Small Vessel Coronary Disease Research Articles

Long-Term Clinical-Pathologic Results of Enzyme Replacement Therapy in Prehypertrophic Fabry Disease Cardiomyopathy.

The limited ability of enzyme replacement therapy (ERT) in removing globotriaosylceramide from cardiomyocytes is recognized for advanced Fabry disease cardiomyopathy (FDCM). Prehypertrophic FDCM is believed to be cured or stabilized by ERT. However, no pathologic confirmation is available. We report here on the long-term clinical-pathologic impact of ERT on prehypertrophic FDCM. Fifteen patients with Fabry disease with left ventricular maximal wall thickness ≤10.5 mm at cardiac magnetic resonance required endomyocardial biopsy because of angina and ventricular arrhythmias. Endomyocardial biopsy showed coronary small-vessel disease in the angina cohort, and vacuoles in smooth muscle cells and cardiomyocytes ≈20% of the cell surface containing myelin bodies at electron microscopy. Patients received α-agalsidase in 8 cases, and β-agalsidase in 7 cases. Both groups experienced symptom improvement except 1 patients treated with α-agalsidase and 1 treated with β-agalsidase. After ERT administration ranging from 4 to 20 years, all patients had control cardiac magnetic resonance and left ventricular endomyocardial biopsy because of persistence of symptoms or patient inquiry on disease resolution. In 13 asymptomatic patients with FDCM, left ventricular maximal wall thickness and left ventricular mass, cardiomyocyte diameter, vacuole surface/cell surface ratio, and vessels remained unchanged or minimally increased (left ventricular mass increased by <2%) even after 20 years of observation, and storage material was still present at electron microscopy. In 2 symptomatic patients, FDCM progressed, with larger and more engulfed by globotriaosylceramide myocytes being associated with myocardial virus-negative lymphocytic inflammation. ERT stabilizes storage deposits and myocyte dimensions in 87% of patients with prehypertrophic FDCM. Globotriaosylceramide is never completely removed even after long-term treatment. Immune-mediated myocardial inflammation can overlap, limiting ERT activity.

Comparison of Drug-Coated Balloon and Drug-Eluting Stent for the Treatment of Small Vessel Disease (from the Dissolve SVD Randomized Trial)

The Dissolve drug-coated balloons (DCBs) is a new-generation DCB coated with paclitaxel of balloon surface, with midchain triglyceride excipient. Although the use of DCBs is a promising technique, little is known about the the clinical efficacy of the novel Dissolve DCB in coronary small vessel disease. This study was a prospective, randomized, multicenter, noninferiority trial comparing the Dissolve DCB with the Resolute drug-eluting stent (DES) in patients with a reference vessel diameter ≥2.25 and ≤2.75mm. Patients with a reference vessel diameter ≥2.00 and <2.25mm were enrolled in the very small vessel registry. The angiographic and clinical follow-up were planned at 9months and 1year in all patients, respectively. The primary end point was 9-month in-segment percentage diameter stenosis. A total of 247 patients with small vessel disease from 10 Chinese sites were included (Dissolve DCB, n=118; Resolute DES, n=129); 30 patients were treated with the DCB in the very small vessel cohort. The 9-month in-segment percentage diameter stenosis was 31.2 ± 2.0% with Dissolve DCB versus 26.1 ± 2.1% with Resolute DES; the 1-sided 97.5% upper confidence limit of the difference was 10.3% (p for noninferiority=0.0002). At 12months, the DCB and DES groups were associated with similar rates of target lesion failure (8.5% vs 6.1%, p=0.28) and major adverse cardiac and cerebrovascular events (20.9% vs 13.6%, p=0.12). In conclusion, the Dissolve DCB was noninferior to the Resolute DES for the primary end point of 9-month in-segment percentage diameter stenosis in this multicenter, head-to-head, randomized trial (a safety and efficacy study of Dissolve In Treatment Of Coronary Small Vessel Disease; NCT03376646).

