Angiographic Features and Clinical Outcomes of Balloon Uncrossable Lesions during Chronic Total Occlusion Percutaneous Coronary Intervention.

Background: Balloon uncrossable lesions are defined as lesions that cannot be crossed with a balloon after successful guidewire crossing. Methods: We analyzed the association between balloon uncrossable lesions and procedural outcomes of 8671 chronic total occlusions (CTOs) percutaneous coronary interventions (PCIs) performed between 2012 and 2022 at 41 centers. Results: The prevalence of balloon uncrossable lesions was 9.2%. The mean patient age was 64.2 ± 10 years and 80% were men. Patients with balloon uncrossable lesions were older (67.3 ± 9 vs. 63.9 ± 10, p < 0.001) and more likely to have prior coronary artery bypass graft surgery (40% vs. 25%, p < 0.001) and diabetes mellitus (50% vs. 42%, p < 0.001) compared with patients who had balloon crossable lesions. In-stent restenosis (23% vs. 16%. p < 0.001), moderate/severe calcification (68% vs. 40%, p < 0.001), and moderate/severe proximal vessel tortuosity (36% vs. 25%, p < 0.001) were more common in balloon uncrossable lesions. Procedure time (132 (90, 197) vs. 109 (71, 160) min, p < 0.001) was longer and the air kerma radiation dose (2.55 (1.41, 4.23) vs. 1.97 (1.10, 3.40) min, p < 0.001) was higher in balloon uncrossable lesions, while these lesions displayed lower technical (91% vs. 99%, p < 0.001) and procedural (88% vs. 96%, p < 0.001) success rates and higher major adverse cardiac event (MACE) rates (3.14% vs. 1.49%, p < 0.001). Several techniques were required for balloon uncrossable lesions. Conclusion: In a contemporary, multicenter registry, 9.2% of the successfully crossed CTOs were initially balloon uncrossable. Balloon uncrossable lesions exhibited lower technical and procedural success rates and a higher risk of complications compared with balloon crossable lesions.

Current challenges and prevention strategies for chronic total occlusion (CTO) complications.

Introduction: Percutaneous coronary intervention (PCI) of chronic total occlusion (CTO) can be challenging, but high success rates (85-90%) are currently achieved at experienced centers with approximately 3% risk for a major periprocedural complication.Areas covered: CTO PCI complications can be categorized according to location such as cardiac and non-cardiac (vascular access complications, thromboembolic complications, contrast-related and radiation injury) complications. Cardiac complications are further subdivided into coronary (acute closure, perforation, and equipment loss or entrapment) and non-coronary (hypotension, myocardial infarction, tamponade, arrhythmias).Expert opinion: In this article, we review strategies to prevent and treat CTO PCI complications. Careful monitoring throughout the case enables prevention and early detection of a complication. If a complication occurs, rapid implementation of treatment using an algorithmic approach can minimize its adverse impact.

Five-Year Outcomes after PCI or CABG for Left Main Coronary Disease.

BACKGROUND: Long-term outcomes after percutaneous coronary intervention (PCI) with contemporary drug-eluting stents, as compared with coronary-artery bypass grafting (CABG), in patients with left main coronary artery disease are not clearly established. METHODS: We randomly assigned 1905 patients with left main coronary artery disease of low or intermediate anatomical complexity (according to assessment at the participating centers) to undergo either PCI with fluoropolymer-based cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). The primary outcome was a composite of death, stroke, or myocardial infarction. RESULTS: At 5 years, a primary outcome event had occurred in 22.0% of the patients in the PCI group and in 19.2% of the patients in the CABG group (difference, 2.8 percentage points; 95% confidence interval [CI], -0.9 to 6.5; P = 0.13). Death from any cause occurred more frequently in the PCI group than in the CABG group (in 13.0% vs. 9.9%; difference, 3.1 percentage points; 95% CI, 0.2 to 6.1). In the PCI and CABG groups, the incidences of definite cardiovascular death (5.0% and 4.5%, respectively; difference, 0.5 percentage points; 95% CI, -1.4 to 2.5) and myocardial infarction (10.6% and 9.1%; difference, 1.4 percentage points; 95% CI, -1.3 to 4.2) were not significantly different. All cerebrovascular events were less frequent after PCI than after CABG (3.3% vs. 5.2%; difference, -1.9 percentage points; 95% CI, -3.8 to 0), although the incidence of stroke was not significantly different between the two groups (2.9% and 3.7%; difference, -0.8 percentage points; 95% CI, -2.4 to 0.9). Ischemia-driven revascularization was more frequent after PCI than after CABG (16.9% vs. 10.0%; difference, 6.9 percentage points; 95% CI, 3.7 to 10.0). CONCLUSIONS: In patients with left main coronary artery disease of low or intermediate anatomical complexity, there was no significant difference between PCI and CABG with respect to the rate of the composite outcome of death, stroke, or myocardial infarction at 5 years. (Funded by Abbott Vascular; EXCEL ClinicalTrials.gov number, NCT01205776.).

