Hard Events AfteR Orsiro Sirolimus-Eluting Stent (HEROES) in STEMI: A Multicenter Registry.

OBJECTIVES: To evaluate the safety and efficacy of the Orsiro sirolimus-eluting stent (Biotronik) in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention (pPCI). Specific drug-eluting stent (DES) platforms might influence pPCI success rate in the mid-to-long term. Orsiro, a hybrid sirolimus DES with thin struts and a biodegradable polymer, may potentially cause less stent malapposition, stent-induced inflammation, and mechanical damage, improving clinical outcomes. METHODS: We retrospectively enrolled all patients who received 1 or more Orsiro DES in the target vessel of pPCI at 9 Italian centers from January 2012 to March 2016. The primary endpoint was a device-oriented composite endpoint (DOCE) of cardiac death, any myocardial infarction clearly attributable to the intervention culprit vessel (TVMI), and ischemic-driven target-lesion revascularization (ID-TLR) at 1-year follow-up. Secondary endpoints were: (1) DOCE at 6-month and 3-year follow-up; (2) any definite/probable stent thrombosis; and (3) any major bleeding. RESULTS: The study cohort comprised 353 patients. At 1-year follow-up, we observed a 3.7% cumulative incidence of DOCE, consisting of 11 cardiac deaths (3.1%), 2 TVMIs (0.6%), and 2 ID-TLRs (0.6%). There was only 1 definite stent thrombosis (0.3%) and 8 bleedings (2.4%). Kaplan-Meier analysis showed DOCE-free survival rates of 96.6% at 6 months, 96.3% at 1 year, and 93.8% at 3 years. CONCLUSIONS: Our findings support the real-world safety and efficacy of the Orsiro stent for pPCI.

Long-Term Follow-Up of Transcatheter Aortic Valve Implantation With Portico Versus Evolut Devices.

New-generation devices such as Evolut and Portico have provided favorable results in patients who underwent transcatheter aortic valve implantation (TAVI) for aortic stenosis, but their comparative effectiveness remains debated, despite its relevance when envisioning TAVI in low-risk patients. We evaluated the safety and efficacy of 2 leading TAVI devices (Evolut and Portico) used by the same team of experienced TAVI operators, focusing on long-term outcomes, including major adverse events (i.e., the composite of death, stroke, myocardial infarction, major vascular complication, or major bleeding). Unadjusted and propensity score-adjusted analyses were carried out. A total of 233 patients were included, 119 (51.1%) receiving Evolut and 114 (49%) Portico. Baseline and procedural data showed significant between-device differences, including functional class, surgical risk, chronic obstructive pulmonary disease, renal function, transesophageal guidance, device size, postdilation, and procedural time (all p <0.05). Yet, acute and in-hospital outcomes were not significantly different (all p >0.05). Follow-up status was ascertained in 228 (98%) patients after 15.0 ± 7.6 months. Unadjusted analysis showed similar rates of major adverse events, as well as the individual risk of death, stroke, myocardial infarction, major vascular complication, major bleeding, and pacemaker implantation (all p >0.05). Even at propensity score-adjusted analysis outcomes were not significantly different with Evolut and Portico (all p >0.05). In conclusion, Evolut and Portico devices yield similarly favorable results at long-term follow-up when used by experienced TAVI operators.

Propensity-score-adjusted comparison of Evolut vs. Portico devices for transcatheter aortic valve implantation.

AIMS: Transcatheter aortic valve implantation has become an established treatment for severe aortic stenosis, thanks to key improvements achieved by new-generation devices. Their comparative effectiveness and safety are, however, still uncertain. METHODS: We queried a prospective registry on transcatheter aortic valve implantation to compare Evolut and Portico devices, focusing on procedural, in-hospital, and mid-term outcomes. Unadjusted and propensity-adjusted analyses were carried out. RESULTS: In all, 233 patients were included, 119 (51.1%) receiving Evolut and 114 (48.9%) Portico. Several differences in baseline and procedural features were evident, including comorbidities, device size, and postdilation (all P < 0.05). Unadjusted analysis for procedural results showed significant differences in fluoroscopy time, left ventricular ejection fraction, and aortic regurgitation (all P < 0.05), whereas device and procedural success rates were not significantly different (both P > 0.05). In-hospital outcomes were not significantly different (all P > 0.05). Survival analysis for mid-term follow-up (6 ±â€Š7 months) outcomes showed no significant differences in death, stroke, myocardial infarction, major vascular complication, or major bleeding (all P > 0.05). Conversely, Evolut appeared associated with lower peak and mean aortic gradients (both P < 0.05), but higher rate of permanent pacemaker implantation (P = 0.043). Propensity-score-adjusted analysis largely confirmed the similar performance of the two devices, including peak and mean aortic gradients (both P > 0.05). However, Evolut continued to be associated even at adjusted analysis with an increased risk of pacemaker implantation (P = 0.018). CONCLUSION: The acute and mid-term comparative safety and effectiveness of Evolut and Portico in experienced hands are similar, with the notable exception of a lower risk of permanent pacemaker implantation with Portico.

