Yukinori Harada

Validation of the DAPT score in patients randomized to 6 or 12 months clopidogrel after predominantly second-generation drug-eluting stents

The DAPT score is a recently-proposed decision tool for guiding optimal duration of dual antiplatelet therapy (DAPT). It showed modest accuracy in prior derivation and validation cohorts of patients with ≥12 months DAPT. This study was aimed to evaluate the validity of the DAPT score in a cohort of patients with 6 or 12 months DAPT after implantation of predominantly second-generation drug-eluting stents. We analyzed data of patients enrolled in the ISAR-SAFE trial. Patients were classified into low (<2) or high (≥2) DAPT score groups. Primary ischaemic (all-cause death, myocardial infarction, definite stent thrombosis or stroke) and bleeding (TIMI major or minor) outcomes were analyzed in the low and high DAPT score groups. Data of 3976 patients were available for DAPT score calculation. 2407 patients (60.5 %) were classified in the low DAPT score group and 1569 patients (39.5 %) in the high DAPT score group. In the low DAPT score group there were no significant differences between 6 and 12 months DAPT regarding ischaemic (1.0 % vs. 1.4 %, HR=0.74, 95 % CI, 0.35-1.57; p=0.43) or bleeding outcomes (0.3 % vs. 0.8 %, HR=0.44, 95 % CI, 0.13-1.42; p=0.17). In the high DAPT score group there were also no significant differences between 6 and 12 months DAPT regarding ischaemic (1.9 % vs. 1.8 %, HR=1.02, 95 % CI, 0.49-2.14; p=0.96) or bleeding (0.3 % vs. 0.5 %, HR=0.51, 95 % CI, 0.09-2.78; p=0.44) outcomes. In conclusion, the DAPT score failed to show a differential treatment effect in patients receiving 6 or 12 months DAPT after contemporary drug-eluting stent implantation.

Impact of stent size on angiographic and clinical outcomes after implantation of everolimus-eluting bioresorbable scaffolds in daily practice: insights from the ISAR-ABSORB registry.

AIMS We sought to evaluate the impact of stent size on angiographic and clinical outcomes after implantation of everolimus-eluting bioresorbable stents (BRS) in routine clinical practice. METHODS AND RESULTS All consecutive patients undergoing BRS implantation at two centres in Munich, Germany, were included prospectively. The patient population was divided according to the diameter of the implanted BRS. Angiographic surveillance was scheduled at six to eight months after stent implantation and films were analysed in a core laboratory. A BRS with 2.5 mm diameter was implanted in 101 patients and BRS >2.5 mm diameter in 318. Baseline patient characteristics were similar in both groups. Reference vessel diameter was 2.36±0.22 mm in patients with an implanted 2.5 mm BRS and 3.03±0.40 mm in the other group (p<0.001). At angiographic follow-up, in-stent late luminal loss (0.28±0.47 mm vs. 0.25±0.52 mm, p=0.74) was similar in both groups, though binary angiographic restenosis was numerically higher in patients treated with a 2.5 mm BRS (12.5% vs. 6.1%, p=0.05). After 12 months, the rate of the composite of death, myocardial infarction or target lesion revascularisation was 15.7% vs. 12.3% (p=0.49). Definite stent thrombosis was detected in 1.0% vs. 3.1% (p=0.31). CONCLUSIONS In patients treated with BRS in routine clinical practice, angiographic and clinical outcomes were comparable in patients treated with a 2.5 mm stent as compared with those treated with a larger stent size.

Five-year follow-up of polymer-free sirolimus- and probucol-eluting stents versus new generation zotarolimus-eluting stents in patients presenting with st-elevation myocardial infarction.

Patients with ST‐segment elevation myocardial infarction (STEMI) undergoing drug‐eluting stent (DES) implantation are at increased risk of late adverse events, partly explained by an exaggerated inflammatory reaction to durable‐polymer stent coatings.

Drug coated balloon angioplasty in the treatment of peripheral artery disease

ABSTRACT Introduction: Conventional therapies for transcatheter treatment of patients with obstructive peripheral artery disease of the lower limb remain compromised by high restenosis rates. Drug-coated balloons (DCB) offer a novel therapeutic alternative for such patients, providing local delivery of antirestenotic drug to the vessel wall, targeting the source of neo-intimal hyperplasia, without the need for a permanent endovascular mechanical scaffold and their inherent limitations. Areas covered: In this article, we present an up-to-date review of the clinical trial literature relating to DCB therapy of infrainguinal obstructive peripheral artery disease as well as a summary of ongoing trials and future directions. Expert commentary: At present, convincing data exists to support the use of DCB in femoropopliteal disease but the role of DCB in the treatment of tibialpedal disease remains less well defined. More randomized data are needed to clarify this, including comparative effectiveness studies against treatment modalities other than PTA, as well as evaluation of their role in combination with adjunctive therapies.