Bypass Surgery or Stenting for Left Main Coronary Artery Disease in Patients With Diabetes.

BACKGROUND: The randomized EXCEL (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial reported a similar rate of the 3-year composite primary endpoint of death, myocardial infarction (MI), or stroke in patients with left main coronary artery disease (LMCAD) and site-assessed low or intermediate SYNTAX scores treated with percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). Whether these results are consistent in high-risk patients with diabetes, who have fared relatively better with CABG in most prior trials, is unknown. OBJECTIVES: In this pre-specified subgroup analysis from the EXCEL trial, the authors sought to examine the effect of diabetes in patients with LMCAD treated with PCI versus CABG. METHODS: Patients (N = 1,905) with LMCAD and site-assessed low or intermediate CAD complexity (SYNTAX scores ≤32) were randomized 1:1 to PCI with everolimus-eluting stents versus CABG, stratified by the presence of diabetes. The primary endpoint was the rate of a composite of all-cause death, stroke, or MI at 3 years. Outcomes were examined in patients with (n = 554) and without (n = 1,350) diabetes. RESULTS: The 3-year composite primary endpoint was significantly higher in diabetic compared with nondiabetic patients (20.0% vs. 12.9%; p < 0.001). The rate of the 3-year primary endpoint was similar after treatment with PCI and CABG in diabetic patients (20.7% vs. 19.3%, respectively; hazard ratio: 1.03; 95% confidence interval: 0.71 to 1.50; p = 0.87) and nondiabetic patients (12.9% vs. 12.9%, respectively; hazard ratio: 0.98; 95% confidence interval: 0.73 to 1.32; p = 0.89). All-cause death at 3 years occurred in 13.6% of PCI and 9.0% of CABG patients (p = 0.046), although no significant interaction was present between diabetes status and treatment for all-cause death (p = 0.22) or other endpoints, including the 3-year primary endpoint (p = 0.82) or the major secondary endpoints of death, MI, or stroke at 30 days (p = 0.61) or death, MI, stroke, or ischemia-driven revascularization at 3 years (p = 0.65). CONCLUSIONS: In the EXCEL trial, the relative 30-day and 3-year outcomes of PCI with everolimus-eluting stents versus CABG were consistent in diabetic and nondiabetic patients with LMCAD and site-assessed low or intermediate SYNTAX scores.(Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization [EXCEL]; NCT01205776).

In-Hospital Outcomes of Chronic Total Occlusion Percutaneous Coronary Interventions in Patients With Prior Coronary Artery Bypass Graft Surgery.

