<h2>Effect of alirocumab on major adverse cardiovascular events according to renal function in patients with a recent acute coronary syndrome: prespecified analysis from the Odyssey Outcomes randomized clinical trial.</h2>
José Tuñón, Philippe Gabriel Steg, Deepak L Bhatt, Vera A Bittner, Rafael Díaz, Shaun G Goodman, J Wouter Jukema, Yong-Un Kim, Qian H Li, Christian Mueller, Alexander Parkhomenko, Robert Pordy, Piyamitr Sritara, Michael Szarek, Harvey D White, Andreas M Zeiher, Gregory G Schwartz, for the Odyssey outcomes investigators
<h2>Objective</h2>
This prespecified analysis of the Odyssey Outcomes trial examined whether the reduction of major adverse cardiovascular events (MACE) with alirocumab, added to intensive or maximum-tolerated statin therapy after Acute Coronary Syndrome (ACS), depends upon the level of estimated glomerular filtration rate (eGFR).
<h2>Methods</h2>
The trial was a randomized, double-blind, placebo-controlled comparison of alirocumab or placebo in 18,918 patients with an ACS (myocardial infarction or unstable angina) 1–12months before randomization. Qualifying patients had persistent dyslipidemia [LDL-C≥ 70mg/dL (1.81mmol/L), nonhigh-density lipoprotein cholesterol (non-HDL-C) ≥ 100mg/dL (2.59mmol/L), or apolipoprotein B≥ 80mg/dL (0.0016mmol/L)] despite treatment with atorvastatin 40–80 mg daily, rosuvastatin 20–40mg daily, or the maximum-tolerated dose of one of these statins (including no statin in case of documented intolerance).
Participants were randomly assigned (1:1) to receive alirocumab 75mg or matching placebo subcutaneously every 2weeks. A treat-totarget design aimed to achieve an LDL-C level of 25–50mg/dL among alirocumab treated patients. Alirocumab 75mg was blindly up-titrated to 150mg if the LDL-C level was &gt;50mg/dL. If LDL-C was &lt;15mg/dL on two consecutive measurements on the 75mg dose of alirocumab, placebo was blindly substituted for the rest of the trial.
<h2>Endpoints</h2>
The primary outcome was a composite of MACE, including death due to coronary heart disease, non-fatal myocardial infarction, ischemic stroke, or unstable angina requiring hospitalization. Death from any cause was a secondary outcome. All outcomes were blindly adjudicated.
This prespecified analysis also investigated whether the effect of alirocumab on MACE and death varied across the range of baseline renal function, analyzed the incidence of adverse effects as a function of eGFR, and looked for potential effects of alirocumab on eGFR.
<h2>Results</h2>
A total of 18 924 patients underwent randomization; Of these, 9462 were assigned to alirocumab and 9462 to placebo.
Alirocumab decreased LDL-C by 62.2% and 48.5% vs. placebo at 4 and 36 months, respectively. Overall, alirocumab reduced risk of the primary outcome (coronary heart disease death, non-fatal myocardial infarction, ischemic stroke, or unstable angina requiring hospitalization) with fewer deaths. There was no interaction between continuous eGFR and treatment on the primary outcome or death (P = 0.14 and 0.59, respectively). Alirocumab reduced primary outcomes in patients with eGFR ≥90mL/min/1.73 m2 (n = 7470; hazard ratio 0.784, 95% confidence interval 0.670–0.919; P = 0.003) and 60 to &lt;90 (n = 9326; 0.833, 0.731–0.949; P= 0.006), but not in those with eGFR&lt; 60 (n = 2122; 0.974, 0.805–1.178; P = 0.784). Adverse events other than local injection-site reactions were similar in both groups across all categories of eGFR.
<h2>Conclusion</h2>
In patients with recent ACS, alirocumab was associated with fewer cardiovascular events and deaths across the range of renal function studied, with larger relative risk reductions in those with eGFR &gt; 60 mL/min/1.73 m2.

Reference

Effect of Alirocumab on MACE in patients with CKD

DYSLIPIDEMIA

CARDIOLOGY

VTE Risk Assessment in Surgical Patients

Watch Prof. Joseph A. Caprini MD Emeritus physician, NorthShore University HealthSystem, Evanston, Illinois answering Why is VTE risk assessment in surgical patients (and beyond) so important?

