Alberto Barioli

Optimal duration of dual antiplatelet therapy after second-generation drug-eluting stent implantation in patients with diabetes: The SECURITY (Second-Generation Drug-Eluting Stent Implantation Followed By Six- Versus Twelve-Month Dual Antiplatelet Therapy)-diabetes substudy

BACKGROUND/OBJECTIVES The randomized SECURITY (Second-Generation Drug-Eluting Stent Implantation Followed by Six- Versus Twelve-Month Dual Antiplatelet Therapy) trial showed the non-inferiority of 6 vs. 12-month DAPT after percutaneous coronary intervention (PCI) with second-generation DES in a low-risk population. Nevertheless, diabetes mellitus (DM) remained a major predictor of adverse cardiovascular events. We aimed to assess the interaction between DAPT duration and outcome in DM patients. METHODS All diabetic patients included in the SECURITY trial treated by second-generation DES PCI were analyzed. The primary endpoint was a composite of cardiac death, myocardial infarction (MI), stroke, definite or probable stent thrombosis (ST), or Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at 12months. The main secondary endpoint was a composite of cardiac death, MI, stroke, definite or probable ST, or BARC type 2, 3, or 5 bleeding at 24months. RESULTS Four hundred-twenty nine DM patients received either 6 (n=206) or 12 (n=223) months of DAPT. The primary endpoint occurred in 3.9% and 5.4% of patients in the 6 and 12-month DAPT group, respectively (log-rank test p=0.83). Similarly, no statistically significant difference in the secondary endpoint was observed between the two study groups (5.4% vs. 7.6%, p=0.620). Stent thrombosis rate was low irrespective of DAPT duration at both 12 (0.5% vs. 0.4%; p=0.804) and between 12 and 24months of follow-up (0.5% vs. 0%, p=0.291). At multivariable analysis, female gender (HR: 3.42; 95% CI 1.32-8.85; p=0.011 and HR 2.28; 95% CI 1.09-4.75; p=0.027) and insulin-treated diabetes mellitus (HR: 2.62; 95% CI 1.15-6.75; p=0.004 and HR: 2.23; 95% CI 1.09-6.33; p=0.003) were independent predictors of both primary and secondary endpoint. CONCLUSIONS In diabetic patients treated by second-generation DES PCI, we failed to find any additional benefit of prolonging DAPT beyond 6months, regardless of insulin-requiring status.

Gender-related differences of diabetic patients undergoing percutaneous coronary intervention with drug-eluting stents: a real-life multicenter experience.

BACKGROUND Gender-based differences in diabetic patients are understudied in the field of percutaneous coronary intervention (PCI) with drug-eluting stents. METHODS Data were obtained from a multicenter registry of 2420 consecutive patients with diabetes mellitus (DM) who underwent PCI with paclitaxel- or sirolimus-eluting stents between 2003 and 2009. Among them, 679 (28.1%) women were compared to 1741 (71.9%) men in terms of clinical aspects and major adverse cardiac events (MACE), including all-cause death, myocardial infarction (MI) and target lesion revascularization (TLR). Target vessel revascularization (TVR) and any revascularization were also reported. RESULTS Women were less numerous, older, used more insulin and showed more tortuous coronary arteries, while men were more frequently smokers and received larger stents. At the median follow-up of 24.3 months (interquartile range 12.3-39.7), MACE, TVR and any revascularization did not significantly differ between females and males (19.9% vs 18.7%, 12.2% vs 13.4%, 14.1% vs 15.1%, respectively). At multivariable analysis of the overall cohort, female gender was not a predictor of MACE (hazard ratio [HR] 1.02, 95% confidence interval [CI] 0.92-2.36, p=0.11), death (HR 1.04, 95% CI 0.84-1.24, p=0.86), MI (HR 1.48, 95% CI 0.92-2.36, p=0.11), and TLR (HR 1.14, 95% CI 0.85-1.52, p=0.38). CONCLUSION In this registry of diabetic patients treated by drug-eluting stents, women were less represented, older and needed more insulin compared to men who, on the other hand, received larger stents. Gender-related outcomes were similar and female sex did not predict MACE.

Six-year clinical outcomes of first-generation drug-eluting stents: a propensity-matched analysis.