BACKGROUND: We examined the procedural outcomes of chronic total occlusions (CTO) percutaneous coronary interventions in patients with prior coronary artery bypass graft surgery (CABG). METHODS AND RESULTS: We compared the clinical, angiographic characteristics and outcomes of 3486 CTO interventions performed in patients with (n=1101) and without (n=2317) prior CABG at 21 centers. Prior CABG patients (32% of total cohort) were older (67±9 versus 63±10 years; P<0.001) and had more comorbidities and lower left ventricular ejection fraction (50% [40-58] versus 55% [45-60]; P<0.001). The CTO target vessel in prior CABG patients was the right coronary artery (56%), circumflex (26%), and left anterior descending artery (17%). The mean J-CTO (2.9±1.2 versus 2.2±1.3; P<0.001) and PROGRESS-CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention; 1.5±1.1 versus 1.2±1.0; P<0.001) score was higher in prior CABG patients. Retrograde (53% versus 30%, P<0.001) and antegrade dissection reentry (35% versus 28%; P<0.001) techniques were used more frequently in prior CABG patients. Prior CABG patients had lower technical (84% versus 89%; P<0.001) and procedural (82% versus 87%, P<0.001) success, but similar incidence of in-hospital major complications (3.1% versus 2.5%; P=0.287). In-hospital mortality (1% versus 0.4%; P=0.016) and coronary perforation (7.1% versus 3.1%; P<0.001) occurred more frequently in prior CABG patients, however, CABG patients had a lower incidence of pericardial tamponade (0.1% versus 1.0%; P=0.002) and pericardiocentesis (0% versus 1.3%; P<0.001). CONCLUSIONS: In a large multicenter CTO percutaneous coronary interventions registry, prior CABG patients had lower success rate but similar overall risk for complications, although mortality was higher and the incidence of tamponade was lower. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02061436.

Procedural Outcomes of Percutaneous Coronary Interventions for Chronic Total Occlusions Via the Radial Approach: Insights From an International Chronic Total Occlusion Registry.

OBJECTIVES: This study examined the frequency and outcomes of radial access for chronic total occlusion (CTO) percutaneous coronary intervention (PCI). BACKGROUND: Radial access improves the safety of PCI, but its role in CTO PCI remains controversial. METHODS: We compared the clinical, angiographic, and procedural characteristics of 3,790 CTO interventions performed between 2012 and 2018 via radial-only access (RA) (n = 747) radial-femoral access (RFA) (n = 844) and femoral-only access (n = 2,199) access at 23 centers in the United States, Europe, and Russia. RESULTS: Patients' mean age was 65 ± 10 years, and 85% were men. Transradial access (RA and RFA) was used in 42% of CTO interventions and significantly increased over time from 11% in 2012 to 67% in 2018 (p < 0.001). RA patients were younger (age 62 ± 10 years vs. 64 ± 10 years and 65 ± 10 years; p < 0.001), less likely to have undergone prior coronary artery bypass graft surgery (18% vs. 39% and 35%; p < 0.001), and less likely to have undergone prior PCI (60% vs. 63% and 66%; p = 0.005) compared with those who underwent RFA and femoral-only access PCI. RA CTO PCI lesions had lower J-CTO (Multicenter CTO Registry in Japan) (2.1 ± 1.4 vs. 2.6 ± 1.3 and 2.5 ± 1.3; p < 0.001) and PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) complication (2.3 ± 1.9 vs. 3.2 ± 2.0 and 3.2 ± 1.9; p < 0.001) scores. The mean sheath size was significantly smaller in the RA group (6.6 ± 0.7 vs. 7.0 ± 0.6 and 7.3 ± 0.8; p < 0.0001), although it increased with lesion complexity. Antegrade dissection re-entry (20% vs. 33% and 32%; p < 0.001) was less commonly used with RA, whereas use of retrograde techniques was highest with RFA (47%). The overall rates of technical success (89% vs. 88% vs. 86%; p = 0.061), procedural success (86% vs. 85% vs. 85%; p = 0.528), and in-hospital major complication (2.47% vs. 3.40% vs. 2.18%; p = 0.830) were similar in all 3 groups, whereas major bleeding was lower in the RA group (0.55% vs. 1.94% and 0.88%; p = 0.013). CONCLUSIONS: Transradial access is increasingly being used for CTO PCI and is associated with similar technical and procedural success and lower major bleeding rates compared with femoral-only access interventions. (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention [PROGRESS CTO]; NCT02061436).

Outcomes Among Patients Undergoing Distal Left Main Percutaneous Coronary Intervention.

