Dual antiplatelet therapy duration after percutaneous coronary intervention using drug eluting stents in high bleeding risk patients: A systematic review and meta-analysis.

BACKGROUND: Optimal dual antiplatelet therapy (DAPT) duration in patients at high bleeding risk (HBR) is not fully defined. We aimed to compare the safety and effectiveness of short-term DAPT (S-DAPT) with longer duration DAPT (L-DAPT) after percutaneous coronary intervention (PCI) with drug eluting stents (DES) in patients at HBR. METHODS: We searched for studies comparing S-DAPT (≤3 months) followed by aspirin or P2Y 12 inhibitor monotherapy against L-DAPT (6-12 months) after PCI in HBR patients. Primary end points of interest were major bleeding and myocardial infarction (MI). Random-effects meta-analyses were performed to calculate odds ratios with 95% CIs. RESULTS: Six randomized trials and 3 propensity-matched studies (n = 16,848) were included in the primary analysis. Compared with L-DAPT (n = 8,422), major bleeding was lower with S-DAPT (n = 8,426) [OR 0.68; 95% CI 0.51-0.89] whereas MI did not differ significantly between the 2 groups [1.16; 0.94-1.44]. There were no significant differences in risks of death, stroke or stent thrombosis (ST) between S-DAPT and L-DAPT groups. These findings were consistent when propensity-matched studies were analysed separately. Finally, there was a numerically higher, albeit statistically non-significant, ST in the S-DAPT arm of patients without an indication for OAC [1.98; 0.86-4.58]. CONCLUSIONS: Among HBR patients undergoing current generation DES implantation, S-DAPT reduces bleeding without an increased risk of death or MI compared with L-DAPT. More research is needed to (1) evaluate risks of late ST after 1 to 3 months DAPT among patients with high ischemic and bleeding risks, (2) defining the SAPT of choice after 1 to 3 months DAPT.

Drug-eluting Stents Versus Bare-metal Stents for Saphenous Vein Graft Interventions: A Systematic Review and Meta-analysis of Studies With Longer Follow-up.

Randomized controlled trials comparing drug eluting stents (DES) with bare-metal stents (BMS) for saphenous vein graft (SVG) interventions have shown conflicting results. We conducted this meta-analysis to evaluate the cumulative evidence for long-term efficacy and safety of DES vs BMS in SVG lesions. A systematic search was conducted of Randomized controlled trials comparing DES vs BMS in patients undergoing percutaneous interventions for SVG lesions. End-points of interest were all-cause death, cardiac death, myocardial infarction, target lesion revascularization and target vessel revascularization at longest available follow-up. Random effects meta-analysis was conducted to estimate risk ratio with 95% confidence intervals for individual end-points. Seven studies with 1639 patients were included in the final analysis. Mean follow-up period was 32 months. Compared with BMS, DES was associated with similar risks of all-cause death (risk ratio 1.06; 95% confidence intervals 0.76-1.48) and cardiac death (0.95; 0.59-1.54). Similarly, there were no differences between DES and BMS in terms of myocardial infarction (0.81; 0.50-1.29), target vessel revascularization (0.73; 0.48-1.110 or target lesion revascularization (1.05; 0.76-1.43). Current analysis suggests no strong evidence for routine DES use in patients undergoing SVG intervention. Future studies should evaluate if SVG lesion characteristics could influence these results.

Percutaneous Axillary Access for Placement of Microaxial Ventricular Support Devices: The Axillary Access Registry to Monitor Safety (ARMS).