One-year outcome from an all-comers population of patients with ST-segment elevation myocardial infarction treated with biolimus-eluting stent with biodegradable polymer.

OBJECTIVES: To evaluate the performance of biolimus-eluting stent (BES) in patients with ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI) in a real world clinical scenario. BACKGROUND: Randomized studies suggest that the BES with biodegradable polymer is more effective and safe than early generation coronary stents in patients with STEMI. METHODS: We included all consecutive STEMI patients undergoing PCI in this prospective, multicenter registry. The primary endpoint of the study was the rate of major adverse cardiac events (MACE), a composite of cardiac death, recurrent myocardial infarction and ischemia-driven target vessel revascularization at 1-year follow-up. RESULTS: Between June and December 2012 we enrolled 311 STEMI patients. The primary endpoint occurred in 3.2% (95% confidence interval: 1.6-5.8) of patients: cardiac death, re-infarction, and ischemia-driven TVR occurred in 2.3%, 1.3%, and 0.6% of patients, respectively. One-year MACE-free survival was 96.8% ± 1.0%. CONCLUSIONS: In a real-world cohort of STEMI patients undergoing PCI, the use of BES is associated with good 1-year clinical outcome. These results confirm and expand previous findings showing the efficacy and safety of BES in the setting of randomized trials.

Twenty year follow-up after successful percutaneous balloon mitral valvuloplasty in a large contemporary series of patients with mitral stenosis.

BACKGROUND: Percutaneous balloon mitral valvuloplasty (PMV) is currently considered the standard of care for suitable patients with rheumatic mitral stenosis. We sought to assess very long-term outcome after PMV. METHODS: Between 1991 and 2010, 482 consecutive patients underwent successful PMV in a single center. Procedural success was defined as post-procedural valve area ≥ 1.5 cm(2) and regurgitation moderate or less, without in-hospital major adverse cardiac and cerebro-vascular events. The primary endpoint was 20-year incidence of major adverse cardiac events (MACE), including cardiovascular death and need for mitral surgery or repeat PMV. RESULTS: Long-term follow-up (mean 11.6 ± 4.9 years; range 0.5 to 20) was completed in 441 (91.5%) patients. The incidence of the primary endpoint was 41.9% (95% confidence interval [CI]: 37.3 to 46.7%). The rate of cardiovascular death, need for mitral surgery or repeat PMV was 9.1% (95% CI: 6.6 to 12.1), 27% (95% CI: 22.9 to 31.4), and 5.9% (95% CI: 3.9 to 8.5), respectively. Cumulative MACE-free survival at 20 years was 35.9 ± 4.7%. At multivariate analysis, male gender (hazard ratio [HR]: 1.99; 95% CI: 1.4-2.8, p < 0.001), echocardiographic score > 8 (HR: 2.19; 95% CI: 1.6-2.9, p < 0.001), atrial fibrillation (HR: 1.54; 95% CI: 1.2-2.1, p = 0.003) and valve area ≤ 1.75 cm(2) after PMV (HR: 3.1; 95% CI: 2.3-4.2, p < 0.001) were identified as independent predictors of the primary endpoint. CONCLUSIONS: Up to 20 years after successful PMV, a sizeable proportion of patients still exhibit a good clinical result.

A prospective registry on carotid artery revascularisation selected by consensus of a cardiovascular team.

