Hironori Kitabata

Two-Year Follow-Up of Outcomes of Second-Generation Everolimus-Eluting Stents Versus First-Generation Drug-Eluting Stents for Stenosis of Saphenous Vein Grafts Used as Aortocoronary Conduits

Second-generation everolimus-eluting stents (EESs) have demonstrated superiority in efficacy and safety compared with first-generation drug-eluting stents (DESs) in the treatment of native coronary artery lesions. The present study evaluated and compared the safety and efficacy of EESs and first-generation DESs in saphenous vein graft lesions. The EES group consisted of 88 patients with 96 lesions, and the first-generation DES group consisted of 243 patients with 317 lesions (sirolimus-eluting stents, n = 212; paclitaxel-eluting stents, n = 105). The end points included target lesion revascularization, target vessel revascularization, major adverse cardiovascular events (composite of all-cause death, myocardial infarction, and target vessel revascularization), and definite stent thrombosis at 2 years. The groups had similar baseline characteristics and graft ages (128.1 ± 77.5 vs 132.4 ± 90.8 months, p = 0.686). The EES group had more type C lesions and less embolic protection device use. The peak postprocedure values of creatinine kinase-MB and troponin I were similar between the 2 groups. Overall, major adverse cardiovascular events occurred in 18.2% of EES patients and 35.0% of first-generation DES patients (p = 0.003), mainly driven by a lower target vessel revascularization rate (6.8% vs 24.5%, p <0.001). The target lesion revascularization rate was lower in the EES group (1.1% vs 11.6%, p = 0.005). Stent thrombosis was low and similar between the 2 groups (0% vs 0.8%, p = 1.000). On multivariate analysis, the type of DES implanted and graft age were the only independent predictors of major adverse cardiovascular events. In conclusion, the superiority of EESs compared with first-generation DESs shown in native artery lesions has been extended to saphenous vein graft lesions and should be considered as the DES of choice for this lesion type.

Bioresorbable metal scaffold for cardiovascular application: Current knowledge and future perspectives

Over the last decade, the introduction of drug-eluting stents has dramatically reduced restenosis and the need for repeat revascularization after implantation of metallic stents. Numerous concerns still remain, however, because of their permanent nature. Thus, the concept of bioresorbable temporary scaffolds composed of biocompatible materials has emerged as a potential alternative to permanent metal stents. Here we focus on metal alloys & discuss preclinical and clinical experiences with bioresorbable metal scaffolds.

Comparison of Adverse Outcomes After Contemporary Percutaneous Coronary Intervention in Women Versus Men With Acute Coronary Syndrome

Previous studies have shown a relation between female gender and adverse outcomes after percutaneous coronary intervention (PCI). The aim of this study was to determine whether there are differences in correlates between genders for these long-term adverse outcomes in patients with acute coronary syndromes. Gender differences were evaluated in the clinical outcomes of 6,929 consecutive patients with acute coronary syndromes from a large, contemporary PCI registry. Rates of major adverse cardiovascular events, defined as all-cause mortality, myocardial infarction, and target lesion revascularization at 1-year follow-up, are reported. Independent correlates of adverse outcomes were identified using multivariate proportional-hazards regression analysis. Women were older (p <0.001); had a higher prevalence of diabetes mellitus (p <0.001), systemic hypertension (p <0.001), chronic renal insufficiency (p = 0.02), peripheral arterial disease (p <0.001), and congestive heart failure (p <0.001); had lower body surface areas (p <0.001); and had higher body mass indexes (p <0.001). Acute coronary syndrome presentation in women tended to be unstable angina pectoris with Canadian Cardiovascular Society class III and IV symptoms, whereas men had more acute myocardial infarctions. At 1 year, the unadjusted rates of all-cause mortality (10.7% vs 7.5%, p <0.001) and major adverse cardiovascular events (16.4% vs 12.7%, p <0.001) were higher in women. There was a stark difference between the genders in independent correlates of mortality and major adverse cardiovascular events at 1 year. Moreover, the traditional correlates did not have the same impact in women as in men. In conclusion, although there are differences in clinical outcomes after PCI for women compared with men, there are different correlates for these adverse outcomes. These gender-based differences should be taken into account when women undergo contemporary PCI.

