Impact of Pacemaker Implantation After Transcatheter Aortic Valve Replacement on Long-Term Survival in Patients With Bicuspid Aortic Valve.

Limited data are available about the impact of permanent pacemaker (PPM) implantation on long-term survival in patients with a bicuspid aortic valve (BAV) and severe aortic stenosis (AS) treated with transcatheter aortic valve replacement (TAVR). We aimed to evaluate the long-term clinical outcomes of patients with BAV with AS who underwent periprocedural PPM implantation after TAVR with a self-expandable prosthesis. Data from patients with BAV and severe AS who underwent TAVR between April 2009 and January 2022 and followed in the framework of the One Hospital ClinicalService-CoreValve Project were collected. Patients were categorized in 2 groups according to PPM implantation after TAVR ("PPM" group) or not ("no PPM" group). The coprimary end points were all-cause death and a composite of cardiac mortality, rehospitalization because of cardiac causes, stroke, and myocardial infarction. Overall, 106 patients were considered (74 in the "no PPM" group and 32 in the "PPM" group). No statistically significant difference was found between the groups in terms of follow-up and baseline characteristics. Patients in the PPM group were more likely to show baseline conduction abnormalities (p = 0.023). Patients in the PPM group were more often treated with older generation prosthesis than those in the no PPM group (28.1% vs 5.4%, respectively, p = 0.013). At 2 years of follow-up, all-cause death in the no PPM and PPM groups occurred in 20.0% and 10.0% of patients, respectively (hazard ratio 0.37, 95% confidence interval 0.08 to 1.67). Similarly, no difference was evident for the composite end point between the 2 groups (no PPM vs PPM: 8 [14.6%] vs 6 [19.3%], hazard ratio 1.67, 95% CI 0.58 to 4.81). In conclusion, patients with severe AS and BAV treated with TAVR complicated by PPM implantation are not exposed to an increased risk of major adverse events at 2 years of follow-up.

A Redo Percutaneous Emergency Intervention of Left Ventricular Assist Device Graft Occlusion.

In patients with advanced heart failure (HF), left ventricular assist devices (LVADs) have demonstrated to be effective in improving the quality of life and reducing further hospitalizations. Although uncommon, LVAD outflow graft obstruction (OGO) is a potentially life-threatening complication and percutaneous treatment has been proposed as a standard intervention strategy in such cases. We report the case of a 69 year old man admitted due to LVAD failure causing unstable HF. Past medical history included percutaneous intervention on the outflow graft with stent implantation one year before. The patient was under chronic treatment with vitamin K antagonists (VKA). Emergent percutaneous angiography was performed, showing recurrent OGO due to thrombosis located at a kinking site, distally to the previously treated segment. Using distal anchoring technique, a balloon-expandable 10 × 79 mm endoprosthesis (GORE® Viabahn® VBX) was effectively positioned and post-dilated. Final angiography confirmed the patency of the stent implanted one-year before. Despite the procedure succeeding in restoring LVAD function, the patient died due to septic shock ten days after. Our case suggests that recurrent OGO can be effectively treated with percutaneous redo and that long-term stent patency can be achieved with a standard antithrombotic treatment, despite further thrombotic events in other segments of the graft are still possible (especially at the kinking site). Moreover, other noncardiac conditions as infective complications, can dramatically impact the clinical course and lead to unfavorable outcomes.

A Comparison Between Gore Cardioform and Amplatzer Septal Occluder for Percutaneous Closure of Patent Foramen Ovale Associated With Atrial Septal Aneurysm: Clinical and Echocardiographic Outcomes.

OBJECTIVES: To evaluate the short- and long-term clinical and echocardiographic outcomes of the percutaneous closure of the patent foramen ovale (PFO) with an atrial septal aneurysm (ASA) using 2 different devices. METHODS: We enrolled 100 patients with PFO and ASA. Fifty consecutive patients had transcatheter closure of the PFO with the Gore Cardioform septal occluder (GSO) (Gore Medical) and a second group of 50 consecutive patients with the Amplatzer PFO occluder (APO) (Abbott). A clinical and transthoracic echocardiographic follow-up was performed at 1, 3, 6, and 12 months after the implant procedure. The primary endpoint was the incidence of moderate-to-severe residual right-to-left shunting (rRLS) at the 6-month follow-up. The procedural results and the recurrence of embolic events at 1 year were also investigated. RESULTS: The procedure was successful in all patients. The immediate postprocedural moderate-to-severe rRLS incidence was similar between the 2 groups (GSO 14% vs APO 12%; P=NS) as well as the incidence of moderate-to-severe rRLS at the 6-month follow-up (GSO 4% vs APO 4%; P=non-significant). In only 1 patient of the GSO group, there was a persistent moderate rRLS at the 1-year follow-up. The 6-month and 1-year complete occlusion rate for all subjects was 93% and 96%, respectively. No devices embolized and no death or recurrent embolic events were observed during hospitalization through the 1-year follow-up. CONCLUSIONS: GSO and APO devices appear to be safe and effective devices for the percutaneous closure of a PFO with ASA, showing similar results for the presence of rRLS at the 6-month follow-up, complete occlusion rate, and clinical embolic recurrences.