Long-term clinical-pathologic results of enzyme replacement therapy in pre-hypertrophic Fabry disease cardiomyopathy

Abstract Background Limited ability of ERT in removing Gb-3 from cardiomyocytes is recognized for advanced FDCM. Pre-hypertrophic FDCM is believed to be cured or stabilized by ERT. However, no pathologic confirmation is available. Purpose Long-term clinical-pathologic impact of ERT on pre-hypertrophic FDCM. Methods Fifteen Fabry patients with LVMWT ≤ 10.5 mm at CMR required EMB because of angina and/or ventricular arrhythmias. EMB showed coronary small vessel disease in angina cohort and vacuoles in smooth muscle cells and cardiomyocytes around 20% of cell surface containing myelin bodies at electron microscopy. Patients received α-agalsidase in 8 and β-agalsidase in 7 cases. Both groups referred symptoms improvement except 2 patients treated with α- and β-agalsidase respectively. After ERT administration ranging from 4 and 20 years all patients had control CMR and LVEMB because of persistence of symptoms or patients enquiry on disease resolution. Results In 13 asymptomatic FDCM patients, LVMWT and LV-mass, cardiomyocyte diameter, vacuole surface/cell surface ratio and vessels remained unchanged even after 20 years observation and storage material was still present at electron microscopy. In 2 symptomatic patients, FDCM progressed with larger and more engulfed by Gb-3 myocytes being associated to myocardial virus-negative lymphocytic inflammation. Conclusions ERT stabilizes storage deposits and myocyte dimensions in 87% of patients with pre-hypertrophic FDCM. Gb-3 is never completely removed even after long-term treatment. Immune-mediated myocardial inflammation can overlap limiting ERT activity. Figure legend Long-term ERT effects on FDCM. ERT improves symptoms, stabilizes storage deposits and left ventricular mass index in 87% of patients with pre-hypertrophic FDCM. In 13% of patients there is a progression of the disease in spite of ERT, with a superimposed immune-mediated myocardial inflammation at EMB.

Clinical characteristics, risk factors, and prognostic analyses of coronary small vessel disease: a retrospective cohort study of 986 patients

ABSTRACT Background and aims Coronary small vessel disease (CSVD) is often associated with significant percutaneous coronary intervention (PCI) related complications, complex lesions, complex PCI, and poor long-term prognosis. We designed this retrospective study to clarify the characteristics, risk factors, and prognostic analyses of CSVD in Chinese populations Methods A total of 986 patients who underwent coronary angiography and stent implantation at the First Affiliated Hospital of Zhejiang University School of Medicine were evaluated. Patients were grouped into CSVD or non-small vessel disease (non-CSVD) according to stent diameter. Clinical data, coronary angiography, and long-term follow-up were recorded. Multivariate logistic regression, the Kaplan–Meier method, Log-rank Test, and Cox regression model were used for statistical analysis. Results Alcohol consumption (OR = 0.420, 95% CI: 0.299–0.588, P < 0.001) was implicated as a negative CSVD correlation factor. CSVD was more likely to be associated with multi-vessel lesions (79.2% vs. 49.4%, P < 0.001), bifurcation lesions (24.0% vs. 12.4%, P < 0.001), chronic total obstruction lesions (29.5% vs. 9.4%, P < 0.001), and long lesions (55.2% vs. 35.7%, P < 0.001), which reduced the efficacy of revascularization (70.1% vs. 85.1%, P < 0.001). In the follow-ups, cardiac death (2.3% vs. 0.4%, P = 0.008), stroke (1.9% vs. 0.3%, P = 0.007), target lesion revascularization (5.8% vs. 2.9%, P = 0.029), target vessel revascularization (6.8% vs. 3.4%, P = 0.016), and non-target vessel revascularization (7.8% vs. 4.0%, P = 0.012) were all substantially higher in CSVD patients. Troponin I level (OR = 1.008, 95% CI: 1.004–1.012, P < 0.001), complete revascularization (OR = 0.292, 95% CI: 0.160–0.531, P < 0.001), and aspirin administration (OR = 0.041, 95% CI: 0.013–0.131, P < 0.001) were independent predictors of MACE events of all patients. Conclusion Compared to non-CSVD, CSVD was associated with more complex lesions, had worse revascularization efficacy, and a poorer prognosis.

