The Hypercholesterolemia Paradox in Percutaneous Coronary Intervention: An Analysis of a Multicenter PCI Registry.
ABSTRACT: Objective The aim of this study was to assess the relationship between hypercholesterolemia (HC) and clinical events through a percutaneous coronary intervention (PCI) registry. HC is a well-known independent risk factor for long-term cardiovascular events after PCI. However, it has been reported to be associated with a lower risk of adverse events in patients with cancer or acute coronary syndrome. Methods We analyzed the relationship between HC and adverse events in patients treated with everolimus-eluting stents (EESs) through the Tokyo-MD PCI study (an all-comer, multicenter, observational registry). The propensity score method was applied to select two groups with similar baseline characteristics. Results The unadjusted population included 1,536 HC patients and 330 non-HC patients. Propensity score matching yielded 314 matched pairs. After baseline adjustment, the outcomes of HC patients were significantly better than those of the non-HC patients with respect to the primary endpoint, which was a combination of mortality from all causes, nonfatal myocardial infarction (MI), nonfatal neurological events, and major bleeding [hazard ratio (HR) 0.56, 95% confidence interval (CI) 0.39-0.81; p=0.002], and the secondary endpoints, which included a combination of mortality from all causes, nonfatal MI, and nonfatal neurological events (HR 0.59, 95% CI 0.39-0.88; p=0.01), and major bleeding (HR 0.42, 95% CI 0.20-0.88; p=0.02). A subgroup analysis showed age as an interaction factor for the primary endpoint (interaction p=0.035). Conclusion HC was associated with better outcomes in patients who underwent EES implantation, even after baseline adjustment.
Project description:Background:In patients with acute ST-segment elevation myocardial infarction (STEMI) who undergo primary percutaneous coronary intervention (PCI), approximately 10% are concomitant with a chronic total occlusion (CTO) in a non-culprit vessel. However, the impact of staged CTO recanalization on prognosis in this cohort remains disputable. This study aimed to compare the long-term outcomes of staged CTO recanalization versus medical therapy in patients with STEMI after primary PCI. Methods:Between January 2005 and December 2016, a total of 287 patients were treated with staged CTO-PCI (n = 91) or medical therapy (n = 196) after primary PCI in our center. The primary endpoint was major adverse cardiovascular and cerebrovascular event (MACCE), defined as a composite of all-cause death, nonfatal myocardial infarction (MI), stroke or unplanned revascularization. After propensity-score matching, 77 pairs of well-balanced patients were identified. Results:The mean follow-up period was 6.06 years. Overall, the incidence of the primary endpoint of MACCE was significantly lower in staged CTO-PCI group than that in medical therapy group in both overall population (22.0% vs. 46.9%; hazard ratio (HR) = 0.48, 95% CI: 0.29-0.77) and propensity-matched cohorts (22.1% vs. 42.9%; HR: 0.48, 95% CI: 0.27-0.86). In addition, staged CTO-PCI was also associated with reduced risk of the composite of cardiac death, nonfatal MI or stroke compared with medical therapy in both overall population (9.9% vs. 26.5%; hazard ratio (HR) = 0.39, 95% CI: 0.19-0.79) and propensity-matched cohorts (9.1% vs. 22.1%; HR: 0.40, 95% CI: 0.16-0.96). After correction of the possible confounders, staged CTO-PCI was independently associated with reduced risks of MACCE (adjusted HR: 0.46, 95% CI: 0.28-0.75), the composite of cardiac death, nonfatal MI or stroke (adjusted HR: 0.45, 95% CI: 0.22-0.94) and all-cause mortality (adjusted HR: 0.32, 95% CI: 0.13-0.83). Moreover, the results of sensitivity analysis were almost concordant with the overall analysis. Conclusions:In patients with STEMI and a concurrent CTO who undergo primary PCI, successful staged recanalization of CTO in the non-culprit vessels is associated with better clinical outcomes during long-term follow-up.
