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.).

Impact of pre-admission physical activity on benefits of physiology-guided complete revascularization in older patients with myocardial infarction: insights from the FIRE trial.

AIMS: The present analysis from the Functional Assessment in Elderly Myocardial Infarction Patients with Multivessel Disease (FIRE) trial aims to explore the significance of pre-admission physical activity and assess whether the benefits of physiology-guided complete revascularization apply consistently to sedentary and active older patients. METHODS AND RESULTS: Patients aged 75 years or more with myocardial infarction (MI) and multivessel disease were randomized to receive physiology-guided complete revascularization or culprit-only strategy. The primary outcome was a composite of death, MI, stroke, or any revascularization within a year. Secondary endpoints included the composite of cardiovascular death or MI, as well as single components of the primary endpoint. Pre-admission physical activity was categorized into three groups: (i) absent (sedentary), (ii) light, and (iii) vigorous. Among 1445 patients, 692 (48%) were sedentary, whereas 560 (39%) and 193 (13%) performed light and vigorous physical activity, respectively. Patients engaging in light or vigorous pre-admission physical activity exhibited a reduced risk of the primary outcome compared with sedentary individuals [light hazard ratio (HR) 0.70, 95% confidence interval (CI) 0.55-0.91 and vigorous HR 0.14, 95% CI 0.07-0.91, respectively]. These trends were also observed for death, cardiovascular death, or MI. When comparing physiology-guided complete revascularization vs. culprit-only strategy, no significant interaction was observed for primary and secondary endpoints when stratified by sedentary or active status. CONCLUSION: In older patients with MI, pre-admission physical activity emerges as a robust and independent prognostic determinant. Physiology-guided complete revascularization stands out an effective strategy in reducing ischaemic adverse events, irrespective of pre-admission physical activity status. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT03772743.

The Functional Assessment in Elderly Myocardial Infarction Patients with Multivessel Disease (FIRE) trial has shown that physiology-guided complete revascularization reduces ischaemic adverse events in older patients with myocardial infarction (MI) and multivessel disease. Older patients who engage in light or vigorous physical activity before hospitalization for MI have a reduced risk of the primary composite outcome of death, MI, stroke, or ischaemia-driven revascularization. These benefits extend to all secondary cardiovascular outcomes as well. In the present subanalysis of the FIRE trial, we find that the positive prognosis associated with physiology-guided complete revascularization holds true even for patients with a sedentary lifestyle. This means that this type of revascularization can effectively reduce ischaemic adverse events in older patients with MI and multivessel disease, regardless of their physical activity levels.

[Spontaneous coronary dissection complicated by Takotsubo syndrome or Takotsubo syndrome complicated by spontaneous coronary dissection: the complex integration of invasive and non-invasive imaging]. / Dissezione coronarica spontanea complicata da sindrome Takotsubo o sindrome Takotsubo complicata da dissezione coronarica spontanea: quando l'integrazione tra imaging invasivo e non invasivo può essere complessa.

Spontaneous coronary artery dissection syndrome and Takotsubo syndrome are similar entities. They have peculiar features in common, such as a predilection for female sex, signs and symptoms compatible with acute coronary syndrome, high probability of restitutio ad integrum. The interdependence between these two diseases is of intriguing diagnostic and therapeutic implication.A 51-year-old woman presented to our attention with chest pain and evidence of ST-segment elevation. Coronary angiography showed the presence of type 2 dissection involving the diagonal branch. A conservative strategy was preferred. A severe emotional stress conditioned the following hours of hospitalization. A Takotsubo-like pattern was detected at focused echocardiogram. Cardiac magnetic resonance imaging confirmed the typical left ventricular motion abnormalities of a stress cardiomyopathy and T2-weighted sequences showed increased late gadolinium enhancement in the diagonal branch area, leading to the diagnosis of a concomitant coronary dissection and Takotsubo cardiomyopathy.

QFR-Based Virtual PCI or Conventional Angiography to Guide PCI: The AQVA Trial.

