Health-Status Outcomes in Older Patients With Myocardial Infarction: Physiology-Guided Complete Revascularization Versus Culprit-Only Strategy.

BACKGROUND: The FIRE trial (Functional Assessment in Elderly Myocardial Infarction Patients With Multivessel Disease) enrolled 1445 older (aged ≥75 years) patients with myocardial infarction and multivessel disease in Italy, Spain, and Poland. Patients were randomized to physiology-guided complete revascularization or treatment of the only culprit lesion. Physiology-guided complete revascularization significantly reduced ischemic adverse events at 1 year. This prespecified analysis investigated the changes between the 2 study groups in angina status, quality of life, physical performance, and frailty. METHODS: Patients underwent validated scales at hospital discharge (baseline) and 1 year later. Angina status was evaluated using the Seattle Angina Questionnaire, health-related quality of life by EQ visual analog scale, physical performance by short physical performance battery, and frailty by the clinical frailty scale. Mixed models for repeated measures analysis were used to study the association between the treatment arms, time, and scales. RESULTS: Baseline and 1-year Seattle Angina Questionnaire, EQ visual analog scale, short physical performance battery, and clinical frailty scale were collected in around two-thirds of the entire FIRE study population. The mean age was 80.9±4.6 years (female sex, 35.9%). Overall, 35.3% were admitted for ST-segment-elevation myocardial infarction, whereas the others were admitted for non-ST-segment-elevation myocardial infarction. Physiology-guided complete revascularization, compared with culprit-only revascularization, was associated with greater improvement in terms of angina status (Seattle Angina Questionnaire summary score, 7.3 [95% CI, 6.1-8.6] points), health-related quality of life (EQ visual analog scale, 6.2 [95% CI, 4.4-8.1] points), and physical performance (short physical performance battery, 1.1 [95% CI, 0.9-1.3] points). After 1 year, patients randomized to culprit-only revascularization experienced a deterioration in frailty status (clinical frailty scale, 0.2 [95% CI, 0.1-0.3] points), which was not observed in patients randomized to physiology-guided complete revascularization. CONCLUSIONS: The present analysis suggested that a physiology-guided complete revascularization is associated with consistent benefits in terms of angina status, quality of life, physical performance, and the absence of further deterioration of the frailty status. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03772743.

OCT guided vs. COmplete pci in patieNts with sT segment elevation myocArdial infarCtion and mulTivessel disease: OCT-CONTACT RCT.

BACKGROUND: In patients with ST-segment elevation myocardial infarction (STEMI), percutaneous coronary intervention (PCI) of the culprit lesion significantly reduces the risk of cardiovascular death. However, the management of non-culprit lesions in patients with the multivessel disease remains a matter of debate in this setting. It's still unclear if a morphological OCT-guided approach, identifying coronary plaque instability, may provide a more specific treatment compared with a standard angiographic/functional approach. METHODS: OCT-Contact is a prospective, multicenter, open-label, non-inferiority randomized controlled trial. Patients with STEMI with successful primary PCI of the culprit lesion will be enrolled after the index PCI. Patients will be deemed eligible if a critical coronary lesion other than the culprit (associated with a diameter of stenosis ≥50%) will be identified during the index angiography. Patients will be randomized in a 1:1 fashion to OCT-guided PCI of non-culprit lesions (Group A) vs. complete PCI (Group B). PCI in group A will be undertaken according to criteria of plaque vulnerability, while in group B the use of fractional flow reserve will be left at the operators' discretion. Major-adverse cardiovascular events (MACE) are a composite of all-cause mortality, non-fatal myocardial infarction (MI) (excluding peri-procedural MI), unplanned revascularization, and NYHA IV heart failure) will be the primary efficacy outcome. Single components of MACE along with cardiovascular mortality will be the secondary endpoints. . Safety endpoints will embrace worsening of renal failure, procedural complications, and bleedings. Patients will be followed for 24 months after randomization. RESULTS: A sample size of 406 patients (203 per group) is required to provide the analysis an 80% power to detect a non-inferiority in the primary endpoint with an alpha error set at 0.05 and a non-inferiority limit of 4%. CONCLUSIONS: A morphological OCT-guided approach may be a more specific treatment compared with the standard angiographic/functional approach in non-culprit lesions of STEMI patients.

