Current-generation Drug-eluting Stents Research Articles

Optical frequency domain imaging-guided versus intravascular ultrasound-guided percutaneous coronary intervention for acute coronary syndromes: the OPINION ACS randomised trial.

The clinical benefits of optical frequency domain imaging (OFDI)-guided percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) remain unclear. We sought to compare intravascular ultrasound (IVUS)- and OFDI-guided PCI in patients with ACS. OPINION ACS is a multicentre, prospective, randomised, non-inferiority trial that compared OFDI-guided PCI with IVUS-guided PCI using current-generation drug-eluting stents in ACS patients (n=158). The primary endpoint was in-stent minimum lumen area (MLA), assessed using 8-month follow-up OFDI. Patients presented with ST-segment elevation myocardial infarction (55%), non-ST-segment elevation myocardial infarction (29%), or unstable angina pectoris (16%). PCI procedural success was achieved in all patients, with comparably low periprocedural complications rates in both groups. Immediately after PCI, the minimum stent area (p=0.096) tended to be smaller for OFDI versus IVUS guidance. Proximal stent edge dissection (p=0.012) and irregular protrusion (p=0.03) were significantly less frequent in OFDI-guided procedures than in IVUS-guided procedures. Post-PCI coronary flow, assessed using corrected Thrombolysis in Myocardial Infarction frame counts, was significantly better in the OFDI-guided group than in the IVUS-guided group (p<0.001). The least squares mean (95% confidence interval [CI]) in-stent MLA at 8 months was 4.91 (95% CI: 4.53-5.30) mm2 and 4.76 (95% CI: 4.35-5.17) mm2 in the OFDI- and IVUS-guided groups, respectively, demonstrating the non-inferiority of OFDI guidance (pnon-inferiority<0.001). The average neointima area tended to be smaller in the OFDI-guided group. The frequency of major adverse cardiac events was similar. Among ACS patients, OFDI-guided PCI and IVUS-guided PCI were equally safe and feasible, with comparable in-stent MLA at 8 months. OFDI guidance may be a potential option in ACS patients. This study was registered in the Japan Registry of Clinical Trials (jrct.niph.go.jp: jRCTs052190093).

Percutaneous coronary intervention for unprotected left main distal bifurcation lesions in elderly people.

In the elderly people with unprotected left main distal bifurcation lesions (ULMD), percutaneous coronary intervention (PCI) is often selected as first choice treatment strategy because of perioperative high risk of coronary artery bypass graft surgery due to their large number of comorbidities. Also, some recent papers reported that geriatric nutritional risk index (GNRI) is also strongly associated with clinical outcomes after interventional procedures in elderly patients. We assessed clinical outcomes after PCI for ULMD and the impact of GNRI in elderly patients. We identified 669 non dialysis patients treated with current generation drug-eluting stent for ULMD from MITO registry. We divided the patients to the following 2 groups; elderly group (n = 240, age ≥75) and young group (n = 429, age <75). Additionally, we could calculate GNRI and divided elderly group into 2 group based on the median value of the GNRI. The primary endpoint was all-cause mortality. All-cause mortality was significantly higher in elderly group [adjusted hazard ratio (HR) 2.37; 95% confidence interval (CI), 1.40-4.02; p = 0.001]. All-cause mortality was significantly higher in low GNRI elderly group compared to other 2 groups (Adjusted HR of elderly with low GNRI: 3.56, 95%CI (1.77-7.14), p < 0.001). Cardiovascular mortality was comparable between two groups. TLR rate was significantly lower in elderly group (adjusted HR 0.57; 95% CI, 0.34-0.97; p = 0.035). The elderly had higher all-cause mortality after PCI for ULMD compared to young people. Especially, the elderly with low GNRI were extremely associated with poorer outcomes.

