Long-Term Outcomes After Treatment With a Paclitaxel-Coated Balloon Versus Balloon Angioplasty: Insights From the PEPCAD-DES Study (Treatment of Drug-eluting Stent [DES] In-Stent Restenosis With SeQuent Please Paclitaxel-Coated Percutaneous Transluminal Coronary Angioplasty [PTCA] Catheter)

ObjectivesThe intention this PEPCAD-DES (Treatment of Drug-eluting Stent [DES] In-Stent Restenosis With SeQuent Please Paclitaxel Eluting Percutaneous Transluminal Coronary Angioplasty [PTCA] Catheter) study update was to demonstrate the safety and efficacy of paclitaxel-coated balloon (PCB) angioplasty in patients with DES-ISR at 3 years.BackgroundIn the PEPCAD-DES trial late lumen loss and the need for repeat target lesion revascularization (TLR) was significantly reduced with PCB angioplasty compared with plain old balloon angioplasty (POBA) in patients with drug-eluting stent in-stent restenosis (DES-ISR) at 6 months. We evaluated whether the clinical benefit of reduced TLR and major adverse cardiac events (MACE) was maintained up to 3 years.MethodsA total of 110 patients with DES-ISR in native coronary arteries with reference diameters ranging from 2.5 mm to 3.5 mm and lesion lengths ≤22 mm were randomized to treatment with either PCB or POBA in a multicenter, randomized, single-blind clinical study. With a 2:1 randomization, 72 patients were randomized to the PCB group and 38 patients to the POBA group. At baseline, there were lesions with at least 2 stent layers in PCB (52.8%, 38 of 72) and POBA (55.3%, 21 of 38) patients.ResultsAt 36 months, the TLR rates were significantly lower in the PCB group compared with the POBA control group (19.4% vs. 36.8%; p = 0.046). Multiple TLRs in individual patients were more frequent in the POBA group compared with the PCB group (more than 1 TLR: POBA, 13.2%; PCB, 1.4%; p = 0.021). The 36-month MACE rate was significantly reduced in the PCB group compared with the POBA group (20.8% vs. 52.6%, log-rank p = 0.001).ConclusionsPCB angioplasty was superior to POBA for the treatment of DES-ISR patients in terms of MACE and TLR for up to 36 months. There was no late catch-up phenomenon. (Treatment of Drug-eluting Stent [DES] In-Stent Restenosis With SeQuent® Please Paclitaxel Eluting Percutaneous Transluminal Coronary Angioplasty [PTCA] Catheter [PEPCAD-DES]; NCT00998439)     

Drug-Coated Balloons Versus Second-Generation Drug-Eluting Stents for the Management of Recurrent Multimetal-Layered In-Stent Restenosis

ObjectivesThis study aimed to investigate the clinical outcomes of patients presenting with recurrent drug-eluting stent (DES) in-stent restenosis (ISR) treated with a second-generation DES or with a drug-coated balloon (DCB).BackgroundTo date, there are no reports of DCB treatment and limited data with regard to the efficacy of further DES implantation for recurrent ISR.MethodsBetween January 2008 and December 2013, 171 lesions were assessed for eligibility (82 lesions in the second-generation DES group and 89 lesions in the DCB group).ResultsAcute gain was greater in the second-generation DES group (second-generation DES, 2.09 ± 0.53 mm vs. DCBs, 1.60 ± 0.62 mm, p < 0.001). The rates of major adverse cardiac events were comparable (at 1 year, DES 14.0% vs. DCBs 12.3%; at 2 years, DES 28.8% vs. DCBs 43.5%, p = 0.21). Major adverse cardiac event rates were mainly driven by target lesion revascularization (at 1 year, DES 12.5% vs. DCBs 10.9%; at 2 years, DES 27.7% vs. DCBs 38.3%; p = 0.40). Definite scaffold thrombosis occurred in 2 patients (1 patient in each group). Multivariable analysis revealed ISR recurrence within 1 year (hazard ratio: 2.43, 95% confidence interval: 1.14 to 5.18, p = 0.02) and lesion length (per 10-mm increase) (hazard ratio: 1.15, 95% confidence interval: 1.00 to 1.32, p = 0.049) to be independent predictors of TLR.ConclusionsThe results after both treatments were equivalent. ISR recurrence within 1 year of the first reintervention and lesion length were independent predictors of future target lesion revascularization. Larger studies are required to confirm the late (>1 year) differences with regard to clinical outcomes.     

Paclitaxel-Coated Balloon in Infrapopliteal Arteries: 12-Month Results From the BIOLUX P-II Randomized Trial (BIOTRONIK'S-First in Man study of the Passeo-18 LUX drug releasing PTA Balloon Catheter vs. the uncoated Passeo-18 PTA balloon catheter in subjects requiring revascularization of infrapopliteal arteries)

