Abstract
Aims
To evaluate the impact of an experimental strategy 23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT) vs. a reference regimen (12-month aspirin ...monotherapy following 12-month DAPT) after complex percutaneous coronary intervention (PCI).
Methods and results
In the present post hoc analysis of the Global Leaders trial, the primary endpoint composite of all-cause death or new Q-wave myocardial infarction (MI) at 2 years was assessed in patients with complex PCI, which includes at least one of the following characteristics: multivessel PCI, ≥3 stents implanted, ≥3 lesions treated, bifurcation PCI with ≥2 stents, or total stent length >60 mm. In addition, patient-oriented composite endpoint (POCE) (composite of all-cause death, any stroke, any MI, or any revascularization) and net adverse clinical events (NACE) composite of POCE or Bleeding Academic Research Consortium (BARC) Type 3 or 5 bleeding were explored. Among 15 450 patients included in this analysis, 4570 who underwent complex PCI had a higher risk of ischaemic and bleeding events. In patients with complex PCI, the experimental strategy significantly reduced risks of the primary endpoint hazard ratio (HR): 0.64, 95% confidence interval (CI): 0.48–0.85 and POCE (HR: 0.80, 95% CI: 0.69–0.93), but not in those with non-complex PCI (Pinteraction = 0.015 and 0.017, respectively). The risk of BARC Type 3 or 5 bleeding was comparable (HR: 0.97, 95% CI: 0.67–1.40), resulting in a significant risk reduction in NACE (HR: 0.80, 95% CI: 0.69–0.92; Pinteraction = 0.011).
Conclusion
Ticagrelor monotherapy following 1-month DAPT could provide a net clinical benefit for patients with complex PCI. However, in view of the overall neutral results of the trial, these findings of a post hoc analysis should be considered as hypothesis generating.
PPCI involving coronary artery aneurysms (CAAs) is challenging because of difficulties in “wiring” the distal part of the lesion, the presence of extensive thrombus burden, and increased risk of ...distal embolization and no reflow (1). ...CAA is a risk factor for stent thrombosis after stenting for acute coronary syndromes (2). ...PPCI-treated patients with STEMI caused by CAA show unacceptable rates of early stent thrombosis causing recurrent MIs. All event rates are calculated as Kaplan-Meier estimates.BARC = bleeding academic research consortium; CL = culprit lesion; EF = ejection fraction; MI = myocardial infarction; RCA = right coronary artery. Patients With Aneurysm as CL (n = 32) Patients Without Aneurysm as CL (n = 2,280) p Value Age, yrs 65.85 ± 11.61 62.94 ± 12.52 0.17 Male 26 (81.3) 1,773 (77.8) 0.637 Diabetes mellitus 7 (21.9) 374 (16.7) 0.441 Previous MI 8 (25.8) 256 (11.4) 0.013 CL = RCA 16 (50.0) 739 (32.4) 0.035 EF at discharge, % 48.28 ± 6.63 48.56 ± 9.40 0.884 Bleeding BARC 3,5 1 (3.2) 17 (0.8) 0.13 30-day event rates Death/MI 5 (15.6) 169 (7.7) 0.091 Death 1 (3.1) 131 (6.0) 0.515 Cardiac death 1 (3.1) 105 (4.7) 0.682 New MI 4 (12.7) 50 (2.3) <0.001...
Several studies established a link between bleeding and mortality in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI); however, it ...is unclear whether bleeding has a direct role in worsening the prognosis or if it is simply a marker of patient frailty. We investigated whether bleeding is an independent predictor of mortality in patients with STEMI treated with pPCI. The relationship between the presence of heart failure on presentation (Killip classification), bleeding occurrence, and outcome was also assessed. Bleeding was defined as the combination of Thrombolysis in Myocardial Infarction major and minor bleeding. Short- and long-term mortalities were estimated using the Kaplan–Meyer analysis. Multivariable analysis was performed by the Cox regression model. As an alternative method to address the potential confounding factors, we performed a propensity-matched analysis adjusted for all variables included in the CRUSADE score. In the 1,911 consecutive patients with STEMI considered, bleeding (observed in 11.4% of patients) was an independent predictor of 30-day (hazard ratio 2.61, 95% confidence interval 1.30 to 5.25, p = 0.007) and 1-year mortality (hazard ratio 1.98, 95% confidence interval 1.13 to 3.47, p = 0.017) but not in a landmark analysis starting from 30 days to 1 year. Bleeding was significantly associated with higher 30-day and 1-year mortality in patients with Killip class ≥II, but not in patients with Killip class I. In conclusion, in-hospital bleeding is independently associated with increased mortality in the early period after STEMI, also after adjusting for variables associated with the risk of bleeding. Bleeding was associated with increased mortality in patients with signs of heart failure at admission, whereas it had no effects in patients with Killip class I.