Post-Procedural Bivalirudin Infusion at Full or Low Regimen in Patients With Acute Coronary Syndrome.

BACKGROUND: The value of prolonged bivalirudin infusion after percutaneous coronary intervention (PCI) in acute coronary syndrome (ACS) patients with or without ST-segment elevation remains unclear. OBJECTIVES: The purpose of this study was to assess efficacy and safety of a full or low post-PCI bivalirudin regimen in ACS patients with or without ST-segment elevation. METHODS: The MATRIX program assigned bivalirudin to patients without or with a post-PCI infusion at either a full (1.75 mg/kg/h for ≤4 h) or reduced (0.25 mg/kg/h for ≤6 h) regimen at the operator's discretion. The primary endpoint was the 30-day composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events (composite of all-cause death, myocardial infarction, or stroke, or major bleeding). RESULTS: Among 3,610 patients assigned to bivalirudin, 1,799 were randomized to receive and 1,811 not to receive a post-PCI bivalirudin infusion. Post-PCI full bivalirudin was administered in 612 (ST-segment elevation myocardial infarction [STEMI], n = 399; non-ST-segment elevation acute coronary syndromes [NSTE-ACS], n = 213), whereas the low-dose regimen was administered in 1,068 (STEMI, n = 519; NSTE-ACS, n = 549) patients. The primary outcome did not differ in STEMI or NSTE-ACS patients who received or did not receive post-PCI bivalirudin. However, full compared with low bivalirudin regimen remained associated with a significant reduction of the primary endpoint after multivariable (rate ratio: 0.21; 95% CI: 0.12 to 0.35; p < 0.001) or propensity score (rate ratio: 0.16; 95% CI: 0.09 to 0.26; p < 0.001) adjustment. Full post-PCI bivalirudin was associated with improved outcomes consistently across ACS types compared with the no post-PCI infusion or heparin groups. CONCLUSIONS: In ACS patients with or without ST-segment elevation, the primary endpoint did not differ with or without post-PCI bivalirudin infusion but a post-PCI full dose was associated with improved outcomes when compared with no or low-dose post-PCI infusion or heparin (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX [MATRIX]; NCT01433627).

Impact of sex on comparative outcomes of bivalirudin versus unfractionated heparin in patients with acute coronary syndromes undergoing invasive management: a pre-specified analysis of the MATRIX trial.

AIMS: Our aim was to assess whether bivalirudin compared with unfractionated heparin (UFH) is associated with consistent outcomes in males and females with acute coronary syndrome (ACS) undergoing invasive management. METHODS AND RESULTS: In the MATRIX programme, 7,213 patients were randomised to bivalirudin or UFH. Patients in the bivalirudin group were subsequently randomly assigned to receive or not a post-PCI bivalirudin infusion. The 30-day co-primary outcomes were major adverse cardiovascular events (MACE), defined as death, myocardial infarction, or stroke, and net adverse clinical events (NACE), defined as MACE or major bleeding. The primary outcome for the comparison of a post-PCI bivalirudin infusion with no post-PCI infusion was a composite of urgent target vessel revascularisation (TVR), definite stent thrombosis (ST), or NACE. The rate of MACE was not significantly lower with bivalirudin than with heparin in male (rate ratio [RR] 0.90, 95% confidence interval [CI]: 0.75-1.07; p=0.22) and female patients (RR 1.06, 95% CI: 0.80-1.40; p=0.67) without significant interaction (pint=0.31), nor was the rate of NACE (males: RR 0.85, 95% CI: 0.72-1.01; p=0.07; females: RR 0.98, 95% CI: 0.76-1.28; p=0.91; pint=0.38). Post-PCI bivalirudin infusion, as compared with no infusion, did not significantly decrease the rate of urgent TVR, definite ST, or NACE (males: RR 0.84, 95% CI: 0.66-1.07; p=0.15; females: RR 1.06, 95% CI: 0.74-1.53; p=0.74; pint=0.28). CONCLUSIONS: In ACS patients, the rates of MACE and NACE were not significantly lower with bivalirudin than with UFH in both sexes. The rate of the composite of urgent TVR, definite ST, or NACE was not significantly lower with a post-PCI bivalirudin infusion than with no post-PCI infusion in both sexes.

