Angiographic Restenosis Research Articles

Neointimal Modification With Scoring Balloon and Efficacy of Drug-Coated Balloon Therapy in Patients With Restenosis in Drug-Eluting Coronary Stents: A Randomized Controlled Trial

ObjectivesThe aim of this study was to compare neointimal modification with scoring balloon pre-dilation before drug-coated balloon (DCB) versus DCB standard therapy in patients presenting with drug-eluting stent (DES) restenosis. BackgroundDCB angioplasty for the treatment of coronary drug-eluting stent restenosis has demonstrated encouraging results. The efficacy of DCB treatment relies on rapid initial drug transfer and tissue retention of the antiproliferative drug. Neointimal modification with scoring balloon pre-dilation may enhance the efficacy of DCB therapy. MethodsIn this randomized, open-label, active-controlled trial, 252 patients with clinically significant DES restenosis were enrolled at 4 centers in Germany. Patients undergoing DCB angioplasty were randomly assigned to treatment with scoring balloon pre-dilation or standard therapy. The primary endpoint of the study was in-segment percentage diameter stenosis on 6- to 8-month follow-up angiography. The secondary endpoints included binary angiographic restenosis and late lumen loss on follow-up angiography, the combined incidence of death or myocardial infarction, target lesion revascularization, and target lesion thrombosis at 1 year. ResultsFollow-up angiographic data at 6 to 8 months were available for 203 patients (80.6%). Scoring balloon pre-dilation compared with standard therapy showed significantly lower rates with respect to the primary endpoint (35.0 ± 16.8% vs. 40.4 ± 21.4%; p = 0.047) and binary angiographic restenosis (18.5% vs. 32.0%; p = 0.026). Late lumen loss was numerically lower after scoring balloon pre-dilation compared with standard therapy (0.31 ± 59 mm vs. 0.41 ± 0.74 mm; p = 0.27). There was no difference between the groups in the incidence of death or myocardial infarction (4.0% vs. 3.4%; p = 0.73). Scoring balloon versus standard therapy showed comparable rates of target lesion revascularization (16.2% vs. 21.8%; p = 0.26). No target lesion thrombosis occurred out to 1 year. ConclusionsIn patients presenting with drug-eluting stent restenosis, neointimal modification with scoring balloon improves the antirestenotic efficacy of DCB therapy. (Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug Eluting Stent In-Stent Restenosis 4 [ISAR-DESIRE 4]; NCT01632371)

Safety and Efficacy of New Biodegradable Polymer-based Sirolimus-Eluting Stents in a Preclinical Model

Introduction and objectivesNew drug-eluting stents (DES) designed to overcome the limitations of existing devices should initially be tested in preclinical studies. Our objective was to analyze the safety and efficacy of new biodegradable polymer-based DES compared with bare-metal stents (BMS) and commercially available DES in a model of normal porcine coronary arteries. MethodsWe randomly implanted 101 stents (BMS and biodegradable polymer-based sirolimus-eluting stents: 3 test stent iterations [BD1, BD2, and BD3], Orsiro, Biomime and Biomatrix) in the coronary arteries of 34 domestic pigs. Angiographic and histomorphometric studies were conducted 1 month (n = 83) and 3 months (n = 18) later. ResultsThe stents were implanted at a stent/artery ratio of 1.31 ± 0.21, with no significant differences between groups. At 1 month, the new test stents (BD1, BD2 and BD3) showed less late loss and angiographic restenosis, as well as lower histologic restenosis and neointimal area (P < .0005), than the BMS. There were no differences in endothelialization, vascular injury, or inflammation between the new test stents and BMS, although the new stents showed higher fibrin deposition (P = .0006). At 3 months, all these differences disappeared, except for a lower neointimal area with the new BD1 stent (P = .027). No differences at any time point were observed between the new test stents and commercially available controls. ConclusionsIn this preclinical model, the new biodegradable polymer-based DES studied showed less restenosis than BMS and no significant differences in safety or efficacy vs commercially available DES.

