Biodegradable Polymer DES (Ultimaster) vs. Magnesium Bioresorbable Scaffold (BRS Magmaris) in Diabetic Population with NSTE-ACS: A One-Year Clinical Outcome of Two Sirolimus-Eluting Stents.

BACKGROUND: Cardiovascular disease (CVD) with significant involvement of coronary artery disease (CAD) remains a major cause of death and disability among the diabetic population. Although percutaneous coronary intervention (PCI) continues to evolve, type 2 diabetes mellitus (T2DM) is a well-established marker of poor clinical prognosis after PCI, which is mainly attributed to the rapid progression of atherosclerosis requiring recurrent revascularizations. Hence, the use of bioresorbable materials could provide some solution to this problem. Material and Methods. The study was divided into two arms. For the first one, we qualified 169 patients with NSTE-ACS treated with PCI who received the drug-eluting stent (DES) coated with a biodegradable polymer Ultimaster (Terumo, Tokyo, Japan). The second arm was composed of 193 patients with ACS who underwent PCI with a magnesium bioresorbable scaffold Magmaris (Biotronik, Berlin, Germany). Both arms were divided into two subsequent groups: the T2DM (59 and 72) and the non-DM (110 and 121, respectively). The primary outcomes were cardiovascular death, myocardial infarction, and in-stent thrombosis. The main secondary outcomes included target lesion failure (TLF) and were recorded at a 1-year-follow-up. RESULTS: There were no significant differences between the diabetic and nondiabetic populations in primary endpoints or main secondary endpoints (TLF, scaffold restenosis, death from any reason, and other cardiovascular events) either in the Ultimaster or Magmaris group. At a 1-year-follow-up, the primary endpoint in the DM t.2 population was recorded in 2.7% Ultimaster vs. 5.1% Magmaris, respectively. At the same time, the TLF occurred in the diabetic group in 4.1% Magmaris and 3.3% in the Ultimaster arm, respectively. CONCLUSION: Both, Ultimaster and Magmaris revealed relative safety and efficiency at a one-year follow-up in the diabetic population in ACS settings. The observed rates of TLF were low, which combined with a lack of in-stent thrombosis suggests that both investigated devices might be an interesting therapeutic option for diabetics with ACS. Nevertheless, further large randomized clinical trials are needed to confirm fully our results.

Intracoronary Imaging Versus Coronary Angiography to Guide Drug-Coated Balloon Intervention in Coronary Artery Disease: A Propensity-Matched Pilot Study Analysis.

Limited data exist about the effect of intracoronary imaging (ICI)-guided drug-coated balloon (DCB) intervention on clinical end points. In all, 1157 patients with coronary artery disease treated with DCB between December 2014 and December 2017 at Beijing Anzhen Hospital were included in the final analysis in this cohort study. The primary end point was the incidence of target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (MI), and target lesion revascularization, and the key secondary end point was the incidence of cardiac death or target vessel MI. The median follow-up for clinical events was 32.0 months (IQR 25.0-40.0). Intracoronary imaging was used in 90 (7.8%) patients. There was no statistically significant difference in TLF (12.2% vs 12.5%, P = .80) between ICI-guided and angiography-guided group. Cardiac death or target vessel MI rates (1.1% vs 3.7%, P = .17) were numerically lower for the ICI-guided cohort. In the propensity score-based analysis, TLF (10.5% vs 16.2%, P = .19) and cardiac death or target vessel MI rates (1.2% vs 2.3%, P = .51) tended to be lower for the ICI-guided cohort. In this observational study, TLF rate tended to decrease in the ICI-guided DCB treatment group compared with angiography-guided procedures. Larger studies are needed.

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

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

Benefits with drug-coated balloon as compared to a conventional revascularization strategy for the treatment of coronary and non-coronary arterial disease: a comprehensive meta-analysis of 45 randomized trials.