Polymer-free drug-coated coronary stents in diabetic patients at high bleeding risk: a pre-specified sub-study of the LEADERS FREE trial.

OBJECTIVE: Diabetics are at increased risk after stent implantation and potentially sensitive to the type of stent and dual anti-platelet therapy (DAPT). The randomized, double-blind LEADERS FREE trial compared 2432 patients at high bleeding risk (HBR) receiving either a polymer-free BA9-coated stent (DCS) or a bare metal stent (BMS) with 1 month of DAPT, and showed superior safety and efficacy of the DCS at 2 years. We report outcomes at 2 years of the pre-specified diabetic subgroup. METHODS AND RESULTS: The diabetic sub-group comprised 805 (33.1%) patients; 262 (10.8%) were insulin-dependent (IDDM). Compared to non-diabetics, diabetics were younger and had more risk factors and multi-vessel disease. They suffered higher rates of death (15.6 vs. 12.2%, p = 0.01), cardiac death (8.3 vs. 5.9%, p = 0.02), myocardial infarction (MI) (11.1 vs. 7.8%, p = 0.009) and definite/probable stent thrombosis (3.1 vs. 1.7%, p = 0.01), but rates of clinically-indicated TLR (9.1 vs. 9.5%, p = 0.93) and BARC 3-5 bleeding (10.2 vs. 8.4%, p = 0.20) were comparable. Compared to diabetic patients treated with a BMS, diabetic DCS recipients required less clinically driven TLR (6.3 vs. 12.2%, p = 0.006). The primary safety endpoint (cardiac death, MI, definite/probable stent thrombosis) occurred numerically less frequently in the DCS group (14.9 vs. 19.7%, p = 0.10), and was significantly lower in IDDM patients (13.8 vs. 25.4%, p = 0.03). BARC 3-5 was similar for patients treated with DCS (9.9%) and BMS (10.5%, p = 0.84). CONCLUSIONS: In diabetic HBR patients, DCS significantly reduced re-intervention rates over BMS, and showed a strong trend towards a safety benefit at 2 years. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov number: NCT01623180.

Comparison of Early and Long-Term Outcomes After Transcatheter Aortic Valve Implantation in Patients with New York Heart Association Functional Class IV to those in Class III and Less.

Our aim was to investigate the impact of a baseline New York Heart Association (NYHA) class IV on clinical outcomes of a large real-world population who underwent transcatheter aortic valve implantation (TAVI). The primary end points were all-cause mortality, cardiovascular mortality, and re-hospitalization, evaluated at the longest available follow-up and by means of a 3-month landmark analysis. The secondary end points were: change in NYHA class, left ventricular ejection fraction, pulmonary pressure and mitral regurgitation. Out of 2,467 patients, 271 (11%) had a NYHA functional class IV at the admission. The latter had higher Society of Thoracic Surgeons (STS) score (9.2% vs 5.5%; p < 0.001) compared to NYHA ≤ III patients, owing to more comorbidities (prior myocardial infarction, severe long-term kidney disease, atrial fibrillation, left ventricular dysfunction, significant mitral regurgitation, pulmonary hypertension). Device success was similar between the two groups (93.7% vs 94.5%; p = 0.583). At a median follow-up of 15 months (interquartile range 4 to 36 months) a lower freedom from primary end points was observed among NYHA IV versus NYHA ≤ III group (survival from all-cause death: 52% vs 58.4%; p = 0.002; survival from cardiovascular death: 72.5% vs 76.5%; p = 0.091; freedom from re-hospitalization: 81.5% vs 85.4%; p = 0.038). However, after adjustment for baseline imbalance, NYHA IV did not influence the relative risk of long-term primary end points. A 3-month landmark analysis showed that NYHA IV independently predicted 3-month all-cause and cardiovascular mortality (hazard ratio: 1.77; 95% CI [1.10 to 2.83]; p = 0.018 and hazard ratio: 1.64; 95% CI [1.03 to 2.59]; p = 0.036, respectively). Instead, after 3-month follow-up NYHA IV did not affect the risk of primary end points. A significant improvement of the secondary end points was noted in both NYHA IV and NYHA ≤≤ III groups. In conclusion, the presence of NYHA class IV in TAVI candidates was associated to a significant increased risk of mortality within 3 months. Patients with baseline NYHA IV who survived at 3 months had a long-term outcome comparable to that of other subjects. Left ventricular systolic function, pulmonary pressure, and mitral insufficiency significantly improved after TAVI regardless of baseline NYHA class IV.