Efficacy of CilostAzol for Below-the-Knee Artery Disease after Balloon AnGioplasty in PatiEnts with Severe Limb Ischemia (CABBAGE Trial)

Optimal medical therapy after endovascular therapy in patients with critical limb ischemia (CLI) remains unclear. Therefore, we investigated whether cilostazol reduce restenosis after balloon angioplasty for infrapopliteal lesions in CLI patients. This study was performed as a multicenter, prospective, randomized, open-label, blinded-end point study with independent angiographic core laboratory adjudication. Sixty patients were eligible and 53 patients were enrolled and allocated. The primary end point was 3-month angiographic restenosis. The main secondary end points included major adverse limb event (MALE defined as requirement of any reintervention or major amputation), perioperative complications, major amputation, all-cause death, and hemorrhagic events. A total of 53 patients were randomized and all received their allocated intervention. Two patients in the cilostazol plus aspirin group and 1 in the aspirin group did not undergo any angioplasty for infrapopliteal stenotic lesions, and therefore were excluded from analysis. Finally, 38 vessels in 25 patients in the cilostazol plus aspirin group and as many cases in the aspirin group were included in the analysis. There were no significant differences in baseline characteristics between the 2 groups. The 3-month restenosis rate was 82% in the cilostazol+aspirin group and 81% in the aspirin group, with no significant difference (P=0.91). The MALE rate was 11% in the cilostazol plus aspirin group and 8% in the aspirin group (P=0.73). In addition, no significant difference was observed in any secondary points. Cilostazol did not reduce 3-month angiographic restenosis after balloon angioplasty for below-the-knee lesion in CLI patients.

IF11. Stent Graft vs Balloon Angioplasty for Treatment of Hemodialysis Prosthetic Graft Outlet Stenosis: A Prospective Randomized Study

Hemodialysis graft outlet stenosis is the most common problem for hemodialysis patients using prosthetic grafts as their vascular access. Currently, balloon angioplasty remains the first-line endovascular treatment for those lesions. However, covered graft implantation seems to be an effective and promising solution. A prospective and randomized study was conducted in a section of vascular surgery of a tertiary medical center in which 98 patients with dialysis grafts with symptomatic outlet stenosis were randomized into two groups: 49 stent graft group patients and 49 balloon angioplasty group patients. After intervention, 3 months, and 6 months, a survey with angiography was done for those patent grafts to compare the rate of angiographic restenosis of the two groups. In addition, the primary patency of two groups was carefully followed, calculated, and analyzed. The postintervention restenosis rate of the stent graft group was obviously better than the balloon group, at 9% vs 69% at 3 months and 29% vs 72% at 6 months. The primary patency rates of stent graft vs balloon groups at 3 months, 6 months, and 12 months were 91.7%, 83.2%, and 46.9% vs 65.3%, 27.8%, and 7.8%. The mean primary patency after treatment was 380.22 ± 28.54 days for the stent graft group and 151.08 ± 16.79 days for balloon group. Stent graft provides a better solution over plain balloon angioplasty on hemodialysis graft outlet stenosis treatment, with a lower postintervention restenosis rate and longer primary patency.

Seguridad y eficacia de nuevos modelos de stents liberadores de sirolimus con polímero biodegradable en el modelo preclínico

Introduction and objectivesNew drug-eluting stents (DES) designed to overcome the limitations of existing devices should initially be tested in preclinical studies. Our objective was to analyze the safety and efficacy of new biodegradable polymer-based DES compared with bare-metal stents (BMS) and commercially available DES in a model of normal porcine coronary arteries. MethodsWe randomly implanted 101 stents (BMS and biodegradable polymer-based sirolimus-eluting stents: 3 test stent iterations [BD1, BD2, and BD3], Orsiro, Biomime and Biomatrix) in the coronary arteries of 34 domestic pigs. Angiographic and histomorphometric studies were conducted 1 month (n = 83) and 3 months (n = 18) later. ResultsThe stents were implanted at a stent/artery ratio of 1.31 ± 0.21, with no significant differences between groups. At 1 month, the new test stents (BD1, BD2 and BD3) showed less late loss and angiographic restenosis, as well as lower histologic restenosis and neointimal area (P < .0005), than the BMS. There were no differences in endothelialization, vascular injury, or inflammation between the new test stents and BMS, although the new stents showed higher fibrin deposition (P = .0006). At 3 months, all these differences disappeared, except for a lower neointimal area with the new BD1 stent (P = .027). No differences at any time point were observed between the new test stents and commercially available controls. ConclusionsIn this preclinical model, the new biodegradable polymer-based DES studied showed less restenosis than BMS and no significant differences in safety or efficacy vs commercially available DES.Full English text available from:www.revespcardiol.org/en

Current State of Bioabsorbable Polymer-Coated Drug-Eluting Stents.

