Drug Coated Balloon (DCB) angioplasty; DCB Norwich Registry (2009-2015) and a Propensity Score Matched Comparison between DCB and Second Generation Drug Eluting Stents.

Background Drug coated balloons are semi compliant balloons coated with a chemotherapeutic drug to reduce neo intimal hyperplasia thus reducing the risk of re-stenosis. The lack of any permanent metal/polymer in the coronary artery may reduce future risk of adverse clinical events. Objectives The main objective of the DCB NORWICH observational registry was to assess the efficacy and safety of drug coated balloon angioplasty in a real world setting. The propensity matched analysis compared clinical outcomes between DCB-only angioplasty and second generation drug eluting stents (DES). Methods All patients who received DCB angioplasty in the Norfolk and Norwich University Hospitals NHS Foundation Trust from 01/01/2009 to 31/12/2015 were included retrospectively in the DCB NORWICH registry study. In the propensity score matched study, DCB-only PCI in de novo vessels were compared to second generation DES. Clinical outcomes were obtained from the National Institute for Cardiovascular Outcomes Research and NHS Digital. Results A total of 1394 lesions in 1122 patients were treated with DCBs. There were 1026 lesions in 812 patients in the de novo group. The mean age was 65.8. 60.1% presented with MI or acute coronary syndrome. 12 month all cause death was 3.6%, MI 3.1% and target lesion revascularisation (TLR) 2.1%. MACE (death, MI, TLR) was 8.1%. No definite treated segment thrombosis was noted up to 12 months. The propensity score matched study had 904 DCB and 1424 DES treated de novo lesions. Results showed no difference in clinical outcomes between PCI with DCB-only strategy vs. 2nd generation DES. The MACE rate for the DCB arm met the pre specified non-inferiority margin of 4.5%. Conclusions DCB-only PCI is safe and feasible in a wide range of patients and showed no difference in clinical outcomes compared to second generation DES up to 12 month

Percutaneous Coronary Intervention in the Elderly: Are Drug-coated Balloons the Future?

Balloon angioplasty revolutionised percutaneous treatment for coronary artery disease four decades ago, but vessel-threatening dissections, elastic recoil and restenosis were major drawbacks to an otherwise successful long-lasting intervention. Subsequent advances with bare metal stents and then drug eluting stents followed, aiming to mitigate the risks of acute vessel closure and restenosis. However, stent implantation often necessitates dual antiplatelet therapy for a prolonged period of time, which in itself can lead to adverse outcomes, especially in the frail elderly population at higher risk of bleeding. More recently, bioabsorbable stents have been implemented in clinical practice enabling earlier intimal coverage of the stent and apposition. However, another addition to the armamentarium of percutaneous coronary intervention is the use of drug-coated balloons without the need for deploying any coronary stents or scaffolds. Drug-coated balloons are semi-compliant balloons coated with an antiproliferative agent that is rapidly released on contact with the vessel intima exerting an anti-restenotic effect. The absence of a metallic scaffold means that the need for antiplatelet therapy can potentially be negated in the longer term if required. In this article, we will review the history of percutaneous coronary intervention and the available evidence for the appropriate use of drug-coated balloons especially in the elderly population. We will conclude this review by demonstrating the potential use of drug-coated balloon rather percutaneous stenting through case examples

Duration of dual antiplatelet therapy in elective drug coated balloon angioplasty

