Mean Reference Vessel Diameter Research Articles

Balón liberador de sirolimus en el tratamiento del síndrome coronario agudo y crónico: el estudio PEACE, un subanálisis del registro EASTBOURNE

Introduction and objectivesThe PEACE study (Performance of a sirolimus-eluting balloon strategy in acute and chronic coronary syndromes) investigated for the first time whether a sirolimus-coated balloon (SCB) (Magic Touch, Concept Medical, India) is associated with different outcomes depending on whether it is used in acute coronary syndromes (ACS) or chronic coronary syndromes (CCS). MethodsThis was a post-hoc analysis from the all-comers EASTBOURNE Registry (NCT03085823). Out of 2083 patients enrolled, an SCB was used to treat 968 (46.5%) ACS and 1115 (53.5%) CCS patients. The primary endpoint was target lesion revascularization at 12 months, while secondary endpoints were angiographic success and major adverse cardiovascular events. ResultsBaseline demographics, mean reference vessel diameter and mean lesion length were comparable between ACS and CCS. Predilatation was more commonly performed in ACS (P=.007). SCB was inflated at a standard pressure in both groups with a slight trend toward longer inflation time in ACS. Angiographic success was high in both groups (ACS 97.4% vs CCS 97.7%, P=.820) with limited bailout stenting. Similarly, at 12 months the cumulative incidence of target lesion revascularization (ACS 6.6% vs CCS 5.2%, P=.258) was comparable between ACS and CCS. Conversely, a higher rate of major adverse cardiovascular events in acute presenters was mainly driven by myocardial infarction recurrencies (ACS 10.4% vs CCS 8.3%, P=.009). In-stent restenosis showed a higher proportion of target lesion revascularization and major adverse cardiovascular events than de novo lesions, independently of the type of presentation at the index procedure. ConclusionsThis SCB shows good performance in terms of acute and 1-year outcomes independently of the clinical presentation.

Long term clinical outcome of sirolimus drug coated balloons in large coronary vessels.

Studies evaluating the safety and efficacy of drug coating balloons (DCB) for the treatment of lesions in large coronary vessel are limited. Our study aimed to evaluate the performance of a sirolimus DCB in large coronary arteries. We analyzed all the procedures included in the EASTBOURNE Registry (NCT03085823) enrolling patients with a clinical indication to percutaneous coronary intervention performed by a sirolimus DCB according to investigator judgment. In the present analysis, a cut-off of 2.75 mm was used to define large coronary arteries. Primary endpoint of the study was clinically driven target lesion revascularization (TLR) at 24 months whereas secondary endpoint included procedural success, myocardial infarction (MI), cardiac death and total mortality. Among the 2123 patients and 2440 lesions enrolled in the EASTBOURNE study between 2016 and 2020, 757 patients/810 lesions fulfilled the criteria for the present analysis. Mean reference vessel diameter was 3.2 ± 0.3 mm with mean lesion length of 22 ± 7 mm. Procedural success was high (96%) and at 2-year follow up the device showed a good efficacy with a TLR rate of 9%. There were 34 deaths (4.5%), 30 MIs (4%) and 8 BARC type 3-5 bleedings (1.1%). In-stent restenosis (629 lesions) and de novo lesions (181) were associated with 11% and 4% rates of TLR at 2 years, respectively (p = 0.003). Clinical performance of a sirolimus DCB in large coronary artery vessels shows promising signals at 2-year follow up, both in de novo and in-stent restenosis lesions.

Clinical feasibility of endovascular recanalization with intravascular ultrasound-guided wiring for chronic total occlusion of below-the-knee arteries

BackgroundRevascularization with endovascular therapy (EVT) for complex below-the-knee (BTK) chronic total occlusion (CTO) remains a challenging problem. The Japanese-BTK (J-BTK) CTO score is reported as an indicator of the difficulty of BTK CTO, with the guidewire (GW) passage success rate decreasing as the grade increases. We previously reported an effective GW crossing method for the intravascular ultrasound (IVUS)-guided parallel wiring of complex BTK CTO. In this study, we investigated the feasibility of EVT using IVUS-guided wiring for BTK CTO.Materials and methodsThis single center, retrospective study analyzed 65 consecutive BTK CTO vessels in which IVUS-guided wiring was attempted after the failure of a conventional antegrade wiring approach from November 2020 to November 2022. The primary endpoint was the clinical success of the target CTO vessel. The secondary endpoints were the GW success rate per grade based on the J-BTK CTO score, number of GW used for CTO crossing, fluoroscopy time, and complications.ResultsTarget vessels were the anterior tibial artery (66.2% of cases), peroneal artery (9.2%), and posterior tibial artery (24.6%). Blunt type CTO entry was performed in 55.4% of cases, calcification of entry was observed in 24.6% of cases, the mean occlusion length was 228.2 ± 93.7 mm, mean reference vessel diameter was 2.1 ± 0.71 mm, and outflow was absent in 38.5% of cases. J-BTK CTO scores of 0/1 (grade A), 2/3 (grade B), 4/5 (grade C), and 6 (grade D) were seen in 18.5%, 43.1%, 36.3%, and 1.5% of cases, respectively. The clinical success rate was 95.4%. The GW success rate by J-BTK CTO grade was as follows: grade A (100%), B (100%), C (91.7%), and D (0%). The mean number of GW used was 3.4 ± 1.4, the mean fluoroscopy time was 72.3 ± 32.5 min, and complications occurred in 7.7% of cases.ConclusionThis study showed a very high clinical success rate despite the difficulty of BTK CTO. IVUS-guided EVT might be a feasible strategy for complex BTK CTO.

