Objectives The goal of this study was to identify clinical and lesion-specific local factors affecting visual-functional mismatch. Background Although lesion severity determined by coronary ...angiography has not been well correlated with physiological significance, the mechanism of the discordance remains poorly understood. Methods The authors assessed quantitative coronary angiography, intravascular ultrasound (IVUS), and fractional flow reserve (FFR) in a prospective cohort of 1,000 patients with 1,129 coronary lesions. Three-dimensional computational simulation studies were performed. Results Lesions with angiographic diameter stenosis (DS) ≥50% and FFR >0.80 (“mismatches”) were seen in 57% of non–left main lesions and in 35% of the left main lesions, respectively (p = 0.032). Conversely, among the lesions with DS <50% and FFR <0.80 (“reverse mismatches”) 16% were found in the non–left main lesions and 40% in the left main lesions (p < 0.001). The independent predictors for mismatch were advanced age, non–left anterior descending artery location, absence of plaque rupture, short lesion length, large minimal lumen area, smaller plaque burden, and greater minimal lumen diameter. Conversely, reverse mismatch was independently associated with younger age, left anterior descending artery location, the presence of plaque rupture, a smaller minimal lumen area, and larger plaque burden. In a computational simulation study, FFR was influenced by DS, lesion length, different lesion shape, plaque eccentricity, surface roughness, and various shapes of plaque rupture. Conclusions There were high frequencies of visual-functional mismatch between angiography and FFR. The discrepancy was related to the clinical and lesion-specific factors frequently unrecognizable by angiography, thus suggesting that coronary angiography cannot accurately predict FFR. (Natural History of FFR-Guided Deferred Coronary Lesions IRIS FFR-DEFER; NCT01366404 )
Objectives We investigated whether statin therapy could be beneficial in patients with acute myocardial infarction (AMI) who have baseline low-density lipoprotein cholesterol (LDL-C) levels below 70 ...mg/dl. Background Intensive lipid-lowering therapy with a target LDL-C value <70 mg/dl is recommended in patients with very high cardiovascular risk. However, whether to use statin therapy in patients with baseline LDL-C levels below 70 mg/dl is controversial. Methods We analyzed 1,054 patients with AMI who had baseline LDL-C levels below 70 mg/dl and survived at discharge from the Korean Acute MI Registry between November 2005 and December 2007. They were divided into 2 groups according to the prescribing of statins at discharge (statin group n = 607; nonstatin group n = 447). The primary endpoint was the composite of 1-year major adverse cardiac events, including death, recurrent MI, target vessel revascularization, and coronary artery bypass grafting. Results Statin therapy significantly reduced the risk of the composite primary endpoint (adjusted hazard ratio HR: 0.56; 95% confidence interval CI: 0.34 to 0.89; p = 0.015). Statin therapy reduced the risk of cardiac death (HR: 0.47; 95% CI: 0.23 to 0.93; p = 0.031) and coronary revascularization (HR: 0.45, 95% CI: 0.24 to 0.85; p = 0.013). However, there were no differences in the risk of the composite of all-cause death, recurrent MI, and repeated percutaneous coronary intervention rate. Conclusions Statin therapy in patients with AMI with LDL-C levels below 70 mg/dl was associated with improved clinical outcome.
