30-day Net Adverse Clinical Events Research Articles

Comparison of Safety and Effectiveness of Bivalirudin Between Diabetic and Nondiabetic Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention

Background: Recurrent thrombotic events remain significantly high in spite of the currently recommended dual antiplatelet (DAPT) and conventional antithrombotic heparin (± GPI/ glycoprotein IIb/IIIa inhibitor) in diabetic ACS patients after PCI compared with non-diabetic even this drug eluting stent (DES) era. Therefore, more potent antithrombotic therapies are warranted for this group of high-risk patients.Comparison of safety and efficacy of newer anticoagulant bivalirudin between diabetic and non-diabetic ACS patients undergoing PCI using bivalirudin versus heparin (± GPI) is less well defined in Bangladeshi population. Objective: To determine and compare the incidence of 30-day major adverse cardiac events (MACEs), stent thrombosis and hemorrhagic complications between diabetic and non-diabetic ACS patients undergoing PCI. Impact of antithrombotic strategy (bivalirudin vs. heparin ± GPI) on the 30- day post PCI clinical outcome was also evaluated and compared between diabetic and non-diabetic subgroup. Methods: In this randomized controlled study, 500 ACS patients aged 18-75 years (200diabetic and 300 non-diabetics) who underwent PCI from November 2018 to October 2019 at the department of cardiology, BSMMU, were randomly assigned, in an open-label fashion to treatment with bivalirudin alone, heparin alone, or heparin plus eptifibatide (GPI) in a 1:1:1 ratio. Among them, 200 patients received Bivalirudin with a loading dose of 0.75 mg/kg, followed by an infusion of 1.75 mg/kg/h for up to 4 hours, 153 patients received UFH with a bolus of 70-100 U/kg (targeted ACT: 200-250 s) and 147 patients got heparin plus eptifibatide as 60 IU/kg heparin along with 180 μg/kg eptifibatide i.v. boluses, followed by a 2 μg /kg /min eptifibatide infusion for 18 hr consistent with current guidelines.Other pre- and post-procedural medications got under current guidelines. Both diabetic and non-diabetic subjects were subdivided into bivalirudin and control group (heparin ± GPI). In diabetic cohort, 100 patients were in bivalirudin and 100 patients were in control group. Among non -diabetic patients, 100 were in bivalirudin and 200 were in control group. The outcome measures were 30-day hemorrhagic complications, stent thrombosis, and MACCEs [death, MI, target lesion revascularization (TLR), and stroke] according to diabetic status. The diabetic and non-diabetic subgroup was also analyzed for the same outcome measure according to antithrombotic strategy. Peri and post PCI clinical follow-up comprised checking office visits and telephone contacts. Results: According to diabetic status, net adverse clinical events (NACEs) were significantly higher in diabetic in comparison to non-diabetic (diabetic vs. non-diabetic, 15% vs. 7.6 %, P=0.008) and was associated with higher incidence of MACCEs (10.5% vs. 4.0%, P=0.004), cardiac death (4 % vs. 1 %, P=0.02) and BARC 2,3,5 grade bleeding events (9% vs. 4 %, P=0.02). In diabetic cohort, incidence of 30-day NACEs was significantly lower in bivalirudin than control group(bivalirudin vs. UFH ± GPI, 6 % vs. 24 %, P=0.004) and was associated with lower incidence of MACCEs (2% vs. 8.5%, P=0.03) and bleeding events (3 % vs. 15 %, P=0.003) whereas incidence of stent thrombosis (2 % vs. 3%, P =0.651) was comparable between the bivalirudin and control groups. There was a significant advantage in favor of bivalirudin treatment among insulin-treated patients with regard to cardiac death at 30-day (bivalirudin vs. control group, 0% vs. 16.6%, p = 0.03) compared with non-insulin treat diabetic patients. However, subgroup analysis of the nondiabetic patients showed that there was no significant difference in the incidence of 30-Day NACEs (4% vs. 9.5%, P=0.09) according anticoagulant status. Multivariate analysis showed that bivalirudin (HR: 0. 202, 95% CI: 0.078 – 0.519, P=0.009) was independent protective factor of 30-day NACEs for diabetic patients. Conclusion: Bivalirudin monotherapy is safer and more efficacious for diabetic ACS patients compared with non-diabetic ACS patients undergoing PCI. J Dhaka Med Coll. 2022; 31(1) : 126-136