AIMS: This prospective registry was designed to evaluate the early and long-term incidence of clinical events in patients with carotid obstructive disease (COD), after carotid artery revascularisation selected by consensus of a cardiovascular team. METHODS AND RESULTS: 403 consecutive patients with COD scheduled for carotid revascularisation were included: 130 were treated with carotid endarterectomy (CEA) and 273 with carotid artery stenting (CAS). Propensity score matching was performed to assemble a cohort of patients in whom all baseline covariates would be well balanced. The occurrence of major adverse cardiac and cerebrovascular events (MACCE), including any death, non-fatal myocardial infarction or stroke, was assessed at 30 days and at long-term follow-up. The incidence of MACCE at 30 days was 4.0% (95% confidence interval: 2.1 to 6.0), without any significant difference between the CAS and CEA groups in unmatched and matched populations. The cumulative freedom from MACCE at two-year follow-up was 80.5%±0.94%, with no statistically significant differences between the CAS and CEA groups, both in the total population and in the matched cohort. CONCLUSIONS: In this registry of patients undergoing carotid artery revascularisation selected by consensus of a cardiovascular team, the early and long-term incidence of clinical events is up to standard.

Persistent enhanced platelet activation in patients with acute myocardial infarction and coronary microvascular obstruction: clinical implications.

About 30% of patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing recanalisation of the infarct-related coronary artery do not achieve valid myocardial reperfusion (no-reflow phenomenon or coronary microvascular obstruction [MVO]). The mechanisms of MVO are incompletely understood. In this study we investigated the role platelet activation in the pathogenesis of coronary MVO in STEMI patients. We enrolled 48 STEMI patients (age 56.2 ± 11 years; 31 men), treated by primary percutaneous coronary intervention (PCI) followed by double anti-platelet treatment, and 20 control patients with stable coronary artery disease (CAD) on single anti-platelet treatment (age 57.5 ± 6 years, 12 men). STEMI patients were divided into two groups: 35 patients with complete myocardial reperfusion (MR) and 13 patients with coronary MVO despite successful PCI. Platelet activation was assessed on admission and at one-month follow-up by measuring platelet receptor expression and monocyte-platelet aggregates (MPAs). Platelet receptor expression, platelet receptor conformational change for fibrinogen binding availability and MPA formation were increased in STEMI patients with MVO compared to both STEMI patients with MR and stable CAD patients, both on admission and at one-month follow-up (p<0.05 for all).Among STEMI patients, platelet activation is greater in those who display coronary MVO, compared to those with MR, after successful PCI, both on admission and one month after STEMI, suggesting that enhanced platelet activation might be involved in the pathogenesis of MVO. The persistence of enhanced platelet activation despite double classical anti-platelet therapy suggests that new anti-platelet strategies should be considered in patients with coronary MVO.

Long-term outcome of provisional side-branch T-stenting for the treatment of unprotected distal left main coronary artery disease.

Percutaneous coronary intervention (PCI) on distal left main (LM) remains an independent predictor of poor outcome. The strategy of implanting one stent on the main branch (MB), with provisional stenting on the side-branch (SB) only when required (provisional T-stenting), has become the default approach to most bifurcation lesions. This prospective registry sought to investigate the long-term safety and efficacy of provisional SB T-stenting for the treatment of unprotected distal LM disease in patients undergoing PCI. From January 2006 to May 2009, 107 consecutive patients affected by unprotected distal LM disease underwent PCI at our center with the intent to use a provisional SB-stenting technique. We evaluated the rate of major adverse cardiac events (MACE) at long-term follow-up (up to 12-41 months). Procedural success was obtained in 98% of patients. A final kissing balloon inflation was performed in 95% and intravascular ultrasound in 83% of patients. Additional stenting on the SB after provisional stenting on MB was required in 29% of lesions. Long-term follow-up (3.5 years; 25-75th percentile and 1.1-4.5 years) was completed in 97% of patients. The cumulative incidence of MACE was 32.7%: all-cause death was 15.8%, nonfatal myocardial infarction 8.4%, and target vessel revascularization 21.5%. At multivariable analysis, age (hazard ratio, 2.08; 95% confidence interval: 2.01-3.32, P = 0.03), European System for Cardiac Operative Risk Evaluation (HR 1.20, 95% CI: 1.04-1.33, P = 0.02), and diabetes mellitus (HR 3.48, 95% CI: 1.12-6.87, P = 0.01) were identified as independent predictors of MACE. In patients with unprotected distal LM disease undergoing PCI, a provisional strategy of stenting the MB only is associated with good long-term clinical outcomes.

