Variation in the frozen lesion size according to the non-occluded application duration and technique for cryoballoon ablation.

OBJECTIVE: The frozen lesion formation created by cryoballoon ablation, especially with non-occluded applications, has not been fully evaluated. This study aimed to validate the lesion size under different cryoballoon ablation settings: application duration, push-up technique, and laminar flow. METHODS: The frozen lesion size was evaluated immediately after ending the freezing with three different application durations (120, 150, and 180 seconds) in porcine hearts (N = 24). During the application, the push-up technique was applied at 10, 20, and 30 seconds after starting the freezing with or without laminar flow. RESULTS: The lesion size was significantly correlated with the nadir balloon temperature (P<0.001). The lesion volume became significantly larger after 150 seconds than 120 seconds (1272mm3 versus 1709mm3, P = 0.004), but not after 150 seconds (versus 1876mm3 at 180 seconds, P = 0.29) with a comparable nadir balloon temperature. Furthermore, the lesion volume became significantly larger with the push-up technique with the largest lesion size with a 20-second push-up after the freezing (1193mm3 without the push-up technique versus 1585mm3 with a push-up at 10 seconds versus 1808mm3 with a push-up at 20 seconds versus 1714mm3 with a push-up at 30 seconds, P = 0.04). Further, the absence of laminar flow was not associated with larger lesion size despite a significantly lower nadir balloon temperature. CONCLUSION: The frozen lesion size created by cryoballoon ablation became larger with longer applications at least 150 seconds and with a push-up technique especially at 20 seconds after the freezing.

Reliable focal and rotational activations in CARTOFINDER mapping using the OctaRay catheter.

INTRODUCTION: The aim of the current study was to elucidated the reliable atrial fibrillation (AF) drivers identified by CARTOFINDER using OctaRay catheter. METHODS AND RESULTS: The reliability of focal and rotational activations identified by CARTOFINDER using OctaRay catheter was assessed by the sequential recordings in each site of both atrium before and after pulmonary vein isolation (PVI) in 10 persistent AF patients. The outcome measures were the reproducibility rate during the sequential recordings and the stability rate between pre- and post-PVI as reliable focal and rotational activations. The study results were compared with those under use of PentaRay catheter (N = 18). Total 68928 points of 360 sites in OctaRay group and 24 177 points of 311 sites in PentaRay were assessed. More focal activation sites were identified in OctaRay group than PentaRay group (7.9% vs. 5.7%, p < .001), although the reproducibility rate and the stability rate were significantly lower in OctaRay group (45.3% vs. 58.9%, p < .001; 11.2% vs. 28.4%, p < .001). Meanwhile, the prevalence of reproducible focal activation sites among overall points was comparable (3.6% vs. 3.3%, p = .08). Regarding rotational activation, more rotational activation sites were identified in OctaRay group (5.1% vs. 0.2%, p < .001), and the reproducibility rate and the stability rate were significantly higher in OctaRay group (45.2% and 12.5% vs. 0.0%, p < .001). Both reliable focal and rotational activation sites were characterized by significantly shorter AF-cycle length (CL) and higher repetition of focal and rotational activations during the recordings compared with the sites of non or unreliable focal and rotational activations. CONCLUSION: In CARTOFINDER, OctaRay catheter could identify reliable focal activation with high resolution and reliable rotational activation compared with PentaRay catheter. The repetitive focal and rotational activations with short AF-CL could be the potential target during ablation.

Intracardiac energy inefficiency during atrial fibrillation rhythm with heart failure: Assessment by echo-vector flow mapping.