BACKGROUND: Drug-coated balloons (DCB) have shown promising results for the percutaneous treatment of de novo and restenotic lesions, involving both the coronary and femoropopliteal district. However, clinical outcomes data associated with the use of this devices are still unclear, with potential warnings on increased mortality being raised from initial studies. We aimed at performing an updated and comprehensive meta-analysis comparing DCB with conventional percutaneous revascularization strategies for the treatment of coronary (CAD) or peripheral artery disease (PAD). METHODS: Literature and main scientific session abstracts were searched for studies comparing DCB vs a standard percutaneous revascularization strategy, with or without stenting, for the treatment of CAD and PAD. The primary efficacy endpoint was mortality. Secondary endpoints were recurrent acute ischemic events (myocardial infarction or amputation) or target lesion revascularization (TLR). RESULTS: We included 45 randomized trials, (CAD: 27 studies, PAD: 18 studies) with an overall population of 7718 patients, (56.4%) randomized to a DCB strategy. At a mean follow-up of19.3 ± 15.2 months, death occurred in 5.8% of the patients, with no significant difference between DCB or conventionally treated patients (5.9% vs 5.7%, OR[95%CI] = 0.89[0.71,1.11], p = 0.31; phet = 0.43). We observed a non-significant reduction in recurrent acute ischemic events, whereas the use of DCB significantly reduced the rate of TLR, with larger benefits observed in patients with PAD and respect to balloon-only angioplasty, while being lower in comparison with stent implantation. No significant interaction was observed with de novo lesions or in-stent restenosis. CONCLUSIONS: Based on the current meta-analysis, the use of drug-coated balloons for the percutaneous treatment of CAD and PAD is associated to a comparable risk of mortality and recurrent acute ischemic events as compared to a conventional revascularization strategy, although offering larger benefits in terms of TLR, especially when compared with balloon-only angioplasty and in femoropopliteal disease.

Long-Term Follow-Up of Percutaneous Coronary Intervention With Paclitaxel-Eluting Balloon Catheter.

Drug-eluting balloons currently constitute a therapeutic tool used in percutaneous coronary interventions (PCI). Long-term results remain unknown. We evaluated the prognosis of PCI using a second generation paclitaxel-eluting balloon (PEB) in real-world patients. We included all PCI with PEB in de novo or in-stent restenosis coronary lesions performed in our unit from March 2009 to March 2019. We assessed the composite of major adverse cardiovascular events (MACE) rate after a median follow-up of 42 months. Consecutive patients (n = 320) with 386 lesions were included; 46.9% presented with stable angina and 53.1% acute coronary syndromes; 52.6% of the lesions were in-stent restenosis and 47.3% de novo lesions with a mean diameter of 2.4 ± 0.5 mm. A bare metal stent was implanted in 6.7% and a drug-eluting stent in 8.5% of patients. The MACE rate was 8%: 10 (2.6%) cardiovascular deaths, 13 (3.4%) myocardial infarctions, and 16 (4.1%) target lesion revascularization. The all-cause death rate was 5.2%. No cases of thrombosis were recorded. In conclusion, PEB was a safe and effective tool to treat in-stent restenosis and de novo coronary lesions, especially small vessel disease, during long-term follow-up.

Drug-Coated Balloon for De Novo Coronary Artery Lesions: A Systematic Review and Trial Sequential Meta-analysis of Randomized Controlled Trials.

OBJECTIVE: To investigate the efficacy of drug-coated balloon (DCB) treatment for de novo coronary artery lesions in randomized controlled trials (RCTs). BACKGROUND: DCB was an effective therapy for patients with in-stent restenosis. However, the efficacy of DCB in patients with de novo coronary artery lesions is still unknown. METHODS: Eligible studies were searched on PubMed, Web of Science, EMBASE, and Cochrane Library Database. Systematic review and meta-analyses of RCTs were performed comparing DCB with non-DCB devices (such as plain old balloon angioplasty (POBA), bare-metal stents (BMS), or drug-eluting stents (DES)) for the treatment of de novo lesions. Trial sequential meta-analysis (TSA) was performed to assess the false positive and false negative errors. RESULTS: A total of 2,137 patients enrolled in 12 RCTs were analyzed. Overall, no significant difference in target lesion revascularization (TLR) was found, but there were numerically lower rates after DCB treatment at 6 to 12 months follow-up (RR: 0.69; 95% CI: 0.47 to 1.01; P = 0.06; TSA-adjusted CI: 0.41 to 1.16). TSA showed that at least 1,000 more randomized patients are needed to conclude the effect on TLR. A subgroup analysis from high bleeding risk patients revealed that DCB treatment was associated with lower rate of TLR (RR: 0.10; 95% CI: 0.01 to 0.78; P = 0.03). The systematic review illustrated that the rate of bailout stenting was lower and decreased gradually. CONCLUSIONS: DCB treatment was associated with a trend toward lower TLR when compared with controls. For patients at bleeding risk, DCB treatment was superior to BMS in TLR.

Predictors of suboptimal coronary blood flow after primary angioplasty and its implications on short-term outcomes in patients with acute anterior STEMI.