Thrombogenicity of biodegradable metals

Biodegradable metals offer a promising means to ameliorate many of the long-term risks associated with vascular devices made of conventional biostable stent metals. While numerous biodegradable metal alloys have been developed and characterized in animal models, knowledge of their blood reactivity and thrombogenicity remains unknown. Metal hemocompatibility is particularly valuable because current generation drug-eluting stents pose a significant long-term thrombosis risk. In this study, four pure metals, widely used as degradable base materials (Fe, Zn, Mg, and Mo), and three alloys commonly used in cardiovascular devices [NiTi, CoCr, and stainless steel (SS)] were evaluated. This work examined how each of these metals activate platelets, coagulation factors, and inflammation using in vitro hemocompatibility assays and a clinically relevant ex vivo non-human primate arteriovenous shunt model. Testing found that while all metals promoted a downstream activation of platelets and coagulation in flowing whole blood, platelet and fibrin attachment to Mg was markedly reduced. Additionally, Fe and Mo trended toward higher platelet attachment and contact pathway activation. Overall, the results suggest that Mg may delay clot initiation, but not eliminate clot formation, indicating the importance of understanding thrombosis in Mg alloys that are currently being developed for clinical use as biodegradable stents.

Ultrathin Polymeric Platform for Drug-Eluting Stent: A proof of concept

Recent innovations in Drug-Eluting Stents (DES) technology have led to the development of new stents with further reduction in strut width, the ultrathin DES, with struts thinner than 70 µm. Ultrathin DES may further improve the efficacy and safety profile of Percutaneous Coronary Intervention (PCI) by reducing the risk of target-lesion and target-vessel failures compared to the current-generation DES. However, the ultrathin DES metallic platform still presents some associated problems, such as biofilm formation, infection, and migration, all related to the cellular response.The present work aims to produce an ultrathin permanent polymeric platform for a new generation of polymeric drug-eluting stents (PDES). In this work, the cellular response was compared with the traditional stainless steel (SS316L) and polycaprolactone (PCL) to determine whether these polymers could address this challenge. An innovative method of tubular 3D micro stereolithography tubular (ST3DT) was used. Different PDES platforms were fabricated with different polymeric materials (based on polyurethane and urethane dimethacrylate). Subsequently, HFL1 fibroblasts were seeded on the PDES, PCL and SS316L for 3 days. The findings from the assays of cell biocompatibility and proliferation (75%PCL), coupled with the successful fabrication of stent struts below 70 µm using the Surgical Guide resin and the ST3DT method, suggest that resin is a promising candidate for a PDES.

Computational modeling of in-stent restenosis: Pharmacokinetic and pharmacodynamic evaluation

Persistence of the pathology of in-stent restenosis even with the advent of drug-eluting stents warrants the development of highly resolved in silico models. These computational models assist in gaining insights into the transient biochemical and cellular mechanisms involved and thereby optimize the stent implantation parameters. Within this work, an already established fully-coupled Lagrangian finite element framework for modeling the restenotic growth is enhanced with the incorporation of endothelium-mediated effects and pharmacological influences of rapamycin-based drugs embedded in the polymeric layers of the current generation drug-eluting stents. The continuum mechanical description of growth is further justified in the context of thermodynamic consistency. Qualitative inferences are drawn from the model developed herein regarding the efficacy of the level of drug embedment within the struts as well as the release profiles adopted. The framework is then intended to serve as a tool for clinicians to tune the interventional procedures patient-specifically.

Natural History and Clinical Outcomes After ST-Segment Elevation Myocardial Infarction Without Stent Insertion

After restoration of coronary perfusion in patients presenting with ST-segment elevation myocardial infarction (STEMI), discrete severe stenotic coronary lesions are not always apparent. There remains ambiguity whether drug-eluting stent (DES) insertion or initial medical management is best practice. Assess short-term clinical outcomes in patients presenting with STEMI without initial stent insertion. Patients who underwent percutaneous coronary intervention for STEMI between 2014 and 2020 were prospectively enrolled and assessed for inclusion. Patients presenting with in-stent restenosis or stent thrombosis, or who did not survive to hospital discharge were excluded. Of 13,871 patients presenting, 456 (3.3%) were treated without initial stenting. These patients were older than those treated with DES (66.1 ± 13.6 vs 62.3 ± 12.4years, p <0.001) and had higher rates of diabetes (23.5% vs 16.0%, p <0.001) and previous revascularization with either percutaneous coronary intervention (14.0% vs 7.3%, p <0.001) or coronary artery bypass graft (3.5% vs 1.8%, p = 0.008). Thirty-day mortality rate was elevated in patients treated without stenting compared with the rate in those receiving DES (4.2% vs 0.9%, p <0.001), as were rates of myocardial infarction (1.3% vs 0.5%, p = 0.026) and major adverse cardiac events (10.5% vs 2.4%, p <0.001). After propensity matching, a trend toward increased mortality remained (4.2% vs 2.0%, p = 0.055). In conclusion, a no-stenting initial strategy, compared with DES insertion, is associated with increased 30-day mortality in those presenting with STEMI without severe stenosis. These data suggest when appropriate, current-generation DES insertion should be undertaken.