AIMS: Intracardiac dynamics during atrial fibrillation(AF) complicated by heart failure(HF) are not fully understood. The aim of this study was to evaluate the impact of intracardiac dynamics assessed by echo-vector flow mapping on AF complicated by HF. METHODS AND RESULTS: We enrolled 76 AF patients receiving sinus restoration therapy and assessed energy loss(EL) by echo-vector flow mapping during both AF rhythm and sinus rhythm. Patients were divided into 2 groups according to serum NT-proBNP level: high NT-proBNP group(≥1800 pg/ml during AF rhythm: N = 19), and low NT-proBNP group(N = 57). Outcome measures were average ELs/stroke volume(SV) in left ventricle(LV) and left atrium(LA). Average EL/SVs during AF rhythm in the LV and LA were significantly larger in the high NT-proBNP group than the low NT-proBNP group(54.2 mE/m·L versus 41.2 mE/m·L, P = 0.02; 3.2 mE/m·L versus 1.9 mE/m·L, P = 0.01). The significantly larger EL/SV in the high NT-proBNP group was recorded for maximum EL/SVs. In patients with high NT-proBNP, large vortex formation with extreme EL was detected in the LV and LA during the diastolic phase. After sinus restoration, the average decrease of EL/SV in the LV and LA was larger in the high NT-proBNP group(-21.4 mE/m·L versus +2.6 mE/m·L, P = 0.04; -1.6 mE/m·L versus -0.3 mE/m·L, P = 0.02). Average EL/SV during sinus rhythm did not significantly differ between the high and low NT-proBNP groups in the LV and LA. CONCLUSIONS: High EL during AF rhythm as intracardiac energy inefficiency was associated with high serum NT-proBNP levels and improved after sinus restoration.

Preclinical evaluation of a paclitaxel-incorporated nanoparticle-coated balloon in rabbit and porcine models.

BACKGROUND: The main drawback of current available drug coated balloons (DCB) is that a certain percentage of the coated drug is lost in the bloodstream during its delivery to the target lesion. We integrated the nanoparticle-mediated drug delivery technology and polydimethylsiloxane (PDMS) as a new excipient to facilitate an efficient drug delivery and uptake by endothelial cells. The present study aimed to evaluate the efficacy of the new DCB. METHOD AND RESULTS: The novel DCB were coated with 5.6mg of paclitaxel-incorporated nanoparticles using PDMS. The efficacy of the new DCB was examined in rabbit iliac stent model (n=12) and in the swine in-stent restenosis model (n=8) by quantitative coronary angiography (QCA) and optical coherence tomography (OCT). At 28days follow-up in the swine in-stent restenosis model, the area stenosis was significantly lower in DCB group as compared with that of the control group in OCT analysis (0.31±0.05 vs 0.49±0.06, p=0.04) though there was no significant differences observed in the rabbit iliac stent model in QCA and OCT analysis. CONCLUSION: The study results indicated that the paclitaxel-incorporated nanoparticle-coated balloon using PDMS has an inhibitory effect for the proliferation of smooth muscle cell in a swine coronary in-stent restenosis model.

Coronary bifurcation model created using a novel directional heat injury catheter.

OBJECTIVES: The present study aimed to develop a swine coronary bifurcation model. BACKGROUND: In human coronary bifurcation lesion, atherosclerotic plaques are usually observed in the lateral wall, whereas the flow divider regions are spared. There is currently no suitable coronary bifurcation animal model, on which a new stent can be tested. METHODS: We developed a novel directional heat injury catheter, which comprised of a non-compliant balloon catheter (diameter: 3.0mm, length: 15mm), and two electrode cables, that were attached to either side of the balloon catheter. The technique was performed on 4 healthy pigs, and assessed in 7 lesions. We inflated the balloon at the main bifurcation branch, following which a high frequency generator was used to transmit heat to the opposite side of the electrode, towards the bifurcation carina (duration: 5min, frequency: 2 times). We performed a post-angiography 28days after the pre-angiography, to observe the distribution of neointima. The neointimal area was divided into the carina side and the opposite side of carina, and the 2 sides were compared. RESULTS: The neointimal area at the opposite side of the carina was significantly larger than the carina side (1.51±0.40mm2 vs. 0.95±0.27mm2, p<0.0001). The percentage of area of stenosis on the opposite side of carina was also higher than that on the carina side (55.4±7.0% vs. 34.9±4.2%, p<0.0001). CONCLUSIONS: We successfully developed a novel swine coronary bifurcation model using directional heat injury catheter.

