Safety and efficacy of a novel traction balloon technique for guide-extension advancement in complex coronary interventions: a case series.

Same-day discharge (SDD) following percutaneous coronary intervention (PCI) is a safe and efficient strategy, especially within dedicated care models like the Radial Lounge. While SDD is well established for standard elective PCI, evidence for its use in complex cases is limited. This sub-analysis evaluated the safety and feasibility of SDD in patients undergoing complex PCI within a structured SDD framework. To assess the incidence of major adverse cardiac events (MACEs)-including in-hospital mortality, 30-day mortality, and 30-day readmission-in patients undergoing complex PCI with SDD, compared to non-complex PCI cases. We retrospectively analyzed elective SDD PCI cases performed between 2015 and 2023 at a single center. Complex PCI was defined by anatomical and procedural criteria, including left main or proximal LAD interventions, saphenous vein grafts, chronic total occlusions, bifurcations, Syntax score > 33, and use of IVUS or Rotablator. Outcomes were compared between complex and non-complex PCI groups. The primary endpoint was 30-day MACE. Of 3725 elective SDD PCIs, 1671 were complex. No significant differences were observed in in-hospital mortality (0.23% vs. 0.19%), 30-day mortality (0% in both), or readmissions. Complex PCI patients had higher rates of diabetes, prior PCI, femoral access, and multivessel interventions. Radial access was more frequent in the non-complex group. The most common complexity criteria were proximal LAD and bifurcations. SDD is a feasible and safe approach for selected complex PCI cases when implemented within a structured care model, supporting broader adoption of SDD protocols to optimize resource utilization without compromising safety.

Background Monotherapy with P2Y12 inhibitors (P2Y12i) is emerging as alternative strategy to dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI). However, early withdrawal of aspirin as part of P2Y12i monotherapy regimens may pose concerns in high-risk patients, such as those undergoing complex PCI. Purpose To evaluate the efficacy and safety of P2Y12i monotherapy after a short course of DAPT (1- to 3-month) compared with standard DAPT (≥12-month) according to PCI complexity. Methods We performed a meta-analysis of randomized trials using random effects models to combine hazard ratios (HRs) with 95% confidence intervals (CIs). No restrictions were applied to the type of P2Y12 receptor inhibitor (clopidogrel, prasugrel, or ticagrelor) or to the definition of complex PCI. Within-trial interactions were pooled to estimate heterogeneity between complex and noncomplex PCI strata. The study protocol was registered in the PROSPERO (CRD42021291027). Results We screened 7,502 unique citations, of which 2,948 were screened at title and abstract level and 576 were judged potentially eligible for full-text assessment. We included in the analysis five trials (1–5) enrolling 31,627 patients, of whom 8,328 (26.3%) underwent complex PCI; characteristics of trials and patient populations are summarized in Table 1. Risk estimates for efficacy and safety outcomes associated with P2Y12i monotherapy and standard DAPT across studies included in the analysis, stratified by complex and noncomplex PCI, are reported in Figure 1. P2Y12i monotherapy compared with standard DAPT was associated with a similar risk of all-cause death, stent thrombosis, and stroke, with no evidence for interaction between complex and noncomplex PCI. We found heterogeneity in the treatment effect of P2Y12i monotherapy vs. standard DAPT with respect to myocardial infarction (P-interaction=0.027). Compared with standard DAPT, P2Y12i monotherapy decreased the risk of myocardial infarction in complex PCI (HR 0.77, 95% CI 0.60–0.99, P=0.042), but not in noncomplex PCI patients (HR 1.09, 95% CI 0.90–1.30, P=0.382). The risk of major bleeding was significantly reduced by P2Y12i monotherapy with a consistent treatment effect (P-interaction=0.699) in both complex and noncomplex PCI strata. Conclusions Patients undergoing complex PCI may derive more benefit and less harm from P2Y12i monotherapy after early aspirin withdrawal compared with standard DAPT, resulting in decreased risks of myocardial infarction and bleeding. Funding Acknowledgement Type of funding sources: None.