Bivalirudin vs. heparin on a background of ticagrelor and aspirin in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: A multicenter prospective cohort study.

Current guidelines recommend potent P2Y12 inhibitors such as ticagrelor over clopidogrel as part of the dual antiplatelet therapy (DAPT) after ST-segment elevation myocardial infarction (STEMI), irrespective of final management strategy. The aim of this multicenter prospective cohort study was to examine the efficacy and safety of bivalirudin with background ticagrelor and aspirin therapy in patients with STEMI undergoing primary percutaneous coronary intervention (PPCI). A total of 800 patients with STEMI who were undergoing PPCI and receiving treatment with aspirin and ticagrelor from three Hospitals between April 2019 and September 2021 were included in this study. The patients were assigned, according to the perioperative anticoagulant, to the bivalirudin group (n = 456) or the heparin group (n = 344). In this study, the primary endpoint was 30-day net adverse clinical events (NACEs), a composite of major adverse cardiac or cerebral events (MACCEs, a composite of cardiac death, recurrent myocardial infarction, ischemia-driven target vessel revascularization, or stroke), or any bleeding as defined by the Bleeding Academic Research Consortium (BARC) definition (grades 1-5). The patients were followed up for 30 days after PPCI. The incidence of NACE was significantly lower in the bivalirudin group than in the heparin group (11.2 vs. 16.0%, P = 0.042), and this significance was mainly a consequence of the reduction in BARC 1 bleeding events in the bivalirudin group compared to the heparin group (3.2 vs. 7.1%, P = 0.010). Results from multivariate Cox regression analysis showed that bivalirudin significantly reduced 30-day NACE (HR: 0.676, 95% CI: 0.462-0.990, P = 0.042) and BARC1 bleeding events (HR: 0.429, 95% CI: 0.222-0.830, P = 0.010). No significant between-group differences were observed for MACCE, all-cause mortality, cardiac death, recurrent myocardial infarction, stroke, target vessel revascularization, stent thrombosis, and BARC2-5 bleeding events at 30 days. In patients with STEMI who were undergoing primary PCI and receiving treatment with aspirin and ticagrelor, bivalirudin was associated with decreased rates in NACE and minimal bleeding events without significant differences in the rates of MACCE or stent thrombosis when compared with heparin. Nevertheless, large randomized trials are warranted to confirm these observations. The trial was registered at the Chinese Clinical Trial Registry (ChiCTR, http://www.chictr.org.cn; identifier [ChiCTR1900022529]). Registered on 15 April 2019. Registration title: Effect of bivalirudin combined with ticagrelor in patients with ST-segment elevation myocardial infarction during primary percutaneous coronary intervention.

Efficacy and safety of bivalirudin application during primary percutaneous coronary intervention in older patients with acute ST-segment elevation myocardial infarction.