Long-Term Outcome of Drug-Coated Balloon vs Drug-Eluting Stent for Small Coronary Vessels: PICCOLETO-II 3-Year Follow-Up

BackgroundNative vessel coronary artery disease represents 1 of the most attractive fields of application for drug-coated balloons (DCBs). To date, several devices have been compared with drug-eluting stents (DESs) in this setting with different outcomes. ObjectivesThe authors sought to compare the short- and long-term performance of the paclitaxel DCB with the everolimus-eluting stent in patients with de novo lesions in small coronary vessel disease. MethodsPICCOLETO II (Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment) was an academic, international, investigator-driven, multicenter, open-label randomized clinical trial in which patients were allocated to a DCB (n = 118) or DES (n = 114). We previously reported the superiority of DCBs regarding in-lesion late lumen loss at 6 months. Herein we report the final 3-year clinical follow-up with the occurrence of major adverse cardiac events (MACEs), a composite of cardiac death, nonfatal myocardial infarction, target lesion revascularization, and its individual components. ResultsThe 3-year clinical follow-up (median 1,101 days; IQR: 1,055-1,146 days) was available for 102 patients allocated to DCB and 101 to DES treatment. The cumulative rate of all-cause death (4% vs 3.9%; P = 0.98), cardiac death (1% vs 1.9%; P = 0.56), myocardial infarction (6.9% vs 2%; P = 0.14), and target lesion revascularization (14.8% vs 8.8%; P = 0.18) did not significantly differ between DCBs and DESs. MACEs and acute vessel occlusion occurred more frequently in the DES group (20.8% vs 10.8% [P = 0.046] and 4% vs 0% [P = 0.042], respectively). ConclusionsThe long-term clinical follow-up of the PICCOLETO II randomized clinical trial shows a higher risk of MACEs in patients with de novo lesions in small vessel disease when they are treated with the current-generation DES compared with the new-generation paclitaxel DCB. (Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment [PICCOLETO II]; NCT03899818)

Prevalence, incidence and clinical outcomes of epicardial coronary artery disease among transthyretin amyloidosis cardiomyopathy patients

BackgroundTransthyretin amyloidosis cardiomyopathy (ATTR-CM) patients are often older and may be at risk for obstructive epicardial coronary artery disease (oeCAD). While ATTR-CM may cause small vessel coronary disease, the prevalence and clinical significance of oeCAD is not well described.Methods and resultsThe prevalence and incidence of oeCAD and its association with all-cause mortality and hospitalization among 133 ATTR-CM patients with ≥ 1-year follow-up was evaluated. The mean age was 78 ± 9 years, 119 (89%) were male, 116 (87%) had wild-type and 17 (13%) had hereditary subtypes. Seventy-two (54%) patients underwent oeCAD investigations, with 30 (42%) receiving a positive diagnosis. Among patients with a positive oeCAD diagnosis, 23 (77%) were diagnosed prior to ATTR-CM diagnosis, 6 (20%) at the time of ATTR-CM diagnosis, and 1 (3%) after ATTR-CM diagnosis. Baseline characteristics between patients with and without oeCAD were similar. Among patients with oeCAD, only 2 (7%) required additional investigations, intervention or hospitalization after ATTR-CM diagnosis. After a median follow-up of 27 months there were 37 (28%) deaths in the study population, including 5 patients with oeCAD (17%). Fifty-six (42%) patients in the study population required hospitalization, including 10 patients with oeCAD (33%). There was no significant difference in the rates of death or hospitalization among ATTR-CM patients with and without oeCAD, and oeCAD was not significantly associated with either outcome by univariable regression analysis.ConclusionsWhile oeCAD is prevalent in ATTR-CM patients, this diagnosis is frequently known at time of ATTR-CM diagnosis and characteristics are similar to patients without oeCAD.

Will the TRANSFORM II trial transform our management of small vessel coronary disease?

Percutaneous coronary interventions (PCI) in small vessels and long lesions are associated with poor outcomes. Drug eluting balloons (DEB) are an acceptable alternative to drug eluting stents (DES) in countries where DEB are commercially available, however there are limited data on sirolimus eluting balloons (SES) for small vessel coronary lesions and no randomized trials. The TRANSFORM II trial will randomize 1325 patients with small vessels (2-3 mm diameter) to receive SEB versus everolimus eluting stents to determine 1 year outcomes. The authors declare no conflict of interests.

Small Coronary Vessel Size: A Great Need for a Standardized Definition

Small Coronary Vessel Size: A Great Need for a Standardized Definition

Biolimus-Coated Balloon in Small-Vessel Coronary Artery Disease: The BIO-RISE CHINA Study.

