Gender differences in percutaneous coronary intervention for chronic total occlusions from the ERCTO study.

BACKGROUND: Gender-specific data addressing percutaneous coronary intervention (PCI) of chronic total occlusion (CTO) in female patients are scarce and based on small sample size studies. AIMS: We aimed to analyze gender-differences regarding in-hospital clinical outcomes after CTO-PCI. METHODS: Data from 35,449 patients enrolled in the prospective European Registry of CTOs were analyzed. The primary outcome was the comparison of procedural success rate in the two cohorts (women vs. men), defined as a final residual stenosis less than 20%, with Thrombolysis In Myocardial Infarction grade flow = 3. In-hospital major adverse cardiac and cerebrovascular events (MACCEs) and procedural complications were deemed secondary outcomes. RESULTS: Women represented 15.2% of the entire study population. They were older and more likely to have hypertension, diabetes, and renal failure, with an overall lower J-CTO score. Women showed a higher procedural success rate (adjusted OR [aOR] = 1.115, confidence interval [CI]: 1.011-1.230, p = 0.030). Apart from previous myocardial infarction and surgical revascularization, no other significant gender differences were found among predictors of procedural success. Antegrade approach with true-to-true lumen techniques was more commonly used than retrograde approach in females. No gender differences were found regarding in-hospital MACCEs (0.9% vs. 0.9%, p = 0.766), although a higher rate of procedural complications was observed in women, such as coronary perforation (3.7% vs. 2.9%, p < 0.001) and vascular complications (1.0% vs. 0.6%, p < 0.001). CONCLUSIONS: Women are understudied in contemporary CTO-PCI practice. Female sex is associated with higher procedural success after CTO-PCI, yet no sex differences were found in terms of in-hospital MACCEs. Female sex was associated with a higher rate of procedural complications.

Acceptance and safety of femoral versus radial access for percutaneous coronary intervention (PCI): results from a large monitor-controlled German registry (QuIK).

BACKGROUND: In 2015 and 2018, European Society of Cardiology guidelines for percutaneous coronary intervention (PCI) favoring radial access over femoral access were published. These recommendations were based on randomized trials suggesting that patients treated radially experienced reduced bleeding complications and all-cause mortality. We aimed to assess acceptance and results of radial access in a real-world scenario by analyzing all PCI cases in the Quality Assurance in Invasive Cardiology (QuIK) registry. METHODS: The QuIK registry prospectively collects data on all diagnostic and interventional coronary procedures from 148 private practice cardiology centers in Germany. Major adverse cardiac and cerebrovascular events (MACE) were defined as myocardial infarction, stroke, or death during hospitalization. RESULTS: From 2012 to 2018, 189,917 patients underwent PCI via either access method. The rate of radial approach steadily increased from 13 to 49%. The groups did not differ significantly with respect to age or extent of coronary disease. Femoral approach was significantly more common in patients with ST elevation myocardial infarction and cardiogenic shock. Overall, there were significant differences in MACE (radial 0.12%; femoral 0.24%; p < 0.0009) and access site complications (radial 0.2%; femoral 0.8% (p < 0.0009). CONCLUSION: Our data reveals an increase in use of radial access in recent years in Germany. The radial approach emerged as favorable regarding MACE in non-myocardial infarction patients, as well as favorable regarding access site complication regardless of indication for percutaneous intervention.

Smartphone-derived multichannel electrocardiogram for exercise stress testing.