BACKGROUND: Suboptimal coronary blood flow after primary percutaneous coronary intervention (PCI) is a complex multifactorial phenomenon. Although extensively studied, defined modifiable risk factors and efficient management strategy are lacking. This study aims to determine the potential causes of suboptimal flow and associated impact on 30-day outcomes in patients presenting with anterior ST-elevation myocardial infarction (STEMI). METHODS: We evaluated a total of 1104 consecutive patients admitted to our hospital from January 2016 to December 2018 with the diagnosis of anterior wall STEMI who had primary PCI. RESULTS: Overall, 245 patients (22.2%) had final post-PCI TIMI flow ≤2 in the LAD (suboptimal flow group) and 859 (77.8%) had final TIMI-3 flow (optimal flow group). The independent predictors of suboptimal flow were thrombus burden grade (Odds ratio (OR) 1.848; p < 0.001), age (OR 1.039 per 1-year increase; p < 0.001), low systolic blood pressure (OR 1.017 per 1 mmHg decrease; p < 0.001), total stent length (OR 1.021 per 1 mm increase; p < 0.001), and baseline TIMI flow ≤1 (OR 1.674; p = 0.018). The 30-day rates of major adverse cardiovascular events (MACE) and cardiac mortality were significantly higher in patients with TIMI flow ≤2 compared to those with TIMI-3 flow (MACE: adjusted risk ratio [RR] 2.021; P = 0.025, cardiac mortality: adjusted RR 2.931; P = 0.031). CONCLUSION: Failure to achieve normal TIMI-3 flow was associated with patient-related (age) and other potentially modifiable risk factors (thrombus burden, admission systolic blood pressure, total stent length, and baseline TIMI flow). The absence of final TIMI-3 flow carried worse short-term clinical outcomes.

Primary Angioplasty in a Catastrophic Presentation: Acute Left Main Coronary Total Occlusion-The ATOLMA Registry.

OBJECTIVES: To determine the outcome predictors of in-hospital mortality in acute total occlusion of the left main coronary artery (ATOLMA) patients referred to emergent angioplasty and to describe the clinical presentation and the long-term outcome of these patients. BACKGROUND: ATOLMA is an uncommon angiographic finding that usually leads to a catastrophic presentation. Limited and inconsistent data have been previously reported regarding true ATOLMA, yet comprehensive knowledge remains scarce. METHODS: This is a multicenter retrospective cohort that includes patients presenting with myocardial infarction due to a confirmed ATOLMA who underwent emergency percutaneous coronary intervention (PCI). RESULTS: In the period of the study, 7930 emergent PCI were performed in the five participating centers, and 46 of them had a true ATOLMA (0.58%). At admission, cardiogenic shock was present in 89% of patients, and cardiopulmonary resuscitation was required in 67.4%. All the patients had right dominance. Angiographic success was achieved in 80.4% of the procedures, 13 patients (28.2%) died during the catheterization, and the in-hospital mortality rate was 58.6% (27/46). At one-year and at the final follow-up, 18 patients (39%) were alive, including four cases successfully transplanted. Multivariate analysis showed that postprocedural TIMI flow was the only independent predictor of in-hospital mortality (OR 0.23, (95% CI 0.1-0.36), p < 0.001). CONCLUSIONS: Our study confirms that the clinical presentation of ATOLMA is catastrophic, presenting a high in-hospital mortality rate; nevertheless, primary angioplasty in this setting is feasible. Postprocedural TIMI flow resulted as the only independent predictor of in-hospital mortality. In-hospital survivors presented an encouraging outcome. ATOLMA and left dominance could be incompatible with life.

Door-to-balloon time in the treatment of ST segment elevation myocardial infarction in a tertiary care center in Saudi Arabia.