BACKGROUND: There has been increasing utilization of short-term mechanical circulatory support devices for a variety of clinical indications. Many patients have suboptimal iliofemoral access options or reasons why early mobilization is desirable. Axillary artery access is an option for these patients, but little is known about the utility of this approach to facilitate short-term use for circulatory support with microaxial pump devices. METHODS: The Axillary Access Registry to Monitor Safety (ARMS) was a prospective, observational multicenter registry to study the feasibility and acute safety of mechanical circulatory support via percutaneous upper-extremity access. RESULTS: One hundred and two patients were collected from 10 participating centers. Successful device implantation was 98% (100 of 102). Devices were implanted for a median of 2 days (interquartile range, 0-5 days; range, 0-35 days). Procedural complications included 10 bleeding events and 1 stroke. There were 3 patients with brachial plexus-related symptoms all consisting of C8 tingling and all arising after multiple days of support. Postprocedural access site hematoma or bleeding was noted in 9 patients. Device explantation utilized closure devices alone in 61%, stent grafts in 17%, balloon tamponade facilitated closure in 15%, and planned surgical explant in 5%. Duration of support appeared to be independently associated with a 1.1% increased odds of vascular complication per day ([95% CI, 0.0%-2.3%] P=0.05). CONCLUSIONS: Percutaneous axillary access for use with microaxial support pumps appears feasible with acceptable rates of bleeding despite early experience. Larger studies are necessary to confirm the pilot data presented here.

Deploying Mechanical Circulatory Support Via the Axillary Artery in Cardiogenic Shock and High-Risk Percutaneous Coronary Intervention.

We sought to study the feasibility of axillary artery as alternative access for mechanical circulatory support (MCS) in cardiogenic shock and high-risk percutaneous coronary intervention (HR-PCI) patients with severe occlusive peripheral artery disease (PAD). In patients with severe PAD, the iliofemoral artery may be so diseased preventing deployment of MCS, precluding the use of lifesaving therapy. In such circumstances, the axillary artery may be a viable access site. Records of all patients presenting with cardiogenic shock or HR-PCI requiring MCS through axillary artery access at our institution from January 2016 to September 2018 were examined. Demographics, clinical, procedural, and outcomes data were collected on all patients. A total of 48 patients presented with cardiogenic shock (60%) or HR-PCI (40%) requiring MCS via axillary artery due to prohibitive PAD (mean age 66 ± 11 years). Admission diagnoses were non-ST segment elevation myocardial infarction (38%), unstable angina (23%), ST segment elevation myocardial infarction (19%), and cardiac arrest (21%). Time from axillary access to activation of Impella was 11.9 ± 4 minutes. Four patients required concomitant Impella RP for right ventricular support due to biventricular cardiogenic shock. Twenty-two patients died before Impella was explanted due to multiorgan failure, stroke, and infection. None of the patients who died had vascular complications related to axillary access. Axillary artery appears to be a viable alternative access for large bore devices in patients with prohibitive PAD. As experience of the field with this approach grows, it may be the default access for deployment of large bore sheaths in the future.

Deployment of acute mechanical circulatory support devices via the axillary artery.

Introduction: Use of acute mechanical circulatory support (MCS) devices for high-risk cardiac intervention, cardiogenic shock, and advanced heart failure is growing. Alternate vascular access options for these devices remains a clinical challenge. Building on experience from trans-aortic valve replacement procedures, the axillary artery is becoming a common access route for acute MCS and represents an important advance in the development of acute MCS technologies. Areas covered: Authors review the clinical data and technical aspect of acute MCS deployment via the axillary artery. Axillary access is particularly useful for patients: 1) with severe peripheral vascular disease, 2) with hostile femoral access due to infection, indwelling endovascular devices, or obesity, and 3) to provide early mobility and ambulation. In this review, we discuss the deployment, technical issues and hemostasis regarding the use of intraaortic balloon pump, specifically, axillary intraaortic balloon pumps, trans-valvular left ventricular Impella pumps and arterial outflow of VA-ECMO. Expert opinion: Vascular comorbidities or device design may limit the traditional iliofemoral access route for acute mechanical circulatory support devices. Large bore access for the deployment of these devices through the axillary artery is feasible and safe when appropriate vascular access and closure techniques are used.