Two-year clinical outcomes of drug-coated balloon angioplasty and angiographic predictors of restenosis among patients with de novo femoropopliteal lesions

ObjectivesWe analyzed the 2-year clinical outcomes of patients with de novo femoropopliteal (FP) lesions who underwent drug-coated balloon (DCB) angioplasty and the angiographic predictors of restenosis. MethodsThis single-center, retrospective, and observational study evaluated 129 de novo FP lesions treated with DCB angioplasty without bailout stenting. Clinical outcomes and risk factors for loss of primary patency were analyzed using univariate and multivariate Cox proportional hazards regression models. ResultsThe participants were aged 48–93 (mean: 73.6 ± 9.8) years, and 31% were women. Approximately 33% of the patients were receiving regular dialysis, and 35% of the affected limbs had critical ischemia. The mean lesion length was 132 ± 96 mm, and the mean reference vessel diameter (RVD) was 4.7 ± 0.8 mm. Forty-three (33%) limbs had chronic total occlusion of the target artery segment. Fifty-seven (44%) and 72 (56%) lesions were treated with DCB angioplasty using IN.PACT Admiral and Lutonix, respectively. The primary patency and amputation-free survival at 2 years were 59.3% and 89.5%, respectively. RVD was found to be an independent predictor of loss of primary patency. Based on the receiver operating characteristic analysis, an RVD of 4.2 mm was the best predictor of loss of primary patency at 2 years. ConclusionsThe short-term clinical outcome of DCB angioplasty for de novo FP lesions was acceptable. Moreover, an RVD of <4.2 mm was an independent predictor of restenosis after DCB angioplasty.

C-29 | Peripheral Artery Intravascular Lithotripsy: A Systematic Review

Intravascular lithotripsy (IVL) has emerged as a novel endovascular therapy for treating PAD. Therefore, we sought to review the literature to assess the efficacy and safety of IVL in treating calcified PAD lesions. We searched PubMed, Embase, and Cochrane central for studies evaluating IVL in PAD. Patient characteristics, lesion characteristics, pre- and post-procedure diameter stenosis, complications, and IVL rates were evaluated. A total of 114 studies were found, out of which nine studies were included in the final analysis. There were a total of 777 patients, of which 66% (515/777) were males. The mean age was 74.8 years (SD 1.47). The mean length of the lesions was 62.54 mm (SD 12.4), with a mean calcified length of 92.13 mm (SD 17.22) and a mean reference vessel diameter (RVD) of 6.27 mm (SD 0.59). The mean pre-procedure diameter percentage stenosis was 72.61% (SD 6.05) and the mean post-procedure diameter stenosis was 22.81% (SD 1.71), with a mean acute gain of 6.96 mm (SD 0.91). IVL was successfully delivered in 89% of the lesions. Complications from the procedure included dissection (7.2%), perforation (0.4%) and embolization (0.13%). There were no incidents of thrombus, no reflow, or abrupt closure. IVL is safe and effective, with high clinical success in patients with difficult-to-treat moderate and severely calcified PAD lesions.

Intravascular lithotripsy during percutaneous coronary intervention for calcified coronary lesions: analysis of patient and procedural characteristics and clinical outcomes

Abstract Funding Acknowledgements Type of funding sources: None. Background/Introduction Coronary artery calcification is frequently encountered during percutaneous coronary intervention (PCI). It can reduce PCI success and increase intra-procedural and post-procedural complications, including stent embolization, under-expansion and mal-apposition. Intravascular lithotripsy (IVL) is a new tool developed to treat calcified coronary lesions. Purpose Retrospective analysis of all cases of intravascular lithotripsy performed within our local health district to examine patient and procedural characteristics and clinical outcomes. Methods All patients undergoing PCI with intravascular lithotripsy between September 2019-August 2021 within our local health district were analysed. Patient and procedural characteristics and clinical outcomes were recorded. Results 67 patients (50 men) were included with mean age 71.4 ± 8.7years. Risk factors prevalence included smoking (34%), hypertension (82%), dyslipidaemia (69%) and diabetes (46%). Trans-radial artery access was used in 38 patients (57%). IVL was performed most commonly in the left anterior descending artery (52%),[Figure 1]. IVL was utilised in 9 chronic total occlusions and 12 bifurcation lesions. Intracoronary (IC) imaging was performed in 59 patients (88%), intravascular ultrasound in 41(61%) and optical coherence tomography in 18 (27%). 41 (69%) patients had imaging performed pre and post IVL and post PCI. IC imaging identified 14 cases with 270º calcification arc and 45 cases with 360º arc. Nine cases (13.4%) required rotational atherectomy prior to IVL (most commonly 1.75mm burr). Mean reference vessel diameter was 3.2 ± 0.3mm. Mean lesion length was 36.3 ± 16.5mm. Mean pre-PCI stenosis was 85.5 ± 10.8%. Drug eluting stents were successfully deployed in 57 cases (85%), 10 had balloon angioplasty alone. Mean stent length was 39.2 ± 17.8mm. Mean post-PCI stenosis was 4.5 ± 13.3% (median 0%). Figure 2 shows a statistically significant increase in minimum lumen diameter and minimum lumen area post-IVL and minimal-stent-area (MSA) post-PCI. Mean stent expansion was 83%. Mean screening time 35.8 ± 17.8 minutes with mean contrast used 207.3 ± 78.7mL. No sustained arrhythmias or side-branch loss occurred. Vessel rupture was recorded in one patient necessitating urgent cardiac surgery (due to oversized balloon) and in 4 cases the IVL balloon could not cross the lesion. Conclusion Our experience shows that IVL is safe and effective and facilitates stent delivery and expansion. Intracoronary imaging is important to determine the need for calcium modification and evaluate its success prior to stent delivery and to confirm optimised stent expansion. Abstract Figure. Breakdown of PCI Artery Abstract Figure. IC Dimensions Pre/Post IVL/Post PCI