Abstract Objectives This study sought to investigate the incidence, management, and clinical relevance of atrial fibrillation (AF) during and after percutaneous coronary intervention (PCI) with ...drug-eluting stents (DES) and evaluate outcomes of different antithrombotic strategies. Background Uncertainty exists regarding the optimal antithrombotic strategy in patients with AF who are undergoing PCI with DES. Methods Using a consecutive series of 10,027 patients who underwent DES implantation between 2003 and 2011, we evaluated the overall prevalence and clinical impact of AF. In addition, we compared the efficacy and safety of dual antiplatelet therapy (DAPT) (aspirin plus clopidogrel) and triple therapy (DAPT plus warfarin) among patients with AF. The primary outcome was a composite of cardiovascular death, myocardial infarction, or stroke. Results Overall, 711 (7.1%) patients had a diagnosis of AF at the index PCI. Patients with AF were older, had more comorbid conditions, and more often had a history of strokes; most patients with AF (88.4%) received DAPT rather than triple therapy (10.5%) at discharge. The rate of primary outcome after PCI during the 6-year follow-up period was significantly higher in patients with AF than in those without AF (22.1% vs. 8.0%; p < 0.001). This trend was consistent for major bleeding (4.5% vs. 1.5%; p < 0.001). After multivariable adjustment, the presence of AF was significantly associated with a higher risk of primary outcome (hazard ratio HR: 2.33; 95% confidence interval CI: 1.95 to 2.79; p < 0.001) and major bleeding (HR: 2.01; 95% CI: 1.32 to 3.06; p = 0.001). Among patients with AF, adjusted risk for the primary outcome was similar between the DAPT group and the triple therapy group (HR: 1.01; 95% CI: 0.60 to 1.69; p = 0.98), but triple therapy was associated with a significantly higher risk of hemorrhagic stroke (HR: 7.73; 95% CI: 2.14 to 27.91; p = 0.002) and major bleeding (HR: 4.48; 95% CI: 1.81 to 11.08; p = 0.001). Conclusions Among patients receiving DES implantation, AF was not rare and was associated with increased ischemic and bleeding risk. In patients with AF, triple therapy was not associated with decreased ischemic events but was associated with increased bleeding risk compared to DAPT.
A Randomized Comparison of Sirolimus- Versus Paclitaxel-Eluting Stent Implantation in Patients With Diabetes Mellitus Seung-Whan Lee, Seong-Wook Park, Young-Hak Kim, Sung-Cheol Yun, Duk-Woo Park, ...Cheol Whan Lee, Myeong-Ki Hong, Kyoung-Suk Rhee, Jei Keon Chae, Jae-Ki Ko, Jae-Hyeong Park, Jae-Hwan Lee, Si Wan Choi, Jin-Ok Jeong, In-Whan Seong, Yoon Haeng Cho, Nae-Hee Lee, June Hong Kim, Kook-Jin Chun, Hyun-Sook Kim, Seung-Jung Park To compare the effectiveness of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES), we randomly compared SES (n = 200) and PES (n = 200) in patients with diabetes mellitus (DM). Six-month in-stent (3.4% vs. 18.2%, p < 0.001) and in-segment restenosis (4.0% vs. 20.8%, p < 0.001) and 9-month target lesion revascularization (2.0% vs. 7.5%, p = 0.017) were significantly lower in the SES versus the PES group. Major adverse cardiac events including death, myocardial infarction, and target lesion revascularization at 9 months (2.0% vs. 8.0%, p = 0.010) were lower in the SES versus the PES group. In conclusion, SES significantly reduced angiographic restenosis and improved clinical outcomes in diabetic patients compared with PES implantation.
To evaluate the impact of cilostazol on neointimal hyperplasia after drug-eluting stent (DES) implantation for long coronary lesions, we performed a randomized multicenter prospective study comparing ...triple antiplatelet therapy (aspirin, clopidogrel, and cilostazol; triple group, n = 250) and dual antiplatelet therapy (aspirin and clopidogrel; standard group, n = 250) for 6 months in patients with long lesions (≥25 mm) requiring a long DES (≥32 mm). The primary end point was in-stent late loss at 6-month angiography. The 2 groups had similar baseline clinical and angiographic characteristics. In-stent late loss (0.22 ± 0.48 mm vs 0.32 ± 0.51 mm, p = 0.031) and in-segment late loss (0.34 ± 0.49 mm vs 0.51 ± 0.49 mm, p = 0.001) at 6-month follow-up angiography were significantly lower in the triple group versus the standard group. There was a trend toward lower rates of in-segment restenosis in the triple group versus the standard group (6.7% vs 11.2%, p = 0.104). Target lesion revascularization (TLR; 2.8% vs 6.8%, p = 0.036) and major adverse cardiac events (2.8% vs 7.6%, p = 0.016), including death, myocardial infarction, and TLR at 9 months were significantly lower in the triple group than in the standard group. At 9 months, the 2 groups had similar rates of stent thrombosis (0.4% vs 0.4%, p = 0.999), death (0% vs 0.8%, p = 0.499), and myocardial infarction (0.4% vs 0.4%, p = 0.999). In conclusion, cilostazol significantly reduced late loss at 6 months after DES implantation and the occurrence of TLR and major adverse cardiac events in patients with long coronary lesions.