ObjectivesThe aim of BIOLUX P-II (BIOTRONIK'S–First in Man study of the Passeo-18 LUX drug releasing PTA Balloon Catheter vs. the uncoated Passeo-18 PTA balloon catheter in subjects requiring revascularization of infrapopliteal arteries) trial was to compare the safety and efficacy of a novel paclitaxel-coated drug-eluting balloon (DEB) versus an uncoated balloon (percutaneous transluminal angioplasty [PTA]) in de novo or native restenotic lesions of the infrapopliteal arteries in patients with claudication and critical limb ischemia.BackgroundDEB have shown promising results in femoropopliteal lesions, but data for infrapopliteal lesions are scarce.MethodsIn this prospective, multicenter, randomized first-in-man study, 72 patients were randomized 1:1 to either a Passeo-18 Lux DEB (Biotronik AG, Buelach, Switzerland) (n = 36) or Passeo-18 PTA (n = 36). Follow-up assessments were scheduled at 1, 6, and 12 months, with angiographic assessment at 6 months. Adverse events were adjudicated by an independent clinical events committee, and angiographic parameters were assessed by an independent core laboratory.ResultsThe primary safety endpoint (a composite of all-cause mortality, target extremity major amputation, target lesion thrombosis, and target vessel revascularization at 30 days) was 0% in the DEB group versus 8.3% in the PTA group (p = 0.239). The primary performance endpoint (patency loss at 6 months) was 17.1% in the DEB group versus 26.1% in the PTA group (p = 0.298), and major amputations of the target extremity occurred in 3.3% versus 5.6% of the patients at 12 months, respectively.ConclusionsThe Passeo-18 Lux DEB has been proven to be safe and effective in infrapopliteal lesions with comparable outcomes to PTA.     

Differential Prognostic Effect Between First- and Second-Generation Drug-Eluting Stents in Coronary Bifurcation Lesions: Patient-Level Analysis of the Korean Bifurcation Pooled Cohorts

ObjectivesThe purpose of this study was to investigate the differential clinical outcomes after percutaneous coronary intervention (PCI) for coronary bifurcation lesions with 1- or 2-stenting techniques using first- or second-generation drug-eluting stents (DES).BackgroundThe 2-stenting technique has been regarded to have worse clinical outcomes than the 1-stenting technique after bifurcation PCI with first-generation DES. However, there has been a paucity of data comparing the 1- and 2-stenting techniques with the use of second-generation DES.MethodsPatient-level pooled analysis was performed with 3,162 patients undergoing PCI using first- or second-generation DES for bifurcation lesions from the “Korean Bifurcation Pooled Cohorts” (COBIS [Coronary Bifurcation Stenting] II, EXCELLENT [Registry to Evaluate Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting], and RESOLUTE-Korea [Registry to Evaluate the Efficacy of Zotarolimus-Eluting Stent]). The 3-year clinical outcomes were compared between 1- and 2-stenting techniques, stratified by the type of DES.ResultsWith first-generation DES, rates of target lesion failure (TLF) or patient-oriented composite outcome (POCO) (a composite of all death, any myocardial infarction, any repeat revascularization, and cerebrovascular accidents) at 3 years were significantly higher after the 2-stenting than the 1-stenting technique (TLF 8.6% vs. 17.5%; p < 0.001; POCO 18.1% vs. 28.5%, p < 0.001). With second-generation DES, however, there was no difference between 1- and 2-stenting techniques (TLF 5.4% vs. 5.8%; p = 0.768; POCO 11.2% vs. 12.9%; p = 0.995). The differential effects of 2-stenting technique on the prognosis according to the type of DES were also corroborated with similar results by the inverse probability weighted model. The 2-stenting technique was a significant independent predictor of TLF in first-generation DES (hazard ratio: 2.046; 95% confidence interval: 1.114 to 3.759; p < 0.001), but not in second-generation DES (hazard ratio: 0.667; 95% confidence interval: 0.247 to 1.802; p = 0.425).ConclusionsPatient-level pooled analysis of 3,162 patients in Korean Bifurcation Pooled Cohorts demonstrated that the 2-stenting technique showed comparable outcomes to 1-stenting technique with second-generation DES, which is different from the results of first-generation DES favoring the 1-stenting technique.     

Long-Term Efficacy and Safety of Paclitaxel-Eluting Balloon for the Treatment of Drug-Eluting Stent Restenosis: 3-Year Results of a Randomized Controlled Trial

ObjectivesThis study sought to investigate the long-term comparative efficacy and safety of paclitaxel-eluting balloon (PEB), paclitaxel-eluting stent (PES), or balloon angioplasty (BA) for the treatment of drug-eluting stent restenosis.BackgroundThe optimal treatment of drug-eluting stent restenosis remains unknown. Although PEB has shown encouraging results, the long-term clinical efficacy and safety of PEB remains poorly defined.MethodsA total of 402 patients with clinically significant restenosis in limus-eluting stents were randomly assigned to receive PEB (n = 137), PES (n = 131), or BA (n = 134). For this analysis, PEB versus PES and PEB versus BA were compared. The primary efficacy and safety endpoints were target lesion revascularization and the composite of death or myocardial infarction.ResultsAt a median follow-up of 3 years, the risk of target lesion revascularization was comparable with PEB versus PES (hazard ratio [HR]: 1.46, 95% confidence interval [CI]: 0.91 to 2.33; p = 0.11) and lower with PEB versus BA (HR: 0.51, 95% CI: 0.34 to 0.74; p < 0.001). The risk of death/myocardial infarction tended to be lower with PEB versus PES (HR: 0.55, 95% CI: 0.28 to 1.07; p = 0.08), due to a lower risk of death (HR: 0.38, 95% CI: 0.17 to 0.87; p = 0.02). The risk of death/myocardial infarction was similar with PEB versus BA (HR: 0.96, 95% CI: 0.46 to 2.0; p = 0.91).ConclusionsAt 3 years, the use of PEB as compared with PES to treat patients with limus-eluting stent restenosis has similar efficacy and safety. PEB remains superior to BA. The sustained efficacy without trade-off in safety supports the role of PEB as treatment option for patients with drug-eluting stent restenosis. (Intracoronary Stenting and Angiographic Results: Drug Eluting Stent In-Stent Restenosis: 3 Treatment Approaches [ISAR-DESIRE 3]; NCT00987324)     