BACKGROUND: Atherosclerotic heart disease is still a leading cause of mortality despite improvements in cardiovascular care. Percutaneous coronary intervention (PCI) is the recommended reperfusion therapy in acute ST-elevation myocardial infarction (STEMI), and the international guideline is to achieve a door-to-balloon (D2B) time within 90 minutes of patient arrival to an emergency department (ED). OBJECTIVES: Describe interventions, data for the study period, challenges in ensuring 24/7 patient access to PCI and quality indicators. DESIGN: Retrospective observational study. SETTING: Tertiary care institution in Riyadh, Saudi Arabia. PATIENTS AND METHODS: We included all acute coronary syndrome patients from 2010-2018 who presented or were transferred to our ED from nearby non-PCI capable hospitals, and for whom a 'code heart' was activated. Electronic medical records and the patient care report from the ambulance services were accessed for data collection. MAIN OUTCOME MEASURES: D2B time, readmission and mortality rate. SAMPLE SIZE AND CHARACTERISTICS: 354 patients, mean age (standard deviation) 55.6 (12.6) years, males 84.5% (n=299). RESULTS: STEMI patients constituted 94% (n=334) of the study group; the others had non-STEMI or unstable angina. Hypertension (51%) was the most prevalent risk factor. Coronary artery stenting was the most frequent intervention (77.4%) followed by medical therapy (14.7%). The most common culprit artery was the left anterior descending (52.5%) followed by the right coronary artery (26.0%). A D2B time of within 90 minutes was achieved in over 85% of the patients in four of the years in the 278 patients who underwent PCI. The median D2B time (interquar-tile range) over 2010-2018 was 79 (31) minutes. CONCLUSION: Meeting the international benchmark of D2B time within 90 minutes for STEMI patients is achievable when the main stakeholders collaborate in patient-centric care. Our patient demographics represent regional trends. LIMITATIONS: Patient acceptance to our institution is based upon eligibility criteria. Transfer of 'code heart' patients from other institutions was carried out by our ambulance team. The credentials and experience of cardiologists, emergency physicians, and ambulance services are not standardized across the country. Therefore, the results may not be generalizable to other institutions. CONFLICT OF INTEREST: None.

Short-term and long-term outcomes of bailout versus planned coronary rotational atherectomy.

The goal of this study was to compare in-hospital and long-term events between bailout rotational atherectomy (RA) and planned RA. In this retrospective study, All patients who underwent percutaneous coronary intervention (PCI) using RA at Nanjing Drum Tower Hospital from November 2011 to December 2018 were enrolled in this study. Planned RA was defined as RA performed immediately before balloon pre-dilation, while bailout RA was defined as RA after failure to expand the balloon or perform any other procedure. In-hospital and long-term major adverse cardiac events (MACE, defined as cardiac mortality, myocardial infarction (MI), target vessel revascularization (TVR) and stroke) were compared between the two groups. After statistical analysis, a total of 211 patients underwent PCI with RA during the study period: 153 in the planned RA group, and 58 in the bailout group. The incidence of coronary dissection was significantly higher in the bailout RA group than in the planned RA group (22.4% vs. 6.5%, P = 0.001). However, no significant difference in in-hospital MACE was found between the two groups (12.1% vs. 13.7%, P = 0.752). There was no difference in all-cause mortality (9.1% vs. 12.5%, P = 0.504) or long-term MACE (13.8% vs. 17.1%, P = 0.560) between the groups. Bailout RA was associated with a significantly longer procedural time (139.86 ± 56.24 min vs. 105.56 ± 36.71 min, P < 0.001) than planned RA. Therefore, compared with bailout RA, planned RA is associated with shorter procedural time and reduced incidence of coronary dissection, with no difference in MACE or mortality.

Drug-Coated Balloons for Coronary Artery Disease: Third Report of the International DCB Consensus Group.

Although drug-eluting stents are still the default interventional treatment of coronary artery disease, drug-coated balloons (DCBs) represent a novel alternative therapeutic strategy in certain anatomic conditions. The effect of DCBs is based on the fast and homogenous transfer of antiproliferative drugs into the vessel wall during single balloon inflation by means of a lipophilic matrix without the use of permanent implants. Although their use is established for in-stent restenosis of both bare-metal and drug-eluting stents, recent randomized clinical data demonstrate a good efficacy and safety profile in de novo small-vessel disease and high bleeding risk. In addition, there are other emerging indications (e.g., bifurcation lesions, large-vessel disease, diabetes mellitus, acute coronary syndromes). Because the interaction among the different delivery balloon designs, doses, formulations, and release kinetics of the drugs used is important, there seems to be no "class effect" of DCBs. On the basis of the amount of recently published data, the International DCB Consensus Group provides this update of previous recommendations summarizing the historical background, technical considerations such as choice of device and implantation technique, possible indications, and future perspectives.

Optimal Stenting Technique for Complex Coronary Lesions: Intracoronary Imaging-Guided Pre-Dilation, Stent Sizing, and Post-Dilation.