INTRODUCTION: The use of mobile devices for electrocardiogram (ECG) recording and the ability to use this technology to immediately review dynamic waveforms is growing tremendously. While over-the-counter ECG devices may display rhythm disorders and ST-segment changes at rest, changes during physical exercise have thus far not been evaluated. We compared a mobile device (smartphone/tablet)-enabled vectorial 4-electrode ECG system (SPE) with the current standard 12­lead (STE) ECG both at rest and during exercise. METHODS AND RESULTS: A total of 428 patients underwent simultaneous ECG testing with both technologies during rest and maximal exercise. The vectorial ECG was displayed as 12­lead ECG, and diagnostic accuracy and ECG quality (independently judged by blinded cardiologists) were compared with the current standard. Signal quality was good with both ECG technologies. At rest, there was excellent agreement between SPE and STE regarding rhythm (98%), AV-conduction (97%), wave duration (90%), and electrical axis (88-97%). During exercise the presence or absence of ST-deviation (>0.1 mm) corresponded in 90% of cases with no statistically significant difference. The positive predictive value was 48.5% and the negative predictive value was 94%. For ST-deviations >0.2 mm the percentage match was 97% during exercise. For rhythm disorders and for intraventricular conduction (left- and right-bundle branch block detection) it was >90%. CONCLUSION: A smart-device-enabled vectorial ECGs system using the CardioSecur system can be used in daily practice to reliably interpret an ECG at rest and during physical exercise, although it is less accurate with respect to the detection of ST-deviation.

Influence of novel X-ray imaging technology on radiation exposure during chronic total occlusion procedures.

OBJECTIVES: We assessed whether use of the novel X-ray imaging technology AlluraClarity (Philips Healthcare, Best, The Netherlands) results in a meaningful reduction of radiation exposure for patients during coronary intervention on chronic total occlusions (CTO-PCI) compared to its predecessor Allura Xper (Philips Healthcare, Best, The Netherlands). BACKGROUND: Percutaneous coronary intervention on chronic total occlusion causes 2- to 10-fold higher radiation burden on patients and operators compared to standard PCI. To avoid iatrogenic damage to our patients and personnel, all efficient ways to reduce radiation should be identified and implemented. METHODS: Radiation exposure of 196 consecutive CTO patients treated in the same laboratory by a single experienced operator (total experience: > 2,500 CTOs, annual experience: > 100 CTOs/year) was analyzed. Ninety-eight CTO-PCIs (n1 ) were performed with the Allura Xper system and 98 patients (n2 ) were treated using AlluraClarity. RESULTS: The two groups had similar BMI (n1 : mean 28.43 kg/m2 ; n2 : mean 28.41 kg/m2 ), procedure duration (n1 : mean 75.9 min; n2 : mean 70.7 min), and J-CTO scores (n1 : mean 2.99; n2 : mean 2.82). The success rates did not differ (n1 : 86/98 successful). n2 : 87/98 successful). The radiation doses, however, revealed significant differences in kerma area product (KAP; absolute reduction of 34%; n1 : mean 61.5 Gycm2 ; n2 : mean 40.8 Gycm2 ; P < 0.002) and cumulative air kerma (AK; absolute reduction of 30%; n1 : mean 966.8 mGy; n2 : mean 675.9 mGy; P < 0.002). CONCLUSION: Use of the novel X-ray imaging technology resulted in a meaningful and significant reduction in patient radiation exposure during complex coronary interventions (CTO-PCI) compared to use of its predecessor. Similar success rates support the operator's subjective impression of similar, and in some cases superior, image quality.

Comparison of the ipsi-lateral versus contra-lateral retrograde approach of percutaneous coronary interventions in chronic total occlusions.