Randomized Comparisons Between Different Stenting Approaches for Bifurcation Coronary Lesions With or Without Side Branch Stenosis

ObjectivesThis study sought to evaluate the optimal percutaneous coronary intervention techniques using drug-eluting stents for bifurcation coronary lesions.BackgroundThe optimal bifurcation stenting technique needs to be evaluated.MethodsThe trial included 2 randomization studies separated by the presence of side branch (SB) stenosis for patients having non–left main bifurcation lesions. For 306 patients without SB stenosis, the routine final kissing balloon or leave-alone approaches were compared. Another randomization study compared the crush or single-stent approaches for 419 patients with SB stenosis.ResultsBetween the routine final kissing balloon and leave-alone groups for nondiseased SB lesions, angiographic restenosis occurred in 17.9% versus 9.3% (p = 0.064), comprising 15.1% versus 3.7% for the main branch (p = 0.004) and 2.8% versus 5.6% for the SB (p = 0.50) from 214 patients (69.9%) receiving 8-month angiographic follow-up. Incidence of major adverse cardiac events including death, myocardial infarction, or target vessel revascularization over 1 year was 14.0% versus 11.6% between the routine final kissing balloon and leave-alone groups (p = 0.57). In another randomization study for diseased SB lesions, 28.2% in the single-stent group received SB stents. From 300 patients (71.6%) receiving angiographic follow-up, between the crush and single-stent groups, angiographic restenosis rate was 8.4% versus 11.0% (p = 0.44), comprising 5.2% versus 4.8% for the main branch (p = 0.90) and 3.9% versus 8.3% for the SB (p = 0.12). One-year major adverse cardiac events rate between the crush and single-stent groups was 17.9% versus 18.5% (p = 0.84).ConclusionsAngiographic and clinical outcomes were excellent after percutaneous coronary intervention using drug-eluting stents with any stent technique for non–left main bifurcation lesions once the procedure was performed successfully.     

Clinical Events and Patient-Reported Chest Pain in All-Comers Treated With Resolute Integrity and Promus Element Stents: 2-Year Follow-Up of the DUTCH PEERS (DUrable Polymer-Based STent CHallenge of Promus ElemEnt Versus ReSolute Integrity) Randomized Trial (TWENTE II)

ObjectivesThis study assessed clinical events and patient-reported chest pain 2 years after treatment of all-comers with Resolute Integrity zotarolimus-eluting stents (Medtronic Vascular, Santa Rosa, California) and Promus Element everolimus-eluting stents (Boston Scientific, Natick, Massachusetts).BackgroundFor both drug-eluting stents (DES), no all-comer outcome data from >12 months of follow-up have been published. Although there is increasing interest in patient-reported chest pain following stenting, data with novel DES are scarce.MethodsThe DUTCH PEERS multicenter trial (TWENTE II) (DUrable Polymer-Based STent CHallenge of Promus ElemEnt Versus ReSolute Integrity) Randomized Trial [TWENTE II]) randomized 1,811 all-comer patients to treatment with 1 type of DES. Monitoring and event adjudication were performed by independent contract research organizations.ResultsThe 2-year follow-up of 1,810 patients (99.9%) was available. The primary composite endpoint target vessel failure occurred in 8.6% and 7.8% of patients treated with zotarolimus- and everolimus-eluting stents, respectively (p = 0.55). Rates of components of target vessel failure were: cardiac death (2.4% vs. 1.9%, p = 0.42); target vessel–related myocardial infarction (2.4% vs. 1.8%, p = 0.33); clinically-indicated target vessel revascularization (4.6% vs. 4.9%, p = 0.83). At 1- and 2-year follow-up, >80% of patients were free from chest pain (no between-stent difference). In addition, >87% of patients were either free from chest pain or experienced pain only at maximal physical exertion, but not during normal daily activities. Patients with chest pain after 12 months at no more than moderate physical effort had a higher risk of target vessel revascularization during the following year (hazard ratio: 1.89 [95% confidence interval: 1.05 to 3.39], p = 0.03).ConclusionsDuring the second year of follow-up, the incidence of adverse clinical endpoints remained similar and low for both DES. The vast majority of patients were free from chest pain.     

