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.

In Vitro and In Vivo Comparative Evaluation of a Shellac-Ammonium Paclitaxel-Coated Balloon versus a Benchmark Device.

OBJECTIVES: The present study was designed to compare the characteristics and performance regarding drug delivery of a novel drug-coated balloon (DCB) to a benchmark device (Restore® versus SeQuent® Please) in an in vitro and in vivo model. BACKGROUND: Although Restore® and SeQuent® are both paclitaxel-coated, they use different coating excipient, shellac-ammonium salt and iopromide, respectively. Preclinical study comparing these two different commercial DCBs regarding their characteristics and effects on early vascular response is sparse. METHODS: Restore® and SeQuent® DCBs were scanned with electron microscopy for surface characteristic assessment. Both DCBs were transported in an in vitro vessel model for the evaluation of drug wash-off rate and particulate formation. Eighteen coronary angioplasties with either Restore® or SeQuent® DCBs were conducted in 6 swine (three coronary vessels each). Histopathological images of each vessel were evaluated for vessel injury. RESULTS: The surface of Restore® DCB was smooth and evenly distributed with hardly visible crystal, while SeQuent® DCB showed a rougher surface with relatively larger apparent crystals. Restore® DCB had a lower drug wash-off rate and fewer large visible particles, compared to the SeQuent® DCB. No significant difference in mean injure score was found between Restore® and SeQuent® group. CONCLUSION: Our results suggest that Restore® is better in preclinical performance regarding less release of particles and lower drug wash-off rate as compared to SeQuent® Please. The Restore® DCB, using stable amorphous coating and shellac-ammonium salt as an excipient, appears to provide an advantage in drug delivery efficacy; however, further clinical studies are warranted.

Finite element analysis of cutting balloon expansion in a calcified artery model of circular angle 180°: Effects of balloon-to-diameter ratio and number of blades facing calcification on potential calcification fracturing and perforation reduction.

Calcified artery lesions cause stent under-expansion and increase the risk of in-stent restenosis and stent thrombosis. Cutting balloons facilitate the fracturing of calcification prior to stent implantation, although vessel dissection and perforation are potential issues. In clinical practice, calcifications having maximum calcium angles ≤ 180° are rarely fractured during conventional balloon angioplasty. We hypothesize that the lesion/device diameter ratio and the number of blades facing a non-circular calcified lesion may be crucial for fracturing the calcification while avoiding vessel injury. The geometries of the cutting balloons were constructed and their finite-element models were generated by folding and wrapping the balloon model. Numerical simulations were performed for balloons with five different diameters and two types of blade directions in a 180° calcification model. The calcification expansion ability was distinctly higher when two blades faced the calcification than when one blade did. Moreover, when two blades faced the calcification model, larger maximum principal stresses were generated in the calcification even when using undersized balloons with diameters reduced by 0.25 or 0.5 mm from the reference diameter, when compared with the case where one blade faced the calcified model and a balloon of diameter equal to the reference diameter was used. When two blades faced the calcification, smaller stresses were generated in the artery adjacent to the calcification; further, the maximum stress generated in the artery model adjacent to the calcification under the rated pressure of 12 atm when employing undersized balloons was smaller than that when only one blade faced the calcification and when lesion-identical balloon diameters were used under a nominal pressure of 6 atm. Our study suggested that undersized balloons of diameters 0.25 or 0.5 mm less than the reference diameter might be effective in not only expanding the calcified lesion but also reducing the risk of dissection.

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).

Balloon Angioplasty Versus Stenting in Patients With ST-Elevated Myocardial Infarction Before Subsequent Coronary Artery By-Pass Grafting.

Decision of ad hoc revascularization strategy in patients who require coronary artery bypass grafting (CABG) following primary percutaneous coronary interventions (PCI) is challenging due to the pros and cons of only-ballooning and stenting. In this study, we aimed to compare the outcomes of only-balloon-angioplasty to stenting in primary PCI in patients with ST elevated myocardial infarction (STEMI) who required a subsequent CABG. We retrospectively analyzed 350 consecutive STEMI patients who needed CABG in addition to primary balloon angioplasty (n = 160) and stenting strategy (n = 190). In-hospital and 5-year outcomes of the patients were compared between the 2 groups. In-hospital mortality rates in the ballooning and stenting groups were not nonsignificantly different (11.2% vs 9.5%, respectively, P = .59); 5-year mortality rates were also similar between the 2 groups (9.2% vs 8.7%, P = .89). Additionally, major bleeding rates (3.8% vs 6.3%, P = .28) did not differ between the 2 groups. In conclusion, our study showed no significant difference in-hospital and long-term mortality rates in patients who require CABG after primary PCI irrespective of the ad hoc revascularization strategy.

