Hiroyoshi Kawamoto

Clinical outcomes of a real-world cohort following bioresorbable vascular scaffold implantation utilising an optimised implantation strategy.

AIMS It has become apparent that, in comparison to metallic stents, bioresorbable vascular scaffolds (BVS) require specific implantation techniques. The aim of this study was to investigate outcomes following BVS implantation using a dedicated strategy for optimal deployment. METHODS AND RESULTS Four hundred consecutive lesions (264 patients) treated with the Absorb BVS were analysed. All procedures were performed based on the following principles: 1) aggressive lesion preparation; 2) high-pressure post-dilation; and 3) a low threshold for intravascular imaging. The majority of target lesions (74.8%) were type B2 or C lesions. Predilation (97.3%) and post-dilation (99.8%) were performed in almost all cases. The mean post-dilation pressure was 21±5 atm, and the total scaffold length per patient was 53.2±32.5 mm. Intravascular imaging was performed in the majority of cases (85.8%) and, when utilised after post-dilatation, a further intervention was required in 24.5% of lesions. The cumulative target lesion failure rates were 7.9% at one year and 11.6% at two years. Definite/probable scaffold thrombosis occurred in three patients (1.2% at one and two years). CONCLUSIONS Clinical outcomes following implantation of current-generation BVS, in a real-world population with a high prevalence of complex lesions, were acceptable when utilising our optimised implantation strategy.

Impact of Strut Width in Periprocedural Myocardial Infarction: A Propensity-Matched Comparison Between Bioresorbable Scaffolds and the First-Generation Sirolimus-Eluting Stent

OBJECTIVES This study aimed to assess the clinical impact of strut width (evaluated by abluminal strut surface area [ASSA]) on periprocedural myocardial infarction (PMI) and clinical outcomes in patients treated with bioresorbable scaffolds (BRS) versus first-generation sirolimus-eluting stents (SES). BACKGROUND To date, there are no reports on the impact of ASSA on PMI and clinical outcomes. METHODS We compared the impact of ASSA on outcomes and PMI in propensity-matched patients treated with BRS and SES. The primary outcome was the incidence of major adverse cardiac events (MACE), defined as the combination of all-cause mortality, follow-up myocardial infarction, and target vessel revascularization, at 30-days and 1-year follow-ups. The secondary endpoint was the incidence of PMI. RESULTS After propensity-matched analysis, 499 patients (147 BRS patients vs. 352 SES patients) were evaluated. Mean ASSA was higher in patients treated with BRS versus SES (BRS: 132.3 ± 76.7 mm(2) vs. SES: 67.6 ± 48.4 mm(2), p < 0.001). MACE was not significantly different between groups (30-days MACE: BRS: 0% vs. SES: 1.4%, p = 0.16, and 1-year MACE: BRS: 15.7% vs. SES: 11.4%, p = 0.67). The incidence of PMI was significantly higher in the BRS group (BRS: 13.1% vs. SES: 7.5%, p = 0.05). Multivariable analyses indicated that treatment of left anterior descending artery and ASSA were independent predictors of PMI. CONCLUSIONS BRS implantation, compared with SES implantation, was associated with a higher incidence of PMI. MACE at 30 days and 1 year were not significantly different. Left anterior descending artery percutaneous coronary intervention and ASSA were independent predictors of PMI.

Provisional vs. two-stent technique for unprotected left main coronary artery disease after ten years follow up: A propensity matched analysis

AIMS There is uncertainty on which stenting approach confers the best long-term outlook for unprotected left main (ULM) bifurcation disease. METHODS AND RESULTS This is a non-randomized, retrospective study including all consecutive patients with 50% stenosis of the left main involving at least 1 of the arteries stemming from the left main treated with drug-eluting stents (DES) in 9 European centers between 2002 and 2004. Patients were divided into two groups: those treated with provisional stentings vs. those treated with two stent strategy. The outcomes of interest were 10-year rates of target lesion revascularization (TLR), major adverse cardiac events (MACE), and their components (cardiovascular death, myocardial infarction [MI], or repeat revascularization), along with stent thrombosis (ST). A total of 285 patients were included, 178 (62.5%) in the provisional stenting group and 87 (37.5%) in the two stent group. After 10 years, no differences in TLR were found at unadjusted analysis (19% vs 25%, p>0.05) nor after propensity score matching (25% vs 28%, p>0.05). Similar rates of MACE (60% vs 66%, p>0.05), death (34% vs 43%, p>0.05), MI (9% vs 14%, p>0.05) and ST were also disclosed at propensity-based analysis. CONCLUSION Even after 10 year follow-up, patients treated with provisional stenting on left main showed comparable rates of target lesion revascularization compared to two stent strategy.

Procedural outcomes of patients with calcified lesions treated with bioresorbable vascular scaffolds.