Impact of Sex on Comparative Outcomes of Radial Versus Femoral Access in Patients With Acute Coronary Syndromes Undergoing Invasive Management: Data From the Randomized MATRIX-Access Trial.

OBJECTIVES: This study sought to assess whether transradial access (TRA) compared with transfemoral access (TFA) is associated with consistent outcomes in male and female patients with acute coronary syndrome undergoing invasive management. BACKGROUND: There are limited and contrasting data about sex disparities for the safety and efficacy of TRA versus TFA for coronary intervention. METHODS: In the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX) program, 8,404 patients were randomized to TRA or TFA. The 30-day coprimary outcomes were major adverse cardiovascular and cerebrovascular events (MACCE), defined as death, myocardial infarction, or stroke, and net adverse clinical events (NACE), defined as MACCE or major bleeding. RESULTS: Among 8,404 patients, 2,232 (26.6%) were women and 6,172 (73.4%) were men. MACCE and NACE were not significantly different between men and women after adjustment, but women had higher risk of access site bleeding (male vs. female rate ratio [RR]: 0.64; p = 0.0016), severe bleeding (RR: 0.17; p = 0.0012), and transfusion (RR: 0.56; p = 0.0089). When comparing radial versus femoral, there was no significant interaction for MACCE and NACE stratified by sex (pint = 0.15 and 0.18, respectively), although for both coprimary endpoints the benefit with TRA was relatively greater in women (RR: 0.73; p = 0.019; and RR: 0.73; p = 0.012, respectively). Similarly, there was no significant interaction between male and female patients for the individual endpoints of all-cause death (pint = 0.79), myocardial infarction (pint = 0.25), stroke (pint = 0.18), and Bleeding Academic Research Consortium type 3 or 5 (pint = 0.45). CONCLUSIONS: Women showed a higher risk of severe bleeding and access site complications, and radial access was an effective method to reduce these complications as well as composite ischemic and ischemic or bleeding endpoints.

Polymer-Free Drug-Coated Coronary Stents Are Cost-Effective in Patients at High Bleeding Risk: Economic Evaluation of the LEADERS FREE Trial.

AIMS: In patients at high risk of bleeding who undergo PCI the biolimus A9 polymer-free drug coated stent (DCS) has superior efficacy and safety compared to a bare metal stent (BMS). We estimated the cost effectiveness of DCS vs. BMS. METHODS AND RESULTS: The Leaders FREE-based economic evaluation estimated service use and quality of life data collected prospectively. The entire trial population was analysed using cost-weights from England, France, Germany, Italy, Scotland and Spain. Country-specific QALYs were derived from EQ-5D scores. We estimated cost per event averted and per QALY gained. DCS use resulted in -0.095 cardiac deaths, target vessel MI, stent thrombosis and revascularization per patient (0.152 vs. 0.237;p<0.001). One-year QALYs were non-significantly higher in the DCS group. Total costs for the index admission were similar between groups. One-year costs using cost-weights from each of the 6 countries, including the additional €300 per DCS stent, ranged from €4,664-8,593 for DCS and €4,845-9,742 for BMS and were lower in the DCS group (England:€-428, France:€-137, Germany:€-33, Italy:€-522, Scotland:€-298, Spain:€-854). CONCLUSIONS: The probability that DCS dominated BMS was >50% in all countries. At a threshold of €10,000 per event averted DCS had a 98% probability of being cost-effective in all 6 countries.

Instantaneous wave-free ratio and fractional flow reserve for the assessment of nonculprit lesions during the index procedure in patients with ST-segment elevation myocardial infarction: The WAVE study.