Prognostic Value of Cardiac Troponin T and Sex in Patients Undergoing Elective Percutaneous Coronary Intervention

Background In patients with stable coronary artery disease undergoing elective percutaneous coronary intervention, the prognostic value of high‐sensitivity cardiac troponin T (hs‐cTnT) and the influence of sex remain poorly defined. Methods and Results Consecutive patients with stable coronary artery disease who underwent elective percutaneous coronary intervention were included. Primary endpoint was all‐cause mortality. Unadjusted hazard ratio (HR) in overall and sex‐specific population and multivariable adjusted HR were calculated by using Cox proportional hazard models. In a total of 5626 patients, elevated hs‐cTnT levels, more than the sex‐specific 99th percentile upper reference limit of normal (URL), were observed in 2221 patients (39%) at baseline. During follow‐up (median, 14.5 months; 25th–75th percentiles, 6.4–27.2 months), 265 patients died. Mortality was higher in patients with the sex‐specific 99th percentile URL compared to those with normal hs‐cTnT (17.3% vs 3.4%; HR=6.10; 95% CI, 4.58–8.14; P<0.001). hs‐cTnT was an independent predictor of mortality in multivariable adjusted models. The C‐statistic was significantly increased by adding hs‐cTnT to the basic prediction model for mortality (0.793–0.815; P<0.001). There was a significant interaction between hs‐cTnT and sex on mortality. Differences in all‐cause mortality between patients with more than the sex‐specific 99th percentile URL and those with normal hs‐cTnT were numerically larger in male than female patients (male, HR=6.45; 95% CI, 4.68–8.87, P<0.001; female, HR=4.29, 95% CI, 2.36–9.03; P<0.001). Conclusions In patients with stable coronary artery disease undergoing elective percutaneous coronary intervention, preprocedural hs‐cTnT was a strong predictor of mortality in both men and women.

TCT-207 Extended validation of a decision tool (DAPT score) in patients randomized to 6 or 12 months dual antiplatelet therapy after percutaneous coronary intervention with predominantly second-generation drug-eluting stents.

TCT-206 Tailoring the Intensity of Antiplatelet Pharmacotherapy to Ischemic and Bleeding Risk: A Cost Optimizing Simulation From PARIS Daniel Leisman, Usman Baber, David Cohen, C. Michael Gibson, Stuart Pocock, Timothy Henry, Philippe Gabriel Steg, George Dangas, David Moliterno, Bernhard Witzenbichler, Annapoorna Kini, Mitchell Krucoff, Jeffrey Bruckel, Antonio Colombo, Alaide Chieffo, Roxana Mehran Icahn School of Medicine at Mount Sinai, New York, New York, United States; Mount Sinai Medical Center, New York, New York, United States; Saint Luke’s Mid America Heart Institute, Kansas City, Missouri, United States; Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States; London School of Hygiene and Tropical Medicine, London, United Kingdom; Cedars Sinai Heart Institute, Los Angeles, California, United States; Groupe Hospitalier Bichat – ClaudeBernard, Paris, France; Mount Sinai Medical Center, New York, New York, United States; University of Kentucky, Lexington, Kentucky, United States; Helios Amper-Klinikum, Dachau, Germany; Unknown, New York, New York, United States; Duke University Medical Center/Duke Clinical Research Institute, Durham, North Carolina, United States; University of Rochester Medical Center; San Raffaele Scientific Institute, Milan, Italy; San Raffaele Scientific Institute, Milan, Italy; Zena and Michael A. Weiner Cardiovascular Institute at Mount Sinai School of Medicine, New York, New York, United States

Angiographic and clinical outcomes of patients treated with drug-coated balloon angioplasty for in-stent restenosis after coronary bifurcation stenting with a two-stent technique.

AIMS We conducted this study to evaluate the efficacy of drug-coated balloon therapy for in-stent restenosis after coronary bifurcation stenting. METHODS AND RESULTS Patients who underwent angioplasty with at least one paclitaxel-coated balloon for in-stent restenosis after bifurcation intervention using a two-stent approach were included. Two types of paclitaxel-coated balloon were used, with either an iopromide (iopromide-PCB) or a butyryl tri-n-hexyl citrate (BTHC-PCB) excipient. Angiographic surveillance was planned at six to eight months. Quantitative coronary angiography analysis was carried out with dedicated bifurcation analysis software. Clinical follow-up was performed to one year. In total, 177 patients were included in this study. Information on the type of stent technique used at the time of the index intervention was available for 145 (81.9%) patients: the culotte technique was used in 123 (69.5%) and T-stenting in 22 (12.4%) patients. Iopromide-PCB and BTHC-PCB were used in 124 (70%) and 53 (30%) patients, respectively. Of 125 patients who underwent angiographic follow-up, 30 cases (24%) of binary restenosis were observed. At one year, the composite endpoint of death, myocardial infarction or target lesion revascularisation was observed in 35 patients (24%). There was no significant difference in the incidence of angiographic and clinical outcomes between iopromide-PCB versus BTHC-PCB. CONCLUSIONS In the setting of in-stent restenosis after coronary bifurcation stenting, drug-coated balloons demonstrated good clinical efficacy without the requirement for further stent implantation. There were similar outcomes between iopromide-PCB and BTHC-PCB.

