Impact of Platelet Reactivity on Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus and Coronary Artery Disease Dominick J. Angiolillo, Esther Bernardo, Manel Sabaté, Pilar ...Jimenez-Quevedo, Marco A. Costa, Jorge Palazuelos, Rosana Hernández-Antolin, Raul Moreno, Javier Escaned, Fernando Alfonso, Camino Bañuelos, Luis A. Guzman, Theodore A. Bass, Carlos Macaya, Antonio Fernandez-Ortiz Type 2 diabetes mellitus (T2DM) patients have increased platelet reactivity compared with nondiabetic patients. Whether high platelet reactivity (HPR) assessed in T2DM patients while in their steady-state phase of dual antiplatelet therapy is associated with an increased risk of major adverse cardiovascular events (MACE) is unknown. Platelet function analyses were performed in 173 T2DM patients on chronic dual antiplatelet therapy. At 2 years, a total of 41 MACE occurred in 19.7% of patients. High platelet reactivity was the strongest independent predictor of MACE (p = 0.001). Patients with HPR had up-regulation of multiple platelet signaling pathways, indicative of global platelet hyperreactivity. Type 2 diabetes mellitus patients with HPR may warrant more potent antithrombotic treatment.
Summary Background Two large trials have reported contradictory results at 1 year after thrombus aspiration in ST elevation myocardial infarction (STEMI). In a 1-year follow-up of the largest ...randomised trial of thrombus aspiration, we aimed to clarify the longer-term benefits, to help guide clinical practice. Methods The trial of routine aspiration ThrOmbecTomy with PCI versus PCI ALone in Patients with STEMI (TOTAL) was a prospective, randomised, investigator-initiated trial of routine manual thrombectomy versus percutaneous coronary intervention (PCI) alone in 10 732 patients with STEMI. Eligible adult patients (aged ≥18 years) from 87 hospitals in 20 countries were enrolled and randomly assigned (1:1) within 12 h of symptom onset to receive routine manual thrombectomy with PCI or PCI alone. Permuted block randomisation (with variable block size) was done by a 24 h computerised central system, and was stratified by centre. Participants and investigators were not masked to treatment assignment. The trial did not show a difference at 180 days in the primary outcome of cardiovascular death, myocardial infarction, cardiogenic shock, or heart failure. However, the results showed improvements in the surrogate outcomes of ST segment resolution and distal embolisation, but whether or not this finding would translate into a longer term benefit remained unclear. In this longer-term follow-up of the TOTAL study, we report the results on the primary outcome (cardiovascular death, myocardial infarction, cardiogenic shock, or heart failure) and secondary outcomes at 1 year. Analyses of the primary outcome were by modified intention to treat and only included patients who underwent index PCI. This trial is registered with ClinicalTrials.gov , number NCT01149044. Findings Between Aug 5, 2010, and July 25, 2014, 10 732 eligible patients were enrolled and randomly assigned to thrombectomy followed by PCI (n=5372) or to PCI alone (n=5360). After exclusions of patients who did not undergo PCI in each group (337 in the PCI and thrombectomy group and 331 in the PCI alone group), the final study population comprised 10 064 patients (5035 thrombectomy and 5029 PCI alone). The primary outcome at 1 year occurred in 395 (8%) of 5035 patients in the thrombectomy group compared with 394 (8%) of 5029 in the PCI alone group (hazard ratio HR 1·00 95% CI 0·87–1·15, p=0·99). Cardiovascular death within 1 year occurred in 179 (4%) of the thrombectomy group and in 192 (4%) of 5029 in the PCI alone group (HR 0·93 95% CI 0·76–1·14, p=0·48). The key safety outcome, stroke within 1 year, occurred in 60 patients (1·2%) in the thrombectomy group compared with 36 (0·7%) in the PCI alone group (HR 1·66 95% CI 1·10–2·51, p=0·015). Interpretation Routine thrombus aspiration during PCI for STEMI did not reduce longer-term clinical outcomes and might be associated with an increase in stroke. As a result, thrombus aspiration can no longer be recommended as a routine strategy in STEMI. Funding Canadian Institutes of Health Research, Canadian Network and Centre for Trials Internationally, and Medtronic Inc.