ObjectiveST-segment elevation myocardial infarction (STEMI) is the most serious type of acute coronary syndrome. This study aimed to investigate the efficacy and safety of bivalirudin application during primary percutaneous coronary intervention (PPCI) in older patients with acute STEMI.MethodsA total of 672 older patients with STEMI (>75 years) who underwent PPCI were studied. The primary endpoints were 30-day net adverse clinical events (NACEs) post-emergency percutaneous coronary intervention, including major adverse cardiac and cerebrovascular events (MACCEs) and Bleeding Academic Research Consortium grades 2 to 5 (BARC 2–5) bleeding events.ResultsThe incidence of NACEs and BARC 2–5 bleeding events in the bivalirudin group was significantly lower than that in the unfractionated heparin group. Multivariate Cox regression analysis showed that bivalirudin significantly reduced 30-day NACEs (odds ratio: 0.700, 95% confidence interval: 0.492–0.995) and BARC 2–5 bleeding events (odds ratio: 0.561, 95% confidence interval: 0.343–0.918). At 1-year follow-up, these results were similar.ConclusionsBivalirudin can be safely and effectively used during PPCI in older patients with STEMI. Bivalirudin reduces the risks of NACEs and bleeding within 30 days after PPCI, without increasing the risks of MACCEs and stent thrombosis compared with heparin.

Meta-analysis of bivalirudin versus heparin in transradial coronary interventions.

We sought to evaluate the efficacy and safety of bivalirudin versus heparin in patients with coronary artery disease undergoing transradial artery coronary intervention (TRI). Bivalirudin and radial artery access are independently associated with improved cardiovascular outcomes. However, data supporting a strategy of combining both to achieve additive improvements in cardiovascular outcomes provide conflicting results. A systematic search was performed to identify randomized controlled trials (RCTs) of bivalirudin, in which vascular access sites were reported. The primary outcome was net adverse clinical events (NACE) at 30 days. Secondary outcomes were long-term NACE, short-, and long-term major adverse cardiovascular events, all-cause mortality, myocardial infarction, unplanned revascularization, stent thrombosis, and major bleeding. We identified 10 RCTs, including 16,328 patients who underwent TRI (mean age 64.6 ± 15.7 years, 72.5% male). Bivalirudin use was associated with decreased 30-day NACE compared with heparin (6.3 vs. 7.4%; risk ratio [RR] = 0.87; 95% confidence interval [CI] = 0.76-0.99; p = .04; number needed to treat = 91). No significant interactions were observed based on clinical presentation, administration of P2Y12 inhibitors, or glycoprotein IIb/IIIa-receptor inhibitors (GPI) use. There were no significant differences between groups in any prespecified secondary outcomes. There was, however, a significant reduction of major bleeding in the bivalirudin group compared with heparin when used in combination with routine GPI (RR = 0.41; 95% CI = 0.19-0.90; p = .03). Among patients undergoing TRI, use of bivalirudin was associated with significantly reduced 30-day NACE compared with heparin. There was no significant difference in long term NACE, ischemic, or bleeding events compared with heparin.

Comparison short time discharge with long time discharge following uncomplicated percutaneous coronary intervention for Non-ST elevation myocardial infarction patients

BackgroundThe rational length of stay following non-complicated percutaneous coronary intervention (PCI) for Non-ST elevation myocardial infarction (NSTEMI) patients remains controversial. Few studies have examined the impact of early discharge on short-term outcomes in NSTEMI patients, but short-time discharge is not uncommon in real world practice. This study examined the impact of short time discharge following non-complicated PCI on 30-day net adverse clinical events in NSTEMI patients.MethodsThis retrospective study enrolled 1424 consecutive patients with NSTEMI diagnoses who underwent non-complicated PCI. Of these patients, 432 were discharged early (< 24 h), whereas the remaining 992 NSTEMI patients underwent routine discharge. The primary end points of the study were the net adverse clinical events including major adverse cardiac or cerebral events or access site vascular/bleeding complications within 30 days. The differences between the two groups were analyzed after propensity score matching to reduce selection bias.ResultsThe incidence of crude 30-day net adverse events was numerically higher in the long-time discharge group at 11.6% (115/992) compared with 8.6% (37/432) in the short-time discharge group, although this difference was not significant (P = 0.09). This difference was mainly due to lesser radial access selected in the long-time discharge group (827/932, 83.4% vs. 387/432, 89.5%, P < 0.0005). After PS matching to balance the access difference, there was no significant difference in the incidence of the events mentioned above between two groups.ConclusionsIf an NSTEMI patient undergoes PCI without any procedural or hospital complications, short-time discharge after successful PCI would be feasible and safe in selected NSTEMI patients.