Incidence and Clinical Impact of Stent Fracture After PROMUS Element Platinum Chromium Everolimus-Eluting Stent Implantation

ObjectivesThis study sought to assess the incidence and clinical impact of stent fracture (SF) after the PROMUS Element platinum-chromium everolimus-eluting stent (PtCr-EES).BackgroundSF remains an unresolved, clinically relevant issue, even in the newer-generation drug-eluting stent era.MethodsFrom March 2012 to August 2013, 816 patients with 1,094 lesions were treated only with PtCr-EES and 700 patients (85.7%) with 898 lesions undergoing follow-up angiography within 9 months after the index procedure were analyzed. SF was defined as complete or partial separation of the stent, as assessed by plain fluoroscopy, intravascular ultrasound, or optical coherence tomography during the follow-up. We assessed the rate of SF and the cumulative incidence of clinically driven target lesion revascularization and definite stent thrombosis within 9 months after the index procedure.ResultsSF was observed in 16 of 898 lesions (1.7%) and 16 of 700 patients (2.2%). Lesions with in-stent restenosis at baseline (odds ratio [OR]: 14.2, 95% confidence intervals [CI]: 5.09 to 39.7; p < 0.001) or hinge motion (OR: 4.31, 95% CI: 1.12 to 16.5; p = 0.03), and total stent length (per 10-mm increase; OR: 1.32, 95% CI: 1.12 to 1.57; p = 0.001) were predictors of SF. Cumulative incidence of clinically driven target lesion revascularization within 9-months was numerically higher in the SF group than that in the non-SF group (18.7% vs. 2.3%). Cumulative incidence of definite stent thrombosis within 9 months after the index procedure was similar between the SF and non-SF groups (0.0% vs. 0.23%).ConclusionsSF after PtCr-EES occurs in 1.7% of lesions and appears to be associated with clinically driven target lesion revascularization.     

A Randomized Comparison of Novel Biodegradable Polymer- and Durable Polymer–Coated Cobalt-Chromium Sirolimus-Eluting Stents

ObjectivesThe aim of this study was to investigate the hypothesis that a novel biodegradable polymer–coated, cobalt-chromium (CoCr), sirolimus-eluting stent (BP-SES) is noninferior in safety and efficacy outcomes compared with a durable polymer (DP)-SES.BackgroundNo randomized trials have the compared safety and efficacy of BP-SES versus DP-SES on similar CoCr platforms, thereby isolating the effect of the polymer type.MethodsIn this prospective, single-blind, randomized trial conducted at 32 Chinese sites, 2,737 patients eligible for coronary stenting were treated with BP- or DP-SES in a 2:1 ratio. The primary endpoint was 12-month target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization. Secondary endpoints included TLF components, and definite/probable stent thrombosis.ResultsAt 12 months, the difference in the primary endpoint of TLF between BP-SES (6.3%) and DP-SES (6.1%) groups was 0.25% (95% confidence interval: −1.67% to 2.17%, p for noninferiority = 0.0002), demonstrating noninferiority of BP-SES to DP-SES. Individual TLF components of cardiac death (0.7% vs. 0.6%, p = 0.62), target vessel myocardial infarction (3.6% vs. 4.3%, p = 0.39), and clinically indicated target lesion revascularization (2.6% vs. 2.2%, p = 0.50) were similar, as were low definite/probable stent thrombosis rates (0.4% vs. 0.6%, p = 0.55).ConclusionsIn this large-scale real-world trial, BP-SES was noninferior to DP-SES for 1-year TLF. (Evaluate Safety and Effectiveness of the Tivoli ® DES and the Firebird ® DES for Treatment of Coronary Revascularization; NCT01681381)     

Relation Between Bioresorbable Scaffold Sizing Using QCA-Dmax and Clinical Outcomes at 1 Year in 1,232 Patients From 3 Study Cohorts (ABSORB Cohort B,ABSORB EXTEND,and ABSORB II)

ObjectivesThis study sought to investigate the clinical outcomes based on the assessment of quantitative coronary angiography–maximal lumen diameter (Dmax).BackgroundAssessment of pre-procedural Dmax of proximal and distal sites has been used for Absorb scaffold size selection in the ABSORB studies.MethodsA total of 1,248 patients received Absorb scaffolds in the ABSORB Cohort B (ABSORB Clinical Investigation, Cohort B) study (N = 101), ABSORB EXTEND (ABSORB EXTEND Clinical Investigation) study (N = 812), and ABSORB II (ABSORB II Randomized Controlled Trial) trial (N = 335). The incidence of major adverse cardiac events (MACE) (a composite of cardiac death, any myocardial infarction [MI], and ischemia-driven target lesion revascularization) was analyzed according to the Dmax subclassification of scaffold oversize group versus scaffold nonoversize group.ResultsOf 1,248 patients, pre-procedural Dmax was assessed in 1,232 patients (98.7%). In 649 (52.7%) patients, both proximal and distal Dmax values were smaller than the nominal size of the implanted scaffold (scaffold oversize group), whereas in 583 (47.3%) of patients, the proximal and/or distal Dmax were larger than the implanted scaffold (scaffold nonoversize group). The rates of MACE and MI at 1 year were significantly higher in the scaffold oversize group than in the scaffold nonoversize group (MACE 6.6% vs. 3.3%; log-rank p < 0.01, all MI: 4.6% vs. 2.4%; log-rank p = 0.04), mainly driven by a higher MI rate within 1 month post-procedure (3.5% vs. 1.9%; p = 0.08). The independent MACE determinants were both Dmax smaller than the scaffold nominal size (odds ratio [OR]: 2.13, 95% confidence interval [CI]: 1.22 to 3.70; p < 0.01) and the implantation of overlapping scaffolds (OR: 2.10, 95% CI: 1.17 to 3.80; p = 0.01).ConclusionsImplantation of an oversized Absorb scaffold in a relatively small vessel appears to be associated with a higher 1-year MACE rate driven by more frequent early MI. (ABSORB Clinical Investigation, Cohort B [ABSORB Cohort B], NCT00856856; ABSORB EXTEND Clinical Investigation [ABSORB EXTEND], NCT01023789; ABSORB II Randomized Controlled Trial [ABSORB II], NCT01425281)     

