Cangrelor, the first intravenous P2Y12 inhibitor (P2Y12-I), has been approved on the basis of thr... more Cangrelor, the first intravenous P2Y12 inhibitor (P2Y12-I), has been approved on the basis of three large RCTs from the CHAMPION program which nevertheless have been criticized for the low bleeding risk of the enrolled patients, the large quote of chronic coronary syndromes, and the use of Clopidogrel as control arm even in the setting of acute coronary syndromes (ACS). We sought to investigate, in the setting of ACS, the comparative performance of Cangrelor in terms of in-hospital ischemic and haemorrhagic outcomes compared with the current gold-standard of oral P2Y12-I. The study retrospectively enrolled 686 consecutive patients admitted to the Divisions of Cardiology of Policlinico of Bari and L. Bonomo Hospital of Andria for ACS and treated with percutaneous coronary intervention. The study population was divided according to the P2Y12-I treatment strategy in two groups: patients given an oral P2Y12-I and patients receiving Cangrelor in the cath lab followed by an oral P2Y12-I. ...
Aims To investigate the prevalence of high bleeding risk (HBR) criteria and compare clinical outc... more Aims To investigate the prevalence of high bleeding risk (HBR) criteria and compare clinical outcomes between HBR and non-HBR patients receiving cangrelor in the peri-percutaneous coronary intervention (PCI) phase. Methods Consecutive patients treated with cangrelor in 7 Italian institutions were retrospectively enrolled in the ICARUS (“Intravenous CAngrelor in high-bleeding Risk patients Undergoing percutaneouS coronary intervention”, NCT05505591) registry. HBR status was assessed according to the Academic Research Consortium (ARC-HBR) definition. The primary endpoint was net adverse clinical events (NACE), defined as a composite of cardiovascular death, myocardial infarction, stroke, definite or probable stent thrombosis and Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding, at 48 hours. Secondary endpoints were assessed at 48 hours and throughout the hospital stay. Results We enrolled 551 patients undergoing PCI with cangrelor between January 2019 and August 2022. H...
Aims To compare the clinical characteristics and in-hospital outcomes of patients undergoing comp... more Aims To compare the clinical characteristics and in-hospital outcomes of patients undergoing complex vs. non-complex percutaneous coronary intervention (PCI) with peri-procedural use of cangrelor. Methods Consecutive patients treated with cangrelor in 6 Italian institutions were retrospectively enrolled in the ICARUS (“Intravenous CAngrelor in high-bleeding Risk patients Undergoing percutaneouS coronary intervention”, NCT05505591) registry. Complex PCI was defined as any of the following: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, or chronic total occlusion. The primary endpoint was net adverse clinical events (NACE), defined as a composite of cardiovascular death, myocardial infarction, stroke, definite or probable stent thrombosis and Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding, at 48 hours. Secondary endpoints were assessed at 48 hours and throughout the hospital stay. Results ...
BackgroundThe itAlian pRospective Study on CANGrELOr (ARCANGELO) was aimed to assess the safety o... more BackgroundThe itAlian pRospective Study on CANGrELOr (ARCANGELO) was aimed to assess the safety of using cangrelor during percutaneous coronary intervention (PCI) in patients with acute coronary syndromes (ACS) in the daily practice.HypothesisThe safety of cangrelor after the transition to oral P2Y12 inhibitors was evaluated as the incidence of bleeding outcomes in the 30 days following PCI according to postauthorization safety study guidelines.MethodsAdults with ACS who were treated with cangrelor in one of the 28 centers involved in the study. Patients who consented to participate were followed in the 30 days following their PCI. Bleedings (Bleeding Academic Research Consortium [BARC] classification), major adverse cardiac events (MACEs), and adverse events were recorded. The interim results at two‐thirds of the enrollment period are presented.ResultsA total of 17 bleedings were observed in the 320 patients who completed the study at this stage. All bleedings were classified as BARC Type 1–2, except for one case of Type 3a (vessel puncture site hematoma). Four patients experienced MACEs (2 acute myocardial infarctions, 1 sudden cardiac death, 1 noncardiovascular death due to respiratory distress, and multiorgan failure). None of the bleedings was rated as related to cangrelor.ConclusionsThe interim results of the ARCANGELO study provide a preliminary confirmation that the use of cangrelor on patients with ACS undergoing PCI is not associated with severe bleedings.