A large-scale, multicenter, retrospective study on efficacy of bivalirudin use during peri-percutaneous coronary intervention period for Chinese patients with coronary heart disease

To observe the efficacy and safety of bivalirudin use in Chinese patients with coronary heart disease (CHD) during the peri-percutaneous coronary intervention(PCI) period. A total of 3 271 patients who underwent PCI and received periprocedural bivalirudin treatment between July 2013 and October 2015 from 88 centers of China were involved in this study. The primary outcome was 30-day net adverse clinical events (NACE a composite of major adverse cardiac or cerebral events (MACE, all-cause death, reinfarction, urgent target vessel revascularization, or stroke) or bleeding), the secondary outcome was stent thrombosis at 30 days. The mean age of enrolled patients was (65.12±12.44) years old, 27.4%(889/3 244) of them were female. Percent of stable coronary disease (SCD), non-ST segment elevation acute coronary syndrome (NSTE-ACS) and ST elevation myocardial infarction (STEMI) was 5.0%(162/3 248), 44.6%(1 450/3 248) and 50.4%(1 636/3 248) respectively. Radial access was performed in 89.5% (2 879/3 271) patients, and 9.7% (316/3 271) and 34.1% (1 115/3 271) patients also received ticagrelor and tirofiban medication. 69.3% (2 266/3 271) patients received post-procedural bivalirudin infusion, in which 46.3% (1 050/2 266) was treated at PCI-does, with a median duration of 2.5(1.0, 4.0) h. During the 30-day follow-up, NACE occurred in 3.45% (103/2 988) patients, the incidence of MACE, death was 2.17% (65/2 994) and 1.03% (31/3 017), respectively and bleeding events were recorded in 1.37% (41/2 996) patients. Four cases (0.13%) of stent thrombosis (3 acute stent thrombosis) were recorded. Peri-PCI Bivalirudin use is safe and related with low bleeding risk in Chinese CHD patients.

Bridge therapy or standard treatment for urgent surgery after coronary stent implantation: Analysis of 314 patients

Intravenous administration of a short acting glycoprotein IIb/IIIa inhibitor has been proposed as a bridge to surgery in patients on dual antiplatelet treatment, but data in comparison with other treatment options are not available. We conducted a retrospective analysis of consecutive patients who underwent un-deferrable, non-emergency surgery after coronary stenting. The bridge therapy was performed after discontinuation of the oral P2Y12 inhibitor by using i.v. tirofiban infusion. Net Adverse Clinical Events (NACE) was the primary outcome.We analyzed 314 consecutive patients: the bridge strategy was performed in 87 patients, whereas 227 were treated with other treatment options and represent the control group. Thirty-day NACE occurred in 8% of patients in the bridge group and in 22.5% in the control group (p<0.01). Bridge therapy was associated with decreased 30-day NACE rate [Odds ratio (OR) 0.30; 95% confidence interval (CI) 0.13–0.39; p<0.01], particularly when the time interval between stenting and surgery was ≤60days (OR 0.09, 95% CI 0.01–0.72; p=0.02). There were no cases of stent thrombosis in the bridge group and 3 (1.3%) in the control group. Bridge therapy was associated with decreased events rates as compared to both patients with and without P2Y12 inhibitors discontinuation in the control group. After adjustment for the most relevant covariates, the favorable effect of the bridge therapy was not materially modified.In conclusion, perioperative bridge therapy using tirofiban was associated with reduced 30-day NACE rate, particularly when surgery was performed within 60days after stent implantation.

