Prevention of in-stent restenosis with drug-eluting balloons in patients with postirradiated carotid stenosis accepting percutaneous angioplasty and stenting.

OBJECTIVE: To investigate the technical safety and outcome of in-stent restenosis (ISR) prevention with drug-eluting balloon (DEB) in patients with postirradiated carotid stenosis (PIRCS) undergoing percutaneous angioplasty and stenting (PTAS). METHODS: Between 2017 and 2021, we prospectively recruited patients with severe PIRCS for PTAS. They were randomly separated into two groups based on endovascular techniques performed with and without DEB. Preprocedural and early postprocedural (within 24 hours) MRI, short-term ultrasonography (6 months after PTAS), and long-term CT angiography (CTA)/MR angiography (MRA), 12 months after PTAS, were performed. Technical safety was evaluated based on periprocedural neurological complications and the number of recent embolic ischemic lesions (REIL) in the treated brain territory on diffusion-weighted imaging of early postprocedural MRI. RESULTS: Sixty-six (30 with and 36 without DEB) subjects were enrolled, with one failure in techniques. For 65 patients in the DEB versus conventional groups, technical neurological symptoms within 1 month (1/29 (3.4%) vs 0/36; P=0.197) and REIL numbers within 24 hours (1.0±2.1 vs 1.3±1.5; P=0.592) after PTAS showed no differences. Peak systolic velocity (PSVs) on short-term ultrasonography was significantly higher in the conventional group (104.13±42.76 vs .81.95±31.35; P=0.023). The degree of in-stent stenosis (45.93±20.86 vs 26.58±8.75; P<0.001) was higher, and there were more subjects (n=8, 38.9% vs 1, 3.4%; P=0.029) with significant ISR (≥ 50%) in the conventional group than in the DEB group on long-term CTA/MRA. CONCLUSIONS: We observed similar technical safety of carotid PTAS with and without DEBs. The number of cases of significant ISR were fewer and the degree of stenosis of ISR was less in primary DEB-PTAS of PIRCS than for conventional PTAS in the 12-month follow-up.

Procedural Results and One-Year Clinical Outcomes of Treatment of Bioresorbable Vascular Scaffolds Restenosis (from the RIBS VII Prospective Study).

Currently, both drug-eluting stents (DES) and drug-eluting balloons are recommended in patients with in-stent restenosis (ISR) of metallic stents. However, the clinical results of repeated interventions in patients with restenosis of bioresorbable vascular scaffolds (BVS) remain unsettled. We sought to assess the results of interventions in patients with BVS-ISR as compared with those obtained in patients with ISR of DES and bare-metal stents (BMS). Restenosis Intrastent: Treatment of Bioresorbable Vascular Scaffolds Restenosis (RIBS VII) is a prospective multicenter study (23 Spanish sites) that included 117 consecutive patients treated for BVS-ISR. Inclusion/exclusion criteria were similar to those of previous RIBS studies. Patients in the RIBS IV (DES-ISR, n = 309) and RIBS V (BMS - ISR, n = 189) randomized trials, were used as controls. Most patients with BVS-ISR were treated with DES (76%). Patients with BVS-ISR were younger, had larger vessels, and after interventions had higher in-segment residual diameter stenosis (19 ± 13%, 15 ± 11%, 15 ± 12%, p <0.001) than those treated for DES-ISR and BMS-ISR, respectively. At 1-year clinical follow-up (obtained in 100% of patients) target lesion revascularization (6%) was similar to that seen in patients with DES-ISR and BMS-ISR (8.7% and 3.7%, p = 0.32). Freedom from death, myocardial infarction, and target vessel revascularization (primary clinical end point) was 8.5%, also similar to that found in patients with DES-ISR and BMS-ISR (14.2% and 7.4%, p = 0.09). Results were also similar when only patients treated with DES in each group were compared and remained unchanged after adjusting for potential confounders in baseline characteristics. Time to BVS-ISR did not influence angiographic or clinical results. This study demonstrates the safety and efficacy of coronary interventions for patients presenting with BVS-ISR. One-year clinical results in these patients are comparable to those seen in patients with ISR of metallic stents (ClinicalTrials.gov ID:NCT03167424).

Endoscopic Internal Thoracic Artery Harvesting with Changes in Scope Position.