Antegrade transcatheter aortic valve implantation using the looped Inoue balloon technique: A pilot study in a swine model.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an established therapy for patients who are inoperable or at high risk for open heart surgery. The retrograde transfemoral approach is the most widely used and is the first choice in TAVI. However, existence of peripheral vascular disease or a small iliofemoral artery often limits the application of the transfemoral approach. Transvenous antegrade transseptal TAVI is an attractive option, but has already been abandoned due to its technical complexities. METHODS AND RESULTS: We have previously described a novel technique to simplify antegrade transseptal balloon aortic valvuloplasty, which utilizes a custom-made Inoue balloon catheter with two stylets. The technique is named as the looped Inoue balloon technique, and its feasibility and efficacy were proven in an animal model and a clinical case. We applied this technique to TAVI. The present study aimed to assess the feasibility of the looped Inoue balloon technique for TAVI in two healthy pigs. The valve implantation was successful in both pigs, although the pigs died soon after the implantation (2 and 24h). The causes of death were access site bleeding (Case 1) and migration of the prosthetic valve (Case 2). CONCLUSIONS: Although several improvements and further studies are required, the study results indicate that antegrade TAVI using the looped Inoue balloon technique is feasible.

Ultrathin Endoscopy-Guided Pericardiocentesis: A Pilot Study in a Swine Model.

BACKGROUND: Pericardiocentesis under echocardiography guidance is a common procedure, but still poses a risk of injury to surrounding tissues. Nowadays, pericardiocentesis is being performed in patients with normal pericardium, for epicardial ablation or atrial appendage exclusion. Access to the normal pericardial space with the conventional needle procedure is very difficult. Thus, development of a novel method enabling safer pericardiocentesis is necessary. The present study aimed to assess the feasibility of using an originally developed ultrathin endoscopy-guided pericardiocentesis device in a swine model. METHODS AND RESULTS: We developed a novel ultrathin endoscopy-guided pericardiocentesis device. The device comprised a 1.2 mm ultrathin endoscope, a 20 G needle, and a grasping forceps. Pericardiocentesis was conducted as follows. A 12 Fr introducer sheath was inserted between the pericardium and the diaphragm under fluoroscopy. The pericardium was grasped with the originally developed forceps under endoscopy guidance to create a space in the pericardial sac. The 20 G needle was then inserted and a coiled-tip guidewire was placed into the pericardial sac. Five independent operators performed pericardiocentesis twice using this technique in a healthy pig with a body weight of approximately 25 kg. Procedural success rate and procedure time were assessed as the primary endpoints. The procedural success rate was 100% in all operators. The average procedure time was 65 ± 40 seconds (median, 46 seconds; interquartile range, 40-85 seconds). No procedure-related complications were noted. CONCLUSIONS: The study results indicate that ultrathin endoscopy-guided pericardiocentesis for normal pericardial space is feasible and safe.

Prediction of the true fractional flow reserve of left main coronary artery stenosis with concomitant downstream stenoses: in vitro and in vivo experiments.

AIMS: The functional impact of downstream coronary stenoses on left main coronary artery (LMCA) stenosis has not been fully elucidated. This study therefore aimed to use in vitro and in vivo experiments to assess two novel equations that predict the true fractional flow reserve (FFR) of a left main coronary artery (LMCA) stenosis with concomitant downstream stenoses. METHODS AND RESULTS: Two novel equations were derived. One equation predicts the true fractional flow reserve (FFR) of an LMCA stenosis with a downstream stenosis (Equation A), and the other predicts the true FFR of an LMCA stenosis with downstream stenoses in both the left anterior descending and left circumflex arteries (Equation B). The equations were validated in both in vitro and in vivo models of the coronary circulation. The agreements between the apparent FFR (FFRapp), the predicted FFR (FFRpred) and the true FFR (FFRtrue) were assessed by Passing-Bablok regression analysis. Passing-Bablok regression analysis revealed that there were fixed proportional errors between FFRapp-m and FFRtrue-m, though a very small fixed error and no proportional errors between FFRpred-m and FFRtrue-m. The absolute differences between FFRpred and FFRtrue were significantly lower as compared to those between FFRapp and FFRtrue in all experiments. CONCLUSIONS: Two novel equations which predict the true FFR of LMCA stenosis were demonstrated to be correct. The study also revealed that the functional impact of downstream stenoses on the LMCA stenosis became stronger when the downstream stenoses became more severe.