Bivalirudin Versus Heparin Anticoagulation in Transcatheter Aortic Valve Replacement: The Randomized BRAVO-3 Trial

BackgroundAnticoagulation is required during transcatheter aortic valve replacement (TAVR) procedures. Although an optimal regimen has not been determined, heparin is mainly used. Direct thrombin inhibition with bivalirudin may be an effective alternative to heparin as the procedural anticoagulant agent in this setting. ObjectivesThe goal of this study was to determine whether bivalirudin offers an alternative to heparin as the procedural anticoagulant agent in patients undergoing TAVR. MethodsA total of 802 patients with aortic stenosis were randomized to undergo transfemoral TAVR with bivalirudin versus unfractionated heparin during the procedure. The 2 primary endpoints were major bleeding within 48 h or before hospital discharge (whichever occurred first) and 30-day net adverse clinical events, defined as the combination of major adverse cardiovascular events (all-cause mortality, myocardial infarction, or stroke) and major bleeding. ResultsAnticoagulation with bivalirudin versus heparin did not meet superiority because it did not result in significantly lower rates of major bleeding at 48 h (6.9% vs. 9.0%; relative risk: 0.77; 95% confidence interval [CI]: 0.48 to 1.23; p = 0.27) or net adverse cardiovascular events at 30 days (14.4% vs. 16.1%; relative risk: 0.89; 95% CI: 0.64 to 1.24; risk difference: –1.72; 95% CI: –6.70 to 3.25; p = 0.50); regarding the latter, the prespecified noninferiority hypothesis was met (pnoninferiority < 0.01). Rates of major adverse cardiovascular events at 48 h were not significantly different (3.5% vs. 4.8%; relative risk: 0.73; 95% CI: 0.37 to 1.43; p = 0.35). At 48 h, the bivalirudin group had significantly fewer myocardial infarctions but more acute kidney injury events than the heparin group; at 30 days, these differences were no longer significant. ConclusionsIn this randomized trial of TAVR procedural pharmacotherapy, bivalirudin did not reduce rates of major bleeding at 48 h or net adverse cardiovascular events within 30 days compared with heparin. Although superiority was not shown, the noninferiority hypothesis was met with respect to the latter factor. Given the lower cost, heparin should remain the standard of care, and bivalirudin can be an alternative anticoagulant option in patients unable to receive heparin in TAVR. (International, Multi-center, Open-label, Randomized Controlled Trial in Patients Undergoing TAVR to Determine the Treatment Effect [Both Safety and Efficacy] of Using Bivalirudin Instead of UFH [BRAVO-2/3]; NCT01651780)

Impact 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.

Radial versus femoral approach comparison in percutaneous coronary intervention with intraaortic balloon pump support: The RADIAL PUMP UP Registry

The role of intraaortic balloon pump (IABP) during percutaneous coronary intervention (PCI) in high-risk acute patients remains debated. Device-related complications and the more complex patient management could explain such lack of clinical benefit. We aimed to assess the impact of transradial versus transfemoral access for PCI requiring IABP support on vascular complications and clinical outcome. We retrospectively analyzed 321 consecutive patients receiving IABP support during transfemoral (n = 209) or transradial (n = 112) PCI. Thirty-day net adverse clinical events (NACEs) (composite of postprocedural bleeding, cardiac death, myocardial infarction, target lesion revascularization, and stroke) were the primary end point, with access-related bleeding and hospital stay as secondary end points. Cardiogenic shock and hemodynamic instability were the most common indications for IABP support. Cumulative 30-day NACE rate was 50.2%, whereas an access site-related bleeding occurred in 14.3%. Patients undergoing transfemoral PCI had a higher unadjusted rate of NACEs when compared with the transradial group (57.4% vs 36.6%, P < .01), mainly due more access-related bleedings (18.7% vs 6.3%, P < .01). Such increased risk of NACEs was confirmed after propensity score adjustment (hazard ratio 0.57 [0.4-0.9], P = .007), whereas hospital stay appeared comparable in the 2 groups. In this observational registry, high-risk patients undergoing PCI and requiring IABP support appeared to have fewer NACEs if transradial access was used instead of transfemoral, mainly due to fewer access-related bleedings. Given the inherent limitations of this retrospective work, including the inability to adjust for unknown confounders, further controlled studies are warranted to confirm or refute these findings.