Although minimally invasive direct coronary artery bypass (MIDCAB) is a less invasive procedure, internal thoracic artery (ITA) harvesting is difficult. A 65-year-old woman was advised to undergo MIDCAB for recurrent in-stent restenosis. We harvested the ITA using three-dimensional endoscopy without robotics and determined the scope position using enhanced computed tomography. We changed the camera installation between the wound and the camera port, according to the harvesting site with a harmonic scalpel using the skeletonized technique. We harvested the ITA from the subclavian vein level superiorly to the xyphoid process level inferiorly.

Stentectomy for LAD "full metal jacket" with in-stent restenosis: How to do it.

We report our technique for the surgical revascularization of symptomatic severe in-stent restenosis of a "full metal jacket" (≥60 mm overlapping stents) of the left anterior descending coronary artery without suitable distal targets: on-pump cardioplegic-arrest stent removal (stentectomy) with endarterectomy and skeletonized left internal mammary artery onlay patch reconstruction. We also describe our follow-up protocol, including antiplatelet/anticoagulation and angiography. With proper patient selection, multidisciplinary collaboration, and surgical expertise, this advanced coronary procedure can be beneficial to a growing population of patients otherwise deemed to be untreatable.

Effect of umbilical cord blood stem cell transplantation on restenosis after endovascular interventional therapy for diabetic hindlimb vascular disease.

This study aimed to investigate the mechanism of human umbilical cord blood stem cell (HUCBSC) transplantation on restenosis after percutaneous transluminal angioplasty (PTA) for diabetic hindlimb vascular disease in rabbits. After successfully preparing a rabbit model of diabetic hindlimb vascular disease, 16 rabbits were randomly assigned to two groups. Of these, 8 rabbits received PTA surgery alone (PTA group), and the other 8 rabbits received PTA and HUCBSC (PTA+HUCBSC group) treatments. Five more healthy rabbits were set as healthy control (HC group). Samples were collected after 4 weeks of treatment. The expressions of regulator of calcineurin 1 (RCAN1) and calcineurin A (CnA) in the diseased artery were detected by immunofluorescence staining. The distribution of HUCBSCs was observed by pathological examination in transplanted artery, distal artery, and liver. Cytology experiments were applied to assess the levels of JAK and STAT3, and the migration and proliferation of human aortic vascular smooth muscle cells (HA-VSMC). In the rabbit model of diabetic vascular lesions in the hindlimbs, we found the stenosis of the femoral artery became more and more serious with time, and the expression level of PCNA positive cells was also gradually increased. The expression levels of RCAN1 and CnA in the PTA+HUCBSC group were significantly lower than those in PTA group. HUCBSC inhibited the migration and proliferation of HA-VSMC via JAK/STAT3 pathway. After HUCBSC local transplantation, HUCBSC had no distal tissue distribution. HUCBSC transplantation may prevent restenosis after PTA of diabetic hindlimb vascular disease through JAK/STAT3 pathway.

Rationale and design of a randomized study comparing the agent drug coated balloon to plain old balloon angioplasty in patients with In-stent restenosis.

BACKGROUND: Drug-coated balloon (DCB) technology was developed as an alternative treatment for obstructive coronary artery disease (CAD) and in-stent restenosis (ISR). Management of coronary ISR is clinically challenging and frequently encountered in practice. The Agent DCB uses an inactive excipient to effectively deliver a targeted, therapeutic dose of paclitaxel to the vessel wall. STUDY DESIGN: AGENT IDE is a prospective, multicenter, randomized controlled trial to evaluate superiority of the Agent DCB to balloon angioplasty in treating patients with ISR. A total of 480 patients with ISR of a previously treated lesion length <26 mm and reference vessel diameter >2.0 mm to ≤4.0 mm will be initially randomized. Subjects presenting with recent myocardial infarction (MI), complex lesions, or thrombus in the target vessel will be excluded. An adaptive group sequential design with one formal interim analysis for sample size re-estimation will be conducted, and the sample size may be increased to a maximum of 600 subjects. The primary endpoint is the rate of 12-month target lesion failure (TLF; composite of any ischemia-driven revascularization of the target lesion (TLR), target vessel related MI, or cardiac death) and will be tested for superiority in the test arm against the control. Functional status and general health-related quality of life will be measured by changes in the EQ-5D scores. Subjects will be followed for 5 years following the index procedure. CONCLUSION: This study will prospectively evaluate the safety and efficacy of Agent DCB in patients treated for coronary ISR.