ObjectiveDrug-eluting stents are more effective in reducing restenosis than bare-metal stents. Paclitaxel-eluting stents (PES) and sirolimus-eluting stents (SES) are the most widely used first-generation drug-eluting stents, but long-term comparative data on these are scant. The aim of the present report is to investigate the 6-year clinical outcomes of PES versus SES in a matched cohort of single-center registry patients. Materials and methodsData were obtained from the observational, monocentric registry of 632 consecutive patients who underwent percutaneous coronary intervention between September 2002 and September 2005 with PES or SES. We assessed the composite and separate occurrence of the major adverse cardiac events (MACE), including death, nonfatal myocardial infarction, and target lesion revascularization (TLR). ResultsAfter a propensity 1 : 1 matching analysis, baseline clinical, procedural, and angiographic characteristics were well balanced between the two groups. Throughout the 6 years of follow-up, there were no significant differences between PES and SES in terms of MACE (P=0.52), all-cause death (P=0.24), myocardial infarction (P=0.25), stent thrombosis (P=0.38), and TLR (P=0.68). The sensitivity analysis on the total unmatched population confirmed this result, the stent type not being predictive of MACE (PES vs. SES group, hazard ratio 0.97, 95% confidence interval 0.66–1.41, P=0.87) or TLR (PES vs. the SES group, hazard ratio 1.35, 95% confidence interval 0.69–2.64, P=0.38). ConclusionIn this ‘real-life’ registry, PES and SES showed a comparable safety and efficacy profile throughout the 6 years of follow-up. The increase in the rate of TLR was slow and comparable between the two groups, even though the ‘late catch-up’ phenomenon showed a different temporal pattern between PES and SES.

Impact of atrial fibrillation on outcomes of patients treated by transcatheter aortic valve implantation: A systematic review and meta-analysis

BACKGROUND Conflicting data have been reported related to the impact of atrial fibrillation (AF) on the outcomes after transcatheter aortic valve implantation (TAVI). We aimed to assess the prognosis of TAVI-treated patients according to the presence of pre-existing or new-onset AF. METHODS Studies published between April 2002 and November 2016 and reporting outcomes of pre-existing AF, new-onset AF, or sinus rhythm in patients undergoing TAVI were identified with an electronic search. Pairwise and network meta-analysis were performed. Outcomes of interest were short- and long-term mortality, stroke, and major bleeding. RESULTS Eleven studies (11,033 individuals) were eligible. Compared to sinus rhythm, short-term and long-term mortality were significantly higher in new-onset AF (short-term OR 2.9, P=.002; long-term OR 2.3, P<.0001) and pre-existing AF groups (short-term OR 2.7, P=.004; long-term OR 2.8, P<.0001). Compared to sinus rhythm, new-onset AF increased the risk of stroke at early (OR 2.1, P<.0001) and late follow-up (OR 1.92, P<.0001), and the risk of early bleedings (OR 1.65, P=.002), while pre-existing AF increased the risk of late stroke (OR 1.3, P=0.03), but not the risk of bleeding. Compared to pre-existing AF, new-onset AF correlated with higher risk of early stroke (OR 1.7, P=.002) and major bleedings (OR 1.7, P=.002). CONCLUSIONS AF is associated with impaired outcomes after TAVI, including mortality, stroke and (limited to new-onset AF) major bleedings. Compared to pre-existing AF, new-onset AF correlates with higher risk of early stroke and major bleedings. Improved management of AF in the TAVI setting, including tailored antithrombotic treatment strategies, remains a relevant need.

Blood oozing: A cause of life-threatening bleeding without overt source after transcatheter aortic valve replacement

