Jailed high-pressure balloon technique is superior to jailed wire technique in protecting side branch of coronary bifurcation lesions.

Objectives. This study investigated the influence of higher pressure protection with a small diameter balloon of side branch (SB) on bifurcation lesions. Background. Of the different coronary stent implantation techniques, the modified jailed balloon technique has become a viable option for bifurcation lesions. However, there was no detailed study on the relationship between the balloon inflation pressure of the main vessel (MV) and SB. Methods. In this study, we collected information of patients who underwent percutaneous coronary intervention (PCI) for bifurcated lesions between March 2019 and December 2022. They were divided into two groups according to the operation way: active jailed balloon technique (A-JBT) group and jailed wire technique (JWT) group. Results. A total of 216 patients were enrolled. The A-JBT group had a larger SB stenosis diameter (1.53 ± 0.69 vs. 0.95 ± 0.52, p < .001), the lower degree of stenosis (44.34 ± 18.30 vs. 63.69 ± 17.34, p < .001) compared to the JWT group. However, the JWT group had a higher incidence of SB occlusion (18.0% vs. 1.9%, p < .001) compared to the A-JBT group. Nevertheless, the success rate for both groups was 100%. Conclusions. This novel high inflation pressure and small diameter balloon approach we propose has significant advantages. There is a lower rate of SB occlusion and SB dissection, which is more cost-effective and provides better clinical outcomes for the patient. This method should be considered in the future for treating bifurcation lesions.

Predictors of late lumen enlargement after drug-coated balloon angioplasty for de novo coronary lesions.

BACKGROUND: Late lumen enlargement (LLE) - a positive remodelling phenomenon - after drug-coated balloon (DCB) angioplasty for stable coronary disease contributes to a lower restenosis rate. However, lesion characteristics promoting LLE remain unclear. AIMS: This study aimed to investigate predictive lesion characteristics for LLE using serial optical frequency domain imaging (OFDI) following DCB angioplasty for de novo coronary artery lesions. METHODS: This retrospective, single-centre observational study included patients with angina pectoris who underwent paclitaxel-coated balloon angioplasty without stenting under OFDI guidance as well as follow-up OFDI. OFDI endpoints were lumen volume, plaque phenotype, and procedure-associated dissection. LLE was defined as a ≥10% increase in the lumen volume of the treated lesion at follow-up. RESULTS: Between August 2016 and December 2019, among patients with successful DCB angioplasty, 108 lesions (83 patients) had available follow-up imaging after a median of 6.1 months. LLE was detected in 44 (40.7%) lesions. Fibrous/fibrocalcific and layered plaques had significantly larger lumen volumes at follow-up than immediately after the index procedure, whereas lipid plaques exhibited no significant difference. Medial dissection with an arc >90° revealed an increased lumen volume. Multivariate analysis showed that layered plaques (odds ratio [OR] 8.73, 95% confidence interval [CI]: 1.92-39.7; p=0.005) and medial dissection with an arc >90° (OR 4.65, 95% CI: 1.63-13.3; p=0.004) were independent LLE predictors. CONCLUSIONS: Layered plaques and extensive medial dissection after DCB angioplasty were associated with higher LLE occurrence in de novo coronary lesions. These findings may be clinically applicable to DCB therapeutic strategies based on plaque features.

Procedural characteristics and cardiovascular outcomes in patients undergoing drug-coated balloon angioplasty for de novo lesions in large coronary arteries: an observational study.

Limited data exist regarding drug-coated balloon (DCB) treatment in de novo large coronary arteries. We sought to demonstrate procedural characteristics, residual stenosis, and clinical outcomes following DCB angioplasty for de novo lesions in large versus small coronary arteries. The study included 184 consecutive patients with 223 de novo coronary lesions undergoing paclitaxel DCB angioplasty between January 2019 and August 2020, who were divided according to whether the DCB diameter was ≥ 3.0 mm (large group, n = 58) or < 3.0 mm (small group, n = 125). The large group had a higher proportion of acute coronary syndrome more commonly with ostial, bifurcation, and calcified lesions in large vessels and received lesion preparation with more frequent use of scoring or cutting balloons and atherectomy devices compared to the small group. Postprocedural angiographic diameter stenosis was smaller in the large group compared to the small group (31% [22-37] vs. 35% [26-42], p = 0.032), and intravascular ultrasound revealed no significant difference in postprocedural area stenosis between the groups (66.2 ± 7.7% vs. 67.9 ± 7.8%; p = 0.26). The median follow-up duration was 995 days. The incidence of a composite of all-cause death, myocardial infarction, stroke, or target lesion revascularization was similar between the groups (log-rank p = 0.41) and was influenced by the presence of acute coronary syndrome and anemia but not by DCB diameter. The rate of cardiovascular outcomes after DCB treatment was comparable in de novo large and small coronary arteries. Notably, well-planned lesion preparation with intravascular imaging guidance was prevalent in large vessels.