Patient-Specific Three-Dimensional Aortocoronary Model for Percutaneous Coronary Intervention of a Totally Occluded Anomalous Right Coronary Artery.

Percutaneous coronary intervention (PCI) for anomalous coronary arteries is often difficult because the support provided by the guide catheter is insufficient. We encountered a patient with severe three-vessel coronary disease including a totally occluded anomalous right coronary artery (RCA) originating from the left sinus of Valsalva. Initial PCI for the anomalous RCA via the transradial approach failed. Therefore, we constructed a three-dimensional (3D) aortocoronary model and conducted an in vitro simulation to plan the second PCI and found that a Judkins left (JL) 3.5 guide catheter in the power position yielded maximum backup support for the anomalous RCA. Thus, the second PCI was conducted using an 8 Fr JL 3.5 guide catheter in the power position via the transfemoral approach. The procedure was smooth and successful, without any adverse events. Our experience suggests that case-specific 3D models are useful for strategic planning of complex PCIs.

In vitro assessment of physiological impact of recipient artery intervention on the contralateral donor artery.

BACKGROUND: Donor artery fractional flow reserve (FFR) often improves after treatment of recipient artery stenosis, but the physiological mechanism underlying this phenomenon has not been elucidated. This study aimed to assess two novel equations that explain the donor-recipient artery interaction. METHOD: Eq. (A) predicts the donor artery FFR after complete release of recipient artery stenosis, while Eq. (B) predicts the donor artery FFR after partial release of recipient artery stenosis. Eq. (B) is a general form of Eq. (A). FFR'1−pred = ((FFR1−CFI1)(FFR2−CFI2)−CFI1CFI2(1−FFR1)(1−FFR2)+CFI1(1−FFR1)(1−CFI2))/((1−C FI1)(FFR2−CFI2)) (A) FFR''1−pred = ((FFR1−CFI1)(FFR2−CFI2)−CFI1CFI2(1−FFR1)(1−FFR2)+CFI1(1−FFR1)(1−CFI2))FFR'2/((1−C FI1)(FFR2−CFI2)) (B) Eqs. (A) and (B) were assessed using an in vitro model of coronary circulation with a collateral channel connecting the donor and recipient arteries. RESULTS: The donor artery FFR always improved after releasing the recipient artery stenosis. A good linear correlation was found between the predicted FFR of Eq. (A) and the actual FFR (n=40, r=0.95, p<0.0001) and between the predicted FFR of Eq. (B) and the actual FFR (n=40, r=0.94, p<0.0001). CONCLUSIONS: Eqs. (A) and (B) accurately predicted the true FFR value of the donor artery in a coronary circulation model and explain the donor-recipient artery interaction observed in clinical practice.

A novel equitation to predict the pressure derived collateral flow index in multiple sequential coronary stenoses.

Coronary collateral circulation is an alternative source of blood supply to the myocardium when the original blood flow is not sufficient. The pressure derived collateral flow index (CFI) calculated with (P w - P v)/(P a - P v) can be measured during angioplasty and predicts the outcome of the patients with ischemic heart disease. However, the necessity of occluding the coronary artery at maximum hyperemia hampers the wide spread use. We mathematically derived a new equation which calculates CFI in sequential stenoses. The present study aimed to validate the equation in an in vitro model of coronary circulation. The predicted CFI is calculated from the following equation: CFI = (FFRpre - FFRpost(1 - ∆FFR))/(FFRpre + ∆FFR - FFRpost). FFRpre/post is the FFR before and after the angioplasty. ∆FFR is the FFR gradient across the target stenosis. The experimental system consisted of a pump, systemic circulation, coronary circulation, and 5 constrictors placed in the coronary artery. A total of 30 different sequential coronary stenoses were randomly created and 30 different pressure data were obtained. The predicted CFI was compared with the true CFI. A close positive correlation (r = 0.90, p < 0.0001) was found between the predicted CFI and the true CFI. The accuracy of the equation was demonstrated in an in vitro model of coronary circulation.