Drug-eluting stents (DES) have been shown to significantly reduce clinical and angiograph-ic restenosis compared to bare metal stents (BMS). The polymer coatings on DES elute antiproliferative drugs to inhibit intimal proliferation and prevent restenosis after stent implantation. Permanent poly-mers which do not degrade in vivo may increase the likelihood of stent-related delayed arterial healing or polymer hypersensitivity. In turn, these limitations may contribute to an increased risk of late clinical events. Intuitively, a polymer which degrades after completion of drug release, leaving an inert metal scaffold in place, may improve arterial healing by removing a chronic source of inflammation, neoath-erosclerosis, and/or late thrombosis. In this way, a biodegradable polymer may reduce late ischemic events. Additionally, improved healing after stent implantation could reduce the requirement for long-term dual antiplatelet therapy and the associated risk of bleeding and cost. This review will focus on bioabsorbable polymer-coated DES currently being evaluated in clinical trials.

Angiographic outcomes of Orsiro biodegradable polymer sirolimus-eluting stents and Resolute Integrity durable polymer zotarolimus-eluting stents: results of the ORIENT trial.

We performed a randomised controlled open-label non-inferiority trial to compare angiographic outcomes between the ultra-thin strut, biodegradable hybrid polymer Orsiro sirolimus-eluting stent (O-SES) and the durable biocompatible polymer Resolute Integrity zotarolimus-eluting stent (R-ZES). A total of 372 patients planned to undergo percutaneous coronary revascularisation were randomly assigned 2:1 to treatment with O-SES or R-ZES (250 and 122 patients, respectively). O-SES was non-inferior to R-ZES for the primary endpoint, in-stent late lumen loss at nine months (median 0.06 mm [interquartile range, -0.09 to 0.24 mm] versus 0.12 mm [-0.07 to 0.32 mm]; p for non-inferiority <0.001; p for superiority=0.205). Percent diameter stenosis was significantly lower in the O-SES group than in the R-ZES group (15.0 [10.0 to 20.0] versus 20.0 [13.3 to 26.0]; p=0.002). Target lesion failure occurred in 2.4% and 3.3% of the O-SES and R-ZES groups, respectively (p=0.621). Subgroup analyses showed consistently similar outcomes between the two groups in terms of the primary endpoint, except for the diabetic subgroup. O-SES was non-inferior to R-ZES in terms of in-stent late loss at nine months. Angiographic restenosis and clinical adverse events were low in both groups. This study confirms the good safety and efficacy profiles of both contemporary coronary stents.

EFFICACY OF SIROLIMUS ELUTING STENTS IMPLANTATION IN DIFFUSE (LONG AND EXTREMELY LONG) CORONARY ATHEROSCLEROTIC LESIONS

Aim . Comparison of efficacy of stents coated with sirolimus (group I — 116 patients), and bare metallic stents (group II — 117 patients) in treatment of diffuse (long) atherosclerotic lesions in coronary arteries. Material and methods. The groups were comparable by main parameters. Diabetes was found in 19% and 13,7%, respectively; multivessel lesion in 87,1% and 80,4%; vessel caliber less than 2,75 mm — 46,5% and 23,9%, respectively. Length of the lesion was 25,9±6,6 mm (28-93 mm) in group I and 22,1±7,8 mm (26-102 mm) in group II. Totally, 473 stents implanted into 232 arteries (2,1 per artery): group I — 184 stents in 116 arteries (overlap of 2> stents in 87,9% cases) and 289 in 117 in group II (superposition of stents in 87,1%). Results . The direct success at short term was noted in 113 patients in group I (97,4%) and in 116 in group II (99,1%) (p=0,74). In both groups there were no cases of acute thrombosis of stents. Subacute thrombosis (in 1-3 weeks) was noted in 2 patients (1,7%) in group I and in 1 (0,85%) in group II (p=0,47). Long term angiographic restenosis was noted in 12 patients from group I (10,6%) and in 66 in group II (56,9%) (p<0,0025). Also, in group II 47 patients from 66 had diffuse restenosis (71,2%), as in group I there was no diffuse restenosis. Survival rate with no MACE or angina in 12 months was 79,8% in group I, and 31% in group II.