Sex-Specific Outcomes After Coronary Intravascular Lithotripsy: A Patient-Level Analysis of the Disrupt CAD Studies

<h2>Abstract</h2><h3>Background</h3> Coronary artery calcification increases the procedural complexity of percutaneous coronary intervention and is associated with worse outcomes, especially in women. Intravascular lithotripsy (IVL) has been demonstrated to be safe and effective for vessel preparation in severely calcified stenotic lesions before stent implantation. Sex-based outcomes of IVL-facilitated stenting have not been defined. <h3>Methods</h3> We performed a patient-level pooled analysis of the 4 prospective, single-arm Disrupt CAD studies that evaluated the safety and efficacy of IVL-facilitated stenting. Patient baseline and procedural characteristics and clinical outcomes were examined based on sex. The primary safety end point was 30-day major adverse cardiovascular events, defined as the composite of cardiac death, myocardial infarction, or target vessel revascularization. The primary efficacy end point was procedural success, defined as stent delivery with residual in-stent stenosis вүӨ30% without in-hospital major adverse cardiovascular events. <h3>Results</h3> A total of 628 patients were included, of which 144 (22.9%) were women. Women were older (<i>P</i> < .001) and more likely to have hyperlipidemia (<i>P</i> = .03), renal insufficiency (<i>P</i> = .05), and prior myocardial infarction (<i>P</i> = .05). Women had smaller mean reference vessel diameter (2.7В вҖӢ ВұВ вҖӢ0.4В вҖӢmm vs 3.0В вҖӢ ВұВ вҖӢ0.5В вҖӢmm, <i>P</i> < .001), shorter lesion length (22.4В вҖӢ ВұВ вҖӢ10.3В вҖӢmm vs 25.0В вҖӢ ВұВ вҖӢ11.7В вҖӢmm, <i>P</i> = .01), and less side branch involvement (22.9% vs 32.4%, <i>P</i> = .03). Severe coronary calcification defined by angiography, stent delivery success, lesion predilatation, post-IVL dilatation, and poststent dilatation was similar between groups. There were no significant differences between women and men in the primary safety end point (8.3% vs 7.1%, <i>P</i> = .61; adjusted odds ratio 1.66; 95% confidence interval 0.78, 3.34; <i>P</i> = .17) or the primary efficacy end point (91.7% vs 92.6%, <i>P</i> = .72; adjusted odds ratio 0.58; 95% confidence interval 0.29, 1.24; <i>P</i> = .15). Post-IVL serious angiographic complications (flow-limiting dissection, perforation, abrupt closure, slow flow, no reflow) were similar for women and men (1.6% vs 2.3%, <i>P</i> = .75). <h3>Conclusions</h3> Despite more comorbidities and smaller vessel size, IVL-facilitated stenting of severely calcified lesions achieves similar safety and efficacy in women and men.

Comparison of Angiographic and Intravascular Ultrasound Vessel Measurements in Infra-Popliteal Endovascular Interventions: The Below-the-Knee Calibration Study

