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The relationship between in-stent calcified nodules (IS-CN) and second-generation drug-eluting stent (G2-DES) stent thrombosis (ST) remains uncertain.We aimed to evaluate the prevalence, clinical demographic and long-term clinical outcomes after G2-DES ST with IS-CN.The prespecified substudy of the REAL-ST registry (a retrospective, multicentre registry of patients with definite ST after first- and G2-DES implantation) enrolled patients who experienced definite G2-DES ST and who underwent pre-intervention intravascular ultrasound imaging at index ST events.IS-CN was observed in 15 out of 118 (13%) definite G2-DES ST cases. The multiple logistic regression model demonstrated that haemodialysis (odds ratio [OR] 12.27, 95% confidence interval [CI]: 1.56-94.54; p=0.02), proximal or mid-right coronary artery lesions (OR 12.79, 95% CI: 1.78-92.13; p=0.01) and severe calcification (OR 13.01, 95% CI: 1.18-142.94; p=0.04) were independently associated with ST with IS-CN. The cumulative 5-year incidence of target lesion revascularisation (TLR) after ST was significantly higher in the IS-CN group than in the non-IS-CN group (p=0.02). Independent predictors of TLR after the index ST events were female sex (hazard ratio [HR] 3.05, 95% CI: 1.20-7.74; p=0.02), diabetes mellitus (HR 3.26, 95% CI: 1.26-8.41; p=0.01) and IS-CN (HR 3.07, 95% CI: 1.16-8.14; p=0.02).IS-CN may be one of the underlying mechanisms of G2-DES ST. Notably, IS-CN was associated with a higher TLR rate after the index ST events, suggesting the need for careful clinical follow-up of ST patients with IS-CN.

Although the simple single stenting rather than complex double stenting is recommended on percutaneous coronary intervention (PCI) for bifurcation lesions, double stenting cannot always be avoided. We investigated the impact of directional coronary atherectomy (DCA), followed by drug-coated balloon (DCB) treatment to reduce the number of stents and avoid complex stenting in PCI for bifurcation lesions and short-term patency. DCA treatment without stents was attempted for 27 bifurcation lesions in 25 patients, of those, 26 bifurcation lesions in 24 patients were successfully treated and 3-month follow-up angiography and optical coherence tomography (OCT) were performed. Sixteen lesions (59.3%) were related to left main trunk distal bifurcations, and 7 (25.9%) were true bifurcation lesions. Among the true bifurcation lesions, 4 lesions (57.1%) needed 1 stent, and the other 3 lesions (42.9%) needed no stents. Among the non-true bifurcation lesions, 1 lesion (5.0%) needed bailout stent and other lesions (95.0%) needed no stents. According to DCA followed by DCB treatment, the angiographic mean diameter stenosis improved from 65.5 ± 15.0% to 7.8 ± 9.8%, and the mean plaque area in intravascular ultrasound improved from 80.4 ± 10.5% to 39.0 ± 11.5%, respectively. Angiographic and OCT late lumen loss values were 0.2 ± 0.6 mm and 1.4 ± 1.9 mm, respectively. No patient had in-hospital major adverse cardiac events (MACE) and 3-month MACE. In conclusion, compared with standard provisional side branch stenting strategy, DCA followed by DCB treatment might reduce the number of stents, avoid complex stenting for major bifurcation lesions and provide good short-term outcomes.

Purpose Optical coherence tomography (OCT) is recommended to be the most appropriate modality in assessing calcium thickness, however, it has limitations associated with infrared attenuation. Although coronary computed tomography angiography (CCTA) detects calcification, it has low resolution and hence not recommended to measure the calcium size. The aim of this study was to devise a simple algorithm to estimate calcium thickness based on the CCTA image. Methods Consecutive patient who had CCTA for suspected coronary artery disease and subsequently went on to have OCT were included in the study. Calcium CT density was collected from CT profile curve. The method to estimate calcium thickness was devised from maximum CT density within the calcification and compared to the measured calcium thickness by OCT. The accuracy of this method was compared to full width at half maximum (FWHM) or inflection point (IP) method. Results A total of 68-patients (238-lesions) divided into derivation and validation dataset at 2:1 ratio (47 patients with 159 lesions and 21 with 79, respectively) were analyzed. Maximum Calcium density and measured calcium-border CT density had a good correlation with a linear equation of y = 0.58x + 201 (r = 0.892, 95% CI: 0.855–0.919, p 2 = 0.481 and 0.527, 95% CI: 0.609–0.842 and 0.497–0.782, p

Vascular inflammation, lipid metabolism, and thrombogenicity play a key role not only in atherogenesis but also in the development of acute coronary syndromes. Biomarkers associated with coronary high-risk plaques defined according to intravascular imaging have not been systematically studied. A total of 69 patients with coronary artery disease who underwent both optical coherence tomography and intravascular ultrasound imaging, and who provided blood specimens were included. Comprehensive biomarkers for inflammation, lipid, and coagulation were analyzed. Composite models sought biomarker patterns associated with thin-cap fibroatheroma (TCFA) and "high-risk plaques" (TCFA and large plaque burden). Two different composite models were developed for TCFA, based on the finding that high sensitivity C-reactive protein (hsCRP), plasminogen activator inhibitor-1, fibrinogen, IL-6, homocysteine and amyloid A levels were elevated, and high-density lipoprotein cholesterol (HDL) and bile acid levels were decreased in these patients. Both composite models were highly accurate for detecting patients with TCFA (area under curve [AUC]: 0.883 in model-A and 0.875 in model-B, both p 0.001). In addition, creatinine, hsCRP, fibrinogen, tumor necrosis factor-α, IL-6, homocysteine, amyloid A, HDL, prothrombin, and bile acid were useful for detecting patients with "high-risk plaques". Two composite models were highly accurate for detection of patients with "high-risk plaques" (AUC: 0.925 in model-A and 0.947 in model-B, both p 0.001). Biomarkers useful for detection of patients with high-risk coronary plaques defined according to intravascular imaging have been identified. These biomarkers may be useful to risk stratify patients and to develop targeted therapy.Clinical Trial Registration https://www.umin.ac.jp/ctr/ , UMIN000041692. Biomarkers and high-risk plaques hsCRP, PAI-1, fibrinogen, IL-6, homocysteine, amyloid A, HDL, and bile acid were useful for detecting patients with TCFA. hsCRP, fibrinogen, IL-6, homocysteine, amyloid A, creatinine, TNFα, HDL, prothrombin, and bile acid were useful for detecting patients with "high-risk plaques" (plaque which has both TCFA and large plaque burden). White arrowhead denotes TCFA. Red and green dashed lines denote lumen area and external elastic membrane area, respectively.