Perfusion Balloon Is Useful for Preventing Obstruction of Left Main Coronary Artery During Transcatheter Aortic Valve Implantation.

The incidence of acute coronary obstruction during transcatheter aortic valve implantation (TAVI) is low (< 1.0%); however, it is associated with high mortality. An 83-year-old female with a history of chest pain and syncope was diagnosed with severe aortic stenosis. Computed tomography showed severely calcified aortic leaflets with a low left coronary ostial height of 7.8 mm, which indicates a high risk of coronary obstruction. TAVI was performed using the right femoral artery approach under general anesthesia. To prevent coronary obstruction and minimize coronary flow obstruction, coronary protection of the left main tract (LMT) via the left radial artery was established with a perfusion balloon. We crossed a 23 mm Sapien 3 transcatheter heart valve and settled it at an appropriate position on the aortic valve. After inflation of the perfusion balloon at the LMT, we started rapid ventricular pacing, and deployed the Sapien 3 using the KBI technique. Hemodynamics were stable and aortography showed excellent coronary flow with no stenosis of the LMT ostium. This strategy may serve as a useful method to prevent coronary obstruction and minimize coronary ischemia.

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

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

The rotational atherectomy with a guide extension catheter for calcified and tortuous lesions in left anterior descending artery: a case report.

BACKGROUND: The interventional treatment of calcified lesions with severe tortuosity in the left anterior descending artery (LAD) was challenging and the report of rotational atherectomy with mother-and-child technique has been scarce. CASE PRESENTATION: An 84-year-old woman was hospitalized for non-ST-segment acute coronary syndrome. Coronary angiography revealed a calcified nodule in the LAD. During rotational atherectomy of the calcified and tortuous lesion in the proximal LAD, eccentric cutting due to wire bias nearly caused perforation. The burr seemed to protrude from the contrast media during angiography. Intravascular ultrasound imaging revealed that extremely eccentric ablation almost reached the adventitia. We successfully ablated the distal calcified nodule by preventing proximal overcutting of the tortuous lesion with support from a guide extension catheter, i.e., the mother-and-child technique, followed by the deployment of the drug-eluting stent. The patient was discharged without chest symptoms and no symptom recurred during 12-month follow-up. CONCLUSION: This case demonstrated that safe ablation of a calcified nodule located distal to a tortuous and calcified lesion in the proximal LAD with the mother-and-child technique.

Rationale and design of a randomized study comparing the agent drug coated balloon to plain old balloon angioplasty in patients with In-stent restenosis.

BACKGROUND: Drug-coated balloon (DCB) technology was developed as an alternative treatment for obstructive coronary artery disease (CAD) and in-stent restenosis (ISR). Management of coronary ISR is clinically challenging and frequently encountered in practice. The Agent DCB uses an inactive excipient to effectively deliver a targeted, therapeutic dose of paclitaxel to the vessel wall. STUDY DESIGN: AGENT IDE is a prospective, multicenter, randomized controlled trial to evaluate superiority of the Agent DCB to balloon angioplasty in treating patients with ISR. A total of 480 patients with ISR of a previously treated lesion length <26 mm and reference vessel diameter >2.0 mm to ≤4.0 mm will be initially randomized. Subjects presenting with recent myocardial infarction (MI), complex lesions, or thrombus in the target vessel will be excluded. An adaptive group sequential design with one formal interim analysis for sample size re-estimation will be conducted, and the sample size may be increased to a maximum of 600 subjects. The primary endpoint is the rate of 12-month target lesion failure (TLF; composite of any ischemia-driven revascularization of the target lesion (TLR), target vessel related MI, or cardiac death) and will be tested for superiority in the test arm against the control. Functional status and general health-related quality of life will be measured by changes in the EQ-5D scores. Subjects will be followed for 5 years following the index procedure. CONCLUSION: This study will prospectively evaluate the safety and efficacy of Agent DCB in patients treated for coronary ISR.