Impact of Stent Expansion Index on Stent Failure After Left Main Stenting

Impact of the stent expansion index (EXPI) in percutaneous coronary intervention (PCI) for unprotected left main distal bifurcation lesions (ULMD) has been not completely understood especially in current-generation drug-eluting stent (cDES) era. We evaluated the impact of EXPI on clinical outcomes after PCI with cDES for ULMD. We identified 342 patients treated with cDES for ULMD and postintervention intravascular ultrasound between January 2010 and December 2019. In this study, the ratio of minimum stent area (MSA) to reference vessel area at the MSA site was adopted to assess the stent expansion. We defined the patients with the first and second tertile as low-intermediate EXPI group and those with the third tertile as high EXPI group and compared the clinical outcomes between both groups. The primary end point was target lesion failure (TLF). TLF was defined as a composite of cardiac death, target lesion revascularization (TLR) ,and myocardial infarction. The MSA was located in the ostium of left anterior descending coronary artery in most cases (318 of 342 patients; 93.0%). There were no significant differences between both groups in the baseline clinical, lesion, and procedural characteristics. The high EXPI group had lower TLF rate than the low-intermediate EXPI group (10.2% vs 19.9%, log-rank p=0.033). In conclusion, this is the first report that the higher ratio of MSA to reference vessel area at the MSA site, which was defined as stent EXPI, was associated with more favorable clinical outcomes after PCI for ULMD.

Treatment of Ostial Right Coronary Artery Narrowings: Outcomes From the Multicenter Prospective e-ULTIMASTER Registry.

Treatment of right coronary artery (RCA) aorto-ostial (AO) lesions with bare-metal stents and first-generation drug-eluting stents (DES) was associated with worse outcomes. This study aimed to assess the effect of RCA-AO stenting with current-generation DES on the clinical outcome. The large all-comer, multicontinental e-ULTIMASTER registry included 37,198 patients of whom 4775 underwent ostial and proximal RCA percutaneous coronary intervention (PCI) using the Ultimaster stent (Terumo). The primary clinical end point was 1-year target lesion failure (TLF), a composite of cardiac death; target vessel-related myocardial infarction; or clinically indicated target lesion revascularization. We compared 591 (12.4%) patients who underwent RCA-AO PCI with 4184 (87.6%) patients who underwent proximal RCA PCI. The RCA-AO group included more men and recorded significantly more comorbidities and more complex coronary anatomy. After propensity matching, the primary end point TLF occurred in 4.49% of the RCA-AO group compared with 3.00% of the proximal RCA group (P = .06). Target vessel revascularization (3.29% vs 1.90%; P = .03) and stent thrombosis (1.23% vs 0.42%, P = .01) were significantly higher among patients with RCA-AO lesions than those among patients with proximal RCA lesions. All-cause mortality was similar between the groups (2.97% vs 2.26%; P = .30). The treatment of RCA-AO with DES is feasible, with similar rates of TLF but with an increased risk of target vessel revascularization and stent thrombosis.

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)

Impact of triglyceride-rich lipoproteins on early in-stent neoatherosclerosis formation in patients undergoing statin treatment