Plaque erosion causing ST-elevation myocardial infarction after consumption of cannabis and N2O in a 27-year old man: a case report.

BACKGROUND: The recreational drugs cannabis and nitrous oxide (N2O) are known for pro-atherogenic effects and are associated with an elevated risk of myocardial infarction. These cardiovascular effects might be underestimated by the public. Culprit-lesion composition of myocardial infarctions associated with cannabis and N2O has been unknown so far. This case report aims to raise the awareness of the adverse cardiovascular effects of cannabis and N2O and reports, for the first time, optical coherence tomography (OCT) findings of the culprit lesion. CASE PRESENTATION: This is a case report of a 27-year old man with anterior ST-segment-elevation myocardial infarction (STEMI) after intoxication with cannabis and N2O. Coronary angiography and OCT revealed plaque erosion with subsequent subtotal thrombotic occlusion of the left anterior descending artery that was successfully treated with 1 drug-eluting stent. The patient was symptom free at 6 months follow-up and had been able to abstain from drug consumption. CONCLUSIONS: This is the first case to demonstrate the association between cannabis and N2O abuse and plaque erosion on OCT in a young man with STEMI. In contrast to smoking, whose adverse effects are well-known, the cardiovascular effects of cannabis and N2O might be underestimated. These adverse effects should gain more awareness in the public to prevent early vascular events in young adults.

Impact of diabetes mellitus on the early-phase arterial healing after drug-eluting stent implantation.

BACKGROUND: Early arterial healing after drug-eluting stent (DES) implantation may enable short dual-antiplatelet therapy (DAPT) strategy. The impact of diabetes mellitus (DM) on this healing has not been elucidated. We used coronary angioscopy (CAS) to compare intravascular status of DM and non-DM patients in the early phase after DES implantation. METHODS: This study was a multicenter retrospective observational study. We analyzed CAS findings of 337 lesions from 270 patients evaluated 3-5 months after DES implantation. We divided the lesion into two groups: DM (n = 149) and non-DM (n = 188). We assessed neointimal coverage (NIC) grades (dominant, maximum and minimum), thrombus adhesion and maximum yellow color grade. NIC was graded as follows: grade 0, stent struts were not covered; grade 1, stent struts were covered by thin layer; grade 2, stent struts were buried under neointima. Yellow color was graded as grade 0, white; grade 1, light yellow; grade 2, yellow; grade 3, intensive yellow. RESULTS: Minimum NIC grade was significantly lower in DM than in non-DM groups (p = 0.002), whereas dominant and maximum NIC grades were similar between them (p = 0.59 and p = 0.94, respectively), as were thrombus adhesion (44.3% vs. 38.8%, p = 0.32) and maximum yellow color grade (p = 0.78). A multivariate analysis demonstrated that DM was an independent predictor of minimum NIC of grade 0 (odds ratio: 2.14, 95% confidence interval: 1.19-3.86, p = 0.011). CONCLUSIONS: DM patients showed more uncovered struts than non-DM patients 3-5 months after DES implantation, suggesting that the recent ultra-short DAPT strategy might not be easily applied to DM patients.

Potential value of guard-wire technology in the interventional treatment for ostial coronary lesions.

BACKGROUND: To explore potential value of guard-wire technology during percutaneous coronary intervention (PCI) in patients with ostial coronary lesions. METHODS: Patients, who underwent PCI, were collected between October 2011 and March 2017. Of the 141 patients, 63 (44.7%) have ostial lesions, and 78 (55.3%) have distal bifurcation sites. They were divided into group A (n = 71) and group B (n = 70). Group A received PCI after guard-wire technology. Group B were given balloon dilation and stent after placing guide wire through target lesion vessel. X-ray exposure time, contrast agent dosage, total PCI duration, pressure incarceration times, cases of malignant arrhythmia and cases of failed PCI of all patients were analyzed, respectively. RESULTS: The general clinical characteristics includes patients age, sex ratio, the proportion of complications, smoking ratio and left ventricular ejection fraction of both groups was not significantly different. X-ray exposure time, contrast agent dosage, PCI total time, stent positioning time, pressure infestation frequency, arrhythmia frequency and complication number of group B were higher than those of group A. There is no case of malignant arrhythmia and case of failed PCI in group A, while there were five malignant arrhythmia and four failed PCI in group B. Contrast agent dosage and cases of failed PCI increased in group B compared with group A. CONCLUSION: The guard wire technology is safer and more feasible to patients with ostial coronary lesions who underwent PCI.

Myocardial ischemia 10 years after a modified Cabrol procedure in a 42-year-old patient with Marfan syndrome.