Background Controversy exists over whether sex has significant interaction with revascularization strategy for unprotected left main coronary artery disease. Higher mortality has been reported among women treated with percutaneous coronary intervention compared with coronary artery bypass grafting. Methods and Results The DELTA (Drug‐Eluting Stents for Left Main Coronary Artery Disease) and DELTA‐2 registries are international, multicentric registries evaluating the outcomes of subjects undergoing coronary revascularization for unprotected left main coronary artery disease. The primary outcome was a composite of death, myocardial infarction, or cerebrovascular accidents. The population consisted of 6253 patients, including 1689 (27%) women. Women were older and more likely to have diabetes and chronic kidney disease than men ( P int =0.012) and all‐cause death (p int =0.037). Among women, compared with percutaneous coronary intervention, coronary artery bypass grafting was associated with lower risk of the primary end point (event rate 9.5% versus 15.3%; adjusted hazard ratio [AHR], 0.53; 95% CI, 0.35–0.79, P Conclusions In women undergoing coronary revascularization for unprotected left main coronary artery disease, coronary artery bypass grafting was associated with lower risk of death, myocardial infarction, or cerebrovascular accidents whereas no significant differences between coronary artery bypass grafting and percutaneous coronary intervention were observed in men. Further dedicated studies are needed to determine the optimal revascularization strategy in women with unprotected left main coronary artery disease.

Background Ventricular‐arterial coupling predicts outcomes in patients with heart failure. The arterial elastance to end‐systolic elastance ratio (Ea/Ees) is a noninvasively assessed index that reflects ventricular‐arterial coupling. We aimed to determine the prognostic value of ventricular‐arterial coupling assessed through Ea/Ees after transcatheter aortic valve replacement to predict clinical events. Methods and Results We retrieved data on 1378 patients (70% women) who underwent transcatheter aortic valve replacement between October 2013 and May 2017 from the OCEAN‐TAVI (Optimized transCathEter vAlvular iNtervention) Japanese multicenter registry. We determined the association between Ea/Ees and the composite end point of hospitalization for heart failure and cardiovascular death by classifying the patients into quartiles based on Ea/Ees values (group 1: 0.666) during the midterm follow‐up after transcatheter aortic valve replacement. During a median follow‐up period of 736 days (interquartile range, 414–956), there were 247 (17.9%) all‐cause deaths, 89 (6.5%) cardiovascular deaths, 130 (9.4%) hospitalizations for heart failure, and 199 (14.4%) composite events of hospitalization for heart failure and cardiovascular death. The incidence of the composite end point was significantly higher in group 2 (hazard ratio [HR], 1.76; 95% CI, 1.08–2.87 [ P =0.024]), group 3 (HR, 2.43; 95% CI, 1.53–3.86 [ P P P =0.015]). Conclusions These findings suggest that a higher Ea/Ees at discharge after transcatheter aortic valve replacement is associated with adverse clinical outcomes during midterm follow‐up. Registration URL: https://www.upload.umin.ac.jp/ . Unique identifier: UMIN000020423.

AIMS The aim of this study was to investigate the predictors of long-term adverse clinical events after implantation of the everolimus-eluting Absorb bioresorbable vascular scaffold (BVS). METHODS AND RESULTS We pooled patient-level databases derived from the large-scale ABSORB EXTEND study and five high-volume international centres. Between November 2011 and November 2015, 1,933 patients underwent PCI with a total of 2,372 Absorb BVS implanted. The median age was 61.0 (IQR 53.0 to 68.6) years, 24% had diabetes, and 68.2% presented with stable coronary artery disease. At a median follow-up of 616 days, MACE occurred in 93 (4.9%) patients, all-cause death in 36 (1.9%) patients, myocardial infarction in 47 (2.5%) patients, and target vessel revascularisation in 72 (3.8%) patients. Definite or probable scaffold thrombosis occurred in 26 (1.3%) patients. On multivariable logistic regression analysis, acute coronary syndromes (hazard ratio [HR] 2.79, 95% confidence interval [CI]: 1.47 to 5.29; p=0.002), dyslipidaemia (HR 1.43, 95% CI: 1.23 to 1.79; p=0.007), scaffold/reference diameter ratio >1.25 (HR 1.49, 95% CI: 1.18 to 1.88; p=0.001), and residual stenosis >15% (HR 1.67, 95% CI: 1.34 to 2.07; p

Background Stent thrombosis (ST) after drug‐eluting stent (DES) implantation remains a life‐threatening complication. Recurrent ST (RST) is not a rare phenomenon, potentially contributing to high mortality after the index ST events. However, little evidence is available about the incidence, risk factors, and clinical outcomes of definite RST after DES thrombosis. Methods and Results From REAL‐ST (Retrospective Multicenter Registry of ST After First‐ and Second‐ Generation DES Implantation), this study evaluated 595 patients with definite ST (first‐generation DES thrombosis, n=314; second‐generation DES thrombosis, n=281). During a median follow‐up of 31 months, we identified 32 patients with definite RST after first‐generation DES thrombosis (n=18) and second‐generation DES thrombosis (n=15). Cumulative incidence of RST was 4.5% and 6.0% at 1 and 5 years, respectively, which did not significantly differ between first‐generation DES thrombosis and second‐generation DES thrombosis. Independent predictors of definite RST were early ST (hazard ratio [HR], 2.38; 95% CI, 1.06–5.35 [ P =0.035]) and multivessel ST (HR, 3.47; 95% CI, 1.03–11.7 [ P =0.044]). Definite RST was associated with a 2.8‐fold increased risk of mortality (adjusted HR, 2.78; 95% CI, 1.35–5.73 [ P =0.006]). Conclusions Cumulative incidence of definite RST did not significantly differ between first‐generation DES thrombosis and second‐generation DES thrombosis. Early ST and multivessel ST were risk factors of definite RST. Definite RST significantly increased mortality after DES thrombosis, highlighting the clinical importance of preventing RST to improve outcomes of patients with ST. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: UMIN000025181.

Objectives. To investigate the relationship between the eccentric calcification of aortic valve and transcatheter heart valve (THV) distortion and the impact of THV distortion on echo parameters and clinical outcomes. Background. The effects of eccentric calcification of the aortic valve on the THV distortion and the relationship between THV distortion and clinical impact were not fully understood. Methods. Patients with symptomatic severe aortic stenosis who were undergoing THV implantation were enrolled. Patients underwent preprocedural, postprocedural multislice computed tomography (MSCT), and follow-up transthoracic echocardiogram (TTE). Delta calcium score (ΔCS) is defined as the difference between the maximum and minimal calcium scores of the three cusps, while valve distortion score (VDS) is defined as the difference between the longest and shortest stent frame, as obtained using MSCT. Patients were divided into two groups according to ΔCS: “noneccentric calcification group” and “eccentric calcification group.” Results. A total of 118 patients were enrolled (59 patients in noneccentric and 59 in eccentric calcification groups). VDS was significantly lower in the noneccentric calcification group than in the eccentric calcification group (1.31 ± 0.82 mm vs. 1.73 ± 0.76 mm, p = 0.004 ). VDS was not associated with the degree of paravalvular leak (PVL) and aortic valvular mean pressure gradient (AVPG) at 30-day and 1-year follow-up TTE and the cumulative rates of all-cause death and rehospitalization at 2-year clinical follow-up. Conclusions. Eccentric valvular calcification was associated with longitudinal THV distortion. However, THV distortion was not associated with PVL, AVPG, and adverse clinical events during midterm follow-up.