Objectives: We sought to answer whether 1-month duration of dual antiplatelet therapy (DAPT) is safe after elective drug-coated balloon only (DCB) angioplasty. Background: The duration of DAPT after elective DCB was called into question after the ESC Focused DAPT Update of 2017. Until then, a 1-month duration of DAPT was considered safe by national consensus groups (German, Italian, and Chinese) supported by data from prospective worldwide registries. The ESC Guidelines recommended a 6-month duration of DAPT based on evidence from in-stent restenosis randomized controlled trials only. Methods: Retrospective, real-world population, single-center analysis conducted from January 1, 2012 to March 31, 2017 in a high-volume, tertiary PCI center. Consecutive patients receiving 1-month duration of DAPT after elective DCB angioplasty were included. We identified a primary composite outcome of cardiac death, myocardial infarction and target lesion revascularization at 6-months. Results: A total of 303 patients (78.5% male) with mean age of 67 ± 12.5 were included. This incorporated 86.1% de novo lesions and 56.5% nonsmall (≥3 mm diameter) coronary arteries treated. There were no reported outcomes of lesion thrombosis, target vessel MI, target lesion revascularization or cardiac death at 6-months. There were two (0.6%) nontarget vessel MIs and one (0.3%) noncardiac death. Conclusion: One-month duration of DAPT appears safe after elective DCB-only angioplasty, highlighting this strategy for patients at high-risk of bleeding. These results also show favorable clinical outcomes for de novo coronary artery disease and nonsmall coronary arteries treated with DCB-only angioplasty. A 1-month duration of DAPT appears a safe and attractive option

Endothelial dysfunction and coronary vasoreactivity - a review of the history, physiology, diagnostic techniques and clinical relevance

The fervency for advancement and evolution in percutaneous coronary intervention has revolutionised the treatment of coronary artery disease. Historically, the focus of the interventional cardiologist was directed at the restoration of luminal patency of the major epicardial coronary arteries, yet whilst this approach is evolving with much greater utilisation of physiological assessment, it often neglects consideration of the role of the coronary microcirculation, which has been shown to clearly influence prognosis. In this review, we explore the narrative of the coronary circulation as more than just a simple conduit for blood but an organ with functional significance. We review organisation and physiology of the coronary circulation, as well as the current methods and techniques used to examine it. We discuss the studies exploring coronary artery endothelial function, appreciating that coronary artery disease occurs on a spectrum of disorder and that percutaneous coronary intervention has a latent effect on the coronary circulation with long-term consequences. It is concluded that greater recognition of the coronary artery endothelium and mechanisms of the coronary circulation should further guide revascularisation strategies

Day case discharge of patients treated with drug coated balloon only angioplasty for de novo coronary artery disease:A single center experience

Objective: To report our initial experience with Drug Coated Balloon (DCB) only angioplasty and propose a protocol to achieve this safely. Background: There are no articles published in the literature currently regarding the safety of same day discharge in patients treated with DCB-only angioplasty. Methods: Retrospective review of all our patients treated with DCB-only angioplasty from Sept 2017 to April 2018 with identification of potential complications relating to same day discharge. Results: A total of 100 consecutive patients who underwent elective DCB-only angioplasty for de novo coronary artery disease and were discharged on the same day as the procedure were included. In 99% no cardiac symptoms relating to the procedure requiring urgent hospitalisation or urgent investigations were identified. One patient was readmitted the next day requiring stenting of the previously treated lesion. Our 30 day mortality was zero. Some 97 hospital bed days were saved with 100 patients treated. Conclusion: Elective day-case DCB-only angioplasty according to our local protocol is safe and cost-effective and should be considered for the majority of the patients

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

Early and late mortality in hospitalised patients with raised cardiactroponin

Aims: Cardiac troponins are measured in acute coronary syndrome (ACS) and other conditions. The authors investigate the prognostic significance of cardiac troponin T (TnT) test and comorbid medical conditions. Methods: Consecutive patients admitted to the Aintree University Hospital, Liverpool, between 2 January 2004 and 29 February 2004 who had TnT measurement were included. Patients were separated into normal (<0.01 �g/l) or raised TnT levels (=0.01 �g/l), and further categorised into: (1) normal TnT with unstable angina; (2) normal TnT with non-ACS; (3) raised TnT with ACS; and (4) raised TnT with non-ACS. Cox regression was used to identify prognostic variables, and logrank test to compare 7-year survival. Results: Of 1021 patients, 313 had raised TnT (195 ACS, 118 non-ACS) and 708 normal TnT (80 ACS, 628 non-ACS). Age (HR 1.06; 95% CI 1.05 to 1.07), congestive cardiac failure (HR 1.37; 95% CI 1.11 to 1.69), cerebrovascular disease (HR 1.37; 95% CI 1.10 to 1.71), chronic obstructive airway disease (HR 1.44; 95% CI 1.19 to 1.75), liver disease (HR 4.16; 95% CI 2.37 to 7.31), renal disease (HR 1.83; 95% CI 1.27 to 2.64), tumour (HR 1.39; 95% CI 1.07 to 1.79), lymphoma (HR 4.81; 95% CI 2.07 to 11.16), metastatic cancer (HR 3.55; 95% CI 2.32 to 5.45) and a higher Charlson's comorbidity score (HR 1.20, 95% CI 1.13 to 1.26) were adverse predictors. Both raised TnT with ACS (HR 1.92, 95% CI 1.54 to 2.39) and raised TnT with non-ACS (HR 2.37, 95% CI 1.87 to 3.00) were associated with worse survival. Raised TnT with non-ACS had a worse survival than raised TnT with ACS (p=0.001). Conclusion: Hospitalised patients with raised TnT levels from any cause predicted a higher mortality than normal TnT, with worst survival in those without an obvious ACS