BACKGROUND Timely myocardial reperfusion by primary percutaneous coronary intervention (pPCI) pre... more BACKGROUND Timely myocardial reperfusion by primary percutaneous coronary intervention (pPCI) prevents the development of left ventricular (LV) dysfunction after myocardial infarction (MI). We aimed to investigate whether bare-metal stents (BMS) and drug eluting stents (DES) differently affect the recovery of LV function in patients with ST-elevation MI (STEMI). METHODS Overall 103anterior STEMI patients were retrospectively analysed. All patients had single vessel disease with culprit lesion at the left anterior descending coronary artery. Patients were categorized in: DES group (n= 67) and BMS group (n=36). Changes in LV contractility were assessed by trans-thoracic echocardiogram as left ventricular wall motion score index (LVWMSI). Follow-up visits were performed between 6 and 12 months after hospital discharge. RESULTS Compared to baseline, LV ejection fraction (EF) remained unchanged between the two groups at the follow-up; LVWMSI significantly improved in patients treated with DES (1.95±0.25 vs 1.78±0.38, p< 0.05), whereas didn't change in those treated with BMS (2.09±0.21 vs 1.98±0.33, p: ns). At follow-up the LVWMSI was significantly higher in patients with DES than with BMS (p=0.048). LV end-systolic and end-diastolic volumes (LVESV, LVEDV) significantly increased in patients receiving a BMS, whereas it didn't change in those receiving a DES (p<0.05). Multivariate analysis adjusted for age, gender, type of stent (DES or BMS), and type of revascularization (primary PCI or rescue PCI or thrombolysis + PCI) showed that DES implantation was an independent predictor of LVWMSI improvement (OR 3.8 (1.143 - 12.969) p=0.03). CONCLUSIONS DES implantation is associated with a favourable impact on LV remodelling and regional contractility.
Optimal medical therapy (OMT) at discharge is recommended after acute coronary syndrome (ACS). Fe... more Optimal medical therapy (OMT) at discharge is recommended after acute coronary syndrome (ACS). Few studies report the impact of OMT on long-term clinical outcome in a real-world scenario. We evaluated the impact of discharge OMT on top of dual-antiplatelet therapy (DAPT) on clinical outcome in the real-world ACS population of the Survey on anTicoagulated pAtients RegisTer ANTIPLATELET registry. The primary end point was major adverse cardiac and cerebrovascular event (MACCE), a composite of death, myocardial infarction, stroke, or target vessel revascularization. The co-primary end point was net adverse cardiac and cerebrovascular event (NACE), based on MACCE plus major bleeding. Consecutive patients with ACS with 1-year follow-up were enrolled. They were evaluated at discharge for the use of a β-blocker, angiotensin-converting enzyme inhibitor/angiotensin II receptor blockers and statins. Optimal medical therapy was defined as the use of ≥2 of 3 medications. At multivariate analysi...
Background Duration of Dual Antiplatelet Therapy (DAPT) following Acute Coronary Syndromes (ACS) ... more Background Duration of Dual Antiplatelet Therapy (DAPT) following Acute Coronary Syndromes (ACS) or Stable Coronary Artery Disease (SCAD) treated with coronary stenting is still debated. Although current guidelines consider several “clinical” criteria to decide for short DAPT (<6 months), standard DAPT (12 months) and prolonged DAPT (>12 months), the relationship between DAPT duration, treatment of bifurcations and its impact on clinical outcome has been poorly investigated in real world registries. Purpose We evaluated the impact of DAPT duration on clinical outcomes in consecutive all-comers patients treated with stenting of coronary artery bifurcation lesions included in the Euro Bifurcation Club -P2BiTO - registry. Methods Data on 5036 consecutive patients who underwent PCI on coronary bifurcation at 17 major coronary intervention centres between January 2012 and December 2014 were collected. The primary endpoint of the study was the cumulative occurrence of Major Adverse ...
Aims To investigate the prevalence of high bleeding risk (HBR) criteria and compare clinical outc... more Aims To investigate the prevalence of high bleeding risk (HBR) criteria and compare clinical outcomes between HBR and non–HBR patients receiving cangrelor in the peri–percutaneous coronary intervention (PCI) phase. Methods Consecutive patients treated with cangrelor in 7 Italian institutions were retrospectively enrolled in the ICARUS (“Intravenous CAngrelor in high–bleeding Risk patients Undergoing percutaneouS coronary intervention”, NCT05505591) registry. HBR status was assessed according to the Academic Research Consortium (ARC–HBR) definition. The primary endpoint was net adverse clinical events (NACE), defined as a composite of cardiovascular death, myocardial infarction, stroke, definite or probable stent thrombosis and Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding, at 48 hours. Secondary endpoints were assessed at 48 hours and throughout the hospital stay. Results We enrolled 551 patients undergoing PCI with cangrelor between January 2019 and August 2022. H...