BACKGROUND: Distal left main (LM) coronary artery bifurcation disease increases percutaneous coronary intervention (PCI) procedural complexity and is associated with worse outcomes than isolated ostial/shaft disease. The optimal treatment strategy for distal LM disease is undetermined. We sought to determine whether outcomes after PCI of LM distal bifurcation lesions are influenced by treatment with a provisional 1-stent versus planned 2-stent technique, and if so, whether such differences are conditioned by the complexity of the LM bifurcation lesion. METHODS AND RESULTS: The clinical and angiographic characteristics, procedural methods and outcomes, and clinical events through 3-year follow-up were compared in patients undergoing distal LM PCI with a 1-stent provisional versus planned 2-stent technique in the EXCEL trial (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization). Among 529 patients undergoing planned distal LM PCI, 344 (65.0%) and 185 (35.0%) were treated with intended 1-stent provisional and planned 2-stent techniques, respectively. The primary composite end point rate of death, myocardial infarction, or stroke at 3 years was significantly lower in patients treated with the provisional 1-stent versus planned 2-stent method (14.1% versus 20.7%; adjusted hazard ratio, 0.55; 95% CI, 0.35-0.88; P=0.01), driven by differences in cardiovascular death (3.3% versus 8.3%, P=0.01) and myocardial infarction (7.7% versus 12.8%, P=0.06). The 3-year rate of ischemia-driven revascularization of the LM complex was also lower in the provisional group (7.2% versus 16.3%, P=0.001). In 342 patients with distal LM bifurcation disease that did not involve both major side branch vessels, the 3-year primary end point was lower with a provisional 1-stent versus planned 2-stent technique (13.8% versus 23.3%, P=0.04), whereas no significant difference was present in 182 patients with distal LM bifurcation disease that did involve both side branch vessels (14.3% versus 19.2%, P=0.36). CONCLUSIONS: Among patients with distal LM bifurcation disease in the EXCEL trial randomized to PCI, 3-year adverse outcomes were worse with planned 2-stent treatment compared with a provisional 1-stent approach, a difference that was confined to patients without major involvement of both LM side branch vessels. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01205776.

Prevalence and Outcomes of Percutaneous Coronary Interventions for Ostial Chronic Total Occlusions: Insights From a Multicenter Chronic Total Occlusion Registry.

BACKGROUND: Ostial chronic total occlusions (CTOs) can be challenging to recanalize. METHODS: We sought to examine the prevalence, angiographic presentation, and procedural outcomes of ostial (side-branch ostial and aorto-ostial) CTOs among 1000 CTO percutaneous coronary interventions (PCIs) performed in 971 patients between 2015 and 2017 at 14 centres in the US, Europe, and Russia. RESULTS: Ostial CTOs represented 16.9% of all CTO PCIs: 9.6% were aorto-ostial, and 7.3% were side-branch ostial occlusions. Compared with nonostial CTOs, ostial CTOs were longer (44 ± 33 vs 29 ± 19 mm, P < 0.001) and more likely to have proximal-cap ambiguity (55% vs 33%, P < 0.001), moderate/severe calcification (67% vs 45%, P < 0.001), a diffusely diseased distal vessel (41% vs 26%, P < 0.001), interventional collaterals (64% vs 53%, P = 0.012), and previous coronary artery bypass graft surgery (CABG) (51% vs 27%, P < 0.001). The retrograde approach was used more often in ostial CTOs (54% vs 29%, P < 0.001) and was more often the final successful crossing strategy (30% vs 18%, P = 0.003). Technical (81% vs 84%, P = 0.280), and procedural (77% vs 83%, P = 0.112) success rates and the incidence of in-hospital major complication were similar (4.8% vs 2.2%, P = 0.108), yet in-hospital mortality (3.0% vs 0.5%, P = 0.010) and stroke (1.2% vs 0.0%, P = 0.030) were higher in the ostial CTO PCI group. In multivariable analysis, ostial CTO location was not independently associated with higher risk for in-hospital major complications (adjusted odds ratio 1.27, 95% confidence intervals 0.37 to 4.51, P = 0.694). CONCLUSIONS: Ostial CTOs can be recanalized with similar rates of success as nonostial CTOs but are more complex, more likely to require retrograde crossing and may be associated with numerically higher risk for major in-hospital complications.

Chronic Total Occlusion Interventions: Update on Current Tips and Tricks.

