In the past Fabio Mangiacapra has collaborated on articles with Etienne Puymirat and Stephane Fournier. One of their most recent publications is Clinical InvestigationInterventional CardiologyLong-term clinical outcome in patients with small vessel disease treated with drug-eluting versus bare-metal stenting. Which was published in journal American Heart Journal.

More information about Fabio Mangiacapra research including statistics on their citations can be found on their Copernicus Academic profile page.

Fabio Mangiacapra's Articles: (9)

Clinical InvestigationInterventional CardiologyLong-term clinical outcome in patients with small vessel disease treated with drug-eluting versus bare-metal stenting

BackgroundDES is superior to BMS in reducing restenosis and repeat revascularization. Available data are less convincing in small vessel disease. Aim of our study is to assess long-term clinical outcome of drug-eluting stents (DES) vs. bare-metal stents (BMS) in small coronary vessel disease.MethodsProcedural and long-term clinical outcomes were assessed in consecutive patients (pts) treated with stenting of native small coronary arteries (reference vessel diameter and implanted stent < 3mm).ResultsPts enrolled were 645: DES group (n = 277) presented more frequently diabetes (173 [62%] vs. 32 [9%], P < .0001), higher body mass index (27 ± 5 vs. 26 ± 4, P = .01) and with previous PCI (115 [42%] vs. 118 [32%], P = .01) as compared to BMS group (n=368). DES group presented more frequently with unstable angina (46 [17%] vs. 38 [10%], P = .02); BMS group presented more frequently with myocardial infarction (103 [28] vs. 43 [15], P = .0002). Reference vessel (2.27 ± 0.36 vs. 2.24 ± 0.36, P = .29), minimal lumen (0.81 ± 0.32 vs. 0.80 ± 0.31, P = .84) and stent diameter (2.59 ± 0.17 vs. 2.60 ± 0.15, P = .69) did not differ between the 2 groups. Lesion length was significantly higher in DES group (15.85 ± 6.81 vs. 13.66 ± 7.18, P = .01). At a median clinical follow-up of 3.0 years (IQR range 2.2-4.6), pts with DES showed significantly lower major adverse cardiac events (MACE, HR 0.51, 95%CI 0.33-0.78) and target vessel revascularization (TVR, HR 0.44, 95%CI 0.25-0.78). No differences were observed between the two groups as to death, myocardial infarction and stent thrombosis.ConclusionsIn small vessel disease, DES was more frequently implanted in pts at higher risk of restenosis, though it demonstrated to be more effective than BMS in reducing MACE and TVR at long-term follow-up.

Clinical InvestigationAcute Ischemic Heart DiseaseCircadian variations of ischemic burden among patients with myocardial infarction undergoing primary percutaneous coronary intervention

BackgroundSeveral parameters of cardiovascular physiology and pathophysiology exhibit circadian rhythms. Recently, a relation between infarct size and the time of day at which it occurs has been suggested in experimental models of myocardial infarction. The aim of this study is to investigate whether circadian rhythms could cause differences in ischemic burden in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI).MethodsIn 353 consecutive patients with STEMI treated by PPCI, time of symptom onset, peak creatine kinase (CK), and follow-up at 30 days were obtained. We divided 24 hours into 4 time groups based on time of symptom onset (00:00-05:59, 06:00-11:59, 12:00-17:59, and 18:00-23:59).ResultsThere was no difference between the groups regarding baseline patients and management's characteristics. At multivariable analysis, there was a statistically significant difference between peak CK levels among patients with symptom onset between 00:00 and 05:59 when compared with peak CK levels of patients with symptom onset in any other time group (mean increase 38.4%, P < .05). Thirty-day mortality for STEMI patients with symptom onset occurring between 00:00 and 05:59 was significantly higher than any other time group (P < .05).ConclusionThis study demonstrates an independent correlation between the infarct size of STEMI patients treated by PPCI and the time of the day at which symptoms occurred. These results suggest that time of the day should be a critical issue to look at when assessing prognosis of patients with myocardial infarction.

Trial DesignRational and design of the INtentional COronary revascularization versus conservative therapy in patients undergOing successful peripheRAl arTEry revascularization due to critical limb ischemia trial (INCORPORATE trial)

AbstractCritical limb ischemia is associated with excessively high risk for cardiovascular events, including myocardial infarction and death. Additionally, in this patient population non-invasive evaluation of coronary artery disease is limited due to (1) inability of exercise testing, (2) frequent occurrence of balanced ischemia and (3) frequent occurrence of diffuse coronary calcification.Intentional Coronary Revascularization Versus Conservative Therapy in Patients Undergoing Peripheral Artery Revascularization Due to Critical Limb Ischemia trial (INCORPORATE trial) is a multicentric international randomized open label clinical trial. Trial will recruit patients, who underwent successful peripheral artery revascularization due to critical limb ischemia and randomize 1:1 to conservative medical therapy versus an immediate invasive strategy to investigate and treat coronary artery disease. The objective is to evaluate whether intentional invasive strategy with ischemia targeted reasonably complete coronary revascularization is superior as compared to conventional primarily conservative approach in terms of spontaneous myocardial infarction and overall survival at 12 months follow-up. The trial is registered at (NCT03712644).

