Is there anybody willing to explain the issue (see my pervious blog).

GIVE ME A LESSON, PLEASE.

Thank you very much. ]]>

1/ The results in the BASKET-PROVE study did NOT reach statistical significance, therefore the differrences between DESs and BMS may have occurred by chance. (Statistics: A P<0.05 means that there is a less than 5% chance that the difference could have occurred by chance.) Both DES showed superior efficacy compared with BMS /it reads in pesentation slide-set/. Yet this superiority was not statistically significant. What is the real weight of evidence then?

2/ One of the commentators tries to calculate the number of TVRs with using bigger number of patients than the number studied. One cannot do this with having in mind that the result obtained int the BASKET-PROVE study is the statistical number and statistics is about probability. Therefore the result of simple multiplication is not exactly the number that would have beed reached with the bigger number of patients studied. Due to the lack of statistical significance, the result might differ either to small or great extent or reach statistical significance in the end.

A degree in physics and mathematics trumps an MBA.

]]>Thanks for pointing out the endpoint was MI plus death. So, as you point out as well the difference is mostly in the first week after implant. “No plausible reason” is a cause for concern. I think this study raises more issues than it answers. The major endpoint is still almost twice as high for BMS as for Sirolimu DES, 4.8% vs 2.6%. This is a huge difference even if it does not achieve statistical significance at the p=0.05 level, and it cannot be ignored. There is a large conceptual difference between saying something is not different and saying that the difference does not achieve statistical significance in a given study. There were fewer than 800 patients in each arm of the study.

In comparison, the GUSTO trial in the 1980’s, declared that the approx. 6.8% mortality in AMI treated with IV TPA was statistically significantly less than the approx 7.5% mortality with IV streptokinase. This led to the almost complete substitution in the US of TPA for SK. The reason the smaller percentage difference in the GUSTO trial was statistically significant and the larger percentage difference in this trial is not statistically significant is that the GUSTO trial had 44,000 patients in two treatment arms and this trial had only 2314 patients in three treatment arms.

PS. I see you have a degree in MBA. I have a degree in physics and mathematics.

]]>Actually, 2 yr total mortality for the stents was similar (sirolimus-eluting stent 3.6%, everolimus-eluting stent 3.2% and bare metal stent 4.4%: NS).

The clinical outcomes at 2 yrs in BASKET PROVE are …

Outcome |
Sirolimus-elutingstent (SES) |
Everolimus-elutingstent (EES) |
Bare-metal stent(BMS) |
BMS vs SES(P value) |
BMS vs EES( P value) |

Total death | 3.6% | 3.2% | 4.4% | 0.71 | 0.46 |

Cardiac death | 1.7% | 1.7% | 2.9% | 0.38 | 0.37 |

Nonfatal MI | 0.9% | 1.7% | 2.6% | 0.13 | 0.51 |

Cardiac death or nonfatal MI | 2.6% | 3.2% | 4.8%* | 0.13 | 0.37 |

While it’s possible that the study was underpowered to detect a clinical difference between the BMS and DES (as pointed out by Dr. Schneider), it is just as plausible that a larger study would have confirmed that there was no significant clinical difference between BMS and DES. Why is this? Previous studies comparing stents have not demonstrated a survival benefit of DES over BMS, even in “high risk patients” (i.e., those with small arteries, diabetes, and acute coronary syndromes). In addition, the graph showing the combined endpoint of cardiac death or MI (see below) shows that the “potential benefit” occurs in the first week of stent implantation. There’s no plausible reason for this, as previous studies have not shown a dramatically increased risk of early stent thrombosis with BMS, as compared to DES.

]]>It is consistent that the story of different stents(drug-eluting or bare-metal) stuck-up at repeated revascularization! Failed to provide meaningful benefit at ‘hard end points'(MI,Stroke,Cardiac death & All-cause mortality etc).Stents are for Angina relief nothing else!

At the end, high risk patient like diabetes,have two options.Either ‘stringent’ medical treatments(with ACEIs,B-blockers,Statins & Anti-platelet agents)plus vigorous lifestyle change(examples,regular 30-min brisk walking,maintain optimal body-weight,5 or more serving of fruits & green-leafy vegetables,whole grain cereals,fish or poultries,low-fat dairy products,limit salt intake, refined carbohydrate & trans-fatty acid etc.) Or CABG!!

I am very sorry for interventionist & tech-industry alike! ]]>

Bare metal stent 2 year mortality is 4.8%

So the difference is not statistically significant at the p=0.05 level. This DOES NOT MEAN there is no difference in mortality. It just means this study is underpowered to prove the significant difference. No way anyone would put a bare metal stent in me if I had a significant coronary stenosis and needed a 3 or 4 mm stent. The conclusion that this study indicates no difference is patently absurd on its face. Hopefully not too many patients will die because of this completely illogical conclusion.

If 100,000 patients with this type of disease get the bare metal stent instead of the sirolimus coated stent this study suggests that there is a high probability that 2,200 people will die unneccessarily over the course of two years.

**Competing interests pertaining specifically to this post, comment, or both:**

None.