A large, prospective, multicentre study of left main PCI using a latest-generation zotarolimus-eluting stent: the ROLEX study.

BACKGROUND: Data on left main (LM) percutaneous coronary interventions (PCI) have mostly been obtained in studies using drug-eluting stent (DES) platforms without dedicated large-vessel devices and with limited expansion capability. AIMS: Our study aimed to investigate the safety and efficacy of LM PCI with the latest-generation Resolute Onyx DES. METHODS: ROLEX (Revascularization Of LEft main with resolute onyX) is a prospective, multicentre study (ClinicalTrials.gov: NCT03316833) enrolling patients with unprotected LM coronary artery disease and a SYNTAX score <33 undergoing PCI with the Resolute Onyx zotarolimus-eluting coronary stent, that includes dedicated extra-large vessel platforms. The primary endpoint (EP) was target lesion failure (TLF): a composite of cardiac death, target vessel myocardial infarction (TVMI) and ischaemia-driven target lesion revascularisation (ID-TLR), at 1 year. All events were adjudicated by an independent clinical event committee. An independent core lab analysed all procedural angiograms. RESULTS: A total of 450 patients (mean age 71.8 years, SYNTAX score 24.5±7.2, acute coronary syndrome in 53%) were enrolled in 26 centres. Of these, 77% of subjects underwent PCI with a single-stent and 23% with a 2-stent technique (8% double kissing [DK] crush, 6% culotte, 9% T/T and small protrusion [TAP] stenting). Intravascular imaging guidance was used in 45% (42% intravascular ultrasound [IVUS], 3% optical coherence tomography [OCT]). At 1 year, the primary EP incidence was 5.1% (cardiac death 2.7%, TVMI 2.7%, ID-TLR 2.0%). The definite/probable stent thrombosis rate was 1.1%. In a prespecified adjusted subanalysis, the primary EP incidence was significantly lower in patients undergoing IVUS/OCT-guided versus angio-guided PCI (2.0 vs 7.6%; hazard ratio [HR] 0.28, 95% confidence interval [CI]: 0.13-0.58; p<0.001). CONCLUSIONS: In this large, multicentre, prospective registry, LM PCI with the Resolute Onyx DES showed good safety and efficacy at 1 year, particularly when guided by intracoronary imaging.

Primary Percutaneous Coronary Intervention with High-Bolus Dose Tirofiban: The FASTER (Favorite Approach to Safe and Effective Treatment for Early Reperfusion) Multicenter Registry.

Objectives: To investigate the safety and clinical efficacy of tirofiban during primary percutaneous coronary interventions (pPCI). Background: Gp IIb/IIIa inhibitors (GPI) use during pPCI has declined over years, mainly for the increased hemorrhagic risk associated to their use and for the availability of potent, fast-acting oral antiplatelet drugs. However, several pharmacodynamic studies showed suboptimal platelet inhibition with P2Y12-blockers, such as prasugrel or ticagrelor. Methods: Patients with ST-segment elevation myocardial infarction (STEMI) undergoing pPCI were prospectively enrolled in a multicenter registry conducted in high-volume centers in Italy. All patients received intraprocedural tirofiban. The primary safety endpoint was the occurrence of in-hospital bleedings according to the Bleeding Academic Research Consortium definition. In-hospital major adverse coronary events (MACE, defined as death, reinfarction, stent thrombosis, and target vessel revascularization), final TIMI flow, myocardial blush grade, and ST-segment resolution were also evaluated. Results: A total of 472 patients (mean age 61 ± 11 years, 83% males) were enrolled in 16 Italian centers from October 2015 to June 2018. Mean basal thrombus grade score was 3.47 ± 1.25. PCI was performed by transradial approach in 88% of patients. We observed a very low rate of 30 days BARC bleedings (2.1%) and MACE (0.8%). Complete (>70%) ST-segment resolution was observed in 67% of patients. Conclusions: In the FASTER registry, the use of tirofiban during primary PCI, performed with a transradial approach in most cases, in patients with high thrombus burden was associated with high rates of complete ST-segment resolution and low rates of in-hospital bleeding and MACE.

Antiplatelet Therapy with Cangrelor in Patients Undergoing Surgery after Coronary Stent Implantation: A Real-World Bridging Protocol Experience.