OBJECTIVES: This study compared the 3-year outcomes of intracoronary imaging-guided pre-dilation, stent sizing, and post-dilation (iPSP) for patients with complex coronary artery lesions. BACKGROUND: The long-term effects of the optimal drug-eluting stent implantation technique in complex coronary artery disease have not been evaluated. METHODS: From the IRIS-DES (Interventional Cardiology Research In-cooperation Society-Drug-Eluting Stents) registry, the study evaluated 9,525 patients who underwent percutaneous coronary intervention for left main, bifurcation, long or diffuse (>30 mm), or angiographically severely calcified lesions. The primary outcome was a composite of cardiac death, target vessel myocardial infarction, and target vessel revascularization. The inverse probability of treatment weighting method was used to adjust for confounding factors. RESULTS: At the index procedure, intravascular ultrasound assessment PSP were performed in 8,522 (89.5%) patients, 5,141 (54.0%) patients, and 5,531 (58.1%) patients, respectively; overall, 3,374 (35.4%) patients underwent stent implantation using all 3 parts of the iPSP strategy and were defined as the iPSP group. At 3 years, the adjusted rate of the primary outcome was significantly lower in iPSP group (5.6% vs 7.9%; adjusted hazard ratio: 0.71; 95% confidence interval: 0.63 to 0.81; p < 0.001). CONCLUSIONS: Among patients undergoing drug-eluting stent implantation in complex coronary artery stenosis, iPSP was associated with a lower risk of cardiac events at 3 years. Therefore, physicians should apply iPSP more actively for the treatment of complex coronary artery stenoses, even in the current era. (Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice [IRIS-DES]; NCT01186133).

Drug-Coated Balloon Angioplasty Versus Drug-Eluting Stent Implantation in Patients With Coronary Stent Restenosis.

BACKGROUND: In patients with coronary in-stent restenosis (ISR) requiring reintervention, it is unclear if the choice of treatment should depend on whether the restenotic stent was a bare-metal stent (BMS) or a drug-eluting stent (DES). OBJECTIVES: This study aimed to assess the comparative efficacy and safety of the 2 most frequently used treatments - angioplasty with drug-coated balloon (DCB) and repeat stenting DES - in patients with BMS-and DES-ISR. METHODS: The DAEDALUS (Difference in Antirestenotic Effectiveness of Drug-Eluting Stent and Drug-Coated Balloon Angioplasty for the Occurrence of Coronary In-Stent Restenosis) study was a pooled analysis of individual patient data from all 10 existing randomized clinical trials comparing DCB angioplasty with repeat DES implantation for the treatment of coronary ISR. In this pre-specified analysis, patients were stratified according to BMS- versus DES-ISR and treatment assigned. The primary efficacy endpoint was target lesion revascularization (TLR) at 3 years. The primary safety endpoint was a composite of all-cause death, myocardial infarction, or target lesion thrombosis at 3 years. Primary analysis was performed by mixed-effects Cox models accounting for the trial of origin. Secondary analyses included nonparsimonious multivariable adjustment accounting also for multiple lesions per patient and 2-stage analyses. RESULTS: A total of 710 patients with BMS-ISR (722 lesions) and 1,248 with DES-ISR (1,377 lesions) were included. In patients with BMS-ISR, no significant difference between treatments was observed in terms of primary efficacy (9.2% vs. 10.2%; hazard ratio [HR]: 0.83; 95% confidence interval [CI]: 0.51 to 1.37) and safety endpoints (8.7% vs. 7.5%; HR: 1.13; 95% CI: 0.65 to 1.96); results of secondary analyses were consistent. In patients with DES-ISR, the risk of the primary efficacy endpoint was higher with DCB angioplasty than with repeat DES implantation (20.3% vs. 13.4%; HR: 1.58; 95% CI: 1.16 to 2.13), whereas the risk of the primary safety endpoint was numerically lower (9.5% vs. 13.3%; HR: 0.69; 95% CI: 0.47 to 1.00); results of secondary analyses were consistent. Regardless of the treatment used, the risk of TLR was lower in BMS- versus DES-ISR (9.7% vs. 17.0%; HR: 0.56; 95% CI: 0.42 to 0.74), whereas safety was not significantly different between ISR types. CONCLUSIONS: At 3-year follow-up, DCB angioplasty and repeat stenting with DES are similarly effective and safe in the treatment of BMS-ISR, whereas DCB angioplasty is significantly less effective than repeat DES implantation in the treatment DES-ISR, and associated with a nonsignificant reduction in the primary composite safety endpoint. Overall, DES-ISR is associated with higher rates of treatment failure and similar safety compared with BMS-ISR.

