombus burden and MPO to thrombus age.

Comparison of 4 different strategies of DAPT after PCI in ACS real world population from a Northern Italy registry.

Aim of the study was to compare four different strategies of dual antiplatelet therapy (DAPT) in patients with acute coronary syndromes (ACS) treated with PCI. DAPT with Clopidogrel, Ticagrelor and Prasugrel has proved to be effective in patients with ACS treated with percutaneous coronary intervention (PCI) by reducing major adverse cardiovascular outcomes (MACE). However, the effect of the different strategies in a real-world population deserves further verification. A retrospective analysis of 2404 discharged ACS patients treated with PCI was performed, with a median follow-up of 1 year. The study population was stratified in four drug treatment cohorts: ASA + Clopidogrel (A-C), ASA + Plavix (A-PLx), ASA + Ticagrelor (A-T), ASA + Prasugrel (A-P). We assessed the incidence of net adverse cardiovascular events (NACE): all-cause death, myocardial infarction (MI), target vessel revascularization (TVR), stroke and bleeding during follow-up. At 1-year, the use of A-C and A-PLx was associated with the highest cumulative incidence of NACE in comparison with A-T and A-P therapies (respectively 14.8 and 29.6% vs. 9.2 and 6%). This difference was mainly driven by the mortality and TVR outcomes. Considering selection bias and differences in the patients baseline characteristics, the association of A-T and A-P seems to be superior in comparison with a DAPT strategy of A-C and A-PLx in low risk ACS-PCI patients from real world. In our Region the prescription is consistent with guidelines recommendations and Clopidogrel and Plavix are still predominantly used in older patients with more comorbidities, and this could partially explain the inferiority of this association.

ANMCO/GICR-IACPR/SICI-GISE Consensus Document: the clinical management of chronic ischaemic cardiomyopathy.

Stable coronary artery disease (CAD) is a clinical entity of great epidemiological importance. It is becoming increasingly common due to the longer life expectancy, being strictly related to age and to advances in diagnostic techniques and pharmacological and non-pharmacological interventions. Stable CAD encompasses a variety of clinical and anatomic presentations, making the identification of its clinical and anatomical features challenging. Therapeutic interventions should be defined on an individual basis according to the patient's risk profile. To this aim, management flow charts have been reviewed based on sustainability and appropriateness derived from recent evidence. Special emphasis has been placed on non-pharmacological interventions, stressing the importance of lifestyle changes, including smoking cessation, regular physical activity, and diet. Adherence to therapy as an emerging risk factor is also discussed.

Prasugrel versus clopidogrel for patients with unstable angina or non-ST-segment elevation myocardial infarction with or without angiography: a secondary, prespecified analysis of the TRILOGY ACS trial.

BACKGROUND: Treatment with prasugrel and aspirin improves outcomes compared with clopidogrel and aspirin for patients with acute coronary syndrome who have had angiography and percutaneous coronary intervention; however, no clear benefit has been shown for patients managed first with drugs only. We assessed outcomes from the TRILOGY ACS trial based on whether or not patients had coronary angiography before treatment was chosen. METHODS: TRILOGY ACS (ClinicalTrials.gov number NCT00699998) was a randomised controlled trial, done at more than 800 sites worldwide. Patients with non-ST-elevation acute coronary syndrome who were selected for management without [corrected] revascularisation were randomly assigned to clopidogrel or prasugrel.The primary endpoint was cardiovascular death, myocardial infarction, or stroke at 30 months. In the present analysis we assessed differences in the primary endpoint by angiography status and whether the effects of treatment on the primary endpoint differed between patients who had angiography before enrolment and those who had not. FINDINGS: 7243 patients younger than 75 years were included in the TRILOGY ACS primary analysis. 3085 (43%) had angiography at baseline, 4158 (57%) had not. Fewer patients who had angiography reached the primary endpoint at 30 months compared with those who did not have angiography, according to Kaplan-Meier analysis (281/3085 [12·8%] vs 480/4158 [16·5%], adjusted hazard ratio [HR] 0·63, 95% CI 0·53-0·75; p<0·0001). The proportion of patients who reached the primary endpoint was lower in the prasugrel group than in the clopidogrel group for those who had angiography (122/1524 [10·7%] vs 159/1561 [14·9%], HR 0·77, 95% CI 0·61-0·98; p=0·032) but did not differ between groups in patients who did not have angiography (242/2096 [16·3%] vs 238/2062 [16·7%], HR 1·01, 0·84-1·20; p=0·94; pinteraction=0·08). Overall, TIMI major bleeding and GUSTO severe bleeding were rare. Bleeding outcomes tended to be higher with prasugrel but did not differ significantly between treatment groups in either angiography cohort. INTERPRETATION: Among patients who had angiography who took prasugrel there were fewer cardiovascular deaths, myocardial infarctions, or strokes than in those who took clopidogrel. This result needs to be corroborated, but it is consistent with previous trials of more versus less intensive antiplatelet treatment. When angiography is done for acute coronary syndrome and anatomic coronary disease confirmed, the benefits and risks of intensive antiplatelet treatment exist whether the patient is treated with drugs or percutaneous coronary intervention. FUNDING: Daiichi Sankyo, Eli Lilly.