BACKGROUND: Functional assessment of non-infarct-related artery lesions during primary percutaneous coronary intervention (PCI) might be useful to avoid revascularization of nonsignificant stenosis and staged procedures, thus reducing hospital stay. We aimed to assess the diagnostic performance of instantaneous wave-free ratio (iFR) as compared with fractional flow reserve (FFR) in this setting. METHODS: In the WAVE study, a prospective, observational, single-center registry (NCT02869906), paired iFR and FFR measurements were performed at the level of non-IRA lesions in patients with ST-segment elevation myocardial infarction both during primary PCI and during staged procedures (5-8 days after). RESULTS: Paired iFR and FFR measurements were available for 66 non-IRA lesions in 50 patients. The iFR and FFR values of non-IRA lesions did not change significantly between the index and staged procedure. Bland-Altman analysis did not show systematic bias for either iFR or FFR repeated measures. Receiver operating characteristic curve analysis showed high accuracy of iFR to identify positive (≤0.80) FFR measurements in the index procedure with an area under the curve of 0.95. A cutoff of ≤0.89 for iFR in the index procedure had the best combination of sensitivity (95%) and specificity (90%) with positive and negative predictive values of 86% and 97%, respectively. Finally, iFR measured during the index procedure was significantly correlated with FFR (r=0.71, r2=0.51; P<.0001). CONCLUSIONS: The WAVE study shows that iFR yields similar diagnostic accuracy to FFR in functional evaluation of non-IRA stenosis in patients with STEMI and multivessel CAD, with the advantage of being adenosine free.

Undernutrition and Overnutrition Burden for Diseases in Developing Countries: The Role of Oxidative Stress Biomarkers to Assess Disease Risk and Interventional Strategies.

The increased life expectancy, urbanization, and unhealthy lifestyle characterized by a shift towards a sedentary lifestyle and decreased energy expenditure are considered the main drivers of epidemiological transition. In particular, developing countries are facing a double burden caused by coexisting under- and over-nutrition, which causes a change in the disease profile from infectious diseases to a chronic degenerative pattern. This review discusses the under- and over-nutrition context in Mauritania and India, two countries that are experiencing a nutritional transition, and where we began a collaboration with local medical staff to integrate interventional and diagnostic guidelines. If many studies about diet and its relationship to non-communicable diseases are available for India, very few nutrition and cardiovascular risk studies have been conducted in Mauritania. Presently, with the exponential increase of nutrition-related diseases, targeted approaches are needed to provide balanced diets in parallel with the development of national preventive health systems and screening programs adapted to local needs. In this context, the measurement of oxidative stress biomarkers could be promising as an additive tool to assess cardiovascular (CV) risk in general population, and ameliorating prevention in patients at CV risk or with overt CV disease. Moreover, the possibility of improving the outcome by the direct employment of antioxidant remains plausible. Moreover, studies on the content of antioxidant in different foods may be helpful to develop a balanced diet, and achieve the maximal nutritional and functional properties of cultivars with benefits for human health.

Effect of Abciximab Therapy in Patients Undergoing Coronary Angioplasty for Acute ST-Elevation Myocardial Infarction Complicated by Cardiogenic Shock.

BACKGROUND: The effect of abciximab on survival in patients with ST-elevation myocardial infarction (STEMI) complicated by cardiogenic shock (CS) undergoing primary percutaneous coronary intervention (PCI) is not clear. METHODS AND RESULTS: We evaluated outcome in 410 consecutive patients with STEMI and CS who underwent PCI treated without (n=123) or with (n=287) abciximab. The endpoint was survival at 1-year follow-up. The predictors of death at 1 year were also investigated. The groups with and without abciximab had similar survival at 1-year follow-up. Propensity score-adjusted Cox proportional hazards model identified age (adjusted hazard ratio [HR], 1.02; 95% confidence interval [95% CI]: 1.01-1.03, P=0.001), oro-tracheal intubation (HR, 1.49; 95% CI: 1.12-1.96, P=0.05), post-PCI TIMI flow grade 0-1 (HR, 2.08; 95% CI: 1.52-2.83, P=0.0001) but not abciximab use (HR, 1.08; 95% CI: 0.70-1.60, P=0.60) as independent predictors of death at 1-year follow-up. Cox adjusted 1-year survival rates were 42.8% and 51.6%, (P=0.56) in patients treated without vs. with abciximab, respectively. CONCLUSIONS: Patients with STEMI complicated by CS undergoing PCI treated with or without abciximab have similar 1-year survival rates; age, final TIMI 0-1 and oro-tracheal intubation are predictors of death.

One-year clinical outcome of elderly patients undergoing angioplasty for ST-elevation myocardial infarction complicated by cardiogenic shock: the importance of 3-vessel disease and final TIMI-3 flow grade.