Coronary angioplasty: Back to the future

Puel and Sigwart, in 1986, deployed the first coronary stent to act as a scaffold preventing vessel closure reducing the incidence of angiographic restenosis. The first stents were bare metal stents. The first drug-eluting stents to be approved were coated with paclitaxel or sirolimus. Since these stents came with a lot of promise but also with risk of thrombosis, the next step was biodegradable stents. These stents are expected to degrade into nontoxic byproducts. They came with a lot of fanfare but are now being viewed with caution because of initial poor results. We do not know what the future holds.

First-in-Human Evaluation of a Novel Polymer-Free Drug-Filled Stent: Angiographic, IVUS, OCT, and Clinical Outcomes From the RevElution Study

ObjectivesThis study sought to assess the safety and effectiveness of the drug-filled stent (DFS) (Medtronic, Santa Rosa, California) in the treatment of patients with coronary artery disease. BackgroundPolymer-free drug-eluting stents have the potential to improve clinical outcomes and facilitate shorter durations of dual antiplatelet therapy. The polymer-free DFS is made from a trilayered continuous wire with an outer cobalt chromium layer, a middle tantalum layer, and an inner lumen coated with sirolimus. Small laser-drilled holes on the abluminal stent surface control drug elution. MethodsThe RevElution trial enrolled 100 patients with de novo coronary lesions 2.25 to 3.50 mm in diameter and length ≤27 mm in 2 cohorts of 50 patients for angiographic, intravascular ultrasound, and clinical assessment at 9 or 24 months, with optical coherence tomography performed in a subset of 30 patients at each time period. The primary endpoint was angiographic in-stent late lumen loss at 9 months compared with Resolute zotarolimus-eluting stent (Medtronic) historical control data. ResultsFifty patients with 56 lesions were treated with DFS in the 9-month cohort. In-stent late lumen loss was 0.26 ± 0.28 mm for DFS and 0.36 ± 0.52 mm for Resolute (pnoninferiority <0.001). The binary angiographic restenosis rate was 0%. Median stent strut coverage by optical coherence tomography was 91.4%, 95.6%, and 99.1% at 1, 3, and 9 months, respectively. One non–Q-wave myocardial infarction occurred, with a 9-month target lesion failure rate of 2.1%. No stent thrombosis occurred. ConclusionsAt 9 months, the polymer-free DFS was safe and effective with high rates of early strut coverage and noninferior late lumen loss compared to Resolute. (Medtronic RevElution Trial [RevElution]; NCT02480348)

Percutaneous Coronary Intervention and Coronary Artery Bypass Grafting in Heart Transplant Recipients With Transplant Coronary Arterial Vasculopathy

BackgroundTransplant coronary arterial vasculopathy (TCAV) is a major cause of death after heart transplantation (HTx). Palliative coronary revascularization has been attempted in patients with severe TCAV; however, the outcome has not been fully elucidated. MethodsNinety-six patients who were treated after HTx at our institute between 1999 and 2015 were screened for TCAV. TCAV was defined as >70% stenosis on coronary angiography (CAG) or a maximal intimal thickness of >0.5 mm in the right or left coronary arteries on intracoronary ultrasonography (IVUS). In the present study, the outcomes of patients with severe TCAV who underwent percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) were investigated. ResultsTCAV containing donor-transmitted atherosclerosis was cumulatively found in 69 patients (71.9% of the total; mean age, 34.6 ± 13.1 years; 52 men; mean follow-up duration, 83.0 ± 60.4 months). Five (7.2%) and 64 (92.8%) of the 69 patients were diagnosed as having TCAV by use of CAG and IVUS, respectively. All 5 patients diagnosed by with the use of CAG underwent coronary revascularization between 1 and 236 months after HTx. Three patients underwent PCI with drug-eluting stents, with a primary success rate of 100%. No angiographic restenosis occurred in 2 patients at 31 and 36 months after PCI, respectively. Meanwhile, 2 patients underwent CABG. No peri-operative complications occurred, and all grafts were patent as assessed by use of CAG at 34 and 5 months after CABG. ConclusionsCoronary revascularization was feasible and effective for severe TCAV with middle-term follow-up.