Background There are only little data available on the comparison of clinical outcomes between a early generation drug eluting stent (eDES) and a current generation drug eluting stent (cDES) for percutaneous coronary intervention (PCI) with double stent strategy (DSS) for unprotected distal left main disease (ULMD). Methods Between April 2005 and December 2015, we recruited 452 consecutive ULMD patients treated with DSS (eDES, 236 patients; cDES, 216 patients). In this study, eDES included Cipher, Taxus, and Endeavor and cDES included Ultimaster, Resolute family, Xience family, Promus family, Synergy, and Nobori. The primary endpoint was target lesion failure (TLF) defined as a composite of cardiac death, target lesion revascularization (TLR) and myocardial infarction (MI) during the median follow-up period of 1,809(IQR: 1,190-2,510) days. Results In entire population, the rate of overall TLR was significantly lower in cDES group than that in eDES group (adjusted HR 0.62, 95% CI 0.40-0.96, p = .032). The rate of TLR for the ostium of LCX was significantly lower in cDES group than that in eDES group (adjusted HR 0.63, 95% CI 0.39-0.99, p = .047). Cardiac mortality, the rate of TLR for LM-LAD, MI and definite/probable ST did not significantly differ between both groups. The results were preserved in the propensity adjusted population. Conclusions cDES significantly improved the clinical outcomes in population treated with DSS mainly driven by the reduction of TLR for the ostium of LCX.

Background: The impact of diabetes mellitus (DM) on clinical outcomes after percutaneous coronary intervention (PCI) for unprotected left main (ULM) distal bifurcation lesions in patients with chronic kidney disease (CKD) is poorly understood in the era of drug-eluting stents (DESs). Objective: We assessed the impact of DM on clinical outcomes after PCI for ULM distal bifurcation lesions in CKD patients compared to patients without DM. Methods: We identified 1,832 consecutive patients who underwent PCI for ULM lesions at New Tokyo Hospital, Matsudo, Japan, San Raffaele Scientific Institute, Milan, Italy, and EMO-GVM, Centro Cuore Columbus, Milan, Italy between January 2005 and August 2015. Of the 1,832 patients, 1,391 were treated with DESs. We excluded 750 patients without CKD and 89 hemodialysis patients. Finally, 552 patients with CKD were included: 219 with DM (DM group) and 333 without DM (no DM group). The primary endpoint was target lesion failure (TLF) at 5 years. TLF was defined as a composite of cardiac death, target lesion revascularization (TLR), and myocardial infarction. Results: Patients in the DM group were more likely to have hypertension, dyslipidemia, peripheral artery disease, and lower ejection fraction and were more frequently using insulin for DM. The TLF rate during the follow-up period was significantly higher in the DM than in the no DM group (adjusted hazard ratio [HR] 1.50; 95% confidence interval [CI] 1.06–2.13; p = 0.023). Cardiac mortality was comparable between both groups (adjusted HR 1.11; 95% CI 0.63–1.95; p = 0.71). The TLR rate was significantly higher in the DM group than in the no DM group (adjusted HR 1.69; 95% CI 1.12–2.54; p = 0.012). Conclusion: DM is strongly associated with adverse event after PCI for ULM distal bifurcation lesions in CKD patients compared to those without DM.

This study evaluated angiographic success and in-hospital outcomes of percutaneous coronary intervention (PCI) with rotational atherectomy (RA) in patients with low left ventricular ejection fraction (LVEF).Between January 2010 and March 2014, 272 consecutive patients with heavily calcified lesions underwent elective PCI with RA. Of these, 33 patients had LVEF ≤35% (low LVEF group), whereas 237 patients had LVEF 35% (preserved LVEF group). The primary endpoint was angiographic success and in-hospital major adverse cardiac events (MACE). MACE included death from any cause, postprocedure onset MI, emergency coronary artery bypass grafting, and target vessel revascularization. The secondary endpoints were MACE and the components within 30days after PCI. The components of MACE were evaluated.Angiographic success, defined as30% residual stenosis with thrombolysis in myocardial infarction flow 3 at final angiography, was achieved in all patients without fatal complications. Intra-aortic ballon pumping (IABP) was used significantly more frequently in the low LVEF group compared with the preserved LVEF group (15.2% vs. 2.1%, p = .003). There were no significant differences between groups regarding in-hospital and clinical outcomes within 30 days following PCI.If medications and mechanical support were appropriately performed, the angiographic success rate and in-hospital MACE rate of PCI with RA in patients with low LVEF could be expected to have good outcomes similar to those for patients with preserved LVEF.

We first report the case highlighting a loop snare wire technique may be a useful percutaneous treatment option when faced with difficulty crossing the Evolut-R system into a surgical valve due to interference between the two prostheses, especially in cases with a very horizontal aorta.

Objectives The aim of this study was to evaluate clinical outcomes of unprotected left main coronary artery percutaneous coronary intervention (PCI) with new-generation drug-eluting stents in a “real world” population. Background PCI of the unprotected left main coronary artery is currently recommended as an alternative to coronary artery bypass grafting (CABG) in selected patients. Methods All consecutive patients with unprotected left main coronary artery stenosis treated by PCI with second-generation drug-eluting stents were analyzed in this international, all-comers, multicenter registry. The results were compared with those from the historical DELTA 1 (Drug Eluting Stent for Left Main Coronary Artery) CABG cohort using propensity score stratification. The primary endpoint was the composite of death, myocardial infarction (MI), or stroke at the median time of follow-up. Results A total of 3,986 patients were included. The mean age was 69.6 ± 10.9 years, diabetes was present in 30.8%, and 21% of the patients presented with acute MI. The distal left main coronary artery was involved in 84.6% of the lesions. At a median of 501 days (≈17 months) of follow-up, the occurrence of the primary endpoint of death, MI, or cerebrovascular accident was lower in the PCI DELTA 2 group compared with the historical DELTA 1 CABG cohort (10.3% vs. 11.6%; adjusted hazard ratio: 0.73; 95% confidence interval: 0.55 to 0.98; p = 0.03). Of note, an advantage of PCI was observed with respect to cerebrovascular accident (0.8% vs. 2.0%; adjusted hazard ratio: 0.37; 95% confidence interval: 0.16 to 0.86; p = 0.02), while an advantage of CABG was observed with respect to target vessel revascularization (14.2% vs. 2.9%; adjusted hazard ratio: 3.32; 95% confidence interval: 2.12 to 5.18; p Conclusions After a median follow-up period of 17 months, PCI with new-generation drug-eluting stents was associated with an overall low rate of the composite endpoint of death, MI, or cerebrovascular accident.