Safety of Reloading Prasugrel in Addition to Clopidogrel Loading in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention.

Patients with acute coronary syndrome undergoing percutaneous coronary intervention (PCI) commonly receive a loading dose of either clopidogrel or prasugrel, in addition to aspirin. The present study aimed to assess the safety of reloading prasugrel in patients who had initially received a loading dose of clopidogrel compared to prasugrel loading alone. The study included a cohort of 606 consecutive patients with acute coronary syndrome who had received a 60-mg loading dose of prasugrel before PCI. These patients were then categorized into clopidogrel preloading (300 or 600 mg) followed by prasugrel reloading (CP-load group, n = 90) and prasugrel loading only (P-load group, n = 516). Both groups received a 10-mg maintenance dose of prasugrel after PCI. The primary end point was in-hospital Thrombolysis In Myocardial Infarction-defined major bleeding. The secondary end points were other in-hospital bleeding complications and major cardiovascular events. Patients in the CP-load group compared to the P-load group were younger, with lower rates of cardiovascular risk factors. Significantly more patients in the CP-load group presented with biomarker-positive myocardial infarction (80.0% vs 30.6%, p ≤0.001) and cardiogenic shock (5.6% vs 1.4%, p = 0.022). No significant differences (p = NS) were seen in Thrombolysis In Myocardial Infarction major bleeding (2.6% vs 2.8%), Thrombolysis In Myocardial Infarction major or minor bleeding (12.2% vs 7.0%), the need for blood transfusion (2.6% vs 2.1%), and vascular complications (1.3% vs 2.0%) between groups. The CP-load group experienced more in-hospital major adverse cardiac events (5.6% vs 1.6%, p = 0.031), urgent coronary artery bypass grafting (3.3% vs 0.2%, p = 0.011), and longer hospital and intensive care unit stays. In conclusion, preloading with clopidogrel should not be prohibitive to reloading with prasugrel in patients presenting with acute coronary syndrome and undergoing PCI with respect to bleeding and vascular complications.

The state of the excimer laser for coronary intervention in the drug-eluting stent era

OBJECTIVES This study aims to determine how excimer laser coronary atherectomy (ELCA) performs in the drug-eluting stent (DES) era. BACKGROUND For more than 20 years, ELCA has been used for coronary intervention. With developments in the coronary intervention field, the role of ELCA is in question. METHODS The study includes 119 patients with 124 lesions who underwent percutaneous coronary intervention (PCI) with ELCA in our institution from January 2004 to May 2011. RESULTS The main indications for ELCA use were saphenous vein graft (SVG) (45 lesions), acute myocardial infarction (AMI) (7 lesions), chronic total occlusion (CTO) (32 lesions), in-stent restenosis (ISR) (15 lesions), and calcified de-novo lesions (25 lesions). High success rates were recorded for the SVG, AMI, CTO, ISR, and calcified lesion indications (91.1%, 85.7%, 93.8%, 86.7%, and 80%; respectively). ELCA related complications were reported in 10 patients (8%); four dissections, three no-reflow phenomena, two perforations, and one thrombus formation. CONCLUSION ELCA is an alternative solution with acceptable performance in the treatment of complex coronary lesions not ideally suitable for balloon angioplasty.