Coronary artery diseaseEfficacy of Clopidogrel Reloading in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention During Chronic Clopidogrel Therapy (from the Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty [ARMYDA-8 RELOAD-ACS] Trial)

Whether an additional clopidogrel load in patients receiving chronic clopidogrel therapy and undergoing percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) is associated with clinical benefit has not been well characterized. The aim of the present study was to evaluate, in a randomized protocol, the safety and effectiveness of clopidogrel reload for patients with ACS undergoing PCI in the background of chronic clopidogrel therapy. A total of 242 patients with non–ST-segment elevation ACS with >10 days of clopidogrel therapy randomly received a 600-mg loading dose of clopidogrel 4 to 8 hours before PCI (n = 122) or placebo (n = 120). The primary end point was the 30-day incidence of major adverse cardiac events (death, myocardial infarction, target vessel revascularization). The primary end point occurred in 4.1% of patients in the reload arm versus 14.1% in the placebo arm (odds ratio 0.26, 95% confidence interval 0.10 to 0.73, p = 0.013). This benefit in the reload arm was mainly from the prevention of periprocedural myocardial infarction (4.1% vs 13%, p = 0.02) and was paralleled by lower periprocedural platelet reactivity. The aggregometry data were consistent with the clinical outcome. No difference was found in the bleeding outcomes between the 2 groups. In conclusion, the results from the Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty (ARMYDA-8 RELOAD-ACS) trial have shown a significant clinical benefit from reloading patients with ACS receiving chronic clopidogrel therapy before PCI. These data might be relevant in clinical practice, given the large number of patients with ACS who are still currently treated with clopidogrel during PCI.

Coronary Artery DiseaseImpact of Chronic Kidney Disease on Platelet Reactivity and Outcomes of Patients Receiving Clopidogrel and Undergoing Percutaneous Coronary Intervention

The impact of chronic kidney disease (CKD) on residual platelet reactivity (PR) in patients undergoing percutaneous coronary intervention (PCI) is still debatable. We sought to investigate the interaction between PR and renal function and the related clinical outcomes in patients with coronary artery disease treated with PCI. Immediately before PCI, we measured PR (as P2Y12 reaction units [PRUs]) in 800 patients on clopidogrel with the VerifyNow P2Y12 assay. High PR was defined as a PRU value of ≥240 and low PR as a PRU value of ≤178. Based on a glomerular filtration rate of < or ≥60 ml/min/1.73 m2, patients were respectively grouped into those with or without moderate-to-severe CKD. Primary end point was the incidence of 30-day net adverse clinical events (NACEs). Patients with moderate-to-severe CKD (n = 173, 21.6%) and those without showed similar PRU values (208 ± 67 vs 207 ± 75, p = 0.819). Yet, NACEs were significantly higher in patients with moderate-to-severe CKD (19.7% vs 9.1%, p <0.001), in terms of both ischemic (12.1% vs 7.2%, p = 0.036) and bleeding events (8.7% vs 2.1%, p <0.001). NACEs were significantly higher when moderate-to-severe CKD was associated with either high PR or low PR (25.4%, p for trend <0.001); this association was the strongest predictor of NACE at multivariate analysis (odds ratio 3.4, 95% confidence interval 2.0 to 5.6, p <0.001). In conclusion, we did not find an association between moderate-to-severe CKD and residual PR on clopidogrel. However, the association of moderate-to-severe CKD with either high or low PR was a strong determinant of adverse events after PCI.

Coronary Artery DiseaseEfficacy and Safety of Paclitaxel-Coated Balloon for the Treatment of In-Stent Restenosis in High-Risk Patients

In-stent restenosis (ISR) is a major cause of failure of percutaneous coronary intervention. The efficacy and safety of drug-coated balloon (DCB) in patients with high-risk clinical features are largely unknown. We enrolled 82 consecutive patients at high risk of bleeding with angiographically significant (diameter stenosis ≥50%) ISR of bare metal stent (BMS) or drug-eluting stent (DES), treated with paclitaxel-coated balloon. All patients presented at least one of the following criteria: high bleeding risk, neoplasm, chronic inflammatory disease, and need for noncardiac surgery. Dual antiplatelet therapy was indicated for 4 weeks after the procedure. At angiographic follow-up, overall late lumen loss was 0.24 ± 0.32 mm, with no significant difference between BMS-ISR and DES-ISR (0.25 ± 0.35 vs 0.22 ± 0.30 mm, p = 0.714). The Kaplan-Meier estimate for major adverse clinical events-free survival at 3 years was 81.4% (82.3% in BMS-ISR vs 79.4% in DES-ISR, log-rank p = 0.866). No stent thrombosis has been recorded. In conclusion, the use of paclitaxel-coated balloon seems to be associated with favorable outcomes after percutaneous coronary intervention for BMS-ISR or DES-ISR in patients with high-risk clinical features and could be considered as a reasonable option in the presence of systemic co-morbidities and contraindications to long-term dual antiplatelet therapy.

