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CRT-500.09 Bioresorbable Vascular (ABSORB) Scaffold Versus Durable Polymer Everolimus Eluting Stent: A Meta-analysis
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CRT-500.09 Bioresorbable Vascular (ABSORB) Scaffold Versus Durable Polymer Everolimus Eluting Stent: A Meta-analysis
CRT-500.10 Ridaforolimus Eluting Stents with Customizable Diffusion Controlled Release Kinetics and Tissue Uptake
Mohammed Ahmed,1 Hafeez Ul-Hassan,1 Lubna Muneer,2 Saurav Chatterjee1 1 Icahn School of Medicine Mount Sinai St. Luke’s Roosevelt Hospital, New York, NY; 2Shadan Institute of Medical Sciences, Hyderabad, India
Abraham R. Tzafriri,1 Peter M. Markham,1 Alan W. LaRochelle,1 Anna-Maria Spognardi,1 Lynn Bailey,1 Ilana Cohen,2 Omar Elmalak,2 Yoram Richter,2 Elazer R. Edelman3 1 CBSET, Lexington, MA; 2Medinol, Tel Aviv, Israel; 3MIT, Cambridge, MA
BACKGROUND Current metallic stents safeguard vessel patency, but long term complications include in-stent thrombosis. Theoretically, bioresorbable scaffolding should reduce the risk of in-stent thrombosis while maintaining early vessel patency. DESIGN A meta-analysis of the available randomized control trials. METHODS Medline, Google Scholar, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) database were searched for randomized controlled trials comparing Absorb BVS with durable polymer EES. OUTCOMES Efficacy (Target Lesion Revascularization (TLR)), and safety (definite or probable stent thrombosis, one year mortality). RESULTS Five randomized controlled trials included 2259 patients of coronary artery disease treated with a BVS versus 1383 patients treated with EES. There was no significant difference in the incidence of TLR (Relative Risk (RR): 1.08, 95% Confidence Interval (CI): 0.74 1.58), definite/probable stent thrombosis (RR 2.00 95% CI: 0.93 - 4.30), 1 year mortality (RR: 1.79, 95% CI: 0.13 - 25.40). CONCLUSION BVS is non-inferior to EES with respect to TLR, stent thrombosis and death.
TECHNOLOGY
JACC: CARDIOVASCULAR INTERVENTIONS, VOL. 9, NO. 4, SUPPL S, 2016
BACKGROUND Drug release from spray coatings applied to cylindrical stents is difficult to customize due to intermixing of successively coated layers. METHODS AND RESULTS Flat sheets of electropolished L-605 Cobalt Chromium alloy were spray coated with a solution of Ridaforolimus and two polymers, folded and welded into cylinders (3.017mm) and sterilized. Ridaforolimus-eluting stents (RES; Medinol, Israel) were incubated in vitro (90d) or implanted (456d) in porcine coronary arteries (1 stent/artery, 1.1-1.3:1 B:A) and drug quantified by LC/MS/ MS. Ridaforolimus release from RES was computationally modeled as a diffusion process based on layer thicknesses and compositions, and coupled to published equations of tissue binding and diffusion to predict arterial tissue content. In vitro release of Ridaforolimus from 11 distinct RES formulations formed by single or multiple spray coat applications of the same composition spanned a dynamic range that was fully matched by the model with a composition-dependent diffusivity. The calibrated computational model accurately predicted in vitro drug release of the 3 multi-layer RES formulations, including the clinically relevant BioNIR formulation which incorporates a rate-lmiting polymer layer sandwitched between two drug loaded layers. Implanted BioNIR stents release 98.1% of the initial Ridaforlimus load within 180d, providing a near constant tissue content of drug (2.2 ng/mg) between 1-30d that slowly declined to trace levels by 456d as FKBP12 bound drug dissociated and diffused out of the artery wall. CONCLUSION Coating flat stationary metal sheets prior to rolling provided customizable diffusion-controlled Ridaforolimus delivery based on designed coating thicknesses and compositions.
CRT-500.11 Misclassification of Pulmonary Hypertension Due to Reliance on Pulmonary Capillary Wedge Pressure or Left Ventricular End-Diastolic Pressure Instead of Direct Mean Left Atrial Pressure Zaher Fanari,1 Kasaiah Makam,2 Mahmudul Haque,3 Sumaya Hammami,1 Andrew Doorey3 1 University of Kansas, Kansas City, KS; 2Christiana Care Health System, Newark, KS; 3Christiana Care Health System, Newark, DE BACKGROUND Pulmonary arterial hypertension (PAH) is typically distinguished from pulmonary venous hypertension (PVH) by documenting a pulmonary capillary wedge pressure (PCWP) < 15 mm Hg. However, PCWP has uncertain utility in establishing PAH. Other suggests using left ventricular end-diastolic pressure (LVEDP) instead. We aim to compare both parameters to the “gold standard” measurement of direct “mean left atrial pressure (m LAP)” obtained through transeptal access. METHODS We examined hemodynamic data from 25 patients with pulmonary hypertension undergoing simultaneous right-heart and left-heart catheterization with transeptal puncture to evaluate mean left atrial pressure.