THROMBOSIS

Ticagrelor vs Clopidogrel in Older Patients With ACS PCI

Watch the video and get to know more on older patients with acute coronary syndrome (ACS) who underwent percutaneous coronary intervention (PCI); clopidogrel is an effective alternative to the more potent P2Y12 inhibitor ticagrelor.

Prophylactic Strategies for VTE in Gynecologic Cancer Patients


Watch This Video, Which Shed the Light on How It Is Safe and Effective to Use Anticoagulants in Gynecologic Cancer Patients Undergoing Major Surgery.

Single Antiplatelet therapy: Insights on earlier use

Watch the video of Prof. Dominick Angiolillo, M.D., Ph.D., Professor &amp; Medical Director of the Cardiovascular Research Program, University of Florida College of Medicine, Jacksonville USA, sharing insights on recent studies that show an emphasis on the early use of single Antiplatelet therapy in PCI patients.

Clopidogrel as the standard of care for elective PCI: Findings from the Alpheus

Watch the video and get to know more on Alpheus trial. Since Percutaneous coronary intervention (PCI)-related myonecrosis is frequent and can affect the long-term prognosis of patients, then stronger platelet inhibition could potentially lower these events and make the PCI procedure safer.

<h2>Main Takeaway</h2>
<ul>
 <li>Risk for net adverse clinical events (NACE) was not significantly different&nbsp;between ticagrelor at 12 months compared with clopidogrel 
 <ul>
 <li>Study population: 62,580 patients with acute coronary syndrome (ACS) who underwent percutaneous coronary intervention (PCI) in routine clinical practice</li>
 </ul></li>
 <li>Ticagrelor was associated with&nbsp;higher risks for haemorrhagic events and dyspnoea&nbsp;vs clopidogrel</li>
</ul>
<h2>Why This Matters</h2>
<ul>
 <li>Recent observational studies&nbsp;question whether ticagrelor vs clopidogrel is associated with better outcomes&nbsp;in routine clinical practice 
 <ul>
 <li>Current guidelines: recommend ticagrelor with aspirin in preference to clopidogrel in patients with ACS</li>
 </ul></li>
</ul>
<h2>Study Design</h2>
Retrospective cohort study:&nbsp;183,579 patients (age range, 30-89 years) with ACS who underwent PCI and received ticagrelor or clopidogrel

Patients were matched using propensity score:
<ul>
 <li>Ticagrelor (n=31,290)</li>
 <li>Clopidogrel (n=31,290)</li>
</ul>
Primary endpoint:&nbsp;NACE at 12 months
<ul>
 <li>Ischaemic events 
 [recurrent acute myocardial infarction, revascularisation or ischaemic stroke]</li>
 <li>Haemorrhagic events 
 [haemorrhagic stroke or gastrointestinal bleeding]</li>
</ul>
Secondary outcomes:&nbsp;NACE or mortality, all-cause mortality, composite ischaemic events, composite haemorrhagic events, individual components of the primary outcome, dyspnoea at 12 months
<h2>Key Results</h2>
95.5% of matched patients used aspirin&nbsp;with ticagrelor or clopidogrel among the 31,290 propensity-matched pairs
The risk for NACE was not significantly different between ticagrelor and clopidogrel groups (HR, 1.05; 95% CI, 1.00-1.10; P=0.06)
<ul>
 <li>No significant difference was found between the 2 groups for: 
 <ul>
 <li>NACE or mortality (HR, 1.03; 95% CI, 0.98-1.08; P=0.21)</li>
 <li>Ischaemic events (HR, 1.03; 95% CI, 0.98-1.08; P=0.32)</li>
 <li>All-cause mortality (HR, 0.97; 95% CI, 0.81-1.16; P=0.74)</li>
 </ul></li>
 <li>Ticagrelor vs clopidogrel group showed a significantly higher risk for: 
 <ul>
 <li>Haemorrhagic events (HR, 1.35; 95% CI, 1.13-1.61; P=0.001)</li>
 <li>Dyspnoea (HR, 1.21; 95% CI, 1.17-1.26; P&lt;0.001)</li>
 </ul></li>
</ul>
<h2>Limitations</h2>
<ul>
 <li>The study did not include information on aspirin dosage, angiographic findings, or PCI procedure</li>
 <li>The burden of overall bleeding events could have been underestimated or overestimated</li>
 <li>Neither the proportion of patients who switched antiplatelet drugs nor its effects were quantified</li>
 <li>The effect of pre-treatment with an antiplatelet agent was not assessed</li>
 <li>The mortality rate might have been underestimated</li>
 <li>Patients who used prasugrel for dual antiplatelet therapy were not included</li>
</ul>

