Merging machine learning and patient preference: a novel tool for risk prediction of percutaneous coronary interventions.

BACKGROUND AND AIMS: Predicting personalized risk for adverse events following percutaneous coronary intervention (PCI) remains critical in weighing treatment options, employing risk mitigation strategies, and enhancing shared decision-making. This study aimed to employ machine learning models using pre-procedural variables to accurately predict common post-PCI complications. METHODS: A group of 66 adults underwent a semiquantitative survey assessing a preferred list of outcomes and model display. The machine learning cohort included 107 793 patients undergoing PCI procedures performed at 48 hospitals in Michigan between 1 April 2018 and 31 December 2021 in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2) registry separated into training and validation cohorts. External validation was conducted in the Cardiac Care Outcomes Assessment Program database of 56 583 procedures in 33 hospitals in Washington. RESULTS: Overall rate of in-hospital mortality was 1.85% (n = 1999), acute kidney injury 2.51% (n = 2519), new-onset dialysis 0.44% (n = 462), stroke 0.41% (n = 447), major bleeding 0.89% (n = 942), and transfusion 2.41% (n = 2592). The model demonstrated robust discrimination and calibration for mortality {area under the receiver-operating characteristic curve [AUC]: 0.930 [95% confidence interval (CI) 0.920-0.940]}, acute kidney injury [AUC: 0.893 (95% CI 0.883-0.903)], dialysis [AUC: 0.951 (95% CI 0.939-0.964)], stroke [AUC: 0.751 (95%CI 0.714-0.787)], transfusion [AUC: 0.917 (95% CI 0.907-0.925)], and major bleeding [AUC: 0.887 (95% CI 0.870-0.905)]. Similar discrimination was noted in the external validation population. Survey subjects preferred a comprehensive list of individually reported post-procedure outcomes. CONCLUSIONS: Using common pre-procedural risk factors, the BMC2 machine learning models accurately predict post-PCI outcomes. Utilizing patient feedback, the BMC2 models employ a patient-centred tool to clearly display risks to patients and providers (https://shiny.bmc2.org/pci-prediction/). Enhanced risk prediction prior to PCI could help inform treatment selection and shared decision-making discussions.

Stingray CART (K14 technique): A novel antegrade dissection reentry strategy.

A novel device based CART technique (K14 technique) has been described with 2 case examples to illustrate the same. This CART has been performed after ADR and Reverse-CART were unsuccessful.

Interventional cardiologists' perceptions of percutaneous coronary intervention quality measurement and feedback.

BACKGROUND: Interventional cardiologists receive feedback on their clinical care from a variety of sources including registry-based quality measures, case conferences, and informal peer interactions. However, the impact of this feedback on clinical care is unclear. METHODS: We interviewed interventional cardiologists regarding the use of feedback to improve their care of percutaneous coronary intervention (PCI) patients. Interviews were assessed with template analysis using deductive and inductive techniques. RESULTS: Among 20 interventional cardiologists from private, academic, and Department of Veterans Affairs practice, 85% were male, 75% performed at least 100 PCIs annually, and 55% were in practice for 5 years or more. All reported receiving feedback on their practice, including formal quality measures and peer learning activities. Many respondents were critical of quality measure reporting, citing lack of trust in outcomes measures and poor applicability to clinical care. Some respondents reported the use of process measures such as contrast volume and fluoroscopy time for benchmarking their performance. Case conferences and informal peer feedback were perceived as timelier and more impactful on clinical care. Respondents identified facilitators of successful feedback interventions including transparent processes, respectful and reciprocal peer relationships, and integration of feedback into collective goals. Hierarchy and competitive environments inhibited useful feedback. CONCLUSIONS: Despite substantial resources dedicated to performance measurement and feedback for PCI, interventional cardiologists perceive existing quality measures to be of only modest value for improving clinical care. Catherization laboratories should seek to integrate quality measures into a holistic quality program that emphasizes peer learning, collective goals and mutual respect.

Eligibility for Low-Dose Rivaroxaban Based on the COMPASS Trial: Insights from the Veterans Affairs Healthcare System.