Objective The aim of the study is to describe the real-world use of the P2Y 12 inhibitor cangrelor as a bridging strategy in patients at high thrombotic risk after percutaneous coronary intervention (PCI) and referred to surgery requiring perioperative withdrawal of dual antiplatelet therapy (DAPT). Materials and Methods We collected data from nine Italian centers on patients with previous PCI who were still on DAPT and undergoing nondeferrable surgery requiring DAPT discontinuation. A perioperative standardized bridging protocol with cangrelor was used. Results Between December 2017 and April 2019, 24 patients (mean age 72 years; male 79%) were enrolled. All patients were at high thrombotic risk after PCI and required nondeferrable intermediate to high bleeding risk surgery requiring DAPT discontinuation (4.6 ± 1.7 days). Cangrelor infusion was started at a bridging dose (0.75 µg/kg/min) 3 days before planned surgery and was discontinued 6.6 ± 1.5 hours prior to surgical incision. In 55% of patients, cangrelor was resumed at 9 ± 6 hours following surgery for a mean of 39 ± 38 hours. One cardiac death was reported after 3 hours of cangrelor discontinuation prior to surgery. No ischemic outcomes occurred after surgery and up to 30-days follow-up. The mean hemoglobin drop was <2 g/dL; nine patients received blood transfusions consistent with the type of surgery, but no life-threatening or fatal bleeding occurred. Conclusion Perioperative bridging therapy with cangrelor is a feasible approach for stented patients at high thrombotic risk and referred to surgery requiring DAPT discontinuation. Larger studies are warranted to support the safety of this strategy.

External applicability of the ISCHEMIA trial: an analysis of a prospective, nationwide registry of patients with stable coronary artery disease.

AIMS: We sought to assess the proportion of patients eligible for the ISCHEMIA trial and to compare the characteristics and outcomes of these patients with those without ISCHEMIA inclusion or with ISCHEMIA exclusion criteria in a contemporary, nationwide cohort of patients with stable coronary artery disease (CAD). METHODS AND RESULTS: Among the 5,070 consecutive patients enrolled in the START registry, 4,295 (84.7%) did not fulfil the inclusion criteria (ISCHEMIA-Not Included or ISCHEMIA-Unclassifiable), 582 (11.5%) had exclusion criteria (ISCHEMIA-Excluded), and the remaining 193 (3.8%) were classified as ISCHEMIA-Like. At one year, the incidence of the primary outcome, a composite of death from cardiovascular (CV) causes, myocardial infarction (MI), or hospitalisation for unstable angina and heart failure, was 0.5% in the ISCHEMIA-Like versus 3.3% in other patients (p=0.03). The composite secondary outcome of CV mortality and MI occurred in 0.5% of the ISCHEMIA-Like patients and in 1.4% of the remaining patients (p=0.1). CONCLUSIONS: In a contemporary real-world cohort of stable CAD patients, only 4% resulted in being eligible for the ISCHEMIA trial. These patients presented an extremely low annual risk of adverse events, especially when compared with other groups of stable CAD patients.

Management and Long-Term Prognosis of Spontaneous Coronary Artery Dissection.

The optimal management and short- and long-term prognoses of spontaneous coronary artery dissection (SCAD) remain not well defined. The aim of this observational multicenter study was to assess long-term clinical outcomes in patients with SCAD. In-hospital and long-term outcomes were assessed in 134 patients with documented SCAD, as well as the clinical impact and predictors of a conservative rather than a revascularization strategy of treatment. The mean age was 52 ± 11, years and 81% of patients were female. SCAD presented as an acute coronary syndromes in 93% of patients. A conservative strategy was performed in 58% of patients and revascularization in 42%. On multivariate analysis, distal versus proximal or mid location of dissection (odds ratio 9.27) and basal Thrombolysis In Myocardial Infarction (TIMI) flow grade 2 or 3 versus 0 or 1 (odds ratio 0.20) were independent predictors of conservative versus revascularization strategy. A conservative strategy was associated with better in-hospital outcomes compared with revascularization (rates of major adverse cardiac events 3.8% and 16.1%, respectively, p = 0.028); however, no significant differences were observed in the long-term outcomes. In conclusion, in this large observational study of patients with SCAD, angiographic features significantly influenced the treatment strategy, providing an excellent short- and long-term prognosis.