Drug-Coated Balloon vs. Drug-Eluting Stents for De Novo Unprotected Left Main Stem Disease: The SPARTAN-LMS Study

The objective of this study is to compare the outcomes of patients treated with drug-coated balloons (DCBs) or second-generation drug-eluting stents (DESs) for de novo unprotected left main stem (LMS) disease. Previous studies comparing the treatment of LMS disease suggest that the mortality for DES PCI is not worse than CABG. There are limited data from studies investigating the treatment of de novo LMS disease with DCB angioplasty. We compared the all-cause and cardiac mortality of patients treated with paclitaxel DCB to those with second-generation DES for de novo LMS disease from July 2014 to November 2019. Data were analysed using Kaplan–Meier analyses and propensity-matched analyses. A total of 148 patients were treated with either a DCB or DES strategy. There was no significant difference in all-cause mortality in the DCB group (19.5%) compared to the DES group (15.9%) (HR 1.42 [0.61–3.32], p = 0.42). Regarding cardiac mortality, 2 (4.9%) were recorded for the DCB group and 7 (6.5%) for the DES group (HR 1.21 [0.31–4.67], p = 0.786); for target vessel myocardial infarction, there were 0 (0%) for the DCB group and 7 (6.5%) for the DES group; and for target lesion revascularisation, there were 3 (7.3%) in the DCB group and 9 (8.3%) in the DES group (HR: 0.89 [0.24–3.30]). p = 0.86. These remained not significant after propensity score matching. We found no difference in the mortality outcomes with DCB angioplasty compared to second-generation DES, with a median follow-up of 33 months. DCB can therefore be regarded as a safe option in the treatment of LMS disease in suitable patients

Paclitaxel drug coated balloon-only angioplasty for de novo coronary artery disease in elective clinical practice

Objective: We aimed to investigate the safety of drug-coated balloon (DCB)-only angioplasty compared to drug-eluting stent (DES), as part of routine clinical practice. Background: The recent BASKETSMALL2 trial demonstrated the safety and efficacy of DCB angioplasty for de novo small vessel disease. Registry data have also demonstrated that DCB angioplasty is safe; however, most of these studies are limited due to long recruitment time and a small number of patients with DCB compared to DES. Therefore, it is unclear if DCB-only strategy is safe to incorporate in routine elective clinical practice. Methods: We compared all-cause mortality and major cardiovascular endpoints (MACE) including unplanned target lesion revascularisation (TLR) of all patients treated with DCB or DES for first presentation of stable angina due to de novo coronary artery disease between 1st January 2015 and 15th November 2019. Data were analysed with Cox regression models and cumulative hazard plots. Results: We present 1237 patients; 544 treated with DCB and 693 treated with DES for de novo, mainly large-vessel coronary artery disease. On multivariable Cox regression analysis, only age and frailty remained significant adverse predictors of all-cause mortality. Univariable, cumulative hazard plots showed no difference between DCB and DES for either all-cause mortality or any of the major cardiovascular endpoints, including unplanned TLR. The results remained unchanged following propensity score matched analysis. Conclusion: DCB-only angioplasty, for stable angina and predominantly large vessels, is safe compared to DES as part of routine clinical practice, in terms of all-cause mortality and MACE including unplanned TLR