Routine Functional Testing or Standard Care in High-Risk Patients after Percutaneous Coronary Intervention.

PURPOSE OF REVIEW: This review aimed to collate the available evidence on outcomes following routine functional stress testing vs standard of care (i.e. symptom-guided stress testing) in high-risk patients following percutaneous coronary intervention (PCI). RECENT FINDINGS: The most recent pragmatic POST-PCI trial provided randomized evidence showing that routine functional stress testing post-PCI did not lead to a reduction in 2-year ischemic cardiovascular events or all-cause mortality, as compared to a symptom-guided standard-of-care approach. This was also true for sub-analyses including multivessel or left main disease, diabetics, as well as following imaging or physiology guided PCI. In the absence of a change in their clinical or functional status suggestive of stent failure, post-PCI routine periodic stress testing in stable patients on guideline-directed medical therapy is currently not recommended by American clinical practice guidelines. While evidence on the cost-effectiveness of routine stress testing strategy is scarce, physician, payer, and policy-level interventions to reduce inappropriate use of routine functional testing need to be addressed.

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.

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 September 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 hospitalization 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.

One-Month Duration Compared with Twelve-Month Duration of Dual Antiplatelet Therapy in Elective Angioplasty for Coronary Artery Disease: Bleeding and Ischaemic Outcomes.

Background/Objectives: The need to determine the safest duration of dual antiplatelet therapy duration after elective angioplasty to reduce bleeding events without an adverse effect on major adverse cardiovascular events (MACE) remains a challenge. Methods: In this investigator-initiated, single-centre cohort study, we identified all patients who underwent PCI for de novo coronary disease for stable angina between January 2015 and November 2019. We compared 1-month and 12-month durations of dual antiplatelet therapy (DAPT) to determine if there was any difference in the primary outcome of major bleeding. The secondary outcome was a patient-oriented composite endpoint of all-cause mortality; any myocardial infarction, stroke, or revascularisation; and the individual components of this composite endpoint. Data were analysed using Cox regression models and cumulative hazard plots. Results: A total of 1025 patients were analysed, of which 340 received 1 month of DAPT and 685 received 12 months of DAPT. There was no difference in major bleeding between the two groups (2.6% vs. 2.5% respectively). On univariable cox regression analysis, no characteristics were predictors of major bleeding. A proportion of 99.7% of patients in the 1-month DAPT arm were treated with a DCB strategy, whilst 93% in the 12-month DAPT group were treated with a DES. There was no difference between the two groups with regards to the composite patient-oriented MACE (11% vs. 12%, respectively) or any individual component of this. These results were unchanged after propensity score matched analysis. Conclusions: A 1-month duration of DAPT, for which 99.7% of patients were treated with a DCB strategy, appears safe and effective when compared with a 12-month duration of DAPT with no difference in major bleeding or MACE.

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.

Assessment of Paclitaxel Drug-Coated Balloon Only Angioplasty in STEMI.

BACKGROUND: Primary percutaneous coronary intervention (pPCI) with drug-eluting stents (DES) has emerged as the standard of care, but stent-related events have persisted. Drug-coated balloon (DCB)-only angioplasty is an emerging technology, although it is not fully evaluated compared with DES in the context of pPCI. OBJECTIVES: The aim of this study was to investigate the safety of DCB-only angioplasty compared with second-generation DES in pPCI. METHODS: All-cause mortality and net adverse cardiac events (cardiovascular mortality, acute coronary syndrome, ischemic stroke or transient ischemic attack, major bleeding, and unplanned target lesion revascularization [TLR]) were compared among all patients treated with DCBs only or with second-generation DES only for first presentation of ST-segment elevation myocardial infarction (STEMI) due to de novo disease between January 1, 2016, and November 15, 2019. Patients treated with both DCBs and DES were excluded. Data were analyzed using Cox regression models, Kaplan-Meier estimator plots and propensity score matching. RESULTS: Among 1,139 patients with STEMI due to de novo disease, 452 were treated with DCBs and 687 with DES. After a median follow-up period of >3 years, all-cause mortality was 49 of 452 and 62 of 687 in the DCB and DES groups, respectively (P = 0.18). On multivariable Cox regression analysis, there was no difference in mortality between DCBs and DES in the full and propensity score-matched cohorts. Age, frailty risk, history of heart failure, and family history of ischemic heart disease remained significant independent predictors of mortality. There was no difference in any of the secondary endpoints, including unplanned TLR. CONCLUSIONS: DCB-only angioplasty appears safe compared with DES for STEMI in terms of all-cause mortality and all net adverse cardiac events, including unplanned TLR. DCB may be an efficacious and safe alternative to DES in selected patient groups. (Drug Coated Balloon Only vs Drug Eluting Stent Angioplasty; NCT04482972).