Long-term outcome in patients with ST segment elevation myocardial infarction and multivessel disease treated with culprit-only, immediate, or staged multivessel percutaneous revascularization strategies: Insights from the REAL registry.

OBJECTIVES: To examine the differences in cardiac outcomes for patients with ST-elevation myocardial infarction (STEMI) and multivessel disease (MVD) as a function of whether they underwent culprit-only primary percutaneous coronary intervention (PPCI) or multivessel PCI, either during PPCI or as a staged procedure. BACKGROUND: MVD occurs in about 40% of patients presenting with STEMI, and it has been associated with a worse outcome compared to single-vessel disease. The most favorable PCI strategy for dealing with significant nonculprit lesions has to be established. METHODS: A total of 2061 STEMI patients with MVD undergoing PPCI, prospectively enrolled in the REAL Registry between July 2002 and December 2010, were considered: 706 underwent culprit-only PPCI; 367 multivessel PCI during the index procedure; 988 had a staged PCI within 60 days. Mortality and outcomes were calculated at 30 days and 2 years. RESULTS: At multivariate analysis, culprit-only PPCI was associated with higher rates of cardiac outcomes as compared to staged multivessel PCI, taken as reference [Hazard Ratio (HR): 2.81, 95% confidence interval (CI): 1.34-5.89, P = 0.006 for 30-day mortality, and HR: 1.93, 95% CI: 1.35-2.74, P = 0.0002 for 2-year mortality, respectively]. Short-term mortality rates were higher in multivessel PCI group as compared to staged PCI group (HR: 2.58, 95% CI: 1.06-6.26, P = 0.03); no differences were observed at 2-year follow-up (HR: 1.08, 95% CI: 0.64-1.82, P = 0.76). CONCLUSIONS: Our findings support the current guidelines recommendation to perform culprit-only PPCI in STEMI patients with MVD without hemodynamic compromise, followed by a staged PCI of noninfarct-related significant lesions.

Complete vs Culprit-Only Revascularization in Older Patients With Myocardial Infarction and High Bleeding Risk: A Randomized Clinical Trial.

Importance: Patients with high bleeding risk (HBR) have a poor prognosis, and it is not known if they may benefit from complete revascularization after myocardial infarction (MI). Objective: To investigate the benefit of physiology-guided complete revascularization vs a culprit-only strategy in patients with HBR, MI, and multivessel disease. Design, Setting, and Participants: This was a prespecified analysis of the Functional Assessment in Elderly MI Patients With Multivessel Disease (FIRE) randomized clinical trial data. FIRE was an investigator-initiated, open-label, multicenter trial. Patients 75 years or older with MI and multivessel disease were enrolled at 34 European centers from July 2019 through October 2021. Physiology treatment was performed either by angiography- or wire-based assessment. Patients were divided into HBR or non-HBR categories in accordance with the Academic Research Consortium HBR document. Interventions: Patients were randomized to either physiology-guided complete revascularization or culprit-only strategy. Main Outcomes and Measures: The primary outcome comprised a composite of death, MI, stroke, or revascularization at 1 year. Secondary outcomes included a composite of cardiovascular death or MI and Bleeding Academic Research Consortium (BARC) types 3 to 5. Results: Among 1445 patients (mean [SD] age, 81 [5] years; 917 male [63%]), 1025 (71%) met HBR criteria. Patients with HBR were at higher risk for the primary end point (hazard ratio [HR], 2.01; 95% CI, 1.47-2.76), cardiovascular death or MI (HR, 1.89; 95% CI, 1.26-2.83), and BARC types 3 to 5 (HR, 3.28; 95% CI, 1.40-7.64). The primary end point was significantly reduced with physiology-guided complete revascularization as compared with culprit-only strategy in patients with HBR (HR, 0.73; 95% CI, 0.55-0.96). No indication of interaction was noted between revascularization strategy and HBR status for primary and secondary end points. Conclusions and Relevance: HBR status is prevalent among older patients with MI, significantly increasing the likelihood of adverse events. Physiology-guided complete revascularization emerges as an effective strategy, in comparison with culprit-only revascularization, for mitigating ischemic adverse events, including cardiovascular death and MI. Trial Registration: ClinicalTrials.gov Identifier: NCT03772743.