Platelet reactivity and coronary microvascular impairment after percutaneous revascularization in stable patients receiving clopidogrel or prasugrel

Highlights•Prasugrel, compared with clopidogrel, attenuates peri-procedural increase in platelet reactivity.•A significant correlation exists between platelet reactivity and coronary microvascular function at the time of PCI.•The more profound platelet inhibition may contribute to the protective effect of prasugrel on coronary microcirculation.

Clinical ResearchCardiovascular RiskInfluence of rs5065 Atrial Natriuretic Peptide Gene Variant on Coronary Artery Disease

ObjectivesThe aim of this study was to investigate the impact of rs5065 atrial natriuretic peptide (ANP) gene variant on coronary artery disease (CAD) and its outcomes and to gain potential mechanistic insights on the association with CAD.BackgroundEither modified ANP plasma levels or peptide structural alterations have been involved in development of cardiovascular events.MethodsThree hundred ninety-three control subjects and 1,004 patients undergoing coronary angiography for suspected CAD (432 stable angina [SA], 572 acute coronary syndrome [ACS]) were genotyped for rs5065 ANP gene variant. Data in SA and ACS groups were replicated in an independent population of 482 stable angina patients (rSA) and of 675 ACS patients, respectively. Clinical follow-up was available for both SA and rSA patients. Plasma N-terminal-proANP, myeloperoxidase, lipoprotein-associated phospholipase A2, and oxidized low-density lipoprotein were assessed in a subgroup of rSA patients.Resultsrs5065 minor allele (MA) was an independent predictor of ACS (odds ratio: 1.90; 95% confidence interval: 1.40 to 2.58, p < 0.001). At follow-up, rs5065 MA was independently associated with a significantly higher rate of major adverse cardiovascular events in the SA group, p < 0.001. Data were replicated in the rSA group at follow-up (p = 0.008). Cox proportional hazard analysis tested by 4 models confirmed higher major adverse cardiovascular events risk in rs5065 MA carriers in both SA and rSA cohorts. Significantly higher myeloperoxidase levels were detected in rs5065 MA carriers (n = 597 [345 to 832 μg/l] vs. n = 488 [353 to 612 μg/l], p = 0.038). No association of rs5065 was observed with N-terminal-proANP levels.ConclusionsThe MA of rs5065 ANP gene variant associates with increased susceptibility to ACS and has unfavorable prognostic value in CAD.

Clinical ResearchHigh Residual Platelet Reactivity After Clopidogrel: Extent of Coronary Atherosclerosis and Periprocedural Myocardial Infarction in Patients With Stable Angina Undergoing Percutaneous Coronary Intervention

ObjectivesWe tested the hypothesis that residual platelet reactivity after clopidogrel correlates with the extent and severity of coronary atherosclerosis in patients undergoing elective percutaneous coronary intervention (PCI).BackgroundPlatelets are actively involved in vascular atherosclerosis.MethodsWe prospectively enrolled 338 patients undergoing PCI for stable angina, loaded with 600-mg clopidogrel. Platelet reactivity was assessed 12 h later by measuring P2Y12 reactivity unit (PRU) with VerifyNow P2Y12 assay (Accumetrics, San Diego, California). High platelet reactivity (HPR) was defined as PRU value ≥240. Presence of multivessel disease (MVD) and total stent length (TSL) were used as surrogate markers of atherosclerosis severity and extension.ResultsPatients with MVD showed higher PRU compared with single-vessel disease (SVD) patients (222 ± 85 vs. 191 ± 73; p < 0.001). The PRU increased with the number of stenotic coronaries (1-vessel disease: 191 ± 73; 2-vessel disease: 220 ± 88; 3-vessel disease: 226 ± 80; p = 0.002). The PRU was higher in the third TSL tertile compared with first tertile (217 ± 83 vs. 191 ± 73; p = 0.048). The HPR was most frequently observed among MVD patients (40.5% vs. 21.6% in patients with SVD, respectively; p < 0.001) and those in the third TSL tertile (35.8% vs. 22.2% first tertile; p = 0.028). Higher incidence of periprocedural myocardial infarction was observed in patients with HPR (41.2% vs. 26.7% in patients without HPR; p = 0.008) and in those in the third tertile TSL (37.7% vs. 23.1% first tertile; p = 0.020). By multivariate analysis, HPR was the only independent predictor of periprocedural myocardial infarction (p = 0.034).ConclusionsPatients with more extensive coronary atherosclerosis have a higher rate of HPR, which might partly account for higher risk of periprocedural MI.

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