Clinical and Angiographic Outcomes With Drug-Coated Balloons for De Novo Coronary Lesions: A Meta-Analysis of Randomized Clinical Trials.

Background The role of drug-coated balloons (DCBs) in the treatment of de novo coronary lesions is not well established. Methods and Results Electronic databases and major conference proceedings were searched for randomized controlled trials that compared DCBs with stents or angioplasty for de novo coronary lesions. The primary outcome was target lesion revascularization. Summary estimates were conducted using random-effects analysis complemented by several subgroup and sensitivity analyses. A total of 14 randomized controlled trials with 2483 patients were included. At a mean follow up of 12 months, DCBs were associated with no difference in the incidence of target lesion revascularization as compared with alternative strategies (risk ratio [RR], 0.79; 95% CI, 0.35-1.76). There was no difference in treatment effect based on the indication (ie, small-vessel disease, myocardial infarction, bifurcation, or high bleeding risk) (Pinteraction=0.22). DCBs were associated with lower target lesion revascularization compared with bare metal stents and similar target lesion revascularization compared with drug-eluting stents (Pinteraction=0.03). There was no difference between DCBs and control in terms of major adverse cardiac events, vessel thrombosis, or cardiovascular mortality. However, DCBs were associated with a lower incidence of myocardial infarction (RR, 0.48; 95% CI, 0.25-0.90) and all-cause mortality (RR, 0.45; 95% CI, 0.22-0.94). Conclusions In patients with de novo coronary lesions, use of DCBs was associated with comparable clinical outcomes irrespective of the indication or comparator device. DCBs had a similar rate of target lesion revascularization compared with drug-eluting stents. A randomized trial powered for clinical outcomes and evaluating the role of DCBs for all-comers is warranted.

Risk of Mortality with Paclitaxel Drug-Coated Balloon in De Novo Coronary Artery Disease.

A recent meta-analysis showed increased mortality with paclitaxel drug-coated balloons (PCB) in peripheral arterial disease. With the absence of a definitive study evaluating the risk of mortality with PCB in de novo coronary artery disease, we performed a systematic review and critical appraisal of the literature analyzing this risk. In this review, we included 17 trials with a total of 1573 patients. Cardiac mortality was reported in 16 studies and all-cause mortality in 14 studies. Eleven studies had <12 months' follow-up; 6 had ≥12 months' follow-up. None of the studies was powered to evaluate any differences in mortality. The majority of the included studies have a Jadad scale ≤2. Ten of 17 studies had no mortality, 4 had numerically higher mortality with PCB, and 3 had lower or same mortality with PCB, when compared to drug-eluting stents. A standard meta-analysis cannot be performed, as most studies did not report hazard ratios or Kaplan-Meier survival plots on mortality. With the available literature, conclusions cannot be made in identifying the association of mortality with PCB in de novo coronary artery disease. There is an urgent need for well-designed studies with long-term follow-up for PCB in de novo coronary artery disease. A recent meta-analysis showed increased mortality with paclitaxel drug-coated balloon (PCB) in peripheries. No studies to date evaluate the risk of mortality with PCB in de novo coronary artery disease. In this systematic review and critical appraisal of literature, we outline why the risk cannot be elucidated from the available literature. A standard meta-analysis using inverse variance method would be incorrect to use, as mortality is a time-to-event data point, and only 1 out of 17 studies reported a Kaplan-Meier survival plot.

Survival After Coronary Revascularization With Paclitaxel-Coated Balloons.