Neoatherosclerosis (NA), which refers to neointimal atherosclerosis within a stent, is considered one of the underlying causes of late-phase stent failure following a newer generation drug-eluting stent (DES) placement procedure. Even contemporary guideline-directed medical therapy may be insufficient to prevent NA. This study aimed to investigate how intricately lipid markers are associated with NA formation in the early phase of treatment with well-maintained low-density lipoprotein cholesterol (LDL-C) levels. We enrolled 114 consecutive patients undergoing statin treatment and percutaneous coronary intervention (PCI) with current-generation DES for coronary artery disease. At a median 12 months after PCI, optical coherence tomography (OCT) was performed. Various lipid markers, including LDL-C, triglyceride (TG), triglyceride-rich lipoprotein cholesterol (TRL-C), non-high-density lipoprotein cholesterol (non-HDL-C), malondialdehyde-modified LDL (MDA-LDL), and several apolipoproteins, were also evaluated. NA was observed in 17 (14.9%) patients. The LDL-C level was equivalent in patients with or without NA (77.2 vs. 69.8 mg/dL; p=0.15). However, the levels of TG, apolipoprotein C3 (apoC3), TRL-C, non-HDL-C, and apolipoprotein B (apoB), and MDA-LDL were significantly higher in the patients with NA. Furthermore, multivariate logistic regression adjusting for HbA1c and stent duration revealed apoC3, TRL-C, non-HDL-C, apoB, and MDA-LDL levels as risk factors for NA. However, when apoB was included as a covariate, other factors became nonsignificant. Abnormal triglyceride-rich lipoprotein metabolism and high atherogenic apoB-containing lipoprotein particle numbers are associated with the formation of NA in patients undergoing statin treatment at a median 12 months post-PCI.

The impact of chronic kidney disease severity on clinical outcomes after current generation drug-eluting stent implantation for left main distal bifurcation lesions: the Milan and New-Tokyo registry

Objectives. The impact of chronic kidney disease (CKD) on clinical outcomes after percutaneous coronary intervention (PCI) for unprotected left main distal bifurcation lesions (ULMD) is not fully understood in current generation drug eluting stent (cDES) era. We assessed clinical outcomes after PCI using cDES for ULMD according to CKD severity based on estimated glomerular filtration rate (eGFR). Design. We identified 720 consecutive patients who underwent PCI using cDES for ULMD at three high volume centers between January 2005 and December 2015. We divided those patients to the following five groups according to eGFR. Each group was defined as follows: no CKD (60 mL/min/1.73 m2 ≤ eGFR), mild CKD (45 ≤ eGFR < 60 mL/min/1.73 m2), moderate CKD (30 ≤ eGFR < 45 mL/min/1.73 m2), severe CKD (15 ≤ eGFR < 30 mL/min/1.73 m2) and hemodialysis (HD). The primary endpoint was target lesion failure (TLF) at 3 years. TLF was defined as a composite of cardiac death, target lesion revascularization (TLR) and myocardial infarction (MI). Results. TLF occurred more frequently in severe CKD and HD group compared with other three groups. Conclusions. The patients who have severe CKD or are on HD, were extremely associated with worse clinical outcomes after PCI for ULMD even with cDES.

Short-term dual antiplatelet therapy for 1-3 months after percutaneous coronary intervention using drug eluting stents: A systematic review and meta-analysis of randomized clinical trials.

The optimal dual antiplatelet therapy (DAPT) duration and regimen in patients undergoing percutaneous coronary intervention (PCI) using current generation drug eluting stents (DES) is still unclear. To compare the safety and efficacy of short-term DAPT (S-DAPT) with longer duration DAPT (l-DAPT) after contemporary PCI. We searched for studies comparing S-DAPT (≤3 months) followed by single antiplatelet therapy (SAPT) with aspirin or a P2Y12 inhibitor against L-DAPT (6-12 months) after PCI with current generation DES. Primary end-points of interest were major bleeding and stent thrombosis (ST) at 1 year. Random-effects meta-analyses were performed to calculate odds ratios with 95% CIs. Eleven RCTs (n = 48,946) were included in the primary analysis. Major bleeding was significantly lower with S-DAPT (n = 24,424) (odd ratio [OR0.65; 95% confidence interval,CI0.52-0.80]) compared with L-DAPT (n = 24,486). There were no differences in ST between the two groups [OR 1.26; 95% CI 0.97-1.63]. There were no significant differences in risks of all-cause death, cardiovascular death or myocardial infarction between S-DAPT and L-DAPT groups. In a subgroup analysis, there was borderline significantly higher ST with 1 month S-DAPT [1.39; 1.0-1.92], but not with 3 months S-DAPT [1.07; 0.70-1.64], when compared to L-DAPT. Finally, there were no significant treatment interactions observed when trials using SAPT with aspirin were compared with those using P2Y12 inhibitor monotherapy. Among patients undergoing current generation DES implantation, S-DAPT for 1-3 months reduces major bleeding without an increase in ischemic events compared with L-DAPT. Three months S-DAPT might provide a better risk-benefit profile based on current analysis. Further study is needed to define the SAPT of choice after 1-3 months DAPT.