Cangrelor, the first intravenous P2Y12 inhibitor (P2Y12-I), has been approved on the basis of thr... more Cangrelor, the first intravenous P2Y12 inhibitor (P2Y12-I), has been approved on the basis of three large RCTs from the CHAMPION program which nevertheless have been criticized for the low bleeding risk of the enrolled patients, the large quote of chronic coronary syndromes, and the use of Clopidogrel as control arm even in the setting of acute coronary syndromes (ACS). We sought to investigate, in the setting of ACS, the comparative performance of Cangrelor in terms of in-hospital ischemic and haemorrhagic outcomes compared with the current gold-standard of oral P2Y12-I. The study retrospectively enrolled 686 consecutive patients admitted to the Divisions of Cardiology of Policlinico of Bari and L. Bonomo Hospital of Andria for ACS and treated with percutaneous coronary intervention. The study population was divided according to the P2Y12-I treatment strategy in two groups: patients given an oral P2Y12-I and patients receiving Cangrelor in the cath lab followed by an oral P2Y12-I. ...
Aims To investigate the prevalence of high bleeding risk (HBR) criteria and compare clinical outc... more Aims To investigate the prevalence of high bleeding risk (HBR) criteria and compare clinical outcomes between HBR and non-HBR patients receiving cangrelor in the peri-percutaneous coronary intervention (PCI) phase. Methods Consecutive patients treated with cangrelor in 7 Italian institutions were retrospectively enrolled in the ICARUS (“Intravenous CAngrelor in high-bleeding Risk patients Undergoing percutaneouS coronary intervention”, NCT05505591) registry. HBR status was assessed according to the Academic Research Consortium (ARC-HBR) definition. The primary endpoint was net adverse clinical events (NACE), defined as a composite of cardiovascular death, myocardial infarction, stroke, definite or probable stent thrombosis and Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding, at 48 hours. Secondary endpoints were assessed at 48 hours and throughout the hospital stay. Results We enrolled 551 patients undergoing PCI with cangrelor between January 2019 and August 2022. H...
Aims To compare the clinical characteristics and in-hospital outcomes of patients undergoing comp... more Aims To compare the clinical characteristics and in-hospital outcomes of patients undergoing complex vs. non-complex percutaneous coronary intervention (PCI) with peri-procedural use of cangrelor. Methods Consecutive patients treated with cangrelor in 6 Italian institutions were retrospectively enrolled in the ICARUS (“Intravenous CAngrelor in high-bleeding Risk patients Undergoing percutaneouS coronary intervention”, NCT05505591) registry. Complex PCI was defined as any of the following: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, or chronic total occlusion. The primary endpoint was net adverse clinical events (NACE), defined as a composite of cardiovascular death, myocardial infarction, stroke, definite or probable stent thrombosis and Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding, at 48 hours. Secondary endpoints were assessed at 48 hours and throughout the hospital stay. Results ...
BackgroundThe itAlian pRospective Study on CANGrELOr (ARCANGELO) was aimed to assess the safety o... more BackgroundThe itAlian pRospective Study on CANGrELOr (ARCANGELO) was aimed to assess the safety of using cangrelor during percutaneous coronary intervention (PCI) in patients with acute coronary syndromes (ACS) in the daily practice.HypothesisThe safety of cangrelor after the transition to oral P2Y12 inhibitors was evaluated as the incidence of bleeding outcomes in the 30 days following PCI according to postauthorization safety study guidelines.MethodsAdults with ACS who were treated with cangrelor in one of the 28 centers involved in the study. Patients who consented to participate were followed in the 30 days following their PCI. Bleedings (Bleeding Academic Research Consortium [BARC] classification), major adverse cardiac events (MACEs), and adverse events were recorded. The interim results at two‐thirds of the enrollment period are presented.ResultsA total of 17 bleedings were observed in the 320 patients who completed the study at this stage. All bleedings were classified as BARC Type 1–2, except for one case of Type 3a (vessel puncture site hematoma). Four patients experienced MACEs (2 acute myocardial infarctions, 1 sudden cardiac death, 1 noncardiovascular death due to respiratory distress, and multiorgan failure). None of the bleedings was rated as related to cangrelor.ConclusionsThe interim results of the ARCANGELO study provide a preliminary confirmation that the use of cangrelor on patients with ACS undergoing PCI is not associated with severe bleedings.
