Intracoronary microcatheter indwelling for continuous pumping of low-dose thrombolytic drugs: A new approach to reperfusion in acute myocardial infarction.

Reperfusion therapy of acute myocardial infarction (AMI) refers to physical or chemical recanalization and restoration of blood flow to an occluded coronary artery, and current techniques for reperfusion therapy include intravenous thrombolysis, percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). The number of patients receiving emergency CABG in the real world is decreasing due to the disadvantages of CABG and the improvement in PCI procedures. Thrombolytic therapy has some disadvantages such as low recanalization rate, high risk of reocclusion and bleeding, and short time window. On the other hand, intracoronary interventional therapy may meet the requirements of "early, complete and persistent" patency of coronary arteries at different time points. However, in the emergency PCI, although thrombus aspiration via a catheter or balloon dilation is performed, residual thrombus with heavy or low TIMI (thrombolysis in myocardial infarction) myocardial perfusion grading is still observed in some patients, suggesting disordered microcirculation. Currently, the treatment of microcirculatory disturbance in emergency PCI mainly employed injection of tirofiban, adenosine, thrombolytic agent or other drugs into the local area via a microcatheter in a short time, all of which can significantly reduce the thrombus load and improve TIMI perfusion. Herein, we report that a microcatheter was indwelled in the coronary artery for continuous pumping of low-dose thrombolytic drugs as reperfusion therapy in 12 patients with acute and subacute MI.

Comparative effectiveness and safety of prasugrel and ticagrelor in patients of acute coronary syndrome undergoing percutaneous transluminal coronary angioplasty: A propensity score-matched analysis.

Evidence on comparative effectiveness and safety of prasugrel and ticagrelor post-percutaneous transluminal coronary angioplasty is scarce in Indian population. In a 1:1 propensity score-matched cohort with 71 individuals in each group, the incidence of a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or coronary revascularization was not significantly different in prasugrel and ticagrelor group (7.04% vs 9.86%; absolute difference, 2.8%; HR, 0.65; 95% CI, 0.21-2.1; p = 0.49). There was no significant difference in bleeding (5.63% vs 9.86%; absolute difference, -4.20%; 95% CI, -13.0%-4.5%) and dyspnea (7.04% vs 12.7%; absolute difference, -5.60%; 95% CI, -15.4%-4.1%).

Burr entrapment in a percutaneous coronary intervention during rotational atherectomy: An experience with 3195 cases.

OBJECTIVES: Burr entrapment is a potentially life-threatening complication of rotational atherectomy (RA). However, owing to its infrequency, there have been no major reports on burr entrapment. This study aimed to evaluate the incidence, treatment, and outcomes of burr entrapment. METHODS: This multicenter retrospective study analyzed patients who had undergone percutaneous coronary interventions (PCIs) and were treated by RA between May 2013 and March 2022. RESULTS: Of the 22 640 PCI procedures, RA was performed in 3195 patients (14.1%), among whom burr entrapment occurred in 22 patients (0.69%). The mean patient age was 78 ± 8.7 years; 64% were male, and 32% were on dialysis. The entrapped burr size was 1.7 ± 0.2 mm, and the burr/artery ratio was 0.6 ± 0.1. In 20 patients (91%), the burr was extracted by strong manual pullback. The other patients underwent balloon angioplasty at the site of the entrapped burr, which might have provided space for successful burr withdrawal. Major adverse cardiac events occurred in 23% of patients. Tamponade requiring pericardiocentesis occurred in two patients (9%). No patients required emergency surgery or suffered an in-hospital death. CONCLUSIONS: Burr entrapment occurred in 0.69% of patients who had undergone RA. Most burrs were extracted by a strong manual pullback. None required emergency surgery, and there were no in-hospital deaths. The results provide a treatment approach and prognosis for burr stuck in the use of RA.

Entrapment and rupture of the guide wire during PTCA: case report and medico-legal considerations.