In Vitro and In Vivo Comparative Evaluation of a Shellac-Ammonium Paclitaxel-Coated Balloon versus a Benchmark Device.

OBJECTIVES: The present study was designed to compare the characteristics and performance regarding drug delivery of a novel drug-coated balloon (DCB) to a benchmark device (Restore® versus SeQuent® Please) in an in vitro and in vivo model. BACKGROUND: Although Restore® and SeQuent® are both paclitaxel-coated, they use different coating excipient, shellac-ammonium salt and iopromide, respectively. Preclinical study comparing these two different commercial DCBs regarding their characteristics and effects on early vascular response is sparse. METHODS: Restore® and SeQuent® DCBs were scanned with electron microscopy for surface characteristic assessment. Both DCBs were transported in an in vitro vessel model for the evaluation of drug wash-off rate and particulate formation. Eighteen coronary angioplasties with either Restore® or SeQuent® DCBs were conducted in 6 swine (three coronary vessels each). Histopathological images of each vessel were evaluated for vessel injury. RESULTS: The surface of Restore® DCB was smooth and evenly distributed with hardly visible crystal, while SeQuent® DCB showed a rougher surface with relatively larger apparent crystals. Restore® DCB had a lower drug wash-off rate and fewer large visible particles, compared to the SeQuent® DCB. No significant difference in mean injure score was found between Restore® and SeQuent® group. CONCLUSION: Our results suggest that Restore® is better in preclinical performance regarding less release of particles and lower drug wash-off rate as compared to SeQuent® Please. The Restore® DCB, using stable amorphous coating and shellac-ammonium salt as an excipient, appears to provide an advantage in drug delivery efficacy; however, further clinical studies are warranted.

Comparison of optical coherence tomography-guided and intravascular ultrasound-guided rotational atherectomy for calcified coronary lesions.

BACKGROUND: To compare the effect and outcomes of optical coherence tomography (OCT)-guided rotational atherectomy (RA) with intravascular ultrasound (IVUS)-guided RA in the treatment of calcified coronary lesions. METHODS: Data of calcified coronary lesions treated with RA that underwent OCT-guided or IVUS-guided from January 2016 to December 2019 at a single-center registry were retrospectively analyzed. The effect and outcomes between underwent OCT-guided RA and IVUS-guided RA were compared. RESULTS: A total of 33 lesions in 32 patients received OCT-guided RA and 51 lesions in 47 patients received IVUS-guided RA. There was no significant difference between OCT-guided RA group and IVUS-guided RA group in clinical baselines characteristics. Comparing the procedural and lesions characteristics of the two groups, the contrast volume was larger [(348.8 ± 110.6) ml vs. (275.2 ± 76.8) ml, P = 0.002] and the scoring balloon was more frequently performed (33.3% vs. 3.9%, P = 0.001) after RA and before stenting in the OCT-guided RA group. Comparing the intravascular imaging findings of the two groups, stent expansion was significantly larger in the OCT-guided RA group ([82 ± 8]% vs. [75 ± 9]%, P = 0.001). Both groups achieved procedural success immediately. There were no significantly differences in the incidence of complications. Although there was no statistical difference in the occurrence of MACE at 1 year between OCT-guided RA group and IVUS-guided RA group (3.1% vs. 6.4%, P = 0.517), no cardiovascular death, TVR and stent thrombosis occurred in OCT-guided RA group. CONCLUSIONS: OCT-guided RA compared to IVUS-guided RA for treating calcified coronary lesions resulted in better stent expansion and may have improved prognosis.

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

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

Double kissing inflation outside the stent secures the patency of small side branch without rewiring.