Postprocedural high-sensitivity troponin T and prognosis in patients with non-ST-segment elevation myocardial infarction treated with early percutaneous coronary intervention

BACKGROUND The association of postprocedural high-sensitivity troponin T (hs-TnT) with prognosis of non-ST-segment elevation myocardial infarction (NSTEMI) patients is incompletely investigated. AIM To assess the prognostic value of hs-TnT in NSTEMI patients undergoing early percutaneous coronary intervention (PCI). METHODS This study included 3783 patients with NSTEMI undergoing early PCI. Preprocedural and peak postprocedural hs-TnT was measured. Patients were divided into 3 groups: a group with postprocedural hs-TnT in the 1st tertile (hs-TnT <105ng/L; n=1264), a group with postprocedural hs-TnT in the 2nd tertile (hs-TnT ≥105ng/L to 470ng/L; n=1258) and a group with postprocedural hs-TnT in the 3rd tertile (hs-TnT >470ng/L; n=1261). The primary outcome was 1-year all-cause mortality. RESULTS Overall, there were 299 deaths: 59 (5.5%), 98 (8.2%) and 142 deaths (12.6%) among patients of the 1st, 2nd and 3rd postprocedural hs-TnT tertiles (unadjusted hazard ratio [HR]=1.65, 95% confidence interval [CI] 1.20 to 2.67; P=0.002 for tertile 2 vs tertile 1 and unadjusted HR=2.41 [1.79-3.25]; P<0.001 for tertile 3 vs tertile 1). After adjustment postprocedural hs-TnT was independently associated with the risk of all-cause mortality (adjusted [HR]=1.22 [1.13-1.33], P<0.001 for 1 unit higher log hs-TnT). Postprocedural hs-TnT improved the risk prediction of the model of all-cause mortality (the C statistic of the model without [with baseline variables only] and with incorporation of postprocedural hs-TnT was 0.759 [0.732-0.782] and 0.772 [0.746-0.794], respectively; P<0.001). CONCLUSIONS In patients with NSTEMI undergoing early PCI, postprocedural hs-TnT is independently associated with increased risk of mortality up to 1year after PCI.

Interventional cardiology: Polymer-free drug-eluting stents — a safe and effective option for ACS

Patients with acute coronary syndromes have an increased risk of stent thrombosis. A considerable proportion of these patients are also at increased risk of bleeding, representing a challenge to optimal selection of stent type and duration of dual antiplatelet therapy. Recent evidence supports polymer-free drug-eluting stents as a safe and effective option for this challenging subset of patients.

Intraindividual Comparison of Everolimus-Eluting Bioresorbable Vascular Scaffolds Versus Drug-Eluting Metallic Stents

Background—The performance of everolimus-eluting bioresorbable vascular scaffold (BVS) versus drug-eluting metallic stent (DES) in the same individual receiving multilesion percutaneous coronary intervention (PCI) remains poorly studied. This report investigates the intraindividual performance of BVS and DES in patients receiving multilesion PCI and follow-up angiography. Methods and Results—Data of patients undergoing BVS implantation for de novo lesions from 2012 to 2014 at 2 centers in Munich, Germany, were prospectively collected. Individuals receiving multilesion PCI with BVS and DES and follow-up angiography at 6 to 8 months were studied. Primary end point was in-device late lumen loss. Secondary end points were binary restenosis, target lesion revascularization, and definite stent/scaffold thrombosis. A total of 90 PCI patients with 239 lesions received BVS (n=112) and DES (n=127). Follow-up angiography after a median of 6.6 months (5.8–7.1) showed a higher degree of late lumen loss in lesions treated with BVS versus DES (0.30±0.59 versus 0.22±0.48 mm; P=0.035). However, the adjustment for baseline angiographic imbalances discarded an influence of stent type on late lumen loss (P=0.82). At the same time point, binary restenosis was comparable between BVS and DES (7.8% versus 8.9%; P=0.90). After a median of 13.2 months (9.2–17.6), target lesion revascularization (9.8% versus 10.2%; P=0.97) and definite stent/scaffold thrombosis (2.7% versus 1.6%; P=0.48) did not differ between BVS and DES. Conclusions—In patients receiving multilesion PCI, BVS displays acceptable intraindividual performance compared with DES. Larger trials, extended follow-up, and continuous device iteration remain essential to improve BVS technology.