Antiplatelet therapy in patients with conservatively managed spontaneous coronary artery dissection from the multicentre DISCO registry.

AIMS: The role of antiplatelet therapy in patients with spontaneous coronary artery dissection (SCAD) undergoing initial conservative management is still a matter of debate, with theoretical arguments in favour and against its use. The aims of this article are to assess the use of antiplatelet drugs in medically treated SCAD patients and to investigate the relationship between single (SAPT) and dual (DAPT) antiplatelet regimens and 1-year patient outcomes. METHODS AND RESULTS: We investigated the 1-year outcome of patients with SCAD managed with initial conservative treatment included in the DIssezioni Spontanee COronariche (DISCO) multicentre international registry. Patients were divided into two groups according to SAPT or DAPT prescription. Primary endpoint was 12-month incidence of major adverse cardiovascular events (MACE) defined as the composite of all-cause death, non-fatal myocardial infarction (MI), and any unplanned percutaneous coronary intervention (PCI). Out of 314 patients included in the DISCO registry, we investigated 199 patients in whom SCAD was managed conservatively. Most patients were female (89%), presented with acute coronary syndrome (92%) and mean age was 52.3 ± 9.3 years. Sixty-seven (33.7%) were given SAPT whereas 132 (66.3%) with DAPT. Aspirin plus either clopidogrel or ticagrelor were prescribed in 62.9% and 36.4% of DAPT patients, respectively. Overall, a 14.6% MACE rate was observed at 12 months of follow-up. Patients treated with DAPT had a significantly higher MACE rate than those with SAPT [18.9% vs. 6.0% hazard ratios (HR) 2.62; 95% confidence intervals (CI) 1.22-5.61; P = 0.013], driven by an early excess of non-fatal MI or unplanned PCI. At multiple regression analysis, type 2a SCAD (OR: 3.69; 95% CI 1.41-9.61; P = 0.007) and DAPT regimen (OR: 4.54; 95% CI 1.31-14.28; P = 0.016) resulted independently associated with a higher risk of 12-month MACE. CONCLUSIONS: In this European registry, most patients with SCAD undergoing initial conservative management received DAPT. Yet, at 1-year follow-up, DAPT, as compared with SAPT, was independently associated with a higher rate of adverse cardiovascular events (ClinicalTrial.gov id: NCT04415762).

[MGuard Dacron mesh-covered stent implantation in patients with ST-elevation myocardial infarction and high thrombotic burden: in-hospital and long-term outcome in a single high-volume center]. / MGuard "Dacron mesh covered" stent per il trattamento della sindrome coronarica acuta con sopraslivellamento del tratto ST in presenza di elevato carico trombotico: outcome intraospedaliero e a lungo termine in un singolo centro ad alto volume.

BACKGROUND: The MGuard (MG) is a stainless-steel closed cell stent covered with an ultra-thin polymer mesh sleeve, which has the purpose of ensuring reduced distal embolization of thrombotic material, thus lowering the risk of no-reflow/slow-flow phenomena. Only few data are available that evaluated the usefulness of the MG stent in patients with ST-elevation myocardial infarction (STEMI) with a high thrombotic burden. METHODS: We prospectively collected data of patients presenting with STEMI and high thrombotic burden (thrombus burden grade 4 or 5 according to the TIMI score) who underwent primary percutaneous coronary intervention (PCI) with MG stent implantation in our center. Lesions involving a bifurcation or very calcified and tortuous vessels were not included. Final TIMI 3 flow, normal myocardial blush grade (MBG), and complete ST-segment resolution were defined as short-term endpoints, whereas major adverse cardiovascular events were evaluated during follow-up. RESULTS: From August 2008 to June 2013, the MG stent was implanted in 104 (9.3%) of 1108 patients who underwent primary PCI. Cardiogenic shock on admission was present in 4 patients (3.8%). Final TIMI 3 flow was achieved in 97.1% of patients, MBG 3 in 56.7%, and regression of ST-segment elevation ≥70% within 90 min was recorded in 64.4% of patients. In-hospital mortality was 2.9% (n=3), and at a mean follow-up of 455±430 days overall major adverse cardiovascular events were 11 (10.6%). Cardiac death occurred in 5 patients (4.9%) and stent thrombosis in 2 (1.9%). CONCLUSIONS: In selected patients with STEMI undergoing primary PCI, the use of the mesh-covered MG stent in vessels with high thrombotic burden despite thrombus aspiration was effective and safe both immediately and at mid-term follow-up.