BACKGROUND: The jailed balloon technique is widely used for coronary bifurcation lesions, but a residual risk of SB occlusion remains, necessitating SB rewiring and further interventions, including balloon inflation or stenting, which may result in failure and SB loss. This study introduced a novel modified technique of small side branch (SB) protection, namely, double kissing inflation outside the stent (DKo) technique, for coronary bifurcations without the need for SB rewiring. METHODS: We performed the DKo technique in consecutive patients in our center from 1/2019 to 12/2019. The procedure was as follows. We inserted a guide wire into both branches followed by proper preparation. The SB balloon was simultaneously inflated with main vessel (MV) stenting. The SB balloon remained in situ until it was kissing inflated with postdilation of the bifurcation core, which is different from traditional strategies. The proximal optimization technique was performed with a short noncompliant balloon strictly not exceeding the bifurcation. Rates of SB loss and in-hospital outcomes were evaluated. RESULTS: The technique was successfully performed in all 117 enrolled patients without any rewiring or SB loss. The mean lesion lengths of the MV and SB were 38.3 ± 19.9 mm and 11.7 ± 7.1 mm, respectively. On average, 1.5 ± 0.6 stents were used per patient, while the mean pressure of the SB balloon was 7.4 ± 3.1 atm. DKo achieved excellent procedural success in the proximal and distal MVs: increased minimal lumen diameter (0.64 ± 0.58 mm to 3.05 ± 0.38 mm, p < 0.001; 0.57 ± 0.63 mm to 2.67 ± 0.35 mm, p < 0.001) and low residual stenosis (11.4 ± 3.4%; 7.2 ± 4.6%). DKo secured the patency of the SB without any rewiring and improved the SB stenosis with minimal lumen diameter (0.59 ± 0.48 mm to 1.20 ± 0.42 mm, p < 0.001) and stenosis (71.9 ± 19.4% to 42.2 ± 14.0%, p < 0.001). No MACE was noted in the hospital. CONCLUSIONS: DKo for bifurcation lesions was shown to be acceptable with high procedural success and excellent SB protection.

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.

Finite element analysis of cutting balloon expansion in a calcified artery model of circular angle 180°: Effects of balloon-to-diameter ratio and number of blades facing calcification on potential calcification fracturing and perforation reduction.

Calcified artery lesions cause stent under-expansion and increase the risk of in-stent restenosis and stent thrombosis. Cutting balloons facilitate the fracturing of calcification prior to stent implantation, although vessel dissection and perforation are potential issues. In clinical practice, calcifications having maximum calcium angles ≤ 180° are rarely fractured during conventional balloon angioplasty. We hypothesize that the lesion/device diameter ratio and the number of blades facing a non-circular calcified lesion may be crucial for fracturing the calcification while avoiding vessel injury. The geometries of the cutting balloons were constructed and their finite-element models were generated by folding and wrapping the balloon model. Numerical simulations were performed for balloons with five different diameters and two types of blade directions in a 180° calcification model. The calcification expansion ability was distinctly higher when two blades faced the calcification than when one blade did. Moreover, when two blades faced the calcification model, larger maximum principal stresses were generated in the calcification even when using undersized balloons with diameters reduced by 0.25 or 0.5 mm from the reference diameter, when compared with the case where one blade faced the calcified model and a balloon of diameter equal to the reference diameter was used. When two blades faced the calcification, smaller stresses were generated in the artery adjacent to the calcification; further, the maximum stress generated in the artery model adjacent to the calcification under the rated pressure of 12 atm when employing undersized balloons was smaller than that when only one blade faced the calcification and when lesion-identical balloon diameters were used under a nominal pressure of 6 atm. Our study suggested that undersized balloons of diameters 0.25 or 0.5 mm less than the reference diameter might be effective in not only expanding the calcified lesion but also reducing the risk of dissection.

Role of IVUS in the rectification of angiographically judged ramus intermedius and its clinical significance.