Ticagrelor vs Clopidogrel in ACS patients undergoing PCI in routine clinical practice

<h2>Main Takeaway</h2>
<ul>
 <li>Clopidogrel-based DAPT (CDAPT) was associated with a&nbsp;lower risk of bleeding events, major adverse cardiac and cerebral events&nbsp;(MACCE), and net adverse clinical events (NACE) than ticagrelor-based DAPT (TDAPT) 
 <ul>
 <li>Risks were similar between CDAPT and prasugrel-based DAPT (PDAPT)</li>
 </ul></li>
</ul>
<h2>Why This Matters</h2>
<ul>
 <li>The findings from this study support&nbsp;clopidogrel as a viable first-choice P2Y12 inhibitor for DAPT after PCI&nbsp;in an East-Asian patient population 
 <ul>
 <li>Recent European guidelines recommended potent P2Y12 inhibitors (ticagrelor and prasugrel) over clopidogrel in acute coronary syndromes, due to their rapid onset of action and strong antiplatelet activity 
 <ul>
 <li>Their safety and effectiveness in the East-Asian patients has often been questioned</li>
 </ul></li>
 </ul></li>
</ul>
<h2>Study Design</h2>
Retrospective study:&nbsp;57,197 patients in the South Korean HIRA database underwent PCI (from January 1 2014 to December 31 2016) and were treated with DAPT including aspirin and one of three P2Y12 inhibitors
<ul>
 <li>Clopidogrel + aspirin (CDAPT) (n=37,500)</li>
 <li>Ticagrelor + aspirin (TDAPT) (n=15,723)</li>
 <li>Prasugrel + aspirin (PDAPT) (n=3,974)</li>
</ul>
<h3>Key exclusion criteria:</h3>
<ul>
 <li>Age &lt;18 years as of the index date (n=6)</li>
 <li>History of PCI or CABG during the baseline period (n=3,434)</li>
 <li>Severe liver or chronic kidney disease (stage 4-5, n=1,315))</li>
 <li>Use of P2Y12 inhibitors during the baseline period (n=39,134)</li>
 <li>Use of oral antithrombotic agents (except low-dose aspirin) during the study period (n=19,849)</li>
</ul>
Key outcomes:&nbsp;the risk of bleeding events, risk of MACCE (a composite of all-cause death, myocardial infarction, stroke and revascularisation), risk of NACE, persistence and adherence rates
<h2>Key Results</h2>
The risk of bleeding events, MACCE, and NACE was significantly higher in the TDAPT group versus the CDAPT group, both at 1-year and in the prolonged periods
<ul>
 <li>Risk of bleeding event: 1-year hazard ratio (HR) = 1.37; 95% confidence interval (CI), 1.28–1.46; prolonged HR = 1.39; 95% CI, 1.31–1.47</li>
 <li>Risk of MACCE: 1-year HR = 1.10; 95% CI, 1.03–1.18; prolonged HR = 1.24; 95% CI, 1.16–1.31</li>
 <li>Risk of NACE: 1-year HR = 1.23; 95% CI, 1.18–1.29; prolonged HR = 1.31; 95% CI, 1.25–1.36</li>
 <li>No significant differences were reported for the risk of bleeding events, MACCE, and NACE between the PDAPT and CDAPT groups (1-year and prolonged periods)</li>
</ul>
The&nbsp;use of clopidogrel correlated with better adherence to DAPT&nbsp;than potent P2Y12 inhibitors
<ul>
 <li>34.9% of patients remained on CDAPT until the end of the prolonged period,&nbsp;whereas only 7.8% and 9.2% remained on TDAPT and PDAPT, respectively</li>
</ul>
<h2>Limitations</h2>
<ul>
 <li>Any association between P2Y12 inhibitors and clinical outcomes should be interpreted cautiously, owing to the observational nature of the study</li>
 <li>There was a lack of information regarding lesion complexity and location at index PCI, baseline laboratory findings, and cardiac function</li>
 <li>The information bias from voluntary/involuntary miscoding may lead to underestimation or overestimation of the outcomes</li>
 <li>The reporting of death was limited to in-hospital death</li>
 <li>It is difficult to generalise study findings in ethnic groups other than the East-Asian populations</li>
 <li>Reasons for P2Y12 inhibitor discontinuation were not identified</li>
</ul>

Is Clopidogrel a viable first choice P2Y12 inhibitor for DAPT after PCI?