BackgroundEndovascular revascularization (ER) via percutaneous transluminal angioplasty (PTA) and stenting are viable options for revascularization in below-the-knee (BTK) peripheral arterial disease. Two-dimensional angiography has been the standard of practice for estimating vessel size and selecting treatment devices during ER. However, in other vascular territories, intravascular ultrasound (IVUS) offers better visualization of the lumen dimensions. PurposeTo compare angiographic and intravascular ultrasound reference vessel (lumen) measurements in below-the-knee peripheral artery interventions. MethodsTwenty consecutive patients were enrolled in the BTK Calibration study from 2 sites in the United States and Australia. Patients with at least one diseased segment in a native infra-popliteal artery (below-the-knee) and a clinical indication for endovascular therapy (EVT) were included with no limitations with regard to vessel diameter or lesion length. Digital subtraction angiography and IVUS imaging were collected pre- and post-PTA and images were sent to an independent core lab for standardized quantitative analysis of the normal-looking reference vessel dimensions when available. The results were presented as least square means with 95% confidence intervals and a p-value of <0.05 was considered significant. ResultsThe overall (N = 19) mean reference vessel diameter for QVA was 2.98 ± 1.24 mm vs. 3.47 ± 0.72 mm for IVUS (mean difference was −0.50 mm, (95% CI: −0.80, −0.20; p = 0.14). As expected, in the proximal segments (N = 12), the mean reference vessel diameters were larger: for QVA, it was 3.17 ± 1.34 mm vs. 3.55 ± 0.76 mm in IVUS, (mean difference was −0.38 mm, (95% CI: -0.79, 0.03; p = 0.40); while in the distal segments (N = 7), mean reference vessel diameters were smaller: for QVA, it was 2.64 ± 1.06 mm vs. 3.33 ± 0.67 mm in IVUS, (mean difference was −0.69 mm, (95% CI: -1.04, 0.34; p = 0.17). We observed a greater degree of acute gain in cases where the treatment balloon size correlated with the IVUS measured reference size. ConclusionAngiography underestimates infrapopliteal reference vessel lumen size even when quantitatively assessed. Adjunctive IVUS imaging use in guiding BTK procedures could help ensure adequate sizing and possibly impact immediate post-procedure indices.

Intravascular Lithotripsy for Treatment of Calcified Infrapopliteal Lesions: Results from the Disrupt PAD III Observational Study

Purpose: To evaluate the safety and effectiveness of the Shockwave S4 intravascular lithotripsy (IVL) catheter in an “all-comers” cohort of patients with calcified infrapopliteal lesions. Materials and Methods: The Disrupt PAD III Observational Study (NCT02923193) is a prospective, nonrandomized, multicenter single-arm study designed to assess the “real-world” acute safety and effectiveness of the Shockwave Peripheral IVL System for the treatment of de novo calcified, stenotic peripheral arteries. Patients were eligible for enrollment if they had claudication or critical limb ischemia (CLI) and at least moderate calcification as assessed by angiography. This subanalysis includes consecutive patients enrolled with angiographic core lab-assessed treatment of infrapopliteal arteries using the Shockwave S4 IVL catheter. Results From July 2018 to August 2020, 101 patients with 114 calcified infrapopliteal arteries treated with the S4 IVL catheter were enrolled at 15 sites in 3 countries. CLI was present in 69.3% of patients. The anterior tibial and tiboperoneal trunk were the most commonly treated vessels with an overall mean reference vessel diameter (RVD) of 3.1±0.8 mm, minimum lumen diameter (MLD) of 0.5±0.6 mm, and a corresponding diameter stenosis of 83.4%±15.8% by core lab assessment. Mean lesion length was 64.7±54.7 mm with moderate to severe calcification in 69.3% of lesions by the Peripheral Academic Research Consortium (PARC) criteria. Adjunctive calcium-modifying technology, defined as scoring or cutting balloon and/or atherectomy, was used in 22.7% of procedures. The average acute gain at the end of the procedure was 2.0±0.7 mm with a residual stenosis <50% achieved in 99.0% of lesions and a mean residual stenosis of 23.3±12.5%. There were no flow-limiting dissection, embolization, slow flow/no-reflow, or abrupt closure events at the end of the procedure. Conclusion This subanalysis of the PAD III Observational Study represents the largest report to-date of IVL treatment of heavily calcified below-the-knee (BTK) lesions in a “real-world” patient cohort. The use of S4 IVL demonstrated consistent acute safety and effectiveness outcomes consistent with prior IVL peripheral studies. These consistent outcomes were achieved with the initial use of the S4 IVL catheter for treatment of complex BTK lesions.

Safety and efficacy of Everolimus-Eluting bioabsorbable Polymer-Coated stent in patients with long coronary lesions: The EVOLVE 48 study.

ObjectivesThe EVOLVE 48 study evaluated the safety and effectiveness of the SYNERGY 48 mm stent for the treatment of long lesions.BackgroundClinical evidence supporting the use of very long stents during percutaneous coronary intervention (PCI) is limited. The bioabsorbable polymer SYNERGY stent has shown good long‐term data in a broad population of patients undergoing PCI.MethodsPatients with lesion length >34‐ ≤44 mm and reference vessel diameter (RVD) ≥2.5‐ ≤ 4.0 mm were enrolled in this prospective, multicenter, single‐arm study. The primary endpoint was 12‐month target lesion failure (TLF; composite of target lesion revascularization [TLR], target‐vessel myocardial infarction [TV‐MI], or cardiac death) compared to a prespecified performance goal (PG).ResultsA total of 100 patients with mean lesion length of 35.34 ± 7.15 mm (26 patients with lesion length > 40 mm) and mean RVD 2.72 ± 0.44 mm were enrolled. Moderate to severe calcification was present in 30% of the patients and 89% had pre‐TIMI flow grade 3. The rates of technical and clinical procedural success were 100%. One‐year TLF was observed in 4.1% patients compared to a prespecified PG of 19.5% (95% upper confidence bound = 9.1%; p < 0.0001). Cardiac death and TLR were each observed in one patient, and TV‐MI in two patients treated with SYNERGY 48 mm stent. Between the 1‐2‐year timeframe, TV‐MI occurred in one additional patient. None of the patients experienced a definite or probable stent thrombosis through 2 years.ConclusionsPCI of long coronary lesions with the 48 mm SYNERGY stent demonstrated good procedural and clinical outcomes through 2 years, supporting its clinical safety and efficacy.