Radial Versus Femoral Randomized Investigation in ST-Segment Elevation Acute Coronary Syndrome: The RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) Study

The purpose of this study was to assess whether transradial access for ST-segment elevation acute coronary syndrome undergoing early invasive treatment is associated with better outcome compared with conventional transfemoral access. In patients with acute coronary syndrome, bleeding is a significant predictor of worse outcome. Access site complications represent a significant source of bleeding for those patients undergoing revascularization, especially when femoral access is used. The RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) was a multicenter, randomized, parallel-group study. Between January 2009 and July 2011, 1,001 acute ST-segment elevation acute coronary syndrome patients undergoing primary/rescue percutaneous coronary intervention were randomized to the radial (500) or femoral (501) approach at 4 high-volume centers. The primary endpoint was the 30-day rate of net adverse clinical events (NACEs), defined as a composite of cardiac death, stroke, myocardial infarction, target lesion revascularization, and bleeding). Individual components of NACEs and length of hospital stay were secondary endpoints. The primary endpoint of 30-day NACEs occurred in 68 patients (13.6%) in the radial arm and 105 patients (21.0%) in the femoral arm (p = 0.003). In particular, compared with femoral, radial access was associated with significantly lower rates of cardiac mortality (5.2% vs. 9.2%, p = 0.020), bleeding (7.8% vs. 12.2%, p = 0.026), and shorter hospital stay (5 days first to third quartile range, 4 to 7 days] vs. 6 [range, 5 to 8 days]; p = 0.03). Radial access in patients with ST-segment elevation acute coronary syndrome is associated with significant clinical benefits, in terms of both lower morbidity and cardiac mortality. Thus, it should become the recommended approach in these patients, provided adequate operator and center expertise is present. (Radial Versus Femoral Investigation in ST Elevation Acute Coronary Syndrome [RIFLE-STEACS]; NCT01420614)

A Therapeutic Window for Platelet Reactivity for Patients Undergoing Elective Percutaneous Coronary Intervention: Results of the ARMYDA-PROVE (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty–Platelet Reactivity for Outcome Validation Effort) Study

This study sought to validate the ability of the VerifyNow P2Y12 assay (Accumetrics, San Diego, California) in predicting both ischemic and bleeding events after elective percutaneous coronary intervention (PCI). High and low levels of platelet reactivity are associated with ischemic and bleeding events, respectively, after PCI. A total of 732 patients on dual antiplatelet therapy undergoing elective PCI were recruited. Platelet reactivity was measured before PCI. The primary endpoint was the 30-day incidence of net adverse clinical events (NACE), defined as the occurrence of ischemic or bleeding events, in relation to P2Y(12) reaction unit (PRU) distribution. At receiver-operating characteristic curve analysis, PRU values could significantly discriminate between patients with and without bleeding events (area under the curve [AUC]: 0.72; 95% confidence interval [CI]: 0.65 to 0.80; p < 0.0001) and those with and without ischemic events (AUC: 0.68; 95% CI: 0.61 to 0.76; p < 0.0001). The optimal cutoffs for bleeding (PRU ≤ 178) and ischemic events (PRU ≥ 239) were used to define 3 groups: low platelet reactivity (LPR) (LPR = PRU ≤ 178), normal platelet reactivity (NPR) (NPR = PRU 179 to 238), and high platelet reactivity (HPR) (HPR = PRU ≥ 239). The incidence of NACE was 14.1% in the LPR group, 7.8% in the NPR group (p = 0.025 vs. LPR group), and 15.4% in the HPR group (p = 0.005 vs. NPR group). At multivariate analysis, PRU values in the NPR group were an independent predictor of reduced risk of 30-day NACE (odds ratio: 0.47, 95% CI: 0.27 to 0.81). A therapeutic window for platelet reactivity measured with the VerifyNow P2Y12 assay can be identified using specific thresholds that define a group of patients at lower risk for both ischemic and bleeding events. Adjunctive measures may be beneficial in patients with higher or lower platelet reactivity in order to improve clinical outcomes after PCI.