In-Stent Yellow Plaque at 1 Year After Implantation Is Associated With Future Event of Very Late Stent Failure: The DESNOTE Study (Detect the Event of Very late Stent Failure From the Drug-Eluting Stent Not Well Covered by Neointima Determined by Angioscopy)

ObjectivesThis study examined whether coronary angioscopy-verified in-stent yellow plaque at 1 year after drug-eluting stent (DES) implantation is associated with future event of very late stent failure (VLSF).BackgroundAtherosclerosis detected as yellow plaque by angioscopy has been associated with future events of acute coronary syndrome. Development of in-stent neoatherosclerosis is a probable mechanism of VLSF.MethodsThis study included 360 consecutive patients who received successful angioscopic examination at 1 year after implantation of a DES. They were clinically followed up for VLSF defined as cardiac death, acute myocardial infarction or unstable angina, or need for revascularization associated with the stent site.ResultsThe follow-up interval was 1,558 ± 890 days (4.3 ± 2.4 years). The incidence of VLSF was significantly higher in the patients with yellow plaque than in those without (8.1% vs. 1.6%; log rank p = 0.02). Multivariable analysis revealed the presence of yellow plaque (hazard ratio [HR]: 5.38; p = 0.02) and absence of statin therapy (HR: 3.25; p = 0.02) as risks of VLSF.ConclusionsIn-stent atherosclerosis evaluated by yellow plaque at 1 year after the implantation of DES and the absence of statin therapy were risks of VLSF. The underlying mechanism of VLSF appeared to be the progression of atherosclerosis as demonstrated by the yellow plaque.     

Randomized Comparison of Everolimus-Eluting Stents and Sirolimus-Eluting Stents in Patients With ST Elevation Myocardial Infarction: RACES-MI Trial

ObjectivesThe aim of the current study was to compare everolimus-eluting stents (EES) with sirolimus-eluting stents (SES) in patients undergoing primary angioplasty.BackgroundDrug-eluting stents may offer benefits in terms of repeat revascularization. However, as shown for first-generation drug-eluting stents, they may be counterbalanced by a potential higher risk of stent thrombosis, especially among patients with ST-segment elevation myocardial infarction (STEMI). No data have been reported so far on the long-term benefits and safety of the new generation of drug-eluting stents in STEMI.MethodsConsecutive STEMI patients admitted within 12 h of symptom onset and undergoing primary angioplasty and stent implantation at a tertiary center with 24-h primary percutaneous coronary intervention capability were randomly assigned to SES or EES. The primary endpoint was a major adverse cardiac event at 3-year follow-up. The secondary endpoints were death, reinfarction, definite or probable stent thrombosis, and target vessel revascularization at 3-year follow-up. No patient was lost to follow-up.ResultsFrom April 2007 to May 2009, 500 patients with STEMI were randomized to EES (n = 250) or SES (n = 250). No difference was observed in terms of baseline demographic and clinical characteristics between the groups. No difference was observed between the groups in terms of number of implanted stents per patient or total stent length. However, a larger reference diameter was observed with SES (3.35 ± 0.51 mm vs. 3.25 ± 0.51 mm, p = 0.001), whereas patients randomized to EES more often received glycoprotein IIb/IIIa inhibitors (54.4% vs. 42.4%, p = 0.006). Follow-up data were available in all patients (1,095 ± 159 days). No significant difference was observed between EES and SES in major adverse cardiac events (16% vs. 20.8%, adjusted hazard ratio [HR]: 0.75 [95% confidence interval (CI): 0.5 to 1.13], p = 0.17), cardiac death (4.4% vs. 5.6%, adjusted HR: 0.77 [95% CI: 0.35 to 1.71], p = 0.53), recurrent MI (6.4% vs. 10%, adjusted HR: 0.62 [95% CI: 0.33 to 1.16], p = 0.13), and target vessel revascularization (4.8% vs. 4.8%, adjusted HR: 1.00 [95% CI: 0.45 to 2.32], p = 0.99). However, EES was associated with a significant reduction in stent thrombosis (1.6% vs. 5.2%, adjusted HR: 0.3 [95% CI: 0.1 to 0.92], p = 0.035).ConclusionsThis study shows that among STEMI patients undergoing primary angioplasty, EES has similar efficacy as SES, but is associated with a significant reduction in stent thrombosis. (Randomized Comparison of Everolimus Eluting Stents and Sirolimus Eluting Stent in Patients With ST Elevation Myocardial Infarction [RACES-MI]; NCT01684982)     

Long-Term Outcomes of Neointimal Hyperplasia Without Neoatherosclerosis After Drug-Eluting Stent Implantation