INTRODUCTION: Low-dose rivaroxaban reduced major adverse cardiac and limb events among patients with stable atherosclerotic vascular disease (ASCVD) in the COMPASS trial. The objective of our study was to evaluate the eligibility and budgetary impact of the COMPASS trial in a real-world population. METHODS: The VA administrative and clinical databases were utilized to conduct a cross-sectional study to identify patients eligible for low-dose rivaroxaban receiving care at all 141 facilities between October 1, 2014 and September 30, 2015. Proportion of patients with stable ASCVD eligible for low-dose rivaroxaban and prevalence of multiple risk enrichment criteria among eligible patients. Pharmaceutical budgetary impact using VA pharmacy pricing. Chi-squared and Student's t tests were used to compare patients eligible versus ineligible patients. RESULTS: From an initial cohort of 1,248,214 patients with ASCVD, 488,495 patients (39.1%) met trial eligibility criteria. Eligible patients were older (74.2 vs 64.5 years) with higher proportion of hypertension (84.1% vs 82.1%) and diabetes (46.2% vs 32.9) compared with ineligible patients (p < 0.001 for all comparisons). A median of 38.7% (IQR 4.6%) of total ASCVD patients per facility were rivaroxaban eligible. Estimated annual VA pharmacy budgetary impact would range from $0.47 billion to $1.88 billion for 25% to 100% treatment penetration. Annual facility level pharmaceutical budgetary impact would be a median of $12.3 million (IQR $8.0-$16.3 million) for treatment of all eligible patients. Among eligible patients, age greater than 65 years was the most common risk enrichment factor (86.9%). Prevalence of eligible patients with multiple enrichment factors varied from 34.2% (one factor) to 6.2% (four or more). CONCLUSION: Over one third of patients with stable ASCVD may qualify for low-dose rivaroxaban within the VA. Additional studies are needed to understand eligibility in other populations and a formal cost-effectiveness analysis is warranted.

SCAI publications committee manual of standard operating procedures.

Evidence-based recommendations for clinical practice are intended to help health care providers and patients make decisions, minimize inappropriate practice variation, promote effective resource use, improve clinical outcomes, and direct future research. The Society for Cardiovascular Angiography and Interventions (SCAI) has been engaged in the creation and dissemination of clinical guidance documents since the 1990s. These documents are a cornerstone of the society's education, advocacy, and quality improvement initiatives. The publications committee is charged with oversight of SCAI's clinical documents program and has created this manual of standard operating procedures to ensure consistency, methodological rigor, and transparency in the development and endorsement of the society's documents. The manual is intended for use by the publications committee, document writing groups, external collaborators, SCAI representatives, peer reviewers, and anyone seeking information about the SCAI documents program.

Management of Out-of-Hospital Cardiac Arrest Complicating Acute Coronary Syndromes.

PURPOSE OF THE REVIEW: Out-of-hospital cardiac arrest (OHCA) complicating acute coronary syndromes (ACS) continues to carry a high rate of morbidity and mortality despite significant advances in EMS and interventional cardiology services. In this review, we discuss an evidence-based approach to the initial care and management of patients with OHCA complicating ACS from the pre-hospital response and initial resuscitation strategy, to advanced therapies such as coronary angiography, targeted-temperature management, neuro-prognostication, and care of the post-arrest patient. RECENT FINDINGS: Early recognition of cardiac arrest and prompt initiation of bystander CPR are the most important factors associated with improved survival. A comprehensive and coordinated approach to in-hospital management, including PCI, targeted temperature management, critical care, and hemodynamic support represents a significant critical link in the chain of survival. OHCA complicated by ACS continues to be one of the most challenging disease states facing healthcare practitioners and maintains a high mortality rate despite substantial advancements in healthcare delivery. A comprehensive approach to in-hospital management and further exploration of novel interventions, including ECMO, may yield opportunities to optimize care and improve outcomes for cardiac arrest patients.

Concomitant Use of Antiplatelets and Anticoagulants in Patients with Coronary Heart Disease and Atrial Fibrillation: What Do Recent Clinical Trials Teach Us?