First clinical experience of the looped Inoue balloon technique for antegrade percutaneous balloon aortic valvuloplasty.

Balloon aortic valvuloplasty (BAV) has played a limited role in the management of patients with severe aortic stenosis. However, BAV is being performed more frequently these days with the emergence of transcatheter aortic valve implantation (TAVI). We previously described a technique named "looped Inoue balloon technique" to simplify the antegrade transvenous BAV by making a loop in the left atrium using two stylets. We present a case in which the looped Inoue balloon technique was successfully applied. The patient was an 83-year-old woman with progressive dyspnea due to severe aortic stenosis. The aortic valve area was 0.39 cm(2) with a mean transvalvular gradient of 46 mmHg. The patient was deemed high risk for surgical aortic valve replacement or TAVI in view of the multiple comorbidities and frailty. Antegrade BAV using the looped Inoue balloon technique was performed. The procedure was successful without any complications. The post procedural aortic valve area increased to 1.15 cm(2) with a mean pressure gradient of 23 mmHg. This is the first report of clinical use of the looped Inoue balloon technique for antegrade BAV.

Utility of a scoring balloon for a severely calcified lesion: bench test and finite element analysis.

We aimed to investigate the effectiveness of a scoring balloon catheter in expanding a circumferentially calcified lesion compared to a conventional balloon catheter using an in vitro experiment setting and elucidate the underlying mechanisms of this ability using a finite element analysis. True efficacy of the scoring device and the underlying mechanisms for heavily calcified coronary lesions are unclear. We employed a Scoreflex scoring balloon catheter (OrbusNeich, Hong Kong, China). The ability of Scoreflex to dilate a calcified lesion was compared with a conventional balloon catheter using 3 different sized calcium tubes. The thickness of the calcium tubes were 2.0, 2.25, and 2.5 mm. The primary endpoints were the successful induction of cracks in the calcium tubes and the inflation pressures required for inducing cracks. The inflation pressure required for cracking the calcium tubes were consistently lower with Scoreflex (p < 0.05, Student t test). The finite element analysis revealed that the first principal stress applied to the calcified plaque was higher by at least threefold when applying the balloon catheter with scoring elements. A scoring balloon catheter can expand a calcified lesion with lower pressure than that of a conventional balloon. The finite element analysis revealed that the concentration of the stress observed in the outside of the calcified plaque just opposite to the scoring element is the underlying mechanism of the increased ability of Scoreflex to dilate the calcified lesion.

In vitro assessment of mathematically-derived fractional flow reserve in coronary lesions with more than two sequential stenoses.

BACKGROUND: Myocardial fractional flow reserve (FFR) is a reliable index in coronary intervention. A simple FFR measurement does not predict the true functional severity of an individual stenosis in multiple sequential coronary stenoses because of complex interaction between the stenoses. Application of the theoretical equations to predict the true FFR of individual stenosis is limited in a tandem lesion. Two novel equations applicable to a multiple sequential coronary stenoses are mathematically derived. One predicts the true FFR of each stenosis (equation A), and the other predicts the true FFR after releasing a given stenosis (equation B). The present study aimed to validate the two derived equations in an in vitro model of coronary circulation. METHODS AND RESULTS: Predictive FFR was compared with true FFR in an in vitro model of three sequential stenoses using linear regression analysis. The difference between apparent FFR and true FFR was compared with the difference between predictive FFR and true FFR. The legitimacy of equation A was first assessed. A close correlation was found between predictive FFR and true FFR (r² = 0.92). The difference between predictive FFR and true FFR was significantly lower compared to the difference between apparent FFR and true FFR (0.18 ± 0.10 vs 0.05 ± 0.05; P<.001). The legitimacy of equation B was also assessed, and a close correlation was found (r² = 0.97). The difference was significantly lower when we applied equation B (0.13 ± 0.06 vs 0.04 ± 0.02; P<.001). CONCLUSIONS: Equations A and B strongly predict the true value of FFR in the experimental model of coronary circulation.