Aims To compare the clinical characteristics and in-hospital outcomes of patients undergoing complex vs. non-complex percutaneous coronary intervention (PCI) with peri-procedural use of cangrelor. Methods Consecutive patients treated with cangrelor in 6 Italian institutions were retrospectively enrolled in the ICARUS (“Intravenous CAngrelor in high-bleeding Risk patients Undergoing percutaneouS coronary intervention”, NCT05505591) registry. Complex PCI was defined as any of the following: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, or chronic total occlusion. The primary endpoint was net adverse clinical events (NACE), defined as a composite of cardiovascular death, myocardial infarction, stroke, definite or probable stent thrombosis and Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding, at 48 hours. Secondary endpoints were assessed at 48 hours and throughout the hospital stay. Results Among 551 patients enrolled in the ICARUS registry and undergoing PCI between January 2019 and August 2022, a total of 534 (97%) patients had complete information on PCI complexity, of whom 173 (32%) underwent complex PCI and 361 (68%) underwent non-complex PCI. In general, patients with complex PCI had similar clinical features compared with non-complex PCI patients, including comparable prevalence of high bleeding risk (HBR) status according to the ARC-HBR definition (35% vs. 30%, p=0.253), but complex PCI patients presented more often with cardiogenic shock (9% vs. 2%, p<0.001). PCI with ≥3 stents implanted was the most frequent criterion of procedural complexity (62%). The incidence of the primary endpoint of 48-hour NACE (10% vs. 7%, p=0.264) and other clinical endpoints occurring at 48 hours or during hospitalization did not differ between complex and non-complex PCI patients. Conclusions Among patients receiving peri-procedural cangrelor, about 30% of cases underwent complex interventions. Notwithstanding higher procedural complexity, short-term clinical outcomes were similar between complex and non-complex PCI patients.

Complex percutaneous coronary intervention (PCI) is associated with a higher risk of ischaemic events. However, no study has analysed the effect of PCI complexity on outcomes in a contemporary cohort of acute coronary syndrome (ACS) patients treated with a dual anti-platelet therapy regimen based on potent P2Y12-inhibitors. Therefore, we performed the current analysis. This analysis included all ACS patients treated with PCI in the Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment (ISAR-REACT) 5 trial. Complex PCI was defined as at least one of: multi-vessel PCI, ≥3 stents implanted, ≥3 lesions treated, and total stented length >60 mm. The primary endpoint was the composite of all-cause death, myocardial infarction (MI), or stroke at 12 months; the safety endpoint was Bleeding Academic Research Consortium types 3-5 bleeding at 12 months. Overall, 3377 patients were included in this analysis (complex PCI, n = 1429; non-complex PCI, n = 1948). The primary endpoint occurred more frequently in the complex PCI group than the non-complex PCI group [10.1% vs. 7.2%, hazard ratio (HR): 1.44, 95% confidence interval (CI) (1.14-1.82), P = 0.002], driven primarily by a higher risk of MI [HR: 1.62, (1.17-2.26), P = 0.004]. The safety endpoint was not statistically different between patients undergoing complex vs. non-complex PCI, although it was numerically higher in the complex PCI group [6.7% vs. 5.3%, HR: 1.28, (0.97-1.70), P = 0.08]. Acute coronary syndrome patients undergoing complex PCI have an increased incidence of ischaemic events compared with ACS patients undergoing non-complex PCI. NCT01944800, Prospective, Randomized Trial of Ticagrelor Vs. Prasugrel in Patients With Acute Coronary Syndrome-Full-Text View-ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT01944800.

Comparative data of durable polymer (DP) versus biodegradable polymer (BP) drug-eluting stents (DES) are limited in patients presenting with acute coronary syndrome (ACS) undergoing complex percutaneous coronary intervention (PCI). We sought to evaluate the efficacy and safety of DP-DES and BP-DES in ACS patients receiving complex PCI. This study was a post hoc analysis of the HOST-REDUCE-POLYTECH-ACS trial. ACS patients were randomly assigned 1:1 to DP-DES or BP-DES in the HOST-REDUCE-POLYTECH-ACS trial. Complex PCI was defined as having at least 1 of the following features: ≥3 stents implanted, ≥3 lesions treated, total stent length ≥60 mm, bifurcation PCI with 2 stents, left main PCI, or heavy calcification. Patient-oriented (POCO, a composite of all-cause death, non-fatal myocardial infarction, and any repeat revascularisation) and device-oriented composite outcomes (DOCO, a composite of cardiac death, target vessel myocardial infarction, or target lesion revascularisation) were evaluated at 12 months. Among 3,301 patients for whom full procedural data were available, 1,140 patients received complex PCI. Complex PCI was associated with higher risks of POCO and DOCO. The risks of POCO were comparable between DP-DES and BP-DES in both the complex (HR 0.87, 95% confidence interval [CI]: 0.57-1.33; p=0.522) and non-complex (HR 0.83, 95% CI: 0.56-1.24; p=0.368; p for interaction=0.884) PCI groups. DOCO was also not significantly different between DP-DES and BP-DES in both the complex (HR 0.74, 95% CI: 0.43-1.27; p=0.278) and non-complex (HR 0.67, 95% CI: 0.38-1.19; p=0.175; p for interaction=0.814) PCI groups. In ACS patients, DP-DES and BP-DES showed similar clinical outcomes irrespective of PCI complexity.