The Impact of Age on Effects of Pre-hospital Initiation of High Bolus Dose of Tirofiban Before Primary Angioplasty for ST-Elevation Myocardial Infarction

Glycoprotein IIb/IIIa inhibitors are favourable in ST-elevation myocardial infarction (STEMI) patients, and the additional value of early pre-hospital high bolus dose tirofiban has recently been established. The aim of this study was to determine the impact of age on myocardial reperfusion and clinical outcomes of pre-hospital administration of high bolus dose tirofiban. This is a pre-specified sub-analysis of the multicentre, double-blind, placebo-controlled, randomised On-TIME 2 trial and it's open label phase. The primary endpoint was mean residual ST segment deviation 1h after primary PCI and was evaluated in three age groups. Of the 466 patients in the highest tertile (≥68years), median age was 74.4years (IQR 71.3-78.6years) and 231 (50%) were randomised to tirofiban. Mean residual ST segment deviation 1 h after PCI was significantly lower in elderly patients pre-treated with tirofiban compared to elderly patients without tirofiban pre-treatment (4.2 ± 5.2mm vs 6.4 ± 7.5mm, p = 0.001). Furthermore, elderly patients pre-treated with tirofiban had a non-significantly higher rate of 30-day major or minor bleeding compared to elderly patients without tirofiban pre-treatment (14.2% vs 9.0%, p = 0.088). 30-day net adverse clinical events in elderly patients with- or without tirofiban was not significantly different (11.9% vs 15.2%, p = 0.300). The effect of pre-hospital initiation of high bolus dose tirofiban on myocardial reperfusion, as determined by ST-segment resolution is highest in the elderly patients. However, this was associated with a trend towards more bleeding complications, resulting in a balanced clinical effect after 30-day follow-up. Future studies should evaluate whether the elderly STEMI patient may benefit from highly effective and safer antiplatelet therapy.

Impact of baseline thrombocytopenia on the early and late outcomes after ST-elevation myocardial infarction treated with primary angioplasty: Analysis from the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial

Thrombocytopenia (TP) is a common abnormality in patients presenting with acute coronary syndrome. Whether baseline TP has any influence on the outcome of patients treated with primary angioplasty for acute myocardial infarction is unknown. We sought to detect the impact of baseline TP on the early and late outcomes of patients with ST-elevation myocardial infarction in the HORIZONS-AMI trial that included a protocol of immediate angiography and primary percutaneous coronary intervention. Baseline TP was found in 4.2% of patients and was associated with a higher incidence of cardiovascular mortality, major bleeding, and major cardiovascular events at short- and long-term follow-up. The 30-day rates of death, major bleeding, major cardiac events, and major cardiac events plus major bleeding were 6.2%, 11.9%, 9.6%, and 18.5% in the TP group, respectively, compared with 2.1%, 7%, 5.2%, and 10.8% in those without TP (P < .05 for all). Similarly, event rates at 2 years were 11.3%, 12.7%, 24.7%, and 30.8% compared with 5.1%, 7.9%, 18.5%, and 23.3% (P < .05). By multivariate analysis, baseline TP was an independent predictor of 30-day net adverse clinical events but not of any 2-year events. We found that baseline TP in patients with ST-elevation myocardial infarction undergoing routine angiography and primary percutaneous coronary intervention is strongly associated with early adverse events and is a maker of late events, related to both ischemia and bleeding.