Objectives This study aimed to validate the SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery) score representing angiographic complexity after unprotected left main coronary artery (ULMCA) ...revascularization. Background The validity of the SYNTAX score has been adequately evaluated. Methods The SYNTAX scores were calculated for 1,580 patients in a large multicenter registry who underwent percutaneous coronary intervention (PCI) (n = 819) or coronary artery bypass graft (CABG) (n = 761) for ULMCA stenosis. The outcomes of interests were 3-year incidences of major adverse vascular events (MAVE), including death, Q-wave myocardial infarction, and stroke and major adverse cardiac and cerebrovascular events (MACCE), including MAVE and target vessel revascularization of ULMCA. Results The incidence of 3-year MAVE was 6.2% in the lowest (≤23), 7.1% in the intermediate (23 to ∼36), and 17.4% in the highest (>36) SYNTAX score tertile groups after PCI (p = 0.010). However, the incidences of MAVE in the CABG group and MACCE in the PCI and CABG groups did not differ among the SYNTAX tertiles. In subgroups, the MAVE (p = 0.005) and MACCE (p = 0.007) rates according to the SYNTAX score tertiles were significantly different in patients receiving drug-eluting stent, not in those receiving bare-metal stent. When compared with the clinical EuroSCORE (European System for Cardiac Operative Risk Evaluation), the C-indexes of SYNTAX score and EuroSCORE were 0.59 and 0.67, respectively, for discrimination of MAVE and 0.53 and 0.57, respectively, for MACCE. Conclusions The angiographic SYNTAX score seems to play a partial role in predicting long-term adverse events after PCI for ULMCA stenosis. A complementary consideration of patient's clinical risk might improve the predictive ability of risk score.
Few studies have compared the ability of sodium bicarbonate plus N-acetylcysteine (NAC) and sodium chloride plus NAC to prevent contrast-induced nephropathy (CIN) in diabetic patients with impaired ...renal function undergoing coronary or endovascular angiography or intervention. Diabetic patients (n = 382) with renal disease (serum creatinine ≥1.1 mg/dl and estimated glomerular filtration rate <60 ml/min/1.73 m2 ) were randomly assigned to receive prophylactic sodium chloride (saline group, n = 189) or sodium bicarbonate (bicarbonate group, n = 193) before elective coronary or endovascular angiography or intervention. All patients received oral NAC 1,200 mg 2 times/day for 2 days. The primary end point was CIN, defined as an increase in serum creatinine >25% or an absolute increase in serum creatinine ≥0.5 mg/dl within 48 hours after contrast exposure. There were no significant between-group differences in baseline characteristics. The primary end point was met in 10 patients (5.3%) in the saline group and 17 (9.0%) in the bicarbonate group (p = 0.17), with 2 (1.1%) and 4 (2.1%), respectively, requiring hemodialysis (p = 0.69). Rates of death, myocardial infarction, and stroke did not differ significantly at 1 month and 6 months after contrast exposure. In conclusion, hydration with sodium bicarbonate is not superior to hydration with sodium chloride in preventing CIN in patients with diabetic nephropathy undergoing coronary or endovascular angiography or intervention.