[Clinical and economical comparison between in-house (Make) and outsourcing (Buy) management of the cardiac catheterization laboratory from two high-volume diagnostic and interventional centers: immediate and 6-month results]. / Confronto clinico ed economico tra gestione aziendale (Make) ed esternalizzata (Buy) del laboratorio di emodinamica di due centri ad elevato volume di procedure diagnostiche ed interventistiche coronariche: risultati immediati e a 6 mesi.

BACKGROUND: Percutaneous coronary interventions (PCI) are widespread procedures in the Italian Healthcare System, but concerns are raised about their economic sustainability. In the last decade, public hospitals have outsourced the PCI services (building and maintaining the technological instruments and the personnel) "buying" them from private companies (Buy) rather than building and maintaining them through public expenditure (Make). The aim of this study was to compare the economic and clinical impact of these two management solutions (Buy and Make) in two community hospitals located in the Turin metropolitan area (Italy). METHODS: We conducted: 1) a quantitative assessment in order to compare differences in the economic impact between Buy and Make for providing PCI; 2) a qualitative assessment comparing the clinical characteristics of two inpatient populations undergoing PCI and then analyzing the efficacy of the procedure in-hospital and at 6-month follow-up. RESULTS: Between January and June 2010, a total of 332 patients underwent PCI at the "degli Infermi" Hospital in Rivoli and 340 at the "Maria Vittoria" Hospital in Turin (Italy). There were no significant differences between the two populations neither about the clinical characteristics nor in procedural efficacy (either immediate or at follow-up). For 600 units of diagnostic-therapeutic pathway, the net present value at a discount rate of 3.5% of the Make project is higher than that of the Buy by €278.402,25, and is therefore the less convenient of the two solutions. The Buy solution is still the more convenient of the two at volumes <700 units. CONCLUSIONS: Our findings show that the Buy solution, if tailored to the specific local needs, provides access to sophisticated technology without making worse quality of services and may save capital expenditure below 700 PCI/years.

Impact of thrombus aspiration during primary percutaneous coronary intervention in cardiogenic shock complicating ST-segment elevation myocardial infarction.

AIM: To assess the impact on in-hospital and long-term survival of thrombus aspiration (TA) during primary percutaneous coronary intervention (PPCI) for ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock (CS). METHODS AND RESULTS: From September 2001 to May 2010 we collected data from 155 patients affected with STEMI complicated by CS undergoing PPCI (12.4% of all PPCI) including 70 patients (45.2%) in TA group and 85 patients (54.8%) in conventional PCI group. Patients in TA group were more likely to have right ventricular infarction (24.3% vs 5.9%, p=0.002), higher mean left ventricular ejection fraction (40% ± 9% vs 35% ± 7%, p<0.0001) and lower left main coronary artery occlusion (2.8% vs 21.2%, p=0.002). TA was associated with a lower rate of in-hospital and long-term mortality (31.4% vs 48.2%, p=0.05 and 42.8% vs 64.7%, p=0.01 respectively) at a mean follow-up time of 6.1 ± 2.1 years. At multivariate analysis the only independent predictor of in-hospital and long-term survival was the procedural success (HR 0.18 95% CI 0.025-0.31, p=0.03 and HR 0.46 95% CI 0.09-0.74, p=0.034 respectively). CONCLUSIONS: In this retrospective study TA, performed during PPCI for STEMI complicated by CS, was not an independent predictor of in-hospital and long-term survival.

Is percutaneous coronary intervention of unprotected left main coronary artery via transradial approach feasible for skilled transfemoral operators? Initial experience in an unselected population.