Background Performing complex percutaneous coronary intervention (PCI) procedures in hospitals with no on-site cardiac surgery (NOSCS) remains controversial due to a lack of contemporary data and guideline support. Methods Victorian Cardiac Outcomes Registry data was analysed including all PCI cases in the state of Victoria, Australia, from 2014 to 2022. Patients were stratified by PCI at sites with on-site cardiac surgery (OSCS) or NOSCS. Complex PCI was defined as PCI to unprotected left main, bifurcation lesions, rotational atherectomy or intravascular lithotripsy use, severe left ventricular systolic dysfunction, chronic total occlusion, or vein graft PCI. The primary outcome was composite MACCE comprising all-cause mortality, stroke, non-fatal MI, emergency CABG, unplanned revascularisation, definite stent thrombosis and major bleeding (BARC 3 & 5) at 30-days. Risk ratio for average treatment effect in the NOSCS cohort was estimated using inverse probability treatment weighting. Results 94,268 total PCI procedures (32.6% NOSCS) were analysed, including 12,459 complex PCI cases (28.7% NOSCS). Patients from NOSCS were younger (65.0 vs 67.4, p<0.001), less likely to have had previous PCI (29.5% vs 34.5%, p<0.001) or CABG (4.6% vs 8.0% p<0.001) and presented more frequently with acute coronary syndromes (NSTEMI [32.0% vs 28.0%, p<0.001; STEMI [23.3% vs 15.2%], p<0.001). A propensity weighted sample of 30,850 OSCS patients and 30,692 NOSCS patients demonstrated no difference in adjusted 30-day MACCE (risk ratio 0.93, 95% CI 0.87-1.01, p=0.051) for all PCI procedures. In a propensity-weighted subgroup of 3,638 OSCS and 3,576 NOSCS patients who underwent complex PCI, there was also no difference in adjusted 30-day MACCE (risk ratio 0.97, 95%CI 0.86-1.09, p=0.60). Unadjusted rates of CABG at 30-days were very low (0.1 vs 0.1%, p=1.00). Conclusion Patients undergoing PCI and complex PCI at NOSCS centres had comparable 30-day outcomes to those treated at OSCS centres. Newer percutaneous therapies such as intravascular lithotripsy and percutaneous left ventricular assist devices may further improve safety and efficacy of high-risk PCI in NOSCS centres as operator experience increases. Increasing PCI and complex PCI capabilities at NOSCS is likely to increase equitable treatment access for more patients.

P2Y12 Inhibitors Monotherapy in Patients Undergoing Complex vs Non-Complex Percutaneous Coronary Intervention: A Meta-Analysis of Randomized Trials

Background Monotherapy with P2Y12 inhibitors (P2Y12i) is emerging as alternative strategy to dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI). However, early withdrawal of aspirin as part of P2Y12i monotherapy regimens may pose concerns in high-risk patients, such as those undergoing complex PCI. Thus, we aimed to evaluate the efficacy and safety of P2Y12i monotherapy compared with standard DAPT according to PCI complexity. Methods We performed a meta-analysis of randomized trials using random effects models to combine hazard ratios (HRs) with 95% confidence intervals (CIs). No restrictions were applied to the type of P2Y12 receptor inhibitor or to the definition of complex PCI. Within-trial interactions were pooled to estimate heterogeneity between complex and noncomplex PCI strata. The study protocol was registered in the PROSPERO (CRD42021291027). Results After screening of 7,502 unique citations, we included in the analysis 5 randomized clinical trial enrolling 31,627 patients, of whom 8,328 (26.3%) underwent complex PCI (Table 1) Risk estimates for efficacy and safety outcomes associated with P2Y12i monotherapy and standard DAPT across studies included in the analysis, stratified by complex and noncomplex PCI, are reported in Figure 1. P2Y12i monotherapy compared with standard DAPT was associated with a similar risk of all-cause death, stent thrombosis, and stroke, with no evidence for interaction between complex and noncomplex PCI. We found heterogeneity in the treatment effect of P2Y12i monotherapy vs. standard DAPT with respect to myocardial infarction (P-interaction=0.027). Compared with standard DAPT, P2Y12i monotherapy decreased the risk of myocardial infarction in complex PCI (HR 0.77, 95%CI 0.60-0.99, P=0.042), but not in noncomplex PCI patients (HR 1.09, 95%CI 0.90-1.30, P=0.382). The risk of major bleeding was significantly reduced by P2Y12i monotherapy with a consistent treatment effect (P-interaction=0.699) in both complex and noncomplex PCI strata. Conclusions Patients undergoing complex PCI may derive more benefit and less harm from P2Y12i monotherapy after early aspirin withdrawal compared with standard DAPT, resulting in decreased risks of myocardial infarction and bleeding.