BACKGROUND: Retrograde recanalization of coronary chronic total occlusions (CTO) via contralateral (CL) collateral connections (CCs) is successful in 60-70% of patients in whom conventional antegrade approach fails or is unpromising. This study describes our experience with retrograde CTO-PCI via ipsi-lateral (IL) CCs in patients with unfavorable CL CCs. METHODS: Between January 2013 and September 2015, 392 consecutive CTO procedures were performed by two high volume CTO-operators and the relevant data were fed into an online registry (ERCTO® EuroCTO-club). Most patients (222/392; 57%) were approached antegradely, whereas 43% were attempted retrogradely (170/392). After exclusion of all procedures performed via bypass-grafts (n = 12), PCI via CL CCs, the CL-group (n = 114/158; 72%), was compared with the IL-group that was attempted via IL CCs (n = 44/158; 28%). RESULTS: Both groups were similar with respect to risk factors and morphologic criteria of CTO-severity. The initial primary strategy was successful in 78% in the CL-group and in 68% in the IL-group. In both patient groups, the initial strategy had to be switched in five patients from CL toward IL (4.4%, n = 5/114) and from IL to CL (11.3% n = 5/44). The rate of major complications was 7% (CL) and 5% (IL), respectively (n.s.). After retrograde failure and cross-over to an antegrade controlled re-entry strategy the overall success rates increased to 92% (CL) and 93% (IL). CONCLUSIONS: In experienced hands retrograde CTO-PCI via IL CCs appears as safe and successful as the CL approach. © 2016 Wiley Periodicals, Inc.

Appropriateness of percutaneous revascularization of coronary chronic total occlusions: an overview.

Coronary chronic total occlusions (CTOs) are commonly encountered in patients undergoing coronary angiography. Several observational studies have demonstrated that successful CTO revascularization is associated with better cardiovascular outcomes and enhanced quality of life (QOL). However, in the absence of randomized trials, its prognostic benefit for patients remains debated. Over the past decade, the interest of the interventional community in CTO percutaneous coronary intervention (PCI) has exponentially grown due to important developments in dedicated equipment and techniques, resulting in high success and low complication rates. Both European and American guidelines have assigned a class IIa (level of evidence B) recommendation for CTO PCI. In the current review, we focus on the impact of CTO revascularization on clinical outcomes and QOL and on appropriate patient selection, and we provide a critical assessment of the current guidelines and recommendations on CTO PCI.

Contemporary outcomes of chronic total occlusion percutaneous coronary intervention in Europe: the ERCTO registry.

BACKGROUND: Percutaneous coronary interventions (PCI) of chronic total occlusions (CTO) have reached high procedural success rates thanks to dedicated equipment, evolving techniques, and worldwide adoption of state-of-the-art crossing algorithms. AIMS: We report the contemporary results of CTO PCIs performed by a large European community of experienced interventionalists. Furthermore, we investigated the impact of different risk factors for procedural major adverse cardiac and cerebrovascular events (MACCE) and trends of employment of specific devices like dual lumen microcatheters, guiding catheter extensions, intravascular ultrasound and calcium-modifying tools. METHODS: We evaluated data from 8,673 CTO PCIs included in the European Registry of Chronic Total Occlusion (ERCTO) between January 2021 and October 2022. RESULTS: The overall technical success rate was 89.1% and was higher in antegrade as compared with retrograde cases (92.8% vs 79.3%; p<0.001). Compared with antegrade procedures, retrograde procedures had a higher complexity of attempted lesions (Japanese CTO [J-CTO] score: 3.0±1.0 vs 1.9±1.2; p<0.001), a higher procedural and in-hospital MACCE rate (3.1% vs 1.2%; p<0.018) and a higher perforation rate with and without tamponade (1.5% vs 0.4% and 8.3% vs 2.1%, respectively; p<0.001). As compared with mid-volume operators, high-volume operators had a higher technical success rate in antegrade and retrograde procedures (93.4% vs 91.2% and 81.5% vs 69.0%, respectively; p<0.001), and had a lower MACCE rate (1.47% vs 2.41%; p<0.001) despite a higher mean complexity of the attempted lesions (J-CTO score: 2.42±1.28 vs 2.15±1.27; p<0.001). CONCLUSIONS: The adoption of different recanalisation techniques, operator experience and the use of specific devices have contributed to a high procedural success rate despite the high complexity of the lesions documented in the ERCTO.

Retrograde Chronic Total Occlusion Percutaneous Coronary Interventions: Predictors of Procedural Success From the ERCTO Registry.