Outcomes and predictors of mortality among octogenarians and older with ST-segment elevation myocardial infarction treated with primary coronary angioplasty.

BACKGROUND: Elderly patients are at high risk of mortality when they present with ST-elevation myocardial infarction (STEMI). However, few data exist about prognostic factors in this sub-group when treated with primary percutaneous coronary intervention (pPCI). HYPOTHESIS: To assess outcome and predictors of mortality among patients aged >80 years treated with pPCI. METHODS: We evaluated 139 consecutive patients (age 85.1 ± 3.9 years, 43.2% males) who underwent pPCI for STEMI. RESULTS: Male patients were younger and were more likely to have a history of coronary artery disease. Overall 30-day and 1-year mortality rates were 20.9% and 28.1%, respectively. Thrombolysis in Myocardial Infarction (TIMI) flow 3 was achieved in 82% of patients. There was a pPCI success rate in male patients. At univariable analysis, older age, diabetes mellitus, Killip class >III, left ventricular ejection fraction (LVEF) <40%, no use of stent, failure of pPCI, systolic blood pressure (SBP) <100 mm Hg, and infarct-related artery (left anterior descending vs others) were associated with higher 1-year mortality. Multivariate analysis identified LVEF <40% (hazard ratio: [HR] = 3.70; 95% confidence interval [CI]: 1.30-7.87; P = 0.0001), age (1-year step, HR: 1.13; 95% CI: 1.04-1.23; P = 0.007), failure of pPCI (HR: 2.93; 95% CI: 1.44-5.98; P = 0.0001), Killip class ≥III (HR: 2.29; 95% CI: 1.03-5.4; P = 0.04) and SBP <100 mm Hg (HR: 2.64; 95% CI: 1.22-5.19; P = 0.01) to be independently associated with increased 1-year mortality. CONCLUSIONS: Our data show that elderly patients with STEMI have a high risk of mortality, which is particularly high in the first 30 days. Older age, LVEF <40% at admission, hemodynamic instability (higher Killip class or low SBP), and postinterventional TIMI flow <3 were independent predictors of mortality in our population.

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.

[Clinical and angiographic predictors of ST-elevation myocardial infarction]. / L'infarto miocardico con sopraslivellamento del tratto ST: predittori prognostici clinici ed angiografici.

Treatment of ST-elevation myocardial infarction has advanced tremendously over the past years; this development has proven to be beneficial in reducing mortality and cardiovascular events. Clinical baseline factors remain the cornerstone of prognostic stratification. Tools for prognostic stratification after myocardial infarction are targeted at evaluating myocardial damage, left ventricular dysfunction, residual ischemia and electrical instability. Primary coronary angioplasty is the preferred therapeutic option because, when it can be performed expeditiously by an experienced team, has shown better clinical outcomes; nevertheless we have to pay attention to avoid procedure-related risks such as bleeding and contrast-induced nephropathy.

[Percutaneous coronary intervention in the elderly]. / Rivascolarizzazione miocardica percutanea nel paziente anziano.

Developed countries are experiencing an unprecedented growth in the number of elderly citizens. Elderly patients represent one third of all admissions for non-ST-elevation acute coronary syndrome in the coronary care unit. Treatment is more complex due to comorbidities. The safety and efficacy of percutaneous coronary intervention in elderly patients have not been extensively studied. Despite their high-risk characteristics and worse outcomes, compared with younger patients, the elderly receive less aggressive treatments. The risk of major bleeding and renal failure are increased with percutaneous coronary intervention; in addition the functional condition remains an important concern. Revascularization in elderly patients is not to be aimed at perfection, but at functional results.

Reducing risk of cardiovascular events in noncardiac surgery.

