Clinical Research in Cardiology最新文献

Background: Robotic-assisted percutaneous coronary intervention (R-PCI) is an efficacious and safe treatment option for coronary artery disease. However, predictors of manual support during R-PCI are unknown, which we aimed to investigate in a multi-center study.

Methods: We utilized patient-level data from R-PCIs carried out from 2020 to 2022 at four sites in Germany. Manual support was defined as the combination of partial manual assistance, where the procedure is ultimately completed using robotic techniques, and manual conversion. A two-step selection process based on akaike information criteria was used to identify the ideal multivariable model predicting manual support.

Results: In 210 patients (median age 69.0 years; 25.7% female), a total of 231 coronary lesions were treated by R-PCI. Manual support was needed in 46 lesions (19.9%). Procedures requiring manual support were associated with significantly longer procedural times, greater total contrast fluid volumes, longer fluoroscopy times, and higher dose-area products. Amongst the predictors of manual support were lesions in the left anterior descending artery [OR: 1.09 (95%-CI: 0.99-1.20)], aorto-ostial lesions [OR: 1.35 (95%-CI: 1.11-1.64)], chronic total occlusions [OR: 1.78 (95%-CI: 1.38-2.31)], true bifurcations [OR: 1.37 (95%-CI: 1.17-1.59)], and severe calcification [OR: 1.13 (95%-CI: 1.00-1.27)].

Conclusion: Our findings reveal that nearly one out five of patients undergoing R-PCI required manual support, which was linked to longer procedure durations. Predictors of manual support reflected characteristics of more complex coronary lesions. These results highlight the limitations of current R-PCI platforms and underscore the need for technical advancements to address different clinical scenarios.

Background and aims: This study aims to investigate the very long-term predictive value of the SYNTAX score and plaque characteristics derived by intravascular ultrasound (IVUS) as well as near-infrared spectroscopy (NIRS), for all-cause mortality in patients with low to intermediate complex coronary artery disease.

Methods: We evaluated 581 patients with chronic or acute coronary syndrome from the European Collaborative Project on Inflammation and Vascular Wall Remodeling in Atherosclerosis (ATHEROREMO) cohort. Flow-limiting lesions were treated with intracoronary stenting. IVUS-VH (n = 581) and NIRS (n = 195) images were obtained in a non-culprit segment ≥ 40 mm. Cox models were applied to relate pre-PCI SYNTAX score and plaque characteristics to very long-term all-cause mortality. Adjusted hazard ratios (aHR), corrected for cardiovascular comorbidities and risk factors, are reported per doubling of the corresponding variable.

Results: Mean (standard deviation) age was 62 (11) years; 76% were men; median SYNTAX score was 9.0 (25th-75th percentile 4.0-15.0). Median follow-up was 12.8 (25th-75th percentile 10.1-13.4) years, and 177 cases of all-cause mortality occurred. SYNTAX score (aHR 1.25, 95% confidence interval [CI] 1.05-1.48; p = 0.012) and percentage dense calcified plaque (aHR 1.21 [1.02-1.42]; p = 0.026) were associated with increased mortality risk, while fibrous plaque (aHR 0.54 [0.34-0.87]; p = 0.011) was related to reduced risk. NIRS features were not associated with very long-term mortality.

Conclusion: Angiography-based SYNTAX score and IVUS-VH-defined fibrous and dense calcified plaque were related to 12-year mortality in patients with low-to-intermediate complex CAD.

Background: Coronary artery disease, especially in the elderly population, can lead to calcification of the arteries, which is tightly connected to an unfavorable prognosis. We investigated the combination of coronary intravascular lithotripsy (IVL) to ease deliverability of drug-coated balloons (DCBs) with the potential favorable effect of DCB in avoiding vessel thrombosis due to lack of foreign body implantation.

Methods: Seventy-three calcified lesions were studied in an open, observational, prospective, single-arm consecutive registry. The role of IVL was studied as to the facilitation of DCB delivery, procedural, angiographic, and clinical outcomes. DCB only angioplasty without stenting was possible in 55 (75%) of these lesions after successful treatment with IVL for the analysis of procedural and long-term outcomes, while 35 patients had 4 months follow-up quantitative angiography to study angiographic success.