BACKGROUND: The influence of age on clinical results of primary percutaneous coronary intervention (PCI) in patients with ST-elevation myocardial infarctions (STEMI) complicated by cardiogenic shock (CS) is poorly investigated. METHODS: In this study, we evaluated the outcome of 216 consecutive all-comer patients with STEMI and CS undergoing PCI who were divided into 2 groups according to age: <75 years (n = 131) or ≥75 years (n = 81). The study endpoint was the incidence of death at 1-year follow-up. The predictors of mortality at 1 year were also investigated. RESULTS: The group <75 years had a significantly lower incidence of death compared with the group ≥75 years at 30 days (39% vs 69%; P=.01) and 1 year (51% vs 79%; P<.001). Cox proportional hazards model identified: age (adjusted hazard ratio [HR] = 1.02; 95% confidence interval [CI], 1.00-1.03; P=.02), 3-vessel disease (HR = 1.47; 95% CI, 1.00-2.17; P=.05), post-PCI TIMI flow grade 0-1 (HR = 2.48; 95% CI, 1.66-3.70; P=.01) and grade 2 (HR = 1.68; 95% CI, 1.01-2.80; P=.05) after PCI as independent predictors of death at 1-year follow-up. CONCLUSIONS: Patients ≥75 years with STEMI complicated by CS and treated by PCI have higher 1-year mortality compared with younger counterparts. Final TIMI 0-2 and 3-vessel disease are strong predictors of death. This finding may be valuable in risk stratification of these patients.

Comparison between the new Gore septal and Amplatzer devices for transcatheter closure of patent foramen ovale. Short- and mid-term clinical and echocardiographic outcomes.

BACKGROUND: The ideal device for percutaneous patent foramen ovale (PFO) occlusion should provide effective closure with long-term biocompatibility and it should have a low profile without interfering with adjacent cardiac structures. Long-term data regarding safety and efficacy of the GORE Septal Occluder (GSO) are lacking. The aim of this study was to investigate the short- and mid-term clinical and echocardiographic outcomes of this device. METHODS AND RESULTS: Forty-five consecutive patients with clinically significant PFO were treated with GSO and their results were compared with those of 45 consecutive patients treated with Amplatzer PFO device (APO). Primary endpoint was the incidence of 6-month residual right-to-left shunting (rRLS). The procedural results and the recurrence of embolic events (REE) at 1 year were also investigated. No differences in terms of embolic risk profile and echocardiographic parameters were observed between the 2 groups. GSO was successfully implanted in all patients without device-related complication. In 2 patients for whom device position was not optimal, the GSO was easily retrieved and a new GSO was successfully repositioned. Immediate moderate-severe rRLS was similar in 2 groups. No cases of severe 6-month rRLS were registered. Two patients (4%) and 1 patient (2%) had moderate 6-month rRLS in the GSO and APO group, respectively (P=NS). No cases of REE were registered at 1-year follow-up. CONCLUSIONS: GSO appears a valuable alternative to Amplatzer device for PFO occlusion.

Effect of multivessel coronary artery disease with or without a concomitant chronic total occlusion on 1-year survival in patients treated with rescue angioplasty.

BACKGROUND: The effect of multivessel disease (MVD) with or without a concomitant chronic total occlusion (CTO) has never been investigated in patients treated with rescue percutaneous coronary intervention (PCI). OBJECTIVES: This study evaluates whether there is an increased rate of death at 1-year follow-up in patients undergoing rescue PCI with angiographic pattern of MVD and a concurrent CTO in comparison with single-vessel disease (SVD) and MVD without CTO. METHODS: Among 551 consecutive patients undergoing rescue PCI, we compared the 1-year survival rates of 361 patients with SVD, 137 with MVD without a CTO, and 53 with MVD and a CTO. RESULTS: The 1-year mortality rates of patients with SVD, MVD without CTO, and MVD with CTO were 5%, 13%, and 27%, respectively (P<.001). The Cox proportional hazard model identified the presence of MVD with CTO as a strong predictor of death at 1-year follow-up (hazard ratio [HR], 3.4; 95% confidence interval [CI], 1.6-7.1; P=.001), while MVD alone did not result as a predictor of outcome (HR, 1.9; 95% CI, 0.9-3.8; P=.064). Adjusted 1-year overall survival rates were 96%, 91.4%, and 83.4% (P=.001) in the groups with SVD, MVD without CTO, and MVD with CTO, respectively. CONCLUSION: Patients with MVD and concurrent CTO have higher mortality rates than those with SVD or MVD without CTO at 1-year follow-up after rescue PCI. MVD with CTO and not MVD alone is a predictor of death at 1-year follow-up.