Intravascular Ultrasound-Derived Predictors for Fractional Flow Reserve in Intermediate Left Main Disease Soo-Jin Kang, Jong-Young Lee, Jung-Min Ahn, Hae Geun Song, Won-Jang Kim, Duk-Woo Park, ...Sung-Cheol Yun, Seung-Whan Lee, Young-Hak Kim, Gary S. Mintz, Cheol Whan Lee, Seong-Wook Park, Seung-Jung Park To determine the best intravascular ultrasound (IVUS) criteria for predicting physiological significance of left main (LM) stenosis, we identified 55 patients with an isolated LM lesion of 30% to 80% angiographic stenosis who underwent IVUS and fractional flow reserve (FFR) before intervention. The independent determinants of FFR were minimal lumen area (MLA) (beta = 0.598, p < 0.001) and plaque rupture (beta = −0.255, p = 0.038). The IVUS MLA value within the LM that best predicted FFR <0.80 was <4.8 mm2 (89% sensitivity, 83% specificity). In addition, the cutoff value of plaque burden to predict FFR <0.80 was ≥72%. In isolated LM disease, an IVUS-derived MLA <4.8 mm2 is a useful criterion for predicting FFR <0.80.
The aim of the present study was to assess the intravascular ultrasound predictors for angiographic edge restenosis after newer generation drug-eluting stent implantation. A total of 820 patients ...(987 lesions) who underwent newer generation drug-eluting stent placement (236 Endeavor zotarolimus-eluting stents, 246 Resolute zotarolimus-eluting stents, and 505 everolimus-eluting stents) with 9 months of angiographic surveillance were enrolled. The post-stenting angiographic and intravascular ultrasound images of 1,668 reference segments (681 proximal and 987 distal) were analyzed. Overall, 37% of angiographically normal proximal reference segments and 21% of angiographically normal distal reference segments had plaque burden >50%. In the overall cohort of 1,668 reference segments, 47 (2.8%) had 9-month angiographic edge restenosis (diameter stenosis >50%). Edge restenosis was predicted by a post-stenting reference segment plaque burden >54.5% (sensitivity 81%, specificity 80%) and a reference segment minimum lumen area of 5.7 mm2 (sensitivity 72%, specificity 59%). The edge restenosis rate was 2.1% in the Endeavor zotarolimus-eluting stents, 2.4% in the Resolute zotarolimus-eluting stents, and 3.4% in the everolimus-eluting stents lesions (p = 0.311). The predictive cutoff of the reference plaque burden was 56.3% for Endeavor zotarolimus-eluting stents, 57.3% for Resolute zotarolimus-eluting stents, and 54.2% for everolimus-eluting stents. The criteria for residual plaque burden were similar between proximal and distal reference segments (56.4% vs 51.9%, respectively), but the minimum lumen area criteria were quite different (<7.1 mm2 for proximal vs <4.8 mm2 for distal reference segments). In conclusion, after newer drug-eluting stent implantation, edge restenosis was predicted by post-stenting reference segment plaque burden >55%.
Abstract Objectives The purpose of this study was to evaluate long-term clinical outcomes after drug-eluting stent–supported percutaneous coronary intervention (PCI) for native coronary total ...occlusion (CTO). Background The benefit of successful recanalization of CTO on prognosis remains uncertain. Methods Between March 2003 and May 2014, 1,173 consecutive patients with CTO of native coronary vessels requiring PCI were enrolled. Drug-eluting stent implantation was performed in all successful procedures (1,004 patients, 85.6%). Results During a median follow-up of 4.6 years, the adjusted risks of all-cause mortality (hazard ratio HR: 1.04; 95% confidence interval CI: 0.53 to 2.04; p = 0.92) and the composite of death or myocardial infarction (HR: 1.05; 95% CI: 0.56 to 1.94; p = 0.89) were found to be comparable between patients with successful and failed CTO-PCI, whereas the adjusted risk of target vessel revascularization (HR: 0.15; 95% CI: 0.10 to 0.25; p < 0.001) and coronary artery bypass grafting (HR: 0.02; 95% CI: 0.006 to 0.06, p < 0.001) was significantly higher in patients with failed CTO-PCI. Among patients (n = 879) in whom complete revascularization for non-CTO vessels was performed, the risk of death or the composite of death or myocardial infarction were not found to differ between patients who underwent successful recanalization of the remaining CTO and patients who did not. This finding was consistent regardless of whether the patient had a multivessel disease including CTO or only had a single CTO disease. Conclusions Successful CTO-PCI compared with failed PCI was not associated with a lesser risk for mortality. However, successful CTO-PCI was associated with significantly less subsequent coronary artery bypass grafting.