Computed tomography coronary angiography in patients with acute myocardial infarction without significant coronary stenosis.

BACKGROUND: It is known that a significant number of patients experiencing an acute myocardial infarction have normal coronary arteries or nonsignificant coronary disease at coronary angiography (CA). Computed tomography coronary angiography (CTCA) can identify the presence of plaques, even in the absence of significant coronary stenosis. This study evaluated the role of 64-slice CTCA in detecting and characterizing coronary atherosclerosis in these patients. METHODS AND RESULTS: Consecutive patients with documented acute myocardial infarction but without significant coronary stenosis at CA underwent late gadolinium-enhanced magnetic resonance and CTCA. Only the 50 patients with an area of myocardial infarction identified by late gadolinium-enhanced magnetic resonance were included in the study. All of the coronary segments were assessed for the presence of plaques. CTCA identified 101 plaques against the 41 identified by CA: 61 (60.4%) located in infarct-related arteries (IRAs) and 40 (39.6%) in non-IRAs. In the IRAs, 22 plaques were noncalcified, 17 mixed, and 22 calcified; in the non-IRAs, 5 plaques were noncalcified, 8 mixed, and 27 calcified (P=0.005). Mean plaque area was greater in the IRAs than in the non-IRAs (6.1±5.4 mm(2) versus 4.2±2.1 mm(2); P=0.03); there was no significant difference in mean percentage stenosis (33.5%±14.6 versus 31.7%±12.2; P=0.59), but the mean remodeling index was significantly different (1.25±0.41 versus 1.08±0.21; P=0.01). CONCLUSIONS: CTCA detects coronary plaques in nonstenotic coronary arteries that are underestimated by CA, and identifies a different distribution of plaque types in IRAs and non-IRAs. It may therefore be valuable for diagnosing coronary atherosclerosis in acute myocardial infarction patients without significant coronary stenosis.

A prospective, randomized trial of intravascular-ultrasound guided compared to angiography guided stent implantation in complex coronary lesions: the AVIO trial.

BACKGROUND: No randomized studies have thus far evaluated intravascular ultrasound (IVUS) guidance in the drug-eluting stent (DES) era. The aim was to evaluate if IVUS optimized DES implantation was superior to angiographic guidance alone in complex lesions. METHODS: Randomized, multicentre, international, open label, investigator-driven study evaluating IVUS vs angiographically guided DES implantation in patients with complex lesions (defined as bifurcations, long lesions, chronic total occlusions or small vessels). Primary study endpoint was post-procedure in lesion minimal lumen diameter. Secondary end points were combined major adverse cardiac events (MACE), target lesion revascularization, target vessel revascularization, myocardial infarction (MI), and stent thrombosis at 1, 6, 9, 12, and 24 months. RESULTS: The study included 284 patients. No significant differences were observed in baseline characteristics. The primary study end point showed a statistically significant difference in favor of the IVUS group (2.70 mm ± 0.46 mm vs. 2.51 ± 0.46 mm; P = .0002). During hospitalization, no patient died, had repeated revascularization, or a Q-wave MI. No difference was observed in the occurrence of non-Q wave MI (6.3% in IVUS vs. 7.0% in angio-guided group). At 24-months clinical follow-up, no differences were still observed in cumulative MACE (16.9%vs. 23.2 %), cardiac death (0%vs. 1.4%), MI (7.0%vs. 8.5%), target lesion revascularization (9.2% vs. 11.9%) or target vessel revascularization (9.8% vs. 15.5%), respectively in the IVUS vs. angio-guided groups. In total, only one definite subacute stent thrombosis occurred in the IVUS group. CONCLUSIONS: A benefit of IVUS optimized DES implantation was observed in complex lesions in the post-procedure minimal lumen diameter. No statistically significant difference was found in MACE up to 24 months.

