IMPORTANCEClopidogrel monotherapy after short dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) has not yet been fully investigated in patients with acute coronary syndrome (ACS).OBJECTIVE To test the hypothesis of noninferiority of 1 to 2 months of DAPT compared with 12 months of DAPT for a composite end point of cardiovascular and bleeding events in patients with ACS. DESIGN, SETTING, AND PARTICIPANTSThis multicenter, open-label, randomized clinical trial enrolled 4169 patients with ACS who underwent successful PCI using cobalt-chromium everolimus-eluting stents at 96 centers in Japan from December 2015 through June 2020. These data were analyzed from June to July 2021.INTERVENTIONS Patients were randomized either to 1 to 2 months of DAPT followed by clopidogrel monotherapy (n = 2078) or to 12 months of DAPT with aspirin and clopidogrel (n = 2091). MAIN OUTCOMES AND MEASURESThe primary end point was a composite of cardiovascular (cardiovascular death, myocardial infarction [MI], any stroke, or definite stent thrombosis) or bleeding (Thrombolysis in MI major or minor bleeding) events at 12 months, with a noninferiority margin of 50% on the hazard ratio (HR) scale. The major secondary end points were cardiovascular and bleeding components of the primary end point. RESULTS Among 4169 randomized patients, 33 withdrew consent. Of the 4136 included patients, the mean (SD) age was 66.8 (11.9) years, and 856 (21%) were women, 2324 (56%) had ST-segment elevation MI, and 826 (20%) had non-ST-segment elevation MI. A total of 4107 patients (99.3%) completed the 1-year follow-up in June 2021. One to 2 months of DAPT was not noninferior to 12 months of DAPT for the primary end point, which occurred in 65 of 2058 patients (3.2%) in the 1-to 2-month DAPT group and in 58 of 2057 patients (2.8%) in the 12-month DAPT group (absolute difference, 0.37% [95% CI, −0.68% to 1.42%]; HR, 1.14 [95% CI, 0.80-1.62]; P for noninferiority = .06). The major secondary cardiovascular end point occurred in 56 patients (2.8%) in the 1-to 2-month DAPT group and in 38 patients (1.9%) in the 12-month DAPT group (absolute difference, 0.90% [95% CI, −0.02% to 1.82%]; HR, 1.50 [95% CI, 0.99-2.26]). The major secondary bleeding end point occurred in 11 patients (0.5%) in the 1to 2-month DAPT group and 24 patients (1.2%) in the 12-month DAPT group (absolute difference, −0.63% [95% CI, −1.20% to −0.06%]; HR, 0.46 [95% CI, 0.23-0.94]). CONCLUSIONS AND RELEVANCEIn patients with ACS with successful PCI, clopidogrel monotherapy after 1 to 2 months of DAPT failed to attest noninferiority to standard 12 months of DAPT for the net clinical benefit with a numerical increase in cardiovascular events despite reduction in bleeding events. The directionally different efficacy and safety outcomes indicate the need for further clinical trials.
Aim:The aim of the present study was to investigate how small dense low-density lipoprotein cholesterol (sdLDL-C) compared with LDL-C affect the long-term prognosis in patients with stable coronary artery disease (CAD). Methods: sdLDL-C measured by heparin magnesium precipitation and LDL particle size measured by non-denatured gradient-gel electrophoresis were compared in 190 consecutive CAD patients who underwent coronary arteriography between 2003 and 2004 who did or did not develop cardiovascular events during a seven-year follow-up period. Cardiovascular events were death caused by cardiovascular diseases (CVDs), onset of acute coronary syndrome, need for coronary and peripheral arterial revascularization, hospitalization for heart failure, surgical procedure for any CVDs, and/or hospitalization for stroke. Results: First-time cardiovascular events were observed in 72 patients. Those who experienced cardiovascular events were older and had higher prevalence rates of hypertension and diabetes; significantly higher Gensini coronary atherosclerotic scores; significantly higher levels of sdLDL-C, sdLDL-C/LDL-C, and LDL-C/high-density lipoprotein cholesterol (HDL-C) ratios; and greater glycated hemoglobin (Hb)A1c and brain natriuretic peptide (BNP) levels. They also had significantly smaller LDL particle sizes, HDL-C, apolipoprotein A-1, and estimated glomerular filtration rate (GFR) compared with patients without cardiovascular events. Conversely, LDL-C, non-HDL-C, apolipoprotein B, remnantlike particle cholesterol, and high-sensitivity C-reactive protein (hs-CRP) levels were similar between the two groups. A Kaplan-Meyer event-free survival curve demonstrated that patients with sdLDL-C ≥ 35 mg/dL (median level) had significantly poorer prognosis compared with those with lower sdLDL-C levels, while patients with LDL-C ≥ 100 mg/dL had a non-significantly lower survival rate. Conclusion: These results confirm that sdLDL-C is a very promising biomarker to predict future cardiovascular events in the secondary prevention of stable CAD. J Atheroscler Thromb, 2014; 21:755-767.
Patients undergoing chronic hemodialysis (HD) are at high risk of restenosis and cardiac events after percutaneous coronary intervention (PCI). This study compared the clinical efficacy of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in patients undergoing HD. Between June 2004 and January 2010, the clinical outcomes of 41 consecutive patients on HD who underwent PCI with SES (62 lesions) were compared with those of 38 consecutive patients on HD who underwent PCI with PES (54 lesions). Patient and lesion characteristics were similar between both groups. The target lesion revascularization (TLR) (SES 36.6 % vs. PES 15.8 %; P = 0.037) was significantly higher with SES (36.6 %) than with PES (15.8 %) (P = 0.037), particularly in the context of severe calcified lesions that required rotational atherectomy (SES 72.7 % vs. PES 16.7 %; P = 0.0067). However, 1 year after PCI, there was no difference between the two groups in all-cause death, myocardial infarction or major adverse cardiac events. Patients undergoing HD are at a high risk of restenosis after PCI, even when using a drug-eluting stent. The TLR was higher with SES than with PES, particularly when used for severe calcified lesions that required rotational atherectomy.
injury (AKI) development. Many studies have demonstrated that worsening renal function due to contrast use is strongly associated with cardiovascular events. 7-9 It is also known that an under-expanding stent is associated with target vessel failure after PCI. 10,11 Thus, a high-quality imaging-guided PCI procedure with less contrast volume should improve the clinical outcomes of patients with CKD and ischemic heart disease. There is some evidence that mini-contrast PCI prevents renal events; 12-16 however, little data are available on the feasibility and safety of zerocontrast PCI for patients with CKD, 17,18 and the long-term I t is well known that patients with chronic kidney disease (CKD) have a high cardiovascular event rate. 1-4 The recent ISCHEMIA-CKD trial demonstrated that an initial invasive strategy did not improve the clinical outcomes in patients with moderate or severe ischemic heart disease and advanced CKD compared with an initial conservative strategy. 5 One explanation may be that most acute coronary syndrome cases occur as a consequence of plaque rupture in arteries without high-grade stenosis. Thus, prevention of acute coronary syndrome by prophylactic revascularization with percutaneous coronary intervention (PCI) is often difficult. 6 The more important cause may be contrast use during the PCI procedure. CKD is the strongest predictor of contrast-associated acute kidney Editorial p ????
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