BACKGROUND: The feasibility and efficacy of percutaneous coronary intervention (PCI) of unprotected left main coronary artery (ULMCA) via transradial access (TRA) is still a matter of concern, mainly in an unselected population. METHODS: We collected data about all PCI performed in patients with ULMCA stenosis by a TRA-dedicated operator and analyzed clinical and procedural characteristics as well as in-hospital and long-term outcomes. RESULTS: From January 2008 to December 2011, 49 PCIs were performed; 27 (55%) via TRA and 22 (45%) via transfemoral access (TFA). Most patients in both groups underwent PCI for acute coronary syndrome (66.7% in the TRA group vs 77.3% in the TFA group, p=0.73). Patients in the TRA group were more hypertensive (81.5% vs 40.9%, p=0.008) and had a higher left ventricular ejection fraction (54.6±10.3 vs 46.1±12.8, p=0.01). There were no significant differences in procedural success (100% in the TRA group vs 90.9% in the TFA group, p=0.38), as well as in procedural time, in fluoroscopic time and in contrast volume. Bleeding complications occurred in 1 patient in the TFA group (4.5%) vs none in the TRA group (p=0.91). In-hospital major adverse cardiac events (MACE) occurred in 1 patient (3.7%) in the TRA group vs 3 (13.6%) in the TFA group (p=0.48). At a follow-up of 32±13 months, MACE occurred in 4 cases (14.8%) in the TRA group vs 7 cases (31.8%) in the TFA group (p=0.28). CONCLUSIONS: The PCI of ULMCA via TRA is feasible with good results, provided that a rigorous learning curve was followed and a TRA volume caseload was maintained.

Very very late thrombosis of a sirolimus-eluting stent: does suboptimal stent expansion take its toll even after three years?

We report the case of a 55-year-old man who underwent coronary angiography in 2004 for early angina following anterior ST-elevation myocardial infarction. Angiography disclosed a critical stenosis in the proximal left anterior descending artery and significant stenoses in the right coronary artery and first obtuse marginal branch, treated with two paclitaxel-eluting stents and a sirolimus-eluting stent, respectively. After completion of a six-month thienopyridine course and while still being on lifelong aspirin, in 2007 he was readmitted for lateral ST-elevation myocardial infarction: angiography revealed stent thrombosis beginning at the proximal edge of the sirolimus-eluting stent implanted in the first obtuse marginal branch. Intravascular ultrasound was performed after thrombectomy but before balloon dilation showing suboptimal stent expansion and a thrombus partially adhering to the sirolimus-eluting stent. The procedure was then successfully completed with the implantation of another sirolimus-eluting stent. This clinical vignette suggests that suboptimal drug-eluting stent deployment may be associated with stent thrombosis well after the traditional time frame of subacute thrombosis.

Sirolimus-eluting stents for the treatment of bare-metal in-stent restenosis: long-term clinical follow up.

BACKGROUND: Studies focusing on short- and mid-term follow up support the beneficial role of sirolimus-eluting stents (SES) in the treatment of in-stent restenosis (ISR), yet no long-term safety and/or efficacy data are available. METHODS: Patients with ISR following bare-metal stenting (BMS) and treated with SES were prospectively studied. Baseline, procedural, and in-hospital data were appraised. The primary endpoint was the rate of major cardiovascular events (MACE) at long-term follow up (>9 months). Secondary endpoints were the individual contributors to MACE. RESULTS: A total of 180 SES were implanted to treat 138 consecutive patients. Procedural success was achieved in all patients without in-hospital death, acute stent thrombosis, stroke, or urgent coronary artery bypass. During follow up, MACE occurred in 5.8% of patients at 6 months, 14.3% at 12 months, and 25% at 24 months. Specifically, all-cause mortality was 1.7% at 6 months, 3.5% at 12 months, and 4.8% at 24 months, for a total of 5 deaths. Target vessel revascularization occurred at 6, 12, and 24 months in 4.2%, 11.2%, and 15.9% of patients, respectively, while target lesion revascularization (TLR) alone accounted for 3.4% at 6 months, 9.6% at 12 months, and 11% at 24 months. Three case of myocardial infarction occurred during follow up (2.2%), without any surgical revascularization or stent thrombosis. CONCLUSIONS: Treatment of ISR with SES appears safe and effective, even if a 10% annual rate of MACE can be expected, with a sizable portion of these due to apparently nontarget lesion events.