PURPOSE OF REVIEW: To summarize novel techniques and developments in chronic total occlusion (CTO) percutaneous coronary intervention (PCI). RECENT FINDINGS: Using an algorithmic, step-by-step approach can help overcome several complex CTO lesions subsets, such as proximal cap ambiguity, ostial location, in-stent occlusion, bifurcations, balloon uncrossable and undilatable lesions. Similarly, an algorithmic approach can help prevent and optimally treat CTO PCI-related complication, such as perforation, radiation, and contrast-induced nephropathy. Continual update and reassessment of each operator's algorithm for performing CTO PCI can lead to improved outcomes.

In-hospital Outcomes of Attempting More Than One Chronic Total Coronary Occlusion Through Percutaneous Intervention During the Same Procedure.

The frequency and outcomes of patients who underwent chronic total occlusion (CTO) percutaneous coronary intervention (PCI) of more than one CTO during the same procedure have received limited study. We compared the clinical and angiographic characteristics and procedural outcomes of patients who underwent treatment of single versus >1 CTOs during the same procedure in 20 centers from the United States, Europe, and Russia. A total of 2,955 patients were included: mean age was 65 ± 10 years and 85% were men with high prevalence of previous myocardial infarction (46%), and previous coronary artery bypass graft surgery (33%). More than one CTO lesions were attempted during the same procedure in 58 patients (2.0%) and 70% of them were located in different major epicardial arteries. Compared with patients who underwent PCI of a single CTO, those who underwent PCI of >1 CTOs during the same procedure had similar J-CTO (2.4 ± 1.3 vs 2.5 ± 1.3, p = 0.579) and Prospective Global Registry for the Study of Chronic Total Occlusion Intervention (1.5 ± 1.2 vs 1.3 ± 1.0 p = 0.147) scores. The multi-CTO PCI group had similar technical success (86% vs 87%, p = 0.633), but higher risk of in-hospital major complications (10.3% vs 2.7%, p = 0.005), and consequently numerically lower procedural success (79% vs 85%, p = 0.197). The multi-CTO PCI group had higher in-hospital mortality (5.2% vs 0.5%, p = 0.005) and stroke (5.2%vs 0.2%, p <0.001), longer procedure duration (162 [117 to 242] vs 122 [80 to 186] minutes, p <0.001) and higher radiation dose (3.6 [2.1 to 6.4] vs 2.9 [1.7 to 4.7] Gray, p = 0.033). In conclusion, staged revascularization may be the preferred approach in patients with >1 CTO lesions requiring revascularization, as treatment during a single procedure was associated with higher risk for periprocedural complications.

In-Hospital Outcomes of Chronic Total Occlusion Percutaneous Coronary Intervention in Patients With Chronic Kidney Disease.

OBJECTIVES: The effect of chronic kidney disease (CKD) on in-hospital outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has received limited study. METHODS: We evaluated the prevalence of CKD and its impact on CTO-PCI outcomes in 1979 patients who underwent 2040 procedures between 2012 and 2017 at 18 centers. CKD was defined as preprocedural estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m². RESULTS: Compared with patients without CKD (n = 1444; 73%), patients with CKD (n = 535; 27%) had more comorbidities (hypertension, diabetes mellitus, heart failure, peripheral arterial disease, prior myocardial infarction, PCI, coronary artery bypass graft surgery, and stroke), and more severe calcification and proximal vessel tortuosity. Patients with and without CKD had similar technical success rates (84% vs 86%; P=.49) and procedural success rates (83% vs 84%; P=.44). Patients with CKD had higher in-hospital mortality rate (1.9% vs 0.3%; P<.001) and in-hospital major adverse cardiovascular event (MACE) rate (4.3% vs 2.2%; P<.01). In-hospital mortality and MACE rates increased with decreasing eGFR levels (P=.03). In multivariate analysis, an independent association was observed between CKD and in-hospital mortality (adjusted odd ratio, 4.4; 95% confidence interval, 1.2-16.0; P=.02), but not overall MACE (adjusted odds ratio, 1.4; 95% confidence interval, 0.8-2.7; P=.28). CONCLUSIONS: CKD is common among patients undergoing CTO-PCI. High success rates can be achieved in patients with decreased glomerular filtration rate, but CKD may be associated with higher in-hospital mortality.

The Hybrid Approach to Chronic Total Occlusion Percutaneous Coronary Intervention: Update From the PROGRESS CTO Registry.