Microcatheter-facilitated reverse wire technique for side branch wiring in bifurcated vessels: an in vitro evaluation.

AIMS: To assess when and how the microcatheter-facilitated reverse wire technique should be applied to cross the guidewire into side branches in coronary bifurcations. METHODS AND RESULTS: Three interventional cardiologists with different levels of experience performed in vitro bench testing using an originally developed coronary bifurcation simulator which had six coronary bifurcations. The bifurcation angles were 90, 105, 120, 135, 150 and 165 degrees (°). Experiment 1 was conducted to assess in what coronary bifurcation the reverse wire technique is required. Antegrade guidewire advancement was conducted with two different guidewires: the spring coil guidewire SION blue and the polymer-jacket hydrophilic guidewire Fielder FC. Experiment 2 was conducted to determine what the optimal guidewire selection and the optimal guidewire shape for the reverse wire technique would be. Assessment of the guidewire crossability into the highly angulated side branch was performed, and then the balloon crossability was assessed. A total of four guidewire types were compared in experiment 2. In experiment 1, guidewire crossing was impossible by conventional antegrade wiring when the bifurcation angle became 150° or more. In experiment 2, guidewire crossing of more than 150° of bifurcation angle was achievable independent of the guidewire types and shape. Balloon deliverability was best when using a polymer-jacket hydrophilic guidewire with a round shape 3 cm from the guidewire tip. CONCLUSIONS: Although the guidewire crossing into the side branch was impossible by conventional antegrade methods when the bifurcation angle became 150° or more, the guidewire crossing into such a highly angulated side branch was easily possible using the reverse wire technique. The optimal guidewire selection for the reverse wire technique is the polymer-jacket hydrophilic guidewire with a round shape 3 cm from the guidewire tip.

Prognostic implications of anemia with or without chronic kidney disease in patients undergoing elective percutaneous coronary intervention.

BACKGROUND: Little is known about the prognostic implications of anemia in patients undergoing elective percutaneous coronary intervention (PCI), especially when they have coexisting chronic kidney disease (CKD). METHODS: We identified 7299 patients who underwent elective PCI from the CREDO-Kyoto registry cohort-2. The primary outcome was 3-year major adverse cardiac events (MACE); composite of all cause death, heart failure hospitalization, and myocardial infarction. RESULTS: In total, 1466 patients (20.0%) had mild anemia (hemoglobin=11.0-11.9 g/dL for women and 11.0-12.9 g/dL for men), and 740 patients (10.1%) had moderate-to-severe anemia (hemoglobin<11.0 g/dL both for women and for men). Compared to the no-anemia group, cumulative incidence of MACE was significantly higher in the mild and moderate-to-severe anemia groups (7.9%, 20.1%, and 34.2%, respectively). The adjusted hazard ratios of mild and moderate-to-severe anemia versus no-anemia for MACE were 1.77 (95% confidence interval: 1.47-2.15) and 2.53 (95% confidence interval: 2.03-3.14), respectively. In a subgroup analysis, significantly higher risk for MACE was consistently observed with mild and moderate-to-severe anemia both in patients with and without CKD. The risk for MACE showed an accretive increment with exacerbation in either the renal function or anemia (interaction p<0.001). CONCLUSIONS: Even mild anemia was associated with significantly worse 3-year clinical outcomes in patients who underwent elective PCI. Coexisting CKD additively increased the risk for MACE in these patients.

A novel device for antegrade percutaneous balloon aortic valvuloplasty: feasibility of the looped Inoue balloon technique in swine model.