ObjectivesThe aim of this study was to investigate the correlation between in-stent neointimal tissue without features of neoatherosclerosis and long-term clinical outcomes.BackgroundRecent studies have reported differential morphological characteristics of in-stent neointimal tissue assessed by optical coherence tomography (OCT).MethodsThe study population consisted of 336 patients with 368 drug-eluting stent-treated lesions. Patients received a follow-up OCT examination without any intervention. OCT-based neointima was categorized as homogeneous (n = 227 lesions in 208 patients), heterogeneous (n = 79 lesions in 73 patients), or layered (n = 62 lesions in 55 patients). Major adverse cardiac events (MACE) (a composite of cardiac death, nonfatal myocardial infarction, or target lesion revascularization) were assessed according to neointimal patterns during long-term clinical follow-up after OCT examination.ResultsThe time interval between stent implantation and OCT examination was similar among the 3 groups (p = 0.64). On multivariate logistic regression analysis, the significant determinant for the heterogeneous neointima was age (odds ratio [OR]: 1.037, 95% confidence interval [CI]: 1.007 to 1.068, p = 0.015) and an initial clinical presentation of acute coronary syndrome (OR: 1.967, 95% CI: 1.159 to 3.339, p = 0.012). The overall median follow-up duration for all patients after follow-up OCT examination was 31.0 months, and this was statistically different among the heterogeneous group (22.0 months), the homogeneous group (34.0 months), and the layered group (28.0 months, overall p = 0.002). MACE occurred more frequently in patients with heterogeneous neointima over a median 31-month follow-up period after OCT examination (13.7% vs. 2.9% in homogeneous vs. 7.3% in layered, p = 0.001). A propensity score–adjusted Cox regression analysis showed that independent risk factors for MACE were inclusion in the heterogeneous neointima (hazard ratio: 3.925, 95% CI: 1.445 to 10.662, p = 0.007) and minimal lumen cross-sectional area (hazard ratio: 0.368, 95% CI: 0.242 to 0.560, p < 0.001).ConclusionsDetermination of neointimal characteristics is helpful in predicting long-term clinical outcomes. Our data suggest that heterogeneous lesions are linked to poor long-term clinical prognoses.     

Outcomes of Spot Stenting Versus Long Stenting After Intentional Subintimal Approach for Long Chronic Total Occlusions of the Femoropopliteal Artery

ObjectivesThis study sought to compare the outcomes of spot stenting versus long stenting after intentional subintimal approach for long femoropopliteal chronic total occlusions (CTO).BackgroundThe optimal stenting strategy following the subintimal recanalization of long femoropopliteal chronic total occlusions has not been investigated.MethodsA total of 196 limbs in 163 patients, implanted with bare nitinol stents after subintimal approach in long femoropopliteal occlusions (lesion length 25 ± 8 cm), were retrospectively analyzed. The primary patency was compared between spot stenting (n = 129) and long stenting (n = 67).ResultsBaseline characteristics and immediate procedural results were similar between groups. Adjusted-primary patency (47% vs. 77%, p < 0.001) and adjusted-freedom from target lesion revascularization (52% vs. 84%, p < 0.001) at 2 years were significantly lower in the long stenting group than in the spot stenting group. The incidence of stent fracture, fracture type, and restenosis pattern did not differ between groups. Long stenting was an independent predictor of restenosis (hazard ratio [HR]: 2.0) along with other risk factors such as nonuse of clopidogrel (HR: 3.3) or cilostazol (HR: 2.2), small stent diameter (HR: 0.6), poor run-off (HR: 1.9), and post-procedural ankle-brachial index (HR: 0.1). Compared with spot stenting after adjustment using inverse probability of treatment weighting, long stenting, especially involving the P2 or P3 segment of the popliteal artery, was independently associated with 7.5-fold increases in restenosis risk (p < 0.001).ConclusionsThe primary patency was significantly higher with spot stenting than with long stenting following subintimal approach for long femoropopliteal chronic total occlusions. The risk of restenosis was especially higher when long stenting was extended to the distal popliteal artery.     

Comparison of Neoatherosclerosis and Neovascularization Between Patients With and Without Diabetes: An Optical Coherence Tomography Study

ObjectivesThis study aimed to investigate the characteristics of neoatherosclerosis (NA) in patients with diabetes mellitus (DM) after drug-eluting stent (DES) implantation using optical coherence tomography.BackgroundNA is an important substrate for stent failure. In vivo NA characteristics in DM patients have not been investigated.MethodsA total of 397 patients with 452 DES who underwent follow-up optical coherence tomography examination after DES implantation were enrolled. Characteristics of NA were compared between DM and non-DM patients. Neovascularization was defined as signal-poor holes or tubular structures with a diameter of 50 to 300 μm.ResultsA total of 123 DES with NA lesions in 115 patients were identified. The incidence of NA was similar between DM and non-DM patients (29.6% vs. 28.6%; p = 0.825). Compared with the non-DM group, neovascularization was more frequently observed in the DM group (55.1% vs. 32.4%; p = 0.012). The multivariate logistic model demonstrated that DM (odds ratio: 3.00; 95% confidence interval: 1.31 to 6.81; p = 0.009) and follow-up duration (odds ratio: 1.03; 95% confidence interval: 1.02 to 1.05; p < 0.001) were the independent predictors for neovascularization in NA lesions. DM patients with glycated hemoglobin ≥7.0% had a higher prevalence of thin-cap fibroatheroma compared with those with glycated hemoglobin <7.0% (40.0% vs. 8.3%; p = 0.01).ConclusionsThe incidence of NA was similar between patients with and without DM. Neovascularization in NA lesions was more frequent in those with DM. Poorly controlled DM patients had a higher incidence of thin-cap fibroatheroma, compared with those with well-controlled DM.     