BACKGROUND: Drug-coated balloons (DCBs) are accepted treatment strategies for coronary in-stent restenosis and are under clinical investigation for lesions without prior stent implantation. A recently published meta-analysis suggested an increased risk of death associated with the use of paclitaxel-coated devices in the superficial femoral artery. The reasons are incompletely understood as potential underlying pathomechanisms remain elusive, and no relationship to the administered dose has been documented. OBJECTIVES: The purpose of this analysis was to investigate the available data on survival after coronary intervention with paclitaxel-coated balloons from randomized controlled trials (RCTs). METHODS: PubMed, Web of science, and the Cochrane library database were searched, and a meta-analysis from RCT was performed comparing DCB with non-DCB devices (such as conventional balloon angioplasty, bare-metal stents, or drug-eluting stents) for the treatment of coronary in-stent restenosis or de novo lesions. The primary outcome was all-cause death. The number of patients lost to follow-up was observed at different time points. Risk estimates are reported as risk ratios (RRs) with 95% confidence intervals (CIs). RESULTS: A total of 4,590 patients enrolled in 26 RCTs published between 2006 and 2019 were analyzed. At follow-up of 6 to 12 months, no significant difference in all-cause mortality was found, however, with numerically lower rates after DCB treatment (RR: 0.74; 95% CI: 0.51 to 1.08; p = 0.116). Risk of death at 2 years (n = 1,477, 8 RCTs) was similar between the 2 groups (RR: 0.84; 95% CI: 0.51 to 1.37; p = 0.478). After 3 years of follow-up (n = 1,775, 9 RCTs), all-cause mortality was significantly lower in the DCB group when compared with control treatment (RR: 0.73; 95% CI: 0.53 to 1.00; p = 0.047) with a number needed to treat of 36 to prevent 1 death. A similar reduction was seen in cardiac mortality (RR: 0.53; 95% CI: 0.33 to 0.85; p = 0.009). CONCLUSIONS: In this meta-analysis, the use of paclitaxel DCBs for treatment of coronary artery disease was not associated with increased mortality, as has been suggested for peripheral arteries. On the contrary, use of coronary paclitaxel-coated balloons was associated with a trend toward lower mortality when compared with control treatments.

A comparison between drug-eluting stent implantation and drug-coated balloon angioplasty in patients with left main bifurcation in-stent restenotic lesions.

BACKGROUND: The current guidelines recommend both repeat stenting and drug-coated balloons (DCB) for in-stent restenosis (ISR) lesions, if technically feasible. However, real-world clinical data on the interventional strategies in patients with left main bifurcation (LMB)-ISR have not been elucidated. METHODS: Seventy-five patients with LMB-ISR, who underwent percutaneous coronary intervention (PCI) between January 2009 and July 2015, were retrospectively reviewed for the present study (repeat drug eluting stent [DES] implantation [n = 51], DCB angioplasty [n = 24]). RESULTS: Analysis of the baseline characteristics showed that the patients in the DCB group had a lower incidence of non-ST segment elevation myocardial infarction/ST segment elevation myocardial infarction at the index PCI (8.3% vs. 25.5%; p = 0.12), higher low-density lipoprotein-cholesterol level (92.9 mg/dL vs. 81.7 mg/dL; p = 0.09), and more "stent-in-stent" lesions (25% vs. 7.8%; p = 0.07) than those in the DES group. A smaller post-procedural minimal target lesion lumen diameter was also noted in the DCB group than in the DES group (2.71 mm vs. 2.85 mm; p = 0.03). The cumulative incidence rates of major adverse cardiac events (MACEs) were similar between both groups (median follow-up duration, 868 days; MACE rate, 25% in the DCB group vs. 25.5% in the DES group; p = 0.96). The multivariate Cox regression analysis indicated that the true bifurcation of ISR was an independent risk predictor of MACEs (hazard ratio, 4.62; 95% confidence interval, 1.572-13.561; p < 0.01). CONCLUSIONS: DES and DCB showed comparable long-term clinical results in patients with LMB-ISR lesions.

Randomised comparison of provisional side branch stenting versus a two-stent strategy for treatment of true coronary bifurcation lesions involving a large side branch: the Nordic-Baltic Bifurcation Study IV.

Background: It is still uncertain whether coronary bifurcations with lesions involving a large side branch (SB) should be treated by stenting the main vessel and provisional stenting of the SB (simple) or by routine two-stent techniques (complex). We aimed to compare clinical outcome after treatment of lesions in large bifurcations by simple or complex stent implantation. Methods: The study was a randomised, superiority trial. Enrolment required a SB≥2.75 mm, ≥50% diameter stenosis in both vessels, and allowed SB lesion length up to 15 mm. The primary endpoint was a composite of cardiac death, non-procedural myocardial infarction and target lesion revascularisation at 6 months. Two-year clinical follow-up was included in this primary reporting due to lower than expected event rates. Results: A total of 450 patients were assigned to simple stenting (n=221) or complex stenting (n=229) in 14 Nordic and Baltic centres. Two-year follow-up was available in 218 (98.6%) and 228 (99.5%) patients, respectively. The primary endpoint of major adverse cardiac events (MACE) at 6 months was 5.5% vs 2.2% (risk differences 3.2%, 95% CI -0.2 to 6.8, p=0.07) and at 2 years 12.9% vs 8.4% (HR 0.63, 95% CI 0.35 to 1.13, p=0.12) after simple versus complex treatment. In the subgroup treated by newer generation drug-eluting stents, MACE was 12.0% vs 5.6% (HR 0.45, 95% CI 0.17 to 1.17, p=0.10) after simple versus complex treatment. Conclusion: In the treatment of bifurcation lesions involving a large SB with ostial stenosis, routine two-stent techniques did not improve outcome significantly compared with treatment by the simpler main vessel stenting technique after 2 years. Trial registration number: NCT01496638.