Transradial access (TRA) is often avoided in favor of the transfemoral access (TFA) during percutaneous coronary interventions of the unprotected left main coronary artery (ULM), due to technical and safety concerns. The aim of this study was to compare the performance of TRA and TFA in the treatment of ULM with second-generation drug-eluting stents. Consecutive patients who underwent percutaneous coronary intervention on ULM with second-generation drug-eluting stents were retrospectively enrolled in the multicenter Failure in Left Main Study With 2nd Generation Stents (FAILS 2) registry. Patients were stratified according to the arterial access. The choice between TRA and TFA was left to each operator's preferences. Bleedings during index hospitalization were the primary end point. Secondary end points were major adverse cardiovascular events (a composite of death, reinfarction, and target lesion revascularization), the single components of major adverse cardiovascular events at follow-up and stent thrombosis. Propensity score matching was executed to account for possible confounding. Overall, 1,247 patients were enrolled (23.2% [289] of female gender, mean age 70.2 ± 10.2 years). Diagnosis at presentation was stable angina in 603 (48.7%) cases, non–ST-segment elevation acute coronary syndrome in 465 (37.3%), ST-segment elevation myocardial infarction in 117 (9.5%). Mean follow-up was 726 ± 654 days. After propensity score with matching, 354 patients were included. The primary end point was significantly reduced in patients treated with TRA (2.0% vs 4.0%, p = 0.042), whereas no differences emerged pertaining the secondary end points, including target lesion revascularization and reinfarction. In conclusion, TRA may reduce in-hospital bleedings in patients undergoing percutaneous treatment of the ULM, without increasing the rate of adverse cardiovascular events at follow-up, and may therefore be safely used in the treatment of the ULM.

Objectives The authors sought to investigate 1-year outcomes in patients treated with bioresorbable everolimus-eluting vascular scaffolds (BVS) for “long coronary lesions.” Background The present substudy derived from the GHOST-EU registry included 1,722 lesions in 1,468 consecutive patients, enrolled between November 2011 and September 2014 at 11 European centers. Methods The lesions were divided into 3 groups according to continuous BVS length: 1) shorter than 30 mm; 2) between 30 and 60 mm; and 3) longer than 60 mm. Primary device-oriented endpoint (target lesion failure [TLF]) was defined as a combination of cardiovascular death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Results Patients with lesions ≥60 mm had more comorbidities and more complex lesion characteristics, including chronic total occlusions (37%), bifurcation lesions (40.3%), higher Syntax score (16.4 ± 7.8), and higher number of scaffolds implanted per lesion (3.3 ± 0.9 mm). The main target vessel was the left anterior coronary artery in all groups. Median follow-up was 384 (interquartile range: 359 to 459) days. One-year follow-up was completed in 70.3% of patients. TLF at 1 year was significantly higher in group C (group A 4.8%, group B 4.5%, group C 14.3%; overall p = 0.001), whereas there were no significant differences between groups A and B. Finally, a numerically higher (but not statistically significant) number of scaffold thromboses were observed in group C when compared with shorter lesions (group A 2.1%, group B 1.1%, group C 3.8%; overall p = 0.29). Conclusions In a real-world setting, treatment of long coronary lesions with BVS ≥60 mm was associated with a higher TLF rate, driven by myocardial infarction and clinically driven target lesion revascularization.

BACKGROUND: A 68-year-old male, with a history of repeat percutaneous intervention for the treatment of severe calcific stenosis of the left circumflex artery and obtuse marginal branch bifurcation, presented with stable angina at a local hospital. He was found to have recurrent in-stent restenosis of this lesion and subsequently underwent a fifth reintervention; however, adequate balloon dilatation was not achievable in spite of non-compliant and cutting balloon use. In view of continuing symptoms despite optimal medical therapy, the patient was transferred to our hospital for further management. INVESTIGATION: Coronary angiography, intravascular ultrasound. DiAGNOSIS: Recurrent in-stent restenosis following prior repeat complex bifurcation stenting. MANAGEMENT: Rotational atherectomy of the multilayered stent struts, followed by successful balloon dilatation with a cutting balloon at high pressure, and treatment with a drug-coated balloon.

Introduction. Transcatheter aortic valve implantation is currently considered an alternative treatment for older patients with severe aortic valve stenosis and increased surgical risk, but can be associated with multiple life-threatening complications. Case outline. An 83-year-old woman with severe symptomatic aortic stenosis, body weight of 29 kg and body surface area of 1.1 m2 underwent transcatheter aortic valve implantation via transapical access. Severe hypotension occurred before the valve implantation, due to temporary distortion of the mitral valve apparatus by stiff wire, leading to acute mitral regurgitation. This complication was immediately recognized by continuous transesophageal echocardiography and managed by simple wire retrieval instead of applying mechanical circulatory support. After rewiring and predilatation of the stenotic aortic valve, a 23 mm balloon-expandable transcatheter stent-prosthetic valve was successfully implanted. Conclusion. This case demonstrates that continuous imaging during transcatheter aortic valve implantation is key to rapid diagnosis of life-threatening complications, associated with the procedure, especially during the early learning curve in transapical approach.

Objectives We assessed clinical outcomes after percutaneous coronary intervention (PCI) for unprotected left main (ULM) using current generation drug eluting stents (cDES) in hemodialysis (HD) patients compared to general populations. Methods We identified 1269 consecutive patients who underwent PCI for ULM distal bifurcation lesions. Of them, 563 patients were treated with cDES (512 non HD and 51 HD patients). The primary endpoint was target lesion failure (TLF) at 3 years, defined as a composite of cardiac death, target lesion revascularization (TLR) and myocardial infarction (MI). Results HD group was more likely to have diabetes mellitus (70.0% vs. 45.8%, p=0.002), peripheral artery disease (56.0% vs. 14.9%, p Conclusions Hemodialysis was strongly associated with adverse events after PCI for ULM distal bifurcation lesions even with cDES.