Successful Retrieval of Entrapped Guide Extension Catheter in the Right Coronary Artery with Heavy Calcifications.

Usage of an optimal guide extension catheter often helps successful outcomes in complex percutaneous coronary intervention. Here, we report a case of successfully retrieving a guide extension catheter entrapped by a coronary stent in the middle RCA. The guide extension catheter was retrieved by anchoring with the stent delivery balloon. Also, our in vitro experiment demonstrated that a "deep seating method" and an "anchoring guide extension catheter method" could be effective in bailing out guide extension catheter entrapment.

Results of paclitaxel-drug-coated balloons (Pantera Lux) for coronary in-stent restenosis: Italian experience from REGistry of Paclitaxel Eluting Balloon in ISR study.

AIMS: Drug-eluting stent (DES) implantation is an effective treatment of in-stent restenosis (ISR). However, literature data indicate that drug-coated balloons (DCBs) may be a valid alternative, particularly for recurrent ISR. We sought to evaluate clinical results on the long-term efficacy of a new DCB for ISR treatment. METHODS: One hundred and ninety-nine patients were treated with paclitaxel drug-coated balloons (Pantera Lux, Biotronik, Switzerland) in the Italian REGistry of Paclitaxel Eluting Balloon in ISR (REGPEB study). Clinical follow-up was scheduled at 1 and 12 months. A subgroup of patients received adjunctive 5-year follow-up. Primary end point was Major Adverse Cardiac Events (MACE) at 1 year. RESULTS: A total of 214 ISR coronary lesions were treated (75.4% DES-ISR). Mean time between stent implantation and DCB treatment is 41 months. DCBs were successfully delivered in 99% of the cases; crossover to a DES occurred in 3% of cases. Procedural success rate was 98.5%. Clinical success rate was 98.5%. First-month follow-up compliance was 98% and freedom from MACE was 96.9%. Twelve-month follow-up compliance was 89.3% with a freedom from MACE rate of 87.3% (CI: 81.3-91.5%). Five-year long-term follow-up showed 65.2% of freedom from MACE. CONCLUSION: Our study confirms that Pantera Lux treatment is effective and well tolerated in ISR, showing good acute and long/very long-term results in the treatment of complex lesions (DES and late ISR).

Drug-coated balloon angioplasty versus balloon angioplasty for treating patients with in-stent restenosis in the femoropopliteal artery: A meta-analysis.

BACKGROUND: The introduction of endovascular surgery has led to frequent stent use, although in-stent restenosis (ISR) remains a challenging issue. Drug-coated balloon (DCB) and conventional balloon angioplasty (BA) are common endovascular procedures for addressing ISR in the femoropopliteal artery. However, there is controversy regarding which procedure provides the greatest benefit to patients. METHODS: The PubMed, EMBASE, and Cochrane Central Register of Controlled Trials databases were searched for prospective controlled trials that compared DCB and BA for patients with ISR in the femoropopliteal artery. The study has been approved by Ethics Committee of Wuhan Central Hospital. RESULTS: The meta-analysis included 6 prospective trials with 541 patients. We found that DCB use was associated with significant reductions in binary restenosis at 6 months (relative risk [RR]: 0.45, 95% confidence interval [CI]: 0.33-0.63; P < .00001), binary restenosis at 1 year (RR: 0.44, 95% CI: 0.34-0.57; P < .00001), target lesion revascularization (TLR) at 6 months (RR: 0.36, 95% CI: 0.20-0.65; P = .0006), and TLR at 1 year (RR: 0.38, 95% CI: 0.27-0.54; P < .00001). The DCB group also had significantly better clinical improvement (RR: 1.39, 95% CI: 1.13-1.71; P = .002), although we did not detect inter-group differences in terms of death, target vessel thrombosis, or ipsilateral amputation. The brand of DCB may a cause of heterogeneity. CONCLUSION: Relative to BA, DCB use increases the durability of treatment for ISR in the femoropopliteal artery, based on significant reductions in binary restenosis and TLR at 6-12 months after the procedure. Furthermore, DCB use was associated with better clinical improvement. However, additional randomized controlled trials are needed to validate these findings.