BACKGROUND Post-procedure non-access site-related bleedings have a significant impact on mortality in patients treated by transcatheter aortic valve replacement (TAVR). Notwithstanding, the source of these bleedings is frequently indeterminate, with potentially serious clinical implications related to lack of diagnosis and treatment. METHODS Out of 513 TAVR performed between June 2007 and January 2016 in the Interventional Cardiology Laboratory of the Department of Cardiac, Thoracic and Vascular Sciences, University Hospital of Padua, we identified few proven cases of concealed bleeding after TAVR due to blood oozing. RESULTS We report three cases of angiographically confirmed post-TAVR non-access bleedings related to spontaneous blood oozing, a life-threatening condition consisting of diffuse capillary hemorrhage developing from vessels not directly involved by the procedure. We hypothesize that spontaneous post-procedural blood oozing may account for a substantial proportion of non-overt, non-access site-related bleeding after TAVR. CONCLUSION The possibility of post-TAVR blood oozing is largely neglected in the literature, and comprehensive categorization of non-access site bleedings in current standardized endpoints of TAVR studies is missing. Early assessment with arterial and venous contrast phase angio-MDCT scans in case of post-TAVR unexplained and persistent anemia may allow diagnosis and treatment of this subtle condition.

Absorb bioresorbable vascular scaffold vs. everolimus-eluting metallic stent in small vessel disease: A propensity matched analysis of COMPARE II, RAI, and MAASSTAD-ABSORB studies

Patients with small vessel disease (SVD) are at higher risk of adverse events after PCI compared to non‐SVD patients. In this subset, the use of bioresorbable vascular scaffolds (BVS) has raised particular concern.

Renal insufficiency and left main coronary artery disease: reconsidering coronary intervention and bypass surgery.

Available evidence suggests that unprotected left main coronary artery (ULMCA) disease treatment with percutaneous coronary intervention (PCI) is safe and provides results comparable to those of coronary artery bypass grafting (CABG) in the presence of isolated or associated lowerseverity left main (LM) lesions [1–3]. A recent meta-analysis [4] comparing the long-term outcomes of PCI with drugeluting stents (DESs) versus CABG for ULMCA stenosis has shown that CABG was associated with a small increased risk of stroke, but reduced risk of repeat revascularization at all time points. Nonetheless, after a plot of four randomized trials including the long-term results of the PRECOMBAT and LEMANS trials was constructed, CABG tended to be superior in terms of event-free survival compared with PCI (Fig. 1a) [1,5–7]. After stratification for lesion complexity using the SYNTAX score (SS), we found that PCI was associated with significantly worse outcome [odds ratio 1.88, 95% confidence interval (CI) 1.23–2.87, P=0.0037] in patients with SS of at least 33 (Fig. 1b and c). These results confirm and support the current guideline recommendations of the American College of Cardiology Foundation/ American Heart Association Task Force guidelines [8], in which PCI choice has been upgraded to class IIa (level of evidence B) for the treatment of ULMCA disease in patients with a low SS (<23) at high surgical risk and to class IIb (level of evidence B) in patients with low to intermediate SS (<33) and increased surgical risk. Differently, the Task Force on Myocardial Revascularization of the European Society of Cardiology and the European Association for Cardio-Thoracic Surgery guidelines [9] provide a stronger recommendation for LM-PCI in patients with stable coronary artery disease – PCI is class I (level of evidence B) when the SS is low (≤22) and class IIa (level of evidence B) when the SS is between 23 and 32. Besides SS, there are no other clinical variables or comorbidities that may indicate the superiority of CABG over PCI in LM patients, with the exception of diabetes. Chronic kidney disease (CKD) is a very well-known and frequently encountered comorbidity in patients with severe coronary artery disease. We previously found that the outcome of patients with CKD treated with DESs was directly related to the degree of renal dysfunction as assessed by the use of kidney disease outcome quality initiative classification. The more severe the renal disease, the higher (i) the presence of associated comorbidities, (ii) the complexity of the coronary lesions, as well as (iii) the rate of ischemic and bleeding complication both at early and at long-term follow-up [10]. Similar results have also been reported by others in the setting of patients with multivessel coronary disease and CKD [11]. Twomore studies confirmed and extended these findings also to the cohort of LM-PCI-treated patients. In these studies, the presence of a CKD remained an independent predictor of all-cause mortality after PCI with BMS and first-generation DES (hazard ratio 4.28, 95% CI 2.10–8.73, P<0.0001) [12] and of increased restenosis rate (hazard ratio 3.74, 95% CI 1.36–10.25, P=0.011) after DES implantation [13]. Yu et al. [14] found that serum creatinine level was an independent predictor of major adverse cardiac and cerebrovascular events in patients with LM treated by DES-PCI, but not in those treated by CABG at a median follow-up of 7 years.