[Feasibility and safety of immediately returning patients transferred for percutaneous coronary intervention in a large metropolitan area]. / Fattibilità e sicurezza dell'immediato reinvio al centro di provenienza dei pazienti sottoposti ad angioplastica coronarica in una vasta area metropolitana.

BACKGROUND: Hospitals without percutaneous coronary intervention (PCI) capabilities are used to transfer patients who need coronary angiography and/or PCI to other centers. In order to optimize economic resources and hospital bed management, PCIs might be performed with an in-service organization, with re-transfer to the community hospital immediately after the procedure. The aim of our study was to evaluate the safety of a consecutive, unselected series of in-service PCIs compared to PCIs performed in patients admitted to hospitals with cath-lab capabilities. METHODS: During 2008, 1030 PCI procedures were performed at the European Hospital and Aurelia Hospital: 905 in patients admitted to a hospital with PCI capabilities (Group I) and 125 (12%) with an in-service strategy (Group II) referring from the Città di Roma Hospital. All treatment protocols were preventively uniformed and standardized. RESULTS: The two groups were statistically comparable in terms of baseline clinical characteristics and/or procedural findings, with the exception for older age (66 +/- 10 vs 70 +/- 10 years, p = 0.004) and a higher prevalence of acute coronary syndromes (56 vs 88%, p < 0.001) and femoral vascular access (94 vs 98%, p = 0.03) in Group II. The rate of left ventricular ejection fraction < or = 35% (20 vs 13%, p = 0.06), multivessel PCI (23 vs 19%, p = 0.4), and glycoprotein IIb/IIIa inhibitor use (15 vs 13%, p = 0.5) was similar between the two groups. Among patients treated with an in-service strategy, 2 (1.6%) were not transferred to the community hospital, because of hemodynamic instability. The in-hospital rate of major clinical events (death for cardiovascular causes, cerebrovascular events, urgent revascularization, stent thrombosis) was 0.75% and 0.8% (p = 0.8), 1.8% and 1% (p = 0.4) for periprocedural myocardial infarction, 1.7% and 1.9% (p = 0.5) for major bleeding, 1.1% and 1.6% (p = 0.6) for vascular complications, in Group I and II, respectively. Left ventricular dysfunction was the only independent predictor of major clinical events (p = 0.003). CONCLUSIONS: A strategy of in-service organization for PCI presents a similar rate of in-hospital clinical events and complications compared to an overnight stay into a hospital with PCI capabilities. Such a strategy may be utilized in order to optimize economic resources and hospital bed management.

Ethanol abolishes ischemic preconditioning in humans.

OBJECTIVES: This study sought to assess the effect of acute alcohol intake on ischemic preconditioning (IPC) in humans using the clinical model of 2 sequential balloon inflations during a percutaneous coronary intervention (PCI). BACKGROUND: Ischemic preconditioning is the most potent form of endogenous myocardial protection from irreversible ischemic injury. Experimental observations suggest that acute ethanol administration might abolish IPC. METHODS: We studied 30 consecutive patients (22 men, mean age 65 years) undergoing elective coronary angioplasty who were randomized to receive an oral dose of 40 g ethylic alcohol (administered as 149 ml of Gordon's Gin) or 149 ml of water 30 min before PCI. Intracoronary electrocardiogram was continuously monitored to assess the greatest ST-segment elevation or depression from baseline. RESULTS: In placebo-treated patients, the change of ST-segment shift during the second inflation was significantly smaller than that during the first inflation (19.3 +/- 9.1 vs. 15.7 +/- 8.7, p = 0.005). In contrast, in gin-treated patients, the change of ST-segment shift during the second inflation was significantly greater than that during the first inflation (18.7 +/- 7.2 vs. 22 +/- 10, p = 0.03). The group-inflation interaction for ST-segment changes was highly significant (p < 0.001). CONCLUSIONS: This randomized, prospective study in humans shows that administration of a moderate dose of ethanol abolishes IPC occurring during sequential episodes of myocardial ischemia and is associated with worsening ischemia. Based on our study, intake of moderate to high doses of alcoholic beverages should be avoided in patients at high risk of acute myocardial infarction.