Head-to-head comparison of sirolimus-eluting stent versus bare metal stent evaluation of the coronary endothelial dysfunction in the same patient presenting with multiple coronary artery lesions: the CREDENTIAL study.

OBJECTIVES: To assess the endothelial dysfunction (ED) after bare metal stents (BMS) and sirolimus eluting stents (SES) implantation in the same patient, overcoming the confounding role of individual variables. BACKGROUND: SES reduce restenosis rate compared to BMS but causes more ED. ED is a potentially unsafe phenomenon, since it is the first step in the cascade of atherosclerosis. Studies showing more pronounced ED with drug eluting stents than BMS involved different series of patients, making the comparison difficult because endothelial function (EF) is responsive to many risk factors. METHODS: we designed a prospective comparison of 6 months post-deployment EF of SES versus BMS implanted in the same patient, but in different coronary segments. Forty-eight lesions were randomly assigned on a 1:1 allocation using block sizing of 4 according to a computer-generated sequence (SAS System, Version 9.1) basis to treatment with SES or BMS. The EF was evaluated by measuring vessel diameter variation in the stented segment, before and after selective intracoronary infusion of acetylcholine (iiAch). RESULTS: In eligible patients, the relative magnitudes of major vasoconstriction were 2.6, 2.9, 4.6, and 3.1 at 5 mm proximal and 5, 10 and 20 mm distal to the stent edge. Overall, a 3.5-fold major distal vasoconstriction after iiAch of SES vs. BMS was calculated. CONCLUSIONS: in the same patients, but treating different coronary segments, SES implantation induces a higher rate of vasoconstriction compared to BMS. The increased vasoconstriction after iiAch is an indicator of ED.

Five-year outcomes in patients with chronic total coronary occlusion treated with drug-eluting vs bare-metal stents: a case-control study.

BACKGROUND: Limited data exist on long-term safety and effectiveness of drug-eluting stents (DESs) in true chronic total coronary occlusion (CTO) settings. We evaluated 5-year clinical outcomes of patients with CTO treated successfully with DES vs bare-metal stent (BMS). METHODS: We compared the 5-year clinical outcomes of 156 patients treated with DES implantation with outcomes of a historical cohort of 159 patients treated with BMS. Primary end point was freedom from major adverse cardiac events (MACEs; defined as death, myocardial infarction [MI], and target lesion revascularization [TLR]); secondary end points were freedom from target vessel failure (TVF; combination of target vessel revascularization, MI, and cardiac death) and TLR at 5 years. RESULTS: After 5 years, the DES group had significantly superior event-free survival from MACE (84% vs 69%; log rank P < 0.001), TVF (71% vs 84%; P = 0.002), and TLR (77% vs 92%; P = 0.0001), compared with the BMS group. The Cox proportional hazards model identified BMS vs DES (adjusted hazard ratio [HR] = 3.37; 95% confidence interval [CI], 1.85-6.17; P = 0.001), final minimal lumen diameter (HR, 0.27; 95% CI, 0.14-0.52; P = 0.0001), and stent length (HR, 1.01; 95% CI, 1.00-1.03; P = 0.03) as independent predictors of MACE at 5-year follow-up. Twelve (7%) and 7 (4%) stent thromboses occurred in the DES and BMS groups (P = 0.23), respectively. CONCLUSIONS: After 5 years, DESs were superior to BMSs in reducing MACE, TVF, and TLR in patients with CTO and should be the preferred strategy.

Long-term outcome of sirolimus-eluting vs bare-metal stent in the setting of acute myocardial infarction: 5-year results of the SESAMI trial.

BACKGROUND: few long-term randomized data on safety and effectiveness of sirolimus-eluting stent (SES) in the ST-segment elevation myocardial infarction (STEMI) setting are available. The aim of the present investigation was to evaluate the 5-year clinical outcome of SES vs bare-metal stent (BMS) implantation in patients with STEMI. METHODS: 320 STEMI patients were randomized to receive SES or BMS. The primary end-point was the incidence of target vessel failure (TVF) at 5-year follow-up. The secondary end-points were the rate of target lesion revascularization (TLR), major adverse cardiovascular events (MACE), death or non-fatal MI and stent thrombosis (ST). Event rates from 1 to 5 years in patients undergoing TLR and those TLR free at 1 year were also investigated. RESULTS: The 5-year survival rate free from TVF and TLR was significantly higher in the SES than in the BMS group (85% vs 76% p=0.038; 92% vs 85% p=0.045, respectively). The lower incidence of adverse events was achieved in the first year of follow-up. The cumulative incidence of MACE, death or non-fatal MI and ST was comparable in the 2 groups at 5-year follow-up. Moreover death or MI incidence was 5% in the patients who did not experience TLR within 1-year and 16% in those who experience TLR in the same period (p=0.033). Predictors of death or MI during 5-year follow-up were TLR within 1 year (OR 3.4, 95% CI 1.1-10.1; p=0.04) and small vessels treatment (OR 4.8 95% CI 1.7-13.0; p=0.002). CONCLUSIONS: The clinical benefits of SES are maintained up to 5years without safety concerns.

