Smoking and outcomes following personalized antiplatelet therapy in chronic coronary syndrome patients: A substudy from the randomized PATH-PCI trial.

BACKGROUND: This is a sub-analysis of the Personalized Antithrombotic Therapy for Coronary Heart Disease after PCI (PATH-PCI) trial in China to explore the relationship between smoking and outcomes following personalized antiplatelet therapy (PAT) in chronic coronary syndrome (CCS) patients undergoing percutaneous coronary intervention (PCI). METHODS: As a single-center, prospective, randomized controlled and open-label trial, the PATH-PCI trial randomized CCS patients undergoing PCI into standard group or personalized group guided by a novel platelet function test (PFT), from December 2016 to February 2018. All patients were divided into smokers and nonsmokers according to their smoking status. Subsequently, we underwent a 180-day follow-up evaluation. The primary endpoint was the net adverse clinical events (NACE). RESULTS: Regardless of smoking status, in the incidence of NACE, there was a reduction with PAT but that the reductions are not statistically significant. In the incidence of bleeding events, we found no statistically significant difference between two groups (smokers: 2.0% vs. 1.4%, HR = 1.455, 95% confidence interval [CI]: 0.595-3.559, p = .412; nonsmokers: 2.2% vs. 1.8%, HR = 1.228, 95% CI: 0.530-2.842, p = .632). In smokers, PAT reduced major adverse cardiac and cerebrovascular events (MACCE) by 48.7% (3.0% vs. 5.9%, HR = 0.513, 95% CI: 0.290-0.908, p = .022), compared with standard antiplatelet therapy (SAT). PAT also reduced the major adverse cardiovascular events (MACE) but there was no statistically difference in the reductions (p > .05). In nonsmokers, PAT reduced MACCE and MACE by 51.5% (3.3% vs. 6.7%, HR = 0.485, 95% CI: 0.277-0.849, p = .011) and 63.5% (1.8% vs. 4.9%, HR = 0.365, 95% CI: 0.178-0.752, p = .006), respectively. When testing p-values for interaction, we found there was no significant interaction of smoking status with treatment effects of PAT (pint-NACE = .184, pint-bleeding = .660). CONCLUSION: Regardless of smoking, PAT reduced the MACE and MACCE, with no significant difference in bleeding. This suggests that PAT was an recommendable regimen to CCS patients after PCI, taking into consideration both ischemic and bleeding risk.

Effectiveness of lipid-lowering therapy on mortality and major adverse cardiovascular event outcomes in patients undergoing percutaneous coronary intervention: a network meta-analysis of randomised controlled trials.

BACKGROUND: Emergency percutaneous coronary intervention (PCI) can quickly restore myocardial perfusion after acute coronary syndrome. Whether and which lipid-lowering regimens are effective in reducing major adverse cardiovascular events (MACEs) and mortality risk after PCI remain unclear. OBJECTIVE: This study assessed the benefits of different lipid-lowering regimens on the risk of MACEs and mortality in the post-PCI population by network meta-analysis. METHODS: Public databases, including PubMed, Embase and the Cochrane Library, were searched from inception to August 2022. Randomised controlled trials (RCTs) on lipid-lowering regimens in post-PCI populations were included and analysed. The outcomes were the incidence of all-cause mortality and MACEs, whether reported as dichotomous variables or as HRs. RESULTS: Thirty-nine RCTs were included. For MACEs, alirocumab plus rosuvastatin (OR: 0.18; 95% CI: 0.07 to 0.44), evolocumab plus ezetimibe and statins (OR: 0.19; 95% CI: 0.06 to 0.59), eicosapentaenoic acid (EPA) plus pitavastatin (HR: 0.67; 95% CI: 0.49 to 0.96) and icosapent ethyl plus statins (HR: 0.73; 95% CI: 0.62 to 0.86) had significant advantages and relatively high rankings. For mortality, rosuvastatin (OR: 0.30; 95% CI: 0.11 to 0.84), ezetimibe plus statins (OR: 0.55; 95% CI: 0.43 to 0.89) and icosapent ethyl plus statins (OR: 0.66; 95% CI: 0.45 to 0.96) had significant advantages compared with the control. CONCLUSION: EPA, especially icosapent ethyl, plus statins had a beneficial effect on reducing the risk of MACEs and mortality in post-PCI patients. Proprotein convertase subtilisin/kexin type-9 inhibitors plus statins were able to reduce the risk of MACEs, but the risk of mortality remained unclear. PROSPERO REGISTRATION NUMBER: CRD42018099600.