BACKGROUND: Post-percutaneous coronary intervention (PCI) quantitative flow ratio (QFR) values ≥0.90 are associated with a low incidence of adverse events. OBJECTIVES: The AQVA (Angio-based Quantitative Flow Ratio Virtual PCI Versus Conventional Angio-guided PCI in the Achievement of an Optimal Post-PCI QFR) trial aims to test whether a QFR-based virtual percutaneous coronary intervention (PCI) is superior to a conventional angiography-based PCI at obtaining optimal post-PCI QFR results. METHODS: The AQVA trial is an investigator-initiated, randomized, controlled, parallel-group clinical trial. A total of 300 patients (356 study vessels) undergoing PCI were randomized 1:1 to receive either QFR-based virtual PCI or angiography-based PCI (standard of care). The primary outcome was the rate of study vessels with a suboptimal post-PCI QFR value, which was defined as <0.90. Secondary outcomes were procedure duration, stent length/lesion, and stent number/patient. RESULTS: Overall, 38 (10.7%) study vessels missed the prespecified optimal post-PCI QFR target. The primary outcome occurred significantly more frequently in the angiography-based group (n = 26, 15.1%) compared with the QFR-based virtual PCI group (n = 12 [6.6%]; absolute difference = 8.5%; relative difference = 57%; P = 0.009). The main cause of a suboptimal result in the angiography-based group is the underestimation of a diseased segment outside the stented one. There were no significant differences among secondary endpoints, although stent length/lesion and stent number/patient were numerically lower in the virtual PCI group (P = 0.06 and P = 0.08, respectively), whereas procedure length was higher in the virtual PCI group (P = 0.06). CONCLUSIONS: The AQVA trial demonstrated the superiority of QFR-based virtual PCI over angiography-based PCI with regard to post-PCI optimal physiological results. Future larger randomized clinical trials that demonstrate the superiority of this approach in terms of clinical outcomes are warranted. (Angio-based Quantitative Flow Ratio Virtual PCI Versus Conventional Angio-guided PCI in the Achievement of an Optimal Post-PCI QFR [AQVA]; NCT04664140).

Long-term outcomes of patients treated with sirolimus-eluting resorbable magnesium scaffolds: Insights from the SHERPA-MAGIC study.

BACKGROUND: The resorbable magnesium scaffold (RMS) is a second-generation bioresorbable scaffold (BRS) that has shown conflicting results in previous studies. These findings suggest that patient selection and implantation technique may have an impact on clinical outcomes. This study aimed to investigate the safety and long-term effectiveness of RMS in a narrowly selected population. METHODS: SHERPA-MAGIC is an investigator-driven, multicenter, prospective, single-arm study that enrolled patients undergoing BRS coronary implantation in 18 Italian centers. The present analysis considered the first 543 enrolled patients treated with RMS, with a minimum follow-up of 1 year. The study protocol included strict criteria for patient selection and standardization of RMS implantation. The primary outcome was the occurrence of the vessel-oriented composite endpoints (VOCE), including cardiac death, target vessel myocardial infarction, and ischemia-driven target vessel revascularization. RESULTS: Overall, 635 vessels were treated. The 1-year cumulative occurrence of VOCE was 22 (3.5%, 95% CI 2.2%-5.2%), which was significantly lower than the prespecified estimation (from 5.5% to 8.5%). At the median follow-up of 3.5 [2.6-4.3] years, there were 3 (0.5%) cardiac deaths, 12 (1.9%) target vessel myocardial infarctions, and 33 (5.2%) ischemia-driven target vessel revascularizations. A total of 37 (5.8%, 95%CI 4.1%-7.9%) VOCEs were detected. Scaffold thrombosis occurred in 4 (0.6%, 95%CI 0.1%-1.6%) cases. Patient-level analysis confirmed the findings of the vessel-level analysis. CONCLUSIONS: These results confirm the safety and performance of RMS technology. If confirmed in randomized controlled trials, they may rekindle interest in the use of scaffolds in daily practice.

Management and Outcomes in the Elderly with Non-ST-Elevation Acute Coronary Syndromes Admitted to Spoke Hospitals with No Catheterization Laboratory Facility.