OBJECTIVES: The aim of this study was to identify independent predictors of procedural success after retrograde chronic total occlusion (CTO) percutaneous coronary intervention (PCI). BACKGROUND: Retrograde CTO PCI is an established technique, but predictors of success remain poorly understood. METHODS: A multivariable logistic regression model was used to analyze potentially important demographic, clinical, anatomical, and technical aspects of retrograde CTO PCI cases uploaded to the multicenter European CTO (ERCTO) Club Registry. RESULTS: In calendar years 2018 and 2019, 2,364 retrograde CTO PCI cases constituted the primary analysis cohort. A primary retrograde strategy was used in 1,953 cases (82.6%), and an initial antegrade approach was converted to retrograde in 411 cases (17.4%). Procedural success was achieved in 1,820 cases (77.0%) and was more likely to occur after a primary retrograde attempt versus conversion from an initial antegrade approach (80.9% vs 58.4%; P < 0.0001). After multivariable analysis, an absence of lesion calcification (OR: 1.86; 95% CI: 1.37-2.51; P < 0.0001), a higher degree of distal vessel opacification (OR: 2.47; 95% CI: 1.72-3.55; P < 0.0001), little or no proximal target vessel tortuosity (OR: 1.84; 95% CI: 1.28-2.64; P = 0.001), Werner collateral connection CC1 (OR: 4.87; 95% CI: 2.90-8.19; P < 0.0001) or CC2 (OR: 5.33; 95% CI: 3.02-9.42; P < 0.0001), and the top tertile of operator volume (>120 cases over 2 years) (OR: 1.88; 95% CI: 1.26-2.79; P = 0.002) were associated with the greatest chance of achieving angiographic success. CONCLUSIONS: Less calcification with good distal vessel opacification, little or absent proximal vessel tortuosity, and visible collateral connections, along with high-volume operator status, were all independently predictive of angiographically successful retrograde CTO PCI.

Microcatheters for antegrade recanalization of chronic total coronary occlusions: Feasibility and safety of the corsair - A retrospective registry-based single operator experience.

BACKGROUND: The Corsair collateral channel dilator was designed for retrograde passage in cases of coronary chronic total occlusion (CTO). Its antegrade use is discouraged and the number of published studies regarding such use is limited. Our single-operator experience examines the feasibility and safety of the Corsair in antegrade recanalization of chronic CTOs in a large cohort. METHODS: We queried the European Registry of Chronic Total Occlusion (ERCTO) for all microcatheters used in antegrade recanalizations between 2008 and 2016. We also retrospectively assessed all 722 coronary interventions for CTOs (624 antegrade, 98 retrograde) between January 2008 and December 2016, performed by a single operator who primarily applied the Corsair as antegrade microcatheter. Patient, procedure, and outcome data was analyzed. RESULTS: In 17,787 cases performed by 93 operators contributing to the ERCTO database, there were 3294 with information on microcatheter type. The FineCross MG (73.9 %) was the most commonly used microcatheter. The Corsair was used in only 1.2 % (excluding patients in the single-operator cohort). In the same period 45.7 % (n = 285) of all 624 antegrade cases handled by our single operator were performed using the Corsair, with no exclusions due to anatomical or morphological criteria. The procedural success rate was 93.7 %. There were 2 cases of cardiac tamponade, 5 cases of minor perforation, and one catheter tip fracture. CONCLUSIONS: The Corsair is rarely used for antegrade recanalization. In this single-operator experience, the antegrade use of the Corsair was safe. The success rate was high, although causative conclusions cannot be drawn.

Experience with the novel unifemoral parallel sheath technique in percutaneous intervention of chronic total coronary occlusions.