Clinical Presentation and Outcomes of Coronary In-Stent Restenosis Across 3-Stent Generations

Background—Clinical presentation of bare metal stent in-stent restenosis (ISR) in patients undergoing target lesion revascularization is well characterized and negatively affects on outcomes, whereas the presentation and outcomes of first- and second-generation drug-eluting stents (DESs) remains under-reported. Methods and Results—The study included 909 patients (1077 ISR lesions) distributed as follows: bare metal stent (n=388), first-generation DES (n=425), and second-generation DES (n=96), categorized into acute coronary syndrome (ACS) or non-ACS presentation mode at the time of first target lesion revascularization. ACS was further classified as myocardial infarction (MI) and unstable angina. For bare metal stent, first-generation DES and second-generation DES, ACS was the clinical presentation in 67.8%, 71.0%, and 66.7% of patients, respectively (P=0.470), whereas MI occurred in 10.6%, 10.1%, and 5.2% of patients, respectively (P=0.273). The correlates for MI as ISR presentation were current smokers (odds ratio, 3.02; 95% confidence interval [CI], 1.78–5.13; P<0.001), and chronic renal failure (odds ratio, 2.73; 95% CI, 1.60–4.70; P<0.001), with a protective trend for the second-generation DES ISR (odds ratio, 0.35; 95% CI, 0.12–1.03; P=0.060). ACS presentations had an independent effect on major adverse cardiac events (death, MI, and re-target lesion revascularization) at 6 months (MI versus non-ACS: adjusted hazard ratio, 4.06; 95% CI, 1.84–8.94; P<0.001; unstable angina versus non-ACS: adjusted hazard ratio, 1.98; 95% CI, 1.01–3.87; P=0.046). Conclusions—ISR clinical presentation is similar irrespective of stent type. MI as ISR presentation seems to be associated with patient and not device-related factors. ACS as ISR presentation has an independent effect on major adverse cardiac events, suggesting that ISR remains a hazard and should be minimized.

Operator learning curve for transradial percutaneous coronary interventions: implications for the initiation of a transradial access program in contemporary US practice ☆ ☆☆

OBJECTIVES Our study aimed to assess the characteristics and outcomes of transfemoral approach (TFA) versus the initial steps of a transradial approach (TRA) program and to assess the learning curve of TRA in contemporary, US practice. BACKGROUND When compared to TFA, TRA has been shown to lower bleeding and vascular complications during percutaneous coronary intervention (PCI). However, use of TRA is still low. There are limited data regarding the characteristics of TRA learning curve, especially in an era with designated TRA equipment. METHODS Consecutive patients undergoing PCI in a single US center were divided into two cohorts according to vascular access approach: the last 250 TFA patients prior to the establishment of a TRA program and the initial 239 TRA patients following the establishment of a TRA program. Subgroup analysis of the TRA group, which was divided into five sequential case groups of 50 cases per group, was performed in order to assess TRA learning curve. RESULTS Overall, the baseline characteristics of TFA vs. TRA groups were comparable. Fluoroscopy time was significantly longer during TRA procedures (18±11 vs. 15±8min, respectively, p=0.002); however, contrast use was lower during TRA procedures (161±72 vs. 180±63ml, respectively, p=0.002). In-hospital outcomes were similar between the two groups, with low frequencies of mortality, myocardial infarction, and stent thrombosis. Subanalysis of TRA group for learning curve assessment showed no major differences in patient demographics among the five subgroups. In the initial cases, more PCI was performed among non-acute cases (62% in patients 1-50 vs. 8-27% in patients 51-239, p<0.001). Despite these differences, characteristics of the treated vessels were similar between groups. There was no significant change in fluoroscopy time or in the amount of iodinated contrast volume delivered. Similarly, no differences in procedural, in-hospital, and long-term outcomes were documented. CONCLUSIONS Adopting TRA as a default is feasible for high-volume operators without significant learning curve effects.