Clinical outcomes after percutaneous coronary intervention for early versus late and very late stent thrombosis: a systematic review and meta-analysis.

Whether the clinical outcomes of stent thrombosis (ST) are different when stratified by time of occurrence remains unclear. The objective of this study was to compare the short- and long-term clinical outcomes after percutaneous coronary intervention (PCI) for early stent thrombosis (EST) versus late stent thrombosis (LST) and very late stent thrombosis (VLST). We enrolled eligible studies searched from the main electronic databases (EMBASE, PubMed, Cochrane). The primary endpoints were in-hospital, 30-day, 1-year and long-term mortality. The secondary endpoints included recurrent stent thrombosis (RST) and target vessel/lesion revascularization (TVR/TLR) during hospitalization, at 30 days, at 1 year and at long-term follow-up. A total of 23 studies with 17,592 patients were included. Compared with mortality rates of the late and very late thrombosis (LST/VLST) group, in-hospital (P = 0.004), 30-day (P < 0.00001), 1-year (P < 0.00001) and long-term mortality rates (P = 0.04) were significantly higher in the EST group. The in-hospital TVR/TLR rates were similar between the EST group and the LST/VLST group. However, a higher trend in TVR/TLR rate at 30 days and a significantly higher TVR/TLR rate at 1 year (P = 0.002) as well as at long-term follow up (P = 0.009) were found in the EST group. EST patients also trended toward higher risk of RST in both short- and long-term follow-up than LST/VLST patients, although differences were not statistically significant. After PCI treatment, patients with EST have worse clinical outcomes in both short- and long-term follow-up than patients with LST/VLST. Further studies are warranted to determine the optimal treatment strategies for EST.

Treatment of In-Stent Restenosis Using Excimer Laser Coronary Atherectomy and Bioresorbable Vascular Scaffold Guided by Optical Coherence Tomography.

The rate of in-stent restenosis (ISR) has become increasingly prevalent with the exponential growth in stent implantation due to an aging population and a higher life expectancy, in addition to the high rates of obesity and diabetes. In this prospective, single operator, all-comer study, we sought to analyze the performance of ELCA followed by bioresorbable vascular scaffold (BVS) placement in patients undergoing percutaneous coronary intervention (PCI) for ISR. A total of 13 patients had ISR treated with a combination of ELCA and BVS, with 9 patients having matched OCT pre, post ELCA and post BVS. Mean age was 65 ± 11.22 and 83% of the patients were male. Hypertension and dyslipidemia were present in 100% of the patients and smoking and diabetes in 50%. After the procedure, we did not detect residual stenosis over 10% in any patient, resulting in a technical success of 100%. No patients had MACE during their hospital stay or within the next six months, resulting in a procedure success of 100%. The mean lumen area increased 0.35 mm2 from pre procedure to post ELCA and 3.58 mm2 from post ELCA to post BVS. The final difference, from pre procedure to post BVS, was a 3.93 mm2 lumen area gain. The mean lumen diameter increased 0.11 mm from baseline to ELCA, 0.95 mm from post laser to BVS implantation and 1.06 mm from pre procedure to post BVS. The NIH area reduced 0.48 mm2 from pre to post ELCA, 1.13mm2 from post ELCA to BVS implantation and 1.61 mm2 from baseline to post BVS implantation. We conclude that ELCA is a safe and feasible debulking method to approach ISR, with high rates of post-procedural BVS success, within six months follow-up.

One-Year Clinical Outcome of Inspiron Stent in All-Comers Population (Analysis from 790 Consecutive Patients).