Impact of Kissing Balloon in Patients Treated With Ultrathin Stents for Left Main Lesions and Bifurcations: An Analysis From the RAIN-CARDIOGROUP VII Study.

BACKGROUND: There are limited data regarding the impact of final kissing balloon (FKI) in patients treated with percutaneous coronary intervention using ultrathin stents in left main or bifurcations. METHODS: All patients undergoing left main or bifurcations percutaneous coronary intervention enrolled in the RAIN registry (Very Thin Stents for Patients With MAIN or BiF in Real Life: The RAIN, a Multicenter Study) evaluating ultrathin stents were included. Major adverse cardiac event (a composite of all-cause death, myocardial infarction, target lesion revascularization, and stent thrombosis) was the primary end point, while its components, along with target vessel revascularization, were the secondary end points. The main analysis was performed comparing patients with and without FKI after adjustment with inverse probability of treatment weighting. Subgroup analyses were performed according to FKI (short [<3 mm] versus long overlap), strategy (provisional versus 2-stent), routine versus bail-out FKI, and the use of imaging and proximal optimization technique. RESULTS: Two thousand seven hundred forty-two patients were included. At 16 months (8-20) follow-up, inverse probability of treatment weighting adjusted rates of major adverse cardiac event were similar between FKI and no-FKI group (15.1% versus 15.5%; P=0.967), this result did not change with use of imaging, proximal optimization technique, or routine versus bail-out FKI. In the 2-stent subgroup, FKI was associated with lower rates of target vessel revascularization (7.8% versus 15.9%; P=0.030) and target lesion revascularization (7.3% versus 15.2%; P=0.032). Short overlap FKI was associated with a lower rate of target lesion revascularization compared with no FKI (2.6% versus 5.4%; P=0.034), while long overlap was not (6.8% versus 5.4%; P=0.567). CONCLUSIONS: In patients with bifurcations or unprotected left main treated with ultrathin stents, short overlap FKI is associated with less restenosis. In a 2-stent strategy, FKI was associated with less target vessel revascularization and restenosis. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03544294.

Percutaneous Treatment and Outcomes of Small Coronary Vessels: A SCAAR Report.

OBJECTIVES: The aim of this study was to investigate the outcomes of patients with de novo lesions in small coronary vessels undergoing percutaneous coronary intervention (PCI) with drug-coated balloons (DCBs) or newer-generation drug-eluting stents (n-DES). BACKGROUND: Notwithstanding the available evidence from a few randomized clinical trials and meta-analyses, the best device for PCI in patients with small-vessel coronary artery disease is not yet established. METHODS: The study included all consecutive patients with de novo lesions in small coronary vessels undergoing PCI in Sweden from April 2009 to July 2017. A small coronary vessel was defined by a device diameter ≤2.5 mm. The primary outcomes were restenosis and definite target lesion thrombosis at 3-year follow-up. The secondary outcomes were the occurrence of all-cause death and myocardial infarction. RESULTS: The study population included 14,788 patients: 1,154 treated with DCBs and 13,634 with n-DES. Overall, 35,541 PCIs were performed using 2,503 DCBs and 33,038 n-DES. The propensity score-adjusted regression analysis showed a significantly higher risk for restenosis in the DCB group compared with the n-DES group (adjusted hazard ratio [HR]: 2.027; 95% confidence interval [CI]: 1.537 to 2.674). Conversely, no difference in the risk for target lesion thrombosis (adjusted HR: 0.741; 95% CI: 0.412 to 1.331) was detected. The risk for all-cause death (adjusted HR: 1.178; 95% CI: 0.992 to 1.399) and myocardial infarction (adjusted HR: 1.251; 95% CI: 0.960 to 1.629) was comparable between groups. CONCLUSIONS: Because of the significantly higher risk for restenosis up to 3 years, this research suggests that DCBs are not an equally effective alternative to n-DES for percutaneous treatment of small coronary vessels.