Endothelial progenitor cell (EPC) mobilization has been reported following tissue damage, whereas no data are available regarding the mobilization of hematopoietic progenitor cells (HPCs). We ...performed the phenotypic and functional analysis of circulating CD34+ progenitor cells in patients with acute myocardial infarction (AMI), assessed from admission up to 60 days, in patients with stable angina pectoris (SA), and in healthy controls (CTRLs). In patients with AMI at admission (T0), the number of circulating CD34+ cells was higher (P < .001) than in CTRLs and became comparable with CTRLs within 60 days. Both the number of CD34+ cells coexpressing CD33, CD38, or CD117 and the number of HPCs was higher (P < .02 for all) in patients with AMI at T0 than in CTRLs, as was the number of hematopoietic colonies (P < .03). Patients with AMI (T0) had a significantly increased number of CD34+ vascular endothelial growth factor receptor 2–positive (VEGFR-2+) cells (P < .002) with respect to CTRLs, including CD34+ CD133+VEGFR-2+ and CD34+ CD117+VEGFR-2+ EPCs. The number of endothelial colonies was higher in patients with AMI (T0) than in CTRLs (P < .05). No significant difference was documented between patients with SA and CTRLs. Spontaneous mobilization of both HPCs and EPCs occurs within a few hours from the onset of AMI and is detectable until 2 months.
Structured Abstract Background The role of percutaneous mitral valve repair (PMVR) in patients with end-stage heart failure (HF) and functional mitral regurgitation (FMR) is unclear. Methods ...Seventy-five consecutive patients with FMR grade ≥ 3 + and severe HF symptoms despite optimal medical therapy and resynchronization therapy underwent PMVR with the MitraClip system (Abbott, Abbott Park, IL, USA) at 3 centers. Clinical evaluation, echocardiography and pro-BNP measurement were performed at baseline and 6-month. Results Mean age was 67 ± 11 years, logistic EuroSCORE = 23 ± 18%, left ventricle ejection fraction (LVEF) 30 ± 9%. In 6 patients (8%) PMVR was performed as a bridge to heart transplant; many patients were dependent from iv diuretics and/or inotropes. Rate of serious adverse in-hospital events was 1.3% (1 patient who died after conversion to cardiac surgery). Sixty-three patients (84%) were discharged with MR ≤ 2 +. At 6-month, 4 patients died (5%), 80% had MR ≤ 2 + and 75% were in New York Heart Association class ≤ II. Median pro-BNP decreased from 4395 pg/mL to 2594 pg/mL (p = 0.003). There were no significant changes in LV end-diastolic volume (222 ± 75 ml vs. 217 ± 79, p = 0.19), end-systolic volume (LVESV, 159 ± 66 ml vs. 157 ± 69, p = 0.54) and LVEF (30 ± 9% vs. 30 ± 12%, p = 0.86). Significant reverse remodeling (reduction of LVESV ≥ 10%) was observed in 25%, without apparent association with baseline characteristics. The number of hospitalizations for HF in comparison with the 6 months before PMVR were reduced from 1.1 ± 0.8 to 0.3 ± 0.6 (p < 0.001). Conclusions In extreme risk HF patients with FMR, PMVR improved symptoms and reduced re-hospitalization and pro-BNP levels at 6 months, despite the lack of LV reverse remodeling.