BACKGROUND: Percutaneous interventions to address chronic coronary occlusions (CTO-PCI) often require simultaneous ipsi- and contralateral coronary injections. Although radial access is increasingly popular, bifemoral artery access is still the preferred choice of CTO operators. The aim of this case series is to demonstrate the feasibility and safety of the unifemoral parallel sheath technique, which avoids two puncture sites, increases patient comfort, and improves procedure ergonomics. It offers rapid second access to the femoral artery adjacent to the first sheath as well as closure by unilateral manual compression without or with 1 or 2 vascular closure devices. RESULTS: We retrospectively evaluated the procedure results in 90 consecutive CTO patients where an ipsilateral parallel sheath access was considered. Placement of the second sheath uneventfully failed in two because of severe femoral calcification and narrowing. In 96.6%, the first sheath was 7 F (3.4% 6F), while the second sheath was 4 F in 22.7%, 5 F in 64.7%, and 6 or 7 F in 11.4% each. No major complications nor severe bleeding events occurred, and the mean drop of hemoglobin was low (0.6 g/dL ± 0.86). CONCLUSION: In CTO-PCI requiring contralateral coronary injections or the retrograde technique, the ipsilateral parallel sheath technique might be a feasible alternative to the standard bifemoral or femoral-radial access.

Radiation Exposure for Percutaneous Interventions of Chronic Total Coronary Occlusions in a Multicenter Registry: The Influence of Operator Variability and Technical Set-up.

AIMS: Radiation exposure is a limiting factor for percutaneous coronary interventions (PCI) of chronic total coronary occlusion (CTO) lesions. This study was designed to analyze changes in patient radiation dose for CTO-PCI and parameters associated with radiation dose. METHODS AND RESULTS: We analyzed a cohort of 12,136 procedures performed by 23 operators between 2012 and 2017 from the European Registry of CTO-PCI. Radiation exposure was recorded as air kerma (AK) and dose area product (DAP). A dose rate index (DRI) was calculated as AK per fluoroscopy time to normalize for individual differences in fluoroscopy time. The lesion complexity increased from Japanese-CTO (J-CTO) score of 2.19 ± 1.44 to 2.46 ± 1.28, with an increase of retrograde procedures from 31.1% to 40.7%; still, procedural success improved from 87.7% to 92.1%. Fluoroscopy time remained similar, but AK decreased by 14.9%, from 2.35 Gy (interquartile range [IQR], 1.29-4.14 Gy) to 2.00 Gy (IQR, 1.08-3.45 Gy) and DAP decreased by 21.5%, from 130 Gy•cm² (IQR, 70-241 Gy•cm²) to 102 Gy•cm² (IQR, 58-184 Gy•cm²). Radiation exposure was determined by the lesion complexity (J-CTO score) and procedural complexity (antegrade or retrograde). DRI was determined by fluoroscopy frame rate and type of equipment used, but the major influence remained interoperator differences. CONCLUSIONS: Radiation exposure decreased during the observation period despite an increase in lesion and procedural complexity. While many operators already achieved a goal of low radiation exposure, there were considerable interoperator differences in radiation management, indicating further potential for improvement.

Differences in patients and lesion and procedure characteristics depending on the age of the coronary chronic total occlusion.

INTRODUCTION: Whether duration of chronic total occlusion (CTO) affects lesion and procedural characteristics remains largely unknown. AIM: To investigate whether CTO duration influences lesion characteristics and revascularization success. MATERIAL AND METHODS: EuroCTO Registry data on patients who had CTO percutaneous coronary intervention between January 2015 and April 2017 were analyzed. Three groups were created based on occlusion age: 3 to 6 months (n = 1415), 7 to 12 months (n = 973), > 12 months (n = 1656). RESULTS: Patients with greater CTO duration were older (63.0 (56.0-70.0); 63.0 (56.0-71.0); 66.0 (59.0-73.0) years respectively; p < 0.001), had more 3-vessel disease (32.2%; 30.9%; 46.1% respectively; p < 0.001) and more frequent prior coronary artery bypass grafting (8.2%; 9.9%; 29.4% respectively; p < 0.001). In multivariate analysis, occlusion duration was associated with moderate/severe calcification (OR = 1.52; 95% CI: 1.28-1.80; p < 0.001), lesion length > 20 mm (OR 1.77; 95% CI 1.49-2.10; p < 0.001), and collateral circulation Werner type 2 (OR = 1.20; 95% CI: 1.01-1.43; p = 0.041). The CTO duration was associated with lower procedural success (OR for success 0.60; 95% CI: 0.46-0.79; p < 0.001). In multivariate analysis in-hospital adverse events did not differ according to duration of CTO. CONCLUSIONS: Coronary artery CTO duration is associated with greater extent of calcification, lesion length, development of collateral circulation and, most importantly, with lower procedural success.