The combined use of Drug-eluting balloon and Excimer laser for coronary artery Restenosis In-Stent Treatment: The DERIST study.

Stents reduce angiographic restenosis in comparison with balloon angioplasty. The rate of in-stent restenosis (ISR), although less frequent than post-angioplasty restenosis, is becoming increasingly prevalent due to the recent exponential increase in the use of intracoronary stents. The aim of this study is to evaluate angiographic and clinical outcomes of PTCA in combination with the use of excimer laser coronary angioplasty (ELCA) and drug-eluting balloon (DEB) in treatment of in-stent restenosis (ISR). This multi-centric case-control study evaluated angiographic and clinical outcomes of PTCA with excimer laser coronary angioplasty (ELCA) and drug-eluting balloon (DEB) in 80 patients with in-stent restenosis (ISR). All patients underwent nine months of clinical and a coronary angiography follow-up. This study showed clinical and angiographic long-term success in the 91% of the patients. The incidence of myocardial infarctions and deaths was lower than the rate after plain balloon angioplasty within the stent. This study showed that excimer laser coronary angioplasty (ELCA) and drug-eluting balloon (DEB) may be an alternative treatment for in-stent restenosis (ISR).

FFR result post PCI is suboptimal in long diffuse coronary artery disease.

The aim of this study was to evaluate the functional result immediately post PCI and at nine-month follow-up, and to ascertain how often a functionally optimal result of >0.95 can be achieved in long coronary lesions treated with long second- or newer-generation DES. Patients receiving DES measuring ≥30 mm with FFR value ≤0.8 were included in the study. Stent length was defined as long (30 to 49 mm; L-DES) and ultra-long (≥50 mm; UL-DES). Angiographic and FFR evaluation was performed before and after PCI and at nine-month follow-up. A total of 74 patients each received a mean stent length of 50.72±14.6 mm. Mean FFR post PCI was 0.88±0.06. An optimal post PCI FFR value of >0.95 was achieved in only 9/74 patients (12.2%), and was not achieved in any UL-DES patients. Only 12/74 (16.2%) had FFR post PCI of 0.91 to 0.95; 8/74 (10.8%) patients remained ischaemic (≤0.8). FFR gradient across the stent was higher in UL-DES patients compared to L-DES patients (0.07±0.03 vs. 0.04±0.03; p=0.001). At follow-up, the angiographic restenosis rate was 4.7%, and the functional restenosis rate was 15.1%. The FFR result post PCI was suboptimal in the majority of patients treated with long DES and was particularly poor when the total stent length exceeded 50 mm.

Impact of coronary collateral circulation on angiographic in-stent restenosis in patients with stable coronary artery disease and chronic total occlusion

ObjectiveThis study aimed to evaluate the relationship between coronary collateralization and in-stent restenosis (ISR) in stable coronary artery disease patients with chronic total occlusion (CTO) after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation. MethodsThe degree of coronary collaterals supplying the distal aspect of a total occlusion from the contra-lateral vessel was graded according to Rentrop classification in 216 patients with stable angina undergoing successful DES based PCI for CTO. Univariable and multivariable logistic regression analyses were performed to assess the potential factors related to angiographic ISR during follow-up. ResultsDespite similar number of diseased coronary arteries, good collateralization (Rentrop score 2 or 3) was more frequently associated with right coronary artery occlusion (60%), whereas poor collaterals (Rentrop score 0 or 1) occurred more often in left anterior descending artery occlusion (40%). Despite similar number of CTO intervened, stent length was longer in patients with good collateralization (59±27mm vs 47±23mm, p=0.001). At mean 18months, the rate of ISR did not significantly differ between patients with good collateralization and those with poor collateralization (12.7% vs 20.2%, p=0.148). At multivariable analysis, age (OR 1.058, 95%CI 1.015–1.104, p=0.008), history of diabetes mellitus (OR 2.382, 95%CI 1.109–5.116, p=0.026) and reference CTO vessel diameter (OR 0.219, 95% CI 0.051–0.951, p=0.043) were independent risk factors for ISR while Rentrop collateral grade (OR 0.795, 95% CI 0.365–1.732, p=0.414) was not associated with ISR. ConclusionsThe occurrence of ISR after successful DES based PCI for CTO may be not influenced by coronary collateralization.