Background: In recent years, due to the increase of complaints for medical malpractice, the Sicilian Regional Health System has adopted proceedings for the direct management of claims by each healthcare facility with the aim of reducing costs of insurance premiums and their relative taxes. Thus this management has led to increased awareness and management of clinical risk through the introduction of mandatory sentinel event monitoring. Case report: A 55-year-old man with acute ischemic heart disease, due to three-vasal coronary diasease, underwent angioplasty perfomed on the second diagonal branch of the anterior descending artery. Simultaneously following the discovery of a major middle tract stenosis, he underwent further angioplasty surgery during which guidewire entrapment occurred, precisely in the proximal section of the vessel, resulting in the rupture and persistence of some fragments despite attempts to extract them. Subsequent antiplatelet therapy was prescribed and no further procedures were indicated for the removal of the guide wire, meanwhile a persistent reactive anxious-depressive state was established. Conclusion: The medico-legal analysis of the case excluded liabilty since it was a fortuitous, unpredictable and inevitable event. However, the patient had not been adequately informed about the possibility of the complication presented, which resulted in prolonged hospitalization and compensation for the psychological disorder suffered as a result of the adverse event. The attempted economic agreement was unsuccessful. A civil lawsuit was subsequently filed by the patient and the Judge's report confirmed the corporate CMC assessment and ruled out that the side effects related to the guideline fragment.

Mid-term results of stent-less coronary intervention using rotational atherectomy and drug-coated balloon for de-novo lesions in hemodialysis patients.

BACKGROUND: Although drug-coated balloon (DCB)-based stent-less percutaneous coronary intervention (PCI) for de-novo lesions has attracted more attention, outcomes of the DCB procedure for hemodialysis (HD) patients are reported to be inferior to those for non-HD patients, similarly to drug-eluting stent (DES). Recent several reports have shown that rotational atherectomy (RA) followed by DCB treatment (RA/DCB) could be an option of revascularization strategy particularly for calcified de-novo lesions even in the new-generation DES era; however, efficacy of the RA/DCB procedure for HD patients remains unclear. METHODS: A total of 47 consecutive cases (53 lesions) undergoing RA/DCB for de-novo lesions were enrolled. According to the presence/absence of HD at baseline, the 47 cases were divided into the HD cases (N.=16) and the non-HD cases (N.=31), and the 53 lesions were divided into the HD lesions (N.=20) and the non-HD lesions (N.=33). RESULTS: The HD cases had a significantly lower prevalence of dyslipidemia and smoking than the non-HD cases. Final RA burr size, DCB diameter used, and angiographic success rate of PCI did not significantly differ between the 2 groups. Preprocedural, post-procedural, and follow-up QCA parameters were also similar between the 2 groups. Twelve-month clinical outcomes were comparable between the 2 groups. CONCLUSIONS: Mid-term outcomes of stent-less PCI using RA/DCB for de-novo lesions in HD patients might be comparable to those in non-HD patients, suggesting efficacy of pretreatment of RA prior to DCB treatment in HD patients.

[Main stem intervention-Is one stent better than two after all?] / Hauptstammintervention ­ Ist ein Stent doch besser als zwei?

The current European Society of Cardiology (ESC) guideline recommendations give equal consideration to percutaneous coronary interventions (PCI) and bypass surgery for the treatment of main stem stenosis. Because of the anatomical setting, interventional treatment of main stem stenosis represents a complex PCI procedure. For this reason, extensive planning of the PCI with the use of intravascular imaging is necessary to assess the extent of calcification in the main stem itself and also in the proximal vascular segment of the anterior interventricular branch (left anterior descending, LAD) and the circumflex branch (RCX). Furthermore, an assessment of the vessel diameter is necessary for planning the PCI as well as for stent selection. Especially in the case of severely calcified lesions, careful and routine dissection of the lesion to be treated is essential. For this purpose, so-called cutting balloons, scoring balloons or debulking devices (rotational atherectomy, orbital atherectomy) can be used. In the case of a main stem stenosis involving the bifurcation, the choice of stent strategy depends on the extent of calcification of the daughter vessels (LAD and RCX), as well as the complexity of the bifurcation stenosis. The superiority of the so-called double kissing (DK) crush technique over a single stent strategy could be confirmed in a randomized trial and should be used in main stem bifurcation stenoses with pronounced calcification of the proximal segments of the LAD and RCX (stenosis length > 10 mm, and > 70% diameter stenosis). The already established 2­stent strategies for the treatment of bifurcation stenosis could be modified or further developed. In preliminary studies the advantage of the so-called DK nano-crush technique and the DK culotte technique could be shown, whereby these initial results still have to be confirmed by larger randomized studies.