BACKGROUND: Marfan syndrome, a genetic disorder of the connective tissue, may cause aortic root dilation with aortic insufficiency, aortic dissection and mitral prolapse with mitral insufficiency. We present a case of a late complication of the modified Cabrol procedure that included replacing the ascending aorta with a composite graft. CASE PRESENTATION: In February 2019, a 42-year-old female patient with Marfan syndrome who presented with chest pain was sent to the Emergency Department. She had undergone the modified Cabrol procedure 10 years prior. Upon presenting, laboratory analysis revealed elevated troponin-I levels. Electrocardiogram showed new inverted T waves over lead I, aVL and V4 to V6. Contrast computed tomography (CT) revealed thrombosis in the Dacron graft. Percutaneous coronary angiography was conducted, and a large thrombus in the graft was noted. Thrombolytic therapy and percutaneous coronary intervention were performed, after which the patient had no more symptoms and was discharged without complications. CONCLUSIONS: Aortic root surgery, including the Cabrol or modified Cabrol procedure, is necessary for complicated cases of aortic dilations, such as in patients with Marfan syndrome, even though the Cabrol or modified Cabrol procedure has a high complication rate. Regarding this case, we were surprised by the timing of the myocardial ischemia and the position of the thrombus, which differed from other cases. To better manage such a patient's condition and to detect the formation of thrombus early, completeness of the graft and possible stenosis of the anastomosis site to avoid preventable myocardial ischemia, we suggest that patients should have regular image follow-up, even years after the Cabrol or modified Cabrol procedure.

Comparison of bailout and planned rotational atherectomy for severe coronary calcified lesions.

BACKGROUND: To compare outcomes of bailout and planned rotational atherectomy (RA) in the treatment of severe calcified coronary lesions. METHODS: Data of patients treated with RA from 2017 to 2018 at a single-center registry were retrospectively analyzed. All patients were divided into planned RA and bailout RA groups, data between two groups were compared. RESULTS: A total of 190 patients were included in this study, 138 patients received planned RA and 52 patients received bailout RA. Baseline clinical characteristics had no significant differences between groups. The number of implanted stents and total stents length were similar. But the number of balloon (1.6 ± 0.8 vs. 2.7 ± 1.3, P < 0.001), procedure time (83.5 ± 26.2 vs. 100.8 ± 36.4 min, P = 0.007), fluoroscopy volume (941 ± 482 vs. 1227 ± 872 mGy, P = 0.012] and contrast amount (237 ± 62 vs. 275 ± 90 ml, P = 0.003) were all lower in planned RA group. Planned RA had a higher procedural success rate (99.3% vs. 92.3%, P = 0.007) and a lower complication incidence (4.3% vs. 17.3%, P = 0.009). But the primary outcomes at 3 years (9.2 and 16.6%, log rank p = 0.24) had no difference between groups. CONCLUSIONS: For severe coronary artery calcification, although planned RA did not improved the long term prognosis compared with bailout RA, but it can improve the immediate procedural success rate, reduce the incidence of complications, the procedure time and the volume of contrast.

A case of successful coronary angioplasty in an achondroplasia patient with total occlusion of an anomalous right coronary artery (case report).

BACKGROUND: Coronary interventions in patients of achondroplasia have been reported rarely in the medical literature. Due to short stature and kyphoscoliosis, endovascular access (Cannulation) of the coronary arteries is usually extremely difficult in such patients. CASE PRESENTATION: A 33 years old patient, a known case of achondroplasia, presented with epigastric pain for 3 h duration to a university hospital, Sudan. Her height was 95 cm and her weight was 38 Kg. A trans-femoral approach for coronary angioplasty was preferred. After it has been extremely difficult to cannulate the left system at first, the cannulation has been performed successfully using 5F, JL3.5 catheter. The angiogram depicted total occlusion of the proximal right coronary artery which was found to be originating from the left coronary sinus of the aorta. Successful trans-femoral coronary angioplasty has been performed with stent placement, and no complications encountered. During her last follow up, 1 year after the procedure, she appeared to be free of symptoms and with no further ischemic attacks or procedure-related complications. CONCLUSIONS: To the best of our knowledge, this is the first reported case of successful coronary angioplasty in achondroplasia patient in whom the occluded artery is an anomalous coronary artery. Literature review, description of the achondroplasia, development of the coronary arteries and the hypothesized theory for the anomaly have been described in this case report. The PCI performed has also been clearly and comprehensively described.

First in man: percutaneous coronary angioplasty using non-fluoroscopic electro-anatomic mapping.

Reduction of radiography exposure and contrast use continue to be challenging goals for interventional cardiology. We present a case where percutaneous coronary intervention was done successfully using an electroanatomic mapping system (NavX™; Abbot Inc. USA); with near zero use of fluoroscopy or contrast agent.

Orbital Atherectomy and Heavily Calcified Saphenous Vein Graft Intervention.