AIMS To compare the feasibility, procedural and clinical outcomes after implantation of bioresorbable vascular scaffolds (BVS) in patients with calcified lesions. METHODS AND RESULTS We assessed the feasibility of BVS implantation and procedural outcomes in patients with and without calcific lesions. The primary outcome was angiographic and procedural success. Secondary outcomes included major adverse cardiovascular events (MACE). Of 163 patients, 62 (38%) had calcified lesions. Patients with calcific lesions had a higher prevalence of diabetes (35.5% vs. 22.8%, p=0.078) and chronic kidney disease (31.1% vs. 13.9%, p=0.008), and higher SYNTAX scores (18.9±9.7 vs. 15.1±9.0, p=0.017). Calcific lesions required longer procedures (126.4±39.8 vs. 106.9±37.1 min, p=0.015), more frequent use of dedicated devices and IVUS. Acute gain (1.83±0.6 vs. 1.86±0.6, p=0.732) and angiographic success were similar (98% non-calcific vs. 95.2% calcific, p=0.369), whereas procedural success was reduced in patients with calcific lesions (94.1% vs. 83.9%, p=0.034) due to higher rates of periprocedural myocardial infarction (MI) (5% vs. 13.1%, p=0.067). During the median follow-up time of 14 months MACE rates (10.9% non-calcific vs. 12.9% calcific, plog-rank=0.546) were similar. CONCLUSIONS Treating calcific lesions with BVS is feasible with high angiographic success rates, at the expense of longer procedure times, aggressive lesion preparation and increased rates of periprocedural MI.

The STENTYS® paclitaxel-eluting stent in the treatment of unprotected distal left main

Vessel tapering represents an important limitation of the balloon‐expandable drug‐eluting stent (DES) in the treatment of distal unprotected left main coronary artery (ULMCA) lesions. In this study, we assessed the suitability of the STENTYS DES(P), a self‐apposing nitinol paclitaxel‐eluting stent, for use in the treatment of distal ULMCA lesions.

Clinical outcomes following bioresorbable scaffold implantation for bifurcation lesions: Overall outcomes and comparison between provisional and planned double stenting strategy

The aim of this study was to investigate clinical outcomes of patients treated with a provisional stenting (PS) versus a double stenting (DS) strategy for coronary bifurcation lesions with bioresorbable scaffolds (BRS). There are limited data available with regards to outcomes following BRS implantation for bifurcation lesions. A total of 132 bifurcation lesions treated with BRS between 2012 and 2014 were analyzed. Of the total of 132 bifurcation lesions, 10 lesions were treated without crossover stenting. 99 lesions (81%) were treated with a PS strategy and 23 lesions (19%) with a DS strategy. The DS group consisted of patients with a greater number of true bifurcation lesions (PS 52.0% vs. DS 91.3%: P < 0.001). In the PS group, seven lesions (7.1%) were crossed‐over to T‐stenting. In the DS group, 13 lesions (57%) were treated with BRS to the side branch (SB). A hybrid stenting technique [BRS to the main branch, and metallic drug‐eluting stent (DES) to the SB] was utilized in 10 (43%) lesions. Target lesion revascularization (TLR) rates were 5.5% for PS and 11.2% for DS (P = 0.49) at 1‐year follow‐up. Definite scaffold thrombosis did not occur at the site of any bifurcation lesion. These findings suggest that BRS implantation for bifurcation lesions is technically feasible. The rates of TLR tended to be higher in the DS group compared to when a PS strategy was employed. Larger studies are eagerly awaited to determine longer‐term follow‐up of this treatment strategy.

The use of a scoring balloon for optimal lesion preparation prior to bioresorbable scaffold implantation: a comparison with conventional balloon predilatation

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<0.001) lesions were more common in the scoring balloon group. Compared to the conventional balloon group, the scoring balloon group demonstrated better procedural IVUS outcomes with regard to both expansion index (defined as scaffold lumen area divided by final post-dilatation balloon cross-sectional area, 0.71 vs. 0.86; p<0.001) and eccentricity index (defined as minimal scaffold diameter divided by maximal scaffold diameter, 0.78 vs. 0.84; p<0.001). The occurrence of ischaemia-driven target lesion revascularisation at one year was similar (6.1% vs. 7.1%; p=0.87). CONCLUSIONS Lesion preparation for complex lesions using a scoring balloon appeared to facilitate optimal sizing and radially concentric expansion of BVS.

Bioresorbable vascular scaffold use for coronary bifurcation lesions: A substudy from GHOST EU registry

The aim of this study was to evaluate midterm outcomes of bioresorbable vascular scaffolds (BVS) implanted in bifurcation lesions.

In-hospital and midterm clinical outcomes of rotational atherectomy followed by stent implantation: The ROTATE multicentre registry

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<0.001), whilst drug-eluting stent (DES) use was associated with a reduction in follow-up MACE (HR 0.42, 95% CI: 0.26-0.67, p<0.001). CONCLUSIONS RA appears to be safe and effective with acceptable in-hospital and follow-up MACE considering the severity of patient and lesion characteristics. DES implantation following RA was associated with a reduction in MACE during the follow-up period.

Rotational atherectomy in very long lesions: Results for the ROTATE registry.

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.