Percutaneous recanalisation of chronic total occlusions: 2019 consensus document from the EuroCTO Club.

Since its inception in December 2006, the EuroCTO Club has strived to provide the framework for state-of-the-art chronic total occlusion (CTO) percutaneous coronary intervention (PCI) in Europe and nearby regions. Among its initiatives, the EuroCTO Club has published a set of recommendations regarding the technical aspects of CTO PCI, whose last edition dates to 2012. The EuroCTO Club consensus document discusses CTO PCI clinical indications, techniques and equipment use, as well as the qualifications of operators/centres. Given the considerable amount of progress made by this subspecialty in recent years, there is a need for an updated document that includes data from recent clinical trials and registries, information on novel devices and techniques, and an up-to-date revision on the training requirements to approach CTO PCI. The current updated consensus document of the EuroCTO Club reflects the expertise of European operators to promote the widespread application of state-of-the-art CTO PCI, not only in Europe but also across neighbouring communities.

Derivation and Validation of a Chronic Total Coronary Occlusion Intervention Procedural Success Score From the 20,000-Patient EuroCTO Registry: The EuroCTO (CASTLE) Score.

OBJECTIVES: The aim was to establish a contemporary scoring system to predict the outcome of chronic total occlusion coronary angioplasty. BACKGROUND: Interventional treatment of chronic total coronary occlusions (CTOs) is a developing subspecialty. Predictors of technical success or failure have been derived from datasets of modest size. A robust scoring tool could facilitate case selection and inform decision making. METHODS: The study analyzed data from the EuroCTO registry. This prospective database was set up in 2008 and includes >20,000 cases submitted by CTO expert operators (>50 cases/year). Derivation (n = 14,882) and validation (n = 5,745) datasets were created to develop a risk score for predicting technical failure. RESULTS: There were 14,882 patients in the derivation dataset (with 2,356 [15.5%] failures) and 5,745 in the validation dataset (with 703 [12.2%] failures). A total of 20.2% of cases were done retrogradely, and dissection re-entry was performed in 9.3% of cases. We identified 6 predictors of technical failure, collectively forming the CASTLE score (Coronary artery bypass graft history, Age (≥70 years), Stump anatomy [blunt or invisible], Tortuosity degree [severe or unseen], Length of occlusion [≥20 mm], and Extent of calcification [severe]). When each parameter was assigned a value of 1, technical failure was seen to increase from 8% with a CASTLE score of 0 to 1, to 35% with a score ≥4. The area under the curve (AUC) was similar in both the derivation (AUC: 0.66) and validation (AUC: 0.68) datasets. CONCLUSIONS: The EuroCTO (CASTLE) score is derived from the largest database of CTO cases to date and offers a useful tool for predicting procedural outcome.

Temporal Trends in Chronic Total Occlusion Interventions in Europe.