OBJECTIVES: The aim of this study was to determine the techniques and outcomes of hybrid chronic total occlusion (CTO) percutaneous coronary intervention (PCI) in a diverse group of patients and operators on 2 continents. BACKGROUND: CTO PCI has been evolving with constant improvement of equipment and techniques. METHODS: Contemporary outcomes of CTO PCI were examined by analyzing the clinical, angiographic, and procedural characteristics of 3,122 CTO interventions performed in 3,055 patients at 20 centers in the United States, Europe, and Russia. RESULTS: The mean age was 65 ± 10 years, and 85% of the patients were men, with high prevalence of diabetes (43%), prior myocardial infarction (46%), prior coronary artery bypass graft surgery (33%), and prior PCI (65%). The CTO target vessels were the right coronary artery (55%), left anterior descending coronary artery (24%), and left circumflex coronary artery (20%). The mean J-CTO (Multicenter Chronic Total Occlusion Registry of Japan) and PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) scores were 2.4 ± 1.3 and 1.3 ± 1.0, respectively. The overall technical and procedural success rate was 87% and 85%, respectively, and the rate of in-hospital major complications was 3.0%. The final successful crossing strategy was antegrade wire escalation in 52.0%, retrograde in 27.1%, and antegrade dissection re-entry in 20.9%; >1 crossing strategy was required in 40.9%. Median contrast volume, air kerma radiation dose, and procedure and fluoroscopy time were 270 ml (interquartile range: 200 to 360 ml), 2.9 Gy (interquartile range: 1.7 to 4.7 Gy), 123 min (interquartile range: 81 to 188 min) and 47 min (interquartile range: 29 to 77 min), respectively. CONCLUSIONS: CTO PCI is currently being performed with high success and acceptable complication rates among various experienced centers in the United States, Europe, and Russia. (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention [PROGRESS CTO]; NCT02061436).

Contemporary Use of Laser During Percutaneous Coronary Interventions: Insights from the Laser Veterans Affairs (LAVA) Multicenter Registry.

BACKGROUND: The contemporary use and outcomes of excimer laser coronary atherectomy (ELCA) in percutaneous coronary intervention (PCI) are not well described. METHODS: We examined the baseline clinical and angiographic characteristics and procedural outcomes of 130 target lesions in 121 consecutive PCIs (n = 116 patients) in which ELCA was performed at three United States Department of Veterans Affairs (VA) medical centers between 2008 and 2016. RESULTS: Mean age was 68.5 ± 9 years and 97% of the patients were men. Patients had high prevalence of diabetes mellitus (63%), prior coronary artery bypass graft surgery (41%), and prior myocardial infarction (60%). The most common target vessel was the left anterior descending (32%), followed by the right coronary artery (30%), circumflex artery (20%), and saphenous vein graft (12%). The target lesions were highly complex, with moderate/severe calcification in 62% and in-stent restenosis in 37%. The most common indication for ELCA was balloon-uncrossable lesions (43.8%), followed by balloon-undilatable lesions (40.8%) and thrombotic lesions (12.3%). Use of ELCA was associated with high technical success rate (90.0%) and procedural success rate (88.8%), and low major adverse cardiac event (MACE) rate (3.45%). Mean procedure time was 120 min (interquartile range [IQR], 81-191 min), air kerma radiation dose was 2.76 Gy (IQR, 1.32-5.01 Gy), and contrast volume was 273 mL (IQR, 201-362 mL). CONCLUSION: In a contemporary multicenter United States registry, ELCA was commonly used in highly complex lesions and was associated with high technical and procedural success rates and low incidence of MACE.

The Impact of Proximal Vessel Tortuosity on the Outcomes of Chronic Total Occlusion Percutaneous Coronary Intervention: Insights From a Contemporary Multicenter Registry.