Percutaneous coronary intervention (PCI) is widely used as a treatment for ischemic heart disease. In particular, a high procedural precision of PCI for the left main coronary artery (LMCA), which supplies coronary artery blood to large amount of myocardium, is required. The restenosis after stent placement and target lesion revascularization of side branches (SB) is still a clinical issue. Regarding the stent implantation for bifurcation or trifurcation lesion, the stent struts should jail the inlets of SB. In such a situation, we clinically do the kissing balloon technique (KBT) to remove the struts existing at the opening of SB. As well as KBT, the proximal optimization technique (POT), which presses the stent against the wall, is also commonly used. However, merits of therapeutic strategies of KBT and POT for the branch are not confirmed from the fluid-dynamical viewpoint. In this study, we examined the influence of a stent in left main coronary artery on blood flow by employing CFD simulations. We investigated the influence of membrane position on the flow in bifurcation as well as of the stent position and shift on the flow in trifurcation. we confirmed that the effect of the stent position on the flow was bigger than that of the area occupied by the stent and that of KBT which moves the stent from the flow peak may be useful. However, it was also suggested that the intimal lining after KBT may cause serious flow inhibition.

Ischemic heart disease, a generic term for angina pectoris and myocardial infarction, is caused by blood flow failure due to a lesion generated in the coronary artery of the heart. Because the ischemic heart disease causes fatal problems, a stent placement technique called the percutaneous coronary intervention (PCI) is frequently performed to expand coarctated arteries to recover the function. However, although the PCI technique is a less-invasive technique, there is a risk of complications such as stent thrombosis and restenosis due to the placed stent. In order to understand the cause and the mechanism of the complications, effects of the stent placement and the stent shape on the blood flow is experimentally investigated. Silicone left coronary artery models were prepared to perform particle tracking velocimetry (PTV) and calculated the wall shear stress (WSS). The measurement results show that the flow structure and the WSS are changed depending on the deformation of the stent and the location of the placed stent.

Background The risk factors and long-term clinical outcomes of patients with definite stent thrombosis (ST) after second-generation drug-eluting stent (DES) implantation have not yet been adequately assessed. Methods and Results The REAL-ST (Retrospective Multicenter Registry of ST After First- and Second-Generation DES Implantation) included 313 definite ST of second-generation DES (early ST, n=179; late ST, n=66; very late ST, n=68). Four patients without definite ST of second-generation DES were identified as control patients for each ST case. Risk factors of definite ST were mostly different according to the timing of ST: ST-segment-elevation myocardial infarction, non-ST-segment-elevation myocardial infarction, and unstable angina at presentation, current smoking, left ventricular ejection fraction40%, prior percutaneous coronary intervention, stent overlap, severely calcified lesion, left main coronary artery lesion, proximal left anterior descending lesion, postdiameter stenosis ≥20%, for early ST; age70 years, ST-segment-elevation myocardial infarction at presentation, hemodialysis, left ventricular ejection fraction40%, in-stent restenosis, and severely calcified lesion for late ST; and proximal left anterior descending lesion and in-stent restenosis for very late ST. Cumulative 4-year incidence of death after the index ST events was significantly higher in the ST patients than control patients (33.0% versus 12.3%, P0.001 for early ST versus control; 30.6% versus 14.2%, P0.001 for late ST versus control; and 28.0% versus 13.0%, P0.001 for very late ST versus control, respectively). Conclusions Risk factors of definite ST after second-generation DES implantation were mostly different according to the timing of ST. Definite ST patients showed unfavorable long-term clinical outcomes compared with those without definite ST. Clinical Trial Registration URL: https://www.umin.ac.jp . Unique identifier: UMIN000025181.

Background: The risk factors and long-term clinical outcomes of patients with definite stent thrombosis (ST) after second-generation drug-eluting stent (DES) implantation have not yet been adequately assessed. Methods and Results: The REAL-ST (Retrospective Multicenter Registry of ST After First- and Second-Generation DES Implantation) included 313 definite ST of second-generation DES (early ST, n=179; late ST, n=66; very late ST, n=68). Four patients without definite ST of second-generation DES were identified as control patients for each ST case. Risk factors of definite ST were mostly different according to the timing of ST: ST-segment–elevation myocardial infarction, non–ST-segment–elevation myocardial infarction, and unstable angina at presentation, current smoking, left ventricular ejection fraction P P P Conclusions: Risk factors of definite ST after second-generation DES implantation were mostly different according to the timing of ST. Definite ST patients showed unfavorable long-term clinical outcomes compared with those without definite ST. Clinical Trial Registration: URL: https://www.umin.ac.jp . Unique identifier: UMIN000025181.

AIMS To establish the value of the SYNTAX Score-II (SS-II) in predicting long-term mortality of patients treated with left main PCI (LM-PCI) using second-generation drug-eluting stents (DES). METHODS AND RESULTS The SYNTAX score (SS) and the SS-II were calculated in 804 patients included in the FAILS-2 registry (failure in left main study with 2nd generation stents). Patients were classified in low (SS-II ≤33; n = 278, 34.6%), intermediate (SS-II 34-43; n = 260, 32.3%) and high (SS-II ≥44; n = 266, 33.1%) SS-II tertiles. Primary endpoint was all-cause mortality. A significant difference in long-term mortality was noted (5.2 ± 3.6 years): 4.1, 7.5, and 16.7% in low, mid and high SS-II tertiles respectively (p

Percutaneous coronary intervention (PCI) has been established as an alternative treatment option to coronary artery by-pass graft (CABG) surgery in patients with left main coronary artery disease (LMCAD). Whether the findings of randomized controlled trials are applicable to a real-world patient population is unclear.We compared the outcomes of PCI with new-generation DES in the all-comer, international, multicenter DELTA-2 registry retrospectively evaluating mid-term clinical outcomes with the historical CABG cohort enrolled in the DELTA-1 registry according to the EXCEL key inclusion or exclusion criteria. The primary endpoint was the composite of death, myocardial infarction, or stroke at the median time of follow-up time of 501 days. The consistency of the effect of DELTA-2 PCI versus DELTA-1 CABG according to the EXCEL enrollment criteria was tested using propensity score-adjusted Cox regression models.Out of 3986 patients enrolled in the DELTA-2 PCI registry, 2418 were EXCEL candidates and 1568 were not EXCEL candidates. The occurrence of the primary endpoint was higher among non-EXCEL candidates compared with EXCEL candidates (15.4% vs. 6.9%; hazard ratio 2.52; 95% confidence interval 2.00-3.16; p 0.001). Among 901 patients enrolled in the historical DELTA-1 CABG cohort, 471 were EXCEL candidates and 430 were not EXCEL candidates. When comparing the DELTA-2 PCI with the DELTA-1 CABG cohort, the occurrence of the primary endpoint was lower in the PCI group compared with the historical CABG cohort among EXCEL candidates (6.9% vs. 10.7%; adjusted hazard ratio: 0.65; 95% confidence interval: 0.45-0.92), while no significant difference was observed among non-EXCEL candidates (15.4% vs. 12.5%; adjusted hazard ratio: 0.94; 95% confidence interval: 0.67-1.33) with evidence of statistical interaction (adjusted interaction p-value = 0.002).In a real-world population, PCI can be selected more favorably as an alternative to CABG in patients fulfilling the enrollment criteria of the EXCEL trial.