One-year clinical outcome of patients treated with or without abciximab in rescue coronary angioplasty.

BACKGROUND: The clinical results of abciximab administration during rescue angioplasty (PCI) are poorly investigated. METHODS: We evaluated the outcome of 406 consecutive patients undergoing rescue PCI treated with (n=218) or without (n=188) abciximab and a clopidogrel loading dose of 300 mg. The end point was the incidence of major cardiac adverse events (MACE) defined as death, recurrent acute myocardial infarction (AMI) and target vessel revascularization at 30 days and 1 year. The predictors of MACE were also investigated. RESULTS: No differences were found in MACE between the groups treated with or without abciximab at 30 days (15 and 20, p=0.67) and 1 year (23 and 29, p=0.85). Stepwise logistic regression analysis identified: cardiogenic shock (Odds Ratio [OR]=17.8, 95% confidence interval [CI] 5-99, p=0.0001), age (OR=1.099, 95% CI 1.04-1.15, p=0.0001), TIMI flow 0-1 after procedure (OR=5.51, 95% CI 1.72-17.6, p=0.004) as independent predictors of MACE at 30 days. Cox proportional hazards model identified: cardiogenic shock (adjusted hazard ratio [HR]=3.83, 95% confidence interval [CI] 1.76-8.35, p=0.01), age (HR=3.7, 95% CI 1.75-8.3, p=0.01), TIMI flow 0-1 after procedure (HR=1.04, 95% CI 1.01-1.07, p=0.001 as predictors of MACE at 1 year). After propensity score adjustments the predictors of MACE did not change. CONCLUSION: There were no differences in MACE at 30 days and 1 year in patients treated with or without abciximab during rescue PCI after a clopidogrel loading dose of 300 mg. Cardiogenic shock, age and TIMI flow 0 and 1 after PCI were predictors of MACE.

Early and mid-term clinical outcome of emergency PCI in patients with STEMI due to unprotected left main coronary artery disease.

OBJECTIVES: Evaluation of acute and mid-term outcomes of patients with ST-elevation myocardial infarction (STEMI) undergoing emergency PCI due to unprotected left main coronary artery (ULMCA) disease. BACKGROUND: STEMI patients due to ULMCA disease represent a rare, high risk group. Percutaneous coronary intervention (PCI) may be the preferred strategy of myocardial revascularization but there are few data about this topic. METHODS: We analyzed 30-day and mid-term mortality of 58 patients with STEMI and ULMCA disease as culprit lesion treated in our centre by emergency PCI between 2000 to 2010. RESULTS: Mean age was 67.3 ± 11.5 years. Thirty (51.7%) patients had cardiogenic shock on admission. PCI success was achieved in 54 patients (93.1%). Mean follow-up was 15.8 ± 10.9 months (median 14, range 6-45). Thirty-day and mid-term mortality rates were 39.7% and 44%. Backward binary logistic regression model identified cardiogenic shock at presentation (OR 12.6, 95% CI 2.97-53.6, P < 0.001), age ≥75 years (OR 5.9, 95% CI 1.3-26.5, P = 0.019) and post-PCI TIMI flow grade <3 (OR 2.9, 95% CI 1.8-5.7 P = 0.02) as independent predictors of 30-day mortality. Cox proportional hazard ratio (HR) identified shock at presentation (HR 5.2, 95% CI 1.8-14.3, P < 0.002), age ≥75 years (HR 3.9, 95% CI 1.8-8.7, P < 0.001), post-PCI TIMI flow grade <3 (HR 4.9, 95% CI 1.6-14.6; P < 0.005) as independent predictors of mid-term mortality. CONCLUSIONS: In patients with STEMI and ULMCA as culprit lesion, emergency PCI is a valuable therapeutic strategy. Early and mid-term survival depends on cardiogenic shock, advanced age, and PCI failure. Patients surviving the first month have good mid-term prognosis.