Percutaneous coronary intervention in the diseased saphenous vein graft differs significantly from that in the diseased native coronary artery. After being exposed to arterial pressures over time, vein grafts have substantially different plaque characteristics, with more inflammatory cells, more diffuse disease, and less calcification. Severe calcification of saphenous vein grafts, although uncommon, poses a high risk of stent underexpansion. Orbital atherectomy for treatment of de novo calcified coronary lesions has been associated with better outcomes at 5-year follow-up. However, there are no published data on the use of orbital atherectomy to treat severely calcified saphenous vein graft lesions. We present the case of a 77-year-old woman with non-ST-segment-elevation myocardial infarction who underwent successful orbital atherectomy to prepare a severely calcified saphenous vein graft lesion for stent implantation.

Stent-Only Versus Adjunctive Balloon Angioplasty Approach for Saphenous Vein Graft Percutaneous Coronary Intervention: Insights From DIVA Trial.

BACKGROUND: Direct stenting without pre-dilation or post-dilation has been advocated for saphenous vein graft percutaneous coronary intervention to decrease the incidence of distal embolization, periprocedural myocardial infarction, and target lesion revascularization. METHODS: We performed a post hoc analysis of patients enrolled in the DIVA (Drug-Eluting Stents Versus Bare Metal Stents in Saphenous Vein Graft Angioplasty; NCT01121224) prospective, double-blind, randomized controlled trial. Patients were stratified into stent-only and balloon-stent groups. Primary end point was 12-month incidence of target vessel failure (defined as the composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization). Secondary end points included all-cause death, stent thrombosis, myocardial infarction, and target lesion revascularization during follow-up. RESULTS: Of the 575 patients included in this substudy, 185 (32%) patients underwent stent-only percutaneous coronary intervention. Patients in the stent-only versus balloon-stent group had similar baseline characteristics and similar incidence of target vessel failure at 12-months (15% versus 19%; hazard ratio, 1.34 [95% CI, 0.86-2.08]; P=0.19). During long-term follow-up (median of 2.7 years), the incidence of definite stent thrombosis (1% versus 5%; hazard ratio, 9.20 [95% CI, 1.23-68.92]; P=0.0085), the composite of definite or probable stent thrombosis (5% versus 11%; hazard ratio, 2.52 [95% CI, 1.23-5.18]; P=0.009), and target vessel myocardial infarction (8% versus 14%; hazard ratio, 1.92 [95% CI, 1.08-3.40]; P=0.023) was lower in the stent-only group. Multivariable analysis showed that a higher number of years since coronary artery bypass grafting and >1 target saphenous vein graft lesions were associated with increased target vessel failure during entire follow-up, while preintervention Thrombolysis in Myocardial Infarction-3 flow was protective. CONCLUSIONS: In patients undergoing percutaneous coronary intervention of de novo saphenous vein graft lesions, there was no difference in target vessel failure at 12 months and long-term follow-up in the stent-only versus the balloon-stent group; however, the incidence of stent thrombosis was lower in the stent-only group, as was target vessel myocardial infarction. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01121224.

A modified predilation, sizing, and postdilation scoring system for patients undergoing metallic drug-eluting stent implantations.

OBJECTIVE: This study sought to assess whether the predilation, scaffold/stent sizing, and postdilation (PSP) score for bioresorbable scaffold (BRS) implantation was associated with outcomes following metallic drug-eluting stent (DES) implantation. BACKGROUND: The PSP score is associated with patients' prognoses after BRS implantation. METHODS: This study involved 2,348 patients who underwent biodegradable polymer DES implantations during the PANDA III trial. The optimal PSP technique was defined according to previous studies of BRS implantations. The main outcome was target lesion failure (TLF) that comprised cardiac death, target-vessel myocardial infarction, or ischemia-driven target lesion revascularization. RESULTS: Twenty-five (1.1%) patients fulfilled all the PSP criteria. The BRS-derived PSP score was of limited prognostic value for 2-year TLF after metallic DES implantation; optimal sizing was a protective factor, but optimal predilation was a risk factor. We built a new PSP model for DESs by identifying the following risk factors: predilation performed with a residual stenosis ≥70% or a balloon-to-quantitative coronary angiography (QCA)-determined reference vessel diameter (RVD) ratio >1:1, sizing performed with an RVD <2.25 mm or a stent diameter >0.25 mm wider than the QCA-RVD, a postprocedural stenosis diameter ≥30%, age, and the baseline SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery (SYNTAX) score. The new PSP scoring system predicted 2-year TLF (area under the curve, 0.69; 95% confidence interval, 0.65-0.73); a cutoff value of 19.2 points identified high-risk patients. CONCLUSIONS: The new PSP scoring system, based on redefined PSP criteria, age, and the SYNTAX score, could help optimize metallic DES implantations.

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.