Resumen Introduccion y objetivos La evidencia sobre los resultados de la intervencion y la evolucion clinica de los pacientes tratados con armazones bioabsorbibles solapados en comparacion con los tratados con stents liberadores de everolimus solapados es escasa. Se evaluan los resultados de pacientes tratados con armazones solapados frente a los tratados con stents liberadores de everolimus emparejados por puntuacion de propension. Metodos Tras aparearlos por puntuacion de propension, se incluyo en este estudio a 70 pacientes consecutivos con angina estable tratados con armazones bioabsorbibles solapados y 70 pacientes tratados con stents liberadores de everolimus de nueva generacion. El objetivo principal fue la tasa a 1 ano de eventos adversos cardiovasculares mayores, definidos como el conjunto de muerte por cualquier causa, infarto de miocardio no asociado a la intervencion y revascularizacion del vaso diana. Resultados Los pacientes de los 2 grupos tenian caracteristicas similares en cuanto a edad (grupo de armazones bioabsorbibles frente a grupo de stents, 64,5 ± 10,3 frente a 66 ± 9,7 anos; p = 0,381), sexo, diabetes mellitus, antecedentes cardiovasculares y puntuacion SYNTAX (armazon frente a stent, 18,6 ± 9,2 frente a 19,4 ± 10,4; p = 0,635). La ganancia aguda tras la intervencion fue significativamente menor en los pacientes tratados con armazones bioabsorbibles (1,82 ± 0,66 frente a 2,03 ± 0,68 mm; p = 0,033). En el seguimiento a 1 ano, la tasa de eventos adversos cardiovasculares mayores estimada no mostro diferencias significativas entre los 2 grupos (el 14,5 y el 14,6%; plog-rank = 0,661). De manera analoga, no se observaron diferencias significativas en las tasas a 1 ano de revascularizacion del vaso diana (el 14,5 y el 10%; plog-rank = 0,816) o de revascularizacion de lesion diana (el 9,7 y el 8,3%; plog-rank = 0,815). Conclusiones El tratamiento de lesiones largas con el uso de armazones bioabsorbibles solapados es viable y proporciona unos resultados a 1 ano aceptables.

AIMS The aim of this multicentre study was to investigate the in-hospital and midterm outcomes of rotational atherectomy (RA) followed by metallic stent implantation. METHODS AND RESULTS Between 2002 and 2013, 1,176 de novo lesions with calcified coronary lesions treated by RA and metallic stent implantation at nine institutions were assessed. Patients with ST-segment elevation myocardial infarction (STEMI) within 30 days, cardiogenic shock before the procedure, lesions with thrombus, and in-stent restenosis were excluded from the current analysis. In-hospital major adverse cardiac events (MACE) occurred in 8.3% of cases, mainly driven by periprocedural myocardial infarction. The incidence of MACE was 16.0% at one-year and 24.9% at two-year follow-up, both driven by target vessel revascularisation (13.5% at one year and 19.8% at two years). Multivariable analysis revealed that dialysis was an independent predictor for both in-hospital MACE (OR 2.33, 95% CI: 1.11-4.87, p=0.03) and follow-up MACE (HR 4.14, 95% CI: 2.87-5.96, p

Introduction and objectives There is limited evidence on procedural and clinical outcomes in patients treated with overlapping bioresorbable scaffolds vs overlapping everolimus-eluting stents. We evaluated the outcomes of propensity-matched patients treated with overlapping scaffolds vs everolimus-eluting stents. Methods After propensity matching, 70 consecutive stable angina patients treated with overlapping bioresorbable scaffolds and 70 patients treated with overlapping new generation everolimus stents were included in this study. The primary outcome was the 1-year rate of major adverse cardiovascular events, defined as the composite of all-cause mortality, nonprocedural myocardial infarction, and target-vessel revascularization. Results Patients in the 2 groups had similar age (scaffold vs stent: 64.5 ± 10.3 vs 66 ± 9.7 years; P = .381), sex, diabetes, previous cardiovascular history, and SYNTAX score (scaffold vs stent: 18.6 ± 9.2 vs 19.4 ± 10.4; P = .635). Postprocedural acute gain was significantly lower in patients treated with scaffolds (1.82 ± 0.66 vs 2.03 ± 0.68 mm; P = .033). At 1-year follow up, the estimated major adverse cardiovascular event rate was not significantly different between the 2 groups (scaffold vs stent: 14.5% vs 14.6%; Plog-rank = .661). Similarly, no significant differences were seen in 1-year rates of target vessel (scaffold vs stent: 14.5% vs 10%; Plog-rank = .816) or target lesion revascularization (scaffold vs stent: 9.7% vs 8.3%; Plog-rank = .815). Conclusions Treating long lesions with overlapping scaffolds is feasible with acceptable 1-year outcomes.

This study investigates clinical outcomes after drug-coated balloon (DCB) treatment for in-stent restenosis (ISR) based on the angiographic result achieved after predilatation and before DCB treatment. Among ISR lesions treated with DCBs, 166 lesions with angiography immediately after predilatation were analyzed. The lesions were divided into 2 groups according to angiographic results after predilatation: (1) "adequate" defined as the presence of Thrombolysis In Myocardial Infarction 3 flow, residual stenosis ≤30%, and no major dissections (n = 98 lesions) or (2) "inadequate" (n = 68 lesions). The reference vessel diameters were larger (2.88 ± 0.39 vs 2.64 ± 0.52 mm, p = 0.001) and lesion lengths shorter in the adequate group (15.4 ± 11.2 vs 19.7 ± 13.9 mm, p = 0.04). During a median follow-up of 808 days, the cumulative target lesion revascularization (TLR) rate was lower in the adequate group (20.3% vs 35.5% at 2 years; p = 0.04). Multivariate analysis indicated that an angiographically inadequate result before DCB treatment was an independent predictor of TLR, even after adjusting for reference vessel diameter and lesion length (hazard ratio 1.99, 95% confidence interval 1.02 to 3.87, p = 0.04). In conclusion, angiographic results after lesion preparation appear to be a good predictor of TLR after DCB treatment for ISR.