<h2>Main Takeaway</h2>
A real-word study of Taiwanese patients with AMI undergoing PC

Showed a comparable 1-year 
 cardiovascular outcome&nbsp;with 
 standard ticagrelor treatment 3 
 months after the event of AMI

Didn’t report statistically 
 significant differences in:
&nbsp;• Hazard risk of death 
 • AMI admission 
 • Major adverse 
 • Cardiovascular events 
 (MACE)

Didn’t show a difference 
 in the risk of bleeding, 
 including major or 
 clinically relevant non- 
 major bleeding

<h2>Why This Matters</h2>
<ul>
 <li>Bleeding risks could be reduced&nbsp;P2Y12 inhibitor de-escalation approach is considered by physicians to reduce additional bleeding risks</li>
 <li>Current studies are not enough&nbsp;Despite recent clinical studies, there’s limited and conflicting evidence on de-escalation strategies. This study aimed to assess the effect of de-escalated P2Y12 inhibitor switching in DAPT on MACE in patients with AMI undergoing PCI;</li>
</ul>
<h2>Study Design</h2>
This retrospective and population-based cohort study utilized data from the Taiwan’s National Health Insurance Research Database (NHIRD).
Key Inclusion Criteria:
<ul>
 <li>Patients who were hospitalized with a primary diagnosis of AMI</li>
</ul>
Key Exclusion Criteria:
<ul>
 <li>Patients aged &lt;18 years, without identification of sex, or Taiwanese citizenship</li>
 <li>Patients not on heparin or antiplatelet therapy, or were only on aspirin therapy, or</li>
 <li>received antiplatelet agents other than ticagrelor at index of AMI</li>
 <li>Patients who had a coronary artery bypass graft</li>
 <li>Death of the patient within 3 months after the index date of AMI</li>
</ul>
Key Outcomes:
<ul>
 <li>Death, AMI readmission, and MACE within one year during the follow-up period</li>
</ul>

<ul>
 <li>10,100 patients were included (de-escalated DAPT group: n = 1,901; unchanged DAPT: n = 8,199)</li>
</ul>

<h3>Number Of Participants</h3>

black

<ul>
 <li>All-cause death&nbsp;(unchanged vs de-escalated DAPT group):&nbsp;Incidence&nbsp;= 2.42&nbsp;(95% confidence interval [CI]: 2.02–2.90) vs 2.89 (95% CI: 2.05–3.91);&nbsp;adjusted HR&nbsp;= 1.20&nbsp;(95% CI: 0.83–1.73; P = 0.336)</li>
 <li>AMI hospitalization&nbsp;(unchanged vs de-escalated DAPT group):&nbsp;Incidence&nbsp;= 3.28&nbsp;(95% CI: 2.81–3.83) vs 3.68 (95% CI: 2.75–4.88);&nbsp;adjusted HR&nbsp;= 1.12&nbsp;(95% CI: 0.80–1.56; P = 0.509)</li>
 <li>MACE&nbsp;(unchanged vs de-escalated DAPT group):&nbsp;Incidence&nbsp;= 4.72&nbsp;(95% CI: 4.13–5.36) vs 4.91 (95% CI: 3.80–6.26);&nbsp;adjusted HR&nbsp;= 1.04&nbsp;(95% CI: 0.78–1.39; P = 0.766)</li>
 <li>Major bleeding&nbsp;(unchanged vs de-escalated DAPT group):&nbsp;Incidence&nbsp;= 2.36&nbsp;(95% CI: 1.95–2.82) vs 2.12 (95% CI: 1.41–3.01);&nbsp;adjusted HR&nbsp;= 0.92&nbsp;(95% CI: 0.61–1.37; P = 0.669)</li>
</ul>

<h3>Incidence Rates And Adjusted Hazard Ratio</h3>

<h2>Limitations</h2>
<ul>
 <li>Patient information such as risk behaviors, diet, and physical activities are not available in the NHIRD.</li>
 <li>Hidden bias of medication selection was introduced as the study data was sourced from an administrative database.</li>
 <li>Missing clinical information, such as the severity of AMI at admission, might have induced non-differential misclassification bias.</li>
 <li>Study results might not be generalizable to other populations, as only Taiwanese patients were included in the analysis.</li>
</ul>

Effect of de-escalated P2Y12 inhibitor switching in dual antiplatelet therapy (DAPT)

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