Drug-coated balloons are a safe and effective option for patients undergoing percutaneous coronary intervention, but prior randomized studies have exclusively used paclitaxel-coated devices. The aim of this study was to assess for the first time the safety and efficacy of a novel biolimus-coated balloon (BCB) in patients with small-vessel coronary disease. In a prospective trial conducted at 10 centers in China, 212 patients with small-vessel native coronary disease (reference vessel diameter 2.0-2.75mm, lesion length≤25mm) were randomized to receive a BCB or an uncoated balloon. The primary endpoint was in-segment late lumen loss at 9months. In the per-protocol population, angiographic late lumen loss at 9months was 0.16 ± 0.29mm in the BCB group vs 0.30 ± 0.35mm with the plain balloon (P=0.001). Late luminal enlargement (positive remodeling) occurred in 29.7% of patients in the BCB group vs 9.8% of patients with plain balloons (P=0.007). In the full analysis set population, after 12months, target lesion failure rates were 6.7% in the BCB group vs 13.9% with the plain balloon (HR: 0.47; 95%CI: 0.19-1.16), and rates of the patient-oriented clinical outcome were 14.3% with the BCB vs 21.8% with the plain balloon (HR: 0.64; 95%CI: 0.33-1.24). In this first-in-human study, a novel BCB showed superior efficacy to plain balloon angioplasty in patients with small-vessel coronary disease undergoing percutaneous coronary intervention. Positive vascular remodeling was more frequent, and there was a trend toward improved clinical outcomes. (A Randomized Trial of a Biolimus-Coated Balloon Versus POBA in Small Vessel Coronary Artery Disease [Brave]; NCT03769623).

Clinical Application of Drug-coated Balloon in Coronary Small Vessel Disease and Stent Restenosis

Clinical Application of Drug-coated Balloon in Coronary Small Vessel Disease and Stent Restenosis

Heart Disease in Women

All women face the threat of heart disease. Knowing the symptoms and risks unique to women, as well as eating a hearthealthy diet and exercising, can help protect you. Heart disease is often thought to be more of a problem for men. However, it’s the most common cause of death for both women and men in the United States. Because some heart disease symptoms in women can differ f Heart attack symptoms for women. The most common heart attack symptom in women is the same as in men some type of chest pain, pressure or discomfort that lasts more than a few minutes or comes and goes. But chest pain is not always severe or even the most noticeable symptom, particularly in women. Women often describe it as pressure or tightness. And, it’s possible to have a heart attack without chest pain. Women are more likely than men to have heart attack symptoms unrelated to chest pain, such as: Neck, jaw, shoulder, upper back or abdominal discomfort, Shortness of breath, Pain in one or both arms, Nausea or vomiting, Sweating, Lightheadedness or dizziness, unusual fatigue, Indigestion. These symptoms may be vague and not as noticeable as the crushing chest pain often associated with heart attacks. This might be because women tend to have blockages not only in their main arteries but also in the smaller ones that supply blood to the heart-a condition called small vessel heart disease or coronary microvascular disease. Women tend to have symptoms more often when resting, or even when asleep, than they do in men. Emotional stress can play a role in triggering heart attack symptoms in women. Because women don’t always recognize their symptoms as those of a heart attack, they tend to show up in emergency rooms after heart damage has occurred. Also, because their symptoms often differ from men’s, women might be diagnosed less often with heart disease than men are. If you have symptoms of a heart attack or think you’re having one, call for emergency medical help immediately. Don’t drive yourself to the emergency room unless you have no other options. Rom those in men, women often don’t know what to look for

Impact of diabetes on outcome with drug-coated balloons versus drug-eluting stents: the BASKET-SMALL 2 trial