Objectives This study aimed to investigate clinical outcomes following bioresorbable scaffold (BRS) optimized with intravascular ultrasound (IVUS), and furthermore expansion of BRS in calcific lesions. Background Although IVUS use has contributed to improved clinical outcomes with metallic stent implantation, it is unclear if this is also true with regards to BRS, especially in calcified lesions. Methods Between May 2012 and April 2015, 291 lesions in 198 patients were treated with BRS with IVUS use. We evaluated overall clinical outcomes at 1-year and investigated the expansion and eccentricity index of BRS amongst quadrants categorized by calcium arc (CA) every 90-degrees. Results The rates of major adverse cardiac events were 5.4% (at 6 months) and 10.7% (at 12 months). TLR was observed in 3.1% at 6-month and 7.5% at 12-month follow up. Although there was a significant difference among quadrants regarding to eccentricity of calcium (0°≦CA

Objectives This study aimed to investigate the long-term outcomes following mini-crush versus culotte stenting with drug-eluting stents (DES) for the treatment of unprotected left main coronary artery (LMCA) disease. Background Both mini-crush and culotte stenting are considered efficacious treatment options when a planned 2-stent strategy is deemed necessary for unprotected LMCA disease. However, there are limited data available with regard to the long-term clinical outcomes of each strategy in this setting. Methods Between July 2002 and November 2013, 225 patients were identified. 135 patients were treated with the mini-crush technique, and 90 patients with culotte stenting. The median follow-up period was 1,263 (IQR 820–1,847) days. Results The mini-crush group had worse lesion and procedural characteristics when compared to the culotte group. There were no significant differences in major adverse cardiac events (MACE) at 5 years (mini-crush 36.0% vs. culotte 41.4%, P = 0.57). Myocardial infarction (MI) and definite stent thrombosis (ST) occurred significantly higher (MI; 0 vs. 11.3%, log-rank P = 0.003, and definite ST; 0 vs. 6.3%, log-rank P = 0.02, respectively) in the culotte group. Cox regression analysis indicated that full stent coverage of the LMCA and SYNTAX score were independent predictors for MACE. Conclusions The incidence of MACE and overall TLR were comparable between groups. However, the rates of MI and definite ST were significantly higher in the culotte group. Full stent coverage of the LMCA may reduce the incidence of MACE when a two-stent strategy is used for the treatment of unprotected LMCA disease. © 2016 Wiley Periodicals, Inc.

Objectives The aim of this study was to evaluate midterm outcomes of bioresorbable vascular scaffolds (BVS) implanted in bifurcation lesions. Background BVS have emerged as an alternative to conventional metallic drug-eluting stents for the treatment of coronary complex lesions. Methods Between November 2011 and January 2014, 1189 patients underwent percutaneous coronary intervention with BVS at 10 European centers (GHOST EU registry). Of these, 289 consecutive patients (302 bifurcation lesions) treated with either single-stenting (n = 260) or double-stenting (n = 42) were evaluated. Results True bifurcations were treated in 44.7%. Intravascular ultrasound and optical coherence tomography were utilized only in 22.2% and 21.2%, respectively. Predilation was performed in 95.4%, while postdilation of the main branch was performed in 61.3%. Final kissing inflation with no or minimal protrusion of a side-branch balloon into main branch was performed in 18.9%. Median follow-up period was 356 (IQR 191–419) days. The Kaplan–Meier estimated rates of target lesion failure and scaffold thrombosis (ST) were 6.4% and 2.5% at 360 days, respectively. Independent predictors for TLF were ACS and diabetes mellitus (HR 4.67; 95% CI: 1.78–12.3; P = 0.002 and HR 3.37; 95% CI: 1.38–8.26; P = 0.008, respectively). Conclusions BVS use for coronary bifurcation lesions in an “all-comer” population was associated with acceptable TLF rates up to midterm follow-up. However, ST rates were higher than seen with contemporary metallic stents possibly due to the low incidence of intravascular guidance and postdilation resulting in a higher likelihood of scaffold underexpansion and malapposition, further supporting the importance of meticulous implantation technique. © 2016 Wiley Periodicals, Inc.

Objectives The objective of this study was to investigate clinical outcomes following single crossover bioresorbable scaffold (BRS) implantation without routine side branch (SB) strut dilation. Background It is unknown whether SB strut dilation is routinely required after single crossover BRS implantation if there is no compromise of the jailed SB. Methods Among 187 bifurcation lesions treated with Absorb BRS, 115 lesions (101 patients) were treated with single crossover BRS implantation. Strut dilation toward SB was considered only when SB was compromised (SB TIMI flow 75%) after main branch (MB) BRS implantation. Clinical outcomes including cardiac death, follow-up myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), and definite scaffold thrombosis (ST) were investigated. Results The majority of target lesions were in the left anterior descending artery (73.0%) and the rate of true bifurcation lesions was 42.6%. SB strut dilation was performed in only 20% of lesions (n = 23), and intravascular imaging was used in most cases (90.4%). The rates of TLR per lesion at 1-year was 3.1% in MB, and 0% in SB. In all patients, the cumulative rate of cardiac death was 1.1% at 1-year, follow-up MI 2.2%, TVR 3.5%, and definite ST 1.0%. Conclusion Clinical outcomes were acceptable in bifurcation lesions treated with single crossover BRS implantation without routine SB strut dilation. © 2016 Wiley Periodicals, Inc.

Background Rotational atherectomy (RA) is relatively contraindicated in patients with lesions ≥25 mm of length. Aim of this study was to evaluate RA safety and efficacy in this subset of patients with new technology and devices. Methods and Results From April 2002 to August 2013, the ROTATE registry included all consecutive patients undergoing RA in 8 centres. They were divided into shorter lesion group (SLG, lesions

Aims Our aim was to assess the feasibility and results of a hybrid approach with a bioresorbable scaffold (BRS) plus a drug-coated balloon (DCB) for the treatment of diffuse coronary artery disease (CAD). Methods and results A retrospective analysis was performed on consecutive patients with diffuse de novo or in-stent restenosis treated with BRS implantation (larger proximal segment) and DCB inflation (smaller distal segment or bifurcation side branch). Endpoints were procedural success, then ischaemia-driven target lesion revascularisation (ID-TLR) and BRS/DCB segment thrombosis rates at follow-up. A total of 42 consecutive patients were treated with the hybrid strategy. Mean patient age was 62±1.02 years, while 12 (28.6%) patients were diabetics. Mean BRS and DCB length were 28.0±5.1 mm and 25.8±8.8 mm, respectively. Procedural success was obtained in all patients, but three (7.3%) patients required bail-out scaffolding for DCB-related dissection. At a median follow-up of 12 months (IQR: 6-18), there were no cases of cardiac death, target vessel myocardial infarction, or BRS/DCB segment thrombosis. ID-TLR occurred in two (4.7%) BRS-treated segments. Conclusions Our data in consecutive patients with diffuse CAD suggest that a hybrid strategy using BRS and DCB in different segments of the diseased vessel is feasible and associated with encouraging clinical outcomes.