BACKGROUND: Due to the technical limitations of coronary artery angiography (CAG), ramus intermedius (RI) is sometimes difficult to distinguish from a high-origin obtuse marginal branch or a high-origin diagonal branch. This study sought to investigate the role of intravascular ultrasonography (IVUS) in the rectification of angiographically judged RI. METHODS: This study retrospectively analyzed 165 patients who were reported to have an RI based on CAG and underwent IVUS implementation from 02/01/2009 to 31/12/2019 in Zhongshan Hospital, Fudan University. Taking IVUS as the gold standard, we calculated the accuracy of RI identification by CAG and evaluated the impact of RI on revascularization strategy. RESULTS: Among the 165 patients, 89 patients (54%) were demonstrated to have an RI on IVUS (IVUS-RI), 32 patients (19%) were identified to have a high-origin diagonal branch on IVUS (IVUS-h-D), and 44 patients (27%) had an actual high-origin obtuse marginal artery on IVUS (IVUS-h-OM). Among 84 patients who underwent one-stent crossover stenting because of left main furcation lesions (48 patients in the IVUS-RI group, 12 patients in the IVUS-h-D group, and 24 in the IVUS-h-OM group), 14.6% of patients in the IVUS-RI group, 33.3% in the IVUS-h-D group and 0% in the IVUS-h-OM group had CAG-RI compromise (P = 0.02), which was defined as severe stenosis of the RI ostium (> 75%) or significant RI flow impairment (TIMI < 3). CONCLUSIONS: Only 54% of CAG-RIs were confirmed by IVUS, which indicates the necessity of preintervention IVUS to distinguish real RIs from other branches in LM furcation lesions.

Results of paclitaxel-drug-coated balloons (Pantera Lux) for coronary in-stent restenosis: Italian experience from REGistry of Paclitaxel Eluting Balloon in ISR study.

AIMS: Drug-eluting stent (DES) implantation is an effective treatment of in-stent restenosis (ISR). However, literature data indicate that drug-coated balloons (DCBs) may be a valid alternative, particularly for recurrent ISR. We sought to evaluate clinical results on the long-term efficacy of a new DCB for ISR treatment. METHODS: One hundred and ninety-nine patients were treated with paclitaxel drug-coated balloons (Pantera Lux, Biotronik, Switzerland) in the Italian REGistry of Paclitaxel Eluting Balloon in ISR (REGPEB study). Clinical follow-up was scheduled at 1 and 12 months. A subgroup of patients received adjunctive 5-year follow-up. Primary end point was Major Adverse Cardiac Events (MACE) at 1 year. RESULTS: A total of 214 ISR coronary lesions were treated (75.4% DES-ISR). Mean time between stent implantation and DCB treatment is 41 months. DCBs were successfully delivered in 99% of the cases; crossover to a DES occurred in 3% of cases. Procedural success rate was 98.5%. Clinical success rate was 98.5%. First-month follow-up compliance was 98% and freedom from MACE was 96.9%. Twelve-month follow-up compliance was 89.3% with a freedom from MACE rate of 87.3% (CI: 81.3-91.5%). Five-year long-term follow-up showed 65.2% of freedom from MACE. CONCLUSION: Our study confirms that Pantera Lux treatment is effective and well tolerated in ISR, showing good acute and long/very long-term results in the treatment of complex lesions (DES and late ISR).

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

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

Successful double-layer metal stents rotational ablation under 2-dimensional and 3-dimensional optical coherence tomography guidance: a case report.

BACKGROUND: Stent ablation with rotational atherectomy has been considered a bail-out strategy for the treatment of severe stent underexpansion. Only a few reports have yet shown rotational ablation for double-layer metal struts. CASE PRESENTATION: We present a case of 80-year-old female patient presented to our hospital because of worsening effort angina. Coronary angiography revealed severe in-stent restenosis in the proximal left anterior descending artery. Optical coherence tomography (OCT) examinations found that severe stenosis occurred at the overlap region with 2-layer underexpanded stents and circumferential calcification beneath them. Under the guidance of 2-dimensional (2D) and 3-dimensional (3D) OCT, we successfully performed percutaneous coronary intervention (PCI) of this lesion after adequate stent ablation, high-pressure balloon dilatation, and subsequent everolimus-eluting stent implantation. The patient recovered well uneventfully and discharged from hospital 7 days later. No restenosis occurred after 12 months. CONCLUSIONS: We report a very rare case of in-stent restenosis due to double-layer underexpanded stents. The entire percutaneous coronary intervention procedure was performed step by step under the guidance of high-resolution OCT. Our findings highlight the specific value of 2D and 3D OCT guidance in double-layer stents rotational ablation.

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

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