Comparison of Outcomes After Percutaneous Coronary Intervention Among Different Coronary Subsets (Stable and Unstable Angina Pectoris and ST-Segment and Non-ST-Segment Myocardial Infarction)

Percutaneous coronary intervention in the setting of acute myocardial infarction is known to predict stent thrombosis (ST). This study aims to compare the ST rates across different coronary subsets. This was an observational cohort study from a large, single-center registry. Included were 12,198 consecutive patients who underwent percutaneous coronary intervention with stenting. Patients were categorized according to their clinical presentation: stable angina pectoris (SAP, n = 3,700), unstable angina pectoris (UAP, n = 2,845), non-ST-segment elevation myocardial infarction (NSTEMI, n = 4,083), and ST-segment elevation myocardial infarction (STEMI, n = 1,570). The study end points were ST rates at 1 year. Patients with STEMI were younger with a lower prevalence of cardiovascular risk factors, except for smoking. More type C lesions were treated in STEMI, whereas drug-eluting stents were used less frequently in patients with STEMI compared with the other groups. Definite ST at 1 year was highest in patients with STEMI (1.4%; vs SAP, 0.4%; UAP, 0.5%; NSTEMI, 0.5%; p <0.001). One-year definite/probable ST rates were SAP, 0.8%; UAP, 1.1%; NSTEMI, 1.4%; and STEMI, 3.2% (p <0.001). On multivariable analysis, STEMI independently predicts definite ST (hazards ratio [HR] 3.07, 95% confidence interval [CI] 1.32 to 7.10), whereas both STEMI (HR 3.36, 95% CI 1.84 to 6.12) and NSTEMI (HR 2.04, 95% CI 1.20 to 3.07) were independent predictors of definite/probable ST. Clopidogrel cessation was the strongest predictor of ST (definite ST, HR 17.00, 95% CI 7.54 to 38.31; definite/probable ST, HR 4.69, 95% CI 2.39 to 9.20). In conclusion, in patients who underwent percutaneous coronary intervention, the acuity of clinical presentation corresponds to an increase in ST incidence. Adherence to clopidogrel is critical to prevent ST in patients who underwent percutaneous coronary intervention, especially in STEMI.

Comparison of Long-Term Outcomes Between Everolimus-Eluting and Sirolimus-Eluting Stents in Small Vessels

Although second-generation everolimus-eluting stents (EESs) have demonstrated superiority over first-generation paclitaxel-eluting stents for a broad subset of patients and lesions, it is unclear whether the same applies to sirolimus-eluting stents (SESs). The present study compared the long-term clinical outcomes between EESs and SESs in patients with small coronary artery disease. A cohort of 643 patients treated with EESs (220 patients with 245 lesions) or SESs (423 patients with 523 lesions) in small vessel lesions (defined as those receiving stents ≤2.5 mm) were retrospectively analyzed. The end points included target lesion revascularization, target vessel revascularization, major adverse cardiovascular events (all-cause death, myocardial infarction, or target lesion revascularization), and definite stent thrombosis at 1 year of follow-up. The baseline characteristics were generally similar between the 2 groups, except that more systemic hypertension was seen in the EES group and more patients had a family history of coronary artery disease in the SES group. The 1-year target lesion revascularization (5.6% vs 4.8%, p = 0.68) and target vessel revascularization (5.6% vs 7.6%, p = 0.33) rates showed no significant differences between the EES and SES groups. Overall major adverse cardiovascular events occurred in 9.1% of the EES- and 8.6% of SES-treated patients (p = 0.83). This similar major adverse cardiovascular events rate remained after adjustment. The rate of stent thrombosis was 0% in the EES group and 1.2% in the SES group (p = 0.17). In conclusion, EESs demonstrated comparable clinical outcomes to those of SESs in small vessel interventions. The absence of stent thrombosis among patients treated with EESs suggests a good safety profile for this second-generation drug-eluting stent, which should be carefully studied in a larger series of patients with small vessel disease.

Safety and long‐term outcomes after percutaneous coronary intervention in patients with human immunodeficiency virus

This study aims to report the long‐term outcomes after percutaneous coronary intervention (PCI) in human immunodeficiency virus (HIV+) patients.