Safety and Efficacy of All Comers Treated with a Paclitaxel Coated Balloon for Below Knee Intervention.

OBJECTIVE: Data on paclitaxel coated balloons (PCBs) for below knee (BTK) angioplasty exhibited conflicting efficacy results, and previous meta-analyses suggested an increased mortality and amputation risk highlighting the need for further research. The aim of this study was to investigate safety and efficacy of PCBs for BTK interventions in a real world cohort. METHODS: Within a single centre cohort study, 552 consecutive patients were included undergoing BTK interventions with and without PCB use. Two year safety and efficacy results were compared in unadjusted and propensity score matched (PSM) analysis. RESULTS: BTK interventions were performed in 157 patients with PCB angioplasty (100% Lutonix 0.014 inch drug coated balloon; Bard Lutonix, New Hope, MN, USA) and 395 patients with plain old balloon angioplasty (POBA). The majority of interventions (> 70%) were performed for chronic limb threatening ischaemia. Mean lesion length was 20.8 ± 12.6 cm; 61.2% in the PCB and 66.7% in the POBA group were occlusions. In the PCB group, more procedures were performed for re-stenotic lesions than POBA (28.5 vs. 17.2%). In PSM analysis (128 matched pairs), the primary efficacy endpoint was freedom from clinically driven target lesion revascularisation (CD TLR), which occurred in 70.1% in the PCB and 73.1% in the POBA group at one year (p = .85; McNemar test). Survival analysis suggested lower rates of major amputations in the PCB group in unadjusted (94.4% ± 2.1 vs. 89.2% ± 1.9 in the POBA group) and PSM analyses (97.2% ± 1.6 vs. 89.3% ± 3.5) through two years, while no differences were seen for CD TLR and all cause mortality between the groups. CONCLUSION: In this all comer analysis, PCBs were found to be safe for BTK interventions with a signal towards lower amputation rates but no benefit was seen for repeat revascularisation.

The Ongoing Saga of the Evolution of Percutaneous Coronary Intervention: From Balloon Angioplasty to Recent Innovations to Future Prospects.

The advances in percutaneous coronary intervention (PCI) have been, above all, dependent on the work of pioneers in surgery, radiology, and interventional cardiology. From Grüntzig's first balloon angioplasty, PCI has expanded through technology development, improved protocols, and dissemination of best-practice techniques. We can nowadays treat more complex lesions in higher-risk patients with favourable results. Guide wires, balloon types and profiles, debulking techniques such as atherectomy or lithotripsy, stents, and scaffolds all represent evolutions that have allowed us to tackle complex lesions such as an unprotected left main coronary artery, complex bifurcations, or chronic total occlusions. Best-practice PCI, including physiology assessment, imaging, and optimal lesion preparation are now the gold standard when performing PCI for sound indications, and new technologies such as intravascular lithotripsy for lesion preparation, or artificial intelligence, are innovations in the steps of 4 decades of pioneers to improve patient care in interventional cardiology. In the present review, major innovations in PCI since the first balloon angioplasty and also uncertainties and obstacles inherent to such medical advances are described.

Acute Myocardial Infarction and Percutaneous Coronary Intervention: What does the Epidemiological Data of the Last Years Indicate?

Abstract Background: ST-segment elevation acute myocardial infarction (STEMI) is a pathological process that involves cardiac muscle tissue death. Intravenous thrombolysis with fibrinolytics or primary percutaneous coronary intervention (PCI), an invasive technique, can be performed for tissue revascularization. PCI has been preferred as compared to non-invasive methods, although few studies have described its use in Brazil. Objectives: The aim of the present study was to analyze data on the use of primary PCI and investigate the relevance of hospitalizations for the treatment of STEMI in the country. Methods: A descriptive, cross-sectional analysis of data from the Brazilian Unified Health system (SUS) Department of Informatics (DATASUS) from 2010 to 2019 was conducted. Results: Hospitalizations for STEMI represented 0.6% of all hospital admissions in Brazil in the analyzed period, 0.9% of hospital costs, and 2.1% of deaths. The number of hospitalizations due to STEMI was 659,811, and 82,793 for PCIs. Length of hospital stay was 36.0% shorter and mortality rate was 53.3% lower in PCI. The mean cost of PCI was 3.5-fold higher than for treatment of STEMI. Conclusions: Data on hospitalizations for STEMI treatment in Brazil revealed high hospitalization and mortality rates, elevated costs, and long hospital stay. Although primary PCI is a more expensive and less used technique than other methods, it can reduce the length of hospital stay and mortality in the treatment of STEMI.