CRT-500.09 Bioresorbable Vascular (ABSORB) Scaffold Versus Durable Polymer Everolimus Eluting Stent: A Meta-analysis
CRT-500.10 Ridaforolimus Eluting Stents with Customizable Diffusion Controlled Release Kinetics and Tissue Uptake
Mohammed Ahmed,1 Hafeez Ul-Hassan,1 Lubna Muneer,2 Saurav Chatterjee1 1 Icahn School of Medicine Mount Sinai St. Luke’s Roosevelt Hospital, New York, NY; 2Shadan Institute of Medical Sciences, Hyderabad, India
Abraham R. Tzafriri,1 Peter M. Markham,1 Alan W. LaRochelle,1 Anna-Maria Spognardi,1 Lynn Bailey,1 Ilana Cohen,2 Omar Elmalak,2 Yoram Richter,2 Elazer R. Edelman3 1 CBSET, Lexington, MA; 2Medinol, Tel Aviv, Israel; 3MIT, Cambridge, MA
BACKGROUND Current metallic stents safeguard vessel patency, but long term complications include in-stent thrombosis. Theoretically, bioresorbable scaffolding should reduce the risk of in-stent thrombosis while maintaining early vessel patency. DESIGN A meta-analysis of the available randomized control trials. METHODS Medline, Google Scholar, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) database were searched for randomized controlled trials comparing Absorb BVS with durable polymer EES. OUTCOMES Efficacy (Target Lesion Revascularization (TLR)), and safety (definite or probable stent thrombosis, one year mortality). RESULTS Five randomized controlled trials included 2259 patients of coronary artery disease treated with a BVS versus 1383 patients treated with EES. There was no significant difference in the incidence of TLR (Relative Risk (RR): 1.08, 95% Confidence Interval (CI): 0.74 1.58), definite/probable stent thrombosis (RR 2.00 95% CI: 0.93 - 4.30), 1 year mortality (RR: 1.79, 95% CI: 0.13 - 25.40). CONCLUSION BVS is non-inferior to EES with respect to TLR, stent thrombosis and death.
TECHNOLOGY
JACC: CARDIOVASCULAR INTERVENTIONS, VOL. 9, NO. 4, SUPPL S, 2016
BACKGROUND Drug release from spray coatings applied to cylindrical stents is difficult to customize due to intermixing of successively coated layers. METHODS AND RESULTS Flat sheets of electropolished L-605 Cobalt Chromium alloy were spray coated with a solution of Ridaforolimus and two polymers, folded and welded into cylinders (3.017mm) and sterilized. Ridaforolimus-eluting stents (RES; Medinol, Israel) were incubated in vitro (90d) or implanted (456d) in porcine coronary arteries (1 stent/artery, 1.1-1.3:1 B:A) and drug quantified by LC/MS/ MS. Ridaforolimus release from RES was computationally modeled as a diffusion process based on layer thicknesses and compositions, and coupled to published equations of tissue binding and diffusion to predict arterial tissue content. In vitro release of Ridaforolimus from 11 distinct RES formulations formed by single or multiple spray coat applications of the same composition spanned a dynamic range that was fully matched by the model with a composition-dependent diffusivity. The calibrated computational model accurately predicted in vitro drug release of the 3 multi-layer RES formulations, including the clinically relevant BioNIR formulation which incorporates a rate-lmiting polymer layer sandwitched between two drug loaded layers. Implanted BioNIR stents release 98.1% of the initial Ridaforlimus load within 180d, providing a near constant tissue content of drug (2.2 ng/mg) between 1-30d that slowly declined to trace levels by 456d as FKBP12 bound drug dissociated and diffused out of the artery wall. CONCLUSION Coating flat stationary metal sheets prior to rolling provided customizable diffusion-controlled Ridaforolimus delivery based on designed coating thicknesses and compositions.
CRT-500.11 Misclassification of Pulmonary Hypertension Due to Reliance on Pulmonary Capillary Wedge Pressure or Left Ventricular End-Diastolic Pressure Instead of Direct Mean Left Atrial Pressure Zaher Fanari,1 Kasaiah Makam,2 Mahmudul Haque,3 Sumaya Hammami,1 Andrew Doorey3 1 University of Kansas, Kansas City, KS; 2Christiana Care Health System, Newark, KS; 3Christiana Care Health System, Newark, DE BACKGROUND Pulmonary arterial hypertension (PAH) is typically distinguished from pulmonary venous hypertension (PVH) by documenting a pulmonary capillary wedge pressure (PCWP) < 15 mm Hg. However, PCWP has uncertain utility in establishing PAH. Other suggests using left ventricular end-diastolic pressure (LVEDP) instead. We aim to compare both parameters to the “gold standard” measurement of direct “mean left atrial pressure (m LAP)” obtained through transeptal access. METHODS We examined hemodynamic data from 25 patients with pulmonary hypertension undergoing simultaneous right-heart and left-heart catheterization with transeptal puncture to evaluate mean left atrial pressure.