PURPOSE OF REVIEW: Coronary heart disease (CHD) and atrial fibrillation (AF) are among the most common cardiovascular diseases. A significant proportion of patients have both CHD and AF and are at increased risk for thrombotic complications. Current therapy for CHD and AF includes antiplatelet and anticoagulant medications, respectively. Patients with concurrent CHD and AF may be prescribed dual antiplatelet therapy (DAPT) in addition to anticoagulation, which increases their bleeding risk. Controversy remains on how to balance risks and benefits in patients with CHD and AF in which multiple antithrombotic therapies may be indicated. RECENT FINDINGS: We review clinical trials and current guidelines for antiplatelet and anticoagulant therapy in CHD and AF. Aspirin and P2Y12 inhibitors are the mainstay of antiplatelet therapy. Vitamin K antagonists (VKAs) are the most commonly used anticoagulant, although the use of non-VKA oral anticoagulants (NOACs) in patients with AF is increasing. Recent studies provide guidance on how to address antithrombotic therapies in patients with concomitant CHD and AF. To date, we have evidence that in patients with AF who undergo percutaneous coronary intervention (PCI), clopidogrel with VKA may be used safely without aspirin. Also, low-dose rivaroxaban in combination with either clopidogrel only or DAPT is as effective as the traditional regimen of triple therapy with VKA and DAPT with lower bleeding risk. Dabigatran with a P2Y12 inhibitor was also found to be safe with less bleeding compared to triple therapy with VKA and DAPT. Use of a single antiplatelet agent with anticoagulation has become a viable choice in patients with CHD and AF, but more clinical trial data is needed to confirm therapy and duration regimens.

Update on the Management of Chronic Total Occlusions in Coronary Artery Disease.

PURPOSE OF THE REVIEW: Chronic total occlusions (CTOs) are found in about a third of patients with coronary artery disease (CAD) and can pose a significant challenge during percutaneous revascularization. However, advances in CTO percutaneous coronary intervention (PCI) strategies, devices, and algorithms have led to significant improvements in successful treatment of CTOs. This review summarizes current management of CTOs in the context of modern PCI techniques and current evidence. RECENT FINDINGS: The hybrid algorithm now provides a standardized, teachable approach to CTO PCI, and success rates are approximately 90% in experienced hands. The first randomized controlled trial in patients with CTOs recently reported that patients with ST elevation myocardial infarction (STEMI) and a CTO in the non-culprit vessel showed an improvement in ejection fraction in patients undergoing CTO PCI of the LAD, but not other vessels. Updated data from the SYNTAX trial showed a benefit with complete revascularization in patients with coronary artery disease (CAD). Incomplete revascularization of CTOs in the PCI group may explain some of the benefit seen with CABG over PCI in patients with complex coronary disease. Contemporary CTO registries have reported success rates of approximately 90%, and the OPEN-CTO registry updates our understanding of CTO PCI complication rates and outcomes. The available evidence highlights the potential benefits of CTO PCI in patients with an indication for revascularization. Technological advancements have paved the way for success rates approaching 90% at high-volume centers, but further studies evaluating outcomes following CTO PCI are needed, with several currently underway.

Fork in the road: Are all bifurcations created equal?

The TRYTON study evaluated routine side branch (SB) stenting with a novel bare metal stent (BMS) designed for true bifurcation lesions (Medina 1,1,1; 1,0,1; 0,1,1) and compared it to a strategy of balloon angioplasty with provisional stenting. It failed to meet the primary endpoint of non-inferiority in target vessel failure mainly driven by peri-procedural myocardial infarction (MI) with elevated CK-MB > 3× the upper limit of normal. In this substudy, 41% of patients who had a SB diameter > 2.25 mm were evaluated and the new stent was found to be non-inferior in the primary outcome of target vessel failure with no difference in post-procedural MI. This substudy suggests that appropriately sized SB stents with TRYTON may be useful when the SB is >2.25 mm in diameter. However, further studies could evaluate routine use of FFR for SBs; drug eluting versions of the stent as well as stents designed for vessels 2.25 mm in diameter which are frequently felt to be clinically larger when not subjected to core lab analysis.

STAR in CTO PCI: When is STAR not a star?

Subintimal tracking and reentry (STAR) has been used as a bailout strategy and involves an uncontrolled dissection and recanalization into the distal lumen to reestablish vessel patency. In the current study, thrombolysis in myocardial infarction (TIMI) flow < 3 was the only variable which they found to be significantly associated with restenosis and reocclusion after stent placement. It may be reasonable to consider second generation drug eluting stent placement in patients receiving STAR that have TIMI 3 flow, however, this should only be done if there is no compromise of major side branches. If unsure, we recommend to perform balloon angioplasty without stenting.

Fracking the Code to Complete Revascularization.