Impact of intravascular ultrasound and final kissing balloon dilatation on long-term clinical outcome in percutaneous revascularization with 1-stent strategy for left main coronary artery stenosis in drug-eluting stent era.

BACKGROUND: It remains uncertain whether intravascular ultrasound (IVUS) use and final kissing balloon (FKB) dilatation would be standard care of percutaneous coronary intervention (PCI) with a simple 1-stent technique in unprotected left main coronary artery (LMCA) stenosis. This study sought to investigate the impact of IVUS use and FKB dilatation on long-term major adverse cardiac events (MACEs) in PCI with a simple 1-stent technique for unprotected LMCA stenosis. METHODS: Between June 2006 and December 2012, 255 patients who underwent PCI with 1 drug-eluting stent for LMCA stenosis were analyzed. Mean follow-up duration was 1663 ± 946 days. Long-term MACEs were defined as death, nonfatal myocardial infarction (MI) and repeat revascularizations. RESULTS: During the follow-up, 72 (28.2%) MACEs occurred including 38 (14.9%) deaths, 21 (8.2%) nonfatal MIs and 13 (5.1%) revascularizations. The IVUS examination and FKB dilatation were done in 158 (62.0%) and 119 (46.7%), respectively. IVUS use (20.3 versus 41.2%; log-rank P < 0.001), not FKB dilatation (30.3 versus 26.5%; log-rank P = 0.614), significantly reduced MACEs. In multivariate analysis, IVUS use was a negative predictor of MACEs [hazards ratio 0.51; 95% confidence interval (CI) 0.29-0.88; P = 0.017], whereas FKB dilatation (hazard ratio 1.68; 95% CI, 1.01-2.80; P = 0.047) was a positive predictor of MACEs. In bifurcation LMCA stenosis, IVUS use (18.7 versus 48.0%; log-rank P < 0.001) significantly reduced MACEs. In nonbifurcation LMCA stenosis, FKB dilatation showed a trend of increased MACEs (P = 0.076). CONCLUSION: IVUS examination is helpful in reducing clinical events in PCI for LMCA bifurcation lesions, whereas mandatory FKB dilatation after the 1-stent technique might be harmful in nonbifurcation LMCA stenosis.

Wolverine cutting balloon in the treatment of stent underexpansion in heavy coronary calcification: bench test using a three-dimensional printer and computer simulation with the finite-element method.

Heavy coronary calcification hinders successful stent implantation, and cutting balloons can be used for post-dilation after stent deployment. However, evidence regarding its use is limited to case reports. Therefore, this study aimed to investigate in-stent dilation in circumferential coronary calcifications using Wolverine cutting balloons, compared with conventional non-compliance (NC) balloons. Circumferential coronary calcification models were designed based on the patient's intravascular ultrasound images. Three-dimensional printed models were subjected to bench tests and software analysis was performed using the finite-element method (FEM). As a result, the bench test showed that higher balloon pressure was needed to dilate the models with stent implantation, either using Wolverine (17.1 ± 2.7 atm) or NC Emerge (18.9 ± 1.8 atm), while lower pressure was needed in models without stents using Wolverine [11.7 ± 2.9 atm, analysis of variance (ANOVA) p < 0.001]. Furthermore, models without stents were all successfully cracked by Wolverine at the first dilation, while models with stent implantation needed more dilations (ANOVA p = 0.0132). The FEM showed similar results that the first principal stress was the highest in Wolverine-dilated models without stents. In conclusion, implanted stents significantly increase the difficulty of balloon dilation and adequate pretreatment is critical for successful coronary stenting.

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.

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.

Comparison of Drug-Eluting Stent and Plain Old Balloon Angioplasty After Rotational Atherectomy in Severe Calcified and Large Coronary.