Background: Contemporary guidelines advocate for early invasive strategy with coronary angiography in patients with non-ST-elevation acute coronary syndromes (NSTE-ACS). Still, the impact of an invasive strategy in older patients remains controversial and may be challenging in spoke hospitals with no catheterization laboratory (cath-lab) facility. Purpose: The purpose of this study was to analyse the characteristics and outcomes of patients ≥80 years old with NSTE-ACS admitted to spoke hospitals. Methods: Observational−retrospective study of all consecutive NSTE-ACS patients admitted to two spoke hospitals of our cardiology network, where a service strategy (same-day transfer between a spoke hospital and a hub centre with a cath-lab facility in order to perform coronary angiography) was available. Patients were followed up for 1 year after the admission date. Results: From 2013 to 2017, 639 patients were admitted for NSTE-ACS; of these, 181 (28%) were ≥80 years old (median 84, IQR 82−89) and represented the study cohort. When the invasive strategy was chosen (in 105 patients, or 58%), 98 patients (93%) were initially managed with a service strategy, whereas the remainder of the patients were transferred from the spoke hospital to the hub centre where they completed their hospital stay. Of the patients managed with the service strategy, a shift of strategy after the invasive procedure was necessary for 10 (10%). These patients remained in the hub centre, while the rest of the patients were sent back to the spoke hospitals, with no adverse events observed during the back transfer. The median time to access the cath-lab was 50 h (IQR 25−87), with 73 patients (70%) reaching the invasive procedure <72 h from hospital admission. A conservative strategy was associated with: older age, known CAD, clinical presentation with symptoms of LV dysfunction, lower EF, renal failure, higher GRACE score, presence of PAD and atrial fibrillation (all p < 0.03). At the 1-year follow-up, the overall survival was significantly higher in patients treated with an invasive strategy compared to patients managed conservatively (94% ± 2 vs. 54% ± 6, p < 0.001; HR: 10.4 [4.7−27.5] p < 0.001), even after adjustment for age, serum creatinine, known previous CAD and EF (adjusted HR: 2.0 [1.0−4.0]; p < 0.001). Conclusions: An invasive strategy may confer a survival benefit in the elderly with NSTE-ACS. The same-day transfer between a spoke hospital and a hub centre with a cath-lab facility (service strategy) is safe and may grant access to the cath-lab in a timely fashion, even for the elderly.

[Service strategy for the early referral to catheterization laboratory of patients admitted with non-ST-elevation acute coronary syndromes in spoke hospitals: 5-year results of the Reggio Emilia province network]. / Strategia "service" per l'accesso precoce all'Emodinamica dei pazienti con sindrome coronarica acuta senza sopraslivellamento del tratto ST ricoverati presso gli ospedali spoke: risultati a 5 anni dei percorsi assistenziali della rete cardiologica provinciale di Reggio Emilia.

BACKGROUND: The service strategy (same-day transfer between the spoke hospital and the hub center with catheterization laboratory facility to perform invasive procedures) has been shown to improve the management of patients with non-ST-elevation acute coronary syndrome admitted to spoke hospitals. However, few data exist about the safety of this strategy and, in particular, the safety of retransferring patients to spoke centers immediately after successful percutaneous coronary intervention. METHODS: We used data from a prospective registry to retrospectively describe the application, performance and outcome of the service strategy in the daily clinical practice in our province, organized in 5 spoke hospitals and a hub center in Reggio Emilia, Italy. RESULTS: From January 2013 to December 2017, 1183 consecutive patients were admitted to the cath-lab in the hub center from spoke hospitals with a diagnosis of non-ST-elevation acute coronary syndrome. Mean age was 68 ± 12 years, with a mean GRACE risk score of 137 ± 3. Overall, 1063 patients (90%) were managed with a service strategy. The mean time between hospital admission and access to the cath-lab for coronary artery angiography ± percutaneous coronary intervention was 46.6 h (27.5-71.2). No major adverse events (all-cause mortality, arrhythmias, or acute myocardial infarction) were observed during the back transfer from the invasive center to the referring non-invasive center. At 30 days, acute myocardial infarction was observed in 1.3% of patients and all-cause mortality was 0.5%. At 1-year follow-up, acute myocardial infarction was reported in 10% of patients and all-cause mortality was 2.8%. CONCLUSIONS: A wide adoption of the service strategy in our provincial network in patients with non-ST-elevation acute coronary syndrome admitted to spoke centers allowed an early access to the cath-lab as recommended by international guidelines. The safety of the service strategy is confirmed in our experience, with no major adverse events occurring during the back transfer.

Coronary stenting using the radial approach in two women with situs viscerum inversus and acute myocardial infarction.

A situs inversus with dextrocardia (DC) is a rare condition in adults. Usually, patients have structurally normal hearts and normal life expectancy. The incidence of coronary artery disease in this setting is similar to that in the general population. Coronary revascularization may present potential difficulties related to the unusual anatomy. Although the radial artery is a safe and effective site of access for coronary interventions, some anatomical variations may make this procedure more complicated. We describe two cases of patients with situs viscerum inversus and acute myocardial infarction who underwent successful transradial percutaneous coronary intervention (PCI). We will show that coronary angioplasty with stent application via the radial approach in patients with DC is feasible and effective also in emergency and urgent care.