Randomized comparison of Zotarolimus-Eluting Endeavor Sprint versus bare-metal stent implantation in uncertain drug-eluting stent candidates: rationale, design, and characterization of the patient population for the Zotarolimus-eluting Endeavor Sprint stent in uncertain DES candidates study.

BACKGROUND: The use of drug-eluting stent (DES) instead of bare-metal stent (BMS) in patients at high stent thrombosis or bleeding risk as well as in those at low restenosis risk (ie, uncertain DES candidates) remains a matter of debate. Zotarolimus-Eluting Endeavor Sprint stent (E-ZES) (Santa Rosa, CA) is a hydrophilic polymer-based second-generation device with unique drug fast-release profile, which may allow for a shorter dual antiplatelet therapy (DAPT) duration without safety concerns. HYPOTHESIS: The primary objective is to assess whether E-ZES implantation followed by a shorter than currently recommended course of DAPT will decrease the incidence of 12-month major adverse cardiovascular events as compared with BMS in undefined DES recipients. Actual duration of DAPT regimen will be dictated by patients' characteristics and not by stent type and, as such, can be as short as 30 days after intervention in both stent groups. STUDY DESIGN: The ZEUS study is an open-label randomized clinical trial conducted at 20 clinical sites in Italy, Switzerland, Portugal, and Hungary. With 1,600 individuals, this study will have 85% power to detect a 33% difference in the primary end point consisting of the composite of death, nonfatal myocardial infarction, or target vessel revascularization. SUMMARY: The ZEUS trial aims to assess whether the use of E-ZES, followed by a DAPT duration regimen based on patients' characteristics and not by stent type, is superior to conventional BMS implantation in undefined DES recipients who qualify for the presence of high thrombosis, bleeding, or low restenosis risk criteria.

Paclitaxel- and sirolimus-eluting stents in older patients with diabetes mellitus: results of a real-life multicenter registry.

BACKGROUND: Older patients and diabetes mellitus (DM) are rapidly increasing in Western world populations. The treatment of coronary artery disease in these patients is challenging because they are complex and at high risk. Performance of the two widely used drug-eluting stents (DES), i.e. sirolimus- (SES) and paclitaxel-eluting stent (PES), is understudied in this subset. AIM: We aimed to explore the impact of the first generation DES choice on mid term outcome in a large and unselected population of diabetic patients older than 65 years. METHODS AND RESULTS: From a multicenter registry of 2,429 diabetic patients treated with sirolimus- (SES) or paclitaxel-eluting stent (PES), 1,417 patients ≥65 years old were analyzed overall and separately for groups aged 65-74 (67%) and ≥75 (33%) years old. SES (55%) were compared to PES (45%) in terms of major adverse cardiac events, including all-cause death, myocardial infarction (MI) and target lesion revascularization (TLR) throughout 1-to-5 year follow-up (median time 24 months). We failed to find at the unadjusted and adjusted analyses statistically significant differences in term of outcome between the two DES, both in the overall cohort and in the two different aged subgroups, also regardless of the insulin treatment. CONCLUSIONS: In this real-life multicenter registry, PES and SES showed a comparable safety and efficacy profile in diabetic patients older than 65 years throughout 1-to-5 years follow-up.

Paclitaxel versus sirolimus eluting stents in diabetic patients: does stent type and/or stent diameter matter?: long-term clinical outcome of 2,429-patient multicenter registry.