Project description:Bleeding after hospital discharge from percutaneous coronary intervention (PCI) is associated with increased risk of subsequent myocardial infarction (MI) and death; however, the timing of adverse events after these bleeding events is poorly understood. Defining this relationship may help clinicians identify critical periods when patients are at highest risk.All patients undergoing PCI from 2004 to 2007 who survived to hospital discharge without a bleeding event were identified from the HMO Research Network-Stent (HMORN-Stent) Registry. Postdischarge rates and timing of bleeding-related hospitalizations, MI, and death were defined. We then assessed the association between postdischarge bleeding-related hospitalizations with death and MI using Cox proportional hazards models. Among 8137 post-PCI patients surviving to hospital discharge without in-hospital bleeding, 391 (4.8%) had bleeding-related hospitalization after discharge, with the highest incidence of bleeding-related hospitalizations occurring within 30 days of discharge (n=79, 20.2%). Postdischarge bleeding-related hospitalization after PCI was associated with subsequent death or MI (hazard ratio, 3.09; 95% confidence interval, 2.41-3.96), with the highest risk for death or MI occurring in the first 60 days after bleeding-related hospitalization (hazard ratio, 7.16; confidence interval, 3.93-13.05).Approximately 1 in 20 post-PCI patients are readmitted for bleeding, with the highest incidence occurring within 30 days of discharge. Patients having postdischarge bleeding are at increased risk for subsequent death or MI, with the highest risk occurring within the first 60 days after a bleeding-related hospitalization. These findings suggest a critical period after bleeding events when patients are most vulnerable for further adverse events.
Project description:<h4>Introduction</h4>The safety and effectiveness of potent P2Y12 inhibitors in East Asians have been questioned because of the higher bleeding tendency and lower thrombotic risk in this population. We comparatively evaluated the safety, effectiveness and treatment persistence of the dual antiplatelet therapies (DAPT) with clopidogrel (CDAPT), ticagrelor (TDAPT) and prasugrel (PDAPT) after percutaneous coronary intervention (PCI) in the Korean population.<h4>Methods</h4>A retrospective cohort study was conducted using Korean National Health Insurance claims data. In 57,197 patients treated with DAPT after PCI, the risk of bleeding events, risk of major adverse cardiac and cerebral events (MACCE: a composite of all-cause death, myocardial infarction [MI], stroke and revascularization), risk of net adverse clinical events (NACE) and persistence and adherence rates were assessed with stabilized inverse probability of treatment weighting.<h4>Results</h4>TDAPT was associated with higher risks of bleeding (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), MACCE (1 year: HR 1.10, 95% CI 1.03-1.18; prolonged: HR 1.24, 95% CI 1.16-1.31) and NACE (1 year: HR 1.23, 95% CI 1.18-1.29; prolonged: HR 1.31, 95% CI 1.25-1.36) than CDAPT both at 1 year and in the prolonged periods, whereas there were no significant differences between PDAPT and CDAPT. Similar results were also observed in a subgroup analysis of patients with baseline MI. CDAPT was associated with higher persistence and adherence rates than TDAPT and PDAPT.<h4>Conclusions</h4>CDAPT was associated with clinical outcomes that were more favorable than those in TDAPT and comparable to those in PDAPT and drug persistence and adherence that were higher than in TDAPT or PDAPT. Clopidogrel may remain a viable first option for post-PCI DAPT in East Asian patients with a low thrombotic risk and a high bleeding tendency.
Project description:Although the new oral P2Y12 inhibitors, prasugrel/ticagrelor have shown greater efficacy than clopidogrel in patients with the acute coronary syndrome, but they have not shown better efficacy in Korean patients. So we evaluated the efficacy of the prasugrel/ticagrelor in patients with myocardial infarction (MI) and diabetes, a more high-risk patients group.From the Korea Acute Myocardial Infarction Registry-National Institute of Health, 3985 patients with MI and diabetes who underwent PCI were enrolled between November 2011 and December 2015. The patients were divided into 2 groups: clopidogrel (n = 2985) and prasugrel/ticagrelor (n = 1000).After propensity score matching, prasugrel/ticagrelor group showed a no significant difference in risk of the composite of cardiac death (CD), recurrent MI or stroke (hazard ratio [HR], 0.705; 95% confidence interval [CI], 0.474-1.048; P = .084). However, the risk of major bleeding was significantly higher in the prasugrel/ticagrelor group. (HR; 2.114, 95% CI; [1.027-4.353], P = .042). In subgroup analysis, major bleeding was significantly increased in the subgroup of creatinine clearance <60 ml/min/1.73 m, hypertension, underwent a trans-femoral approach and diagnosed as NSTEMI among the prasugrel/ticagrelor group.The use of prasugrel/ticagrelor did not improve the composite of CD, recurrent MI or stroke, however, significantly increased major bleeding events in Korean patients with MI and diabetes undergoing PCI.