Prognostic Impact of Target Lesion Revascularization on Long-Term Cardiac Mortality After Current-Generation Drug-Eluting Stent Implantation for Left Main Distal Bifurcation: the Milan and New-Tokyo (MITO) Registry

BackgroundThere are scarce data about the incidence and impact on clinical outcomes of target lesion revascularization (TLR) after percutaneous coronary intervention (PCI) for unprotected left main distal bifurcation lesions (ULMD) in current generation drug eluting stent (cDES) era. ObjectivesWe evaluated the incidence and impact on clinical outcomes of TLR after PCI using cDES for ULMD. MethodsWe identified 720 patients treated with cDES for ULMD at New Tokyo Hospital (Matsudo, Japan), San Raffaele Scientific Institute and EMO-GVM Centro Cuore Columbus (Milan, Italy) between January 2005 and December 2015. We divided those patients in 2 groups; TLR group (n = 107), no TLR group (n = 613). The TLR group was comprised patients undergoing a repeat revascularization by PCI or coronary artery bypass grafting of the target lesion. Analysis using propensity score adjustment was also performed. The primary endpoint was cardiac mortality. Additionally, we analyzed the impact of TLR for each main branch (MB) or side branch on cardiac mortality using multivariate Cox regression analysis. ResultsCardiac mortality was significantly higher in TLR group than in no TLR group (adjusted HR 1.96; 95 % CI, 1.50–3.62; p = 0.032). Cardiac mortality was also significantly higher in TLR group after propensity score adjustment. TLR for MB was identified as an independent predictor of cardiac death on multivariate Cox regression analysis. ConclusionsThe TLR, especially the TLR for MB, after PCI even with cDES for ULMD, was strongly associated with worse cardiac mortality.

The vascular response to ultrathin biodegradable polymer sirolimus-eluting stent at 2-weeks and 1-year follow up in patients with ST-elevation myocardial infarction

Abstract Background Recent clinical study suggests newer-generation drug-eluting stents (DES) that combine ultrathin strut and nano-coating with biodegradable polymers sirolimus-eluting stent (BP-SES) could improve long-term clinical outcomes in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) over current generation DES. However, the details of vascular response in very early and chronic phase have not been systematically addressed. Objective and method We exploratory investigate early and chronic vascular response following BP-SES implantation in patients with STEMI to reveal mechanism of the favorable clinical outcomes in recent studies using frequency domain-optical coherence tomography (FD-OCT). Consecutive twenty-four patients with STEMI who underwent FD-OCT after primary PCI and were eligible for follow-up FD-OCT at 2 weeks and 1 year after implantation were enrolled between June 2018 and August 2020. OCT was performed immediately after PCI, at 2-weeks (2W) and 1-year (1Y) after the primary PCI. Struts were recorded as uncovered if any part was visibly exposed in the lumen or covered if a layer of tissue covered all reflecting surfaces. Struts of stents that are smaller than 3.0mm of diameter with more than 80μm between the center reflection and the adjacent vessel surface were recorded as malapposed. The reduction of atherothrombotic protrusion burden within the stent was also assessed. Results Twenty-four patients (age 64.9±11.4 years, male 83.3%) were enrolled. The percentage of uncovered struts significantly decreased from post-PCI to 2W follow-up and from 2W follow-up to 1Y follow-up (62±20% post-PCI versus 27±11% at 2W follow up, p&amp;lt;0.0001 and 2W follow-up versus 3.3±3.3% at 1Y follow up, p&amp;lt;0.0001). Malapposed struts also decreased from post-PCI to 2W follow-up (4.1±3.6% post-PCI versus 1.5±2.2% at 2W follow-up, p&amp;lt;0.0001), but no significant difference was shown between 2W follow-up and 1Y follow-up (2W follow-up versus 1.0±2.3 at 1Y follow up, p=0.12). The average protrusion area of athero-thrombotic burden decreased (0.57±0.32 at post-PCI versus 0.42±0.22 mm2 at 2W follow up, p&amp;lt;0.0001) and its volume showed similar tendency (16.6±10.7 at post-PCI versus 12.9±8.23 mm3 at 2W follow up, p=0.0011). Thrombus was shown in all patients at post-PCI, but two patients (8.0%) showed it at 1Y follow-up. Conclusion(s) This study elucidated very early and chronic vascular responses following ultrathin strut BP-SES implantation in STEMI patients by FD-OCT. It showed resolution of athero-thrombotic materials in very early phase and favorable progression of strut coverage in very early and chronic phase. Funding Acknowledgement Type of funding sources: None.