Age and outcomes following personalized antiplatelet therapy in chronic coronary syndrome patients: a post hoc analysis of the randomized PATH-PCI trial.

It is particularly important to establish more effective and safer antiplatelet treatment strategies according to age. The present subanalysis of the PATH-PCI trial was to determine the safety and efficacy of any dual-antiplatelet therapy (DAPT) strategy in different age groups. We randomized 2285 chronic coronary syndrome (CCS) patients undergoing percutaneous coronary intervention (PCI) into a standard group or a personalized group from December 2016 to February 2018. The personalized group received personalized antiplatelet therapy (PAT) based on a novel platelet function test (PFT). The standard group received standard antiplatelet therapy (SAT). Then, all patients were divided according to age (under the age of 65 years and aged 65 years or over) to investigate the association and interaction of age on clinical outcomes at 180 days. In the patients under the age of 65 years, the incidence of NACEs was decreased in the personalized group compared to the standard group (5.1% vs. 8.8%, HR: 0.603, 95% CI: 0.409-0.888, P = .010). The rates of MACCEs (3.3% vs. 7.7%, HR: 0.450, 95% CI: 0.285-0.712, P = .001), MACEs (2.2% vs. 5.4%, HR: 0.423, 95% CI: 0.243-0.738, P = .002) also decreased. We did not find a significant difference in bleeding between the groups. In the patients aged 65 years or over, no difference in the primary endpoint was found (4.9% vs. 4.2%, P = .702), and comparable rates of survival were observed with the two strategies (all Ps > 0.05). The present study shows that PAT according to PFT was comparable to SAT at the 180-day follow-up for both ischemic and bleeding endpoints in CCS patients aged 65 years or over who underwent PCI. In patients under the age of 65 years, PAT can reduce ischemic events but does not increase bleeding, and it is an effective and safe treatment strategy. It may be necessary for young CCS patients after PCI to undergo PAT early after PCI.

What is the context? The PATH-PCI trial reported that personalized antiplatelet therapy (PAT) based on a novel platelet function test (PFT) can greatly reduce the incidence of ischemic events.Antiplatelet strategies may have very different effects on clinical outcomes in patients in China who are undergoing PCI at different ages.What is new? PL-12 is a new point-of-care platelet function analyzer that is used to test the platelet maximum aggregation rate (MAR).We explored the efficacy and safety of different antiplatelet strategies in chronic coronary syndrome (CCS) patients in different age groups.What is the impact? PAT according to PFT was comparable to standard antiplatelet therapy (SAT) at the 180-day follow-up for both ischemic and bleeding endpoints in CCS patients aged 65 years or over who underwent PCI.In patients under the age of 65 years, PAT can reduce ischemic events but not increase bleeding.PAT may be an effective and safe treatment strategy in CCS patients under the age of 65 years who underwent PCI.Abbreviation: PCI: percutaneous coronary intervention; CCS: chronic coronary syndrome; DAPT: dual antiplatelet therapy; PAT: personalized antiplatelet therapy; SAT: standard antiplatelet therapy; PFT: platelet function test; NACEs: net adverse clinical events; MACCEs: major adverse cardiac and cerebrovascular events; MACEs: major adverse cardiovascular events.