Biodegradable polymer-based, argatroban-eluting, cobalt-chromium stent (JF-04) for treatment of native coronary lesions: final results of the first-in-man study and lessons learned.

The aim of the study was to investigate the six-month angiographic and nine-month clinical follow-up outcomes in a first-in-man study using the biodegradable polymer-based cobalt-chromium argatroban-eluting stent (JF-04) for treatment of native coronary atherosclerotic lesions. A total of 31 patients with either stable or unstable angina, or silent myocardial ischaemia, exhibiting de novo coronary lesions were enrolled at seven Japanese sites. The lesions were treated with the JF-04 stent after predilatation. The primary endpoint was angiographic in-stent late loss six months after implantation. The secondary endpoints included angiographic restenosis and in-stent volume obstruction by intravascular ultrasound at six months and target vessel failure (TVF) at nine months. Procedural success was achieved in 100% of cases. At six months, angiographic in-stent late loss was 1.01±0.48 mm and binary restenosis was observed in nine cases (29.0%). Among these restenotic cases, most (n=8) demonstrated advanced angiographic restenosis patterns, including diffuse/proliferative restenosis and total occlusion. At nine months, TVF was observed in four cases (12.9%), exclusively attributed to target vessel revascularisation. This argatroban-eluting stent failed to inhibit neointimal hyperplasia sufficiently, despite the theoretical benefits and promising clinical experience with local drug delivery.

Randomised comparison of drug-eluting versus bare-metal stenting in patients with non-ST elevation myocardial infarction

ObjectiveThe superiority of drug-eluting stents (DES) over bare-metal stents (BMS) in patients with ST elevation myocardial infarction (STEMI) is well studied; however, randomised data in patients with non-ST elevation myocardial...

Culotte stenting vs. TAP stenting for treatment of de-novo coronary bifurcation lesions with the need for side-branch stenting: the Bifurcations Bad Krozingen (BBK) II angiographic trial.

In percutaneous coronary intervention for de-novo coronary bifurcation lesions, the optimal technique for provisional side-branch stenting is still a matter of debate. We tested whether in this setting culotte stenting reduces the incidence of restenosis as compared with T-and-protrusion (TAP) stenting. This trial included 300 patients with a coronary bifurcation lesion requiring a side-branch stent. Patients were randomly assigned to culotte stenting or TAP stenting using drug-eluting stents in a 1:1 fashion. Primary endpoint was maximal per cent diameter stenosis of the bifurcation lesion at 9-month angiographic follow-up. As clinical endpoints we assessed target lesion re-intervention (TLR) and target lesion failure (composite of cardiac death, target vessel myocardial infarction, and TLR).Angiographic follow-up was available in 91% of the patients. After culotte stenting, the maximum per cent diameter stenosis in the treated bifurcation lesion was 21 ± 20% as compared with 27 ± 25% after TAP stenting (P = 0.038). The respective corresponding binary restenosis rates were 6.5 and 17% (P = 0.006). The 1-year incidence of TLR was 6.0% after culotte stenting vs. 12.0% after T-stenting (P = 0.069). Target lesion failure occurred in 6.7% of the culotte group and in 12.0% of the TAP group (P = 0.11). Only one patient of the culotte group incurred a definite stent thrombosis during 1-year follow-up. Compared with the TAP stenting, culotte stenting was associated with a significantly lower incidence of angiographic restenosis.

Prospective multi-center registry to evaluate efficacy and safety of the newly developed diamond-like carbon-coated cobalt\u2013chromium coronary stent system