Use of intravascular ultrasound and long-term cardiac death or myocardial infarction in patients receiving current generation drug-eluting stents

Long-term follow-up data on differential effects of intravascular ultrasound (IVUS) according to lesion complexity are limited in patients undergoing percutaneous coronary intervention (PCI). The current study compared long-term clinical outcomes between IVUS-guided and angiography-guided PCI in patients with second-generation drug-eluting stents (DES). Between February 2008 and December 2015, 5488 patients undergoing PCI with second-generation DES were recruited from an institutional registry of Samsung Medical Center. The primary outcome was a composite of cardiac death or myocardial infarction (MI) during 46 months of median follow-up (interquartile range: 32–102 months). IVUS-guided PCI was performed in 979 patients (17.8%). IVUS-guided PCI was associated with a significantly lower risk of cardiac death or MI compared with angiography-guided PCI (5.7% vs. 12.9%, hazard ratio 0.408, 95% confidence interval 0.284–0.587, p < 0.001). Results were consistent after propensity score matching analysis with 801 matched pairs. In subgroup analysis, there was no significant interaction between lesion complexity (defined by complex procedures, Pinteraction = 0.819, ACC/AHA lesion classification, Pinteraction = 0.401 or SYNTAX score, Pinteraction = 0.149) and use of IVUS for risk of cardiac death or MI. IVUS-guided second-generation DES implantation was associated with a significantly lower long-term risk of cardiac death or MI compared with angiography guidance, regardless of lesion complexity.

Dual antiplatelet therapy duration after percutaneous coronary intervention using drug eluting stents in high bleeding risk patients: A systematic review and meta-analysis

BackgroundOptimal dual antiplatelet therapy (DAPT) duration in patients at high bleeding risk (HBR) is not fully defined. We aimed to compare the safety and effectiveness of short-term DAPT (S-DAPT) with longer duration DAPT (L-DAPT) after percutaneous coronary intervention (PCI) with drug eluting stents (DES) in patients at HBR. MethodsWe searched for studies comparing S-DAPT (≤3 months) followed by aspirin or P2Y 12 inhibitor monotherapy against L-DAPT (6-12 months) after PCI in HBR patients. Primary end points of interest were major bleeding and myocardial infarction (MI). Random-effects meta-analyses were performed to calculate odds ratios with 95% CIs. ResultsSix randomized trials and 3 propensity-matched studies (n = 16,848) were included in the primary analysis. Compared with L-DAPT (n = 8,422), major bleeding was lower with S-DAPT (n = 8,426) [OR 0.68; 95% CI 0.51-0.89] whereas MI did not differ significantly between the 2 groups [1.16; 0.94-1.44]. There were no significant differences in risks of death, stroke or stent thrombosis (ST) between S-DAPT and L-DAPT groups. These findings were consistent when propensity-matched studies were analysed separately. Finally, there was a numerically higher, albeit statistically non-significant, ST in the S-DAPT arm of patients without an indication for OAC [1.98; 0.86-4.58]. ConclusionsAmong HBR patients undergoing current generation DES implantation, S-DAPT reduces bleeding without an increased risk of death or MI compared with L-DAPT. More research is needed to (1) evaluate risks of late ST after 1 to 3 months DAPT among patients with high ischemic and bleeding risks, (2) defining the SAPT of choice after 1 to 3 months DAPT.

Quality of Life After Fractional Flow Reserve-Guided PCI Compared With Coronary Bypass Surgery.