Randomized Comparison of FFR-Guided and Angiography-Guided Provisional Stenting of True Coronary Bifurcation Lesions: The DKCRUSH-VI Trial (Double Kissing Crush Versus Provisional Stenting Technique for Treatment of Coronary Bifurcation Lesions VI)

ObjectivesThis study sought to compare the outcomes of fractional flow reserve (FFR)–guided and angiography (Angio)–guided provisional side-branch (SB) stenting for true coronary bifurcation lesions.BackgroundAngio-guided provisional SB stenting after stenting of the main vessel provides favorable outcomes for the majority of coronary bifurcation lesions. Whether an FFR-guided provisional stenting approach is superior has not been studied.MethodsA total of 320 patients with single Medina 1,1,1 and 0,1,1 coronary bifurcation lesions undergoing stenting with a provisional SB approach were randomly assigned 1:1 to Angio-guided and FFR-guided groups. SB stenting was performed for Thrombolysis In Myocardial Infarction flow grade <3, ostial SB stenosis >70%, or greater than type A dissection after main vessel stenting in the Angio-guided group and for SB-FFR <0.80 in the FFR-guided group. The primary endpoint was the 1-year composite rate of major adverse cardiac events (cardiac death, myocardial infarction, and clinically driven target vessel revascularization).ResultsComparing the Angio-guided and FFR-guided groups, treatment of the SB (balloon or stenting) was performed in 63.1% and 56.3% of lesions respectively (p = 0.07); stenting of the SB was attempted in 38.1% and 25.9%, respectively (p = 0.01); and, when attempted, stenting was successful in 83.6% and 73.3% of SBs, respectively (p = 0.01). The 1-year composite major adverse cardiac event rate was 18.1% in both groups (hazard ratio: 0.91, 95% confidence interval: 0.48 to 1.88; p = 1.00). The 1-year target vessel revascularization and stent thrombosis rates were 6.9% and 5.6% (p = 0.82) and 1.3% and 0.6% (p = 0.56) in the Angio-guided and FFR-guided groups, respectively.ConclusionsIn this multicenter, randomized trial, angiographic and FFR guidance of provisional SB stenting of true coronary bifurcation lesions provided similar 1-year clinical outcomes. (Randomized Study on DK Crush Technique Versus Provisional Stenting Technique for Coronary Artery Bifurcation Lesions; ChiCTR-TRC-07000015)     

Hybrid Revascularization for Multivessel Coronary Artery Disease

ObjectivesThe aim of this study was to assess the feasibility of hybrid coronary revascularization (HCR) in patients with multivessel coronary artery disease (MVCAD) referred for standard coronary artery bypass grafting (CABG).BackgroundConventional CABG is still the treatment of choice in patients with MVCAD. However, the limitations of standard CABG and the unsatisfactory long-term patency of saphenous grafts are commonly known.MethodsA total of 200 patients with MVCAD involving the left anterior descending artery (LAD) and a critical (>70%) lesion in at least 1 major epicardial vessel (except the LAD) amenable to both PCI and CABG and referred for conventional surgical revascularization were randomly assigned to undergo HCR or CABG (in a 1:1 ratio). The primary endpoint was the evaluation of the safety of HCR. The feasibility was defined by the percent of patients with a complete HCR procedure and the percent of patients with conversions to standard CABG. The occurrence of major adverse cardiac events such as death, myocardial infarction, stroke, repeated revascularization, and major bleeding within the 12-month period after randomization was also assessed.ResultsMost of the pre-procedural characteristics were similar in the 2 groups. Of the patients in the hybrid group, 93.9% had complete HCR and 6.1% patients were converted to standard CABG. At 12 months, the rates of death (2.0% vs. 2.9 %, p = NS), myocardial infarction (6.1% vs. 3.9%, p = NS), major bleeding (2% vs. 2%, p = NS), and repeat revascularization (2% vs. 0%, p = NS) were similar in the 2 groups. In both groups, no cerebrovascular incidents were observed.ConclusionsHCR is feasible in select patients with MVCAD referred for conventional CABG. (Safety and Efficacy Study of Hybrid Revascularization in Multivessel Coronary Artery Disease [POL-MIDES]; NCT01035567).     

Coronary Vessel Wall Contrast Enhancement Imaging as a Potential Direct Marker of Coronary Involvement: Integration of Findings From CAD and SLE Patients