Background A major limitation of primary percutaneous coronary intervention (PPCI) for the treatment of ST-elevation myocardial infarction (STEMI) is impaired microvascular perfusion due to ...embolization and obstruction of microcirculation with thrombus. Manual thrombectomy has the potential to reduce distal embolization and improve microvascular perfusion. Clinical trials have shown mixed results regarding thrombectomy. Objective The objective of this study is to evaluate the efficacy of routine upfront manual aspiration thrombectomy during PPCI compared with percutaneous coronary intervention alone in patients with STEMI. Design This is a multicenter, prospective, open, international, randomized trial with blinded assessment of outcomes. Patients with STEMI undergoing PPCI are randomized to upfront routine manual aspiration thrombectomy with the Export catheter (Medtronic CardioVascular, Santa Rosa, CA) or to percutaneous coronary intervention alone. The primary outcome is the composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening New York Heart Association class IV heart failure up to 180 days. The trial uses an event-driven design and will recruit 10,700 patients. Summary The TOTAL trial will determine the effect of routine manual aspiration thrombectomy during PPCI on clinically important outcomes.
Objectives This study sought to evaluate the impact of SYNTAX score (SXscore), and compare its performance in isolation and combination with the PAMI (The Primary Angioplasty in Myocardial Infarction ...Study) score, for the prediction of 1-year clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention. Background Patients with STEMI were excluded from the original SYNTAX score (SXscore) algorithm. Therefore, the utility of using the SXscore in this patient group remains undefined. Methods SXscore was calculated retrospectively in 807 patients with STEMI enrolled in the randomized STRATEGY (Single High-Dose Bolus Tirofiban and Sirolimus-Eluting Stent Versus Abciximab and Bare-Metal Stent in Acute Myocardial Infarction) and MULTISTRATEGY (Multicenter Evaluation of Single High-Dose Bolus Tirofiban Versus Abciximab With Sirolimus-Eluting Stent or Bare-Metal Stent in Acute Myocardial Infarction Study) clinical trials. Clinical outcomes of all-cause death, reinfarction, and clinically driven target vessel revascularization were subsequently stratified according to SXscore tertiles: SXLOW ≤9 (n = 311), 9 < SXMID ≤16 (n = 234), SXHIGH >16 (n = 262). Results At 1-year follow-up, all clinical outcomes including mortality, mortality/reinfarction, major adverse cardiac events (MACE) (a composite of all-cause death, reinfarction and target vessel revascularization), and definite, definite/probable, and any stent thrombosis were all significantly higher in patients in the highest SXscore tertile. SXscore was identified as an independent predictor of mortality, MACE, and stent thrombosis out to 1-year follow-up. The combination SYNTAX-PAMI score led to a net reclassification improvement of 15.7% and 4.6% for mortality and MACE, respectively. The C-statistics for the SXscore, PAMI score, and the combined SYNTAX-PAMI score were 0.65, 0.81, and 0.73 for 1-year mortality, and 0.68, 0.64, and 0.69 for 1-year MACE, respectively. Conclusions SXscore does have a role in the risk stratification of patients with STEMI having primary percutaneous coronary intervention; however, this ability can be improved through a combination with clinical variables. (Multicentre 2×2 Factorial Randomised Study Comparing Tirofiban Versus Abciximab and SES Versus BMS in AMI; NCT00229515 )