BACKGROUND: The study focuses on the evolution of practice, procedural outcomes, and in-hospital complications of chronic total occlusion percutaneous coronary intervention in Europe. METHODS AND RESULTS: Data from 17 626 procedures enrolled in European Registry of Chronic Total Occlusion between January 2008 and June 2015 were assessed. The mean patient age was 63.9±10.9 years; 85% were men. Procedural success increased from 79.7% to 89.3% through the study period. Patients enrolled during the years had increasing comorbidities and lesion complexity (J-CTO score [Multicenter CTO Registry of Japan] increased from 1.76±1.03 in 2008 to 2.17±0.91 in 2015; P for trend, <0.001). Retrograde approach utilization steadily increased from 10.1% in 2008 to 29.9% in 2015 ( P for trend, <0.001). Antegrade dissection reentry adoption was low, not exceeding 5.5%. In-hospital mortality decreased during the study period from 0.4% to 0.1% ( P for trend, <0.001), whereas in-hospital complication rates remained essentially unchanged, in the range 4.4% to 5.2% ( P for trend, 0.390). CONCLUSIONS: Chronic total occlusion percutaneous coronary intervention has shown a steady increase in procedural success rate over time, with unchanged complication rates, despite the increasing complexity of the lesions attempted. The J-CTO score predictive value for procedural success was low for the entire registry and had no predictive ability for the retrograde approach.

High adherence to therapy and low cardiac mortality and morbidity in patients after acute coronary syndrome systematically managed by office-based cardiologists in Germany: 1-year outcomes of the ProAcor Study.

We aimed to assess patient acceptance and effectiveness of a 12-month structured management program in patients after an acute coronary syndrome (ACS) event who were treated in a special setting of office-based cardiologists. The program comprised patient documentation with a specific tool (Bundesverband Niedergelassener Kardiologen [German Federation of Office-Based Cardiologists] cardiac pass with visit scheduling) shared by the hospital physician and the office-based cardiologist, the definition of individual treatment targets, and the systematic information of patients in order to optimize adherence to therapy. Participating centers (36 hospitals, 60 office-based cardiologists) included a total of 1,003 patients with ACS (ST-segment elevation myocardial infarction [STEMI] 44.3%, non-ST-segment elevation myocardial infarction [NSTEMI] 39.5%, unstable angina pectoris [UA] 15.2%, and unspecified 1.0%). During follow-up, treatment rates with cardiac medication remained high in all groups, with dual antiplatelet therapy in 91.0% at 3 months, 90.0% at 6 months, and 82.8% at 12 months, respectively. Twelve months after the inclusion, a total of 798 patients (79.6%) still participated in the program. Eighteen patients (1.8%) had died after discharge from hospital (6 in the STEMI, 12 in the NSTEMI group), while for 58 the status was unknown (5.8%). Based on a conservative approach that considered patients with unknown status as dead, 1-year mortality was 7.6%. Recurrent cardiac events were noted in 14.9% at 1 year, with an about equal distribution across STEMI and NSTEMI patients. In conclusion, patients' acceptance of the ProAcor program as determined by adherence rates over time was high. Treatment rates of recommended medications used for patients with coronary heart disease were excellent. The 1-year mortality rate was comparatively low.

A double-blind, randomized, placebo-controlled multicenter clinical trial to evaluate the effects of the angiotensin II receptor blocker candesartan cilexetil on intimal hyperplasia after coronary stent implantation.

BACKGROUND: Preclinical data suggest beneficial effects of angiotensin II receptor blockers (ARBs) on neointima formation after vascular injury. Preliminary clinical data, however, revealed conflicting results. The AACHEN trial was a double-blind, randomized, placebo-controlled clinical multicenter trial to evaluate the effects of candesartan cilexetil on intimal hyperplasia after coronary stent implantation. METHODS: A total of 120 patients (61 +/- 9 years, 83% male) were randomized to receive either 32 mg candesartan cilexetil (active) or placebo starting 7 to 14 days before elective coronary stent implantation. A follow-up angiography including intravascular ultrasound assessment of the target lesion was performed 24 +/- 2 weeks after stent implantation. The primary end point was defined as the difference in neointimal area between groups as assessed by intravascular ultrasound. Secondary end points included differences in angiographic parameters (ie, restenosis rate) and incidence of major cardiac events. RESULTS: The mean stent length measured 15.0 +/- 4.9 mm in the active and 14.6 +/- 5.7 mm in the placebo group (P = .81). There was no significant difference in neointimal area between groups (2.1 +/- 1.0 vs 2.1 +/- 1.5 mm2, P = 1.00), nor were there differences in angiographic end point parameters. Major cardiac event rates were not significantly different between treatment groups (8% vs 11%, P = .75). CONCLUSIONS: High-dose candesartan cilexetil therapy in patients with symptomatic coronary artery disease undergoing coronary stent implantation does not reduce clinical event rates, restenosis rates, or neointimal proliferation after elective stent implantation.