BACKGROUND: Drug-eluting stents (DES) are more effective in reducing restenosis than bare-metal stents. Less certain is the relative performance of the two widely used DES-sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES)-in diabetic patients undergoing percutaneous coronary intervention (PCI). OBJECTIVES: We studied the long-term effectiveness and safety of SES versus PES in diabetic patients, overall and grouped by the size of the stent placed in the native-stented vessel. METHODS: Data were obtained from an observational, multicenter registry of 2,429 consecutive patients with DM who underwent PCI between August 2003 and August 2009 with SES (n = 1,370) or PES (n = 1,059). Data were analyzed separately for patients with small stents (<3.0 mm, n = 1,274) vs. only large (≥3.0 mm, n = 1,155). RESULTS: At Cox-adjusted analysis of the overall cohort, there was no significant difference between SES and PES with regard to death/myocardial infarction (D/MI) (P = 0.6) or target lesion revascularization (TLR) (P = 0.3) either in "small-stent" (D/MI, P = 0.8; TLR, P = 0.2) or "large stent" group (D/MI, P = 0.8; TLR, P = 0.4) throughout 1 to 5-year follow-up. These results were confirmed by sensitivity, propensity-score matched analysis (717 matched pairs) that failed to find differences in the safety and efficacy between SES and PES. CONCLUSIONS: In this large observational study, PES and SES were equally safe and efficacious in diabetic patients undergoing PCI in clinical practice, regardless of the stent size.

Safety of cangrelor and transition to oral P2Y12 inhibitors in patients undergoing percutaneous coronary intervention: the ARCANGELO study.

Aims: Cangrelor is the only intravenous P2Y12 inhibitor available. Safety, efficacy, and transitioning from cangrelor to oral P2Y12 inhibitors were recorded in patients with acute coronary syndrome (ACS). The ARCANGELO study aims to assess the safety of cangrelor on bleeding and the effects of the transition to oral P2Y12 inhibitors in a real-world setting according to the European Medical Agency's requirement. Methods and results: Adult patients with ACS undergoing percutaneous coronary intervention (PCI) receiving cangrelor were included in the study. Patients were followed for 30 days. Incidence of bleeding events, major adverse cardiac events, and transition strategy to oral P2Y12 were recorded. Among 1004 ACS patients undergoing PCI, 995 (99.1%) were eligible for the analysis; 597 (60.0%) of them had ST-segment elevation myocardial infarction. A total of 925 (93.1%) patients underwent PCI by radial catheter access, and 972 (97.2%) received drug-eluting stents. All eligible patients received bolus and cangrelor infusion between 2 and 4 h in 95% of the cases. A total of 730 patients (73.4%) received ticagrelor, 127 (12.8%) prasugrel, and 138 (13.9%) clopidogrel as transition therapy. Bleeding, according to Bleeding Academic Research Consortium (BARC) criteria, within 30 days post-PCI occurred in 5.2% of patients (95% confidence interval: 3.9-6.8%); 0.5% experienced a moderate (BARC 3), and all others mild (BARC 1-2) bleeding events. Major adverse cardiac events occurred in 14 (1.4%) patients, principally all-cause mortality (n = 6 patients) and myocardial infarction (n = 7 patients). Conclusion: The use of cangrelor in ACS patients undergoing PCI and the transition strategy to P2Y12 inhibitors are confirmed as safe and effective in daily practice.

[Right heart catheterization in Italian catheterization laboratories: results of the SICI-GISE national survey promoted by the GISE Young Committee]. / Il cateterismo cardiaco destro nei laboratori di emodinamica italiani: risultati dell'indagine nazionale SICI-GISE promossa dal Comitato GISE Young.

BACKGROUND: Over the past decades, the improvements in the diagnostic power and availability of non-invasive cardiac imaging techniques have led to a decline of right heart catheterization (RHC) performance. However, RHC remains the gold standard for diagnosing pulmonary hypertension and an essential tool for the evaluation of patient candidacy to heart transplantation. METHODS: This survey was carried out jointly by the Young Committee of GISE, with the support of the SICI-GISE Society, and the ICOT group, with the aim of evaluating how the interventional cardiology community perform RHC. A web-based questionnaire based on 20 questions was distributed to SICI-GISE members. RESULTS: The survey was distributed to 1550 physicians with 174 (11%) responses. Most centers perform few procedures per year (<10 RHC/year) and a dedicated cardiologist is usually lacking. Patients were frequently admitted as ordinary hospitalization regimen and the most frequent indication for RHC was the hemodynamic assessment of pulmonary hypertension, followed by diagnostics of valvular diseases and advanced heart failure/heart transplantation. Indeed, the majority of participants (86%) are involved in transcatheter procedures for structural heart disease. The average time taken to perform the RHC was approximately 30-60 min. The femoral access (60%) was the most frequently used, usually by an echo-guided approach. Two-thirds of participants discontinued oral anticoagulant therapy before RHC. Only 27% of centers assess wedge position from an integrated analysis. Furthermore, the edge pressure is detected in the end-diastolic cardiac phase in half cases and in the end-expiratory phase in only 31%. The most commonly used method for cardiac output calculation was the indirect Fick method (58%). CONCLUSIONS: Guidance on the best practice for performing RHC is currently lacking. A more precise standardization of this demanding procedure is warranted.