The purpose of this multi-center, non-randomized, and open-label clinical trial was to determine the non-inferiority of diamond-like carbon (DLC)-coated cobalt–chromium coronary stent, the MOMO DLC coronary stent, relative to commercially available bare-metal stents (MULTI-LINK VISION®). Nineteen centers in Japan participated. The study cohort consisted of 99 patients from 19 Japanese centers with single or double native coronary vessel disease with de novo and restenosis lesions who met the study eligibility criteria. This cohort formed the safety analysis set. The efficacy analysis set consisted of 98 patients (one case was excluded for violating the eligibility criteria). The primary endpoint was target vessel failure (TVF) rate at 9 months after stent placement. Of the 98 efficacy analysis set patients, TVF occurred in 11 patients (11.2 %, 95 % confidence interval 5.7–19.2 %) at 9 months after the index stent implantation. The upper 95 % confidence interval for TVF of the study stent was lower than that previously reported for the commercially available MULTI-LINK VISION® (19.6 %), demonstrating non-inferiority of the study stent to MULTI-LINK VISION®. All the TVF cases were related to target vascular revascularization. None of the cases developed in-stent thrombosis or myocardial infarction. The average in-stent late loss and binary restenosis rate at the 6-month follow-up angiography were 0.69 mm and 10.5 %, respectively, which are lower than the reported values for commercially available bare-metal stents. In conclusion, the current pivotal clinical study evaluating the new MOMO DLC-coated coronary stent suggested its low rates of TVF and angiographic binary restenosis, and small in-stent late loss, although the data were considered preliminary considering the small sample size and single arm study design.

Complex coronary bifurcation revascularization by means of very minimal crushing and ultrathin biodegradable polymer DES: Feasibility and 1-year outcomes of the "Nano-crush" technique.

To assess feasibility and 1-year outcomes of ultrathin biodegradable polymer double stenting using a very minimal crushing (nano-crush technique) in a series of patients with large (≥2.5mm) complex coronary bifurcation. From January 2015 to June 2016, patients referred for large (≥2.5mm) complex coronary bifurcation percutaneous coronary interventions (PCI) were enrolled to receive Orsiro (Biotronik Inc., Bulack, Switzerland) double stenting using a very minimal crush technique (nano-crush). Per our institutional protocol, follow-up was conducted by physical examination at 1, 6, 12month and yearly whereas angiographic control was eventually scheduled at 6-8months on the basis of symptoms recurrence or/and positive induced ischemia tests. Fifty-two patients (15 females mean age 77.2±6.2years) were enrolled. Mean angles between main branch and side branch were 63.6±21.3°. The mean diameter and length of implanted stents were 3.8±0.4mm and 27.1±8.7mm in main branch and 2.8±0.3mm and 22.1±.7.1mm in side branch. Immediate success was 100%. Clinical follow-up was available for 100% of patients: at a mean follow-up of 12.0±2.6months, no patient death, or acute myocardial infarction or target vessel revascularization were observed. Angiographic follow-up was available in 25/52 patients (48%) at a mean time from the procedure of 7.2±0.5months and showed no significant angiographic restenosis. The revascularization of complex large (≥2.5mm) coronary bifurcation disease using the nano-crush technique and the ultrathin polymer biodegradable stent appeared feasible in our small study with promising 1year outcomes.

A Pilot Study on Culottes versus Crossover Single Stenting for True Coronary Bifurcation Lesions.

The purpose of our study was to compare clinical and angiographic outcomes of planned culottes technique with that of provisional crossover single stenting in the treatment of true coronary bifurcation lesions (CBL) with drug-eluting stent (DES). True CBL patients (n = 104) were randomly assigned to either the provisional stenting of the side branch (crossover group) or the culottes group. Additional side branch (SB) stenting in the crossover group was required if there was thrombolysis in myocardial infarction flow ≤ 1 flow). The primary end point was the occurrence of major adverse cardiac events (MACE) at nine months, including cardiac death, myocardial infarction, target lesion/vessel revascularization and in-stent thrombosis. The secondary end point was angiographic in-segment restenosis at nine months. The rate of MACE at nine months was similar between the crossover and culottes groups (7.7% vs. 7.7%, p = 1.000). Additional SB stenting in the crossover group was required in 3.8% of patients. There was one procedural occlusion of SB in the crossover group. At nine months, the rate of in-segment restenosis was similar in the parent main vessel (0% vs. 1.9%, p = 1.000), main branch (1.9% vs. 7.7%, p = 0.363) and SB (17.3% vs. 9.6%, p = 0.250) between the crossover and culottes groups, respectively. This study demonstrated that there is no significant difference in cumulative MACE or in-segment restenosis between crossover and culottes groups. Larger randomized clinical trials are warranted to re-evaluate the outcomes of the provisional crossover stenting versus the culottes stenting techniques utilizing DES for true CBL.