Cystatin C is associated with an increased coronary atherosclerotic burden and a stable plaque phenotype in patients with ischemic heart disease and normal glomerular filtration rate.

OBJECTIVE: Cystatin C (Cys-C) is an accurate marker of renal function. Recent studies have shown that serum Cys-C levels predict the risk of cardiovascular events. The causes of this association, however, are largely unknown. METHODS AND RESULTS: Seventy consecutive patients (age 62+/-12, male sex 87%) undergoing coronary angiography because of typical chest pain and found to have coronary artery disease were included in the present study. Patients with abnormal creatinine-derived glomerular filtration rate (<90ml/min/1.73m(2)) were excluded in order to avoid the well-known effect of overt renal insufficiency on coronary atherosclerosis. Coronary angiography was evaluated by two expert angiographers who assessed disease severity and extent according to the Sullivan's score and lesion morphology. In all patients, Cys-C and C-Reactive Protein (CRP) serum levels were measured on admission. Multivariable analysis was performed to assess independent predictors of angiographic measures. Diabetes was the only predictor of disease severity (p=0.005), while male sex (p=0.03), hypercholesterolemia (p=0.04), diabetes (p<0.0001) and Cys-C (p<0.0001) were independent predictors of disease extent. Independent predictors of smooth lesions were diabetes (p<0.001) and Cys-C (p=0.005). No correlation was found between Cys-C and CRP serum levels (p=0.6). CONCLUSION: Cys-C is associated with coronary atherosclerosis extent and a smooth lesion morphology. The long-term prognostic role of Cys-C might be accounted for by a greater atherosclerotic burden, a necessary substrate for plaque destabilization.

Postoperative coronary artery spasm complicating aortic valve replacement: implications for identification and treatment.

We report a case of coronary spasm soon after aortic valve replacement associated with hemodynamic and arrhythmic instability. The spasm was demonstrated at coronary angiography and was resolved with the intracoronary infusion of nitrates and antiarrhythmics.

Outcome of overlapping heterogenous drug-eluting stents and of overlapping drug-eluting and bare metal stents.

Overlapping homogenous drug-eluting stents (DESs) may be used instead of overlapping bare metal stents (BMSs) to treat coronary lesions longer than available stents. Yet, no data are available on patients treated with overlapping heterogenous DESs or DESs and BMSs. We prospectively assessed 9-month clinical outcome and 6-month angiographic late loss (evaluated at 5 different lesion segments) in a consecutive series of 40 patients who received overlapping homogenous DESs (sirolimus-eluting stent [SES] or paclitaxel-eluting stent [PES]), heterogenous DESs (SES + PES), or overlapping DESs and BMSs. In 8 patients (7 with angiographic follow-up) with overlapping heterogenous DESs, no angiographic or clinical adverse event was observed. Moreover, in-segment late loss was similar to that of patients who received homogenous DESs. In 8 patients (7 with angiographic follow-up) with overlapping DESs and BMSs, there was a higher incidence of major adverse events (3 repeat percutaneous coronary interventions and 1 death, 50% adverse event rate) and worse in-segment binary restenosis rate compared with patients treated with homogenous or heterogenous DESs (p = 0.02 and 0.012, respectively). Late lumen loss at the site of stent overlap showed significant differences according to type of overlapped stent (1.00 +/- 0.76 mm in DES-BMS overlap, 0.32 +/- 0.55 mm in PES-PES overlap, 0.13 +/- 0.11 in SES-PES overlap, and 0.08 +/- 0.10 mm in SES-SES overlap, p = 0.005). In conclusion, the present study suggests that overlap of DESs and BMSs should be avoided because the antirestenotic effect of DESs is skewed by contiguous BMS implantation. Overlap between SESs and PESs in this very preliminary report was associated with no specific adverse event.

Baseline systemic inflammatory status and no-reflow phenomenon after percutaneous coronary angioplasty for acute myocardial infarction.