AIMS: The goal of this study was to evaluate the performance of the InspironTM coronary stent (Scitech Medical™, Goiás, Brazil). The InspironTM sirolimus-eluting stent uses an ultrathin L-605 cobalt-chromium alloy with a 75 µm strut thickness platform coated with an abluminal biodegradable polymer. The polymer is eliminated from the body through the tricarboxylic acid cycle in 6-9 months, releasing 80% of the drug within 30 days after its deployment. METHODS: It was a prospective, single-center registry. To represent clinical practice, all patients undergoing percutaneous coronary intervention were included in this registry. There were no exclusion criteria. Clinical follow-ups were performed at twelve months. The endpoints were the occurrence of all-cause death, definite stent thrombosis, and new revascularization. RESULTS: Between November 2017 and May 2019, 790 patients were included (1067 lesions). The mean age was 60.42 ± 14.94 years, and 74.7% presented with acute coronary syndrome. Diabetes mellitus was present in 43.9% of patients, and previous myocardial infarction and previous percutaneous coronary intervention were present in 17.9% and 11.3%, respectively. Angiographic success was achieved in 99.1%. The incidence of all-cause death was 11.5% (6.2% in-hospital and 5.3% in the follow-up) and definitive stent thrombosis was 0.2%. New revascularization was performed in only 5.8% (target lesion revascularization: 2.2%; progression of disease in another lesion: 3.6%). Based on the multivariate regression analysis, only chronic renal failure was an independent predictor of adverse events (OR: 3.3; 95% CI: 1.22-8.92). CONCLUSION: The result of this single-center registry demonstrates the safety and excellent performance of the InspironTM stent in daily clinical practice with a low rate of adverse cardiac events.

Circulating microRNA-21 as Stable Blood-Based Markers for Patients With ISR After PCI.

It recently has been reported that the in-stent restenosis (ISR) of expanded area after percutaneous coronary intervention (PCI) within six months can become a serious postoperative complication. A real-time quantitative PCR was used to analyze the expression of serum miR-21 in 33 ISR and 37 non-ISR patients after PCI. Expression of miR-21 was significantly higher in the ISR group compared with that in the NISR group, and a similar trend also occurred in factor- (TNF-α) level, Interleukin -6 (IL-6) level, and plaque area (PLA). However, a contrary trend occurred in the external elastic membrane area (EEM) and minimal lumen area (MLA). This study suggests that the increased expression of serum miR-21 is related to ISR after PCI, and miR-21 can be a new predictor of ISR.

Cracking the Plaque With Coronary Lithotripsy: Mechanistic Insights From Optical Coherence Tomography.

Coronary lithoplasty is a promising technique that can overcome issues regarding the treatment of undilatable, heavily calcified, de novo, and in-stent restenotic lesions, allowing plaque modification and successful stent deployment, as demonstrated by intravascular imaging.

The effect of the debulking by excimer laser coronary angioplasty on long-term outcome compared with drug-coating balloon: insights from optical frequency domain imaging analysis.

This study evaluated the 1-year efficacy of excimer laser coronary angioplasty (ELCA) before drug-coated balloon (DCB) dilatation for the treatment of in-stent restenosis (ISR). Forty consecutive patients with ISR were treated by DCB with or without the use of ELCA (ELCA plus DCB, N = 20; DCB alone, N = 20). Debulking efficiency (DE) value was defined as the neointima area on optical frequency domain imaging (OFDI) debulked by ELCA. The patients in the ELCA plus DCB group were divided into two groups (greater DE (GDE), N = 10; smaller DE (SDE), N = 10) based on the median value of DE. Thereafter, the ISR segment was prepared with a scoring balloon, followed by DCB. At follow-up, binary restenosis and target lesion revascularization (TLR) were evaluated. There were no significant differences in baseline characteristics such as age, comorbidity, and ISR type. Overall, the incidence of neoatherosclerosis in the ISR segment was 17.5%. Post-PCI, acute gain of minimum lumen diameter on quantitative coronary angiography and of minimum lumen area on OFDI was numerically higher in the GDE than in the SDE and the DCB alone group. At follow-up, the occurrences of binary restenosis and TLR in the ELCA plus DCB group were 20.0% and 10.0%; these values in the DCB alone group were 20.0% and 20.0%, respectively. Two patients from the SDE and none from the GDE developed TLR. DCB alone treatment was inferior to ELCA plus DCB treatment. However, greater ELCA debulking might be required to obtain optimal outcomes.

Percutaneous coronary angioplasty versus coronary artery bypass grafting in the treatment of unprotected left main stenosis: updated 5-year outcomes from the randomised, non-inferiority NOBLE trial.