Abstract Objectives To evaluate the impact of diabetes mellitus on 3 year clinical outcome in patients undergoing drug-coated balloon (DCB) or drug-eluting stent (DES) treatment for de-novo lesions. Background For the treatment of de-novo coronary small vessel disease DCB are non-inferior to DES regarding clinical outcome up to 3 years. Methods In this prespecified analysis of a multicenter, randomized, non-inferiority trial, including 758 patients with de-novo lesions in coronary vessels &amp;lt;3mm who were randomized 1:1 to DCB (n=382) or DES (n=376) and followed over 3 years for major adverse cardiac events (MACE: cardiac death, non-fatal myocardial infarction [MI], and target-vessel revascularization [TVR]), outcome was analyzed regarding the presence or absence of diabetes mellitus. Results In non-diabetic patients (n=506) rates of MACE (13.0% vs. 11.5%, hazard ratio [HR] 1.24, 95% confidence interval [CI] 0.73–2.09, p=0.43), cardiac death (2.8% vs. 2.9%, HR 0.97, 95% CI 0.32–2.92, p=0.96), non-fatal MI (5.1% vs. 4.8%, HR 1.00, 95% CI 0.44–2.28, p=0.99), and TVR (8.8% vs. 6.1%, HR 1.64, 95% CI 0.83–3.25, p=0.16) were similar in DCB and DES. In diabetic patients (n=252) rates of MACE (19.3% vs. 22.2%, HR 0.82, 95% CI 0.45–1.48, p=0.51), cardiac death (8.8% vs. 5.9%, HR 2.01, 95% CI 0.76–5.31, p=0.16), non-fatal MI (7.1% vs. 9.8%, HR 0.55, 95% CI 0.21–1.49, p=0.24) were similar in DCB and DES, whereas TVR was significantly lower with DCB compared to DES (9.1% vs. 15.0%, HR 0.40, 95% CI 0.17–0.94, p=0.036). In addition, need for TVR was highest in diabetic patients treated with DES (Picture 1). Conclusions The rates of MACE are similar in DCB and DES in de-novo coronary lesions of diabetic and non-diabetic patients. In diabetic patients the need for TVR was significantly lower with DCB compared to DES. Funding Acknowledgement Type of funding sources: Foundation. Main funding source(s): Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung, Basel Cardiovascular Research Foundation, and B Braun Medical AG. Picture 1

Long-Term Efficacy and Safety of Drug-Eluting Stent Versus Drug-Coated Balloon for De Novo Lesions in Small-Vessel Coronary Disease: A Systematic Review and Meta-Analysis

Long-Term Efficacy and Safety of Drug-Eluting Stent Versus Drug-Coated Balloon for De Novo Lesions in Small-Vessel Coronary Disease: A Systematic Review and Meta-Analysis

Predictors of Favorable Angiographic Outcomes After Drug-Coated Balloon Use for de novo Small Vessel Coronary Disease (DCB-ONLY).

We evaluated the angiographic parameter and clinical outcomes of drug-coated balloon (DCB) to assess the optimal angiographic criteria in de novo small vessel disease (SVD). Patients (n = 424, mean age: 64.4 ± 11.2 years, men: 69.8%) at 20 sites in Korea were prospectively enrolled. The primary end point was late luminal loss (LLL) at 9-month follow-up angiography. Secondary end points included restenosis rates, target lesion failure (TLF), and DCB-related thrombosis during the 12-month follow-up period. We included 403 patients for analysis excluding 21 patients who required bailout stenting. Baseline mean reference vessel .diameter was 2.52 ± 0.39 mm and mean minimal luminal diameter (MLD) was 0.71 ± 0.40 mm. The mean MLD was 1.54 ± 0.37 mm after DCB. Late luminal loss was -0.01 ± 0.43 mm and restenosis was noted in 26 patients (12.2%). Minimal luminal diameter >1.6 mm and %diameter stenosis (DS) <45% after DCB was associated maintenance of MLD without LLL at 9-months. Multivariate analysis demonstrated that %DS at baseline and post-MLD was associated with the restenosis. During 12-month follow-up, TLF was 2.6% including 1 cardiac death, 1 myocardial infarction, and 10 ischemia-driven target lesion revascularizations. Drug-coated balloon showed a low restenosis and lower LLL despite high in-segment DS. Post-MLD and % DS may be helpful to get optimal results in de novo SVD after DCB.

A Non-inferiority, Randomized Clinical Trial Comparing Paclitaxel-Coated Balloon Versus New-Generation Drug-Eluting Stents on Angiographic Outcomes for Coronary De Novo Lesions

BackgroundDrug-coated balloon (DCB) has been proved efficacy for coronary small vessel disease, but data regarding outcomes of DCB in common de novo lesions (including reference vessel diameter more than 3.0mm) compared with new-generation drug-eluting stent (DES) are lacking. We hypothesized that a DCB-only strategy for coronary de novo lesions would be non-inferior to DES treatment on angiographic outcomes.MethodsIn this randomized controlled trial, we compared the effect of DCB with DES on late lumen loss (LLL) at 9-month angiographic follow-up and 12-month major adverse cardiac events (MACEs), including death, non-fatal myocardial infarction, target lesion revascularization (TLR), and target vessel revascularization (TVR).ResultsFrom July 2017 to July 2018, 288 consecutive patients with reference vessel diameter (RVD) between 2.25 and 4.0mm were screened. After proper pre-dilation, 170 patients were enrolled and randomized to the DCB and the DES groups at 1:1 ratio. Seven patients withdrew the consent forms during hospital stay (1 in DCB group, 6 in DES group). Two patients in DCB group underwent bailout stenting due to severe dissection after DCB release. The primary endpoint of 9-month LLL was −0.19±0.49mm with the DCB versus 0.03±0.64mm with the DES. The one-sided 97.5% upper confidence limit of the difference was −0.04mm, achieving non-inferiority of the DCB compared with the DES (P=0.019). The 12-month cumulative MACE rate was similar in the DCB and DES groups (2.44% vs. 6.33%, P=0.226).ConclusionsIn this prospective study, the DCB only strategy for de novo lesion was non-inferior to the new-generation DES in terms of 9-month late lumen loss.