[Management of patients with myocardial ischemia/infarction with non-obstructive coronary artery disease in Italian catheterization laboratories: results of the SICI-GISE national survey promoted by the GISE Young Committee]. / Diagnosi e trattamento dei pazienti affetti da ischemia/infarto miocardico in assenza di coronaropatia ostruttiva nei laboratori di emodinamica italiani: risultati dell'indagine nazionale SICI-GISE promossa dal Comitato GISE Young.

BACKGROUND: Myocardial ischemia (INOCA) and acute myocardial infarction with non-obstructive coronary artery disease (MINOCA) represent emerging entities in the landscape of interventional cardiology. These conditions have heterogeneous pathophysiological mechanisms and clinical presentations, complex diagnostics, and high prognostic significance. METHODS: This survey was carried out jointly by the GISE Young Committee with the support of the SICI-GISE Society and the ICOT group with the aim of evaluating the implementation of diagnostic-therapeutic pathways in cases of suspected/confirmed INOCA and MINOCA diseases. A web-based questionnaire based on 22 questions was distributed to SICI-GISE and ICOT members. RESULTS: The survey was distributed to 1550 physicians with 104 (7%) responses. The majority of participants included interventional cardiologists (70%), in two-thirds of cases working in centers with high volume of procedures (>1000 coronary angiographies/year), who estimated a <10% annual rate of INOCA and MINOCA cases in their case load. Approximately 25% of the participants stated that they do not have the option of performing any investigation for the evaluation of patients with suspected INOCA, and less than 50% make use of advanced invasive testing for the diagnosis of MINOCA, including physiology and intravascular imaging tests. It also turns out that about 50% of respondents reported the present and future absence of dedicated diagnostic-therapeutic pathways. Even with a high perception of the clinical relevance of these diseases, about 40% of the respondents rely on clinical experience or do not deal with their management, also reporting a low prevalence of dedicated follow-up care (20% of cases followed at dedicated outpatient clinics). Factors predominantly limiting the prevalence of appropriate diagnostic and treatment pathways included the cost of materials, lack of training and expertise of practitioners, and of solid data on the long-term clinical efficacy of treatments. CONCLUSIONS: Currently, the proper management of INOCA and MINOCA disease is widely advocated but poorly implemented in clinical practice. To reverse the trend and solve the remaining controversies, it is necessary to enhance awareness, produce robust scientific data, and implement dedicated pathways for patients.

[SICI-GISE/SICOA Consensus document: Clinical follow-up of patients after acute coronary syndrome or percutaneous coronary intervention]. / Documento di consenso SICI-GISE/SICOA: La gestione del follow-up del paziente dopo sindrome coronarica acuta e/o angioplastica coronarica.

In the last decades, advances in percutaneous coronary intervention (PCI) strategies have significantly reduced the risk of procedural complications and in-hospital mortality of patients with acute coronary syndromes (ACS), thus increasing the population of stable post-ACS patients. This novel epidemiological scenario emphasizes the importance of implementing secondary preventive and follow-up strategies. The follow-up of patients after ACS or elective PCI should be based on common pathways and on the close collaboration between hospital cardiologists and primary care physicians. However, the follow-up strategies of these patients are still poorly standardized. This SICI-GISE/SICOA consensus document was conceived as a proposal for the long-term management of post-ACS or post-PCI patients based on their individual residual risk of cardiovascular adverse events. We defined five patient risk classes and five follow-up strategies including medical visits and examinations according to a specific time schedule. We also provided a short guidance for the selection of the appropriate imaging technique for the assessment of left ventricular ejection fraction and of non-invasive anatomical or functional tests for the detection of obstructive coronary artery disease. Physical and pharmacological stress echocardiography was identified as the first-line imaging technique in most of cases, while cardiovascular magnetic resonance should be preferred when an accurate evaluation of left ventricular ejection fraction is needed. The standardization of the follow-up pathways of patients with a history of ACS or elective PCI, shared between hospital doctors and primary care physicians, could result in a more cost-effective use of resources and potentially improve patient's long-term outcome.