Background The optimal duration of dual antiplatelet therapy after coronary drug-eluting stent placement in adults with stable coronary artery disease (SCAD) versus acute coronary syndromes (ACS) ...remains uncertain. Methods and Results This was a prespecified subgroup analysis of the GLOBAL LEADERS trial. Participants were randomly assigned 1:1 to the experimental or reference strategy, stratified by ACS (experimental, n=3750; reference, n=3737) versus SCAD (experimental, n=4230; reference, n=4251). The experimental strategy was 75 to 100 mg aspirin daily plus 90 mg ticagrelor twice daily for 1 month, followed by 23 months of ticagrelor monotherapy. The reference strategy was 75 to 100 mg aspirin daily plus either 75 mg clopidogrel daily (for SCAD) or 90 mg ticagrelor twice daily (for ACS) for 12 months, followed by aspirin monotherapy for 12 months. The primary end point at 2 years was a composite of all-cause mortality or non-fatal centrally adjudicated new Q-wave myocardial infarction. The key secondary safety end point was site-reported Bleeding Academic Research Consortium grade 3 or 5 bleeding. The primary end point occurred in 147 (3.92%) versus 169 (4.52%) patients with ACS (rate ratio RR, 0.86; 95% CI, 0.69-1.08;
=0.189), and in 157 (3.71%) versus 180 (4.23%) patients with SCAD (RR, 0.87; 95% CI, 0.71-1.08;
=0.221) with experimental and reference strategy, respectively (
-interaction=0.926). Bleeding Academic Research Consortium grade 3 or 5 bleeding occurred in 73 (1.95%) versus 100 (2.68%) patients with ACS (RR, 0.73; 95% CI, 0.54-0.98;
=0.037), and in 90 (2.13%) versus 69 (1.62%) patients with SCAD (RR, 1.32; 95% CI, 0.97-1.81;
=0.081;
-interaction=0.007). Conclusions While there was no evidence for differences in efficacy between treatment strategies by subgroup, the experimental strategy appeared to reduce bleeding risk in patients with ACS but not in patients with SCAD. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01813435.
Background. The survival benefit of complete versus infarct-related artery (IRA)-only revascularization during the index hospitalization in patients resuscitated from an out-of-hospital cardiac ...arrest (OHCA) with multivessel disease is unknown. Methods. We considered all the OHCA patients prospectively enrolled in the Lombardia Cardiac Arrest Registry (Lombardia CARe) from 1 January 2015 to 1 May 2021 who underwent coronary angiography (CAG) at the Fondazione IRCCS Policlinico San Matteo (Pavia). Patients’ prehospital, angiographical and survival data were reviewed. Results. Out of 239 patients, 119 had a multivessel coronary disease: 69% received IRA-only revascularization, and 31% received a complete revascularization: 8 during the first procedure and 29 in a staged-procedure after a median time of 5 days IQR 2.5−10.3. The complete revascularization group showed significantly higher one-year survival with good neurological outcome than the IRA-only group (83.3% vs. 30.4%, p < 0.001). After correcting for cardiac arrest duration, shockable presenting rhythm, peak of Troponin-I, creatinine on admission and the need for circulatory support, complete revascularization was independently associated with the probability of death and poor neurological outcome HR 0.3 (95%CI 0.1−0.8), p = 0.02. Conclusions. This observation study shows that complete myocardial revascularization during the index hospitalization improves one-year survival with good neurological outcome in patients resuscitated from an OHCA with multivessel coronary disease.
Minimally invasive mitral valve repair has a favorable risk-benefit profile in patients with significant de novo mitral regurgitation. Its role in patients with prior mitral valve repair is ...uncertain. We aimed to appraise the outcome of patients undergoing transcatheter edge-to-edge repair (TEER) with prior transcatheter or surgical mitral valve repair (SMVR).
We queried the Italian multicenter registry on TEER with MitraClip, distinguishing naïve patients from those with prior TEER or (SMVR). Inhospital and long-term clinical/echocardiographic outcomes were appraised. The primary outcome was the occurrence of death or rehospitalization for heart failure. A total of 2238 patients were included, with 2169 (96.9%) who were naïve to any mitral intervention, 29 (1.3%) with prior TEER, and 40 (1.8%) with prior SMVR. Several significant differences were found in baseline clinical and imaging features. Respectively, device success was obtained in 2120 (97.7%), 28 (96.6%), and 38 (95.0%,
=0.261) patients; procedural success in 2080 (95.9%), 25 (86.2%), and 38 (95.0%;
=0.047); and inhospital death in 61 (2.8%), 1 (3.5%), and no (
=0.558) patients. Clinical follow-up after a mean of 14 months showed similar rates of death, cardiac death, rehospitalization, rehospitalization for heart failure, and their composite (all
>0.05). Propensity score-adjusted analysis confirmed unadjusted analysis, with lower procedural success for the prior TEER group (odds ratio, 0.28 95% CI, 0.09-0.81;
=0.019) but similar odds ratios and hazard ratios for all other outcomes in the naïve, TEER, and SMVR groups (all
>0.05).