Time to treatment and ST-segment resolution in high-risk patients with acute myocardial infarction transferred from community hospitals for coronary angioplasty after pharmacological treatment.

OBJECTIVE: To evaluate the impact of symptom-onset-to-balloon delay on ST-segment resolution (STR) in patients with acute myocardial infarction transferred from community hospitals for angioplasty after pharmacological treatment. The study design was prospective, single centre registry. METHODS: Between October 2000 and December 2003, 330 consecutive patients aged < or =75 years with high-risk myocardial infarction were considered; 193 patients underwent primary percutaneous coronary intervention (PCI) (group P), whereas 137 patients were given pharmacological therapy and were immediately transferred to the hospital with PCI facilities (group F). RESULTS: Compared with group P, group F showed a longer time to treatment (253 +/- 136 vs. 195 +/- 141 min; P < 0.0001) and a higher percentage of Thrombolysis In Myocardial Infarction flow grade 2-3 at pre-PCI angiography (107 [78.1%] vs. 48 [24.8%]; P < 0.0001). The rate of STR > or =70% was similar in groups P and F (121 [62.7%] vs. 94 [68.6%]; P = 0.41). Even after accounting for baseline variables, STR <70% was not significantly related to the transfer strategy (adjusted hazard ratio 0.94, 95% confidence interval 0.94-1.77; P = 0.8). Patients with incomplete STR showed a higher six-month mortality compared with patients with complete STR (10 [8.85%] vs. 6 [2.76%]; P = 0.027). CONCLUSIONS: The STR index predicts survival in patients with ST-elevation myocardial infarction treated with angioplasty either directly or after pharmacological treatment and hospital transfer. Pharmacological facilitation seems to be able to counterbalance the negative consequences of the transfer-related time delay on myocardial reperfusion as evaluated by the STR index.

Acute myocardial infarction due to spontaneous coronary artery dissection treated with primary coronary angioplasty: a case report.

We report the case of a young woman referred to our hospital for anterior ST-elevation myocardial infarction to be treated with primary coronary angioplasty. Angiography showed total dissection of the left anterior descending coronary artery, which was successfully treated with primary coronary angioplasty and multiple coronary stent implantation. Spontaneous coronary artery dissection is an unusual cause of acute coronary syndrome, which occurs more frequently in women with many pregnancies (our patient had eight sons before hospital admission for acute myocardial infarction). Although technically challenging, primary coronary angioplasty is a good strategy for treating coronary artery dissection.

Economic appraisal of the angioplasty procedures performed in 2004 in a high-volume diagnostic and interventional cardiology unit.

OBJECTIVE: Growing interest in the use of drug-eluting stents (DESs) in coronary angioplasty has prompted the Healthcare Agency of the Emilia Romagna Region to draw up recommendations for their appropriate clinical use in high-risk patients. Since the adoption of any new technology necessitates economic appraisal, we analysed the resource consumption of the various types of angioplasty procedures and the impact on the budget of a cardiology department. METHODS: A retrospective economic appraisal was carried out on the coronary angioplasty procedures performed in 2004 in the Department of Interventional Cardiology of Reggio Emilia. On the basis of the principles of activity-based costing, detailed hospital costs were estimated for each procedure and compared with the relevant diagnosis-related group (DRG) reimbursement. RESULTS: In 2004, the Reggio Emilia hospital performed 806 angioplasty procedures for a total expenditure of euro 5,176,268. These were 93 plain old balloon angioplasty procedures (euro 487,329), 401 procedures with bare-metal stents (euro 2,380,071), 249 procedures with DESs (euro 1,827,386) and 63 mixed procedures (euro 481,480). Reimbursements amounted to euro 5,816,748 (11% from plain old balloon angioplasty, 50% from bare-metal stent, 31% from DES and 8% from mixed procedures) with a positive margin of about euro 680,480 between costs incurred and reimbursements obtained, even if the reimbursement for DES and mixed procedures was not covering all the incurred costs. CONCLUSIONS: Analysis of the case-mix of procedures revealed that an overall positive margin between costs and DRG reimbursements was achieved. It therefore emerges that adherence to the indications of the Healthcare Agency of the Emilia Romagna Region for the appropriate clinical use of DESs is economically sustainable from the hospital enterprise point of view, although the DRG reimbursements are not able to differentiate among resource consumptions owing to the adoption of innovative technologies.