Previous studies have shown that quality of life improves after coronary revascularization more so after coronary artery bypass grafting (CABG) than after percutaneous coronary intervention (PCI). This study aimed to evaluate the effect of fractional flow reserve guidance and current generation, zotarolimus drug-eluting stents on quality of life after PCI compared with CABG. The FAME 3 trial (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) is a multicenter, international trial including 1500 patients with 3-vessel coronary artery disease who were randomly assigned to either CABG or fractional flow reserve-guided PCI. Quality of life was measured using the European Quality of Life-5 Dimensions (EQ-5D) questionnaire at baseline and 1 and 12 months. The Canadian Cardiovascular Class angina grade and working status were assessed at the same time points and at 6 months. The primary objective was to compare EQ-5D summary index at 12 months. Secondary end points included angina grade and work status. The EQ-5D summary index at 12 months did not differ between the PCI and CABG groups (difference, 0.001 [95% CI, -0.016 to 0.017]; P=0.946). The trajectory of EQ-5D during the 12 months differed (P<0.001) between PCI and CABG: at 1 month, EQ-5D was 0.063 (95% CI, 0.047 to 0.079) higher in the PCI group. A similar trajectory was found for the EQ (EuroQol) visual analogue scale. The proportion of patients with Canadian Cardiovascular Class 2 or greater angina at 12 months was 6.2% versus 3.1% (odds ratio, 2.5 [95% CI, 0.96-6.8]), respectively, in the PCI group compared with the CABG group. A greater percentage of younger patients (<65 years old) were working at 12 months in the PCI group compared with the CABG group (68% versus 57%; odds ratio, 3.9 [95% CI, 1.7-8.8]). In the FAME 3 trial, quality of life after fractional flow reserve-guided PCI with current generation drug-eluting stents compared with CABG was similar at 1 year. The rate of significant angina was low in both groups and not significantly different. The trajectory of improvement in quality of life was significantly better after PCI, as was working status in those <65 years old. URL: https://www. gov; Unique identifier: NCT02100722.

Napkin ring formation in culotte stenting using current-generation drug-eluting stents in left main coronary artery bifurcation.

Napkin ring formation in culotte stenting using current-generation drug-eluting stents in left main coronary artery bifurcation.

Drug-Coated Balloon for Small Coronary Artery Disease in Patients With and Without High-Bleeding Risk in the BASKET-SMALL 2 Trial.

Patients at high-bleeding risk (HBR) undergoing percutaneous coronary intervention represent a challenging patient population. The use of drug-coated balloon (DCB) allows shorter duration of dual antiplatelet therapy compared with drug-eluting stents (DES) and reduces thrombotic risk due to the absence of a permanent implant. The present analysis aimed to investigate if the effect of DCB versus DES differed between patients with and without HBR treated with percutaneous coronary intervention in small coronary arteries. This prespecified subgroup analysis of a multicenter, randomized, noninferiority trial included 758 patients with de novo lesions in coronary vessels <3 mm and an indication for percutaneous coronary intervention, randomized to DCB (n=382) or second-generation DES (n=376). Patients were followed over 3 years for major adverse cardiac events. Of the 758 patients randomized, 155 (20%) had HBR; these patients had higher mortality at 3 years (hazard ratio [95% CI], 3.09 [1.78-5.36]; P<0.001). Rates of major bleeding events were overall low but tended to be lower after DCB versus DES (1.6% versus 3.7%; P=0.064), were similar in patients with HBR (4.5% versus 3.4%) but less frequent in DCB-versus DES-treated patients without HBR (0.9% versus 3.8%). There was no difference in major adverse cardiac events between DCB and DES regardless of bleeding risk (HBR, hazard ratio: 1.16 [0.51-2.62]; P=0.719 versus non-HBR, 0.96 [0.62-1.49]; P=0.863). DCBs were similarly safe and effective as current-generation DES in the treatment of coronary arteries <3 mm, regardless of bleeding risk. In patients treated with DCB, there was a trend towards a reduction of severe bleeding events at 3 years. URL: https://www. gov; Unique identifier: NCT01574534.

Science, Medicine, and the Anesthesiologist

Science, Medicine, and the Anesthesiologist