It remains unknown whether intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) can improve the clinical outcomes of complex PCI to a level equivalent to that of non-complex PCI. In the OPTIVUS-Complex PCI (Optimal Intravascular Ultrasound-Guided Complex PCI) Study multivessel cohort, a total of 1011 patients who underwent multivessel PCI involving a target lesion in the left anterior descending coronary artery (LAD) were divided into 2 groups: complex PCI (N = 760) and non-complex PCI groups (N = 251). Complex PCI was defined as a procedure with the following characteristics: 3 vessels treated, 3 stents implanted, 3 lesions treated, bifurcation with 2 stents implanted, total stent length > 60mm, or target of chronic total occlusion. The primary endpoint was major adverse cardiac and cerebrovascular event (MACCE) defined by a composite of death, myocardial infarction, stroke, or any coronary revascularization. The cumulative 1-year incidences of the primary endpoint and any coronary revascularization were not significantly different between the complex and non-complex PCI groups (10.9% vs. 8.3%, P = 0.24, and 7.7% vs. 4.8%, P = 0.12, respectively). In the multivariable Cox proportional hazards models, there was no significant excess risk of the complex PCI group relative to the non-complex PCI group for the primary endpoint (HR, 1.35; 95%CI, 0.83-2.18; P = 0.22), or for any coronary revascularization (HR, 1.64; 95%CI, 0.87-3.06; P = 0.11). After optimal IVUS-guided multivessel PCI with a target lesion in the LAD, 1-year risk of MACCE or coronary revascularization in patients with complex PCI was numerically higher than that in patients with non-complex PCI.

IntroductionStent thrombosis (ST) is a serious and potentially life-threatening complication of primary or complex high-risk percutaneous coronary intervention (PCI). Multiple factors are said to precipitate ST, related to the patient's clinical comorbidities, lesion characteristics, operative technique, and post-procedural care. The older-generation stents were thought to be involved in early ST. Though the new generation of drug-eluting stents decreases the incidence of early and late ST, patients are still at risk of very late stent thrombosis (VLST).ObjectiveTo evaluate the frequency, risk factors, and outcomes of definite ST in developing and resource-constrained countries like Pakistan, where PCIs, including primary PCI, complex PCI, and PCI in high-risk populations, are performed routinely.MethodsThis observational cross-sectional study included all patients who underwent primary and complex high PCI between 2012 and 2017 at TABBA Heart Institute (THI), Karachi, Pakistan.ResultsWe included a total of 6587 patients in our study, and among the enrolled sample size, 22 (0.33%) had definite ST. Acute stent thrombosis (AST) was found in seven patients, sub-acute stent thrombosis (SAST) in 10, late stent thrombosis (LST) in two, and VLST were observed in three patients. The basic characteristics of our study ST population were as follows: mean age was 58 years, 95.5% were male, 4.5% were female, nine patients (40%) had diabetes mellitus, 15 patients (68%) had hypertension, 11 (50%) had dyslipidemia, and four patients were smokers (18%).ConclusionThe frequency, risk factors, and rate of mortality of definite ST in the Pakistani population who underwent primary and complex high-risk PCI reflect nearly equal statistics observed in other studies. As seen in other international studies, the incidence rate of VLST was higher in our population.

The monorail GuidezillaTM guide extension catheter was designed to provide additional backup and facilitate device delivery in percutaneous coronary intervention (PCI) for complex coronary anatomy such as chronic total occlusion (CTO), extreme vessel tortuosity, diseased bypass grafts, and anomalous coronary arteries, among others.The present retrospective, single-center study included 188 consecutive patients who underwent PCI using the Guidezilla catheter from March 2015 to August 2016. Study outcomes were rates of target lesion crossing success, procedural success, and complications.The Guidezilla catheter was used most commonly in PCI of CTOs (45%) and heavy proximal calcification (37%), followed by tortuosity (10%), previously deployed proximal stents (4%), and coronary artery anomaly (4%). The right coronary artery (48%) was most commonly intervened followed by the left ascending (35%) and left circumflex (17%) arteries. Rates of target lesion crossing success and procedural success were both 99%, with one device-related periprocedural complication, namely proximal vessel dissection secondary to deep insertion which was successfully treated with stent implantation. Ninety percent of PCI were performed and completed successfully by radial access.In a single center with experienced operators, the use of the Guidezilla guide extension catheter in PCI of complex coronary anatomy performed mostly via radial artery access appeared safe and efficacious, and greatly facilitated device delivery.