Provisional use of rotational atherectomy (RA) is indicated for procedural success in heavily calcified lesions. In the current study, RA use at three high volume percutaneous coronary intervention (PCI) centers between 2005 and 2013 was 1.4%. MACE rate was 17.8% at median follow-up of 22 months. Peripheral vascular disease (PVD), diabetes mellitus (DM), acute coronary syndrome (ACS), and SYNTAX > 23 were found to be independently associated with MACE. With increasing complexity of disease and SYNTAX score, there is usually an increase in severity of calcification and need for atherectomy. Complete revascularization with residual SYNTAX reduced to < 8 is associated with improved outcomes. Incompleteness of revascularization in patients with SYNTAX > 33 rather than procedural success of the target vessel with atherectomy may have contributed to the adverse outcomes.

TandemHeart placement for cardiogenic shock in acute severe mitral regurgitation and right ventricular failure.

We report a case of a patient with severe mitral regurgitation (MR) due to infective endocarditis with preserved left ventricular systolic function complicated by severe pulmonary hypertension, right ventricular (RV) dysfunction, and cardiogenic shock. He was evaluated by cardiothoracic surgery for mitral valve replacement (MVR). It appeared that the high pulmonary artery pressure (PAP) had been chronic with acute worsening, thus raising concerns that it may not promptly reverse after MVR, putting him at high risk for postoperative RV failure and increasing the risk of mortality. A TandemHeart (TH) percutaneous ventricular assist device (pVAD) was placed with improvement in hemodynamics following which MVR was done. To our knowledge, this is the first report of the preoperative use of the TH pVAD in severe acute MR for hemodynamic stabilization in preparation for MVR.

T wave inversions in leads with ST elevations in patients with acute anterior ST elevation myocardial infarction is associated with patency of the infarct related artery.

OBJECTIVES: Following reperfusion therapy, early T wave inversions (TWI) have been shown to be a marker of successful reperfusion. We aimed to evaluate the relationship of TWI on the presenting ECG with spontaneous reperfusion as assessed by coronary angiography in patients with ST elevation (STE) myocardial infarction (STEMI). METHODS: Data of 146 consecutive patients presenting to the St. Luke's Episcopal Hospital Emergency Department with acute STEMI undergoing primary percutaneous coronary intervention (p-PCI) between January, 2007 and October, 2010 were retrospectively analyzed. Clinical data, ECG and angiographic data were reviewed. Patients were dichotomized based on T wave morphology on the presenting ECG into 2 groups - those with TWI and those with positive T waves (PTW). RESULTS: Thirty-one patients (21.2%) had TWI, while 115 (78.8%) had PTW. Sixty-four (43.8%) patients had anterior STE and 75 (51.3%) had inferior STE. Anterior STE was more likely to have TWI than non-anterior (29.7% vs. 14.6; p=0.014). By angiography, infarct related artery (IRA) patency (TIMI 2-3 flow) was seen in 45 (30.8%). TWI was more likely to be associated with IRA patency compared to PTW (51.6% vs. 25.2%; p=0.008). In patients with anterior STEMI and TWI, patent IRA was seen more frequently compared to those with PTW (68.4% vs. 20%; p<0.001). There was no association of T wave morphology and TIMI flow in patients with non-anterior STEMI. Patients presenting with stuttering symptoms were more likely to have TWI (70.4% vs. 10.2%; p <0.001) suggesting recurrent episodes of reperfusion and ischemia. CONCLUSIONS: In anterior STEMI patients, TWI on the presenting ECG is associated with spontaneous reperfusion. This relationship was not found among patients with non-anterior STEMI.

Pitfalls in diagnosing ST elevation among patients with acute myocardial infarction.

OBJECTIVES: Patients with ST elevation (STE) in ≥ 2 leads or ST depression (STD) confined to V1-V4 are defined as potential STE myocardial infarction (STEMI). We evaluated the incidence of missed STEMI over an 11-month period. METHODS: Consecutive patients with a discharge diagnosis of non STEMI were retrospectively evaluated. Clinical data, ECG and angiographic data were reviewed. RESULTS: Of the 198 patients screened, 140 were included. Forty-nine patients (35%) met the STEMI criteria: 6 (12%) had STD confined to V1-V3, 20 (41%) had STD in V1-V6, 7 (14%) had STE in V1-V3, 2 (4%) had STE in I and aVL, 11 (22%) had STE in inferior leads, and 6 (12%) had STE in V4-V6. CONCLUSIONS: A significant percentage of patients met STEMI ECG criteria. A large number of patients with STD in V1-V6 had angiographic evidence compatible with inferolateral (posterior) STEMI equivalent.