Inhibition of restenosis with a paclitaxel-eluting, polymer-free coronary stent: the European evaLUation of pacliTaxel Eluting Stent (ELUTES) trial.

BACKGROUND: The use of a stent to deliver a drug may reduce in-stent restenosis. Paclitaxel interrupts the smooth muscle cell cycle by stabilizing microtubules, thereby arresting mitosis. METHODS AND RESULTS: On the basis of prior animal studies, the European evaLUation of the pacliTaxel Eluting Stent (ELUTES) pilot clinical trial (n=190) investigated the safety and efficacy of V-Flex Plus coronary stents (Cook Inc) coated with escalating doses of paclitaxel (0.2, 0.7, 1.4, and 2.7 microg/mm2 stent surface area) applied directly to the abluminal surface of the stent in de novo lesions compared with bare stent alone. The primary efficacy end point was angiographic percent diameter stenosis at 6 months. At angiographic follow-up, percent diameter stenosis was 33.9+/-26.7% in controls (n=34) and 14.2+/-16.6% in the 2.7-microg/mm2 group (n=31; P=0.006). Late loss decreased from 0.73+/-0.73 to 0.11+/-0.50 mm (P=0.002). Binary restenosis (> or =50% at follow-up) decreased from 20.6% to 3.2% (P=0.056), with no significant benefit from intermediate paclitaxel doses. Freedom from major adverse cardiac events in the highest (effective) dose group was 92%, 89%, and 86% at 1, 6, and 12 months, respectively (P=NS versus control). No late stent thromboses were seen in any treated group despite clopidogrel treatment for 3 months only. CONCLUSIONS: Paclitaxel applied directly to the abluminal surface of a bare metal coronary stent, at a dose density of 2.7 microg/mm2, reduced angiographic indicators of in-stent restenosis without short- or medium-term side effects.

High-dose 7-hexanoyltaxol-eluting stent with polymer sleeves for coronary revascularization: one-year results from the SCORE randomized trial.

OBJECTIVES: The Study to COmpare REstenosis Rate between QueST and QuaDDS-QP2 (SCORE) trial was a multicenter, randomized, open-label trial comparing the safety and performance of 13- and 17-mm QuaDDS stents (n = 126) (Quanam Medical Corp., Santa Clara, California/Boston Scientific Corp., Natick, Massachusetts) versus uncoated control stents (n = 140) in focal, de novo coronary lesions. BACKGROUND: The pioneering drug-delivery QuaDDS stent used four to six acrylate polymer sleeves, each loaded with 800 microg of the paclitaxel derivative 7-hexanoyltaxol. METHODS: Clinical end points were assessed at 1, 6, and 12 months post procedure. Quantitative coronary angiography and intravascular ultrasound were performed post procedure and at six-month follow-up. RESULTS: In the QuaDDS group, early stent thrombosis and myocardial infarction (MI) rates were significantly higher, leading to premature cessation of enrollment. For the QuaDDS group, the stent thrombosis rate increased from 3.2% to 10.3% between 1 and 12 months, associated with increased non-Q-wave MI and death rates. The angiographic restenosis rate at six months was reduced from 32.7% (control) to 7.4% (p < 0.0001). However, the primary end point was not met with six-month target vessel revascularization (TVR) rate as well as the composite major adverse cardiac event rates (cardiac death, MI, and TVR) comparable between groups. CONCLUSIONS: Despite angiographic indications of potential anti-restenotic benefit, increased rates of stent thrombosis, MI, and cardiac death associated with the QuaDDS stent show an unacceptable safety profile.