Cardiac adverse events are a major cause of complications in noncardiac surgery. The benefit of preventive coronary artery revascularisation in stable patients before noncardiac surgery has recently been clarified: in the short-term there is no reduction in the number of postoperative myocardial infarction, deaths or hospital length of stay. Coronary artery revascularisation should be limited to these patients who have a well-defined need for the procedure, independent of the need of noncardiac surgery. Optimising medical therapy remains the best option for reducing perioperative complications in stable patients: the addition of statin therapy in candidates for noncardiac surgery with known or strongly suspected coronary disease may be conceived. There is compelling evidence for the use of beta-blockers in reducing cardiac risk. This review presents the studies that support the beneficial effect of beta-blockers, pharmacological effects and some practical aspects in noncardiac surgery. In the management of most of these patients, the use of beta-blockers can aid in the avoidance of a preoperative stress test. The remaining problem to solve is the cost-effective identification of the small group of patients in which the protective effect of beta-blocker therapy is insufficient and a cardiac revascularisation should be considered.

[Cardiologic assessment in candidates for non-cardiac surgery]. / Valutazione cardiologica nei pazienti candidati a chirurgia non cardiaca.

Cardiovascular complications are important causes of morbidity and mortality with major non cardiac procedures. The aim of preoperative cardiac evaluation is more appropriately the initiation of a process of communication between Cardiologist, Surgeon and Anesthesiologist, with the purpose of performing an evaluation of patient's clinical risk profile and of providing the more cost-effective strategy to reduce risk of cardiac complications. There is general agreement that an accurate clinical evaluation is necessary and often sufficient for preoperative cardiac risk assessment. Several indices for prediction of cardiac complications--based on the history and physical examination of the patient--have been proposed and many of them have been validated by following studies. An effective preoperative evaluation must focus four crucial data: clinical predictors and functional capacity of the patient and, on the other side, the specific risk of the type of surgical operation and its character of election or emergency. According to the integrated valuation of these four parameters we can identify the patients who need additional noninvasive testing from those who can directly undergo noncardiac surgery. Preoperative testing should be limited to circumstances in which the results will affect patient management and outcomes. Coronary angiography and following revascularization have the same indications as if performed in the non-operative setting.

[The impact of comorbidity in the management of octogenarians with non-ST-elevation acute coronary syndrome]. / Impatto decisionale delle patologie associate nella scelta tra strategia aggressiva e conservativa nei pazienti ottuagenari con sindrome coronarica acuta senza sopraslivellamento ST.

BACKGROUND: Octogenarians are the fastest growing segment of our population and show a high prevalence of coronary disease. Despite these trends they are underrepresented in randomized controlled trials on acute coronary syndromes. Although older patients with acute coronary syndromes are at increased risk of death or reinfarction, they are less likely to be treated with an aggressive strategy. METHODS: In a retrospective analysis, we evaluated 176 consecutive octogenarians admitted to our Division of Cardiology with non-ST-elevation acute coronary syndrome, the causes of their exclusion from cardiac catheterization, and in particular the impact of associated comorbid conditions. RESULTS: Demographic characteristics, left ventricular ejection fraction and medical therapy were comparable in the groups of patients treated with a conservative or aggressive strategy. Cardiovascular risk factors and the TIMI risk score were similarly distributed between the two groups. The most important cause of exclusion from coronary angiography was the presence of comorbidity (77% of patients of this group). In order to assess the total comorbidity burden, we applied the Charlson comorbidity index to this group and found that 32% of patients excluded from aggressive strategy did not show a so severe associate disorder complexity. CONCLUSIONS: The use of a validated index to measure associated disorders is advisable in our clinical practice to properly assess illness severity, in order to not deny an interventional procedure which could improve the quality of life of the oldest patients.

[Beta-blocker therapy and risk reduction in non-cardiac surgery]. / Terapia betabloccante e riduzione del rischio nella chirurgia non cardiaca.

Cardiovascular complications are important causes of morbidity and mortality with major noncardiac procedures. Preoperative cardiac evaluation aims at assessing the patient's clinical risk profile in order to provide the more cost-effective strategy to reduce the risk of cardiac complications. Among different ways to reduce the incidence of perioperative cardiac complications, compelling evidence comes from the use of beta-blockers: in the absence of absolute contraindications, beta-blocker therapy should be administered to all patients at intermediate-high risk for coronary events who have to undergo noncardiac surgery. Even if the number of patients enrolled in these studies is relatively small, the use of beta-blockers before noncardiac surgery has been shown to be associated with a significant reduction in major cardiac events so that this therapy may reduce the need for additional noninvasive tests in some groups of patients. Coronary angiography and revascularization should have the same indications as if performed in the nonoperative setting.