INTRODUCTION: We examined the impact of proximal vessel tortuosity on the outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). METHODS: The baseline clinical and angiographic characteristics and procedural outcomes of 1618 consecutive CTO-PCIs performed between 2012 and 2016 at 14 United States centers in 1589 patients were reviewed. RESULTS: Mean patient age was 65.3 ± 10.0 years and 85% were men. Moderate/severe proximal vessel tortuosity was present in 35.7% of target lesions. Compared with non-tortuous lesions, tortuous lesions had longer length (30 mm [interquartile range, 20-50 mm] vs 28 mm [interquartile range, 16-40 mm]; P<.001), more proximal cap ambiguity (36% vs 28%; P<.01), and more frequent utilization of the retrograde approach (52% vs 37%; P<.001). Moderate/severe proximal vessel tortuosity was associated with lower technical success rates (84.1% vs 91.3%; P<.001) and procedural success rates (82.3% vs 89.9%; P<.001), but similar incidence of major cardiac adverse events (3.0% vs 2.5%; P=.59). Moderate/severe tortuosity was associated with longer procedure time and fluoroscopy time, higher air kerma radiation dose, and larger contrast volume. CONCLUSION: In a contemporary multicenter registry, moderate/severe proximal vessel tortuosity was present in approximately one-third of target CTO lesions and was associated with more frequent use of the retrograde approach and lower success rates, but similar complication rates.

Impact of Calcium on Chronic Total Occlusion Percutaneous Coronary Interventions.

We sought to examine the impact of calcific deposits on the outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). The outcomes of 1,476 consecutive CTO PCIs performed in 1,453 patients (65.5 ± 10 years, 85% male) between 2012 and 2016 at 11 US centers were evaluated. Moderate or severe quantity of calcium was present in 58% of target lesions. Calcified lesions were more tortuous and more likely to have proximal cap ambiguity and interventional collaterals. PCI of moderately/severely calcified CTOs more often required use of the retrograde approach (54% vs 30%, p <0.001) and was associated with longer procedure and fluoroscopy time and higher air kerma radiation dose and contrast volume. Moderate/severe quantity of calcium was associated with lower technical (86.6% vs 93.8%, p <0.001) and procedural (84.4% vs 92.7%, p <0.001) success rates and higher incidence of major adverse cardiac events (3.7% vs 1.8%, p = 0.033). On multivariate analysis, the presence of moderate/severe quantity of calcium was not independently associated with technical success. Balloon angioplasty was the most common lesion preparation technique for calcified lesions, followed by rotational atherectomy and laser. To conclude, in a contemporary, multicenter registry, moderate/severe calcific deposits were present in 58% of attempted CTO lesions and were associated with higher use of the retrograde approach, lower success, and higher complication rates. However, on multivariable analysis, the amount of calcium was not independently associated with technical success.

Management of Guidewire Entrapment With Laser Atherectomy.

A 62-year-old man was referred for percutaneous coronary intervention of a severe circumflex lesion. The guidewire became entangled in the previously implanted left anterior descending artery stent. The left main was engaged with a second guide catheter, followed by balloon dilations, various microcatheters, and laser atherectomy. The wire eventually fractured without protruding into the aorta. The circumflex lesion was stented with two stents, followed by left main stenting that covered the fragment. Caution should be used when wiring through stents; wire fracture can be treated with stent implantation, as long as the wire fragment does not protrude into the aorta.

Everolimus-Eluting Stents or Bypass Surgery for Left Main Coronary Artery Disease.