Project description:Clopidogrel low response (CLR) is an independent risk factor of adverse outcomes in patients undergoing percutaneous coronary intervention (PCI), and intensified antiplatelet treatments (IAT) guided by platelet function assays might overcome laboratory CLR. However, whether IAT improves clinical outcomes is controversial.Relevant trials were identified in PubMed, the Cochrane Library, and the Chinese Medical Journal Network databases from their establishment to September 9, 2014. Trials were screened using predefined inclusion criteria. Conventional meta-analysis and cumulative meta-analysis were performed using the Review Manager 5.0 and STATA 12.0 software programs.Thirteen randomized controlled trials involving 5111 patients with CLR were recruited. During a follow-up period of 1-12 months, the incidences of cardiovascular (CV) death, nonfatal myocardial infarction (MI), and stent thrombosis were significantly lower in the IAT arm than in the conventional antiplatelet treatment arm (relative risk [RR] = 0.45, 95% confidence interval [CI]: 0.36-0.57, P < 0.000,01), whereas bleeding was similar between the two arms (RR = 1.05, 95% CI: 0.86-1.27, P = 0.65).IAT guided by platelet function assays reduces the risk of CV death, nonfatal MI, and stent thrombosis (ST) without an increased risk of bleeding in patients undergoing PCI and with CLR.
Project description:Bivalirudin has been shown to be safe and efficacious compared with heparin plus glycoprotein IIb/IIIa inhibitor (GPI) in patients undergoing percutaneous coronary intervention (PCI). Whether bivalirudin would have the beneficial effects in female patients undergoing PCI remains unknown. We searched the literature for randomized controlled trials that assessed bivalirudin versus heparin plus GPI therapy in female patients undergoing PCI. The primary efficacy end point was major adverse cardiovascular events (MACE) within 30 days. The secondary efficacy end points were 30-day incidence of all-cause mortality, myocardial infarction (MI), urgent/ischemia-driven revascularization of target vessel. The safety end point was major bleeding up to 30 days. A total of 4,501 female patients were included in five randomized trials. No significant difference in MACE emerged between bivalirudin and heparin plus GPI at 30 days (8.15% vs 8.76%, RR 0.94, 95% CI 0.77-1.16, P = .57). There were no significant differences in rates of mortality (1.28% vs 1.91%, RR 0.74, 95% CI 0.45-1.20, P = .22), MI (5.46% vs 5.25%, RR 1.02, 95% CI 0.79-1.32, p = .88), or target vessel revascularization (2.13% vs 1.65%, RR 1.43, 95% CI 0.88-2.30, P = .15). Compared with heparin plus GPI, bivalirudin was associated with a significant reduction in 30-day major bleeding (5.32% vs 9.20%, RR 0.58, 95% CI 0.47-0.72, P < .0001). In conclusion, bivalirudin is associated with a significant reduction in 30-day major bleeding without increased ischemic events compared with heparin plus GPI in female patients undergoing PCI.
Project description:Recent large clinical trials show lower rates of late cardiovascular events by extending clopidogrel >12 months after percutaneous coronary revascularization (PCI). However, concerns of increased bleeding have elicited support for limiting prolonged treatment to high-risk patients.The aim of this analysis was to determine the effect of prolonging clopidogrel therapy >12 months versus ?12 months after PCI on very late outcomes in patients with diabetes mellitus (DM).Using the Veterans Health Administration, 28,849 patients undergoing PCI between 2002 and 2006 were categorized into 3 groups: 1) 16,332 without DM; 2) 9,905 with DM treated with oral medications or diet; and 3) 2,612 with DM treated with insulin. Clinical outcomes, stratified by stent type, ?4 years after PCI were determined from the Veterans Health Administration and Medicare databases and risk was assessed by multivariable and propensity score analyses using a landmark analysis starting 1 year after the index PCI. The primary endpoint of the study was the risk of all-cause death or myocardial infarction (MI).In patients with DM treated with insulin who received drug-eluting stents (DES), prolonged clopidogrel treatment was associated with a decreased risk of death (hazard ratio [HR]: 0.59; 95% confidence interval [CI]: 0.42 to 0.82) and death or MI (HR: 0.67; 95% CI: 0.49 to 0.92). Similarly, in patients with noninsulin-treated DM receiving DES, prolonged clopidogrel treatment was associated with less death (HR: 0.61; 95% CI: 0.48 to 0.77) and death or MI (HR: 0.61; 95% CI: 0.5 to 0.75). Prolonged clopidogrel treatment was not associated with a lower risk in patients without DM or in any group receiving bare-metal stents.Extending the duration of clopidogrel treatment >12 months may decrease very late death or MI only in patients with DM receiving first-generation DES. Future studies should address this question in patients receiving second-generation DES.