ObjectivesThis study investigated the feasibility of visual and quantitative assessment of coronary vessel wall contrast enhancement (CE) for detection of symptomatic atherosclerotic coronary artery disease (CAD) and subclinical coronary vasculitis in autoimmune inflammatory disease (systemic lupus erythematosus [SLE]), as well as the association with aortic stiffness, an established marker of risk.BackgroundCoronary CE by cardiac magnetic resonance (CMR) is a novel noninvasive approach to visualize gadolinium contrast uptake within the coronary artery vessel wall.MethodsA total of 75 subjects (CAD: n = 25; SLE: n = 27; control: n = 23) underwent CMR imaging using a 3-T clinical scanner. Coronary arteries were visualized by a T2-prepared steady state free precession technique. Coronary wall CE was visualized using inversion-recovery T1 weighted gradient echo sequence 40 min after administration of 0.2 mmol/kg gadobutrol. Proximal coronary segments were visually examined for distribution of CE and quantified for contrast-to-noise ratio (CNR) and total CE area.ResultsCoronary CE was prevalent in patients (93%, n = 42) with a diffuse pattern for SLE and a patchy/regional distribution in CAD patients. Compared with control subjects, CNR values and total CE area in patients with CAD and SLE were significantly higher (mean CNR: 3.9 ± 2.5 vs. 6.9 ± 2.5 vs. 6.8 ± 2.0, respectively; p < 0.001; total CE area: median 0.8 [interquartile range (IQR): 0.6 to 1.2] vs. 3.2 [IQR: 2.6 to 4.0] vs. 3.3 [IQR: 1.9 to 4.5], respectively; p < 0.001). Both measures were positively associated with aortic stiffness (CNR: r = 0.61, p < 0.01; total CE area: 0.36, p = 0.03), hypercholesterolemia (r = 0.68, p < 0.001; r = 0.61, p < 0.001) and hypertension (r = 0.40, p < 0.01; r = 0.32, p < 0.05).ConclusionsWe demonstrate that quantification of coronary CE by CNR and total CE area is feasible for detection of subclinical and clinical uptake of gadolinium within the coronary vessel wall. Coronary vessel wall CE may become an instrumental novel direct marker of vessel wall injury and remodeling in subpopulations at risk.     

Long-Term Clinical Outcomes of Final Kissing Ballooning in Coronary Bifurcation Lesions Treated With the 1-Stent Technique: Results From the COBIS II Registry (Korean Coronary Bifurcation Stenting Registry)

ObjectivesThis study investigated the impact of final kissing ballooning (FKB) after main vessel (MV) stenting on outcomes in patients with coronary bifurcation lesions after application of the 1-stent technique.BackgroundAlthough FKB has been established as the standard method for bifurcation lesions treated with a 2-stent strategy, its efficacy in a 1-stent approach is highly controversial.MethodsThis study enrolled 1,901 patients with a bifurcation lesion with a side branch diameter ≥2.3 mm, treated solely with the 1-stent technique using a drug-eluting stent from 18 centers in Korea between January 1, 2003 and December 31, 2009. The primary outcome was major adverse cardiac events (MACE)—cardiac death, myocardial infarction, or target lesion revascularization. Propensity score-matching analysis was also performed.ResultsFKB was performed in 620 patients and the post minimal lumen diameter of the MV and side branch was larger in the FKB group than in the non-FKB group. During follow-up (median 36 months), the incidence of MACE (adjusted hazard ratio [HR]: 0.68, 95% confidence interval [CI]: 0.46 to 0.99; p = 0.048) was lower in the FKB group than the non-FKB group. After propensity score matching (545 pairs), the FKB group had a lower incidence of MACE (adjusted HR: 0.50, 95% CI: 0.30 to 0.85; p = 0.01), and target lesion revascularization in the MV (adjusted HR: 0.51, 95% CI: 0.28 to 0.93; p = 0.03) and both vessels (adjusted HR: 0.47, 95% CI: 0.25 to 0.90; p = 0.02) than in the non-FKB group.ConclusionsIn coronary bifurcation lesions, we demonstrated that the 1-stent technique with FKB was associated with a favorable long-term clinical outcome, mainly driven by the reduction of target lesion revascularization in the MV or both vessels as a result of an increase in minimal lumen diameter. (Korean Coronary Bifurcation Stenting Registry II [COBIS II]: NCT01642992)     

Outcomes After Percutaneous Coronary Intervention With Stents in Patients Treated With Thoracic External Beam Radiation for Cancer

ObjectivesThe aim of this study was to assess outcomes after percutaneous coronary intervention (PCI) with stents in patients treated with thoracic external beam radiation therapy (EBRT).BackgroundThoracic EBRT for cancer is associated with long-term cardiotoxic sequelae. The impact of EBRT on patients requiring coronary stents is unclear.MethodsWe analyzed outcomes after PCI in cancer survivors treated with curative thoracic EBRT before and after stenting between 1998 and 2012. Reference groups were propensity-matched cohorts with stenting but no EBRT. Primary endpoint was target lesion revascularization (TLR), a clinical surrogate for restenosis. Secondary endpoints included myocardial infarction (MI) and cardiac and overall mortality.ResultsWe identified 115 patients treated with EBRT a median 3.6 years after stenting (group A) and 45 patients treated with EBRT a median 2.2 years before stenting (group B). Long-term mean TLR rates in group A (3.2 vs. 6.6%; hazard ratio: 0.6; 95% confidence interval: 0.2 to 1.6; p = 0.31) and group B (9.2 vs. 9.7%; hazard ratio: 1.2; 95% confidence interval: 0.4 to 3.4; p = 0.79) were similar to rates in corresponding control patients (group A: 1,390 control patients; group B: 439 control patients). Three years post-PCI, group A had higher overall mortality (48.6% vs. 13.9%; p < 0.001) but not MI (4.8% vs. 4.3%; p = 0.93) or cardiac mortality (2.3% vs. 3.6%; p = 0.66) rates versus control patients. There were no significant differences in MI, cardiac, or overall mortality rates in group B.ConclusionsThoracic EBRT is not associated with increased stent failure rates when used before or after PCI. A history of PCI should not preclude the use of curative thoracic EBRT in cancer patients or vice versa. Optimal treatment of cancer should be the goal.