Drug‑coated balloons in the treatment of acute myocardial infarction (Review)

Drug-eluting stents are the standard revascularization strategy for the treatment of symptomatic coronary artery disease. However, in-stent restenosis (ISR), stent thrombosis and reinfarction of target lesions following stent implantation present challenges. Drug-coated balloons (DCBs), which deliver antiproliferative drugs into the vessel wall without stent implantation, are a novel treatment option for percutaneous coronary intervention and have been proven to act as a promising strategy in the treatment of ISR and coronary small vessel disease. However, their role in acute myocardial infarction (AMI) remains unclear. The present review discusses current evidence for the treatment of AMI with DCBs.

Drug-Coated Balloon Versus Drug-Eluting Stent for Small Coronary Vessel Disease: PICCOLETO II Randomized Clinical Trial.

This study sought to compare the performance of a novel drug-coated balloon (DCB) (Elutax SV, Aachen Resonance, Germany), with an everolimus-eluting stent (EES) (Abbott Vascular, Santa Clara, California) in patients with de novo lesions. Small vessel coronary artery disease (SVD) represents one of the most attractive fields of application for DCB. To date, several devices have been compared with drug-eluting stents in this setting, with different outcomes. The PICCOLETO II (Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment) trial was an international, investigator-driven, multicenter, open-label, prospective randomized controlled trial where patients with de novo SVD lesions were randomized to DCB or EES. Primary study endpoint was in-lesion late lumen loss (LLL) at 6months (independent core laboratory), with the noninferiority between the 2 arms hypothesized. Secondary endpoints were minimal lumen diameter, percent diameter stenosis at angiographic follow-up, and the occurrence of major adverse cardiac events at 12months. Between May 2015 and May 2018, a total of 232 patients were enrolled at 5 centers. After a median of 189 (interquartile range: 160 to 202) days, in-lesion LLL was significantly lower in the DCB group (0.04 vs. 0.17mm; p=0.001 for noninferiority; p=0.03 for superiority). Percent diameter stenosis and minimal lumen diameter were not significantly different. At 12-month clinical follow-up, major adverse cardiac events occurred in 7.5% of the DES group and in 5.6% of the DCB group (p=0.55). There was a numerically higher incidence of spontaneous myocardial infarction (4.7% vs. 1.9%; p=0.23) and vessel thrombosis (1.8% vs. 0%; p=0.15) in the DES arm. In this multicenter randomized clinical trial in patients with de novo SVD lesions, a new-generationDCBwas found superior to EES in terms of LLL as the angiographic pattern and comparable in terms of clinicaloutcome.(DrugEluting Balloon Efficacy for Small Coronary Vessel Disease Treatment [PICCOLETO II]; NCT03899818).

Long-term efficacy and safety of drug-coated balloons versus drug-eluting stents for small coronary artery disease (BASKET-SMALL 2): 3-year follow-up of a randomised, non-inferiority trial