Drug-eluting stent (DES) is well known to be effective in severely calcified lesion after rotational atherectomy (ROTA). However, there are still some situations when stents should be avoided and plain old balloon angioplasty (POBA) should be the preferred option. The present study aims to explore whether POBA is comparably effective to DES in large and calcified coronary pretreated by ROTA in clinical outcomes.Consecutive patients treated for severely calcified lesions in the large (≥ 3 mm) coronary using ROTA + DES or ROTA + POBA were retrospectively analyzed. The major adverse cardiac events (MACE), including all-cause/cardiac death and target lesion revascularization (TLR) at 1 year and 2 years posttreatment, were compared between groups using the Cox regression analysis to identify independent predictors of TLR and MACE.The analysis included 285 cases in the ROTA + DES group and 47 cases in the ROTA + POBA group, without relevant differences in clinical baseline characteristics. Of note, lesion length was greater in the ROTA + DES group (37.2 versus 19.3 mm, P < 0.001); the ROTA + DES group had a higher rate of chronic total occlusion (CTO) lesions, with 8.4%, and the ROTA + POBA group had none. The inhospital/30-day mortality rate (5.3%, ROTA + DES; 6.4%, ROTA + POBA) and the 12- and 24-month all-cause/cardiac mortality rate (9.3%, ROTA + DES; 7.7%, ROTA + POBA) were not significantly different between the two groups. TLR rates were not significantly different between the two groups at 12 (4.6%, ROTA + DES; 4.3%, ROTA + POBA) and 24 (5.3%, ROTA + DES; 6.4%, ROTA + POBA) months.Outcomes were comparable for ROTA + DES and ROTA + POBA in severely calcified large coronary artery intervention with respect to midterm death or TLR rate, especially for short lesion of < 20 mm.

Late Stent Thrombosis After Drug-Coated Balloon Coronary Angioplasty for In-Stent Restenosis.

A 41-year-old woman with chest pain for 6 hours was admitted to our chest pain center, presenting with acute myocardial infarction. Coronary angiography showed acute total occlusion in the proximal left anterior descending artery due to late stent thrombosis. After thrombus aspiration and intracoronary administration of 0.5 mg tirofiban, repeated angiography showed that no obvious residual stenosis remained. The patient underwent drug-coated balloon angioplasty 69 days ago and was then administered dual antiplatelet treatment (aspirin and clopidogrel) uninterruptedly. Genetic testing found that both cytochrome P450 2C19 (CYP2C19) (G681A) and glycoprotein Ia (GPIa) (C807T, G873A) were hybrid mutant types, demonstrating that the patient was possibly resistant to clopidogrel and aspirin simultaneously. Thus, clopidogrel was replaced by ticagrelor and no more cardiovascular adverse events occurred during the 2-year follow-up.

Long-term safety of paclitaxel drug-coated balloon-only angioplasty for de novo coronary artery disease: the SPARTAN DCB study.

OBJECTIVES: We aimed to investigate long-term survival of paclitaxel DCB for percutaneous coronary intervention (PCI). BACKGROUND: Safety concerns have been raised over the use of paclitaxel devices for peripheral artery disease recently, following a meta-analysis suggesting increased late mortality. With regard to drug-coated balloon (DCB) angioplasty for coronary artery intervention however, there is limited data to date regarding possible late mortality relating to paclitaxel. METHODS: We compared all-cause mortality of patients treated with paclitaxel DCB to those with non-paclitaxel second-generation drug-eluting stents (DES) for stable, de novo coronary artery disease from 1st January 2011 till 31st December 2018. To have homogenous groups allowing data on safety to be interpreted accurately, we excluded patients with previous PCI and patients treated with a combination of both DCB and DES in subsequent PCIs. Data were analysed with Kaplan-Meier curves and Cox regression statistical models. RESULTS: We present 1517 patients; 429 treated with paclitaxel DCB and 1088 treated with DES. On univariate analysis, age, hypercholesterolaemia, hypertension, peripheral vascular disease, prior myocardial infarction, heart failure, smoking, atrial fibrillation, decreasing estimated glomerular filtration rate (eGFR) [and renal failure (eGFR < 45)] were associated with worse survival. DCB intervention showed a non-significant trend towards better prognosis compared to DES (p = 0.08). On multivariable analysis age, decreasing eGFR and smoking associated with worse prognosis. CONCLUSION: We found no evidence of late mortality associated with DCB angioplasty compared with non-paclitaxel second-generation DES in up to 5 years follow-up. DCB is a safe option for the treatment of de novo coronary artery disease.