In carefully selected patients, TEER can be performed using the MitraClip device even after prior TEER or SMVR.
Background Elderly patients have high ischemic and bleeding rates after acute coronary syndrome; however, the occurrence of these complications over time has never been studied. This study sought to ...characterize average daily ischemic rates ( ADIRs ) and average daily bleeding rates ( ADBRs ) over 1 year in patients aged >74 years with acute coronary syndrome undergoing percutaneous coronary intervention who were randomized in the Elderly ACS 2 trial, comparing low-dose prasugrel (5 mg daily) with clopidogrel (75 mg daily). Methods and Results ADIRs and ADBRs were calculated as the total number of events, including recurrent events, divided by the number of patient-days of follow-up and assessed within different clinical phases: acute (0-3 days), subacute (4-30 days), and late (31-365 days). Generalized estimating equations were used to test the least squares mean differences for the pairwise comparisons of ADIRs and ADBRs and the pairwise comparison of clopidogrel versus prasugrel effects. Globally, ADIRs were 2.6 times (95% CI, 2.4-2.9) higher than ADBRs . ADIRs were significantly higher in the clopidogrel arm than in the low-dose prasugrel arm in the subacute phase ( P
<0.001) without a difference in ADBRs ( P
=0.35). In the late phase, ADIRs remained significantly higher with clopidogrel ( P
<0.001), whereas ADBRs were significantly higher with low-dose prasugrel ( P
<0.001). Conclusions Ischemic burden was greater than bleeding burden in all clinical phases of 1-year follow-up of elderly patients with acute coronary syndrome treated with percutaneous coronary intervention. Low-dose prasugrel reduced ischemic events in the subacute and chronic phases compared with clopidogrel, whereas bleeding burden was lower with clopidogrel in the late phase. Clinical Trial Registration URL : http://www.clinicaltrials.gov . Unique identifier: NCT 01777503.
A 12-lead electrocardiogram (ECG) after the return of spontaneous circulation (ROSC) is recommended to diagnose a ST-segment elevation myocardial infarction (STEMI). In the early post-ROSC phase, the ...ECG can show signs of ischemia not necessarily of coronary origin and post-ROSC hypoperfusion could affect ECG reliability. We sought for an association between peripheral perfusion index (PI) values after ROSC and the percentage of false-positive ECG for STEMI.
We considered all the consecutive patients with sustained ROSC after OHCA, admitted to the Fondazione IRCCS Policlinico San Matteo (Pavia) between January 1st, 2015 and December 31st, 2020. ECGs were defined false-positive if meeting the STEMI criteria but without a critical obstructive coronary artery disease worthy of treatment. The mean value of PI over 30 min-monitoring (MPI30) were calculated.
Among 351 eligible patients post-ROSC ECG, PI monitoring and an invasive coronary angiography (ICA) were available in 84 cases. The rate of false positive was 16/54 (29.6%) and it differed significantly in the three MPI30 tertiles T1 (0.2–1): 28.6%; T2 (1.1–2.5): 24.1%; T3 (2.6–6.9): 3.7%, p = 0.04; p for trend = 0.02. Cardiac arrest duration OR 1.06 (95 %CI 1–1.1), p = 0.007 and MPI30 T3 vs T1: OR 0.09 (95 %CI 0.01–0.8), p = 0.03 were significantly associated with the probability of acquiring a false-positive ECG. This association was also confirmed when MPI30 was adjusted for cardiac arrest duration OR 0.2 (95 %CI 0.1–0.6), p=<0.001.
The rate of false-positive ECG for STEMI after ROSC is related with low perfusion. Our results could help to identify the adequate candidates for an immediate ICA.
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