Government Regulation and Percutaneous Coronary Intervention Volume, Access and Outcomes: Insights From the Washington State Cardiac Care Outcomes Assessment Program.

Background It is unclear how to geographically distribute percutaneous coronary intervention (PCI) programs to optimize patient outcomes. The Washington State Certificate of Need program seeks to balance hospital volume and patient access through regulation of elective PCI. Methods and Results We performed a retrospective cohort study of all non-Veterans Affairs hospitals with PCI programs in Washington State from 2009 to 2018. Hospitals were classified as having (1) full PCI services and surgical backup (legacy hospitals, n=17); (2) full services without surgical backup (new certificate of need [CON] hospitals, n=9); or (3) only nonelective PCI without surgical backup (myocardial infarction [MI] access hospitals, n=9). Annual median hospital-level volumes were highest at legacy hospitals (605, interquartile range, 466-780), followed by new CON, (243, interquartile range, 146-287) and MI access, (61, interquartile range, 23-145). Compared with MI access hospitals, risk-adjusted mortality for nonelective patients was lower for legacy (odds ratio [OR], 0.59 [95% CI, 0.48-0.72]) and new-CON hospitals (OR, 0.55 [95% CI, 0.45-0.65]). Legacy hospitals provided access within 60 minutes for 90% of the population; addition of new CON and MI access hospitals resulted in only an additional 1.5% of the population having access within 60 minutes. Conclusions Many PCI programs in Washington State do not meet minimum volume standards despite regulation designed to consolidate elective PCI procedures. This CON strategy has resulted in a tiered system that includes low-volume centers treating high-risk patients with poor outcomes, without significant increase in geographic access. CON policies should re-evaluate the number and distribution of PCI programs.

Potential Impact of the 2019 ACC/AHA Guidelines on the Primary Prevention of Cardiovascular Disease Recommendations on the Inappropriate Routine Use of Aspirin and Aspirin Use Without a Recommended Indication for Primary Prevention of Cardiovascular Disease in Cardiology Practices: Insights From the NCDR PINNACLE Registry.

BACKGROUND: Aspirin is recommended in patients with atherosclerotic cardiovascular disease for secondary prevention. In patients without atherosclerotic cardiovascular disease and not at high 10-year risk, there is no evidence aspirin reduces adverse cardiovascular events and it could increase bleeding. The 2019 American College of Cardiology/American Heart Association Guidelines on Primary Prevention of Cardiovascular Disease state that aspirin may be considered for primary prevention (class IIb) in patients 40 to 70 years that are at higher risk of atherosclerotic cardiovascular disease and that routine use of aspirin should be avoided (class III:Harm) for patients >70 years. We examined the frequency of patients on aspirin for primary prevention that would have been considered unindicated or potentially harmful per the recent guideline where aspirin discontinuation may be beneficial. METHODS: To assess the potential impact, within the National Cardiovascular Disease Registry Practice Innovation and Clinical Excellence Registry, we assessed 855 366 patients from 400 practices with encounters between January 1, 2018 and March 31, 2019, that were receiving aspirin for primary prevention. We defined inappropriate use as the use of aspirin in patients <40 or >70 years and use without a recommended indication as use of aspirin in patients 40 to 70 years with low, borderline, or intermediate 10-year atherosclerotic cardiovascular disease risk. Frequency of inappropriate use and use without a recommended indication were calculated and practice-level variation was evaluated using the median rate ratio. RESULTS: Inappropriate use occurred in 27.6% (193 674/701 975) and use without a recommended indication in 26.0% (31 810/122 507) with significant practice-level variation in inappropriate use (predicted median practice-level rate 33.5%, interquartile range, 24.1% to 40.8%; median rate ratio, 1.71 [95% CI, 1.67-1.76]). CONCLUSIONS: Immediately before the 2019 American College of Cardiology/American Heart Association Guidelines on Primary Prevention of Cardiovascular Disease, over one-fourth of patients in this national registry were receiving aspirin for primary prevention inappropriately or without a recommended indication with significant practice-level variation. These findings help to determine the potential impact of guideline recommendations on contemporary use of aspirin for primary prevention.