Clinical outcomes of drug-eluting balloon for treatment of small coronary artery in patients with acute myocardial infarction.

There were good clinical outcomes of drug-eluting balloon (DEB) use in de novo lesions and in-stent restenosis (ISR) lesions. However, few studies focused on DEB use in patients with acute myocardial infarction (AMI). The aim of this study was to retrospective evaluate the efficacy of DEB for patients of AMI with de novo small coronary artery disease. Between March 2016 and March 2018, patients of AMI with de novo small coronary artery (reference diameter 2.0-2.8mm) and received percutaneous coronary intervention (PCI) were enrolled. 268 patients were divided into DEB group (PCI with further DEB, n = 56) and drug-eluting stent (DES) group (PCI with further DES, n = 212). The primary endpoint was major adverse cardiac events (MACE; all-cause death, non-fatal myocardial infarction, target lesion revascularization and target vessel revascularization) at 24months. A subset of patients underwent angiographic follow-up. Clinical characteristics were balanced in the two groups. Mean reference vessel diameter was similar between the DEB and DES groups (2.64 ± 0.17mm vs 2.65 ± 0.14mm, P = 0.625). The 24-month MACE rates were 17.5% in DEB group and 16.4% in DES group (P = 0.853). Stent thrombosis was seen in three patients (1.46%) in DES group. There was no vessel thrombosis noted in the DEB group. Angiographic follow-up was performed in 35.71% of DEB group and 27.25% of DES group. Late lumen loss was similar between the two groups (DEB 0.14 ± 0.13mm, DES 0.19 ± 0.12mm, P = 0.442). DEB is a reasonable strategy for AMI with small coronary artery. Compared with DES, DEB is an alternative strategy which had similar 24-month clinical outcomes.

Combining the Passeo-18 Lux Drug-Coated Balloon and the Pulsar-18 Bare Metal Stent: 12- and 24-Month Outcomes of the BIOLUX 4EVER Investigator-Initiated Trial

Purpose: To report the outcomes after treating stenotic or occluded femoropopliteal lesions with a drug-coated balloon (DCB) followed by the implantation of a thin-strut self-expanding bare metal stent in the BIOLUX 4EVER trial (ClinicalTrials.gov identifier NCT02211664). Materials and Methods: The prospective, multicenter, physician-initiated BIOLUX 4-EVER trial was conducted at 5 centers in Belgium and enrolled 120 patients (mean age 70.9±10.5 years; 79 men) with symptomatic stenotic or occluded de novo femoropopliteal lesions. A fifth of the patients had diabetes mellitus and nearly half had previous peripheral artery interventions. The lesions were a mean 83.3±49.5 mm long with a mean reference vessel diameter of 5.26±0.59 mm. Lesions were treated with a Passeo-18 Lux DCB followed by the implantation of a Pulsar-18 bare metal stent. Follow-up visits were conducted at 1, 6, 12, and 24 months postprocedure; the main outcome was primary patency at 12 months. Results: Technical success was obtained in all patients. Primary patency was observed in 89.9% of patients (95% CI 84.0% to 95.8%) at 12 months and in 83.5% at 24 months (95% CI 89.9% to 97.3%), and freedom from target lesion revascularization was 93.6% (95% CI 89.9% to 97.3%) and 86.1% (95% CI 79.9% to 92.3%), respectively. Ten patients died throughout the course of the trial (90.7% survival at 24 months), all of noncardiovascular causes. The ankle-brachial index improved from 0.68±0.09 at baseline to 0.93±0.11 and 0.93±0.12 at 12- and 24-month follow-up visits (p<0.001). An improvement of at least 1 Rutherford category was observed in 91 of 94 patients (96.8%) at 12 months and 78 of 83 patients (93.4%) at 24 months (p<0.001). Conclusion: The combination of a Passeo-18 Lux DCB followed by a Pulsar-18 stent implantation produced safe and effective outcomes in the treatment of femoropopliteal lesions at up to 24 months. Adding paclitaxel to the bare nitinol stent platform by predilating with a Passeo-18 Lux DCB seems to increase efficacy at 1 and 2 years compared with the use of bare metal stents only, which were investigated in the precursor 4-EVER study.