BACKGROUND: Systemic inflammation is involved in several pathological cardiovascular processes. However, whether it plays a role in the no-reflow phenomenon occurring in patients with acute myocardial infarction (AMI) after percutaneous coronary intervention (PCI) is unknown. METHODS: We studies 60 consecutive patients (59.5+/-12 years, 82% males) with a first ST-segment elevation AMI, treated by primary or rescue PCI within 6 h of symptom onset. Angiographic indexes of no-reflow, evaluated at the end of the procedure, included coronary TIMI flow grading, corrected TIMI frame count (c-TFC) and myocardial blush grade (MBG). ECG indexes of no-reflow included the lack of ST segment resolution (defined as a reduction <50% of the measured ST-segment elevation at 90 min, compared to the admission ECG), as analyzed both in the single lead with the maximal ST elevation and in all leads showing ST elevation on admission. Patients were divided into two groups according to baseline high-sensitivity C-reactive protein (CRP) serum levels measured on admission: high CRP group (CRP>5 mg/L) and low CRP group (CRP<5 mg/L). RESULTS: A similar prevalence of final TIMI flow<3 and MBG<3 was observed in patients with high and low CRP serum levels (30% vs. 12%, p=0.1, and 50% vs. 53%, p=1.0, respectively), and c-TFC was also similar in the two groups (26+/-4.5 vs. 24+/-6, p=0.5). Accordingly, the prevalence of lack of ST-segment resolution in the two groups was similar, both by the single-lead method (25% vs. 25%, p=1.0) and the multiple-lead method (29% vs. 19%, p=0.4). CONCLUSION: In this study we failed to demonstrate any significant association between CRP serum levels on admission and coronary no-reflow, as assessed by both angiographic and ECG parameters in AMI patients treated by successful primary or rescue PCI within 6 h of chest pain onset.

A case of fatal stent thrombosis after Carbostent implantation: is clopidogrel alone antiplatelet therapy a safe alternative to aspirin alone antiplatelet therapy?

We describe a case of fatal stent thrombosis after Carbostent implantation and clopidogrel alone antiplatelet therapy in a patient affected by rectal cancer who does not tolerate aspirin. He had three-vessel disease, with occlusion of the right and left anterior descending coronary artery and a severe stenosis of the proximal left circumflex. High-risk circumflex percutaneous coronary intervention (PCI) was performed under left ventricular assistance by Impella device with an optimal final angiographic result. After 2 h, however, the patient developed chest pain with marked ST segment elevation in the infero-lateral leads, due to stent thrombosis, and hypotention which rapidly degenerated into cardiac arrest, electromechanical dissociation and death. At the present time the choice between PCI at high risk of stent thrombosis followed by low risk cancer resection and cancer resection at high risk of peri-operative myocardial infarction followed by low risk PCI remains difficult.

Effects of carbon-coated coronary stents on the markers of inflammation, thrombin generation and platelet and endothelial activation.

BACKGROUND: The effects of stent carbon coating on the activation of inflammatory and endothelial cells and of coagulation were assessed in patients undergoing coronary artery stent implantation. METHODS: Forty-four consecutive patients with stable angina and an isolated significant stenosis in a native coronary vessel undergoing stent implantation were randomized to a carbon-coated stent (Carbostent, n = 23) or an uncoated stent with a similar design (Multilink, n = 21). The markers of inflammation, of hemostasis and of platelet and endothelial activation were determined before and 6, 24, 48 and 72 hours after the procedure. RESULTS: Procedural success was achieved in all cases and no patient presented with major in-hospital adverse events. In both the Carbostent and Multilink groups, the median (interquartile range) plasma levels of C-reactive protein significantly increased after the procedure (p < 0.001 and p = 0.002 vs baseline levels, respectively), reaching a peak at 48 hours, without any difference between groups (p = 0.76). Similarly, in both groups the plasma levels of fibrinogen, thrombin-antithrombin III complexes, prothrombin fragments F1 + 2, plasminogen activator inhibitor-1, soluble E-selectin, soluble P-selectin and von Willebrand factor significantly increased after the procedure (all p < 0.05 vs baseline values), without any difference between groups (all p = NS). CONCLUSIONS: This study confirms that the markers of inflammation, of endothelial and platelet activation and of thrombin generation significantly increase after successful coronary artery stent implantation. More importantly, it demonstrates that carbon coating does not modify the biologic response of the vessel wall to stent implantation.