Results: Despite the severe calcifications, the DCB could be advanced in time in all cases: delivery was easy and without any (n = 43), with minimal resistance (n = 6), and some friction (n = 6), and the average delivery time was 30.9 s. Angiographic follow-up at 4 months revealed only 1 binary restenosis and no increase in percent stenosis (26%). Average late lumen gain was 0.04 mm (95%CI =  - 0.15 mm; 0.07 mm). 30.3% of the lesions showed a negative in-lesion late loss, i.e., a late lumen gain of ≥ 0.20 mm.

Conclusion: Lesion preparation of severely calcified coronary stenoses with IVL greatly facilitates DCB delivery. Like non-calcified lesions, the calcified lesions treated did not show significant late lumen loss and a tendency towards late lumen gain.

Background: Limited data is available for long-term outcomes after percutaneous coronary intervention (PCI) of coronary drug-eluting stent (DES) in-stent restenosis (ISR) in diabetics.

Aims: Thus, the aim of this observational, retrospective study was to close this lack of evidence.

Methods: Between January 2007 and February 2021, a total of 3511 patients with 5497 ISR lesions were treated at two large-volume centers in Munich, Germany, of which 1242 (35.4%) were diabetics. Endpoints of interest were the rates of cardiac death, repeat revascularization, and myocardial infarction (MI). Survival was analyzed using the Kaplan-Meier method. Differences between the groups were tested with the log-rank test. Conventional multivariable analysis with adjustment for relevant variables was performed.

Results: After 10 years, the rates of cardiac death were 42.8% for diabetics and 32.8% for nondiabetics (HR_adj 1.55 [95% CI, 1.31-1.81], p < 0.001). MI occurred in 15.9% of diabetics and in 9.7% of non-diabetics (HR_adj 1.70 [95% CI, 1.36-2.11], p < 0.001). The rates of repeat revascularization of target lesion (HR_adj 1.17 [95% CI, 1.02-1.34], p = 0.028), target vessel, and nontarget vessel were significantly higher in diabetics as compared to nondiabetics. No statistically relevant difference was found regarding the rate of stent thrombosis. Compared to non-insulin-dependent diabetics, insulin-dependent diabetics show higher rates of cardiac death and MI, but comparable revascularization rates in both diabetic groups.

Conclusions: In the long term, the rates of cardiac death, MI, and repeat revascularization after PCI of DES-ISR are significantly higher in diabetics, particularly in insulin-dependent diabetics, than in nondiabetics.

Background: Transradial access (TRA) is recommended as the primary route for coronary angiography (CAG) and percutaneous coronary intervention (PCI). In recent years, a more distal puncture site in the area of the anatomical snuffbox (distal radial access; dRA) has been established. In this randomized multicenter trial, we aim to demonstrate the superiority of dRA with respect to the rate of radial artery occlusion (RAO) compared with the traditional proximal radial access (pRA).

Methods: Patients scheduled for CAG or PCI in five cardiology centers in Germany were randomized for standard pRA or dRA. The primary endpoint was a reduced rate of RAO (superiority) after 30 days. Secondary endpoints included crossover rate, hand function assessed by QuickDASH test, duration of the puncture and procedure, and the puncture success rate. Proximal and distal radial artery patency was examined by ultrasound within 48 h and after 30 days.

Results: A total of 254 patients were enrolled (mean age: 66 ± 10 years, 71% male gender, 48% PCI). The trial was halted prematurely after 50% of the planned population. The primary endpoint was numerically reduced in the dRA group (N = 1/128; 0.9%) compared with the pRA group (N = 3/126, 2.8%), but the difference was not statistically significant (P = 0.36). Puncture success was high in both arms (N = 240/254, 94%) and no statistically significant difference between the two puncture sites (dRA: 91%; pRA: 98%) was observed. Major complications were not encountered.

Conclusion: The rate of radial artery occlusion after dRA for coronary intervention was not significantly reduced compared with pRA.

Trial registration: This study is registered in ClinicalTrials: NCT04194606.

Background: The use of drug-coated balloons (DCB) in percutaneous coronary interventions (PCI) is increasing due to potential benefits mainly by avoiding foreign material although a widespread application area beyond in-stent restenosis lacks robust clinical data to date. As such, we aimed to assess the safety and efficacy of DCBs in treating de novo lesions.

Methods: For this analysis, we included all patients treated with DCB in a de novo lesions from 2010 to 2019 at our institution. We performed a 1:1 propensity score matching to pair each DCB intervention with a comparable DES intervention. Follow-up continued until 09/2022 to assess clinical outcomes.