Sex-Related Differences in the Long-Term Outcomes of Patients with Femoropopliteal Arterial Disease Treated with the IN.PACT Drug-Coated Balloon in the IN.PACT SFA Randomized Controlled Trial: A Post Hoc Analysis

PurposeTo evaluate sex-related disparities in long-term outcomes of patients with peripheral artery disease (PAD) treated with IN.PACT drug-coated balloon (DCB) or percutaneous transluminal angioplasty (PTA). Materials and MethodsA post hoc analysis of the IN.PACT SFA trial was performed. Participants with Rutherford Clinical Classification 2–4 PAD and femoropopliteal artery lesions up to 18 cm long were randomly assigned to treatment with DCB (n = 220) or PTA (n = 111). Effectiveness outcomes were evaluated, including 36-month primary patency (freedom from binary restenosis and freedom from clinically driven [CD] target lesion revascularization [TLR]). ResultsIn the DCB group, women were significantly older (69.4 y ± 9.9) than men (66.4 y ± 9.1; P = .025). Mean reference vessel diameter (RVD) was significantly smaller in women (4.4 mm ± 0.68) compared with men (4.8 mm ± 0.89, P < .001). Primary patency was 65.4% in women and 71.8% in men (P = .302). Freedom from CD-TLR was 81.1% in women and 86.4% in men (P = .285). Women treated with PTA were older (70.4 y ± 8.3) than men (66.9 y ± 9.5; P = .063). Mean RVD was significantly smaller in women (4.2 mm ± 0.77) compared with men (4.9 mm ± 0.77, P < .001). Primary patency was 42.3% in women and 46.7% in men (P = .551). Freedom from CD-TLR was 59.4% in women and 75.5% in men (P = .109). No significant differences were noted in safety and mortality outcomes. ConclusionsIn both groups, women were older and had smaller vessels. Particularly in the PTA group, women had worse clinical outcomes, though not reaching statistical significance. Further evaluation is necessary to understand the disparate nature of disease progression and outcomes following endovascular treatment in women compared with men.

Routine use of optical coherence tomography in bioresorbable vascular scaffold implantation: insights on technique optimization and long-term outcomes.

Data from prior studies have shown increased risk of adverse outcomes with bioresorbable vascular scaffolds (BVS) compared with drug-eluting stents. The objective of this study was to study the long-term outcomes with routine use of optical coherence tomography (OCT) for optimization of BVS implantation. Clinical, procedural, and outcome data were collected for all patients who received ABSORB BVS between February 2014 and March 2016 in our tertiary center (n=86). Preimplantation and postimplantation OCT was performed in all cases. Outcomes of interest included acute device success and long-term clinical outcomes including cardiac mortality, target vessel myocardial infarction, ischemia-driven target lesion revascularization, and scaffold thrombosis. A total of 86 patients were included (106 lesions, 115 BVS implanted). Mean age was 59.5±10.9 years, with 66% men. Mean lesion length was 25.2±15.6 mm and mean reference vessel diameter was 3.42±0.45 mm. Type B2/C accounted for 40% of the lesions. All scaffold implantations followed the predilation, proper sizing, and postdilation strategy. Of the 115 scaffolds analyzed, 11 (9.5%) required further intervention based on prespecified OCT endpoints. On multivariate regression analysis, complex coronary lesion (type B2/C) was the single independent predictor of OCT use in scaffold optimization (odds ratio=6.3, 95% confidence interval: 1.3-7.8, P=0.02). At a mean follow-up duration of 31±7.1 months, no cases of cardiac mortality, target vessel myocardial infarction, ischemia-driven target lesion revascularization, or scaffold thrombosis were reported. Operators may consider OCT use for optimization of BVS implantation particularly in patients with complex coronary lesions.

Efficacy and Safety of Polymer-Free Ultrathin Strut Sirolimus-Probucol Coated Drug-Eluting Stents for Chronic Total Occlusions: Insights from the Coroflex ISAR 2000 Worldwide Registry.

Objective Coronary revascularization in chronic total occlusion (CTO) is associated with improved clinical outcomes. The choice of the coronary stent is crucial in maintaining long-term vessel patency after CTO revascularization. We investigated the efficacy and safety of polymer-free ultrathin strut sirolimus-probucol coated drug-eluting stents (PF-SES) for CTO lesions. Methods Patients with CTO lesions treated with PF-SES were identified from the prospective multicenter international ISAR 2000 registry. The primary endpoint was clinically driven target lesion revascularization (TLR) at 9 months. Secondary endpoints were 9-month major adverse cardiac events (death, myocardial infarction, or TLR) (MACE) and the occurrence of stent thrombosis. Results A total of 111 patients with CTO lesions (n=127) were available for analysis. The 9-month clinical follow-up rate was 91%. The mean reference vessel diameter and lesion length were 2.76 mm ± 0.40 and 26.8 mm ± 13.1, respectively. The overall DAPT duration was 9.7 ± 2.8 months. Only one (1%) in-hospital MI was reported. The TLR and MACE rates at 9 months were 2% (2/101) and 5.9% (6/101), respectively. The 9-month accumulated rates of definite or probable stent thrombosis was 0% (0/101). Conclusion Revascularizations for CTO with PF-SES are associated with low rates of TLR and MACE at 9 months with no stent thrombosis. These initial findings need to be compared with results of other new generation DES of larger studies.