In the treatment of de-novo coronary small vessel disease, drug-coated balloons (DCBs) are non-inferior to drug-eluting stents (DESs) regarding clinical outcome up to 12 months, but data beyond 1 year is sparse. We aimed to test the long-term efficacy and safety of DCBs regarding clinical endpoints in an all-comer population undergoing percutaneous coronary intervention. In this prespecified long-term follow-up of a multicentre, randomised, open-label, non-inferiority trial, patients from 14 clinical sites in Germany, Switzerland, and Austria with de-novo lesions in coronary vessels <3 mm and an indication for percutaneous coronary intervention were randomly assigned 1:1 to DCB or second-generation DES and followed over 3 years for major adverse cardiac events (ie, cardiac death, non-fatal myocardial infarction, and target-vessel revascularisation [TVR]), all-cause death, probable or definite stent thrombosis, and major bleeding (Bleeding Academic Research Consortium bleeding type 3-5). Analyses were performed on the full analysis set according to the modified intention-to-treat principle. Dual antiplatelet therapy was recommended for 1 month after DCB and 6 months after DES with stable symptoms, but 12 months with acute coronary syndromes. The study is registered with ClinicalTrials.gov, NCT01574534 and is ongoing. Between April 10, 2012, and Feb 1, 2017, of 883 patients assessed, 758 (86%) patients were randomly assigned to the DCB group (n=382) or the DES group (n=376). The Kaplan-Meier estimate of the rate of major adverse cardiac events was 15% in both the DCB and DES groups (hazard ratio [HR] 0·99, 95% CI 0·68-1·45; p=0·95). The two groups were also very similar concerning the single components of adverse cardiac events: cardiac death (Kaplan-Meier estimate 5% vs 4%, HR 1·29, 95% CI 0·63-2·66; p=0·49), non-fatal myocardial infarction (both Kaplan-Meier estimate 6%, HR 0·82, 95% CI 0·45-1·51; p=0·52), and TVR (both Kaplan-Meier estimate 9%, HR 0·95, 95% CI 0·58-1·56; p=0·83). Rates of all-cause death were very similar in DCB versus DES patients (both Kaplan-Meier estimate 8%, HR 1·05, 95% CI 0·62-1·77; p=0·87). Rates of probable or definite stent thrombosis (Kaplan-Meier estimate 1% vs 2%; HR 0·33, 95% CI 0·07-1·64; p=0·18) and major bleeding (Kaplan-Meier estimate 2% vs 4%, HR 0·43, 95% CI 0·17-1·13; p=0·088) were numerically lower in DCB versus DES, however without reaching significance. There is maintained efficacy and safety of DCB versus DES in the treatment of de-novo coronary small vessel disease up to 3 years. Swiss National Science Foundation, Basel Cardiovascular Research Foundation, and B Braun Medical.

TCT CONNECT-246 Drug Coated Balloon (DCB)-Only Angioplasty in De Novo Large Vessel vs. Small Vessel Coronary Disease

TCT CONNECT-246 Drug Coated Balloon (DCB)-Only Angioplasty in De Novo Large Vessel vs. Small Vessel Coronary Disease

1-Year Outcomes with COMBO Stents in Small-Vessel Coronary Disease: Subgroup Analysis From the COMBO Collaboration

BackgroundSmall vessel diameter is associated with higher risk of target lesion revascularization (TLR) after percutaneous coronary intervention (PCI). The COMBO sirolimus-eluting biodegradable-polymer stent has a proprietary anti-CD34 antibody layer to enhance homogeneous endothelialization, which may be advantageous in treating small vessels. ObjectiveWe examined for differences in 1-year clinical outcomes after PCI by maximum implanted stent diameter from the COMBO collaboration. MethodsThe COMBO collaboration (n = 3614) is a patient-level pooled dataset of patients undergoing PCI with COMBO stents in the MASCOT and REMEDEE multicenter registries. Stent diameter was available in 3590 (99.3%) patients. We compared patients receiving COMBO stents <3 mm versus ≥3 mm. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, target vessel-myocardial infarction (TV-MI) or clinically driven TLR. Secondary outcomes included stent thrombosis (ST). Adjusted outcomes were assessed using Cox regression methods. ResultsThe study included 792 (22%) patients with small stents <3 mm and 2798 (78%) patients with large stents ≥3 mm. Small stent patients included more women with lower body mass index and higher prevalence of diabetes but similar prevalence of acute coronary syndrome. Risk of 1-year TLF was similar in small and large stent groups (4.4% vs. 3.8%, HR 1.12, 95% CI 0.74–1.72, p = 0.58). There were no differences in the rates of cardiac death (1.7% vs. 1.5%, p = 0.74), TV-MI (1.4% vs. 1.2%, p = 0.58) or TLR (2.7% vs. 2.1%, p = 0.31). Definite or probable ST occurred in 1.3% of the small stent and 0.7% of the large stent PCI patients, p = 0.14, HR 2.13, 95% CI 0.93–5.00, p = 0.07. ConclusionsOne-year ischemic outcomes after COMBO PCI were similar irrespective of stent diameter in this all-comers international cohort.