Aims Our aim was to investigate one-year outcomes in patients treated with bioresorbable scaffolds (BRS) for "off-label" versus currently "established" indications. Methods and results Consecutive patients treated with BRS between May 2012 and September 2014 in two centres were retrospectively recruited. Patients who met inclusion criteria as defined by the ABSORB III study were allocated to the established indication group (ESTG; 21 patients with 35 lesions) and the remaining patients to the off-label group (OFLG; 168 patients with 225 lesions). Target vessel failure (TVF) and ischaemia-driven target lesion revascularisation (id-TLR) at one year were evaluated in both groups. Patients in the OFLG had a higher prevalence of diabetes mellitus and longer lesion length. Predilatation, post-dilatation and intracoronary imaging were conducted in the majority of patients. At one-year follow-up, TVF (0% vs. 7.8%, p=0.32) and id-TLR (0% vs. 4.5%, p=0.31) occurred only in the OFLG with no adverse events in the ESTG. Definite stent thrombosis occurred in two OFLG patients (1.3%). Conclusions In a real-world setting, the majority (88.9%) of patients were treated with BRS for off-label indications. Off-label use of BRS appears to be associated with an acceptable occurrence of outcomes considering the greater complexity of this patient group.

AIMS Meticulous lesion preparation prior to bioresorbable vascular scaffold (BVS) implantation has been strongly recommended. The aim of this study was to investigate if there was a benefit associated with scoring balloon use in lesion preparation in comparison to conventional balloons prior to implantation of a BVS. METHODS AND RESULTS Of the lesions treated with BVS between May 2012 and July 2014, 155 lesions in the conventional balloon group and 29 lesions in the scoring balloon group were included. Procedures without predilatation and those which utilised cutting balloon or rotational atherectomy devices were excluded. Complex (B2/C lesion: 76.1% vs. 93.1%; p=0.028), restenotic (5.2% vs. 17.2%; p=0.036) and calcified (36.1% vs. 79.3%; p

Transcatheter aortic valve implantation (TAVI) is now the treatment of choice for patients with symptomatic aortic stenosis who are inoperable or with high surgical risk. Data with regards to contemporary clinical practice and long-term outcomes are sparse. To evaluate temporal changes in TAVI practice and explore procedural and long-term clinical outcomes of patients in a contemporary "real-world" population, outcomes of 829 patients treated from November 2007 to May 2015, at the San Raffaele Scientific Institute, Milan, Italy, were retrospectively analyzed. Median follow-up was 568 days, with the longest follow-up of 2,677 days. Overall inhospital mortality was 3.5%. During the study period, there was a trend toward treating younger, lower risk patients. Overall mortality rates were 3.5% (30 days), 14% (1 year), 22% (2 years), 29% (3 years), 37% (4 years), 47% (5 years), 53% (6 years), and 72% (7 years). The survival probability at 5 years was significantly higher in patients treated through the transfemoral (TF) route compared to other vascular access sites (log rank p

OBJECTIVES We aimed to investigate procedural feasibility and outcomes associated with planned rotational atherectomy (RA) for severely calcified coronary lesions. BACKGROUND Limited data are available addressing the benefits of planned RA compared to provisional RA. METHODS Between 2002 and 2013, all patients with calcified lesions treated by RA were enrolled. Of these, patients treated with planned RA (358 patients) were compared to those treated with provisional RA (309 patients). RESULTS In-hospital major adverse cardiovascular events (MACE) were tended to be better in the planned RA group (unadjusted OR: 0.76; 95% CI: 0.44-1.31, P = 0.32, and adjusted OR: 0.59; 95% CI: 0.33-1.05, P = 0.07). The number of pre-dilation balloon catheters was significantly lower in the planned RA group (1.17 ± 0.60 vs. 1.47 ± 0.76, P

This study assesses clinical outcomes after drug-eluting balloon treatment for recurrent in-stent restenosis lesions based on the number of metallic layers.We enrolled 304 consecutive patients (333 lesions) treated with percutaneous coronary intervention using drug-eluting balloon for in-stent restenosis lesions between March 2014 and June 2015. Per the number of stent layers previously implanted to the lesion, the patients were categorized into 3 groups, 1 stent layer (1L), 166 patients; 2 stent layers (2L), 87 patients; and ≥3 stent layers (≥3L), 51 patients. The end points were major adverse cardiovascular events (MACE), including cardiac death, target lesion revascularization, myocardial infarction, and definite or probable stent thrombosis. No significant differences were observed in patients' baseline characteristics among the groups. The 1-year MACE and target lesion revascularization rates were significantly higher in the ≥3L group than those in the 1L and 2L groups (MACE: 1L, 16.9%; 2L, 16.1%; and ≥3L, 43.1%, P0.01; target lesion revascularization: 1L, 14.5%; 2L, 14.9%; and ≥3L, 41.2%, P0.01). The multivariable Cox regression analysis revealed that the number of metallic layers (≥3L compared with 1L; hazard ratio, 3.17; [95% CI, 1.75-5.76]; P0.01 and hemodialysis [hazard ratio, 2.21; (95% CI, 1.12-4.36); P=0.02]) were independent predictors for MACE. No significant differences were observed in the occurrence of cardiac death among the groups ( P=0.34).Seemingly, drug-eluting balloon is less effective for ≥3L in-stent restenosis lesions. Hemodialysis and in-stent restenosis with the number of metallic layers are independent predictors for MACE.

BACKGROUND:Treatment of patients with ULMCA (unprotected left main coronary artery disease) with percutaneous coronary intervention (PCI) has been compared with coronary artery bypass graft (CABG), without conclusive results.METHODS:All randomized controlled trials (RCTs) and observational studies with multivariate analysis comparing PCI and CABG for ULMCA were included. Major cardiovascular events (MACEs, composite of all-cause death, MI, definite or probable ST, target vessel revascularization and stroke) were the primary end points, whereas its single components were the secondary ones, along with stent thrombosis, graft occlusion and in-hospital death and stroke. Subgroup analyses were performed according to Syntax score.RESULTS:Six RCTs (4717 patients) and 20 observational studies with multivariate adjustment (14 597 patients) were included. After 5 (3-5.5) years, MACE rate was higher for PCI [odds ratio (OR) 1.10, 95% confidence interval (CI) 1.07-1.14], without difference in death, whereas more relevant risk of MI was because of observational studies. Coronary stenting increased risk of revascularization (OR 1.52; 95% CI 1.34-1.72). At meta-regression, performance of PCI was improved by use of intra-coronary imaging and worsened by first generation stents, whereas two arterial grafts increased benefit of CABG. For patients with Syntax score less than 22, MACE rates did not differ, whereas for higher values, CABG reduced MACE because of lower risk of revascularization. Incidence of graft occlusion was 3.24% (2.25-4.23), whereas 2.13% (1.28-2.98: all CI 95%) of patients experienced stent thrombosis.CONCLUSION:Surgical revascularization reduces risk of revascularization for ULMCA patients, especially for those with Syntax score greater than 22, with a higher risk of in-hospital death. Intra-coronary imaging and use of arterial grafts improved performance of revascularization strategies.