Early and late mortality in hospitalised patients with raised cardiac troponin T.

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 µg/l) or raised TnT levels (≥ 0.01 µg/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.

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.

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.

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

BACKGROUND: 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. Drugcoated 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. CONCLUSION: We will conclude this review by demonstrating the potential use of drug-coated balloon rather percutaneous stenting through case examples.

Safety and Efficacy of Transcatheter Aortic Valve Replacement in the Treatment of Pure Aortic Regurgitation in Native Valves and Failing Surgical Bioprostheses: Results From an International Registry Study.

OBJECTIVES: The aim of this study was to evaluate the use of transcatheter heart valves (THV) for the treatment of noncalcific pure native aortic valve regurgitation (NAVR) and failing bioprosthetic surgical heart valves (SHVs) with pure severe aortic regurgitation (AR). BACKGROUND: Limited data are available about the "off-label" use of transcatheter aortic valve replacement (TAVR) to treat pure severe AR. METHODS: The study population consisted of patients with pure severe AR treated by TAVR at 18 different centers. Study endpoints were device success, early safety, and clinical efficacy at 30 days, as defined by Valve Academic Research Consortium 2 criteria. RESULTS: A total of 146 patients were included, 78 patients in the NAVR group and 68 patients in the failing SHV group. In the NAVR group, device success, early safety, and clinical efficacy were 72%, 66%, and 61%, respectively. Device success and clinical efficacy were significantly better with newer generation THVs compared with old-generation THVs (85% vs. 54% and 75% vs. 46%, respectively, p < 0.05); this was mainly due to less second THV implantations and a lower rate of moderate to severe paravalvular regurgitation (10% vs. 24% and 3% vs. 27%, respectively). Independent predictors of 30-day mortality were body mass index <20 kg/m2, STS surgical risk score >8%, major vascular or access complication, and moderate to severe AR. In the failing SHV group, device success, early safety, and clinical efficacy were 71%, 90%, and 77%, respectively. CONCLUSIONS: TAVR for pure NAVR remains a challenging condition, with old-generation THVs being associated with THV embolization and migration and significant paravalvular regurgitation. Newer generation THVs show more promising outcomes. For those patients with severe AR due to failing SHVs, TAVR is a valuable therapeutic option.

Drug-coated Balloon-only Angioplasty for Native Coronary Disease Instead of Stents.

Coronary angioplasty has vastly improved both in technique and devices since the first angioplasty in 1977. Currently, stent implantation is used almost ubiquitously, despite being developed originally to treat vessel threatening dissections. Newer concepts including absorbable polymers or fully bioabsorbable scaffolds are constantly being developed. However, we find the concept of no permanent implant whilst still delivering a chemotherapeutic drug to reduce restenosis very attractive given the long term implications of a metallic stent, which include restenosis, late thrombosis and neo-atheroma formation. The use of a drug-coated balloon-only approach to de novo angioplasty will avoid the late thrombotic problems whilst also reducing early restenosis, simplifying the procedure and reducing the dual antiplatelet duration to 1 month. We review the current literature and highlight our practice with regard to use of drug-coated balloons in treatment of de novo coronary artery disease.