BACKGROUND Timely myocardial reperfusion by primary percutaneous coronary intervention (pPCI) pre... more BACKGROUND Timely myocardial reperfusion by primary percutaneous coronary intervention (pPCI) prevents the development of left ventricular (LV) dysfunction after myocardial infarction (MI). We aimed to investigate whether bare-metal stents (BMS) and drug eluting stents (DES) differently affect the recovery of LV function in patients with ST-elevation MI (STEMI). METHODS Overall 103anterior STEMI patients were retrospectively analysed. All patients had single vessel disease with culprit lesion at the left anterior descending coronary artery. Patients were categorized in: DES group (n= 67) and BMS group (n=36). Changes in LV contractility were assessed by trans-thoracic echocardiogram as left ventricular wall motion score index (LVWMSI). Follow-up visits were performed between 6 and 12 months after hospital discharge. RESULTS Compared to baseline, LV ejection fraction (EF) remained unchanged between the two groups at the follow-up; LVWMSI significantly improved in patients treated with DES (1.95±0.25 vs 1.78±0.38, p< 0.05), whereas didn't change in those treated with BMS (2.09±0.21 vs 1.98±0.33, p: ns). At follow-up the LVWMSI was significantly higher in patients with DES than with BMS (p=0.048). LV end-systolic and end-diastolic volumes (LVESV, LVEDV) significantly increased in patients receiving a BMS, whereas it didn't change in those receiving a DES (p<0.05). Multivariate analysis adjusted for age, gender, type of stent (DES or BMS), and type of revascularization (primary PCI or rescue PCI or thrombolysis + PCI) showed that DES implantation was an independent predictor of LVWMSI improvement (OR 3.8 (1.143 - 12.969) p=0.03). CONCLUSIONS DES implantation is associated with a favourable impact on LV remodelling and regional contractility.
Optimal medical therapy (OMT) at discharge is recommended after acute coronary syndrome (ACS). Fe... more Optimal medical therapy (OMT) at discharge is recommended after acute coronary syndrome (ACS). Few studies report the impact of OMT on long-term clinical outcome in a real-world scenario. We evaluated the impact of discharge OMT on top of dual-antiplatelet therapy (DAPT) on clinical outcome in the real-world ACS population of the Survey on anTicoagulated pAtients RegisTer ANTIPLATELET registry. The primary end point was major adverse cardiac and cerebrovascular event (MACCE), a composite of death, myocardial infarction, stroke, or target vessel revascularization. The co-primary end point was net adverse cardiac and cerebrovascular event (NACE), based on MACCE plus major bleeding. Consecutive patients with ACS with 1-year follow-up were enrolled. They were evaluated at discharge for the use of a β-blocker, angiotensin-converting enzyme inhibitor/angiotensin II receptor blockers and statins. Optimal medical therapy was defined as the use of ≥2 of 3 medications. At multivariate analysi...
Background Duration of Dual Antiplatelet Therapy (DAPT) following Acute Coronary Syndromes (ACS) ... more Background Duration of Dual Antiplatelet Therapy (DAPT) following Acute Coronary Syndromes (ACS) or Stable Coronary Artery Disease (SCAD) treated with coronary stenting is still debated. Although current guidelines consider several “clinical” criteria to decide for short DAPT (<6 months), standard DAPT (12 months) and prolonged DAPT (>12 months), the relationship between DAPT duration, treatment of bifurcations and its impact on clinical outcome has been poorly investigated in real world registries. Purpose We evaluated the impact of DAPT duration on clinical outcomes in consecutive all-comers patients treated with stenting of coronary artery bifurcation lesions included in the Euro Bifurcation Club -P2BiTO - registry. Methods Data on 5036 consecutive patients who underwent PCI on coronary bifurcation at 17 major coronary intervention centres between January 2012 and December 2014 were collected. The primary endpoint of the study was the cumulative occurrence of Major Adverse ...
Aims To investigate the prevalence of high bleeding risk (HBR) criteria and compare clinical outc... more Aims To investigate the prevalence of high bleeding risk (HBR) criteria and compare clinical outcomes between HBR and non–HBR patients receiving cangrelor in the peri–percutaneous coronary intervention (PCI) phase. Methods Consecutive patients treated with cangrelor in 7 Italian institutions were retrospectively enrolled in the ICARUS (“Intravenous CAngrelor in high–bleeding Risk patients Undergoing percutaneouS coronary intervention”, NCT05505591) registry. HBR status was assessed according to the Academic Research Consortium (ARC–HBR) definition. The primary endpoint was net adverse clinical events (NACE), defined as a composite of cardiovascular death, myocardial infarction, stroke, definite or probable stent thrombosis and Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding, at 48 hours. Secondary endpoints were assessed at 48 hours and throughout the hospital stay. Results We enrolled 551 patients undergoing PCI with cangrelor between January 2019 and August 2022. H...
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