Limited data are available on the risk of periprocedural myocardial infarction (MI) in patients undergoing complex versus noncomplex percutaneous coronary intervention (PCI). We assessed the risk of periprocedural MI according to the fourth Universal definition of myocardial infarction (UDMI) and several other criteria among patients undergoing elective PCI in a prospective, single-center registry. Complex PCI included at least one of the following: 3 coronary vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, treatment of chronic total occlusion, and use of rotational atherectomy. Between 2017 and 2021, we included 1010 patients with chronic coronary syndrome, of whom 226 underwent complex PCI (22.4%). The rate of periprocedural MI according to the fourth UDMI was significantly higher in complex compared to noncomplex PCI patients (26.5% vs. 14.5%, p < 0.001). Additionally, periprocedural MI was higher in the complex PCI group using SCAI (4% vs. 1.1%, p = 0.009), ARC-2 (13.7% vs. 8.0%, p = 0.013), ISCHEMIA (5.8% vs. 1.7%, p = 0.002), and EXCEL criteria (4.9% vs. 2.0%, p = 0.032). SYNTAX periprocedural MI occurred at low rates in both groups (0.9% vs. 0.6%, p = 0.657). Complex PCI was an independent predictor of the fourth UDMI periprocedural MI (odds ratio [OR] 1.54, 95% confidence interval [CI]: 1.04-2.27, p = 0.031). In patients with chronic coronary syndrome undergoing elective PCI, complex PCI is associated with a significantly higher risk of periprocedural MI using multiple definitions. These findings highlight the importance of considering upfront this risk in the planning of complex PCI procedures.

BackgroundThe performance of third‐generation drug‐eluting stents with ultrathin struts and advanced polymer technology in complex percutaneous coronary intervention (PCI) remains unclear. This study compared the clinical outcomes of Coroflex ISAR polymer‐free sirolimus‐eluting stent (SES) and Orsiro biodegradable polymer SES, 2 third‐generation drug‐eluting stents, based on PCI complexity.MethodsA post hoc analysis of the HOST‐IDEA (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis–Coronary Intervention With Next‐Generation Drug‐Eluting Stent Platforms and Abbreviated Dual Antiplatelet Therapy) trial, which randomized 2013 patients undergoing PCI with Coroflex ISAR or Orsiro SES based on the duration of dual antiplatelet therapy (3 versus 12 months), was conducted herein. The baseline characteristics were balanced through propensity score matching. Complex PCI satisfied ≥1 of the following criteria: ≥3 stents implanted, ≥3 lesions or vessels treated, bifurcation PCI, total stent length of ≥60 mm, left main PCI, or heavy calcification. Target lesion failure (TLF) at 1 year, a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization, was the primary end point.ResultsEach stent group comprised 546 patients after propensity score matching. In total, 336 and 756 patients underwent complex PCI and noncomplex PCI, respectively. Complex PCI exhibited a significant association with a higher risk of TLF compared with noncomplex PCI (5.7% versus 1.3%, P<0.01). In the complex PCI group, the TLF rate in the Coroflex ISAR SES group was significantly higher than that in the Orsiro SES group (8.9% versus 2.4%; hazard ratio [HR], 3.74 [95% CI, 1.24–11.26]; P=0.02). However, the TLF rates in the 2 stent groups in the noncomplex PCI group were comparable (1.1% versus 1.6%; HR, 0.66 [95% CI, 0.19–2.35]; P=0.53; P for interaction=0.04). Multivariable analysis identified Coroflex ISAR SES and chronic kidney disease as independent predictors of TLF.ConclusionsOrsiro SES was associated with significantly better TLF outcomes than the Coroflex ISAR SES in complex PCI; however, no significant difference was observed in noncomplex PCI.

Risk of contrast-induced nephropathy in patients undergoing complex percutaneous coronary intervention

Efficacy of the RADPAD Protective Drape During Real World Complex Percutaneous Coronary Intervention Procedures