Project description:OBJECTIVE:To evaluate the association of successive percutaneous coronary intervention (PCI) modalities with balloon angioplasty (BA), bare-metal stent (BMS), drug-eluting stents (DES), and pharmacotherapy over the last 3 decades with outcomes among patients with diabetes in routine clinical practice. RESEARCH DESIGN AND METHODS:We examined outcomes in 1,846 patients with diabetes undergoing de novo PCI in the multicenter, National Heart, Lung, and Blood Institute-sponsored 1985-1986 Percutaneous Transluminal Coronary Angioplasty (PTCA) Registry and 1997-2006 Dynamic Registry. Multivariable Cox regression models were used to estimate the adjusted risk of events (death/myocardial infarction [MI], repeat revascularization) over 1 year. RESULTS:Cumulative event rates for postdischarge (31-365 days) death/MI were 8% by BA, 7% by BMS, and 7% by DES use (P = 0.76) and for repeat revascularization were 19, 13, and 9% (P < 0.001), respectively. Multivariable analysis showed a significantly lower risk of repeat revascularization with DES use when compared with the use of BA (hazard ratio [HR] 0.41 [95% CI 0.29-0.58]) and BMS (HR 0.55 [95% CI 0.39-0.76]). After further adjustment for discharge medications, the lower risk for death/MI was not statistically significant for DES when compared with BA. CONCLUSIONS:In patients with diabetes undergoing PCI, the use of DES is associated with a reduced need for repeat revascularization when compared with BA or BMS use. The associated death/MI benefit observed with the DES versus the BA group may well be due to greater use of pharmacotherapy.
Project description:Eptifibatide is indicated during percutaneous coronary intervention (PCI) with continuation for 18-24 hours post procedure but is associated with bleeding. We examined the efficacy and safety of shorter post-PCI eptifibatide infusions in high-risk non-ST-segment elevation acute coronary syndrome (NSTE ACS) patients.EARLY ACS patients treated with PCI and eptifibatide were grouped by post-procedure infusion duration: <10, 10-13, 13-17, and 17-25 (per protocol) hours. Adjusted estimated event rates for 96-hour death/myocardial infarction (MI)/recurrent ischaemia requiring urgent revascularization (RIUR), 30-day death/MI, post-PCI packed red blood cell (PRBC) transfusion, and GUSTO (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries) moderate/severe bleeding were obtained using inverse-propensity weighting to account for informative censoring of infusions.Among 3271 eptifibatide-treated PCI patients, there were 66 96-hour death/MI/RIUR events, 94 30-day death/MI events, 127 PRBC transfusions, and 115 GUSTO moderate/severe bleeds. Compared with per protocol, patients receiving post-PCI infusions <10 hours had similar adjusted estimated rates of 96-hour death/MI/RIUR (absolute difference 0.021 higher; 0.040 vs. 0.019, 95% CI -0.023 to 0.064; p=0.35) and 30-day death/MI (0.020 higher; 0.046 vs. 0.026, 95% CI -0.021 to 0.062; p=0.34). There were also no differences in ischaemic outcomes between infusions of 10-17 hours and per-protocol infusions. Adjusted estimated rates of PRBC transfusion were higher for the <10-hour infusion group compared with per protocol (0.048 higher; 0.079 vs. 0.031, 95% CI 0.005 to 0.091, p=0.03) but were similar for other groups. Adjusted GUSTO moderate/severe bleeding rates were similar to per-protocol rates for all groups.In high-risk NSTE ACS patients, post-PCI eptifibatide infusions <18 hours were not associated with worse ischaemic outcomes. Shorter eptifibatide infusions in this population may be feasible.
Project description:The potential benefit of long-term dual antiplatelet therapy (DAPT) for secondary prevention of atherothrombotic events is unclear. Data from different randomized controlled trials (RCT) using different agents in different subgroups showed inconsistent results.We performed a systematic review and meta-analysis from RCTs that tested different prolonged durations of DAPT for secondary prevention. Long term DAPT arm was defined as those receiving DAPT for more than 12months. Long-term aspirin arm was defined as those receiving either aspirin alone long term or DAPT for less than 12months.The use of long term DAPT was associated with a significant decrease in composite of death, myocardial infarction (MI) and stroke (6.08% vs. 6.71%; odds ratio OR=0.86 [0.78-0.94]; P=0.001). This reduction of death, MI and stroke was mainly noticed in patients with prior MI or stroke, but not with PAD or multiple risk factors. The reduction was seen with post PCI patients with prasugrel and only in those with prior MI with clopidogrel and ticagrelor. Long-term use of DAPT was associated with significant increase in major bleeding (1.47% vs. 0.88%; OR=1.65 [1.23-2.21]; P=0.001).Long-term use of DAPT for secondary prevention is associated with lower risk of death, MI and stroke beneficial especially in patients with prior MI and stroke, but it is associated with increased risk of bleeding. Prolonging DAPT requires careful assessment of the trade-off between ischemic and bleeding complications and should probably be reserved for patients with higher risk for atherothrombotic events.