Optical Coherence Tomography Findings in Patients With Coronary Stent Thrombosis: A Report of the PRESTIGE Consortium (Prevention of Late Stent Thrombosis by an Interdisciplinary Global European Effort).

Stent thrombosis (ST) is a serious complication following coronary stenting. Intravascular optical coherence tomography (OCT) may provide insights into mechanistic processes leading to ST. We performed a prospective, multicenter study to evaluate OCT findings in patients with ST. Consecutive patients presenting with ST were prospectively enrolled in a registry by using a centralized telephone registration system. After angiographic confirmation of ST, OCT imaging of the culprit vessel was performed with frequency domain OCT. Clinical data were collected according to a standardized protocol. OCT acquisitions were analyzed at a core laboratory. Dominant and contributing findings were adjudicated by an imaging adjudication committee. Two hundred thirty-one patients presenting with ST underwent OCT imaging; 14 (6.1%) had image quality precluding further analysis. Of the remaining patients, 62 (28.6%) and 155 (71.4%) presented with early and late/very late ST, respectively. The underlying stent type was a new-generation drug-eluting stent in 50.3%. Mean reference vessel diameter was 2.9±0.6 mm and mean reference vessel area was 6.8±2.6 mm2. Stent underexpansion (stent expansion index <0.8) was observed in 44.4% of patients. The predicted average probability (95% confidence interval) that any frame had uncovered (or thrombus-covered) struts was 99.3% (96.1-99.9), 96.6% (92.4-98.5), 34.3% (15.0-60.7), and 9.6% (6.2-14.5) and malapposed struts was 21.8% (8.4-45.6), 8.5% (4.6-15.3), 6.7% (2.5-16.3), and 2.0% (1.2-3.3) for acute, subacute, late, and very late ST, respectively. The most common dominant finding adjudicated for acute ST was uncovered struts (66.7% of cases); for subacute ST, the most common dominant finding was uncovered struts (61.7%) and underexpansion (25.5%); for late ST, the most common dominant finding was uncovered struts (33.3%) and severe restenosis (19.1%); and for very late ST, the most common dominant finding was neoatherosclerosis (31.3%) and uncovered struts (20.2%). In patients presenting very late ST, uncovered stent struts were a common dominant finding in drug-eluting stents, and neoatherosclerosis was a common dominant finding in bare metal stents. In patients with ST, uncovered and malapposed struts were frequently observed with the incidence of both decreasing with longer time intervals between stent implantation and presentation. The most frequent dominant observation varied according to time intervals from index stenting: uncovered struts and underexpansion in acute/subacute ST and neoatherosclerosis and uncovered struts in late/very late ST.

First Report of the Resolute Onyx 2.0-mm Zotarolimus-Eluting Stent for the Treatment of Coronary Lesions With Very Small Reference Vessel Diameter

ObjectivesThe aim of this study was to explore the safety and efficacy of a dedicated drug-eluting stent for the treatment of coronary lesions with very small reference vessel diameter (RVD). BackgroundSmaller RVD is associated with increased risk for restenosis and target lesion failure (TLF) after stent implantation. MethodsThis was a prospective, single-arm, multicenter trial of the Resolute Onyx 2.0-mm zotarolimus-eluting stent. The primary endpoint was 12-month TLF, which was compared with a pre-specified performance goal. Subjects with stable or unstable angina or ischemia, target lesions ≤27 mm in length, and RVD ≥2.0 and <2.25 mm were eligible for enrollment. A subset of subjects underwent follow-up angiography at 13 months post-procedure. ResultsA total of 101 subjects with 104 lesions were enrolled. The mean age was 67.3 ± 9.6 years, 47% of subjects had diabetes, the mean lesion length was 12.6 ± 6.3 mm, and the mean RVD was 1.91 ± 0.26 mm. The rate of TLF at 12 months was 5.0%, fulfilling the pre-specified performance goal of 19% (p < 0.001). The rates of target lesion revascularization and target vessel myocardial infarction were 2.0% and 3.0%, respectively. There were no episodes of stent thrombosis. In-stent late lumen loss was 0.26 ± 0.48 mm, and the rate of binary restenosis was 12.0%. ConclusionsIn this first report of a drug-eluting stent with a dedicated size to treat lesions with RVD <2.25 mm, the Resolute Onyx 2.0-mm zotarolimus-eluting stent was associated with a low rate of TLF and late lumen loss, without a signal for stent thrombosis. This novel-sized drug-eluting stent appears to be a feasible option for the treatment of coronary lesions in extremely small vessels. (Medtronic Resolute Onyx 2.0 mm Clinical Study; NCT02412501)

Long-Term Clinical Outcomes of Patients Treated With Everolimus-Eluting Bioresorbable Stents in Routine Practice: 2-Year Results of the ISAR-ABSORB Registry