BACKGROUND: Patients with obstructive left main coronary artery disease are usually treated with coronary-artery bypass grafting (CABG). Randomized trials have suggested that drug-eluting stents may be an acceptable alternative to CABG in selected patients with left main coronary disease. METHODS: We randomly assigned 1905 eligible patients with left main coronary artery disease of low or intermediate anatomical complexity to undergo either percutaneous coronary intervention (PCI) with fluoropolymer-based cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). Anatomic complexity was assessed at the sites and defined by a Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score of 32 or lower (the SYNTAX score reflects a comprehensive angiographic assessment of the coronary vasculature, with 0 as the lowest score and higher scores [no upper limit] indicating more complex coronary anatomy). The primary end point was the rate of a composite of death from any cause, stroke, or myocardial infarction at 3 years, and the trial was powered for noninferiority testing of the primary end point (noninferiority margin, 4.2 percentage points). Major secondary end points included the rate of a composite of death from any cause, stroke, or myocardial infarction at 30 days and the rate of a composite of death, stroke, myocardial infarction, or ischemia-driven revascularization at 3 years. Event rates were based on Kaplan-Meier estimates in time-to-first-event analyses. RESULTS: At 3 years, a primary end-point event had occurred in 15.4% of the patients in the PCI group and in 14.7% of the patients in the CABG group (difference, 0.7 percentage points; upper 97.5% confidence limit, 4.0 percentage points; P=0.02 for noninferiority; hazard ratio, 1.00; 95% confidence interval, 0.79 to 1.26; P=0.98 for superiority). The secondary end-point event of death, stroke, or myocardial infarction at 30 days occurred in 4.9% of the patients in the PCI group and in 7.9% in the CABG group (P<0.001 for noninferiority, P=0.008 for superiority). The secondary end-point event of death, stroke, myocardial infarction, or ischemia-driven revascularization at 3 years occurred in 23.1% of the patients in the PCI group and in 19.1% in the CABG group (P=0.01 for noninferiority, P=0.10 for superiority). CONCLUSIONS: In patients with left main coronary artery disease and low or intermediate SYNTAX scores by site assessment, PCI with everolimus-eluting stents was noninferior to CABG with respect to the rate of the composite end point of death, stroke, or myocardial infarction at 3 years. (Funded by Abbott Vascular; EXCEL ClinicalTrials.gov number, NCT01205776 .).

Effect of Previous Failure on Subsequent Procedural Outcomes of Chronic Total Occlusion Percutaneous Coronary Intervention (from a Contemporary Multicenter Registry).

We sought to examine the impact of previous failure on the outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). We examined the clinical and angiographic characteristics and procedural outcomes of 1,213 consecutive patients who underwent 1,232 CTO PCIs from 2012 to 2015 at 12 US centers. Mean age was 65 ± 10 years, and 84.8% of patients were men. A previously failed attempt had been performed in 215 patients (17.5%). As compared with patients without previous CTO PCI failure, patients with previous failure had higher Multicenter CTO Registry in Japan CTO score (2.40 ± 1.13 vs 3.28 ± 1.29, p <0.0001) and were more likely to have in-stent restenosis (10.5% vs 28.4%, p <0.0001) and to undergo recanalization attempts using the retrograde approach (41% vs 50%, p = 0.011). Technical (90% vs 88%, p = 0.390) and procedural (89% vs 86%, p = 0.184) success were similar in the 2 study groups; however, median procedure time (125 vs 142 minutes, p = 0.026) and fluoroscopy time (45 vs 55 minutes, p = 0.015) were longer in the previous failure group. In conclusion, a previously failed CTO PCI attempt is associated with higher angiographic complexity, longer procedural duration, and fluoroscopy time, but not with the success and complication rates of subsequent CTO PCI attempts.

One-year outcomes in 1,010 unselected patients treated with the PROMUS Element everolimus-eluting stent: the multicentre PROMUS Element European Post-Approval Surveillance Study.

AIMS: The PROMUS™ Element™ European Post-Approval Surveillance Study (PE-Prove) is a prospective, open-label, multicentre observational study designed to assess outcomes following PROMUS Element everolimus-eluting stent implantation in an unselected patient population. METHODS AND RESULTS: A total of 1,010 patients were enrolled at 40 clinical sites in Europe, including 24.9% with medically treated diabetes, 50.0% with Type B2/C lesions, 6.1% with chronic total occlusion, 17.8% with acute myocardial infarction (MI ≤24 hours pre-procedure), and 20.1% with unstable angina. The target lesion was the culprit for ST-segment elevation MI in 7.3% of patients. The one-year, per patient target vessel failure rate was 6.2% (60/975), 3.4% (33) being related to the PROMUS Element stent. Rates of cardiac death, MI, and Academic Research Consortium (ARC) definite/probable stent thrombosis were 1.7%, 3.5%, and 0.6%, respectively. The target vessel revascularisation rate was 3.2% (31/975), 2.1% (20) being related to the PROMUS Element stent. CONCLUSIONS: In a large and relatively complex group of "real-world" patients, coronary artery revascularisation with the PROMUS Element everolimus-eluting stent provides favourable results with low event rates consistent with those reported for other contemporary drug-eluting stents.