OBJECTIVES: The study aimed to assess the feasibility of a novel device and technique for antegrade percutaneous balloon aortic valvuloplasty (BAV) in a swine model. BACKGROUND: BAV is currently being applied more frequently compared to the past with the advent of transcatheter aortic valve replacement. Although the antegrade BAV approach offers several advantages over the retrograde approach, the antegrade approach is technically more complicated and demanding. METHODS: We developed a novel balloon catheter and a technique to simplify the antegrade BAV. The balloon catheter was designed to make a loop in left atrium by inserting two different sized stylets. The balloon catheter was easily dropped into the left ventricle via the mitral valve while maintaining the loop. The balloon catheter was advanced to the ascending aorta by holding the two stylets. Then, the balloon was inflated. We named the technique as the looped Inoue balloon technique. The feasibility of the looped Inoue balloon technique was assessed in a healthy swine with a body weight of 40 kg by four independent operators. Every operator conducted the procedure twice. RESULTS: The procedural success rate was 100% in all operators. The average procedure time was 170 ± 35 sec. No procedure related complications were noted. CONCLUSIONS: The study results indicate that the antegrade BAV using the looped Inoue balloon technique is feasible and may simplify the antegrade approach.

ß-Blocker therapy and cardiovascular outcomes in patients who have undergone percutaneous coronary intervention after ST-elevation myocardial infarction.

The effect of ß-blockers in ST-elevation myocardial infarction (STEMI) patients who have undergone primary percutaneous coronary intervention (PCI) has not been adequately evaluated. Using a large multi-center registry in Japan, we identified 3,692 patients who underwent PCI within 24 h from onset of STEMI and were discharged alive from 2005 to 2007. Three-year cardiovascular outcomes were compared between the 2 groups of patients with (N = 1,614) or without (N = 2,078) ß-blocker prescription at discharge. Compared with patients in the no-ß group, patients in the ß group were younger, more frequently male, more often had hypertension and atrial fibrillation but less often had chronic obstructive pulmonary disease than in the no-ß group. Statins and angiotensin-converting enzyme inhibitors/angiotensin receptor blockers were more frequently prescribed in the ß group. Crude incidence of cardiac death and/or recurrent myocardial infarction (cardiac death/MI) tended to be higher in the ß group (7.6 vs. 6.2%, log-rank p = 0.1). After adjusting for potential confounders, ß-blockers were associated with significantly higher risk for cardiac death/MI (hazard ratio 1.43, 95% CI: 1.06-1.94, p = 0.01). ß-Blocker prescription at discharge was not associated with better cardiovascular outcomes in patients who underwent PCI after STEMI. Large-scale randomized controlled trials are needed to evaluate the role of ß-blocker therapy in these patients.

ß-blocker use in patients after percutaneous coronary interventions: one size fits all? Worse outcomes in patients without myocardial infarction or heart failure.

BACKGROUND: The influence of ß-blocker therapy on prognosis in patients with coronary artery disease (CAD) who underwent percutaneous coronary intervention (PCI) has not been fully explored. METHODS AND RESULTS: We identified 5288 CAD patients who did not have myocardial infarction (MI) or heart failure (HF) but underwent PCI from a large multi-center registry enrolling consecutive patients undergoing first coronary revascularization from 2005 to 2007. The primary outcome was a composite endpoint of cardiac death and/or MI (cardiac death/MI) at 3 years after hospital discharge for PCI. ß-blockers were prescribed in 1117 patients (ß group, 21.1%) at discharge, while 4171 patients did not (no-ß group, 78.9%). Patients in the ß group more often had hypertension, multivessel disease, use of statin and angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, but less often had chronic obstructive pulmonary disease. The 3-year incidence of cardiac death/MI was higher in the ß group (4.9% vs. 3.4%, log-rank p=0.02). After adjusting for potential confounders, ß-blocker therapy was associated with significantly increased risk for cardiac death/MI (hazard ratio 1.48, 95% confidence interval 1.05-2.10, p=0.02). CONCLUSIONS: ß-blocker therapy was associated with worse 3-year clinical outcomes in CAD patients who underwent PCI but had no history of MI or HF. Randomized trials are warranted to identify appropriate subsets of patients who could truly benefit from long-term use of ß-blockers in this setting.