Toolbox for Coronary Chronic Total Occlusion Percutaneous Coronary Intervention.

Since the publication of the hybrid algorithm there has been rapid development of new specialty wires, microcatheters, guide extensions, and low-profile balloons to facilitate successful coronary chronic total occlusion percutaneous coronary intervention. With development of new devices, it is best to categorize them by design and intended task. This enables a safe and systematic approach to coronary chronic total occlusion percutaneous coronary intervention and avoid overlap and waste. This article serves as a guide for tool selection for the interventional cardiologist performing coronary chronic total occlusion percutaneous coronary intervention.

Outcomes of Acute Myocardial Infarction in Patients with Familial Hypercholesteremia.

BACKGROUND: There is a paucity of contemporary data regarding the outcomes of acute myocardial infarction among patients with familial hypercholesteremia. METHODS: We queried the Nationwide Readmissions Database (2016-2018) for hospitalizations with acute myocardial infarction. Multivariable regression analysis was used to compare in-hospital outcomes and 30-day readmissions among patients with and without familial hypercholesteremia. RESULTS: The analysis included 1,363,488 hospitalizations with acute myocardial infarction. The prevalence of familial hypercholesteremia was 0.07% among acute myocardial infarction admissions. Compared with those without familial hypercholesteremia, admissions with familial hypercholesteremia were younger and had less comorbidities but were more likely to have had prior infarct and revascularization. Admissions with familial hypercholesteremia were more likely to present with ST-elevation myocardial infarction and undergo revascularization. After multivariable adjustment, there was no difference in in-hospital case fatality among patients with hypercholesteremia compared with those without it (adjusted odds ratio [aOR] = 0.76; 95% confidence interval [CI] 0.41-1.39). Admissions with acute myocardial infarction and familial hypercholesteremia had higher adjusted rates of cardiac arrest and utilization of mechanical support. There were no group differences in overall 30-day readmission (aOR 0.75; 95% CI 0.51-1.10) or 30-day readmission for acute myocardial infarction. However, a nonsignificant trend toward higher readmission for percutaneous coronary intervention was observed among patients with familial hypercholesteremia (aOR 1.89; 95% CI 0.98-3.64). CONCLUSION: In this contemporary nationwide observational analysis, patients with familial hypercholesteremia represent a small proportion of the overall population with acute myocardial infarction and have a distinctive clinical profile but do not appear to have worse in-hospital case fatality compared with those without familial hypercholesteremia.

Intravascular coronary brachytherapy combined with a drug-coated balloon.

BACKGROUND: Coronary artery disease leads to stenosis of the major cardiac vessels, resulting in ischemia and infarction. Percutaneous intervention (PCI) with balloon angioplasty can re-open stenosed vessels. Drug eluting stents (DES) and intravascular brachytherapy (IVBT) and drug-coated balloons (DCBs) are proven to decrease the likelihood of another restenosis after PCI, but neither is completely effective. Due to the limited long-term effectiveness of IVBT or DCB used separately for salvage PCI, we combined the two in some poor prognosis patients. METHODS: Combined IVBT+DCB was intended for a total of 36 patients from 2015-2020. PCI with some combination of ballooning, laser and directional/rotational atherectomy was used to maximally open the stenotic region prior to IVBT+DCB. Beta-radiation brachytherapy for all patients was done with a Novoste Beta-Cath. Lutonix 4.0 x 40 mm paclitaxel-coated balloons (Bard, Murray Hill, NJ) were employed. RESULTS: Overall survival at two years was 88%. Nine patients had follow-up angiograms, all for cardiac symptoms. Time from IVBT+DCB to follow-up angiography ranged from 4 to 33 months. The average months PCI-free interval before brachy therapy was 11.1 mos (95% CI 1.03-23.25) versus 23.3 mos after VBT (23.3 95% CI 12.3-32.3). The mean difference was 11.2 mos (95% CI 1.06-21.4, p < 0.031). None of the follow-up angiographic procedures displayed evidence of what could be interpreted as radiation damage. CONCLUSIONS: In this uncontrolled series, IVBT plus DCB appeared to lengthen the ISR-free interval relative to what had been achieved prior to the combined intervention. We view these results as mildly encouraging, worthy of further study.