BACKGROUND: Percutaneous coronary intervention (PCI) is increasingly used in revascularisation of patients with left main coronary artery disease in place of the standard treatment, coronary artery bypass grafting (CABG). The NOBLE trial aimed to evaluate whether PCI was non-inferior to CABG in the treatment of left main coronary artery disease and reported outcomes after a median follow-up of 3·1 years. We now report updated 5-year outcomes of the trial. METHODS: The prospective, randomised, open-label, non-inferiority NOBLE trial was done at 36 hospitals in nine northern European countries. Patients with left main coronary artery disease requiring revascularisation were enrolled and randomly assigned (1:1) to receive PCI or CABG. The primary endpoint was major adverse cardiac or cerebrovascular events (MACCE), a composite of all-cause mortality, non-procedural myocardial infarction, repeat revascularisation, and stroke. Non-inferiority of PCI to CABG was defined as the upper limit of the 95% CI of the hazard ratio (HR) not exceeding 1·35 after 275 MACCE had occurred. Secondary endpoints included all-cause mortality, non-procedural myocardial infarction, and repeat revascularisation. Outcomes were analysed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT01496651. FINDINGS: Between Dec 9, 2008, and Jan 21, 2015, 1201 patients were enrolled and allocated to PCI (n=598) or CABG (n=603), with 17 subsequently lost to early follow-up. 592 patients in each group were included in this analysis. At a median of 4·9 years of follow-up, the predefined number of events was reached for adequate power to assess the primary endpoint. Kaplan-Meier 5-year estimates of MACCE were 28% (165 events) for PCI and 19% (110 events) for CABG (HR 1·58 [95% CI 1·24-2·01]); the HR exceeded the limit for non-inferiority of PCI compared to CABG. CABG was found to be superior to PCI for the primary composite endpoint (p=0·0002). All-cause mortality was estimated in 9% after PCI versus 9% after CABG (HR 1·08 [95% CI 0·74-1·59]; p=0·68); non-procedural myocardial infarction was estimated in 8% after PCI versus 3% after CABG (HR 2·99 [95% CI 1·66-5·39]; p=0·0002); and repeat revascularisation was estimated in 17% after PCI versus 10% after CABG (HR 1·73 [95% CI 1·25-2·40]; p=0·0009). INTERPRETATION: In revascularisation of left main coronary artery disease, PCI was associated with an inferior clinical outcome at 5 years compared with CABG. Mortality was similar after the two procedures but patients treated with PCI had higher rates of non-procedural myocardial infarction and repeat revascularisation. FUNDING: Biosensors.

Longitudinal Stent Deformation: Precise Diagnosis With Optical Coherence Tomography.

Longitudinal stent deformation is a recognized complication of coronary angioplasty; however, it is difficult to detect angiographically. This case illustrates the value of OCT to identify and correctly diagnose longitudinal stent deformation.

Effect of drug-coated balloon angioplasty on in-stent restenotic coronary lesions analyzed with optical coherence tomography and serial coronary artery angioscopy.

Drug-coated balloon angioplasty (DCBA) has been recognized for its utility in preventing in-stent re-restenosis (ISR); however, imaging of the neointima immediately after treatment and during follow-up has only been described in a few case reports. This study aimed to determine the efficacy and mechanism of the DCBA using imaging studies both immediately after the DCBA and during the follow-up period. We enrolled 15 consecutive patients who underwent DCBA for in-stent restenosis (ISR). The in-stent neointimal volume was evaluated using optical coherence tomography (OCT), and the in-stent yellow grade was assessed using coronary angioscopy (CAS) immediately after DCBA and during the median follow-up period of 9 (8-15) months. The neointimal volume was significantly reduced from 77.1 ± 36.2 mm3 at baseline to 60.2 ± 23.9 mm3 immediately after DCBA (p = 0.0012 vs. baseline) and to 46.7 ± 21.9 mm3 during the follow-up (p = 0.0002 vs. post DCBA). The yellow grade of the residual plaques at the ISR lesion, which indicated plaque vulnerability, was significantly decreased in the follow-up CAG (from baseline: 1.79 ± 1.03, during the follow-up: 0.76 ± 0.82; p < 0.0001). These data suggest that DCBA may inhibit neointimal formation and provide angioscopic intimal stabilization for ISR lesions.