Results: A total of 303 patients with de novo lesion were matched to 303 patients with comparable baseline characteristics. The median follow-up time was 5.7 years (IQR 2.7-9.3). There were no significant differences in cardiovascular (CV) mortality (HR 1.01 [95% CI 0.87-1.19], p value 0.874), all-cause mortality (HR 1.05 [95% CI 0.91-1.22], p value 0.491), MACE (HR 1.10 [95% CI 0.96-1.26], p value 0.170), acute myocardial infarction (HR 1.08 [95% CI 0.90-1.19], p value 0.308), or any revascularization (HR 1.03 [95% CI 0.90-1.19], p value 0.671) between both groups. However, we observed a trend toward lower rates of target lesion revascularization in patients with small vessel disease (HR 0.84 [95% CI 0.68-1.02], p value 0.072), and in side branch lesions (HR 0.79 [95% CI 0.58-1.04], p value 0.096).

Conclusion: DCBs demonstrated long-term safety and efficacy in de novo lesions, with promising trends in reducing target lesion revascularization in small vessel disease and side branches.

Background: Drug-coated balloons (DCBs) are increasingly used to treat coronary artery disease, and their safety and efficacy profile can vary based on the eluted drug and excipient. Head-to-head comparisons of paclitaxel-coated balloons (PCBs) according to contemporary excipient formulations are scant.

Methods: Consecutive patients undergoing DCB angioplasty with either urea PCB (Prevail, Medtronic, Dublin, Ireland) or iopromide PCB (Sequent Please / NEO, B. Braun, Melsungen, Germany) at two Italian institutions from 2021 to 2024 were retrospectively enrolled. The primary endpoint was target lesion failure (TLF), a composite including target lesion revascularization, target vessel myocardial infarction, and cardiac death, at 1 year. Clinical endpoints were compared through propensity score adjustment for clinical and angiographic variables.  RESULTS: A total of 448 patients were included, with 211 patients (240 lesions) treated with urea PCB and 237 patients (287 lesions) treated with iopromide PCB. The prevalence of in-stent restenosis (ISR) was 30% in the urea PCB group and 23% in the iopromide PCB (p = 0.070). At 1 year, the cumulative incidence of TLF was 8.1% in both groups (adjusted hazard ratio (HR): 0.90, 95% CI: 0.27-3.00). Rates of secondary endpoints were also similar. Subgroup analyses showed no significant interaction between treatment groups and any of the prespecified subgroups, including lesion type (de novo vs. in-stent restenosis; p_interaction = 0.848).  CONCLUSIONS: In this first head-to-head comparison, the Prevail urea PCB and Sequent Please / NEO iopromide PCB demonstrated comparable clinical safety and efficacy profiles at 1 year.

Background: Intravascular ultrasound (IVUS) plays a central role in complex percutaneous coronary interventions (PCI). While guidance for stenting and optimization is the most common reason for IVUS use, the technical application of IVUS for greater procedural efficiency is becoming increasingly important. The impact of IVUS has been only partially investigated in its technical aspect.

Methods: We analyzed 15,226 CTO-PCIs from the EuroCTO registry between January 2022 and December 2023. We compared CTO PCI procedures performed with or without IVUS and further categorized IVUS use based on its application (technical reasons or stent optimization).

Results: IVUS was used in 22% (n = 3393) of cases and increased consistently from 12 to 24% between 2016 and 2023. Guidance for stenting and optimization remained the most common indication (86.4% of IVUS cases). Importantly, IVUS was utilized in 7.2% (n = 1092) of cases for technical reasons, mainly to identify the proximal cap (55.7% of technical indications, n = 608). IVUS-guided CTO-PCIs showed higher J-CTO scores (2.46 ± 1.20 vs. 2.19 ± 1.25; p < 0.001) and greater use of the retrograde approach (28% vs. 19%; p < 0.001). Technical success rates were comparable between the IVUS and angiographic groups (90% vs. 92%; p = ns). High-experience IVUS users achieved greater technical success compared to low- and intermediate-experience users (p < 0.010). On multivariable analysis, IVUS use was an independent predictor of technical success (odds ratio 1.39, 95% CI from 1.07 to 1.82, p value = 0.016).

Conclusions: IVUS in CTO PCI is primarily used for stent optimization. However, there is an increasing use of IVUS for technical reasons resulting in similar technical success rates even in more complex lesions and standing out as an independent predictor of success. Experience seems to play a role, with an advantage for highly experienced users.