Treatment of patients with drug-eluting stent (DES) in-stent restenosis (ISR) is particularly challenging. We sought to compare results of drug-eluting balloons in patients with DES-ISR with those in ...patients with bare-metal stent (BMS) ISR. A pooled analysis of the Restenosis Intra-Stent: Drug-Eluting Balloon versus Everolimus-Eluting Stent IV and V randomized trials was performed. Both trials had identical inclusion and exclusion criteria. Results of drug-eluting balloons in 95 patients with BMS-ISR and 154 patients with DES-ISR were compared. Patients with DES-ISR were more frequently diabetics, presented more often as an acute coronary syndrome and had more severe lesions and more frequently a focal pattern, including edge-ISR. Late angiographic findings (92% of eligible patients), including minimal lumen diameter (1.80 ± 0.6 vs 2.01 ± 0.6 mm, p = 0.001; absolute mean difference 0.21 mm; 95% confidence interval 0.04 to 0.38; p = 0.014) and restenosis rate (19% vs 9.5%, p <0.05) were poorer in DES-ISR. Results were consistent across 10 prespecified subgroups. Moreover, on multiple linear regression analysis, minimal lumen diameter at follow-up remained significantly smaller in patients with DES-ISR after adjusting for potential confounders ( adjusted absolute mean difference 0.17 mm; 95% confidence interval 0.04 to 0.41; p = 0.019). Finally, at 1-year clinical follow-up (100% of patients), rates of target vessel revascularization (16% vs 6%, p = 0.02) and of the main combined clinical end point (18% vs 8%, p = 0.03) were significantly higher in patients treated for DES-ISR. In conclusion, this study confirms the efficacy of DEB for patients with ISR. However, the long-term clinical and angiographic results of DEB are poorer in patients with DES-ISR than in those with BMS-ISR. ( ClinicalTrials.gov Identifier: NCT01239953 & NCT01239940 ).
Delayed endothelization and late vessel remodeling might stimulate thrombus deposition and DES thrombosis especially in "real-world" situations (1-2). ...a prolonged dual antiplatelet regimen has ...been advocated in these patients (1-2). ...our findings underscore the critical role of IVUS to guide repeated procedures in this challenging setting.
Abstract Intraoperative iatrogenic type A aortic dissection is a rare but known complication of cardiac surgery, with an incidence of 0.06% to 0.23%. Results are frequently catastrophic. The ...endovascular approach has made advances as an alternative treatment for aortic disease. However, the apical approach for transcatheter thoracic endovascular aortic repair is not well known. We present a 5-year follow-up of a case of iatrogenic type A aortic dissection after minimally invasive mitral valve repair successfully resolved by medical stabilization and subsequent transapical thoracic endovascular aortic repair.
Objectives This study sought to compare the efficacy of drug-eluting balloons (DEB) with that of everolimus-eluting stents (EES) in patients with bare-metal stents (BMS) in-stent restenosis (ISR). ...Background Treatment of patients with ISR remains a challenge. Methods This was a prospective, multicenter, randomized trial comparing DEB with EES in patients with bare-metal stents (BMS) in-stent restenosis (ISR). The primary endpoint was the minimal lumen diameter at 9 months' follow-up. Results A total of 189 patients with BMS-ISR from 25 Spanish sites were included (95 were allocated to DEB and 94 to EES). Procedural success was achieved in all patients. At late angiography (median 249 days; 92% of eligible patients), patients in the EES arm had a significantly larger minimal lumen diameter (2.36 ± 0.6 mm vs. 2.01 ± 0.6 mm, p < 0.001; absolute mean difference: 0.35 mm; 95% confidence interval CI: 0.16 to 0.53) and a lower percent of diameter stenosis (13 ± 17% vs. 25 ± 20%, p < 0.001). However, late loss (0.04 ± 0.5 mm vs. 0.14 ± 0.5 mm, p = 0.14) and binary restenosis rate (4.7% vs. 9.5%, p = 0.22) were very low and similar in both groups. Clinical follow-up (median 365 days) was obtained in all (100%) patients. Occurrences of the combined clinical outcome measure (cardiac death, myocardial infarction, and target vessel revascularization; 6% vs. 8%; hazard ratio HR: 0.76; 95% CI: 0.26 to 2.18, p = 0.6) and the need for target vessel revascularization (2% vs. 6%; HR: 0.32: 95% CI: 0.07 to 1.59, p = 0.17) were similar in the 2 groups. Conclusions In patients with BMS-ISR, both DEB and EES provided excellent clinical results with a very low rate of clinical and angiographic recurrences. However, compared with DEB, EES provide superior late angiographic findings. (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs. Everolimus-eluting Stent RIBS V; NCT01239953 )
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