Decreased free fatty acid levels associated with adverse clinical outcomes in coronary artery disease patients with type 2 diabetes: findings from the PRACTICE study.

AIMS: Increased free fatty acid (FFA) levels are known to be strongly associated with mortality in coronary artery disease (CAD) patients and the development of type 2 diabetes (T2DM). However, few studies have been large enough to accurately examine the relationship between FFA levels and mortality in CAD patients with T2DM. METHODS AND RESULTS: From December 2016 to October 2021, 10 395 CAD patients enrolled in PRACTICE, a prospective cohort study in China, were divided into four groups according to baseline FFA concentration. We investigated mortality, including all-cause mortality (ACM) and cardiac mortality (CM), as the primary endpoint. The secondary endpoints were major adverse cardiovascular and cerebrovascular events (MACCEs) and major adverse cardiovascular events (MACEs). The median follow-up time was 24 months. In the total cohort, there were 222 ACMs, 164 CMs, 718 MACEs, and 803 MACCEs recorded. After controlling for baseline variables, the association between FFA levels and the risk of mortality presented a non-linear U-shaped curve, with the lowest risk at 310 µmol/L. We also identified a non-linear U-shaped relationship for ischaemic events (MACE or MACCE) with the lowest risk at 500 µmol/L. Subgroup analysis showed that a U-shaped relationship between FFA and mortality or ischaemic events was observed only in individuals with T2DM but not in non-diabetic CAD patients. CONCLUSIONS: A non-linear U-shaped association was identified between baseline FFA levels and mortality or ischaemic events in CAD patients with T2DM.

From December 2016 to October 2021, 10 395 coronary artery disease (CAD) patients enrolled in PRACTICE, a prospective cohort study in China, were divided into four groups according to baseline free fatty acid (FFA) concentration. We investigated mortality, including all-cause mortality (ACM), and cardiac mortality (CM), as the primary endpoints. The secondary endpoints were major adverse cardiovascular and cerebrovascular events (MACCEs) and major adverse cardiovascular events (MACEs). The median follow-up time was 24 months. Finally, we were surprised to find that high and low FFA levels were associated with a higher risk of mortality and ischaemic events in CAD patients with T2DM. Baseline plasma FFA levels may be a more powerful, effective, and easily detectable biomarker of adverse outcomes in CAD patients with T2DM. As the FFA increases, a U-shaped curve appears in the poor long-term prognosis.

Age-Bilirubin-International Normalized Ratio (INR)-Creatinine (ABIC) Score, a Potential Prognostic Model for Long-Term Mortality of CAD Patients After PCI.

Background: Given that age, international normalized ratio (INR), total bilirubin, and creatinine are reported to be independent risk factors for predicting outcome in patients with coronary artery disease (CAD), it is possible that the age-bilirubin-INR-creatinine (ABIC) score might be a potential prognostic model for patients with CAD. Methods: A total of 6046 CAD patients after percutaneous coronary intervention (PCI) from the retrospective cohort study (Identifier: ChiCTR-ORC-16010153) were evaluated finally. The primary outcome long-term mortality and secondary endpoints mainly major adverse cardiovascular and cerebrovascular events (MACCEs) were recorded. Multivariate Cox regression models were used to determine risk factors for mortality and MACCEs. Results: The ABIC score was significantly higher in the death group than in the survival group. After adjusting for other CAD risk factors, the ABIC score was identified to be an independent risk factor for long-term mortality by multivariate Cox analysis. When in the high ABIC group, the incidence of all-cause mortality would increased 1.7 times (adjusted HR=1.729 (1.347-2.218), P<0.001), and 1.5 times for cardiac death (adjusted HR=1.482 (1.126-1.951), P=0.005). Conclusion: The present study indicated that ABIC score≥7.985 predicts high long-term mortality and cardiac death risk for PCI patients. The ABIC score might be a potential prognostic model for patients with PCI.