ObjectivesThe aim of this study was to report clinical outcomes in patients treated in routine practice 2 years after everolimus-eluting bioresorbable stent (BRS) implantation. BackgroundLong-term results in patients undergoing BRS implantation in routine clinical practice are sparse, and existing evidence from randomized trials considers mostly selected patients. MethodsThe ISAR-ABSORB registry enrolled consecutive patients undergoing BRS implantation in routine clinical practice at 2 high-volume centers in Germany. Angiographic follow-up was scheduled after 6 to 8 months and clinical follow-up to 24 months. The primary endpoint was the composite of death, myocardial infarction, or target lesion revascularization, and secondary endpoints included individual components of the primary endpoint and definite stent thrombosis. Event rates were calculated using the Kaplan-Meier method. ResultsA total of 419 patients were included. The mean age was 66.6 ± 10.9 years, 31.5% had diabetes, and 39.0% presented with acute coronary syndrome. Forty-nine percent of lesions were considered complex (American College of Cardiology/American Heart Association type B2 or C), and 13.1% were bifurcation lesions. The mean reference vessel diameter was 2.89 ± 0.46 mm. At 2 years, the primary endpoint had occurred in 21.6% of patients: death in 6.3%, myocardial infarction in 3.9%, target lesion revascularization in 16.0%, and definite stent thrombosis in 3.8%. ConclusionsLong-term follow-up of patients treated with BRS in routine practice showed higher event rates than expected. Future studies are required to determine the impact of changes in implantation technique and to define the optimal duration of dual antiplatelet therapy in these patients.

Bioresorbable Vascular Scaffolds for the Treatment of Chronic Total Occlusions: An International Multicenter Registry.

There are only limited studies reporting clinical outcomes after bioresorbable vascular scaffold (BVS; Absorb; Abbott Vascular, Santa Clara, CA) implantation for coronary chronic total occlusions (CTO). The aim of this study was to evaluate the real-world feasibility and safety of BVS implantation for the treatment of CTO. We retrospectively evaluated CTO cases treated with BVS from a multicenter registry. The primary end point was target lesion failure defined as a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization. From September 2012 to November 2015, 65 patients with CTO were successfully treated with BVS. The mean age of patients was 60.8±11.0 years; 89.2% were male and 40.0% diabetic. The mean ejection fraction was 57.7±10.8%. The mean reference vessel diameter and CTO lesion length were 3.0±0.4 and 20.2±3.0 mm, respectively. The mean number of BVS deployed per patient was 1.8±0.7, of which mean diameter and total length were 3.0±0.4 and 47.6±19.9 mm, respectively. Postdilatation with noncompliant balloons (mean diameter 3.3±0.3 mm) was performed at high pressures (18.6±5.3 atm) in all cases. Intravascular ultrasound (n=34) or optical coherence tomography (n=31) was performed in all cases. During the follow-up period (median: 453 days, 25th and 75th percentiles: 230 and 703), there were no occurrences of target lesion failure or scaffold thrombosis. BVS implantation for the treatment of CTO seems feasible and safe. Appropriate lesion preparation, high-pressure postdilatation, and the use of intravascular imaging are recommended to obtain the best possible final result.

The outcomes of patients with very small coronary artery disease treated with thin strut cobalt chromium bare metal stents: an observational study.

BackgroundPercutaneous coronary interventions (PCI) in coronary artery disease (CAD) with very small vessel diameters remains controversial and challenging. These lesions are usually more diffuse, calcified and tortuous. The usage of thin strut bare metal stents (BMS) with excellent crossing profiles in a very small caliber coronary lesions has increased the likelihood of procedural success.ObjectivesThis observational study assessed the 9-month clinical outcomes in an ‘all-comers’ population with very small caliber CAD after implantation of thin strut cobalt chromium BMS.MethodsThin strut cobalt chromium BMS implantation in a priori pre-defined subgroups was investigated in a non-randomized, international, multi-center ‘all-comers’ observational study. Primary end-point was the 9-month clinically driven target lesion revascularization (TLR) rate. Secondary end-points included the 9-month major adverse cardiac event (MACE) and procedural success rates. Data collection was done using an established electronic data acquisition form with built-in plausibility checks.ResultsA total of 783 patients with a mean age of 70.4 ± 12.8 years were enrolled, 205 (26.2 %) of them had vessel diameters of 2.5 mm and smaller which was defined as CAD with very small reference vessel calibers. Older age and diabetics were associated with higher incidences of very small caliber vessels. The mean reference vessel diameter in the very small vessel group was 2.05 ± 0.27 mm and mean diameter for vessels >2.5 mm was 3.41 ± 0.55 mm. Pre-dilatation was performed more often in the very small vessel patients (52.2 vs. 42.2 %; p value 0.007). There was no difference in the overall technical success rates in very small vessel disease group (97.9 vs. 97.7 %). The 9-month TLR rate was 6.3 % for the very small vessels and 3.7 % for vessels >2.5 mm (p = 0.129). The 9-month and in-hospital MACE rates in the very small vessel group and patient with vessel diameters >2.5 mm were not significantly different (13.1 vs. 9.2 %; p = 0.1265 and 5.2 vs. 3.7 %; p = 0.349) respectively.ConclusionThis study has demonstrated that the use of thin strut cobalt chromium BMS in very small vessel CAD was reasonably safe and efficacious in the context of ‘real-world’ practice.